Contract analysis

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

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

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 m

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, co

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

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

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