[sheet: Master Timeline]
Milestone ID | Phase | Milestone / Task Description | Target Start Date | Target Completion Date | Actual Completion Date | Duration (days) | Status | Responsible Party — Organization | Responsible Party — Individual | Dependencies | Critical Path | Notes / Comments
M-001 | Phase 1: Engagement & Preliminary Assessment | Calderwood & Harkness conflict check completed | April 18, 2025 | April 18, 2025 | 1 | Complete | Calderwood & Harkness LLP | Miriam Calloway | None | No | No conflicts identified with respect to NovaSense Medical Technologies Inc. or any other party
M-002 | Phase 1: Engagement & Preliminary Assessment | Calderwood & Harkness engagement opened; engagement letter dated (Ref. No. 1037-00002) | April 22, 2025 | April 22, 2025 | 1 | Complete | Calderwood & Harkness LLP / Solstice Biomedical Inc. | Miriam Calloway / Marcus Hale | M-001 | No | Engagement letter to Solstice Biomedical Inc. (U.S. subsidiary, Delaware File No. 7834291, 220 Westbrook Drive, Suite 400, Cambridge, MA 02142). Hourly rates: Calloway $1,150/hr, Strauss $1,050/hr, Whitfield $625/hr, Morrissey $475/hr. Estimated fees $650,000. Retainer $75,000.
M-003 | Phase 1: Engagement & Preliminary Assessment | $75,000 retainer received from Solstice Biomedical Inc. | April 28, 2025 | April 28, 2025 | 1 | Complete | Solstice Biomedical Inc. | Marcus Hale | M-002 | No
M-004 | Phase 1: Engagement & Preliminary Assessment | Crestline IP Advisory LLC — FTO preliminary assessment delivered | April 10, 2025 | April 10, 2025 | 1 | Complete | Crestline IP Advisory LLC | Dr. Raymond Cho | None | No | Low-to-moderate risk re U.S. Patent 10,847,221 (enzyme coating). Design-around efforts underway. Full claim chart analysis in progress. Fee estimate: $215,000.
M-005 | Phase 1: Engagement & Preliminary Assessment | Regulatory strategy memorandum — 510(k) pathway analysis, predicate selection, revised timeline assessment | April 22, 2025 | May 15, 2025 | 23 | In Progress | Calderwood & Harkness LLP | Amy Whitfield / Sean Morrissey | M-002, M-004 | No | Covers traditional 510(k) submission covering both C14 and R7 as a system. Product code QKQ, 21 C.F.R. § 862.1355, Class II. Primary predicate K211034 (NovaSense GlucoTrack NX-500, cleared June 18, 2022). Secondary predicate K230489 (NovaSense GlucoTrack NX-700, cleared March 7, 2024). Original client target Q1 2026 assessed as aggressive; revised target Q3 2026.
M-006 | Phase 1: Engagement & Preliminary Assessment | Predicate device comparison table completed | April 22, 2025 | May 20, 2025 | 28 | In Progress | Calderwood & Harkness LLP / Pinnacle Regulatory Consulting Group LLC | Sean Morrissey / Thomas Greenbaum | M-002 | No | Comparing Lumina CGM vs. K211034 and K230489. Also references Solstice GlucoStrip RX-200 (K192847, cleared Nov. 14, 2019) for corporate pedigree.
M-007 | Phase 1: Engagement & Preliminary Assessment | Device classification analysis memo (product code QKQ, 21 C.F.R. § 862.1355) | April 22, 2025 | May 20, 2025 | 28 | In Progress | Calderwood & Harkness LLP | Sean Morrissey | M-002 | No | Includes analysis of FDA reclassification order effective March 2024
M-008 | Phase 1: Engagement & Preliminary Assessment | iCGM special controls memo | April 28, 2025 | May 25, 2025 | 27 | In Progress | Calderwood & Harkness LLP | Amy Whitfield | M-007 | No | MARD target ≤ 9.0%; ≥ 99% Zones A+B per Clarke Error Grid. FDA guidance 'Integrated Continuous Glucose Monitoring Systems' (Sept. 2023). De Novo DEN170088.
