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PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED — ATTORNEY WORK PRODUCT

CALDERWOOD & HARKNESS LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005

MEMORANDUM

April 24, 2025

TO:

Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd.

Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.

Dr. Aisling Burke, Chief Technology Officer, Solstice Biomedical Devices Ltd.

FROM:

Miriam Calloway, Responsible Partner, Healthcare & Life Sciences Practice Group, Calderwood & Harkness LLP

Amy Whitfield, Lead Associate, Healthcare & Life Sciences Practice Group, Calderwood & Harkness LLP

RE:

Freedom-to-Operate / Intellectual Property Risk Assessment Summary — Solstice Lumina™ CGM System — NovaSense Medical Technologies Inc. Patent Portfolio

Engagement Reference No.: 1037-00002

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I. Privileged Communication Notice

This Memorandum constitutes a privileged and confidential communication protected by the attorney-client privilege, the work product doctrine, and all other applicable privileges and protections. It has been prepared by Calderwood & Harkness LLP in anticipation of potential litigation and for the express purpose of rendering legal advice to the client. This Memorandum reflects the mental impressions, conclusions, opinions, and legal theories of attorneys at Calderwood & Harkness LLP.

This Memorandum has been prepared at the direction of Calderwood & Harkness LLP for the exclusive use of Solstice Biomedical Devices Ltd. ("SBD"), an Irish company, and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI"), a Delaware corporation (collectively, "Solstice" or the "Company"). It is intended solely for the use of the individuals identified in the header of this Memorandum and such other officers and employees of Solstice as may be authorized to receive it in accordance with the guidelines set forth in Section VIII below.

This Memorandum and its contents are not to be disclosed, disseminated, distributed, or otherwise made available to any third party without the prior written consent of Calderwood & Harkness LLP. Unauthorized disclosure may result in a waiver of the attorney-client privilege, the work product protection, or both, and could cause significant and irreparable harm to Solstice's legal interests.

The underlying freedom-to-operate analysis referenced in this Memorandum was prepared by Crestline IP Advisory LLC ("Crestline"), patent and FTO counsel retained by Solstice at the direction of Calderwood & Harkness LLP. Crestline's work product, including the Preliminary FTO Assessment Report dated April 10, 2025, was prepared under the supervision of Dr. Raymond Cho, Patent Attorney, Crestline IP Advisory LLC, 75 Federal Street, Suite 1800, Boston, MA 02110. Crestline's work product is also protected under the common-interest privilege and the work product doctrine, pursuant to the common-interest agreement executed between Calderwood & Harkness LLP and Crestline IP Advisory LLC on February 14, 2025. All communications between Calderwood & Harkness, Crestline, and Solstice regarding the subject matter of this Memorandum are protected by these privileges.

Any dissemination of this Memorandum or its contents within Solstice should be strictly limited to individuals who have a legitimate need to know for the purpose of obtaining or acting upon legal advice. In particular, distribution of this Memorandum or any substantive discussion of its contents with Pinnacle Regulatory Consulting Group LLC, Whitmore Laboratories, Veltrano CRO, Clearwater IRB, or any other non-legal consultants, vendors, or service providers should be discussed with Calderwood & Harkness before any such disclosure occurs, in order to preserve the applicable privileges. Please contact Miriam Calloway or Amy Whitfield at the contact information provided at the conclusion of this Memorandum before making any such disclosure.

II. Executive Summary

Calderwood & Harkness LLP has reviewed the Preliminary Freedom-to-Operate Assessment Report prepared by Crestline IP Advisory LLC (Dr. Raymond Cho, Patent Attorney), dated April 10, 2025 (the "Crestline Preliminary Report"), concerning the United States patent portfolio of NovaSense Medical Technologies Inc. ("NovaSense") as it relates to Solstice's Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "Lumina System"), comprising the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter. This Memorandum summarizes the key findings and risk assessments from the Crestline Preliminary Report and provides Calderwood & Harkness's legal analysis, recommendations, and guidance regarding next steps.

NovaSense Medical Technologies Inc. is a Delaware corporation (File No. 5429876) headquartered at 4800 Innovation Parkway, San Diego, California 92121. NovaSense reported fiscal year 2024 revenues of approximately $1.24 billion. NovaSense holds a portfolio of fourteen (14) United States utility patents directed to continuous glucose monitoring sensor electrode chemistry and signal processing algorithms. NovaSense's patent counsel of record is Marlowe Asset Management Patent Group LLP, specifically Patricia Langford, Partner, whose office is located at 2200 Wilson Boulevard, Suite 1100, Arlington, Virginia 22201. NovaSense is a significant participant in the CGM market and, as discussed further below, manufactures the devices that Solstice has identified as the primary and secondary predicate devices for its planned 510(k) submission.

Based on Crestline's preliminary analysis, three (3) NovaSense patents have been identified as most relevant to the Lumina CGM System. The remaining eleven (11) patents in the NovaSense portfolio were reviewed by Crestline and determined to be either expired, directed to unrelated technology (e.g., insulin delivery systems, non-CGM diagnostic platforms), or clearly non-overlapping with the Lumina System's technology. Those eleven patents are catalogued in the Crestline Preliminary Report but are not discussed in detail in this Memorandum.

The overall intellectual property risk associated with the NovaSense patent portfolio is characterized as low-to-moderate. The primary area of concern is U.S. Patent No. 10,847,221, titled "Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating," which relates to enzyme coating architecture for electrochemical glucose sensors. Solstice's proprietary PtIr-4G electrode coating technology employed in the C14 sensor shares certain structural similarities with the multi-layer coating architecture claimed in this patent, although important distinctions exist. The remaining two identified patents — U.S. Patent No. 11,234,567 (signal processing algorithm) and U.S. Patent No. 11,502,893 (wireless transmission protocol) — present low infringement risk based on Crestline's preliminary analysis.

No formal dispute, correspondence, demand, or litigation currently exists between Solstice (or any Solstice entity) and NovaSense relating to intellectual property or any other matter. NovaSense has not communicated with Solstice regarding its patent portfolio, nor is Calderwood & Harkness aware of any indication that NovaSense is presently aware of Solstice's planned U.S. market entry with the Lumina System.

Design-around efforts are currently underway by SBD's engineering team under the direction of Dr. Aisling Burke, CTO, targeting the identified overlap with U.S. Patent No. 10,847,221. Concurrently, Crestline is conducting a full claim-by-claim chart analysis of all three identified patents against both the current Lumina design and the proposed alternative electrode deposition process. This detailed claim chart analysis remains in progress as of the date of this Memorandum, with an expected completion date in early June 2025. Calderwood & Harkness will issue a supplemental risk assessment memorandum upon receipt and review of Crestline's final analysis.

For reference, Crestline IP Advisory LLC was retained by Solstice in February 2025, and the FTO analysis engagement fee is $215,000 per the engagement letter between Crestline and Solstice dated February 10, 2025.

III. Background and Context

A. The Solstice Lumina™ CGM System

The Solstice Lumina™ CGM System is a two-component continuous glucose monitoring system intended for the United States market. Solstice plans to seek marketing authorization via the traditional 510(k) premarket notification pathway, with the submission covering both the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter as an integrated system.

Lumina C14 Implantable Sensor. The Lumina C14 is a subcutaneously implantable continuous glucose monitoring sensor designed for a fourteen (14)-day wear duration. The C14 utilizes Solstice's proprietary fourth-generation enzymatic electrochemical biosensor technology featuring a platinum-iridium electrode coating designated "PtIr-4G." The PtIr-4G technology represents the core innovation of the Lumina System's sensing platform and incorporates a multi-layer enzymatic coating deposited onto a platinum-iridium (PtIr) electrode substrate. The C14 sensor communicates wirelessly with the R7 reader/transmitter via Bluetooth Low Energy (BLE) 5.2 protocol. The intended use population is persons aged eighteen (18) years and older diagnosed with Type 1 or Type 2 diabetes mellitus. The C14 sensor has a glucose measurement range of 40–400 mg/dL and a warm-up time of sixty (60) minutes or less following subcutaneous insertion.

Lumina R7 Wearable Reader/Transmitter. The Lumina R7 is an arm-worn wearable device that receives continuous glucose data from the C14 sensor via BLE 5.2. The R7 provides a real-time glucose display, trend arrows indicating the direction and rate of glucose change, and eight (8)-hour trend graphs. The R7 includes configurable hypoglycemia and hyperglycemia alerts with an alert latency of five (5) minutes or less. The R7 also communicates with the Lumina mobile application, which is available on both iOS and Android platforms, to provide extended data visualization, data sharing, and remote monitoring capabilities.

Software Components. The Lumina System incorporates the following software components: Lumina Firmware v3.4.2 (embedded firmware for the C14 sensor); Lumina Reader OS v2.1.0 (operating system for the R7 reader/transmitter); LuminaPredict Algorithm v2.1 (proprietary glucose prediction and signal processing algorithm); and Lumina Mobile App v1.0.3 (companion mobile application for iOS and Android devices).

Existing Regulatory Status. The Lumina CGM System has been commercially available in the European Union since September 2024. The system received CE marking under the European Union Medical Devices Regulation (EU MDR 2017/745), with CE Certificate No. MCA-2024-07319 issued on September 12, 2024, by Meridian Conformity Assessment GmbH, Notified Body No. 0483. No existing FDA clearance or approval has been obtained for the Lumina System in the United States. Solstice previously obtained 510(k) clearance from FDA for the GlucoStrip RX-200 Test Strip Reader (510(k) No. K192847, cleared November 14, 2019), which is a self-monitoring blood glucose test strip reader representing a significantly different technology platform from the Lumina CGM System. The Lumina System represents a substantial technology evolution from the GlucoStrip RX-200 and is not suitable as a predicate for the Lumina 510(k) submission.

B. NovaSense as Predicate Device Manufacturer

NovaSense Medical Technologies Inc. is the manufacturer of the devices that Solstice has identified as the primary and secondary predicate devices for its planned 510(k) submission for the Lumina CGM System. This relationship between Solstice's planned regulatory pathway and NovaSense's product portfolio merits particular attention in the context of the FTO analysis.

Primary Predicate Device. The primary predicate device identified for the Lumina 510(k) submission is the NovaSense GlucoTrack NX-500 CGM System, which received 510(k) clearance under 510(k) No. K211034 on June 18, 2022. The NX-500 is classified under product code QKQ and is a Class II device. The NX-500 features a ten (10)-day enzymatic electrochemical sensor with BLE wireless data transmission to an external reader/display device.

Secondary Predicate / Reference Device. The secondary predicate and reference device identified for the Lumina submission is the NovaSense GlucoTrack NX-700 CGM System, which received 510(k) clearance under 510(k) No. K230489 on March 7, 2024. The NX-700 is also classified under product code QKQ as a Class II device. The NX-700 features a fourteen (14)-day sensor wear duration (matching the Lumina C14's intended wear duration), enhanced BLE 5.0 wireless communication, and an updated glucose prediction algorithm. The NX-700 represents NovaSense's most recent cleared CGM platform and is technologically closer to the Lumina System than the NX-500.

Significance of the Predicate Relationship. The use of NovaSense devices as predicates for Solstice's substantial equivalence argument heightens the importance of understanding NovaSense's patent portfolio and the intellectual property risks associated with Solstice's market entry. While predicate device selection for 510(k) purposes is an independent regulatory determination and does not implicate patent rights — FDA's clearance of a device as substantially equivalent to a predicate does not confer any patent license — the practical reality is that the commercial launch of a device found to infringe NovaSense patents could result in enforcement action by NovaSense regardless of whether Solstice obtains FDA clearance. NovaSense would have standing to seek injunctive relief, damages, or both under 35 U.S.C. § 271 in the event of patent infringement, irrespective of the device's regulatory status. Furthermore, the predicate device relationship means that NovaSense will likely become aware of the Lumina System's existence and its technological similarities to NovaSense's products upon FDA's public posting of any 510(k) clearance decision summary, if not sooner.

