1037-00002 · Client 1037 · Strategy & Analysis

mdufa-small-business-analysis-memo.docx DOCUMENT Finance & Banking

34 / 40 ← → ✕

MEMORANDUM

PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT PRIVILEGED

To: Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd. Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.

From: Calderwood & Harkness LLP Amy Whitfield, Lead Associate, Healthcare & Life Sciences Reviewed by: Miriam Calloway, Responsible Partner, Healthcare & Life Sciences

Date: April 22, 2025

Re: MDUFA Small Business Qualification Analysis — Solstice Biomedical Inc. 510(k) User Fee Assessment for the Solstice Lumina™ CGM System

Engagement Reference No.: 1037-00002

I. Executive Summary

This memorandum addresses whether Solstice Biomedical Inc. ("SBI"), a Delaware corporation (File No. 7834291) and wholly owned U.S. subsidiary of Solstice Biomedical Devices Ltd. ("SBD"), qualifies as a "small business" under the Medical Device User Fee Amendments ("MDUFA") for the purpose of obtaining reduced 510(k) premarket notification review fees. The question arises in connection with SBI's planned traditional 510(k) submission for the Solstice Lumina™ Continuous Glucose Monitoring System, comprising the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter (collectively, the "Lumina CGM System" or the "Device").

Bottom-Line Conclusion: SBI does not qualify for small business status under MDUFA. Accordingly, the standard FY2025 510(k) review fee of $22,417 applies to SBI's planned submission.

The basis for this conclusion is straightforward. While SBI's standalone U.S. revenue of approximately $22.8 million (FY2024) falls well below the applicable $100 million gross receipts threshold for small business qualification, the MDUFA small business determination requires that the applicant's revenue be combined with the gross receipts or sales of all affiliates, including any parent company and all entities under common ownership or control. SBD, as the sole owner of SBI and the entity exercising control over SBI's management and policies, is an "affiliate" of SBI within the meaning of the statute and applicable FDA guidance. SBD's global consolidated revenue for FY2024 was €187.4 million, which converts to approximately $204.3 million at a reference exchange rate of €1 = $1.09. This consolidated revenue figure exceeds the $100 million small business threshold by more than a factor of two.

As a result, SBI should not submit a Small Business Certification Request to FDA and should budget for the standard 510(k) review fee in its U.S. market entry cost projections. The detailed analysis supporting this conclusion is set forth in the sections that follow.

II. Background

A. The Applicant Entity

Solstice Biomedical Inc. is a Delaware corporation, registered with the Delaware Division of Corporations under File No. 7834291. SBI maintains its principal offices at 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142. SBI was incorporated in Delaware and serves as the primary vehicle through which the Solstice group of companies conducts its U.S.-based commercial and regulatory operations in the medical device sector. SBI is the intended holder of the 510(k) clearance for the Solstice Lumina™ CGM System and will serve as the U.S. establishment registered with FDA for the manufacture, distribution, and post-market surveillance of the Device.

SBI is a wholly owned subsidiary of Solstice Biomedical Devices Ltd. ("SBD"), an Irish private limited company registered with the Companies Registration Office of Ireland under CRO No. 648231. SBD is headquartered at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. SBD serves as the global parent of the Solstice group and oversees the strategic direction, product development, and commercial operations of all affiliated entities, including SBI. SBD holds 100% of the issued and outstanding equity of SBI, and SBD's board of directors retains ultimate authority over SBI's governance, including the appointment and removal of SBI's officers and directors.

For FY2024 (the twelve-month period ending December 31, 2024), SBI reported revenue of approximately $22.8 million, derived principally from the sale of previously cleared medical device accessories and OEM sensor components to third-party device manufacturers in the United States. This revenue figure is drawn from SBI's internal unaudited financial statements, which were prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP") and reconciled to SBD's consolidated financial statements. SBI currently employs approximately 95 individuals in the United States, including regulatory affairs, quality assurance, engineering, and commercial personnel.

SBD's global consolidated revenue for FY2024 was €187.4 million, as reported in audited consolidated financial statements prepared in accordance with International Financial Reporting Standards ("IFRS") and audited by Broadleaf Accounting Partners LLP, an independent external auditor headquartered at 12 Harcourt Street, Dublin D02 P890, Ireland. The audit was conducted under the supervision of audit partner Declan Murray. The Solstice group employs approximately 820 individuals globally across its operations in Ireland, the United States, Germany, and Singapore.

B. Planned 510(k) Submission

SBI intends to submit a traditional 510(k) premarket notification to FDA for the Solstice Lumina™ CGM System. The Device comprises two integrated components:

1. Lumina C14 Implantable Sensor — a subcutaneously implanted, enzyme-based electrochemical glucose sensor designed for continuous interstitial glucose measurement for up to 14 days per wear cycle.

2. Lumina R7 Wearable Reader/Transmitter — a skin-worn transmitter unit that wirelessly communicates with the Lumina C14 sensor, processes raw glucose signal data using a proprietary algorithm, and transmits calibrated glucose readings to a compatible mobile application and/or dedicated receiver display.

The Device is intended for prescription use by adults (18 years of age and older) with diabetes mellitus for the management of diabetes, including the replacement of fingerstick blood glucose testing for diabetes treatment decisions, subject to certain use conditions to be specified in the labeling.

The anticipated product code for the Lumina CGM System is QKQ, corresponding to the regulatory classification for electrode-type continuous glucose monitoring systems under 21 C.F.R. § 862.1355, which classifies such devices as Class II medical devices subject to special controls. SBI intends to pursue a traditional 510(k) pathway, as opposed to an abbreviated or special 510(k), based on the scope of technological differences between the Lumina CGM System and the identified predicate devices, as well as the extent of clinical performance data that SBI anticipates submitting in support of substantial equivalence.

The primary predicate device for purposes of the 510(k) submission is the NovaSense GlucoTrack NX-500 CGM System (510(k) No. K211034, cleared by FDA on June 18, 2022). The secondary predicate device is the NovaSense GlucoTrack NX-700 CGM System (510(k) No. K230489, cleared by FDA on March 7, 2024). SBI's pre-submission strategy, predicate device selection rationale, and substantial equivalence arguments are being developed under separate workstreams and are not addressed in this memorandum.

