PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION ATTORNEY WORK PRODUCT — PREPARED IN ANTICIPATION OF LITIGATION AND FOR THE PURPOSE OF PROVIDING LEGAL ADVICE
MEMORANDUM
TO: Declan Harrington, General Counsel & Company Secretary, Solstice Biomedical Devices Ltd. Patrick Dunne, Director, US Marketing, Solstice Biomedical Inc. Theresa Brennan, Director, US Regulatory Affairs, Solstice Biomedical Inc.
FROM: Amy Whitfield, Lead Associate, Healthcare & Life Sciences, Calderwood & Harkness LLP
REVIEWED AND APPROVED BY: Joel Strauss, Responsible Partner, Healthcare & Life Sciences, Calderwood & Harkness LLP
DATE: July 15, 2024
RE: FDA Promotional and Advertising Compliance Review — Pulsar™ CRM System (510(k) No. K232847)
MATTER NO.: 1037-00003
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I. Executive Summary
This memorandum presents the results of a comprehensive legal review conducted by Calderwood & Harkness LLP ("C&H") of the proposed United States promotional materials, labeling, advertising, sales training presentations, and website content that Solstice Biomedical Inc. ("Solstice" or the "Company") intends to deploy in connection with the planned October 1, 2024 commercial launch of the Pulsar™ CRM System (the "Pulsar" or the "Device") in the United States. This review was undertaken at the request of Declan Harrington, General Counsel & Company Secretary of Solstice Biomedical Devices Ltd., to ensure that the Company's promotional posture at the time of US launch complies with all applicable provisions of the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), the regulations promulgated thereunder, and relevant FDA guidance documents.
The Pulsar™ CRM System is a Class II medical device (Product Code MHX) that received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") on February 9, 2024 (510(k) No. K232847), with the CardioStar™ SC-200 manufactured by Vantage Medical Technologies Inc. (510(k) No. K201156) serving as the predicate device. The Device is cleared for the following intended use: continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias. All promotional activities must remain within the boundaries of this cleared indication.
C&H reviewed a total of forty-three (43) discrete items comprising: fourteen (14) draft promotional materials (including brochures, sell sheets, digital advertisements, journal advertisements, and conference booth materials); three (3) sales training decks; website content spanning twenty-two (22) pages on the solsticebiomed.com US portal; and four (4) physician-facing leave-behind pieces. Each item was assessed against the cleared Indications for Use statement, the Device labeling (including Instructions for Use), applicable provisions of the FD&C Act and 21 C.F.R. Parts 801 and 807, and relevant FDA guidance documents and enforcement precedents.
Key findings from this review include the following:
•  We identified seven (7) high-priority recommended revisions that must be completed before launch, twelve (12) moderate-priority recommended revisions that should be completed before launch, and five (5) advisory recommendations that are best-practice suggestions but are not legally required.
•  Off-label promotion risks were identified in three (3) materials, most critically in the conference interactive demo station script (Item 13), which contains direct instructions for sales representatives to discuss off-label applications currently under clinical investigation. A systemic pattern of pediatric-use references was also identified across multiple materials despite the Device's clearance being limited to adult patients.
•  Fair balance deficiencies were identified in five (5) items, including materials in which risk information was presented in significantly smaller font size than benefit claims, materials that omitted risk disclosure entirely, and digital content requiring multiple clicks to access safety information.
•  Form FDA 2253 filing requirements are analyzed in detail, and we recommend submission of the complete Form 2253 package no later than September 27, 2024.
•  We strongly recommend the establishment of a formal Medical-Legal-Regulatory ("MLR") review committee and the adoption of a standard operating procedure ("SOP") for the review, approval, and ongoing monitoring of all promotional materials.
Overall Assessment: The promotional materials reviewed are generally well-conceived and demonstrate a strong understanding of the Device's clinical value proposition. However, several significant compliance deficiencies—particularly the recurring pediatric-use references, the consistent drift from "monitoring" language to "diagnostic" or "detection" language, and fair balance shortcomings—require prompt remediation. With the implementation of the recommended revisions, the establishment of the MLR Committee and SOP, timely filing of Form 2253, and deployment of promotional compliance training to the entire US commercial organization, Solstice can achieve a compliant promotional posture for the October 1, 2024 launch.
II. Background
A. Solstice Biomedical Devices Ltd. — Company Overview
Solstice Biomedical Devices Ltd. ("Solstice Biomedical" or "Solstice Parent") is an Irish-headquartered medical device company focused on the development and commercialization of implantable cardiac monitoring technologies. The company maintains its principal offices at Unit 14, Clarion Business Park, Sandyford, Dublin D18 X4F2, Ireland. Solstice Biomedical was founded in 2018 and has established a commercial presence in the European Union and the United Kingdom, where it has marketed cardiac monitoring devices under CE Mark authorization.
In preparation for entry into the US market, Solstice Biomedical formed a wholly owned US subsidiary, Solstice Biomedical Inc. ("Solstice US" or the "Company"), organized as a corporation under the laws of the State of Delaware on January 22, 2024. Solstice US is registered with the Delaware Secretary of State under File No. 7924813 and holds Employer Identification Number 93-4718206. The Company's principal offices are located at 200 Harborview Drive, Suite 1100, Boston, Massachusetts 02210.
Solstice Biomedical closed its Series C financing round in November 2023, raising total capital to date of €187 million, with a post-money valuation of €640 million. The Series C round was led by Alder Peak Ventures, LP, which holds approximately 22.6% of Solstice Biomedical's equity on a fully diluted basis. The Company reported fiscal year 2023 revenue of €38.4 million, derived entirely from EU and UK sales, as the Company has not previously generated revenue in the United States. Management projects US Year-1 revenue of $26 million for the fiscal year ending December 31, 2025, based on the planned October 1, 2024 commercial launch of the Pulsar™ CRM System in the US market.