C. Scope of the Crestline FTO Analysis

Crestline IP Advisory LLC was engaged by Solstice in February 2025, at the direction of Calderwood & Harkness LLP, to conduct a comprehensive freedom-to-operate analysis regarding NovaSense's fourteen (14) United States utility patents related to CGM sensor electrode chemistry and signal processing algorithms. The scope of the Crestline engagement encompasses: (i) identification and review of all relevant NovaSense U.S. patents; (ii) comparison of the claims of each identified patent against the technical features of the Lumina CGM System; (iii) assessment of infringement risk under the doctrines of literal infringement and infringement under the doctrine of equivalents; (iv) identification of potential design-around strategies; and (v) evaluation of potential invalidity arguments, including prior art analysis.

The Preliminary FTO Assessment Report was delivered by Crestline on April 10, 2025. This Memorandum is based on the findings and conclusions set forth in that preliminary report. A full claim-by-claim chart analysis is currently ongoing, covering the Lumina C14 sensor technology (including electrode chemistry, enzyme coating architecture, and wireless transmission capabilities) and the Lumina R7 reader/transmitter (including signal processing algorithms and wireless protocol implementation). The full claim chart analysis will encompass both the current Lumina design and the proposed alternative electrode deposition process that is being developed as part of the design-around effort described in Section VI below.

IV. Identification of Relevant NovaSense Patents

Of the fourteen (14) U.S. utility patents in the NovaSense portfolio reviewed by Crestline, three (3) have been identified as having potential relevance to the Lumina CGM System. Each of these patents is discussed in detail below, together with Crestline's preliminary risk assessment and Calderwood & Harkness's analysis.

A. U.S. Patent No. 10,847,221 — "Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating"

Patent Information:

Subject Matter and Claim Scope. U.S. Patent No. 10,847,221 (the "'221 Patent") is directed to a multi-layer enzyme coating architecture for electrochemical glucose sensors used in continuous glucose monitoring applications. The claims cover specific layer compositions, deposition methods, and electrode configurations designed to enhance sensor accuracy, stability, and longevity over multi-day wear periods. The '221 Patent contains four (4) independent claims and eighteen (18) dependent claims. The independent claims are generally directed to: (i) an electrochemical glucose sensor comprising a working electrode with a multi-layer enzyme coating having at least three distinct functional layers (Claim 1); (ii) a method of manufacturing an electrochemical glucose sensor comprising depositing a multi-layer enzyme coating onto a working electrode (Claim 8); (iii) a continuous glucose monitoring system comprising a sensor having a multi-layer enzyme coating architecture with specified layer thickness ratios (Claim 14); and (iv) a method of monitoring glucose in a patient using a subcutaneously implanted sensor having a multi-layer enzyme coating (Claim 19). The claims recite specific structural features including layer ordering, composition ranges, and relationships between layer thicknesses that are relevant to the Lumina C14 sensor's PtIr-4G technology.

Relevance to the Lumina C14 Sensor. The PtIr-4G electrode coating technology employed in the Lumina C14 sensor utilizes a multi-layer enzyme coating architecture deposited onto a platinum-iridium (PtIr) electrode substrate. The NovaSense '221 Patent specification describes a platinum base electrode throughout its detailed description and examples, and the claims generally recite a "working electrode" without specifying the electrode substrate material. The Lumina C14's PtIr-4G technology is differentiated from NovaSense's disclosed embodiment by its platinum-iridium composition (as opposed to a pure platinum electrode) and by Solstice's proprietary electrodeposition process. However, the multi-layer enzyme coating structure used in the Lumina C14 sensor shares certain structural similarities with the multi-layer coating approach claimed in the '221 Patent, including the use of multiple distinct functional layers performing analogous roles (e.g., enzyme immobilization layer, interference rejection layer, biocompatibility membrane layer).

Risk Assessment: Low-to-Moderate.

Crestline's preliminary assessment concludes that the '221 Patent presents a low-to-moderate risk of infringement. While the PtIr-4G technology is differentiated by several important features, certain structural aspects of the multi-layer coating architecture overlap with claim elements of the '221 Patent. The key factors informing this assessment are as follows:

Distinguishing Features (Favoring Non-Infringement):

• Electrode Substrate Composition. Solstice uses a platinum-iridium (PtIr) alloy electrode substrate, whereas NovaSense's specification consistently describes and exemplifies a pure platinum electrode. Although certain independent claims recite only a "working electrode" without specifying the substrate material, the prosecution history and specification may support a narrower construction.

• Enzyme Layer Ordering and Composition. The ordering of the functional layers in the PtIr-4G coating differs from the specific layer ordering described in NovaSense's specification and recited in certain dependent claims. Additionally, the specific enzyme formulations and concentrations used in Solstice's coating differ from those disclosed by NovaSense.

• Layer Thickness Parameters. The thickness parameters of the individual layers in the PtIr-4G coating differ from the thickness ranges and ratios recited in certain claims of the '221 Patent.

• Proprietary Deposition Process. Solstice's electrodeposition process for the PtIr-4G coating employs a different methodology from the deposition methods described in the '221 Patent specification, which may be relevant to the method claims.

Areas of Concern (Favoring Potential Infringement):

• Broad Independent Claim Language. Certain independent claims of the '221 Patent, particularly Claim 1, use relatively broad language to describe the multi-layer enzyme coating architecture. Depending on the construction given to claim terms such as "multi-layer enzyme coating," "distinct functional layers," and "working electrode," these claims may be broad enough to encompass the PtIr-4G variation.

• Structural Similarities. The high-level structural approach of using multiple distinct functional layers deposited onto a working electrode for the purpose of continuous glucose monitoring is shared between the Lumina C14 design and the '221 Patent claims.

• Doctrine of Equivalents. Even if literal infringement is avoided, certain claim elements may be met under the doctrine of equivalents if the PtIr-4G coating is found to perform substantially the same function, in substantially the same way, to achieve substantially the same result as the corresponding limitations in the '221 Patent claims.

The '221 Patent presents the highest relative risk among the three NovaSense patents assessed and is the focus of the design-around effort described in Section VI below. The ongoing detailed claim chart analysis by Crestline will provide a more definitive assessment of infringement risk, including a thorough analysis of the prosecution history and relevant prior art that may inform claim construction and potential invalidity arguments.

B. U.S. Patent No. 11,234,567 — "Signal Processing Algorithm for Continuous Analyte Monitoring"

Patent Information:

Subject Matter and Claim Scope. U.S. Patent No. 11,234,567 (the "'567 Patent") is directed to a signal processing algorithm for filtering, calibrating, and predicting analyte concentrations in continuous monitoring systems. The claims recite specific algorithmic steps, including particular mathematical transformations (e.g., specific Kalman filter implementations, wavelet decomposition techniques), calibration sequences (e.g., multi-point retrospective calibration using capillary blood glucose reference values), and predictive modeling methodologies. The '567 Patent contains three (3) independent claims and twelve (12) dependent claims, generally directed to: (i) a method of processing a continuous analyte signal using a series of defined computational steps; (ii) a non-transitory computer-readable medium storing instructions for executing the defined signal processing methodology; and (iii) a continuous analyte monitoring system comprising a processor configured to execute the defined signal processing algorithm.

Relevance to the Lumina System. Solstice's LuminaPredict Algorithm v2.1 performs analogous high-level functions to the algorithm described in the '567 Patent, including glucose signal processing, noise filtering, calibration, and glucose concentration prediction. Both algorithms operate within continuous glucose monitoring systems and produce predictive glucose values for display to the user. However, the LuminaPredict Algorithm v2.1 employs a fundamentally different computational methodology from the specific algorithmic steps recited in the '567 Patent claims.

Risk Assessment: Low.

Crestline's preliminary assessment concludes that the '567 Patent presents a low risk of infringement. The claims of the '567 Patent are narrowly drafted around NovaSense's specific algorithmic implementation, including particular mathematical transformations, specific calibration sequences, and defined computational steps that differ materially from the methodology employed by LuminaPredict v2.1. Key factors supporting this assessment include:

• The LuminaPredict v2.1 algorithm uses a fundamentally different computational approach from the specific algorithmic steps recited in the '567 Patent claims, including different filtering methodologies, different calibration techniques, and a different predictive modeling framework.

• The overlap between Solstice's algorithm and the '567 Patent claims is limited to the high-level functional objective of glucose prediction and signal processing — functions that are inherently performed by all CGM signal processing algorithms and are not, in themselves, patentable subject matter.

• The claims of the '567 Patent recite specific mathematical transformations and defined sequences of computational steps that are not present in the LuminaPredict v2.1 implementation, supporting a finding of non-infringement under both literal infringement and doctrine of equivalents analyses.

• Crestline's preliminary review of the dependent claims confirms the low risk assessment, as the dependent claims further narrow the scope to NovaSense-specific implementation details.

A full analysis of all independent and dependent claims against the LuminaPredict v2.1 algorithm is underway as part of Crestline's final claim chart analysis. Based on the preliminary assessment, however, Calderwood & Harkness does not consider the '567 Patent to present a material infringement risk.

C. U.S. Patent No. 11,502,893 — "Wireless Transmission Protocol for Implantable Biosensors"

Patent Information:

Subject Matter and Claim Scope. U.S. Patent No. 11,502,893 (the "'893 Patent") is directed to a wireless data transmission protocol specifically designed for implantable biosensor applications. The claims recite a proprietary protocol layer including specific features related to power management, data packet structure, error correction methods, and timing sequences for data transmission between an implantable biosensor and an external reader device. The '893 Patent contains three (3) independent claims and fourteen (14) dependent claims, generally directed to: (i) a method of transmitting data from an implantable biosensor to an external device using a defined protocol with specified packet structure and error correction; (ii) an implantable biosensor system comprising a sensor and external reader configured to communicate using the defined protocol; and (iii) a non-transitory computer-readable medium storing instructions for implementing the defined wireless transmission protocol.

Relevance to the Lumina System. Both the Lumina C14 sensor and the Lumina R7 reader/transmitter use Bluetooth Low Energy (BLE) 5.2 for wireless data communication. NovaSense's '893 Patent claims a specific proprietary protocol layer built on top of BLE technology. The question of relevance turns on whether Solstice's BLE 5.2 implementation falls within the scope of NovaSense's protocol claims.

Risk Assessment: Low.

Crestline's preliminary assessment concludes that the '893 Patent presents a low risk of infringement. The key factors supporting this assessment are as follows:

• The claims of the '893 Patent are directed to a proprietary protocol layer that is specific to NovaSense's implementation, including defined data packet structures, specific error correction algorithms, and particular power management sequences that are distinct from standard BLE protocol features.

• Solstice's BLE 5.2 implementation uses standard Bluetooth Special Interest Group (SIG) specifications for the underlying wireless communication stack. Solstice has developed its own application-layer protocol for data transmission between the C14 sensor and R7 reader, which differs from the NovaSense-specific protocol claimed in the '893 Patent.

• The distinction between Solstice's BLE 5.2 stack and NovaSense's BLE 5.0-based custom protocol further supports non-infringement, as the underlying wireless technology generations differ and the protocol implementations built on top of those respective standards are technically distinct.