SBI's target submission date for the Lumina CGM 510(k) is April 30, 2026. This date falls within the federal fiscal year 2026 (October 1, 2025 through September 30, 2026); however, because the applicable user fee is assessed based on the fee schedule in effect at the time of submission, and because FDA publishes the fee schedule annually effective October 1, the FY2026 fee schedule will technically govern. As discussed further in Section V.C below, the FY2025 fee schedule serves as the best currently available reference point for budgeting purposes, given that the FY2026 fee schedule has not yet been published as of the date of this memorandum. Regardless of whether the FY2025 or FY2026 fee schedule ultimately applies, the qualification analysis under the MDUFA small business definition is the same and produces the same result.

C. Relevance of Fee Determination

The 510(k) user fee is one component of the total estimated external regulatory costs for SBI's U.S. market entry program for the Lumina CGM System. The current total estimated external regulatory cost budget for the program is $6,127,417, which encompasses the 510(k) user fee, clinical study costs (including an anticipated U.S. pivotal clinical performance study), biocompatibility testing, electromagnetic compatibility and electrical safety testing, third-party laboratory and consulting fees, predicate device benchmarking, and post-clearance establishment and listing fees, among other line items. The 510(k) user fee of $22,417 represents a relatively modest fraction (approximately 0.37%) of the total program budget.

Notwithstanding the comparatively small magnitude of the fee differential between the standard and small business rates, an accurate qualification analysis is necessary for two independent reasons. First, proper budgeting requires that all cost line items be based on correct assumptions, and the regulatory affairs and finance teams at SBI and SBD have requested confirmation of the applicable fee amount for incorporation into the program budget and related financial planning. Second, and more importantly, claiming small business status to FDA when the applicant does not in fact qualify could constitute a material misrepresentation to the Agency. FDA takes the accuracy of small business certifications seriously, and an erroneous claim—even if made in good faith—could result in the assessment of additional fees, delays in the review process, or other adverse administrative consequences. It is therefore essential that SBI's fee classification be determined correctly before the submission is filed.

III. MDUFA Legal Framework

A. Statutory and Regulatory Basis

The Medical Device User Fee Amendments ("MDUFA") were first enacted as part of the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) and have been reauthorized on a recurring basis approximately every five years since that time. The most recent reauthorization was enacted as Title III of the FDA User Fee Reauthorization Act of 2022, commonly referred to as MDUFA V (Pub. L. 117-180, Title III, signed into law on September 30, 2022). MDUFA V authorizes FDA to collect user fees for various categories of premarket submissions and related activities through FY2027.

The statutory authority for MDUFA user fees is codified at 21 U.S.C. § 379j (Section 738 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.). Section 738 establishes the categories of fees that FDA may collect, sets forth the methodology for calculating fee amounts, and defines the eligibility criteria for reduced fees applicable to small businesses and other qualifying entities. In addition to the statutory text, FDA has issued guidance documents and published Federal Register notices further elaborating on the fee schedule, the small business qualification process, and the mechanics of fee payment and certification.

FDA publishes the applicable user fee rates annually in the Federal Register, typically in a notice issued during the summer months preceding each fiscal year. The FY2025 fee schedule, applicable to submissions received by FDA during the period from October 1, 2024, through September 30, 2025, was published in the Federal Register on August 2, 2024. The FY2026 fee schedule, which will govern submissions received from October 1, 2025, through September 30, 2026, has not yet been published as of the date of this memorandum. Because SBI's planned submission date of April 30, 2026 falls within FY2026, the FY2026 fee schedule will technically apply; however, for the purposes of this analysis, the FY2025 fee amounts are used as the current best available reference, with the understanding that the FY2026 amounts may be adjusted modestly based on FDA's annual fee recalculation methodology.

It is important to note that user fees under MDUFA are assessed at the time of submission, not at the time the device is cleared or at any other milestone. A 510(k) submission that is received by FDA without payment of the applicable fee (or with payment of an incorrect fee amount) may be refused for filing or placed on administrative hold until the correct fee is received. Accordingly, accurate determination of the fee amount, including the applicant's eligibility (or ineligibility) for small business reduced fees, is a necessary prerequisite to a successful submission.

B. Small Business Definition Under MDUFA

The MDUFA small business definition is central to the analysis in this memorandum. Under Section 738 of the FD&C Act, a "small business" is generally defined as a business, including any affiliate of such business, having gross receipts or sales of not more than a specified dollar threshold in the most recent tax year. For the current MDUFA V cycle, the applicable threshold is $100 million in gross receipts or sales.

The critical feature of this definition—and the dispositive factor in the present analysis—is the requirement that the applicant's revenue be combined with the gross receipts or sales of all affiliates. The statute does not permit an applicant to look solely at its own standalone revenue; rather, the revenues of the applicant and all affiliates must be aggregated and measured against the threshold on a consolidated basis.

FDA defines the term "affiliate" broadly for purposes of MDUFA. An affiliate of an applicant includes any entity that controls the applicant, any entity that is controlled by the applicant, and any entity that is under common control with the applicant. The concept of "control" is defined as the power to direct or cause the direction of the management and policies of an entity, whether through ownership of voting securities, by contract, or otherwise. This definition is intentionally expansive and is designed to prevent applicants from artificially structuring their corporate organizations to fall below the small business threshold when the economic reality of the enterprise exceeds it.

In practical terms, the affiliate aggregation rule means that a U.S. subsidiary of a large foreign parent company cannot claim small business status on the basis of its own relatively modest U.S. revenue if the parent company's global consolidated revenue exceeds the threshold. Similarly, two or more commonly owned entities must combine their revenues for purposes of the calculation, even if each entity independently falls below the threshold.

FDA's guidance on the small business qualification process requires applicants seeking small business status to submit a Small Business Certification Request to FDA, typically in advance of the planned submission. The certification request requires the applicant to identify all affiliates and to provide information regarding the gross receipts or sales of the applicant and all affiliates for the most recent tax year. FDA reviews the certification request and, if the applicant qualifies, issues a Small Business Qualification Decision recognizing the applicant's eligibility for reduced fees. The qualification decision is generally valid for the fiscal year in which it is issued, and applicants must recertify annually if they wish to maintain small business status for subsequent submissions.

C. FY2025 Fee Amounts

The FY2025 user fee schedule, as published in the Federal Register, establishes the following relevant fee amounts for 510(k) premarket notification submissions:

• Standard 510(k) Review Fee (FY2025): $22,417

• Small Business 510(k) Review Fee (FY2025): A significantly reduced rate is available to qualified small businesses. The exact FY2025 small business 510(k) rate, while published in the Federal Register notice, is not material to the present analysis because, as demonstrated below, SBI does not qualify for small business status. For reference, the small business 510(k) fee has historically been set at approximately 25% to 50% of the standard rate, but the precise discount varies from year to year based on FDA's fee methodology and the total revenue base of small business applicants.