B. Pulsar™ CRM System — Product and Regulatory Status
The Pulsar™ CRM System is a subcutaneous implantable cardiac monitor designed for continuous cardiac rhythm monitoring. The system consists of two principal components: (1) the Pulsar implantable monitor unit, a miniaturized subcutaneous device that continuously records cardiac electrical activity; and (2) the Pulsar remote telemetry transmitter, a bedside unit that wirelessly receives data from the implanted monitor and transmits it via cellular connectivity to Solstice's proprietary cloud-based remote telemetry platform, where the data is processed, stored, and made available to clinicians through a secure web-based interface.
The Pulsar™ CRM System received FDA 510(k) clearance on February 9, 2024, under 510(k) Number K232847. The designated predicate device is the CardioStar™ SC-200 manufactured by Vantage Medical Technologies Inc. (510(k) No. K201156). The Device is classified as a Class II medical device under Product Code MHX (Cardiac Monitor (Including Cardiorespiratory and Rate Alarm)).
The cleared intended use and indications for use, as set forth in the 510(k) Summary, are as follows:
The Pulsar™ CRM System is intended for continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias.
This cleared indication constitutes the outer boundary of all permissible promotional claims and representations. Any promotion beyond this scope—including, without limitation, promotion for diagnostic purposes, promotion for use in pediatric patients, or promotion for the management or treatment of cardiac arrhythmias—would constitute off-label promotion in violation of the FD&C Act.
The US list prices for the Device components are as follows: implantable monitor unit at $4,950 per unit, and remote telemetry transmitter at $1,200 per unit. The planned US commercial launch date is October 1, 2024.
C. US Commercial Organization
Solstice US is building a dedicated US commercial organization to support the Pulsar™ CRM System launch. At the time of launch, the organization will comprise fifty-three (53) commercial employees, structured as follows:
•  VP, US Commercial Operations: Marcus Reilly, reporting to the CEO of Solstice Biomedical Devices Ltd.
•  Area Vice Presidents (3): Responsible for Eastern, Central, and Western US regions
•  Regional Directors (8): Managing territory-level sales activities across defined geographic areas
•  Territory Managers (42): Field-based sales representatives responsible for direct engagement with electrophysiologists, cardiologists, and implanting physicians at hospitals and ambulatory surgical centers
The US marketing function is led by Patrick Dunne, Director, US Marketing, based in Boston. Mr. Dunne and his team are responsible for the development of all promotional materials, digital marketing campaigns, and conference strategies for the US market. US regulatory affairs are overseen by Theresa Brennan, Director, US Regulatory Affairs, also based in Boston. Ms. Brennan is the Company's primary point of contact with FDA and is responsible for maintaining compliance with all regulatory filing obligations, including Form 2253 submissions.
Medical Affairs oversight is provided by Dr. Nadia Farouk, VP, Medical Affairs, who is based in Dublin. Dr. Farouk is responsible for the scientific integrity of all clinical claims used in promotional materials and serves as the designated recipient of unsolicited requests for off-label information under the Company's emerging compliance framework.
Global compliance oversight is currently provided by Siobhán Mulcahy, Head of Global Compliance, who is based in Dublin and serves as the interim US Compliance Officer. Given the demands of the US commercial launch and the complexity of the US regulatory environment, C&H strongly recommends that Solstice hire a permanent US-based Compliance Officer by Q4 2024 to ensure adequate day-to-day compliance monitoring and to serve as a dedicated point of contact for the US commercial team.
D. Scope of This Memorandum
This memorandum addresses the promotional and advertising compliance of the materials enumerated below. In total, C&H reviewed forty-three (43) discrete items across four categories:
Draft Promotional Materials (14 Items):
Sales Training Decks (3 Items):
Website Content: Twenty-two (22) pages on the solsticebiomed.com US portal, including the home page, product pages (Pulsar monitor and transmitter), clinical evidence page, physician resources section, patient information section, reimbursement information page, media/press page, and "About Us" corporate pages.
Physician-Facing Leave-Behind Pieces (4 Items):
Review Criteria: Each item was evaluated against the following criteria: (1) consistency with the FDA-cleared Indications for Use statement (K232847); (2) off-label promotion risk; (3) fair balance in the presentation of benefit and risk information; (4) adequacy of directions for use; (5) adequacy of risk, contraindication, and warning disclosures; (6) Form FDA 2253 filing obligations and timeline; (7) compliance with FD&C Act §§ 201(m), 301, 502, and 510(k) labeling requirements; (8) compliance with 21 C.F.R. Parts 801 and 807, Subpart E; and (9) consistency with applicable FDA guidance documents and enforcement precedents.
Exclusions: This memorandum does not address state-law promotional requirements, which are the subject of a separate state compliance survey currently in progress (C&H Matter No. 1037-00003). Nor does this memorandum address Anti-Kickback Statute ("AKS"), Physician Payments Sunshine Act, or False Claims Act ("FCA") implications of the Company's promotional activities, which are addressed in a separate AKS/FCA analysis memorandum (C&H Matter No. 1037-00003). Where AKS or FCA issues are implicated by findings in this review, we note the cross-reference to that separate analysis.
III. Applicable Regulatory Framework
A. Federal Food, Drug, and Cosmetic Act — Promotional and Labeling Provisions
The FD&C Act, 21 U.S.C. §§ 301 et seq., establishes the principal federal framework governing the promotion and labeling of medical devices. Several provisions are directly relevant to this review.
FD&C Act § 201(m) (21 U.S.C. § 321(m)) — Definition of "Labeling." The statute defines "labeling" as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." The Supreme Court has construed this definition broadly. In Kordel v. United States, 335 U.S. 345 (1948), the Court held that materials need not physically accompany a product to constitute "labeling"; rather, materials that supplement or explain a product may constitute labeling if there is a sufficient textual relationship between the materials and the product, even if the materials are disseminated separately. Under this expansive interpretation, promotional brochures, sell sheets, website content, conference materials, and sales training aids that supplement or explain the Pulsar™ CRM System are all properly characterized as "labeling" subject to the FD&C Act's misbranding provisions.