• Crestline's preliminary review of both the independent and dependent claims confirms this assessment. The dependent claims further narrow the scope to NovaSense-specific protocol features — including specific timing parameters, packet sizes, and error correction methodologies — that are not employed by Solstice's implementation.

Based on the preliminary assessment, Calderwood & Harkness does not consider the '893 Patent to present a material infringement risk. The full claim chart analysis by Crestline will provide additional confirmation.

V. Overall Risk Characterization and Summary Table

The following table summarizes the risk assessment for each of the three NovaSense patents identified as relevant to the Solstice Lumina CGM System:

Overall Portfolio Risk Assessment: Low-to-Moderate. The aggregate intellectual property risk associated with the NovaSense patent portfolio, as it relates to the Lumina CGM System, is assessed as low-to-moderate. This risk is concentrated primarily in U.S. Patent No. 10,847,221 and its claims directed to multi-layer enzyme coating architecture. The remaining two identified patents present low risk based on the preliminary analysis.

Remaining NovaSense Patents. The remaining eleven (11) NovaSense patents (of the fourteen (14) total patents in the reviewed portfolio) were examined by Crestline and determined to present no material risk to the Lumina CGM System. These patents were classified as follows: three (3) patents are expired; four (4) patents are directed to technology unrelated to continuous glucose monitoring sensors (including insulin pump delivery systems, non-enzymatic diagnostic assays, and data management software platforms); and four (4) patents, while directed to CGM-related technology, contain claims that are clearly non-overlapping with the Lumina System's technical features based on claim scope analysis. These eleven patents are not discussed in detail in this Memorandum but are catalogued and individually assessed in Crestline's Preliminary FTO Assessment Report, which is maintained as a privileged document by Calderwood & Harkness.

VI. Design-Around Efforts and Mitigation Strategy

A. Engineering Design-Around for U.S. Patent No. 10,847,221

In light of the low-to-moderate risk assessment associated with U.S. Patent No. 10,847,221, SBD's engineering team, under the direction of Dr. Aisling Burke, Chief Technology Officer, has initiated development of an alternative electrode deposition process designed to reduce or eliminate the identified overlap between the Lumina C14's PtIr-4G technology and the claims of the '221 Patent.

The alternative process modifies the multi-layer coating sequence and composition to create greater differentiation from the NovaSense patent claims. Specifically, the engineering team has identified modifications to the layer ordering, the composition of certain functional layers, and the deposition parameters that are intended to move the Lumina C14 design further from the claim scope of the '221 Patent while preserving or improving the sensor's analytical performance characteristics.

Crestline IP Advisory LLC is reviewing the revised design as of April 22, 2025, to assess whether the proposed modifications sufficiently address the identified claim overlap. This review will include a comparison of the revised design against each relevant claim of the '221 Patent (independent and dependent claims), an assessment of infringement risk under both literal infringement and doctrine of equivalents theories, and an evaluation of whether the modifications create any new potential overlap with other patents in the NovaSense portfolio or with patents held by other third parties.

Timeline for Design-Around Assessment. Crestline expects to complete its review of the revised design within four (4) to six (6) weeks from the date of its receipt of the technical documentation, with a target completion date of early June 2025. The engineering team is working to finalize technical documentation for the alternative process and provide it to Crestline as expeditiously as possible.

Impact on Device Performance and Regulatory Submission. Any design modifications to the electrode coating architecture must be carefully evaluated for their impact on several critical parameters:

• Analytical Performance. The Lumina C14 sensor is designed to achieve a Mean Absolute Relative Difference (MARD) target of ≤ 9.0%. Any modification to the electrode coating must maintain or improve this performance level. Pre-clinical and clinical performance data generated with the modified design may be required to support the 510(k) submission.

• Biocompatibility. Modifications to the electrode coating composition may trigger the need for updated biocompatibility testing in accordance with ISO 10993 standards. This testing is being conducted by Whitmore Laboratories (engagement start date: March 3, 2025; A2LA Accreditation Certificate No. 3847.01; Dr. James Haverford, Director of Biocompatibility Testing). Coordination with Whitmore will be necessary to determine whether additional testing is required for the modified design.

• Regulatory Submission. The Pre-Submission (Pre-Sub) meeting package and the subsequent 510(k) submission must accurately describe the commercial embodiment of the Lumina C14 sensor, including its electrode coating architecture. If design modifications are adopted, the device description in these regulatory submissions must reflect the modified design.

B. Ongoing Crestline Analysis — Full Claim Chart

Crestline is conducting a detailed claim-by-claim chart analysis for all three identified NovaSense patents against both the current Lumina C14 and R7 designs and the proposed alternative electrode deposition process. The claim chart analysis will map each claim element of each relevant patent claim to the corresponding technical feature of the Lumina System (or the proposed revised design), providing a systematic and detailed assessment of infringement risk.

The expected completion date for the full claim chart analysis is approximately eight (8) weeks from the date of the Crestline Preliminary Report (April 10, 2025), which corresponds to a target completion date of early June 2025. This timeline is consistent with the design-around assessment timeline described above.

Upon receipt of the final Crestline analysis, Calderwood & Harkness will review the claim charts and underlying analysis, provide an updated legal risk assessment, and issue a supplemental memorandum to Solstice with revised recommendations and guidance as appropriate.

C. Additional Mitigation Options

In addition to the design-around effort and the ongoing claim chart analysis, Calderwood & Harkness recommends that Solstice consider the following additional mitigation strategies:

1. Patent Prosecution Monitoring. Calderwood & Harkness recommends establishing a patent watch service to monitor NovaSense's ongoing patent prosecution activity, including any continuation applications, continuation-in-part applications, divisional applications, or reissue proceedings filed by NovaSense at the United States Patent and Trademark Office. This monitoring will provide early warning of any new patent claims that may be relevant to the Lumina System and will allow Solstice to assess the evolving scope of NovaSense's intellectual property rights in real time. Additionally, monitoring should extend to new patent applications filed by NovaSense or its inventors in the CGM sensor space, which could signal the direction of NovaSense's ongoing research and development and the potential for future intellectual property conflicts.

2. Potential Inter Partes Review (IPR). If the claim scope of U.S. Patent No. 10,847,221 cannot be adequately designed around and the full claim chart analysis confirms a meaningful infringement risk, Solstice should consider filing a petition for inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB) challenging the validity of the relevant claims of the '221 Patent. An IPR petition would need to be supported by prior art references establishing that the challenged claims are unpatentable as anticipated or obvious under 35 U.S.C. §§ 102 and 103. Crestline has identified several potentially relevant prior art references in its preliminary analysis, but a full prior art assessment and patentability analysis should be conducted before any IPR strategy is finalized. This assessment should be undertaken after completion of the final claim chart analysis, at which point the specific claims of concern and the relevant prior art can be evaluated in detail.

3. Licensing Negotiations. Potential licensing negotiations with NovaSense are not recommended at this stage. Premature outreach to NovaSense regarding licensing could alert NovaSense to Solstice's planned U.S. market entry with the Lumina CGM System and the predicate device relationship, potentially prompting NovaSense to take preemptive action, including enforcement of its patent rights or modification of its competitive strategy. Licensing discussions, if appropriate, should be deferred until: (a) the full FTO analysis is complete and the scope of any infringement risk is clearly defined; (b) the design-around effort has been evaluated; and (c) Solstice's strategic position, including its regulatory timeline and market entry plans, is more fully established. Calderwood & Harkness will advise on the timing and approach for any licensing discussions, if warranted, following completion of the full analysis.

4. Insurance Coverage Review. Solstice's current product liability insurance policy, underwritten by Atlas Underwriting Partners Ltd. (Policy No. AUP-PL-2024-00893; limits of $25 million per occurrence / $50 million aggregate; policy period October 1, 2024 through September 30, 2025), does not cover patent infringement claims, demands, or litigation costs. Patent infringement is expressly excluded under the standard commercial general liability and product liability policy forms. Accordingly, Solstice should consider obtaining separate intellectual property indemnity insurance or IP litigation cost insurance as a supplement to the existing Atlas policy. Such coverage can provide reimbursement for defense costs and, in some policies, indemnity for damages arising from patent infringement claims. Calderwood & Harkness can provide referrals to insurance brokers with experience in IP insurance products for the medical device industry.

VII. Implications for Regulatory Strategy

The FTO analysis and the intellectual property risk assessment summarized in this Memorandum do not affect the regulatory pathway or predicate device selection for the Lumina CGM System's 510(k) submission. FDA clearance under the 510(k) pathway is a determination of substantial equivalence to a legally marketed predicate device and is independent of patent rights. FDA does not consider patent ownership or infringement in rendering its clearance decisions, and a 510(k) clearance does not constitute a license under any third-party patent. Accordingly, the selection of the NovaSense GlucoTrack NX-500 and NX-700 as predicate devices remains appropriate from a regulatory perspective irrespective of the FTO analysis outcomes.

However, the FTO analysis has practical implications for the regulatory timeline and submission strategy that must be carefully managed:

Pre-Sub Meeting Package Alignment. Any design-around modifications to the PtIr-4G electrode coating must be finalized before the Pre-Submission (Pre-Sub) meeting package is submitted to FDA, to ensure that the device description presented to the Center for Devices and Radiological Health (CDRH) accurately reflects the commercial embodiment of the Lumina C14 sensor. The current target date for Pre-Sub package submission is June 16, 2025, for a Pre-Sub meeting with CDRH, Office of Health Technology 2 (OHT2), Division of Chemistry and Toxicology Devices, targeted for August 14, 2025. If the design-around modifications are not finalized by the Pre-Sub submission date, Solstice will face a choice between: (a) submitting the Pre-Sub package based on the current PtIr-4G design with the understanding that a subsequent design modification may require a revised device description; or (b) delaying the Pre-Sub submission to allow the design-around assessment to be completed. Calderwood & Harkness recommends close coordination between the engineering, regulatory, and legal teams on this timing issue.

Biocompatibility Testing. If the design modifications alter the electrode chemistry or coating composition of the Lumina C14 sensor, updated biocompatibility testing under ISO 10993 may be required to support the 510(k) submission. This determination will require input from Whitmore Laboratories (Dr. James Haverford, Director of Biocompatibility Testing; engagement commenced March 3, 2025; A2LA Accreditation Certificate No. 3847.01) regarding the scope and nature of any additional testing that may be needed. Coordination with Pinnacle Regulatory Consulting Group LLC (Dr. Sandra Ellison and Thomas Greenbaum; engagement commenced January 15, 2025) will also be necessary to assess the impact of any design modifications on the overall regulatory submission strategy, including the biocompatibility and performance testing sections of the 510(k).

Regulatory Timeline. The current regulatory timeline for the Lumina CGM System is as follows: Pre-Sub meeting package submission target of June 16, 2025; Pre-Sub meeting target of August 14, 2025; 510(k) submission target of April 30, 2026; anticipated FDA clearance target of Q3 2026; and planned commercial launch target of Q4 2026. Based on current critical path analysis, the FTO workstream is not on the critical path of the regulatory timeline, provided that the design-around review by Crestline is completed by early June 2025 and any resulting design modifications can be incorporated into the Pre-Sub package without delay. Calderwood & Harkness will monitor the FTO workstream closely and will advise Solstice promptly if any developments suggest a potential impact on the regulatory timeline.

VIII. Privilege and Confidentiality Considerations

Calderwood & Harkness reiterates and emphasizes the following privilege and confidentiality considerations in connection with the FTO analysis and this Memorandum:

Attorney-Client Privilege and Work Product Protection. All communications between Calderwood & Harkness LLP, Crestline IP Advisory LLC, and Solstice (including SBD and SBI) relating to the FTO analysis, the NovaSense patent portfolio, and the intellectual property risk assessment for the Lumina CGM System are protected by the attorney-client privilege and the work product doctrine. These protections extend to this Memorandum, the Crestline Preliminary FTO Assessment Report, all claim charts and analyses prepared by Crestline, and all related correspondence, notes, and work papers.