As noted above, the FY2026 fee schedule has not yet been published and may differ modestly from the FY2025 schedule. However, the qualification analysis is independent of the specific fee amount and is based solely on the comparison of consolidated affiliate revenue to the $100 million threshold.

IV. Analysis of SBI's Small Business Qualification

A. SBI Standalone Revenue

SBI reported revenue of approximately $22.8 million for FY2024, its most recent completed fiscal year. This revenue was derived primarily from the sale of previously cleared medical device accessories and OEM sensor components manufactured and distributed by SBI within the United States. The FY2024 revenue figure is drawn from SBI's internal unaudited financial statements, which have been reviewed by SBI's controller and reconciled to SBD's consolidated financial statements prepared under IFRS.

On a standalone basis, SBI's revenue of $22.8 million is well below the $100 million MDUFA small business threshold. If SBI were an independent entity with no parent company or affiliates, it would clearly qualify for small business status and would be eligible for the reduced 510(k) review fee.

However, as discussed in Section III.B above, the MDUFA small business determination does not permit a standalone analysis. The statute and FDA guidance explicitly require that the applicant's revenue be combined with the gross receipts or sales of all affiliates, including any parent company and all entities under common ownership or control. Accordingly, SBI's standalone revenue is relevant only as one component of the consolidated calculation, and the standalone figure alone is insufficient to establish eligibility.

B. Affiliate Analysis — Relationship to SBD

The affiliate analysis under MDUFA turns on whether SBD and SBI are "affiliates" within the meaning of the statute and FDA guidance. As set forth below, the answer is unambiguously yes.

SBI is a wholly owned subsidiary of Solstice Biomedical Devices Ltd. SBD holds 100% of the issued and outstanding shares of SBI's common stock. SBD's board of directors has the power to appoint and remove SBI's officers and directors, to approve SBI's annual budget and strategic plan, and to direct SBI's management and policies on all material matters. SBD exercises this power actively and regularly through its governance of SBI, including through quarterly board meetings, annual strategic planning sessions, and ongoing operational oversight by SBD's executive management team.

Under the MDUFA affiliate definition, SBD "controls" SBI because SBD possesses the power to direct or cause the direction of SBI's management and policies through its ownership of 100% of SBI's voting securities. This is the most straightforward and unambiguous form of control recognized under the MDUFA framework. There is no question that SBD and SBI are affiliates for purposes of the small business determination.

Moreover, to the extent that SBD owns or controls any other subsidiaries or affiliated entities (which, based on publicly available information, includes subsidiaries in Germany and Singapore), the revenues of those entities would likewise be included in the consolidated calculation. However, because SBD's consolidated financial statements already incorporate the revenues of all subsidiaries and affiliates (including SBI), the use of SBD's consolidated revenue figure as the basis for the calculation captures all relevant affiliate revenue without the need for a separate entity-by-entity aggregation.

C. Consolidated Revenue Calculation

SBD's global consolidated revenue for FY2024 was €187.4 million, as reported in the audited consolidated financial statements prepared by SBD's management and audited by Broadleaf Accounting Partners LLP. Broadleaf is an independent external auditing firm headquartered at 12 Harcourt Street, Dublin D02 P890, Ireland, and the audit was conducted under the supervision of audit partner Declan Murray. The financial statements were prepared in accordance with International Financial Reporting Standards ("IFRS") as adopted by the European Union and were issued with an unqualified audit opinion.

Because the MDUFA small business threshold is denominated in U.S. dollars, it is necessary to convert SBD's euro-denominated revenue into U.S. dollars for purposes of the comparison. Using a reference exchange rate of €1 = $1.09, SBD's global consolidated revenue of €187.4 million converts to approximately $204.3 million (€187.4M × $1.09 = $204.27M, rounded to $204.3M).

A note on the exchange rate methodology is warranted. FDA has not prescribed a specific exchange rate or conversion methodology for purposes of the MDUFA small business determination. In practice, applicants with foreign parent companies or affiliates typically use either the average exchange rate for the relevant fiscal year (as published by a recognized source such as the European Central Bank, the Federal Reserve, or a comparable institution) or the exchange rate in effect on the last day of the relevant fiscal year. The €1 = $1.09 rate used in this memorandum is a reasonable reference rate consistent with prevailing EUR/USD exchange rates during the FY2024 period. Importantly, the selection of any reasonable exchange rate does not affect the outcome of the analysis: at any plausible EUR/USD conversion rate within the range observed over the past several years (approximately €1 = $1.05 to €1 = $1.15), SBD's consolidated revenue of €187.4 million would convert to a U.S. dollar figure significantly in excess of $100 million. Even at the most unfavorable plausible rate of €1 = $1.05, the converted revenue would be approximately $196.8 million—still nearly double the $100 million threshold.

The consolidated global revenue of SBD and all affiliates, including SBI, is therefore approximately $204.3 million, which far exceeds the $100 million MDUFA small business threshold.

D. Conclusion on Qualification

Based on the foregoing analysis, SBI does not qualify as a small business under MDUFA. The consolidated revenue of SBD and its affiliates—approximately $204.3 million—is more than double the applicable $100 million threshold. The fact that SBI's standalone U.S. revenue of $22.8 million falls below the threshold is irrelevant under the MDUFA framework, which mandates affiliate revenue aggregation.

Accordingly, the standard FY2025 510(k) review fee of $22,417 applies to SBI's planned 510(k) premarket notification submission for the Solstice Lumina™ CGM System. SBI is not eligible for the reduced small business 510(k) fee rate.

V. Practical Implications and Recommendations

A. Fee Budgeting

The standard 510(k) review fee of $22,417 (based on the FY2025 fee schedule) has been incorporated as a line item in the total estimated external regulatory costs of $6,127,417 for the Lumina CGM U.S. market entry program. Because the conclusion of this memorandum confirms that SBI does not qualify for the small business reduced fee, no adjustment to the program budget is required at this time with respect to the 510(k) user fee line item.