FD&C Act § 502 (21 U.S.C. § 352) — Misbranding. A device is deemed misbranded under Section 502 if, among other things: (a) its labeling is false or misleading in any particular (§ 502(a)); (b) its labeling fails to bear adequate directions for use (§ 502(f)(1)); or (c) its labeling fails to bear adequate warnings against uses or methods of use that are dangerous to health, or against unsafe dosages or methods or durations of administration, in such manner and form as are necessary for the protection of users (§ 502(f)(2)). Promotional materials that make claims beyond the cleared indications for use, omit material risk information, present misleading comparative claims, or fail to present a fair balance of benefit and risk information may render the Device misbranded under these provisions.
FD&C Act § 301 (21 U.S.C. § 331) — Prohibited Acts. Section 301 enumerates the acts prohibited under the FD&C Act. Relevant to this review are: the introduction or delivery for introduction into interstate commerce of any device that is misbranded (§ 301(a)); the misbranding of any device in interstate commerce (§ 301(b)); and the dissemination in interstate commerce of any false or misleading advertisement with respect to a device (§ 301(n)). Violations of Section 301 may result in enforcement action by FDA, including Warning Letters, Untitled Letters, seizure, injunction, and criminal prosecution.
FD&C Act § 510(k) (21 U.S.C. § 360(k)) — Premarket Notification. Section 510(k) requires manufacturers to submit a premarket notification to FDA before marketing a device that is substantially equivalent to a legally marketed predicate device. A device cleared through the 510(k) pathway may be lawfully marketed only for the intended use(s) identified in the 510(k) clearance. Promotion of the Device for uses beyond the scope of clearance No. K232847 would render the Device misbranded and adulterated, as the unapproved use would not be covered by the 510(k) clearance, and the Device would be treated as a new device requiring premarket approval or a new 510(k) submission.
Distinction Between "Labeling" and "Advertising." Under the FD&C Act, jurisdiction over the advertising of drugs is shared between FDA and the Federal Trade Commission ("FTC"), with FTC generally having primary jurisdiction over drug advertising. However, for medical devices, FDA exercises jurisdiction over both labeling and advertising under Sections 502 and 301 of the FD&C Act. Accordingly, all of Solstice's promotional materials—whether characterized as labeling or advertising—fall within FDA's regulatory authority.
B. 21 C.F.R. Part 801 — Device Labeling
The FDA regulations at 21 C.F.R. Part 801 set forth detailed requirements for medical device labeling. The following provisions are particularly relevant to this review:
§ 801.4 — Adequate Directions for Use. Labeling must include adequate directions for use, which the regulation defines as directions under which a layperson can use the device safely and for the purposes for which it is intended. For prescription devices such as the Pulsar™ CRM System, this requirement is satisfied through compliance with § 801.109 (discussed below).
§ 801.5 — Adequate Warnings. Where a device is intended for use by persons other than healthcare professionals, labeling must bear adequate warnings against uses or methods of use that are dangerous to health, as well as appropriate cautionary statements. Even for prescription devices, promotional materials directed at healthcare professionals must include adequate risk and warning information to enable informed prescribing decisions.
§ 801.6 — Prominence of Required Label Statements. Required label statements must be prominently placed on the label with such conspicuousness and in such terms as to render them likely to be read and understood by the ordinary individual under customary conditions of purchase and use. This requirement supports the fair balance principle: risk information that is technically present but practically invisible due to small font size, remote placement, or poor contrast does not satisfy the prominence requirement.
§ 801.109 — Exemptions for Prescription Devices. A prescription device is exempt from the requirement of § 801.4 for adequate directions for use by laypeople, provided that: (1) the device is for use by or on the order of a licensed practitioner; (2) the labeling bears the statement "Caution: Federal law restricts this device to sale by or on the order of a [physician/licensed practitioner]" (or equivalent); and (3) the labeling provides adequate information for the healthcare professional to use the device safely and effectively for its intended purposes, including indications, effects, routes, methods, frequency and duration of administration, hazards, contraindications, side effects, and precautions.
C. 21 C.F.R. Part 807, Subpart E — Premarket Notification of Advertising (Form 2253)
The regulations at 21 C.F.R. Part 807, Subpart E establish requirements for the submission of advertising and promotional labeling samples to FDA.
§ 807.81 and § 807.87 — Submission Requirements. Under § 807.81(a)(3) and § 807.87(e), manufacturers of devices cleared through the 510(k) process must submit to FDA, at the time of initial commercial distribution or at the time an advertisement or labeling material is first disseminated after clearance—whichever comes first—a copy or specimen of the device's labeling and any advertising material relating to the device. This obligation is fulfilled through the submission of Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling for Devices).
Form FDA 2253 — Filing Mechanics. Form 2253 serves as the cover sheet for the submission of samples of advertising and promotional labeling to FDA's Center for Devices and Radiological Health ("CDRH"). The form requires identification of the device, the 510(k) number, the establishment registration number, a description of each item submitted, and a certification by the responsible person. Submissions are made electronically through the FDA CDRH electronic submission portal.
Timing. For the Pulsar™ CRM System, given the planned October 1, 2024 launch date, all launch-ready promotional materials must be submitted via Form 2253 on or before October 1, 2024. We recommend that the submission be completed no later than September 27, 2024 to account for any processing or technical issues with the electronic submission system.
Scope of Submission. The Form 2253 requirement applies to all labeling and advertising materials, including but not limited to print brochures, sell sheets, journal advertisements, digital advertisements, website content, and sales aids that may be disseminated to or accessed by healthcare professionals or the public. Any new or revised promotional material created after the initial submission must be filed via Form 2253 at the time of its first dissemination.
D. FDA Guidance Documents
In addition to the statute and regulations, FDA has issued several guidance documents that inform the analysis of medical device promotional compliance. While guidance documents do not carry the force of law, they represent FDA's current thinking on the topics addressed and are highly relevant to enforcement decision-making. The following guidance documents were considered in this review:
•  "Guidance for Industry and FDA Staff: Promotion of FDA-Regulated Medical Products Using the Internet and Social Media" — This guidance addresses the application of FDA's promotional requirements to digital media, including websites, social media platforms, paid search advertising, and other online channels. It clarifies that online content is subject to the same promotional requirements as traditional print materials and provides specific recommendations for space-limited digital formats.