Common-Interest Agreement. A common-interest agreement has been executed between Calderwood & Harkness LLP and Crestline IP Advisory LLC, dated February 14, 2025, establishing the framework for sharing privileged information and work product between the two firms for the common purpose of providing legal advice to Solstice. Crestline's work product was prepared at the direction of counsel (Calderwood & Harkness) for the purpose of rendering legal advice to the client (Solstice), and is protected under both the common-interest privilege and the work product doctrine.

Restrictions on Third-Party Dissemination. Solstice should not disseminate the FTO findings, analysis, risk assessments, or recommendations contained in this Memorandum (or in any other privileged communications relating to the FTO analysis) to third parties without first consulting with Calderwood & Harkness. This restriction applies to, among others:

• Pinnacle Regulatory Consulting Group LLC (Dr. Sandra Ellison, Thomas Greenbaum)

• Whitmore Laboratories (Dr. James Haverford)

• Veltrano CRO

• Clearwater IRB

• Any other non-legal consultants, vendors, contractors, or service providers

Disclosure of privileged information to non-legal third parties outside the attorney-client relationship risks waiver of the privilege. In certain circumstances, it may be possible to share limited, non-privileged information with regulatory or technical consultants on a need-to-know basis without waiving the privilege, but such disclosure should be carefully considered and coordinated with Calderwood & Harkness in advance.

Coordination with Irish Counsel. If Solstice wishes to share any portion of the FTO analysis with its Irish counsel, Hargrove & Endicott LLP (Ciara Brennan, Partner; 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland), for purposes of coordinating EU MDR compliance, global IP strategy, or other cross-border legal matters, this should be done under an explicit common-interest or joint-defense agreement between Calderwood & Harkness LLP and Hargrove & Endicott LLP. Calderwood & Harkness can prepare the necessary agreement for execution by both firms. Until such an agreement is in place, FTO-related materials should not be shared with Hargrove & Endicott.

Internal Distribution. Internal distribution of this Memorandum and related FTO materials within Solstice should be limited to the following individuals, all on a strictly need-to-know basis for purposes of obtaining or acting upon legal advice:

• Dr. Eoin Gallagher, Chief Executive Officer, Solstice Biomedical Devices Ltd.

• Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd.

• Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.

• Dr. Aisling Burke, Chief Technology Officer, Solstice Biomedical Devices Ltd.

• Fiona Drennan, Director of Quality Assurance, Solstice Biomedical Devices Ltd.

Any requests to expand the internal distribution list should be directed to Calderwood & Harkness for approval.

IX. Recommended Next Steps and Action Items

Based on the analysis and findings summarized in this Memorandum, Calderwood & Harkness recommends the following next steps and action items:

1. Crestline Final Claim Chart Review. Solstice should await Crestline's final claim-by-claim chart analysis, which is expected to be completed in early June 2025. The final analysis will cover all three identified NovaSense patents (U.S. Patent Nos. 10,847,221; 11,234,567; and 11,502,893) against both the current Lumina C14 and R7 designs and the proposed alternative electrode deposition process. The Crestline FTO analysis engagement fee is $215,000, as established in the Crestline engagement letter dated February 10, 2025. Calderwood & Harkness will review the final analysis upon receipt and prepare a supplemental risk assessment memorandum for Solstice.

2. Engineering Design-Around Confirmation. Dr. Aisling Burke and the SBD engineering team should finalize the alternative electrode deposition process as expeditiously as possible and provide complete technical documentation to Crestline for review. The technical documentation should include detailed descriptions of the revised layer compositions, deposition parameters, layer ordering, and thickness specifications, as well as any performance data generated with the revised design. Timeliness is critical, as the design-around assessment must be completed in advance of the Pre-Sub package submission target date.

3. Impact Assessment on Regulatory Submission. If design-around modifications are adopted, Solstice should coordinate with Pinnacle Regulatory Consulting Group LLC (Dr. Sandra Ellison, Thomas Greenbaum) and Whitmore Laboratories (Dr. James Haverford) to assess the impact of the modifications on the Pre-Sub device description, biocompatibility testing scope, and performance testing requirements. This assessment should be initiated promptly upon a determination that the design modifications will be incorporated into the commercial design. Any disclosure of the reasons for the design modification (i.e., the FTO analysis) to Pinnacle or Whitmore should be discussed with Calderwood & Harkness in advance to preserve privilege.

4. Pre-Sub Package Alignment. Solstice should ensure that the device description in the Pre-Sub meeting package accurately reflects the final commercial design of the Lumina C14 sensor, incorporating any design-around modifications that are adopted. The target submission date for the Pre-Sub meeting package is June 16, 2025, for a Pre-Sub meeting with CDRH, OHT2, Division of Chemistry and Toxicology Devices, currently targeted for August 14, 2025. Close coordination among the engineering, regulatory, and legal teams will be essential to meet this timeline.

5. Patent Watch. Calderwood & Harkness recommends establishing a patent prosecution monitoring service to track NovaSense's patent activity at the U.S. Patent and Trademark Office, including continuation applications, reissue proceedings, and new patent filings in the CGM sensor space. This monitoring should be established as soon as practicable. Crestline or an alternative patent watch service provider can be engaged for this purpose; Calderwood & Harkness will coordinate the engagement.

6. IP Insurance Evaluation. Solstice should evaluate the availability and cost of intellectual property litigation cost insurance or IP indemnity coverage as a supplement to the existing Atlas Underwriting Partners Ltd. product liability policy (Policy No. AUP-PL-2024-00893). Calderwood & Harkness can provide referrals to insurance brokers experienced in IP insurance for medical device companies. This evaluation should be undertaken in parallel with the ongoing FTO analysis and need not await the final Crestline report.

7. Updated Risk Assessment. Calderwood & Harkness will issue an updated FTO risk assessment memorandum upon receipt and review of Crestline's final claim chart analysis. The updated memorandum will provide revised risk assessments for each identified patent, an evaluation of the effectiveness of the design-around modifications, and updated recommendations regarding mitigation strategies, including potential IPR petitions and the timing of any licensing discussions.

X. Conclusion

Based on the Preliminary FTO Assessment Report prepared by Crestline IP Advisory LLC and Calderwood & Harkness's review and analysis of that report, the overall intellectual property risk associated with the NovaSense Medical Technologies Inc. patent portfolio, as it relates to the Solstice Lumina™ CGM System, is assessed as low-to-moderate.

The primary area of concern is U.S. Patent No. 10,847,221, "Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating," and its claims directed to multi-layer enzyme coating architecture for electrochemical glucose sensors. While Solstice's proprietary PtIr-4G electrode coating technology is differentiated from the NovaSense patent by several important features — including the platinum-iridium electrode substrate, different enzyme layer ordering and composition, and a proprietary deposition process — certain structural similarities exist that give rise to the low-to-moderate risk characterization. The design-around effort currently underway by SBD's engineering team is expected to further mitigate this risk, and Crestline's ongoing detailed claim chart analysis will provide a more definitive assessment.

U.S. Patent Nos. 11,234,567 (signal processing algorithm) and 11,502,893 (wireless transmission protocol) present low infringement risk based on Crestline's preliminary analysis. The claims of these patents are narrowly drafted around NovaSense-specific implementations that differ materially from Solstice's technology.

Calderwood & Harkness recommends that Solstice proceed with the current regulatory timeline for the Lumina CGM System while monitoring the FTO workstream closely. Based on the current analysis, no delay to the Pre-Sub meeting package submission (target June 16, 2025), the 510(k) submission (target April 30, 2026), or the commercial launch timeline (target Q4 2026) is anticipated at this time, provided that the design-around review by Crestline is completed on schedule by early June 2025 and any resulting design modifications are incorporated into the regulatory submissions in a timely manner.

This Memorandum constitutes a preliminary legal assessment based on the Crestline Preliminary FTO Assessment Report dated April 10, 2025. It will be supplemented upon completion of Crestline's full claim-by-claim chart analysis, at which time Calderwood & Harkness will issue an updated and comprehensive FTO risk assessment memorandum incorporating the final analysis and revised recommendations.

Calderwood & Harkness remains available to discuss the contents of this Memorandum with the Solstice team at your convenience. Please do not hesitate to contact us with any questions.

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Miriam Calloway Responsible Partner, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-4100

Email: m.calloway@calderwoodharkness.com

By: ________

Amy Whitfield Lead Associate, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-4127

Email: a.whitfield@calderwoodharkness.com

ENCLOSURES / ATTACHMENTS

Note: The Crestline IP Advisory LLC Preliminary FTO Assessment Report, dated April 10, 2025, is referenced throughout this Memorandum but is not attached hereto. The Crestline Preliminary Report is a privileged document maintained separately by Calderwood & Harkness LLP and is available upon request from Calderwood & Harkness. Requests for access to the Crestline Preliminary Report should be directed to Miriam Calloway or Amy Whitfield at the contact information set forth above.

PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED — ATTORNEY WORK PRODUCT This Memorandum is intended exclusively for the use of the addressees identified herein. Unauthorized dissemination, distribution, or copying of this Memorandum or its contents is strictly prohibited and may constitute a waiver of applicable legal privileges.

Field	Detail
Patent No.	U.S. 10,847,221
Title	Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating
Issue Date	December 1, 2020
Expiration Date	November 14, 2037
Assignee	NovaSense Medical Technologies Inc.
Named Inventors	Dr. Harold Yuen; Dr. Priya Anand; Michael Strauss
Subject Matter	Multi-layer enzyme coating architecture for electrochemical glucose sensors
Field	Detail
Patent No.	U.S. 11,234,567
Title	Signal Processing Algorithm for Continuous Analyte Monitoring
Issue Date	January 25, 2022
Expiration Date	March 22, 2039
Assignee	NovaSense Medical Technologies Inc.
Named Inventors	Dr. Wei-Lin Chen; Sarah Kowalski; Dr. Harold Yuen
Subject Matter	Signal processing algorithm for filtering, calibrating, and predicting analyte concentrations
Field	Detail
Patent No.	U.S. 11,502,893
Title	Wireless Transmission Protocol for Implantable Biosensors
Issue Date	November 15, 2022
Expiration Date	June 8, 2040
Assignee	NovaSense Medical Technologies Inc.
Named Inventors	Michael Strauss; Dr. Elena Markov; Ryan Choi
Subject Matter	Wireless data transmission protocol for implantable biosensor applications
Patent No.	Title	Issue Date	Expiration Date	Subject Matter Category	Relevant Lumina Component	Risk Rating

U.S. 10,847,221	Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating	Dec. 1, 2020	Nov. 14, 2037	Electrode Chemistry / Enzyme Coating Architecture	Lumina C14 Sensor	Low-to-Moderate
U.S. 11,234,567	Signal Processing Algorithm for Continuous Analyte Monitoring	Jan. 25, 2022	Mar. 22, 2039	Signal Processing Algorithm	Lumina C14 (firmware) / Lumina R7 (reader OS) / LuminaPredict Algorithm	Low
U.S. 11,502,893	Wireless Transmission Protocol for Implantable Biosensors	Nov. 15, 2022	Jun. 8, 2040	Wireless Transmission Protocol	Lumina C14 Sensor / Lumina R7 Reader	Low

PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED — ATTORNEY WORK PRODUCT
CALDERWOOD & HARKNESS LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005
MEMORANDUM
April 24, 2025
TO:
Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd.
Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.
Dr. Aisling Burke, Chief Technology Officer, Solstice Biomedical Devices Ltd.
FROM:
Miriam Calloway, Responsible Partner, Healthcare & Life Sciences Practice Group, Calderwood & Harkness LLP
Amy Whitfield, Lead Associate, Healthcare & Life Sciences Practice Group, Calderwood & Harkness LLP
RE:
Freedom-to-Operate / Intellectual Property Risk Assessment Summary — Solstice Lumina™ CGM System — NovaSense Medical Technologies Inc. Patent Portfolio
Engagement Reference No.: 1037-00002
Right-click to update Table of Contents
I. Privileged Communication Notice
This Memorandum constitutes a privileged and confidential communication protected by the attorney-client privilege, the work product doctrine, and all other applicable privileges and protections. It has been prepared by Calderwood & Harkness LLP in anticipation of potential litigation and for the express purpose of rendering legal advice to the client. This Memorandum reflects the mental impressions, conclusions, opinions, and legal theories of attorneys at Calderwood & Harkness LLP.
This Memorandum has been prepared at the direction of Calderwood & Harkness LLP for the exclusive use of Solstice Biomedical Devices Ltd. ("SBD"), an Irish company, and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI"), a Delaware corporation (collectively, "Solstice" or the "Company"). It is intended solely for the use of the individuals identified in the header of this Memorandum and such other officers and employees of Solstice as may be authorized to receive it in accordance with the guidelines set forth in Section VIII below.
This Memorandum and its contents are not to be disclosed, disseminated, distributed, or otherwise made available to any third party without the prior written consent of Calderwood & Harkness LLP. Unauthorized disclosure may result in a waiver of the attorney-client privilege, the work product protection, or both, and could cause significant and irreparable harm to Solstice's legal interests.
The underlying freedom-to-operate analysis referenced in this Memorandum was prepared by Crestline IP Advisory LLC ("Crestline"), patent and FTO counsel retained by Solstice at the direction of Calderwood & Harkness LLP. Crestline's work product, including the Preliminary FTO Assessment Report dated April 10, 2025, was prepared under the supervision of Dr. Raymond Cho, Patent Attorney, Crestline IP Advisory LLC, 75 Federal Street, Suite 1800, Boston, MA 02110. Crestline's work product is also protected under the common-interest privilege and the work product doctrine, pursuant to the common-interest agreement executed between Calderwood & Harkness LLP and Crestline IP Advisory LLC on February 14, 2025. All communications between Calderwood & Harkness, Crestline, and Solstice regarding the subject matter of this Memorandum are protected by these privileges.
Any dissemination of this Memorandum or its contents within Solstice should be strictly limited to individuals who have a legitimate need to know for the purpose of obtaining or acting upon legal advice. In particular, distribution of this Memorandum or any substantive discussion of its contents with Pinnacle Regulatory Consulting Group LLC, Whitmore Laboratories, Veltrano CRO, Clearwater IRB, or any other non-legal consultants, vendors, or service providers should be discussed with Calderwood & Harkness before any such disclosure occurs, in order to preserve the applicable privileges. Please contact Miriam Calloway or Amy Whitfield at the contact information provided at the conclusion of this Memorandum before making any such disclosure.
II. Executive Summary
Calderwood & Harkness LLP has reviewed the Preliminary Freedom-to-Operate Assessment Report prepared by Crestline IP Advisory LLC (Dr. Raymond Cho, Patent Attorney), dated April 10, 2025 (the "Crestline Preliminary Report"), concerning the United States patent portfolio of NovaSense Medical Technologies Inc. ("NovaSense") as it relates to Solstice's Solstice Lumina™ Continuous Glucose Monitoring System (the "Lumina CGM System" or the "Lumina System"), comprising the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter. This Memorandum summarizes the key findings and risk assessments from the Crestline Preliminary Report and provides Calderwood & Harkness's legal analysis, recommendations, and guidance regarding next steps.
NovaSense Medical Technologies Inc. is a Delaware corporation (File No. 5429876) headquartered at 4800 Innovation Parkway, San Diego, California 92121. NovaSense reported fiscal year 2024 revenues of approximately $1.24 billion. NovaSense holds a portfolio of fourteen (14) United States utility patents directed to continuous glucose monitoring sensor electrode chemistry and signal processing algorithms. NovaSense's patent counsel of record is Marlowe Asset Management Patent Group LLP, specifically Patricia Langford, Partner, whose office is located at 2200 Wilson Boulevard, Suite 1100, Arlington, Virginia 22201. NovaSense is a significant participant in the CGM market and, as discussed further below, manufactures the devices that Solstice has identified as the primary and secondary predicate devices for its planned 510(k) submission.
Based on Crestline's preliminary analysis, three (3) NovaSense patents have been identified as most relevant to the Lumina CGM System. The remaining eleven (11) patents in the NovaSense portfolio were reviewed by Crestline and determined to be either expired, directed to unrelated technology (e.g., insulin delivery systems, non-CGM diagnostic platforms), or clearly non-overlapping with the Lumina System's technology. Those eleven patents are catalogued in the Crestline Preliminary Report but are not discussed in detail in this Memorandum.
The overall intellectual property risk associated with the NovaSense patent portfolio is characterized as low-to-moderate. The primary area of concern is U.S. Patent No. 10,847,221, titled "Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating," which relates to enzyme coating architecture for electrochemical glucose sensors. Solstice's proprietary PtIr-4G electrode coating technology employed in the C14 sensor shares certain structural similarities with the multi-layer coating architecture claimed in this patent, although important distinctions exist. The remaining two identified patents — U.S. Patent No. 11,234,567 (signal processing algorithm) and U.S. Patent No. 11,502,893 (wireless transmission protocol) — present low infringement risk based on Crestline's preliminary analysis.
No formal dispute, correspondence, demand, or litigation currently exists between Solstice (or any Solstice entity) and NovaSense relating to intellectual property or any other matter. NovaSense has not communicated with Solstice regarding its patent portfolio, nor is Calderwood & Harkness aware of any indication that NovaSense is presently aware of Solstice's planned U.S. market entry with the Lumina System.
Design-around efforts are currently underway by SBD's engineering team under the direction of Dr. Aisling Burke, CTO, targeting the identified overlap with U.S. Patent No. 10,847,221. Concurrently, Crestline is conducting a full claim-by-claim chart analysis of all three identified patents against both the current Lumina design and the proposed alternative electrode deposition process. This detailed claim chart analysis remains in progress as of the date of this Memorandum, with an expected completion date in early June 2025. Calderwood & Harkness will issue a supplemental risk assessment memorandum upon receipt and review of Crestline's final analysis.
For reference, Crestline IP Advisory LLC was retained by Solstice in February 2025, and the FTO analysis engagement fee is $215,000 per the engagement letter between Crestline and Solstice dated February 10, 2025.
III. Background and Context
A. The Solstice Lumina™ CGM System
The Solstice Lumina™ CGM System is a two-component continuous glucose monitoring system intended for the United States market. Solstice plans to seek marketing authorization via the traditional 510(k) premarket notification pathway, with the submission covering both the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter as an integrated system.
Lumina C14 Implantable Sensor. The Lumina C14 is a subcutaneously implantable continuous glucose monitoring sensor designed for a fourteen (14)-day wear duration. The C14 utilizes Solstice's proprietary fourth-generation enzymatic electrochemical biosensor technology featuring a platinum-iridium electrode coating designated "PtIr-4G." The PtIr-4G technology represents the core innovation of the Lumina System's sensing platform and incorporates a multi-layer enzymatic coating deposited onto a platinum-iridium (PtIr) electrode substrate. The C14 sensor communicates wirelessly with the R7 reader/transmitter via Bluetooth Low Energy (BLE) 5.2 protocol. The intended use population is persons aged eighteen (18) years and older diagnosed with Type 1 or Type 2 diabetes mellitus. The C14 sensor has a glucose measurement range of 40–400 mg/dL and a warm-up time of sixty (60) minutes or less following subcutaneous insertion.
Lumina R7 Wearable Reader/Transmitter. The Lumina R7 is an arm-worn wearable device that receives continuous glucose data from the C14 sensor via BLE 5.2. The R7 provides a real-time glucose display, trend arrows indicating the direction and rate of glucose change, and eight (8)-hour trend graphs. The R7 includes configurable hypoglycemia and hyperglycemia alerts with an alert latency of five (5) minutes or less. The R7 also communicates with the Lumina mobile application, which is available on both iOS and Android platforms, to provide extended data visualization, data sharing, and remote monitoring capabilities.
Software Components. The Lumina System incorporates the following software components: Lumina Firmware v3.4.2 (embedded firmware for the C14 sensor); Lumina Reader OS v2.1.0 (operating system for the R7 reader/transmitter); LuminaPredict Algorithm v2.1 (proprietary glucose prediction and signal processing algorithm); and Lumina Mobile App v1.0.3 (companion mobile application for iOS and Android devices).
Existing Regulatory Status. The Lumina CGM System has been commercially available in the European Union since September 2024. The system received CE marking under the European Union Medical Devices Regulation (EU MDR 2017/745), with CE Certificate No. MCA-2024-07319 issued on September 12, 2024, by Meridian Conformity Assessment GmbH, Notified Body No. 0483. No existing FDA clearance or approval has been obtained for the Lumina System in the United States. Solstice previously obtained 510(k) clearance from FDA for the GlucoStrip RX-200 Test Strip Reader (510(k) No. K192847, cleared November 14, 2019), which is a self-monitoring blood glucose test strip reader representing a significantly different technology platform from the Lumina CGM System. The Lumina System represents a substantial technology evolution from the GlucoStrip RX-200 and is not suitable as a predicate for the Lumina 510(k) submission.
B. NovaSense as Predicate Device Manufacturer
NovaSense Medical Technologies Inc. is the manufacturer of the devices that Solstice has identified as the primary and secondary predicate devices for its planned 510(k) submission for the Lumina CGM System. This relationship between Solstice's planned regulatory pathway and NovaSense's product portfolio merits particular attention in the context of the FTO analysis.
Primary Predicate Device. The primary predicate device identified for the Lumina 510(k) submission is the NovaSense GlucoTrack NX-500 CGM System, which received 510(k) clearance under 510(k) No. K211034 on June 18, 2022. The NX-500 is classified under product code QKQ and is a Class II device. The NX-500 features a ten (10)-day enzymatic electrochemical sensor with BLE wireless data transmission to an external reader/display device.
Secondary Predicate / Reference Device. The secondary predicate and reference device identified for the Lumina submission is the NovaSense GlucoTrack NX-700 CGM System, which received 510(k) clearance under 510(k) No. K230489 on March 7, 2024. The NX-700 is also classified under product code QKQ as a Class II device. The NX-700 features a fourteen (14)-day sensor wear duration (matching the Lumina C14's intended wear duration), enhanced BLE 5.0 wireless communication, and an updated glucose prediction algorithm. The NX-700 represents NovaSense's most recent cleared CGM platform and is technologically closer to the Lumina System than the NX-500.
Significance of the Predicate Relationship. The use of NovaSense devices as predicates for Solstice's substantial equivalence argument heightens the importance of understanding NovaSense's patent portfolio and the intellectual property risks associated with Solstice's market entry. While predicate device selection for 510(k) purposes is an independent regulatory determination and does not implicate patent rights — FDA's clearance of a device as substantially equivalent to a predicate does not confer any patent license — the practical reality is that the commercial launch of a device found to infringe NovaSense patents could result in enforcement action by NovaSense regardless of whether Solstice obtains FDA clearance. NovaSense would have standing to seek injunctive relief, damages, or both under 35 U.S.C. § 271 in the event of patent infringement, irrespective of the device's regulatory status. Furthermore, the predicate device relationship means that NovaSense will likely become aware of the Lumina System's existence and its technological similarities to NovaSense's products upon FDA's public posting of any 510(k) clearance decision summary, if not sooner.