We note, however, that the FY2026 fee schedule (which will govern the submission if it is filed on the target date of April 30, 2026) has not yet been published. The FY2026 standard 510(k) fee may differ modestly from the FY2025 amount of $22,417 due to FDA's annual recalculation methodology, which accounts for inflation and other factors. We recommend that SBI's regulatory affairs and finance teams monitor the Federal Register for the publication of the FY2026 fee schedule (expected in approximately July or August 2025) and update the program budget accordingly if the FY2026 amount differs from the FY2025 figure used in the current estimate.

B. Small Business Certification

SBI should not submit a Small Business Certification Request to FDA. The MDUFA small business qualification process requires the applicant to certify, among other things, the gross receipts or sales of the applicant and all affiliates for the most recent tax year. Given that SBD's consolidated revenue clearly exceeds the $100 million threshold, submitting a certification request would either result in a denial of small business status by FDA (an unnecessary expenditure of time and administrative resources) or, worse, could raise concerns about the accuracy and good faith of SBI's representations to the Agency if the certification request were to contain inaccurate or incomplete information regarding affiliate revenue.

If SBI were to erroneously claim small business status—whether through an intentional misrepresentation or an inadvertent error—and this were later discovered by FDA, the consequences could include, without limitation:

• Assessment of additional fees representing the difference between the small business rate and the standard rate, plus any applicable penalties or interest;

• Delay or hold on the review of SBI's 510(k) submission pending resolution of the fee discrepancy;

• Potential reputational harm to SBI's relationship with FDA, which could affect future interactions with the Agency, including pre-submission meetings, requests for additional information, and the review of subsequent submissions; and

• In extreme cases, potential referral for investigation of fraud or false statements under applicable federal law, although this outcome would be unlikely absent evidence of intentional misrepresentation.

Given these risks, and given the clarity of the disqualification analysis, the prudent course is to forgo any small business certification request and to pay the standard 510(k) fee at the time of submission.

C. Fee Payment Timing

The 510(k) user fee must be paid at the time of submission. Payment is typically made electronically through the U.S. government's pay.gov portal, which FDA uses for the collection of user fees. SBI should initiate the fee payment process sufficiently in advance of the planned submission date to ensure that payment is confirmed and a payment confirmation number is available for inclusion in the 510(k) cover letter and the electronic submission record.

SBI should take particular care to confirm the applicable fee amount against the then-current fiscal year fee schedule at the time of actual submission. As noted above, SBI's target submission date is April 30, 2026, which falls within FY2026. The FY2026 fee schedule will govern. If, however, the submission date were to slip beyond September 30, 2026 (i.e., into FY2027), the FY2027 fee schedule would apply and the fee amount may differ. SBI's regulatory affairs team should coordinate with finance to ensure that the correct fee amount is paid in connection with the submission, regardless of any changes to the submission timeline.

We also note that FDA periodically updates the pay.gov payment process and submission fee instructions. SBI should consult the FDA MDUFA user fee webpage and the most current edition of FDA's "Guidance for Industry and FDA Staff: Medical Device User Fee Cover Sheet (Form FDA 3601)" or its successor guidance for the most up-to-date payment instructions at the time of submission.

D. Future Reconsideration

Small business status under MDUFA is assessed annually, and an applicant's qualification may change from year to year if its revenue or corporate structure changes. Accordingly, if SBD's consolidated revenue were to fall below the $100 million threshold in a future year—for example, due to a material divestiture, corporate restructuring, spin-off, or other transaction that results in SBI no longer being an affiliate of an entity with revenue exceeding the threshold—SBI could seek small business qualification for submissions made in that subsequent period.

Based on our current understanding of SBD's business and corporate structure, no such changes are currently anticipated. SBD's consolidated revenue of €187.4 million reflects a diversified global medical device business with established product lines and growing market presence, and there is no indication that revenue will decline to a level approaching the $100 million threshold in the near term. However, should circumstances change, we would be pleased to revisit this analysis in connection with any future premarket submissions.

VI. Summary Table

VII. Closing

This memorandum is provided for informational purposes in connection with the Calderwood & Harkness LLP engagement relating to the regulatory strategy for the Solstice Lumina™ CGM System and specifically addresses the MDUFA user fee qualification analysis for SBI's planned 510(k) submission. This memorandum does not constitute tax advice, and SBI and SBD should consult their respective tax advisors with respect to any tax-related questions arising from the user fee determination or the characterization of user fee payments for tax purposes.

We trust this analysis is responsive to the questions raised by SBI and SBD regarding the applicable 510(k) user fee. Should you have any questions regarding the analysis set forth herein, or should you wish to discuss any aspect of the MDUFA fee framework, the small business qualification process, or the broader regulatory strategy for the Lumina CGM System, please do not hesitate to contact the undersigned.

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Amy Whitfield Lead Associate, Healthcare & Life Sciences Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Direct: (202) 555-7814 awhitfield@calderwoodharkness.com

Reviewed by:

________________________________________

Miriam Calloway Responsible Partner, Healthcare & Life Sciences Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Direct: (202) 555-7802 mcalloway@calderwoodharkness.com

CONFIDENTIALITY NOTICE: This memorandum is a privileged and confidential attorney-client communication prepared by Calderwood & Harkness LLP for the exclusive use of Solstice Biomedical Inc. and Solstice Biomedical Devices Ltd. in connection with Engagement Reference No. 1037-00002. This memorandum is protected by the attorney-client privilege and the work product doctrine. Any unauthorized review, use, disclosure, or distribution of this memorandum is strictly prohibited. If you have received this memorandum in error, please notify the sender immediately and destroy all copies.

Parameter	Value
Applicant	Solstice Biomedical Inc. (Delaware File No. 7834291)
Parent Company	Solstice Biomedical Devices Ltd. (Ireland CRO No. 648231)
Ownership Structure	SBI is a wholly owned subsidiary of SBD (100% equity)
SBI FY2024 Revenue (standalone)	$22.8M
SBD FY2024 Global Revenue (consolidated, audited)	€187.4M (≈ $204.3M at €1 = $1.09)
MDUFA Small Business Threshold	$100M (gross receipts/sales, inclusive of affiliates)
Qualifies as Small Business?	No
Applicable FY2025 510(k) Review Fee	$22,417 (standard rate)
Device	Solstice Lumina™ CGM System (C14 sensor / R7 reader-transmitter)
Submission Type	Traditional 510(k)
Product Code / Regulation	QKQ / 21 C.F.R. § 862.1355 (Class II)
Planned Submission Date	April 30, 2026