•  "Presenting Risk Information in Prescription Drug and Medical Device Promotion" (2009) — Although originally focused on prescription drugs, FDA has applied the principles of this guidance to medical device promotion. It addresses the presentation of risk information in promotional materials, emphasizing the importance of fair balance, comparable prominence of risk and benefit information, and avoidance of techniques that minimize or obscure risk disclosures.
•  "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (December 2011) — This guidance distinguishes between impermissible proactive off-label promotion and permissible responses to genuinely unsolicited requests for information about unapproved uses. It provides a framework for companies to establish compliant processes for handling such requests, including channeling unsolicited inquiries to Medical Affairs or scientific/medical information departments.
•  "Guidance for Industry: Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers" — This guidance addresses the boundaries of permissible truthful and non-misleading communications about FDA-regulated products.
•  Selected FDA Enforcement Letters — C&H also reviewed relevant Warning Letters and Untitled Letters issued by FDA to medical device companies for promotional and advertising violations. These enforcement actions provide practical interpretive guidance on the standards that FDA applies in evaluating promotional compliance. A summary of key enforcement precedents is provided in Appendix F to this memorandum.
E. Off-Label Promotion — Legal Standards
A manufacturer may not promote a medical device for uses that are beyond the scope of its FDA-cleared intended use and indications for use. The cleared indication for the Pulsar™ CRM System is narrow and specific: continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias. Several categories of potential off-label promotion risk are relevant to this review:
•  Pediatric use: The Device is cleared for use in "adult patients" only. Any promotional claim, imagery, case study, or data reference that implies suitability for use in pediatric or adolescent patients constitutes promotion of an unapproved use.
•  Diagnostic vs. monitoring distinction: The Device is cleared for "monitoring"—the continuous recording and transmission of cardiac rhythm data. Promotional claims that characterize the Device as capable of "diagnosing" arrhythmias, "detecting" cardiac conditions, or "predicting" adverse cardiac events suggest a diagnostic capability that exceeds the monitoring indication.
•  Treatment or management implications: The Device is a monitoring tool, not a therapeutic device. Promotional language suggesting that the Device can be used to manage, treat, or guide treatment of cardiac arrhythmias exceeds the monitoring indication.
•  Population expansion: Any promotion suggesting suitability for use in patient populations not covered by the clearance—such as pediatric patients, neonates, or specific disease subpopulations not encompassed by "suspected or documented cardiac arrhythmias"—constitutes off-label promotion.
The legal landscape regarding off-label promotion has evolved in recent years, particularly in light of the decisions in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) and Amarin Pharma, Inc. v. FDA, No. 15-cv-3588 (S.D.N.Y. 2015), which raised significant First Amendment questions regarding the government's ability to restrict truthful and non-misleading speech about lawful products, including off-label uses. However, it is critical to note that despite this evolving jurisprudence, FDA has not formally revised its enforcement posture regarding off-label promotion for medical devices. The agency continues to issue Warning Letters and Untitled Letters to device manufacturers for off-label promotional activities, and the Department of Justice continues to pursue enforcement actions—including under the False Claims Act—against companies engaged in off-label promotion schemes. Accordingly, C&H recommends that Solstice maintain a conservative compliance posture that confines all promotional activities to the cleared indications for use.
Moreover, the distinction between impermissible off-label promotion and permissible truthful and non-misleading scientific exchange is fact-intensive and context-dependent. While a manufacturer may disseminate peer-reviewed scientific literature discussing off-label uses in response to genuinely unsolicited requests, proactive distribution of such materials to drive sales constitutes promotion. Solstice should implement robust policies and procedures to maintain this distinction, including the unsolicited request SOP discussed in Section XI below.
F. Fair Balance Requirements
All promotional materials for the Pulsar™ CRM System must present a fair balance of information relating to the Device's benefits and its risks, side effects, contraindications, and warnings. The fair balance requirement is a cornerstone of FDA's promotional compliance framework and applies to all forms of labeling and advertising.
The fair balance standard requires that:
1.  Risk information must be presented with comparable prominence and readability as benefit claims. Materials that feature benefit claims in large, bold, colorful text while relegating risk information to small, inconspicuous text at the bottom of a page or on a separate page violate the fair balance requirement.
2.  Specific risks, contraindications, and warnings from the cleared labeling must be included. Promotional materials must disclose the risks identified in the Device's cleared labeling, including but not limited to risks associated with the implantation procedure, device-related adverse events, electromagnetic interference, and MRI compatibility limitations.
3.  Selective omission of risk information is impermissible. FDA has specifically targeted promotional materials that "broaden" a device's indicated use through the selective omission of risk information or limitations identified in the cleared labeling. A promotional piece that highlights the Device's benefits without disclosing its limitations creates a misleading impression of the Device's risk-benefit profile.
4.  Space-constrained formats must still provide access to risk information. For digital advertisements and other space-limited formats, FDA's guidance on internet and social media promotion provides that the material must include, at minimum, a brief statement of important risks and a clear, conspicuous link to the full risk information, accessible in no more than one click.
FDA has made fair balance a significant enforcement priority. Numerous Warning Letters and Untitled Letters have cited medical device companies for presenting promotional materials that emphasized efficacy claims while minimizing or omitting risk disclosures. Solstice must ensure that each promotional item includes risk information of sufficient prominence, completeness, and accessibility to satisfy the fair balance standard.
IV. Review of Draft Promotional Materials
A. Methodology.  C&H conducted a line-by-line review of each of the fourteen (14) draft promotional materials identified in Section II.D above. Each item was reviewed against the following reference documents: (1) the 510(k) Summary for K232847; (2) the cleared Indications for Use statement; (3) the Device labeling, including the Instructions for Use ("IFU") for both the implantable monitor and the remote telemetry transmitter; (4) the predicate device comparison included in the 510(k) submission; and (5) the clinical data and bench testing data referenced in the 510(k) submission and provided to C&H by Theresa Brennan.
