Contract analysis

1. Introduction and Purpose This section of the Pre-Submission (Q-Sub) meeting package provides a clinical study protocol synopsis for Protocol SBD-LUM-CL-001 ("LUMINA-US"), a prospective, multicenter clinical study designed to generate clinical evidence supporting a traditional 510(k) premarket notification submission covering both the Lumina C14 implantable continuous glucose monitoring sensor and the Lumina R7 wea

2. Sponsor Information The following entities and individuals are responsible for the sponsorship, regulatory oversight, and conduct of the LUMINA-US clinical study: Sponsor / 510(k) Applicant: Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States Telephone: (617) 555-4200 VP of U.S. Operations: Marcus Hale Primary U.S. operational contact for regulatory correspondence, site agreem

3. Device Description Summary 3.1 Solstice Lumina™ CGM System Overview The Solstice Lumina™ Continuous Glucose Monitoring System ("Solstice Lumina™ CGM System" or "Lumina System") is a two-component integrated system comprising the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter. These two components work together to provide continuous, real-time glucose monitoring for persons with diabete

4. Study Synopsis 4.1 Protocol Identification The protocol version will be finalized and dated following the Pre-Submission meeting with FDA, currently targeted for August 14, 2025. Any substantive modifications to the study design, endpoints, or statistical analysis plan resulting from FDA feedback will be incorporated into Protocol Version 1.0 prior to finalization. The protocol will be submitted to the Clearwater

1. MARD stratified by glucose concentration range: • Hypoglycemic range: < 70 mg/dL • Euglycemic range: 70–180 mg/dL • Hyperglycemic range: > 180 mg/dL

2. MARD stratified by day of sensor wear: • Days 1–3 (early wear period, including sensor stabilization) • Days 4–7 (mid-early wear period) • Days 8–10 (mid-late wear period) • Days 11–14 (late wear period, approaching end of sensor life)

3. Percentage of paired data points in Clarke Error Grid Zones A, B, C, D, and E, with the pre-specified success criterion that ≥ 99% of paired data points fall within Zones A+B combined.

4. Sensor survival rate: Proportion of sensors completing the full 336-hour wear period, analyzed using Kaplan-Meier methodology with censoring for non-device-related discontinuations.

5. Incidence and severity of device-related adverse events: Tabulated by event type (insertion site reactions, systemic reactions, device malfunctions, other), severity (mild, moderate, severe), and causality (related, possibly related, unrelated).

6. User labeling comprehension scores: Percentage of subjects achieving ≥ 90% correct responses on the pre-use and post-use labeling comprehension questionnaires, analyzed separately for key comprehension domains (sensor insertion, glucose value interpretation, trend arrow interpretation, alert response). 4.5 Study Population 4.5.1 Enrollment Target. The total planned enrollment for the LUMINA-US study is 350 subject

1. Age ≥ 18 years at the time of informed consent.

2. Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus, documented in the subject's medical record.

3. Currently receiving insulin therapy (multiple daily injections or continuous subcutaneous insulin infusion) or oral antidiabetic medications (or a combination thereof) for at least 3 months prior to screening.

4. Glycated hemoglobin (HbA1c) between 6.0% and 12.0%, inclusive, measured at the screening visit or within 30 days prior to screening using a laboratory-based HbA1c assay.

5. Willing and able to comply with all study procedures for the 14-day sensor wear period, including attendance at all scheduled in-clinic accuracy sessions, daily fingerstick blood glucose measurements during the home-use period, and completion of study questionnaires.

6. Able to provide written informed consent in English prior to any study-related procedures. 4.5.3 Key Exclusion Criteria. Subjects meeting any of the following criteria will be excluded from enrollment:

1. Known allergy or hypersensitivity to adhesives, medical-grade adhesive tapes, or any component material of the Lumina CGM System, including but not limited to platinum, iridium, sensor membrane materials, or the adhesive patch material.

2. Skin conditions at proposed sensor insertion sites (upper arm) that would interfere with sensor placement, adhesion, or clinical assessment of insertion site reactions, including but not limited to: dermatitis, psoriasis, eczema, excessive scarring, lipodystrophy, or tattoos at the insertion site.

3. Current participation in another clinical study involving an investigational drug, device, or biologic, or participation in such a study within 30 days prior to screening.

4. Pregnancy, currently breastfeeding, or intent to become pregnant during the study period. Female subjects of childbearing potential must have a negative urine pregnancy test at screening.

5. Use of acetaminophen (paracetamol) at doses exceeding 1 gram per day on a regular basis. Acetaminophen is a known potential interferent with electrochemical glucose sensing technology and may affect sensor accuracy. Occasional use of acetaminophen at doses ≤ 1 g/day is permitted, provided it is documented in the subject's diary.

6. Severe renal impairment, defined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m², calculated using the CKD-EPI equation at screening.

7. Medical conditions that may interfere with study glucose monitoring or confound the interpretation of study results, including but not limited to: current dialysis treatment, hydroxyurea therapy, severe anemia (hemoglobin < 8 g/dL), or any condition known to cause clinically significant discrepancies between interstitial and blood glucose concentrations.

8. Any condition or circumstance that, in the opinion of the investigator, would make the subject unsuitable for study participation or would compromise the subject's ability to comply with study procedures. 4.6 Clinical Study Sites The LUMINA-US study will be conducted at six (6) U.S. clinical sites. Sites will be selected from academic medical centers, endocrinology/diabetes specialty clinics, and clinical research

5. Contract Research Organization The Sponsor has engaged a contract research organization (CRO) to support the operational conduct of the LUMINA-US clinical study. CRO: Veltrano Clinical Research Organization Inc. Address: 500 North Capitol Street, Suite 700, Indianapolis, IN 46204 Key Contact: Dr. Lisa Fontaine, VP of Clinical Operations Dr. Fontaine will serve as the primary CRO contact for the LUMINA-US study and

6. Institutional Review Board Central IRB: Clearwater Institutional Review Board LLC Address: 3200 Bayshore Boulevard, Tampa, FL 33629 IRB Registration No.: IRB-2019-04821 Clearwater Institutional Review Board LLC is an independent, commercial institutional review board registered with the U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP), and is accredited by the Association

7. Informed Consent A draft informed consent form (ICF) is currently being prepared in accordance with the requirements of 21 C.F.R. Part 50 (Protection of Human Subjects: Informed Consent of Human Subjects) and applicable state laws. The informed consent form is being prepared by the Sponsor's regulatory affairs team in consultation with regulatory counsel (Calderwood & Harkness LLP) and the CRO (Veltrano Clinical R

8. Safety Monitoring and Adverse Event Reporting 8.1 Safety Monitoring Plan Continuous and systematic monitoring of device-related adverse events will be conducted throughout the 14-day sensor wear period and the 7-day post-removal follow-up period for each enrolled subject. Safety monitoring is a critical component of the LUMINA-US study and is designed to generate comprehensive safety data to support the 510(k) sub

9. Investigational Device Exemption (IDE) Considerations 9.1 IDE Exemption Analysis Solstice Biomedical Inc. has conducted a thorough analysis of the Investigational Device Exemption (IDE) requirements applicable to the LUMINA-US clinical study and anticipates that the study qualifies for exemption from the full IDE requirements under 21 C.F.R. § 812.2(c)(3). Under 21 C.F.R. § 812.2(c)(3), investigations of diagnosti