MEMORANDUM
PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT PRIVILEGED
To: Dr. Niamh Tierney, Vice President of Regulatory Affairs, Solstice Biomedical Devices Ltd. Marcus Hale, Vice President of U.S. Operations, Solstice Biomedical Inc.
From: Calderwood & Harkness LLP Amy Whitfield, Lead Associate, Healthcare & Life Sciences Reviewed by: Miriam Calloway, Responsible Partner, Healthcare & Life Sciences
Date: April 22, 2025
Re: MDUFA Small Business Qualification Analysis — Solstice Biomedical Inc. 510(k) User Fee Assessment for the Solstice Lumina™ CGM System
Engagement Reference No.: 1037-00002
I. Executive Summary
This memorandum addresses whether Solstice Biomedical Inc. ("SBI"), a Delaware corporation (File No. 7834291) and wholly owned U.S. subsidiary of Solstice Biomedical Devices Ltd. ("SBD"), qualifies as a "small business" under the Medical Device User Fee Amendments ("MDUFA") for the purpose of obtaining reduced 510(k) premarket notification review fees. The question arises in connection with SBI's planned traditional 510(k) submission for the Solstice Lumina™ Continuous Glucose Monitoring System, comprising the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter (collectively, the "Lumina CGM System" or the "Device").
Bottom-Line Conclusion: SBI does not qualify for small business status under MDUFA. Accordingly, the standard FY2025 510(k) review fee of $22,417 applies to SBI's planned submission.
The basis for this conclusion is straightforward. While SBI's standalone U.S. revenue of approximately $22.8 million (FY2024) falls well below the applicable $100 million gross receipts threshold for small business qualification, the MDUFA small business determination requires that the applicant's revenue be combined with the gross receipts or sales of all affiliates, including any parent company and all entities under common ownership or control. SBD, as the sole owner of SBI and the entity exercising control over SBI's management and policies, is an "affiliate" of SBI within the meaning of the statute and applicable FDA guidance. SBD's global consolidated revenue for FY2024 was €187.4 million, which converts to approximately $204.3 million at a reference exchange rate of €1 = $1.09. This consolidated revenue figure exceeds the $100 million small business threshold by more than a factor of two.
As a result, SBI should not submit a Small Business Certification Request to FDA and should budget for the standard 510(k) review fee in its U.S. market entry cost projections. The detailed analysis supporting this conclusion is set forth in the sections that follow.
II. Background
A. The Applicant Entity
Solstice Biomedical Inc. is a Delaware corporation, registered with the Delaware Division of Corporations under File No. 7834291. SBI maintains its principal offices at 220 Westbrook Drive, Suite 400, Cambridge, Massachusetts 02142. SBI was incorporated in Delaware and serves as the primary vehicle through which the Solstice group of companies conducts its U.S.-based commercial and regulatory operations in the medical device sector. SBI is the intended holder of the 510(k) clearance for the Solstice Lumina™ CGM System and will serve as the U.S. establishment registered with FDA for the manufacture, distribution, and post-market surveillance of the Device.
SBI is a wholly owned subsidiary of Solstice Biomedical Devices Ltd. ("SBD"), an Irish private limited company registered with the Companies Registration Office of Ireland under CRO No. 648231. SBD is headquartered at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. SBD serves as the global parent of the Solstice group and oversees the strategic direction, product development, and commercial operations of all affiliated entities, including SBI. SBD holds 100% of the issued and outstanding equity of SBI, and SBD's board of directors retains ultimate authority over SBI's governance, including the appointment and removal of SBI's officers and directors.
For FY2024 (the twelve-month period ending December 31, 2024), SBI reported revenue of approximately $22.8 million, derived principally from the sale of previously cleared medical device accessories and OEM sensor components to third-party device manufacturers in the United States. This revenue figure is drawn from SBI's internal unaudited financial statements, which were prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP") and reconciled to SBD's consolidated financial statements. SBI currently employs approximately 95 individuals in the United States, including regulatory affairs, quality assurance, engineering, and commercial personnel.
SBD's global consolidated revenue for FY2024 was €187.4 million, as reported in audited consolidated financial statements prepared in accordance with International Financial Reporting Standards ("IFRS") and audited by Broadleaf Accounting Partners LLP, an independent external auditor headquartered at 12 Harcourt Street, Dublin D02 P890, Ireland. The audit was conducted under the supervision of audit partner Declan Murray. The Solstice group employs approximately 820 individuals globally across its operations in Ireland, the United States, Germany, and Singapore.
B. Planned 510(k) Submission
SBI intends to submit a traditional 510(k) premarket notification to FDA for the Solstice Lumina™ CGM System. The Device comprises two integrated components:
1.  Lumina C14 Implantable Sensor — a subcutaneously implanted, enzyme-based electrochemical glucose sensor designed for continuous interstitial glucose measurement for up to 14 days per wear cycle.
2.  Lumina R7 Wearable Reader/Transmitter — a skin-worn transmitter unit that wirelessly communicates with the Lumina C14 sensor, processes raw glucose signal data using a proprietary algorithm, and transmits calibrated glucose readings to a compatible mobile application and/or dedicated receiver display.
The Device is intended for prescription use by adults (18 years of age and older) with diabetes mellitus for the management of diabetes, including the replacement of fingerstick blood glucose testing for diabetes treatment decisions, subject to certain use conditions to be specified in the labeling.
The anticipated product code for the Lumina CGM System is QKQ, corresponding to the regulatory classification for electrode-type continuous glucose monitoring systems under 21 C.F.R. § 862.1355, which classifies such devices as Class II medical devices subject to special controls. SBI intends to pursue a traditional 510(k) pathway, as opposed to an abbreviated or special 510(k), based on the scope of technological differences between the Lumina CGM System and the identified predicate devices, as well as the extent of clinical performance data that SBI anticipates submitting in support of substantial equivalence.
The primary predicate device for purposes of the 510(k) submission is the NovaSense GlucoTrack NX-500 CGM System (510(k) No. K211034, cleared by FDA on June 18, 2022). The secondary predicate device is the NovaSense GlucoTrack NX-700 CGM System (510(k) No. K230489, cleared by FDA on March 7, 2024). SBI's pre-submission strategy, predicate device selection rationale, and substantial equivalence arguments are being developed under separate workstreams and are not addressed in this memorandum.
SBI's target submission date for the Lumina CGM 510(k) is April 30, 2026. This date falls within the federal fiscal year 2026 (October 1, 2025 through September 30, 2026); however, because the applicable user fee is assessed based on the fee schedule in effect at the time of submission, and because FDA publishes the fee schedule annually effective October 1, the FY2026 fee schedule will technically govern. As discussed further in Section V.C below, the FY2025 fee schedule serves as the best currently available reference point for budgeting purposes, given that the FY2026 fee schedule has not yet been published as of the date of this memorandum. Regardless of whether the FY2025 or FY2026 fee schedule ultimately applies, the qualification analysis under the MDUFA small business definition is the same and produces the same result.
