Contract analysis

I. Executive Summary This memorandum provides legal guidance to Solstice Biomedical Devices Ltd. ("Solstice" or "SBD") and its wholly owned U.S. subsidiary, Solstice Biomedical Inc. ("SBI"), a Delaware corporation (Delaware Secretary of State File No. 7834291), regarding the scope of permissible marketing and promotional activities in the United States for the Solstice Lumina™ Continuous Glucose Monitoring System (th

1. Pre-clearance promotional restrictions — the legal boundaries governing what Solstice may and may not communicate regarding the Lumina CGM System prior to FDA clearance, including the management of EU marketing materials accessible from the United States;

2. The statutory and regulatory framework governing promotional claims — including the Federal Food, Drug, and Cosmetic Act ("FD&C Act"), FDA regulations and guidance documents, and the overlapping jurisdiction of the Federal Trade Commission ("FTC");

3. Post-clearance promotional claim parameters — the standards of truthfulness, non-misleadingness, adequate substantiation, and fair balance that apply to promotional claims following 510(k) clearance;

4. Comparative advertising limitations — with particular attention to the risks associated with promotional comparisons to products manufactured by NovaSense Medical Technologies Inc. ("NovaSense"), including the GlucoTrack NX-500 and GlucoTrack NX-700, which serve as predicate devices in SBI's 510(k) submission;

5. Off-label promotion risks — the prohibition on promoting the Lumina CGM System for uses, indications, or patient populations not included in the cleared labeling, and the narrow carve-outs for permissible scientific exchange; and

6. Social media and digital marketing considerations — the application of FDA promotional requirements to the evolving landscape of social media marketing, digital advertising, influencer engagements, and online content. This memorandum is intended to serve as a comprehensive reference for Solstice's regulatory affairs, marketing, commercial, and communications teams. We strongly recommend that all external-facing pr

II. Statutory and Regulatory Framework The regulatory framework governing promotional claims for medical devices in the United States is principally derived from the FD&C Act and its implementing regulations, supplemented by FDA guidance documents and the overlapping enforcement authority of the FTC. This Section provides a detailed overview of the statutory and regulatory provisions most relevant to Solstice's promo

Section 502 of the FD&C Act, codified at 21 U.S.C. § 352, establishes the central standard for device labeling and promotional claims. Under Section 502(a), a device is deemed "misbranded" if its labeling is "false or misleading in any particular." This standard is intentionally broad and encompasses not only affirmatively false statements but also statements that are technically accurate yet misleading by virtue of

Section 502(f) further provides that a device is misbranded unless its labeling contains adequate directions for use and adequate warnings against unsafe use. While this provision is most directly relevant to the device's physical labeling, it also informs the requirement for "fair balance" in promotional materials, as discussed in Section IV.C below. B. Section 501 and Adulteration — Pre-Market Clearance Requirement

III. Pre-Clearance Promotional Restrictions A. General Prohibition on Pre-Clearance Promotion The single most important rule governing Solstice's U.S. promotional activities during the pre-clearance period is straightforward: Solstice may not promote the Lumina CGM System in the United States prior to receiving 510(k) clearance from FDA. This prohibition is absolute, derives directly from Sections 301, 501(f), and 50

1. Geo-fencing or geo-targeting of EU promotional content. Solstice should implement geo-fencing or geo-targeting technology on its EU-facing promotional websites and digital advertising campaigns to restrict access from U.S.-based IP addresses. While geo-fencing is not a perfect solution (users may employ VPNs or proxy servers to circumvent geographic restrictions), it demonstrates good faith efforts to limit U.S. a

2. Disclaimers on EU-facing websites. All EU-facing promotional websites for the Lumina CGM System should include a prominent disclaimer — visible upon initial page load or through a geographic acknowledgment interstitial — stating that the product is CE-marked for sale in the European Union and is not cleared by the FDA for sale or distribution in the United States. A suggested form of disclaimer is: "The Solstice L

3. Separation of EU and U.S. website domains. Solstice should maintain separate website domains or clearly delineated website sections for EU and U.S. audiences. The EU promotional website should operate on a distinct domain (e.g., lumina-cgm.eu or lumina.solstice-biomedical.eu) that is clearly separate from SBI's U.S. corporate website (associated with the SBI offices at 220 Westbrook Drive, Suite 400, Cambridge, MA

4. Social media geographic disclaimers. Solstice's EU-based social media accounts should include geographic identifiers in their profiles (e.g., "Solstice Biomedical – Europe") and should include disclaimers in their bios or profile descriptions indicating that the promoted products are available in the EU and are not cleared for sale in the U.S. Where platform functionality permits, Solstice should use geographic ta

5. Training of EU marketing personnel. Solstice's EU marketing team should receive specific training on U.S. pre-clearance promotional restrictions and the risk of U.S. spillover from EU marketing activities. EU marketing personnel should understand that their activities, even if directed at EU audiences, may have U.S. regulatory implications and should be designed to minimize U.S. exposure. This training should be d

IV. Post-Clearance Promotional Framework A. Cleared Indications for Use as the Boundary Upon receipt of 510(k) clearance, which is targeted for Q3 2026, Solstice will be permitted to promote the Lumina CGM System in the United States — but only within the boundaries established by the device's cleared indications for use. The cleared indications for use, as stated on FDA Form 3881 and reflected in the cleared labelin

V. Comparative Advertising Limitations A. General Principles of Comparative Advertising for Medical Devices Comparative advertising — promotional material that explicitly or implicitly compares the advertised device to a competing product — is not prohibited per se under FDA regulations or the FD&C Act. However, comparative advertising is subject to heightened scrutiny for truthfulness, non-misleadingness, and adequa

Section 43(a) of the Lanham Act, codified at 15 U.S.C. § 1125(a), provides a private right of action for any person who believes that he or she is or is likely to be damaged by a false or misleading description of fact, or a false or misleading representation of fact, used in commercial advertising or promotion. Unlike FDA enforcement, which is initiated by a government agency, Lanham Act claims are brought by privat

VI. Off-Label Promotion Risks A. Definition and Scope "Off-label" promotion refers to the promotion of a medical device for uses, indications, patient populations, or conditions that are not included in the device's FDA-cleared labeling. While healthcare professionals are free to use cleared medical devices for off-label purposes based on their independent medical judgment, manufacturers are prohibited from promoting