M-009 | Phase 1: Engagement & Preliminary Assessment | FTO/IP risk assessment summary memo to Solstice | April 22, 2025 | May 15, 2025 | 23 | In Progress | Calderwood & Harkness LLP | Miriam Calloway / Amy Whitfield | M-004 | No | Summarizes Crestline findings re NovaSense patents: U.S. 10,847,221 (exp. Nov. 14, 2037), U.S. 11,234,567 (exp. March 22, 2039), U.S. 11,502,893 (exp. June 8, 2040). NovaSense patent counsel: Marlowe Asset Management Patent Group LLP (Patricia Langford).
M-010 | Phase 1: Engagement & Preliminary Assessment | MDUFA small business qualification analysis memo | April 22, 2025 | May 10, 2025 | 18 | In Progress | Calderwood & Harkness LLP | Sean Morrissey | M-002 | No | SBI does not qualify: U.S. revenue $22.8M but consolidated parent revenue €187.4M ≈ $204.3M at €1=$1.09 exceeds threshold. Standard FY2025 510(k) fee $22,417 applies.
M-011 | Phase 2: Pre-Submission Preparation | Pre-Sub (Q-Sub) meeting request submitted to FDA CDRH | June 2, 2025 | 1 | Not Started | Solstice Biomedical Inc. / Calderwood & Harkness LLP | Dr. Niamh Tierney / Miriam Calloway | M-005, M-006, M-007 | Yes | Cover letter + FDA Form 3514. Device: Solstice Lumina™ CGM System (C14 + R7). Addressed to OHT2 — Division of Chemistry and Toxicology Devices. SBI as sponsor at 220 Westbrook Drive, Suite 400, Cambridge, MA 02142.
M-012 | Phase 2: Pre-Submission Preparation | Pre-Sub meeting package submitted to FDA (60 days prior to meeting) | June 16, 2025 | 1 | Not Started | Solstice Biomedical Inc. / Calderwood & Harkness LLP / Pinnacle Regulatory Consulting Group LLC | Dr. Niamh Tierney / Amy Whitfield / Dr. Sandra Ellison | M-011 | Yes | Package includes: Executive Summary, Device Description, Predicate Comparison & SE Discussion, Proposed Performance Testing Plan, Proposed Clinical Study Protocol Summary (SBD-LUM-CL-001 'LUMINA-US'), and Questions for FDA. 60-day advance requirement for Aug. 14 meeting.
M-013 | Phase 2: Pre-Submission Preparation | Internal memo: Pre-Sub strategy and anticipated FDA feedback | June 2, 2025 | June 12, 2025 | 10 | Not Started | Calderwood & Harkness LLP | Amy Whitfield / Sean Morrissey | M-011 | No | Attorney work product / privileged. Contingency analysis if FDA rejects primary predicate, requires PMA, demands additional clinical endpoints, or reclassifies device.
M-014 | Phase 2: Pre-Submission Preparation | Pre-Sub meeting with FDA (CDRH, OHT2 — Division of Chemistry and Toxicology Devices) | August 14, 2025 | 1 | Not Started | Solstice Biomedical Inc. / Calderwood & Harkness LLP / Pinnacle Regulatory Consulting Group LLC | Dr. Niamh Tierney / Marcus Hale / Miriam Calloway / Dr. Sandra Ellison | M-012 | Yes | Teleconference format preferred. Topics: predicate acceptance, clinical study design, IDE exemption, software documentation, cybersecurity, biocompatibility scope, iCGM pathway.
M-015 | Phase 3: Clinical & Testing Strategy | Biocompatibility testing complete (Whitmore Laboratories Inc.) | March 3, 2025 | August 31, 2025 | 181 | In Progress | Whitmore Laboratories Inc. | Dr. James Haverford | M-014 (feedback may alter scope) | Yes | ISO 10993 series. C14 sensor: cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity, implantation, hemocompatibility, genotoxicity. R7 reader: cytotoxicity, sensitization, irritation. A2LA Certificate No. 3847.01. Cost: $485,000. Whitmore engaged March 3, 2025.
M-016 | Phase 3: Clinical & Testing Strategy | EMC / electrical safety testing complete (Whitmore Laboratories Inc.) | March 3, 2025 | August 31, 2025 | 181 | In Progress | Whitmore Laboratories Inc. | Dr. James Haverford | M-014 | No | Cost: $175,000. Per Whitmore quote dated March 3, 2025.