C. Relevance of Fee Determination
The 510(k) user fee is one component of the total estimated external regulatory costs for SBI's U.S. market entry program for the Lumina CGM System. The current total estimated external regulatory cost budget for the program is $6,127,417, which encompasses the 510(k) user fee, clinical study costs (including an anticipated U.S. pivotal clinical performance study), biocompatibility testing, electromagnetic compatibility and electrical safety testing, third-party laboratory and consulting fees, predicate device benchmarking, and post-clearance establishment and listing fees, among other line items. The 510(k) user fee of $22,417 represents a relatively modest fraction (approximately 0.37%) of the total program budget.
Notwithstanding the comparatively small magnitude of the fee differential between the standard and small business rates, an accurate qualification analysis is necessary for two independent reasons. First, proper budgeting requires that all cost line items be based on correct assumptions, and the regulatory affairs and finance teams at SBI and SBD have requested confirmation of the applicable fee amount for incorporation into the program budget and related financial planning. Second, and more importantly, claiming small business status to FDA when the applicant does not in fact qualify could constitute a material misrepresentation to the Agency. FDA takes the accuracy of small business certifications seriously, and an erroneous claim—even if made in good faith—could result in the assessment of additional fees, delays in the review process, or other adverse administrative consequences. It is therefore essential that SBI's fee classification be determined correctly before the submission is filed.
III. MDUFA Legal Framework
A. Statutory and Regulatory Basis
The Medical Device User Fee Amendments ("MDUFA") were first enacted as part of the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) and have been reauthorized on a recurring basis approximately every five years since that time. The most recent reauthorization was enacted as Title III of the FDA User Fee Reauthorization Act of 2022, commonly referred to as MDUFA V (Pub. L. 117-180, Title III, signed into law on September 30, 2022). MDUFA V authorizes FDA to collect user fees for various categories of premarket submissions and related activities through FY2027.
The statutory authority for MDUFA user fees is codified at 21 U.S.C. § 379j (Section 738 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.). Section 738 establishes the categories of fees that FDA may collect, sets forth the methodology for calculating fee amounts, and defines the eligibility criteria for reduced fees applicable to small businesses and other qualifying entities. In addition to the statutory text, FDA has issued guidance documents and published Federal Register notices further elaborating on the fee schedule, the small business qualification process, and the mechanics of fee payment and certification.
FDA publishes the applicable user fee rates annually in the Federal Register, typically in a notice issued during the summer months preceding each fiscal year. The FY2025 fee schedule, applicable to submissions received by FDA during the period from October 1, 2024, through September 30, 2025, was published in the Federal Register on August 2, 2024. The FY2026 fee schedule, which will govern submissions received from October 1, 2025, through September 30, 2026, has not yet been published as of the date of this memorandum. Because SBI's planned submission date of April 30, 2026 falls within FY2026, the FY2026 fee schedule will technically apply; however, for the purposes of this analysis, the FY2025 fee amounts are used as the current best available reference, with the understanding that the FY2026 amounts may be adjusted modestly based on FDA's annual fee recalculation methodology.
It is important to note that user fees under MDUFA are assessed at the time of submission, not at the time the device is cleared or at any other milestone. A 510(k) submission that is received by FDA without payment of the applicable fee (or with payment of an incorrect fee amount) may be refused for filing or placed on administrative hold until the correct fee is received. Accordingly, accurate determination of the fee amount, including the applicant's eligibility (or ineligibility) for small business reduced fees, is a necessary prerequisite to a successful submission.
B. Small Business Definition Under MDUFA
The MDUFA small business definition is central to the analysis in this memorandum. Under Section 738 of the FD&C Act, a "small business" is generally defined as a business, including any affiliate of such business, having gross receipts or sales of not more than a specified dollar threshold in the most recent tax year. For the current MDUFA V cycle, the applicable threshold is $100 million in gross receipts or sales.
The critical feature of this definition—and the dispositive factor in the present analysis—is the requirement that the applicant's revenue be combined with the gross receipts or sales of all affiliates. The statute does not permit an applicant to look solely at its own standalone revenue; rather, the revenues of the applicant and all affiliates must be aggregated and measured against the threshold on a consolidated basis.
FDA defines the term "affiliate" broadly for purposes of MDUFA. An affiliate of an applicant includes any entity that controls the applicant, any entity that is controlled by the applicant, and any entity that is under common control with the applicant. The concept of "control" is defined as the power to direct or cause the direction of the management and policies of an entity, whether through ownership of voting securities, by contract, or otherwise. This definition is intentionally expansive and is designed to prevent applicants from artificially structuring their corporate organizations to fall below the small business threshold when the economic reality of the enterprise exceeds it.
In practical terms, the affiliate aggregation rule means that a U.S. subsidiary of a large foreign parent company cannot claim small business status on the basis of its own relatively modest U.S. revenue if the parent company's global consolidated revenue exceeds the threshold. Similarly, two or more commonly owned entities must combine their revenues for purposes of the calculation, even if each entity independently falls below the threshold.
FDA's guidance on the small business qualification process requires applicants seeking small business status to submit a Small Business Certification Request to FDA, typically in advance of the planned submission. The certification request requires the applicant to identify all affiliates and to provide information regarding the gross receipts or sales of the applicant and all affiliates for the most recent tax year. FDA reviews the certification request and, if the applicant qualifies, issues a Small Business Qualification Decision recognizing the applicant's eligibility for reduced fees. The qualification decision is generally valid for the fiscal year in which it is issued, and applicants must recertify annually if they wish to maintain small business status for subsequent submissions.
C. FY2025 Fee Amounts
The FY2025 user fee schedule, as published in the Federal Register, establishes the following relevant fee amounts for 510(k) premarket notification submissions:
•  Standard 510(k) Review Fee (FY2025): $22,417