C. Scope of the Crestline FTO Analysis
Crestline IP Advisory LLC was engaged by Solstice in February 2025, at the direction of Calderwood & Harkness LLP, to conduct a comprehensive freedom-to-operate analysis regarding NovaSense's fourteen (14) United States utility patents related to CGM sensor electrode chemistry and signal processing algorithms. The scope of the Crestline engagement encompasses: (i) identification and review of all relevant NovaSense U.S. patents; (ii) comparison of the claims of each identified patent against the technical features of the Lumina CGM System; (iii) assessment of infringement risk under the doctrines of literal infringement and infringement under the doctrine of equivalents; (iv) identification of potential design-around strategies; and (v) evaluation of potential invalidity arguments, including prior art analysis.
The Preliminary FTO Assessment Report was delivered by Crestline on April 10, 2025. This Memorandum is based on the findings and conclusions set forth in that preliminary report. A full claim-by-claim chart analysis is currently ongoing, covering the Lumina C14 sensor technology (including electrode chemistry, enzyme coating architecture, and wireless transmission capabilities) and the Lumina R7 reader/transmitter (including signal processing algorithms and wireless protocol implementation). The full claim chart analysis will encompass both the current Lumina design and the proposed alternative electrode deposition process that is being developed as part of the design-around effort described in Section VI below.
IV. Identification of Relevant NovaSense Patents
Of the fourteen (14) U.S. utility patents in the NovaSense portfolio reviewed by Crestline, three (3) have been identified as having potential relevance to the Lumina CGM System. Each of these patents is discussed in detail below, together with Crestline's preliminary risk assessment and Calderwood & Harkness's analysis.
A. U.S. Patent No. 10,847,221 — "Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating"
Patent Information:
Subject Matter and Claim Scope. U.S. Patent No. 10,847,221 (the "'221 Patent") is directed to a multi-layer enzyme coating architecture for electrochemical glucose sensors used in continuous glucose monitoring applications. The claims cover specific layer compositions, deposition methods, and electrode configurations designed to enhance sensor accuracy, stability, and longevity over multi-day wear periods. The '221 Patent contains four (4) independent claims and eighteen (18) dependent claims. The independent claims are generally directed to: (i) an electrochemical glucose sensor comprising a working electrode with a multi-layer enzyme coating having at least three distinct functional layers (Claim 1); (ii) a method of manufacturing an electrochemical glucose sensor comprising depositing a multi-layer enzyme coating onto a working electrode (Claim 8); (iii) a continuous glucose monitoring system comprising a sensor having a multi-layer enzyme coating architecture with specified layer thickness ratios (Claim 14); and (iv) a method of monitoring glucose in a patient using a subcutaneously implanted sensor having a multi-layer enzyme coating (Claim 19). The claims recite specific structural features including layer ordering, composition ranges, and relationships between layer thicknesses that are relevant to the Lumina C14 sensor's PtIr-4G technology.
Relevance to the Lumina C14 Sensor. The PtIr-4G electrode coating technology employed in the Lumina C14 sensor utilizes a multi-layer enzyme coating architecture deposited onto a platinum-iridium (PtIr) electrode substrate. The NovaSense '221 Patent specification describes a platinum base electrode throughout its detailed description and examples, and the claims generally recite a "working electrode" without specifying the electrode substrate material. The Lumina C14's PtIr-4G technology is differentiated from NovaSense's disclosed embodiment by its platinum-iridium composition (as opposed to a pure platinum electrode) and by Solstice's proprietary electrodeposition process. However, the multi-layer enzyme coating structure used in the Lumina C14 sensor shares certain structural similarities with the multi-layer coating approach claimed in the '221 Patent, including the use of multiple distinct functional layers performing analogous roles (e.g., enzyme immobilization layer, interference rejection layer, biocompatibility membrane layer).
Risk Assessment: Low-to-Moderate.
Crestline's preliminary assessment concludes that the '221 Patent presents a low-to-moderate risk of infringement. While the PtIr-4G technology is differentiated by several important features, certain structural aspects of the multi-layer coating architecture overlap with claim elements of the '221 Patent. The key factors informing this assessment are as follows:
Distinguishing Features (Favoring Non-Infringement):
• Electrode Substrate Composition. Solstice uses a platinum-iridium (PtIr) alloy electrode substrate, whereas NovaSense's specification consistently describes and exemplifies a pure platinum electrode. Although certain independent claims recite only a "working electrode" without specifying the substrate material, the prosecution history and specification may support a narrower construction.
• Enzyme Layer Ordering and Composition. The ordering of the functional layers in the PtIr-4G coating differs from the specific layer ordering described in NovaSense's specification and recited in certain dependent claims. Additionally, the specific enzyme formulations and concentrations used in Solstice's coating differ from those disclosed by NovaSense.
• Layer Thickness Parameters. The thickness parameters of the individual layers in the PtIr-4G coating differ from the thickness ranges and ratios recited in certain claims of the '221 Patent.
• Proprietary Deposition Process. Solstice's electrodeposition process for the PtIr-4G coating employs a different methodology from the deposition methods described in the '221 Patent specification, which may be relevant to the method claims.
Areas of Concern (Favoring Potential Infringement):
• Broad Independent Claim Language. Certain independent claims of the '221 Patent, particularly Claim 1, use relatively broad language to describe the multi-layer enzyme coating architecture. Depending on the construction given to claim terms such as "multi-layer enzyme coating," "distinct functional layers," and "working electrode," these claims may be broad enough to encompass the PtIr-4G variation.
• Structural Similarities. The high-level structural approach of using multiple distinct functional layers deposited onto a working electrode for the purpose of continuous glucose monitoring is shared between the Lumina C14 design and the '221 Patent claims.
• Doctrine of Equivalents. Even if literal infringement is avoided, certain claim elements may be met under the doctrine of equivalents if the PtIr-4G coating is found to perform substantially the same function, in substantially the same way, to achieve substantially the same result as the corresponding limitations in the '221 Patent claims.
The '221 Patent presents the highest relative risk among the three NovaSense patents assessed and is the focus of the design-around effort described in Section VI below. The ongoing detailed claim chart analysis by Crestline will provide a more definitive assessment of infringement risk, including a thorough analysis of the prosecution history and relevant prior art that may inform claim construction and potential invalidity arguments.
B. U.S. Patent No. 11,234,567 — "Signal Processing Algorithm for Continuous Analyte Monitoring"
Patent Information:
Subject Matter and Claim Scope. U.S. Patent No. 11,234,567 (the "'567 Patent") is directed to a signal processing algorithm for filtering, calibrating, and predicting analyte concentrations in continuous monitoring systems. The claims recite specific algorithmic steps, including particular mathematical transformations (e.g., specific Kalman filter implementations, wavelet decomposition techniques), calibration sequences (e.g., multi-point retrospective calibration using capillary blood glucose reference values), and predictive modeling methodologies. The '567 Patent contains three (3) independent claims and twelve (12) dependent claims, generally directed to: (i) a method of processing a continuous analyte signal using a series of defined computational steps; (ii) a non-transitory computer-readable medium storing instructions for executing the defined signal processing methodology; and (iii) a continuous analyte monitoring system comprising a processor configured to execute the defined signal processing algorithm.
Relevance to the Lumina System. Solstice's LuminaPredict Algorithm v2.1 performs analogous high-level functions to the algorithm described in the '567 Patent, including glucose signal processing, noise filtering, calibration, and glucose concentration prediction. Both algorithms operate within continuous glucose monitoring systems and produce predictive glucose values for display to the user. However, the LuminaPredict Algorithm v2.1 employs a fundamentally different computational methodology from the specific algorithmic steps recited in the '567 Patent claims.
Risk Assessment: Low.
Crestline's preliminary assessment concludes that the '567 Patent presents a low risk of infringement. The claims of the '567 Patent are narrowly drafted around NovaSense's specific algorithmic implementation, including particular mathematical transformations, specific calibration sequences, and defined computational steps that differ materially from the methodology employed by LuminaPredict v2.1. Key factors supporting this assessment include:
• The LuminaPredict v2.1 algorithm uses a fundamentally different computational approach from the specific algorithmic steps recited in the '567 Patent claims, including different filtering methodologies, different calibration techniques, and a different predictive modeling framework.
• The overlap between Solstice's algorithm and the '567 Patent claims is limited to the high-level functional objective of glucose prediction and signal processing — functions that are inherently performed by all CGM signal processing algorithms and are not, in themselves, patentable subject matter.
• The claims of the '567 Patent recite specific mathematical transformations and defined sequences of computational steps that are not present in the LuminaPredict v2.1 implementation, supporting a finding of non-infringement under both literal infringement and doctrine of equivalents analyses.
• Crestline's preliminary review of the dependent claims confirms the low risk assessment, as the dependent claims further narrow the scope to NovaSense-specific implementation details.
A full analysis of all independent and dependent claims against the LuminaPredict v2.1 algorithm is underway as part of Crestline's final claim chart analysis. Based on the preliminary assessment, however, Calderwood & Harkness does not consider the '567 Patent to present a material infringement risk.
C. U.S. Patent No. 11,502,893 — "Wireless Transmission Protocol for Implantable Biosensors"
Patent Information:
Subject Matter and Claim Scope. U.S. Patent No. 11,502,893 (the "'893 Patent") is directed to a wireless data transmission protocol specifically designed for implantable biosensor applications. The claims recite a proprietary protocol layer including specific features related to power management, data packet structure, error correction methods, and timing sequences for data transmission between an implantable biosensor and an external reader device. The '893 Patent contains three (3) independent claims and fourteen (14) dependent claims, generally directed to: (i) a method of transmitting data from an implantable biosensor to an external device using a defined protocol with specified packet structure and error correction; (ii) an implantable biosensor system comprising a sensor and external reader configured to communicate using the defined protocol; and (iii) a non-transitory computer-readable medium storing instructions for implementing the defined wireless transmission protocol.
Relevance to the Lumina System. Both the Lumina C14 sensor and the Lumina R7 reader/transmitter use Bluetooth Low Energy (BLE) 5.2 for wireless data communication. NovaSense's '893 Patent claims a specific proprietary protocol layer built on top of BLE technology. The question of relevance turns on whether Solstice's BLE 5.2 implementation falls within the scope of NovaSense's protocol claims.
Risk Assessment: Low.
Crestline's preliminary assessment concludes that the '893 Patent presents a low risk of infringement. The key factors supporting this assessment are as follows:
• The claims of the '893 Patent are directed to a proprietary protocol layer that is specific to NovaSense's implementation, including defined data packet structures, specific error correction algorithms, and particular power management sequences that are distinct from standard BLE protocol features.
• Solstice's BLE 5.2 implementation uses standard Bluetooth Special Interest Group (SIG) specifications for the underlying wireless communication stack. Solstice has developed its own application-layer protocol for data transmission between the C14 sensor and R7 reader, which differs from the NovaSense-specific protocol claimed in the '893 Patent.
• The distinction between Solstice's BLE 5.2 stack and NovaSense's BLE 5.0-based custom protocol further supports non-infringement, as the underlying wireless technology generations differ and the protocol implementations built on top of those respective standards are technically distinct.