Each promotional claim in each material was classified into one of three categories:
(1) Consistent with Cleared Labeling — The claim is supported by and consistent with the cleared Indications for Use statement and the Device labeling. No revision required.
(2) Requiring Revision for Accuracy or Fair Balance — The claim is not per se inconsistent with the cleared indication but presents accuracy, substantiation, or fair balance concerns that should be addressed before launch to mitigate enforcement risk.
(3) Presenting Off-Label Promotion Risk — The claim, imagery, or content extends beyond the scope of the cleared indication and, if disseminated, could constitute impermissible off-label promotion.
Each material was also assigned a priority rating:
High Priority — Must be revised before launch. Material presents significant off-label promotion risk, material fair balance deficiency, or unsubstantiated claims that could trigger FDA enforcement action.
Moderate Priority — Should be revised before launch. Material presents compliance concerns that, while unlikely to trigger immediate enforcement action, represent best-practice deficiencies that could become problematic over time or in the context of an FDA inspection or audit.
Advisory — Recommended revision as a matter of best practice, but not legally required. Material is technically compliant but could be improved to strengthen the Company's overall compliance posture.
B. Brochures and Sell Sheets (Items 1–5)
Item 1 — Pulsar™ CRM System Physician Brochure (8-page, full color)
This brochure is the Company's primary physician-facing promotional piece and will be widely distributed by territory managers during sales calls. The brochure is generally well-constructed and presents the Device's features, clinical benefits, and implantation procedure in a manner that is largely consistent with the cleared indications. However, two issues require revision:
Issue 1 — Diagnostic Claim (Page 3): The brochure contains the following claim on page 3: "Pulsar enables early diagnosis of atrial fibrillation." This claim presents a significant risk of being construed as a diagnostic claim that exceeds the Device's cleared monitoring indication. The Pulsar™ CRM System is cleared for "continuous cardiac rhythm monitoring," not for the diagnosis of any specific arrhythmia. While continuous monitoring data may, in clinical practice, assist a physician in reaching a diagnosis, the Device itself does not diagnose. The distinction between monitoring and diagnosis is one that FDA has enforced in prior Warning Letters to device manufacturers. We recommend revising this claim to: "Pulsar enables continuous monitoring that may assist clinicians in the detection of atrial fibrillation episodes." This revised language accurately describes the Device's role as a monitoring tool while preserving the marketing message. Priority: HIGH.
Issue 2 — Fair Balance Deficiency: The brochure devotes pages 1 through 6 to benefit claims, clinical data, and product features, with text presented in 12-point font. The risk information section—including contraindications, warnings, and precautions drawn from the Device labeling—is located on page 8 (the back page) and is presented in 6-point font. This disparity in prominence between benefit and risk information represents a clear fair balance deficiency. Under the standards set forth in FDA's guidance on risk information presentation and in numerous enforcement letters, risk information must be presented with comparable prominence and readability as benefit claims. We recommend increasing the font size of the risk information section to no less than 10-point font and relocating at least a summary of the most significant risks to a more prominent position within the brochure—ideally on page 2 or 3, proximate to the benefit claims. Priority: HIGH.
Item 2 — Pulsar™ Quick Reference Sell Sheet (single-page, double-sided)
The sell sheet is designed as a concise, visually impactful leave-behind for use during brief physician interactions. The sheet presents key product specifications and clinical advantages on the front and technical details on the reverse.
Issue Identified — Unsubstantiated Comparative Superiority Claim: The sell sheet contains the following claim: "Superior signal quality compared to all competitive devices." This is a superlative comparative claim that requires substantiation. C&H reviewed the clinical data and bench testing data provided by the Company and included in the 510(k) submission. While the 510(k) submission includes bench testing data demonstrating that the Pulsar's signal quality meets FDA performance standards and is substantially equivalent to the predicate device (CardioStar™ SC-200), the submission does not include head-to-head comparative data against "all competitive devices." Without adequate substantiation, this claim is potentially false or misleading under FD&C Act § 502(a) and could trigger an FDA Untitled Letter or Warning Letter. We recommend one of the following alternatives: (a) remove the superlative comparative claim entirely; (b) replace it with a factual, substantiated claim (e.g., "Pulsar delivers high-fidelity signal quality that meets or exceeds FDA performance standards"); or (c) if the Company possesses head-to-head bench testing data supporting the comparative claim, provide that data to C&H for review and include appropriate citations and qualifications in the sell sheet. If the claim is based solely on bench testing (rather than clinical data), it must be qualified accordingly (e.g., "based on bench testing under controlled laboratory conditions"). Priority: HIGH.
Item 3 — Pulsar™ Remote Telemetry Platform Data Sheet (4-page)
The data sheet describes the technical features and capabilities of the remote telemetry platform, including data transmission protocols, cloud storage architecture, and clinician interface functionality. The material is generally compliant with the cleared labeling and does not present off-label promotion concerns.
Issue Identified — Cloud Data Security Claims: The data sheet includes claims regarding the cloud platform's data security features, including references to "HIPAA-compliant encryption" and "SOC 2 Type II certification." While these claims are not inconsistent with the Device labeling, C&H recommends that Theresa Brennan's regulatory team verify that these specific security claims are consistent with the cybersecurity documentation submitted to FDA as part of the 510(k) submission. Any discrepancy between the promotional claims and the information submitted to FDA could create a misbranding risk. Priority: MODERATE.
Items 4 and 5 — Conference-Specific Pieces (ACC 2025 and HRS 2025 Booth Handouts)
These two conference-specific handouts are abbreviated versions of the physician brochure, customized for distribution at the American College of Cardiology 2025 Annual Scientific Session and the Heart Rhythm Society 2025 Annual Meeting, respectively. Both items are generally consistent with the cleared indications and present an acceptable risk-benefit balance.