•  Small Business 510(k) Review Fee (FY2025): A significantly reduced rate is available to qualified small businesses. The exact FY2025 small business 510(k) rate, while published in the Federal Register notice, is not material to the present analysis because, as demonstrated below, SBI does not qualify for small business status. For reference, the small business 510(k) fee has historically been set at approximately 25% to 50% of the standard rate, but the precise discount varies from year to year based on FDA's fee methodology and the total revenue base of small business applicants.
As noted above, the FY2026 fee schedule has not yet been published and may differ modestly from the FY2025 schedule. However, the qualification analysis is independent of the specific fee amount and is based solely on the comparison of consolidated affiliate revenue to the $100 million threshold.
IV. Analysis of SBI's Small Business Qualification
A. SBI Standalone Revenue
SBI reported revenue of approximately $22.8 million for FY2024, its most recent completed fiscal year. This revenue was derived primarily from the sale of previously cleared medical device accessories and OEM sensor components manufactured and distributed by SBI within the United States. The FY2024 revenue figure is drawn from SBI's internal unaudited financial statements, which have been reviewed by SBI's controller and reconciled to SBD's consolidated financial statements prepared under IFRS.
On a standalone basis, SBI's revenue of $22.8 million is well below the $100 million MDUFA small business threshold. If SBI were an independent entity with no parent company or affiliates, it would clearly qualify for small business status and would be eligible for the reduced 510(k) review fee.
However, as discussed in Section III.B above, the MDUFA small business determination does not permit a standalone analysis. The statute and FDA guidance explicitly require that the applicant's revenue be combined with the gross receipts or sales of all affiliates, including any parent company and all entities under common ownership or control. Accordingly, SBI's standalone revenue is relevant only as one component of the consolidated calculation, and the standalone figure alone is insufficient to establish eligibility.
B. Affiliate Analysis — Relationship to SBD
The affiliate analysis under MDUFA turns on whether SBD and SBI are "affiliates" within the meaning of the statute and FDA guidance. As set forth below, the answer is unambiguously yes.
SBI is a wholly owned subsidiary of Solstice Biomedical Devices Ltd. SBD holds 100% of the issued and outstanding shares of SBI's common stock. SBD's board of directors has the power to appoint and remove SBI's officers and directors, to approve SBI's annual budget and strategic plan, and to direct SBI's management and policies on all material matters. SBD exercises this power actively and regularly through its governance of SBI, including through quarterly board meetings, annual strategic planning sessions, and ongoing operational oversight by SBD's executive management team.
Under the MDUFA affiliate definition, SBD "controls" SBI because SBD possesses the power to direct or cause the direction of SBI's management and policies through its ownership of 100% of SBI's voting securities. This is the most straightforward and unambiguous form of control recognized under the MDUFA framework. There is no question that SBD and SBI are affiliates for purposes of the small business determination.
Moreover, to the extent that SBD owns or controls any other subsidiaries or affiliated entities (which, based on publicly available information, includes subsidiaries in Germany and Singapore), the revenues of those entities would likewise be included in the consolidated calculation. However, because SBD's consolidated financial statements already incorporate the revenues of all subsidiaries and affiliates (including SBI), the use of SBD's consolidated revenue figure as the basis for the calculation captures all relevant affiliate revenue without the need for a separate entity-by-entity aggregation.
C. Consolidated Revenue Calculation
SBD's global consolidated revenue for FY2024 was €187.4 million, as reported in the audited consolidated financial statements prepared by SBD's management and audited by Broadleaf Accounting Partners LLP. Broadleaf is an independent external auditing firm headquartered at 12 Harcourt Street, Dublin D02 P890, Ireland, and the audit was conducted under the supervision of audit partner Declan Murray. The financial statements were prepared in accordance with International Financial Reporting Standards ("IFRS") as adopted by the European Union and were issued with an unqualified audit opinion.
Because the MDUFA small business threshold is denominated in U.S. dollars, it is necessary to convert SBD's euro-denominated revenue into U.S. dollars for purposes of the comparison. Using a reference exchange rate of €1 = $1.09, SBD's global consolidated revenue of €187.4 million converts to approximately $204.3 million (€187.4M × $1.09 = $204.27M, rounded to $204.3M).
A note on the exchange rate methodology is warranted. FDA has not prescribed a specific exchange rate or conversion methodology for purposes of the MDUFA small business determination. In practice, applicants with foreign parent companies or affiliates typically use either the average exchange rate for the relevant fiscal year (as published by a recognized source such as the European Central Bank, the Federal Reserve, or a comparable institution) or the exchange rate in effect on the last day of the relevant fiscal year. The €1 = $1.09 rate used in this memorandum is a reasonable reference rate consistent with prevailing EUR/USD exchange rates during the FY2024 period. Importantly, the selection of any reasonable exchange rate does not affect the outcome of the analysis: at any plausible EUR/USD conversion rate within the range observed over the past several years (approximately €1 = $1.05 to €1 = $1.15), SBD's consolidated revenue of €187.4 million would convert to a U.S. dollar figure significantly in excess of $100 million. Even at the most unfavorable plausible rate of €1 = $1.05, the converted revenue would be approximately $196.8 million—still nearly double the $100 million threshold.
The consolidated global revenue of SBD and all affiliates, including SBI, is therefore approximately $204.3 million, which far exceeds the $100 million MDUFA small business threshold.
D. Conclusion on Qualification
Based on the foregoing analysis, SBI does not qualify as a small business under MDUFA. The consolidated revenue of SBD and its affiliates—approximately $204.3 million—is more than double the applicable $100 million threshold. The fact that SBI's standalone U.S. revenue of $22.8 million falls below the threshold is irrelevant under the MDUFA framework, which mandates affiliate revenue aggregation.
Accordingly, the standard FY2025 510(k) review fee of $22,417 applies to SBI's planned 510(k) premarket notification submission for the Solstice Lumina™ CGM System. SBI is not eligible for the reduced small business 510(k) fee rate.
V. Practical Implications and Recommendations
A. Fee Budgeting
The standard 510(k) review fee of $22,417 (based on the FY2025 fee schedule) has been incorporated as a line item in the total estimated external regulatory costs of $6,127,417 for the Lumina CGM U.S. market entry program. Because the conclusion of this memorandum confirms that SBI does not qualify for the small business reduced fee, no adjustment to the program budget is required at this time with respect to the 510(k) user fee line item.