• Crestline's preliminary review of both the independent and dependent claims confirms this assessment. The dependent claims further narrow the scope to NovaSense-specific protocol features — including specific timing parameters, packet sizes, and error correction methodologies — that are not employed by Solstice's implementation.
Based on the preliminary assessment, Calderwood & Harkness does not consider the '893 Patent to present a material infringement risk. The full claim chart analysis by Crestline will provide additional confirmation.
V. Overall Risk Characterization and Summary Table
The following table summarizes the risk assessment for each of the three NovaSense patents identified as relevant to the Solstice Lumina CGM System:
Overall Portfolio Risk Assessment: Low-to-Moderate. The aggregate intellectual property risk associated with the NovaSense patent portfolio, as it relates to the Lumina CGM System, is assessed as low-to-moderate. This risk is concentrated primarily in U.S. Patent No. 10,847,221 and its claims directed to multi-layer enzyme coating architecture. The remaining two identified patents present low risk based on the preliminary analysis.
Remaining NovaSense Patents. The remaining eleven (11) NovaSense patents (of the fourteen (14) total patents in the reviewed portfolio) were examined by Crestline and determined to present no material risk to the Lumina CGM System. These patents were classified as follows: three (3) patents are expired; four (4) patents are directed to technology unrelated to continuous glucose monitoring sensors (including insulin pump delivery systems, non-enzymatic diagnostic assays, and data management software platforms); and four (4) patents, while directed to CGM-related technology, contain claims that are clearly non-overlapping with the Lumina System's technical features based on claim scope analysis. These eleven patents are not discussed in detail in this Memorandum but are catalogued and individually assessed in Crestline's Preliminary FTO Assessment Report, which is maintained as a privileged document by Calderwood & Harkness.
VI. Design-Around Efforts and Mitigation Strategy
A. Engineering Design-Around for U.S. Patent No. 10,847,221
In light of the low-to-moderate risk assessment associated with U.S. Patent No. 10,847,221, SBD's engineering team, under the direction of Dr. Aisling Burke, Chief Technology Officer, has initiated development of an alternative electrode deposition process designed to reduce or eliminate the identified overlap between the Lumina C14's PtIr-4G technology and the claims of the '221 Patent.
The alternative process modifies the multi-layer coating sequence and composition to create greater differentiation from the NovaSense patent claims. Specifically, the engineering team has identified modifications to the layer ordering, the composition of certain functional layers, and the deposition parameters that are intended to move the Lumina C14 design further from the claim scope of the '221 Patent while preserving or improving the sensor's analytical performance characteristics.
Crestline IP Advisory LLC is reviewing the revised design as of April 22, 2025, to assess whether the proposed modifications sufficiently address the identified claim overlap. This review will include a comparison of the revised design against each relevant claim of the '221 Patent (independent and dependent claims), an assessment of infringement risk under both literal infringement and doctrine of equivalents theories, and an evaluation of whether the modifications create any new potential overlap with other patents in the NovaSense portfolio or with patents held by other third parties.
Timeline for Design-Around Assessment. Crestline expects to complete its review of the revised design within four (4) to six (6) weeks from the date of its receipt of the technical documentation, with a target completion date of early June 2025. The engineering team is working to finalize technical documentation for the alternative process and provide it to Crestline as expeditiously as possible.
Impact on Device Performance and Regulatory Submission. Any design modifications to the electrode coating architecture must be carefully evaluated for their impact on several critical parameters:
• Analytical Performance. The Lumina C14 sensor is designed to achieve a Mean Absolute Relative Difference (MARD) target of ≤ 9.0%. Any modification to the electrode coating must maintain or improve this performance level. Pre-clinical and clinical performance data generated with the modified design may be required to support the 510(k) submission.
• Biocompatibility. Modifications to the electrode coating composition may trigger the need for updated biocompatibility testing in accordance with ISO 10993 standards. This testing is being conducted by Whitmore Laboratories (engagement start date: March 3, 2025; A2LA Accreditation Certificate No. 3847.01; Dr. James Haverford, Director of Biocompatibility Testing). Coordination with Whitmore will be necessary to determine whether additional testing is required for the modified design.
• Regulatory Submission. The Pre-Submission (Pre-Sub) meeting package and the subsequent 510(k) submission must accurately describe the commercial embodiment of the Lumina C14 sensor, including its electrode coating architecture. If design modifications are adopted, the device description in these regulatory submissions must reflect the modified design.
B. Ongoing Crestline Analysis — Full Claim Chart
Crestline is conducting a detailed claim-by-claim chart analysis for all three identified NovaSense patents against both the current Lumina C14 and R7 designs and the proposed alternative electrode deposition process. The claim chart analysis will map each claim element of each relevant patent claim to the corresponding technical feature of the Lumina System (or the proposed revised design), providing a systematic and detailed assessment of infringement risk.
The expected completion date for the full claim chart analysis is approximately eight (8) weeks from the date of the Crestline Preliminary Report (April 10, 2025), which corresponds to a target completion date of early June 2025. This timeline is consistent with the design-around assessment timeline described above.
Upon receipt of the final Crestline analysis, Calderwood & Harkness will review the claim charts and underlying analysis, provide an updated legal risk assessment, and issue a supplemental memorandum to Solstice with revised recommendations and guidance as appropriate.
C. Additional Mitigation Options
In addition to the design-around effort and the ongoing claim chart analysis, Calderwood & Harkness recommends that Solstice consider the following additional mitigation strategies:
1. Patent Prosecution Monitoring. Calderwood & Harkness recommends establishing a patent watch service to monitor NovaSense's ongoing patent prosecution activity, including any continuation applications, continuation-in-part applications, divisional applications, or reissue proceedings filed by NovaSense at the United States Patent and Trademark Office. This monitoring will provide early warning of any new patent claims that may be relevant to the Lumina System and will allow Solstice to assess the evolving scope of NovaSense's intellectual property rights in real time. Additionally, monitoring should extend to new patent applications filed by NovaSense or its inventors in the CGM sensor space, which could signal the direction of NovaSense's ongoing research and development and the potential for future intellectual property conflicts.
2. Potential Inter Partes Review (IPR). If the claim scope of U.S. Patent No. 10,847,221 cannot be adequately designed around and the full claim chart analysis confirms a meaningful infringement risk, Solstice should consider filing a petition for inter partes review (IPR) before the Patent Trial and Appeal Board (PTAB) challenging the validity of the relevant claims of the '221 Patent. An IPR petition would need to be supported by prior art references establishing that the challenged claims are unpatentable as anticipated or obvious under 35 U.S.C. §§ 102 and 103. Crestline has identified several potentially relevant prior art references in its preliminary analysis, but a full prior art assessment and patentability analysis should be conducted before any IPR strategy is finalized. This assessment should be undertaken after completion of the final claim chart analysis, at which point the specific claims of concern and the relevant prior art can be evaluated in detail.
3. Licensing Negotiations. Potential licensing negotiations with NovaSense are not recommended at this stage. Premature outreach to NovaSense regarding licensing could alert NovaSense to Solstice's planned U.S. market entry with the Lumina CGM System and the predicate device relationship, potentially prompting NovaSense to take preemptive action, including enforcement of its patent rights or modification of its competitive strategy. Licensing discussions, if appropriate, should be deferred until: (a) the full FTO analysis is complete and the scope of any infringement risk is clearly defined; (b) the design-around effort has been evaluated; and (c) Solstice's strategic position, including its regulatory timeline and market entry plans, is more fully established. Calderwood & Harkness will advise on the timing and approach for any licensing discussions, if warranted, following completion of the full analysis.
4. Insurance Coverage Review. Solstice's current product liability insurance policy, underwritten by Atlas Underwriting Partners Ltd. (Policy No. AUP-PL-2024-00893; limits of $25 million per occurrence / $50 million aggregate; policy period October 1, 2024 through September 30, 2025), does not cover patent infringement claims, demands, or litigation costs. Patent infringement is expressly excluded under the standard commercial general liability and product liability policy forms. Accordingly, Solstice should consider obtaining separate intellectual property indemnity insurance or IP litigation cost insurance as a supplement to the existing Atlas policy. Such coverage can provide reimbursement for defense costs and, in some policies, indemnity for damages arising from patent infringement claims. Calderwood & Harkness can provide referrals to insurance brokers with experience in IP insurance products for the medical device industry.
VII. Implications for Regulatory Strategy
The FTO analysis and the intellectual property risk assessment summarized in this Memorandum do not affect the regulatory pathway or predicate device selection for the Lumina CGM System's 510(k) submission. FDA clearance under the 510(k) pathway is a determination of substantial equivalence to a legally marketed predicate device and is independent of patent rights. FDA does not consider patent ownership or infringement in rendering its clearance decisions, and a 510(k) clearance does not constitute a license under any third-party patent. Accordingly, the selection of the NovaSense GlucoTrack NX-500 and NX-700 as predicate devices remains appropriate from a regulatory perspective irrespective of the FTO analysis outcomes.
However, the FTO analysis has practical implications for the regulatory timeline and submission strategy that must be carefully managed:
Pre-Sub Meeting Package Alignment. Any design-around modifications to the PtIr-4G electrode coating must be finalized before the Pre-Submission (Pre-Sub) meeting package is submitted to FDA, to ensure that the device description presented to the Center for Devices and Radiological Health (CDRH) accurately reflects the commercial embodiment of the Lumina C14 sensor. The current target date for Pre-Sub package submission is June 16, 2025, for a Pre-Sub meeting with CDRH, Office of Health Technology 2 (OHT2), Division of Chemistry and Toxicology Devices, targeted for August 14, 2025. If the design-around modifications are not finalized by the Pre-Sub submission date, Solstice will face a choice between: (a) submitting the Pre-Sub package based on the current PtIr-4G design with the understanding that a subsequent design modification may require a revised device description; or (b) delaying the Pre-Sub submission to allow the design-around assessment to be completed. Calderwood & Harkness recommends close coordination between the engineering, regulatory, and legal teams on this timing issue.
Biocompatibility Testing. If the design modifications alter the electrode chemistry or coating composition of the Lumina C14 sensor, updated biocompatibility testing under ISO 10993 may be required to support the 510(k) submission. This determination will require input from Whitmore Laboratories (Dr. James Haverford, Director of Biocompatibility Testing; engagement commenced March 3, 2025; A2LA Accreditation Certificate No. 3847.01) regarding the scope and nature of any additional testing that may be needed. Coordination with Pinnacle Regulatory Consulting Group LLC (Dr. Sandra Ellison and Thomas Greenbaum; engagement commenced January 15, 2025) will also be necessary to assess the impact of any design modifications on the overall regulatory submission strategy, including the biocompatibility and performance testing sections of the 510(k).
Regulatory Timeline. The current regulatory timeline for the Lumina CGM System is as follows: Pre-Sub meeting package submission target of June 16, 2025; Pre-Sub meeting target of August 14, 2025; 510(k) submission target of April 30, 2026; anticipated FDA clearance target of Q3 2026; and planned commercial launch target of Q4 2026. Based on current critical path analysis, the FTO workstream is not on the critical path of the regulatory timeline, provided that the design-around review by Crestline is completed by early June 2025 and any resulting design modifications can be incorporated into the Pre-Sub package without delay. Calderwood & Harkness will monitor the FTO workstream closely and will advise Solstice promptly if any developments suggest a potential impact on the regulatory timeline.