Issue Identified: Both items contain minor formatting inconsistencies in the presentation of the full cleared Indications for Use statement. Specifically, the Indications for Use statement is presented in an abbreviated format that omits the words "in adult patients." The full cleared statement must be reproduced without abbreviation or omission. We recommend that the full text of the Indications for Use statement—"continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias"—be included verbatim in all conference materials. Priority: MODERATE.
C. Digital Advertisements (Items 6–9)
Item 6 — Programmatic Display Ad (300×250 banner)
This digital display advertisement is designed for programmatic placement on medical professional websites and cardiology-focused digital properties. The banner format presents inherent space constraints that limit the amount of text that can be included.
Issue Identified — Omission of Risk Disclosure: The current draft of the display ad contains benefit claims and a call to action but includes no risk disclosure whatsoever—no contraindications, no warnings, no precautions, and no link to full risk information. Under FDA's guidance on internet and social media promotion, space-constrained digital formats must, at minimum, include a brief statement of the most significant risks and a clear, conspicuous hyperlink providing one-click access to the full prescribing information and risk disclosures. The complete omission of any risk information in a promotional digital advertisement is a significant fair balance violation that is highly likely to attract FDA enforcement attention. We recommend that the display ad be revised to include: (a) a brief risk statement (e.g., "Important Safety Information: See full prescribing information, including risks and contraindications"); and (b) a clearly visible hyperlink providing one-click access to the full safety information page on the solsticebiomed.com website. Priority: HIGH.
Item 7 — Paid Search Ad Copy (Strathmore Systems)
This item is a paid search advertisement designed for display on Severin Industries search results pages when healthcare professionals search for cardiac monitoring-related terms. The character limitations imposed by the Strathmore Systems format further constrain the amount of information that can be presented.
Issue Identified — Inconsistent Indication Language: The current ad copy includes the phrase "cardiac diagnostics" in the headline: "Pulsar™ CRM — Advanced Cardiac Diagnostics." The Device is cleared for cardiac rhythm monitoring, not for cardiac diagnostics. The use of the word "diagnostics" in a paid search advertisement is particularly concerning because it appears as a headline-level claim in a format where the ad copy is the entirety of the promotional message—there is no accompanying context or qualifying language. Moreover, paid search ads may appear to a broad audience, including non-specialists who may interpret "diagnostics" as a claim that the Device diagnoses cardiac conditions. We recommend revising the headline to "Pulsar™ CRM — Advanced Cardiac Monitoring" and adding the indication statement to the ad extension: "Cleared for continuous cardiac rhythm monitoring in adult patients." Priority: HIGH.
Items 8 and 9 — Social Media Ad Templates (Westmark Health IT and X)
These items are template advertisements for deployment on Westmark Health IT and X (formerly Fenmore Solutions) social media platforms. Both templates include the claim that Pulsar is a "revolutionary technology" for cardiac monitoring.
Issue Identified — Puffery Concerns: While the word "revolutionary" is arguably puffery—a non-specific, non-quantifiable promotional claim that a reasonable audience would not interpret as a factual assertion—C&H recommends caution in using such language for a medical device that is new to the US market and has not yet established a significant clinical track record in the United States. FDA has not established a bright-line rule regarding puffery in medical device promotion, but enforcement actions have cited companies for making promotional claims that, while perhaps individually defensible, contribute to an overall impression that exaggerates the device's clinical significance. We recommend toning down the language from "revolutionary" to "advanced" or "innovative," which convey a similar marketing message with a lower risk profile. Priority: MODERATE.
D. Journal Advertisements (Items 10–11)
Item 10 — Full-Page Journal Ad (*Electrophysiology Today*)
This full-page journal advertisement is well-structured and represents one of the stronger promotional pieces in the portfolio. It includes the cleared Indications for Use statement, a listing of contraindications, and a summary of significant risks and warnings. The visual design presents benefit and risk information in a reasonably balanced manner.
Issue Identified — Headline Implication: The advertisement headline reads: "The Future of Arrhythmia Management." While this headline is clearly intended as aspirational branding language, the word "Management" could imply that the Device plays a role in the therapeutic management of arrhythmias—which exceeds the monitoring indication. In the context of a journal advertisement directed at electrophysiologists, the word "management" carries specific clinical connotations that include treatment planning and therapeutic intervention. We recommend revising the headline to: "The Future of Cardiac Rhythm Monitoring." This revision preserves the aspirational tone while aligning the headline with the cleared indication. Priority: MODERATE.
Item 11 — Half-Page Journal Ad (*Cardiology Practice Review*)
This half-page advertisement is designed for placement in a cardiology-focused professional journal. The reduced format (relative to the full-page ad in Item 10) presents layout challenges for achieving fair balance.
Issue Identified — Fair Balance Deficiency: In the current layout, benefit claims and product imagery occupy approximately 75% of the available ad space, with risk information compressed into four (4) lines of small-font text at the bottom of the advertisement. This allocation is inconsistent with the fair balance requirement. While there is no regulatory bright-line rule specifying exact proportions, FDA enforcement precedent strongly suggests that risk information should constitute a meaningful and prominent portion of any promotional piece. C&H recommends rebalancing the layout to dedicate at least 30% of the available ad space to risk, safety, contraindication, and warning information, with the risk text presented in a font size no smaller than 80% of the font size used for benefit claims. Priority: HIGH.
E. Conference Booth Materials (Items 12–14)
Item 12 — Booth Panel Graphics
The conference booth panel graphics include large-format photographic imagery depicting physicians and patients alongside product imagery and key marketing messages.
Issue Identified — Pediatric Imagery: The booth panel graphics include a photograph depicting a pediatric patient (appearing to be approximately 8–10 years of age) alongside an adult patient. The Pulsar™ CRM System is cleared for use in adult patients only. The inclusion of pediatric imagery in a promotional context implies that the Device is suitable for or indicated for use in pediatric patients, which constitutes promotion of an off-label use. This is particularly concerning in a high-visibility format such as a conference booth, which will be viewed by hundreds or thousands of healthcare professionals at major cardiology conferences. We strongly recommend removing all pediatric imagery from the booth panel graphics and replacing it with imagery that clearly depicts adult patients. All photographic models used in future promotional materials should be demonstrably adult. Priority: HIGH.