We note, however, that the FY2026 fee schedule (which will govern the submission if it is filed on the target date of April 30, 2026) has not yet been published. The FY2026 standard 510(k) fee may differ modestly from the FY2025 amount of $22,417 due to FDA's annual recalculation methodology, which accounts for inflation and other factors. We recommend that SBI's regulatory affairs and finance teams monitor the Federal Register for the publication of the FY2026 fee schedule (expected in approximately July or August 2025) and update the program budget accordingly if the FY2026 amount differs from the FY2025 figure used in the current estimate.
B. Small Business Certification
SBI should not submit a Small Business Certification Request to FDA. The MDUFA small business qualification process requires the applicant to certify, among other things, the gross receipts or sales of the applicant and all affiliates for the most recent tax year. Given that SBD's consolidated revenue clearly exceeds the $100 million threshold, submitting a certification request would either result in a denial of small business status by FDA (an unnecessary expenditure of time and administrative resources) or, worse, could raise concerns about the accuracy and good faith of SBI's representations to the Agency if the certification request were to contain inaccurate or incomplete information regarding affiliate revenue.
If SBI were to erroneously claim small business status—whether through an intentional misrepresentation or an inadvertent error—and this were later discovered by FDA, the consequences could include, without limitation:
•  Assessment of additional fees representing the difference between the small business rate and the standard rate, plus any applicable penalties or interest;
•  Delay or hold on the review of SBI's 510(k) submission pending resolution of the fee discrepancy;
•  Potential reputational harm to SBI's relationship with FDA, which could affect future interactions with the Agency, including pre-submission meetings, requests for additional information, and the review of subsequent submissions; and
•  In extreme cases, potential referral for investigation of fraud or false statements under applicable federal law, although this outcome would be unlikely absent evidence of intentional misrepresentation.
Given these risks, and given the clarity of the disqualification analysis, the prudent course is to forgo any small business certification request and to pay the standard 510(k) fee at the time of submission.
C. Fee Payment Timing
The 510(k) user fee must be paid at the time of submission. Payment is typically made electronically through the U.S. government's pay.gov portal, which FDA uses for the collection of user fees. SBI should initiate the fee payment process sufficiently in advance of the planned submission date to ensure that payment is confirmed and a payment confirmation number is available for inclusion in the 510(k) cover letter and the electronic submission record.
SBI should take particular care to confirm the applicable fee amount against the then-current fiscal year fee schedule at the time of actual submission. As noted above, SBI's target submission date is April 30, 2026, which falls within FY2026. The FY2026 fee schedule will govern. If, however, the submission date were to slip beyond September 30, 2026 (i.e., into FY2027), the FY2027 fee schedule would apply and the fee amount may differ. SBI's regulatory affairs team should coordinate with finance to ensure that the correct fee amount is paid in connection with the submission, regardless of any changes to the submission timeline.
We also note that FDA periodically updates the pay.gov payment process and submission fee instructions. SBI should consult the FDA MDUFA user fee webpage and the most current edition of FDA's "Guidance for Industry and FDA Staff: Medical Device User Fee Cover Sheet (Form FDA 3601)" or its successor guidance for the most up-to-date payment instructions at the time of submission.
D. Future Reconsideration
Small business status under MDUFA is assessed annually, and an applicant's qualification may change from year to year if its revenue or corporate structure changes. Accordingly, if SBD's consolidated revenue were to fall below the $100 million threshold in a future year—for example, due to a material divestiture, corporate restructuring, spin-off, or other transaction that results in SBI no longer being an affiliate of an entity with revenue exceeding the threshold—SBI could seek small business qualification for submissions made in that subsequent period.
Based on our current understanding of SBD's business and corporate structure, no such changes are currently anticipated. SBD's consolidated revenue of €187.4 million reflects a diversified global medical device business with established product lines and growing market presence, and there is no indication that revenue will decline to a level approaching the $100 million threshold in the near term. However, should circumstances change, we would be pleased to revisit this analysis in connection with any future premarket submissions.
VI. Summary Table
VII. Closing
This memorandum is provided for informational purposes in connection with the Calderwood & Harkness LLP engagement relating to the regulatory strategy for the Solstice Lumina™ CGM System and specifically addresses the MDUFA user fee qualification analysis for SBI's planned 510(k) submission. This memorandum does not constitute tax advice, and SBI and SBD should consult their respective tax advisors with respect to any tax-related questions arising from the user fee determination or the characterization of user fee payments for tax purposes.
We trust this analysis is responsive to the questions raised by SBI and SBD regarding the applicable 510(k) user fee. Should you have any questions regarding the analysis set forth herein, or should you wish to discuss any aspect of the MDUFA fee framework, the small business qualification process, or the broader regulatory strategy for the Lumina CGM System, please do not hesitate to contact the undersigned.
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Amy Whitfield Lead Associate, Healthcare & Life Sciences Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Direct: (202) 555-7814 awhitfield@calderwoodharkness.com
Reviewed by:
________________________________________
Miriam Calloway Responsible Partner, Healthcare & Life Sciences Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Direct: (202) 555-7802 mcalloway@calderwoodharkness.com
CONFIDENTIALITY NOTICE: This memorandum is a privileged and confidential attorney-client communication prepared by Calderwood & Harkness LLP for the exclusive use of Solstice Biomedical Inc. and Solstice Biomedical Devices Ltd. in connection with Engagement Reference No. 1037-00002. This memorandum is protected by the attorney-client privilege and the work product doctrine. Any unauthorized review, use, disclosure, or distribution of this memorandum is strictly prohibited. If you have received this memorandum in error, please notify the sender immediately and destroy all copies.
Parameter | Value
Applicant | Solstice Biomedical Inc. (Delaware File No. 7834291)
Parent Company | Solstice Biomedical Devices Ltd. (Ireland CRO No. 648231)
Ownership Structure | SBI is a wholly owned subsidiary of SBD (100% equity)
SBI FY2024 Revenue (standalone) | $22.8M
SBD FY2024 Global Revenue (consolidated, audited) | €187.4M (≈ $204.3M at €1 = $1.09)
MDUFA Small Business Threshold | $100M (gross receipts/sales, inclusive of affiliates)
Qualifies as Small Business? | No
Applicable FY2025 510(k) Review Fee | $22,417 (standard rate)
Device | Solstice Lumina™ CGM System (C14 sensor / R7 reader-transmitter)
Submission Type | Traditional 510(k)
Product Code / Regulation | QKQ / 21 C.F.R. § 862.1355 (Class II)
Planned Submission Date | April 30, 2026

MEMORANDUM

PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT PRIVILEGED

CALDERWOOD & HARKNESS LLP

Record

Parties

Dates

Amounts