VIII. Privilege and Confidentiality Considerations
Calderwood & Harkness reiterates and emphasizes the following privilege and confidentiality considerations in connection with the FTO analysis and this Memorandum:
Attorney-Client Privilege and Work Product Protection. All communications between Calderwood & Harkness LLP, Crestline IP Advisory LLC, and Solstice (including SBD and SBI) relating to the FTO analysis, the NovaSense patent portfolio, and the intellectual property risk assessment for the Lumina CGM System are protected by the attorney-client privilege and the work product doctrine. These protections extend to this Memorandum, the Crestline Preliminary FTO Assessment Report, all claim charts and analyses prepared by Crestline, and all related correspondence, notes, and work papers.
Common-Interest Agreement. A common-interest agreement has been executed between Calderwood & Harkness LLP and Crestline IP Advisory LLC, dated February 14, 2025, establishing the framework for sharing privileged information and work product between the two firms for the common purpose of providing legal advice to Solstice. Crestline's work product was prepared at the direction of counsel (Calderwood & Harkness) for the purpose of rendering legal advice to the client (Solstice), and is protected under both the common-interest privilege and the work product doctrine.
Restrictions on Third-Party Dissemination. Solstice should not disseminate the FTO findings, analysis, risk assessments, or recommendations contained in this Memorandum (or in any other privileged communications relating to the FTO analysis) to third parties without first consulting with Calderwood & Harkness. This restriction applies to, among others:
• Pinnacle Regulatory Consulting Group LLC (Dr. Sandra Ellison, Thomas Greenbaum)
• Whitmore Laboratories (Dr. James Haverford)
• Veltrano CRO
• Clearwater IRB
• Any other non-legal consultants, vendors, contractors, or service providers
Disclosure of privileged information to non-legal third parties outside the attorney-client relationship risks waiver of the privilege. In certain circumstances, it may be possible to share limited, non-privileged information with regulatory or technical consultants on a need-to-know basis without waiving the privilege, but such disclosure should be carefully considered and coordinated with Calderwood & Harkness in advance.
Coordination with Irish Counsel. If Solstice wishes to share any portion of the FTO analysis with its Irish counsel, Hargrove & Endicott LLP (Ciara Brennan, Partner; 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland), for purposes of coordinating EU MDR compliance, global IP strategy, or other cross-border legal matters, this should be done under an explicit common-interest or joint-defense agreement between Calderwood & Harkness LLP and Hargrove & Endicott LLP. Calderwood & Harkness can prepare the necessary agreement for execution by both firms. Until such an agreement is in place, FTO-related materials should not be shared with Hargrove & Endicott.
Internal Distribution. Internal distribution of this Memorandum and related FTO materials within Solstice should be limited to the following individuals, all on a strictly need-to-know basis for purposes of obtaining or acting upon legal advice:
• Dr. Eoin Gallagher, Chief Executive Officer, Solstice Biomedical Devices Ltd.
• Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd.
• Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.
• Dr. Aisling Burke, Chief Technology Officer, Solstice Biomedical Devices Ltd.
• Fiona Drennan, Director of Quality Assurance, Solstice Biomedical Devices Ltd.
Any requests to expand the internal distribution list should be directed to Calderwood & Harkness for approval.
IX. Recommended Next Steps and Action Items
Based on the analysis and findings summarized in this Memorandum, Calderwood & Harkness recommends the following next steps and action items:
1. Crestline Final Claim Chart Review. Solstice should await Crestline's final claim-by-claim chart analysis, which is expected to be completed in early June 2025. The final analysis will cover all three identified NovaSense patents (U.S. Patent Nos. 10,847,221; 11,234,567; and 11,502,893) against both the current Lumina C14 and R7 designs and the proposed alternative electrode deposition process. The Crestline FTO analysis engagement fee is $215,000, as established in the Crestline engagement letter dated February 10, 2025. Calderwood & Harkness will review the final analysis upon receipt and prepare a supplemental risk assessment memorandum for Solstice.
2. Engineering Design-Around Confirmation. Dr. Aisling Burke and the SBD engineering team should finalize the alternative electrode deposition process as expeditiously as possible and provide complete technical documentation to Crestline for review. The technical documentation should include detailed descriptions of the revised layer compositions, deposition parameters, layer ordering, and thickness specifications, as well as any performance data generated with the revised design. Timeliness is critical, as the design-around assessment must be completed in advance of the Pre-Sub package submission target date.
3. Impact Assessment on Regulatory Submission. If design-around modifications are adopted, Solstice should coordinate with Pinnacle Regulatory Consulting Group LLC (Dr. Sandra Ellison, Thomas Greenbaum) and Whitmore Laboratories (Dr. James Haverford) to assess the impact of the modifications on the Pre-Sub device description, biocompatibility testing scope, and performance testing requirements. This assessment should be initiated promptly upon a determination that the design modifications will be incorporated into the commercial design. Any disclosure of the reasons for the design modification (i.e., the FTO analysis) to Pinnacle or Whitmore should be discussed with Calderwood & Harkness in advance to preserve privilege.
4. Pre-Sub Package Alignment. Solstice should ensure that the device description in the Pre-Sub meeting package accurately reflects the final commercial design of the Lumina C14 sensor, incorporating any design-around modifications that are adopted. The target submission date for the Pre-Sub meeting package is June 16, 2025, for a Pre-Sub meeting with CDRH, OHT2, Division of Chemistry and Toxicology Devices, currently targeted for August 14, 2025. Close coordination among the engineering, regulatory, and legal teams will be essential to meet this timeline.
5. Patent Watch. Calderwood & Harkness recommends establishing a patent prosecution monitoring service to track NovaSense's patent activity at the U.S. Patent and Trademark Office, including continuation applications, reissue proceedings, and new patent filings in the CGM sensor space. This monitoring should be established as soon as practicable. Crestline or an alternative patent watch service provider can be engaged for this purpose; Calderwood & Harkness will coordinate the engagement.
6. IP Insurance Evaluation. Solstice should evaluate the availability and cost of intellectual property litigation cost insurance or IP indemnity coverage as a supplement to the existing Atlas Underwriting Partners Ltd. product liability policy (Policy No. AUP-PL-2024-00893). Calderwood & Harkness can provide referrals to insurance brokers experienced in IP insurance for medical device companies. This evaluation should be undertaken in parallel with the ongoing FTO analysis and need not await the final Crestline report.
7. Updated Risk Assessment. Calderwood & Harkness will issue an updated FTO risk assessment memorandum upon receipt and review of Crestline's final claim chart analysis. The updated memorandum will provide revised risk assessments for each identified patent, an evaluation of the effectiveness of the design-around modifications, and updated recommendations regarding mitigation strategies, including potential IPR petitions and the timing of any licensing discussions.
X. Conclusion
Based on the Preliminary FTO Assessment Report prepared by Crestline IP Advisory LLC and Calderwood & Harkness's review and analysis of that report, the overall intellectual property risk associated with the NovaSense Medical Technologies Inc. patent portfolio, as it relates to the Solstice Lumina™ CGM System, is assessed as low-to-moderate.
The primary area of concern is U.S. Patent No. 10,847,221, "Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating," and its claims directed to multi-layer enzyme coating architecture for electrochemical glucose sensors. While Solstice's proprietary PtIr-4G electrode coating technology is differentiated from the NovaSense patent by several important features — including the platinum-iridium electrode substrate, different enzyme layer ordering and composition, and a proprietary deposition process — certain structural similarities exist that give rise to the low-to-moderate risk characterization. The design-around effort currently underway by SBD's engineering team is expected to further mitigate this risk, and Crestline's ongoing detailed claim chart analysis will provide a more definitive assessment.
U.S. Patent Nos. 11,234,567 (signal processing algorithm) and 11,502,893 (wireless transmission protocol) present low infringement risk based on Crestline's preliminary analysis. The claims of these patents are narrowly drafted around NovaSense-specific implementations that differ materially from Solstice's technology.
Calderwood & Harkness recommends that Solstice proceed with the current regulatory timeline for the Lumina CGM System while monitoring the FTO workstream closely. Based on the current analysis, no delay to the Pre-Sub meeting package submission (target June 16, 2025), the 510(k) submission (target April 30, 2026), or the commercial launch timeline (target Q4 2026) is anticipated at this time, provided that the design-around review by Crestline is completed on schedule by early June 2025 and any resulting design modifications are incorporated into the regulatory submissions in a timely manner.
This Memorandum constitutes a preliminary legal assessment based on the Crestline Preliminary FTO Assessment Report dated April 10, 2025. It will be supplemented upon completion of Crestline's full claim-by-claim chart analysis, at which time Calderwood & Harkness will issue an updated and comprehensive FTO risk assessment memorandum incorporating the final analysis and revised recommendations.
Calderwood & Harkness remains available to discuss the contents of this Memorandum with the Solstice team at your convenience. Please do not hesitate to contact us with any questions.
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Miriam Calloway Responsible Partner, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-4100
Email: m.calloway@calderwoodharkness.com
By: ________
Amy Whitfield Lead Associate, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-4127
Email: a.whitfield@calderwoodharkness.com
ENCLOSURES / ATTACHMENTS
Note: The Crestline IP Advisory LLC Preliminary FTO Assessment Report, dated April 10, 2025, is referenced throughout this Memorandum but is not attached hereto. The Crestline Preliminary Report is a privileged document maintained separately by Calderwood & Harkness LLP and is available upon request from Calderwood & Harkness. Requests for access to the Crestline Preliminary Report should be directed to Miriam Calloway or Amy Whitfield at the contact information set forth above.
PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED — ATTORNEY WORK PRODUCT This Memorandum is intended exclusively for the use of the addressees identified herein. Unauthorized dissemination, distribution, or copying of this Memorandum or its contents is strictly prohibited and may constitute a waiver of applicable legal privileges.
Field | Detail
Patent No. | U.S. 10,847,221
Title | Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating
Issue Date | December 1, 2020
Expiration Date | November 14, 2037
Assignee | NovaSense Medical Technologies Inc.
Named Inventors | Dr. Harold Yuen; Dr. Priya Anand; Michael Strauss
Subject Matter | Multi-layer enzyme coating architecture for electrochemical glucose sensors
Field | Detail
Patent No. | U.S. 11,234,567
Title | Signal Processing Algorithm for Continuous Analyte Monitoring
Issue Date | January 25, 2022
Expiration Date | March 22, 2039
Assignee | NovaSense Medical Technologies Inc.
Named Inventors | Dr. Wei-Lin Chen; Sarah Kowalski; Dr. Harold Yuen
Subject Matter | Signal processing algorithm for filtering, calibrating, and predicting analyte concentrations
Field | Detail
Patent No. | U.S. 11,502,893
Title | Wireless Transmission Protocol for Implantable Biosensors
Issue Date | November 15, 2022
Expiration Date | June 8, 2040
Assignee | NovaSense Medical Technologies Inc.
Named Inventors | Michael Strauss; Dr. Elena Markov; Ryan Choi
Subject Matter | Wireless data transmission protocol for implantable biosensor applications
Patent No. | Title | Issue Date | Expiration Date | Subject Matter Category | Relevant Lumina Component | Risk Rating
U.S. 10,847,221 | Electrochemical Glucose Sensor with Multi-Layer Enzyme Coating | Dec. 1, 2020 | Nov. 14, 2037 | Electrode Chemistry / Enzyme Coating Architecture | Lumina C14 Sensor | Low-to-Moderate
U.S. 11,234,567 | Signal Processing Algorithm for Continuous Analyte Monitoring | Jan. 25, 2022 | Mar. 22, 2039 | Signal Processing Algorithm | Lumina C14 (firmware) / Lumina R7 (reader OS) / LuminaPredict Algorithm | Low
U.S. 11,502,893 | Wireless Transmission Protocol for Implantable Biosensors | Nov. 15, 2022 | Jun. 8, 2040 | Wireless Transmission Protocol | Lumina C14 Sensor / Lumina R7 Reader | Low

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