Item 13 — Interactive Demo Station Script
The interactive demo station script provides territory managers with structured talking points for use when demonstrating the Pulsar™ CRM System at conference booth demo stations.
Issue Identified — Direct Instruction to Discuss Off-Label Applications: The demo station script contains the following language on page 4:
"If physicians express interest in broader applications, you may discuss potential off-label applications being studied in ongoing trials, including use in adolescent patients with cryptogenic stroke and in patients with unexplained syncope. Reference the ongoing PULSAR-PEDS and PULSAR-SYNCOPE studies."
This language constitutes an explicit instruction to territory managers to engage in proactive off-label promotion. It is the most serious compliance deficiency identified in this review. Under current FDA enforcement standards, instructing sales representatives to proactively discuss off-label applications—even those under clinical investigation—constitutes impermissible off-label promotion. The existence of ongoing clinical trials does not authorize promotional discussion of the investigational uses. Moreover, the reference to specific study names and specific off-label patient populations (adolescents with cryptogenic stroke, patients with unexplained syncope) transforms what might otherwise be characterized as general scientific discussion into targeted promotion of specific unapproved uses.
We recommend complete removal of this language from the demo station script. It should be replaced with a compliant script directing territory managers to respond to unsolicited questions about off-label uses by directing the inquirer to Medical Affairs (Dr. Nadia Farouk) in accordance with the Company's unsolicited request SOP. Suggested replacement language:
"If a physician asks about uses not covered by the current FDA clearance, respond: 'That's a great question. Our cleared indication is for continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias. For questions about other potential applications, I can connect you with our Medical Affairs team, who would be happy to discuss the published scientific literature.' Document the request and submit it to Medical Affairs within 24 hours via the unsolicited request form."
Priority: HIGH.
Item 14 — Giveaway Item Specifications
This item comprises specifications for branded promotional giveaway items (pens, notepads, and USB drives) to be distributed at conference booths. All items are valued at under $10 per unit, consistent with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (2020 Revision).
Assessment: Compliant. No revisions required. Priority: N/A.
F. Summary Table of Recommended Revisions to Promotional Materials
The following table summarizes the recommended revisions identified in Sections IV.B through IV.E above. A more detailed version of this table, including the specific language at issue, recommended revised language, responsible party, and target completion date for each item, is provided in Appendix A.
Summary Totals: 7 High-Priority items requiring mandatory revision before launch; 7 Moderate-Priority items that should be revised before launch; the remaining items across training decks, website, and leave-behinds bring the total to 7 High, 12 Moderate, and 5 Advisory across all 43 items reviewed, as detailed in subsequent sections and in Appendix A.
V. Review of Sales Training Decks
A. Training Deck 1 — "Pulsar™ CRM System Product Training" (87 Slides)
This presentation was prepared by Patrick Dunne's marketing team and is intended to serve as the primary product training resource for the US commercial organization. The deck covers device features, clinical benefits, implantation procedure, remote telemetry platform operation, cleared indications and contraindications, competitive landscape, and objection-handling techniques. It is generally thorough and well-organized, and the majority of its content is consistent with the cleared labeling and FDA requirements.
However, three issues were identified:
Issue 1 — Slide 34: Unsubstantiated Competitive Comparison Chart. Slide 34 presents a competitive comparison chart positioning the Pulsar™ CRM System against three unnamed competitive devices across eight performance metrics (signal quality, battery life, device size, insertion time, data transmission speed, remote monitoring capability, MRI compatibility, and cost). For six of the eight metrics, the chart indicates that Pulsar is "superior" to all three competitive devices, with green checkmarks for Pulsar and red X marks for the unnamed competitors. This chart presents multiple compliance concerns. First, the superiority claims are not substantiated by the data provided to C&H or included in the 510(k) submission. Second, even if some claims could be substantiated on the basis of bench testing or published specifications, the presentation format—with green checkmarks and red X marks—creates an overall impression of comprehensive superiority that may not be supportable. Third, the use of unnamed competitors may be viewed as a deliberate effort to make competitive claims without accountability.
We recommend one of two approaches: (a) remove the competitive comparison chart entirely and replace it with a factual feature specification table that presents Pulsar's features without comparative value judgments; or (b) substantiate each comparative claim with specific data references (e.g., published specifications, peer-reviewed head-to-head studies, or bench testing data under standardized conditions), name the specific competitive devices being compared, and present the comparison in a balanced manner that acknowledges areas where competitive devices may offer comparable or superior performance. Priority: HIGH.
Issue 2 — Slide 52: Off-Label Pediatric Use Discussion. Slide 52 is titled "Emerging Clinical Evidence" and includes a discussion of "emerging clinical evidence for use in syncope patients under 18." The slide summarizes preliminary results from the PULSAR-PEDS study, an ongoing European clinical trial evaluating the Pulsar in adolescent patients aged 12–17 with unexplained syncope. This slide constitutes training on off-label use. Training sales representatives on off-label applications—regardless of whether the data is described as "emerging" or "investigational"—equips those representatives to discuss off-label uses in the field and creates an inference that the Company intends for them to do so. This is impermissible.
We recommend that Slide 52 be removed entirely from the training deck. Territory managers should not be trained on off-label applications of the Device. If the Company wishes to provide territory managers with guidance on how to respond to physician inquiries about off-label use (including pediatric use), that guidance should be limited to the unsolicited request SOP—i.e., directing the inquirer to Medical Affairs. Priority: HIGH.
Issue 3 — Slides 71–73: European Registry Study Data. Slides 71 through 73 present clinical data from a European registry study of the Pulsar™ CRM System. While the inclusion of clinical evidence in product training materials is generally appropriate, two concerns warrant attention. First, C&H was not provided with confirmation that the registry study has been published in a peer-reviewed journal. If the study is unpublished or available only as a conference abstract, its inclusion in training materials intended for dissemination to the commercial team raises concerns about the dissemination of unpublished data. Second, if the registry data is referenced in materials that territory managers may share with physicians (even informally), it may constitute promotional labeling subject to the same standards as the promotional materials reviewed in Section IV.
We recommend that: (a) the Company confirm that the referenced registry study has been published in a peer-reviewed journal and provide C&H with the citation for verification; (b) if the study is unpublished, it should be removed from the training deck pending publication and Medical Affairs review; and (c) if the study is published, appropriate citations should be included on the relevant slides, and the slides should include a disclaimer noting any limitations of the study design. Priority: MODERATE.
B. Training Deck 2 — "Selling the Pulsar™ — Territory Manager Field Guide" (45 Slides)
This presentation is focused on sales technique, objection handling, and practical selling strategies for territory managers. Two moderate-priority issues were identified:
Issue 1 — Slide 12: Billing and Coding Assistance. Slide 12, titled "Supporting Hospital Adoption," suggests that territory managers offer to "help with billing codes" for hospitals considering adoption of the Pulsar™ CRM System. Specifically, the slide includes talking-point language such as: "We can walk your billing department through the correct codes to ensure maximum reimbursement for Pulsar implantations."
The provision of accurate reimbursement information to healthcare professionals is generally permissible and is a common industry practice. However, the approach suggested on Slide 12 goes beyond the provision of general coding information and implies that territory managers will provide hands-on coding assistance designed to "ensure maximum reimbursement." This approach raises several concerns. First, territory managers are not qualified coding professionals and should not be providing coding advice. Second, the phrase "ensure maximum reimbursement" could be construed as a guarantee of reimbursement, which would be misleading and potentially implicate the Anti-Kickback Statute (by suggesting that the Company is providing a financial incentive in the form of guaranteed reimbursement to induce adoption of the Device). Third, if territory managers provide incorrect coding advice that results in the submission of inaccurate claims to federal healthcare programs, the Company could face False Claims Act liability.
We recommend revising Slide 12 to instruct territory managers to: (a) provide general coding information using only the Company's approved reimbursement information sheet (which includes appropriate disclaimers); (b) direct specific coding and billing questions to the Company's dedicated reimbursement support hotline; and (c) include the following disclaimer in all reimbursement discussions: "Coding and reimbursement information is provided for informational purposes only and does not guarantee coverage or payment by any third-party payor. Each provider is responsible for determining the appropriate codes and submitting accurate claims." Priority: MODERATE.
Issue 2 — Slide 28: ROI Calculator. Slide 28 presents a "sample ROI calculator" that projects the revenue a hospital could generate from Pulsar implantations based on assumed implant volumes, reimbursement rates, and operating margins. The calculator includes specific dollar figures and projected annual returns.
Health economic claims, including return-on-investment projections, require substantiation under the same standards applicable to other promotional claims. Unsubstantiated economic projections can be considered misleading and may trigger FDA enforcement action. Moreover, overstated or unrealistic economic projections may create expectations that are not met in practice, leading to customer dissatisfaction and potential legal exposure.
We recommend that: (a) the ROI calculator be reviewed by Medical Affairs (Dr. Farouk) and the Company's health economics team to verify that the underlying assumptions are reasonable and substantiated; (b) the calculator include a prominent disclaimer stating that "Projected financial returns are illustrative only and are based on assumptions that may not reflect actual experience. Individual results will vary based on implant volumes, payor mix, negotiated reimbursement rates, and other factors"; and (c) the calculator not be distributed to healthcare professionals as a standalone piece without the contextualizing training deck and disclaimer. Priority: MODERATE.
C. Training Deck 3 — "Pulsar™ Remote Telemetry Platform — Technical Training" (62 Slides)
This presentation focuses on the technical features and operation of the Pulsar remote telemetry transmitter and cloud-based platform. It is intended for territory managers and clinical support staff who will assist with initial setup and troubleshooting at hospital sites. The deck is generally compliant, as its content is primarily technical and functional in nature and is consistent with the cleared labeling and Instructions for Use.
Issue Identified — Slide 41: Future Software Upgrades. Slide 41 discusses "future software upgrades" that will "expand monitoring capabilities" of the remote telemetry platform. Specifically, the slide references planned updates to the platform's arrhythmia detection algorithms, the addition of new data visualization features, and potential integration with third-party electronic health record ("EHR") systems.
While the discussion of product development plans is not inherently prohibited, claims about future features that will "expand monitoring capabilities" could be construed as promotion of features and uses that are not currently cleared by FDA. If the planned software upgrades would constitute a modification to the Device's intended use or performance characteristics, they may require a new 510(k) submission or other regulatory action before they can be marketed.
We recommend adding a disclaimer to Slide 41 and any related materials stating: "Features described as 'planned' or 'future' are not currently available and have not been cleared or approved by FDA. Their availability is subject to development timelines and regulatory clearance. Solstice makes no representation or commitment regarding the timing, availability, or regulatory status of future features." Priority: ADVISORY.
VI. Review of Website Content
A. Scope of Website Review
C&H reviewed all twenty-two (22) pages of the solsticebiomed.com US portal as of the date of this memorandum. The pages reviewed include:
•  Home page
•  Pulsar™ CRM System main product page
•  Pulsar™ Remote Telemetry Transmitter product page
•  Clinical Evidence page
•  Physician Resources section (4 pages)
•  Patient Information section (3 pages)
•  Reimbursement Information page
•  Media/Press page
•  "About Us" corporate pages (3 pages)
•  Careers page
•  Contact Us page
•  Legal/Privacy pages (3 pages)
Under FDA's guidance on the promotion of FDA-regulated medical products using the internet and social media, all website content accessible to US audiences constitutes "labeling" within the meaning of FD&C Act § 201(m) and is subject to the same promotional and labeling requirements as traditional print materials. The website therefore must comply with all provisions of FD&C Act §§ 301 and 502, 21 C.F.R. Part 801, and the fair balance requirements discussed in Section III.F above.