M-017 | Phase 3: Clinical & Testing Strategy | IDE exemption analysis memo finalized (21 C.F.R. § 812.2(c)(3) NSR determination) | May 1, 2025 | June 30, 2025 | 60 | Not Started | Calderwood & Harkness LLP | Amy Whitfield | M-005 | Yes | Anticipate NSR exemption for diagnostic device study. To be confirmed via Pre-Sub. IRB responsibilities under NSR pathway.
M-018 | Phase 3: Clinical & Testing Strategy | Clinical study agreement with Veltrano CRO reviewed and executed | May 15, 2025 | July 31, 2025 | 77 | Not Started | Calderwood & Harkness LLP / Solstice Biomedical Inc. / Veltrano Clinical Research Organization Inc. | Amy Whitfield / Marcus Hale / Dr. Lisa Fontaine | M-005 | Yes | MSA review. Budget: $4,200,000 (350 subjects × $12,000/subject). Veltrano at 500 North Capitol St., Suite 700, Indianapolis, IN 46204.
M-019 | Phase 3: Clinical & Testing Strategy | IRB submission to Clearwater Institutional Review Board LLC | July 1, 2025 | August 1, 2025 | 31 | Not Started | Solstice Biomedical Inc. / Calderwood & Harkness LLP | Dr. Niamh Tierney / Amy Whitfield | M-017, M-018 | Yes | Clearwater IRB Registration No. IRB-2019-04821. 3200 Bayshore Blvd., Tampa, FL 33629. Submission to include protocol, ICF, investigator brochure, recruitment materials.
M-020 | Phase 3: Clinical & Testing Strategy | IRB approval received for LUMINA-US (Protocol SBD-LUM-CL-001) | August 1, 2025 | September 1, 2025 | 31 | Not Started | Clearwater Institutional Review Board LLC | IRB Committee | M-019 | Yes | Required before clinical study commencement
M-021 | Phase 3: Clinical & Testing Strategy | Informed consent form finalized | May 15, 2025 | July 15, 2025 | 61 | Not Started | Calderwood & Harkness LLP / Solstice Biomedical Inc. | Amy Whitfield / Dr. Niamh Tierney | M-017 | No | 21 C.F.R. Part 50 compliance. Risk disclosures for subcutaneous CGM sensor implantation. Data privacy provisions. FDA inspection rights language.
M-022 | Phase 3: Clinical & Testing Strategy | Software documentation checklist and gap analysis completed | May 1, 2025 | June 30, 2025 | 60 | Not Started | Calderwood & Harkness LLP / Pinnacle Regulatory Consulting Group LLC | Sean Morrissey / Thomas Greenbaum | M-005 | No | Software Level of Concern: Major. IEC 62304:2006/A1:2015. SBOM required. Firmware v3.4.2 (C14), Reader OS v2.1.0 (R7), LuminaPredict v2.1, Mobile App v1.0.3.
M-023 | Phase 3: Clinical & Testing Strategy | Cybersecurity premarket submission checklist completed | May 1, 2025 | June 30, 2025 | 60 | Not Started | Calderwood & Harkness LLP / Pinnacle Regulatory Consulting Group LLC | Sean Morrissey / Thomas Greenbaum | M-005 | No | FDA guidance 'Cybersecurity in Medical Devices' (Sept. 2023). BLE 5.2 wireless, mobile app, cloud connectivity. STRIDE threat modeling. SBOM. Vulnerability assessment. Patch management. Authentication/encryption.
M-024 | Phase 3: Clinical & Testing Strategy | LUMINA-US clinical study commenced (Protocol SBD-LUM-CL-001) | September 15, 2025 | 1 | Not Started | Solstice Biomedical Inc. / Veltrano Clinical Research Organization Inc. | Dr. Niamh Tierney / Dr. Lisa Fontaine | M-014, M-015, M-018, M-020 | Yes | Prospective, single-arm, multicenter. 350 subjects (175 T1D + 175 T2D). 6 U.S. clinical sites. Evaluates MARD (target ≤ 9.0%), safety, user labeling comprehension. 14-day sensor wear per subject.
M-025 | Phase 3: Clinical & Testing Strategy | Atlas Underwriting Partners Ltd. product liability policy expiration | September 30, 2025 | N/A | Not Started | Solstice Biomedical Devices Ltd. / Atlas Underwriting Partners Ltd. | Marcus Hale | None | No | Policy No. AUP-PL-2024-00893. $25M per occurrence / $50M aggregate. Inception Oct. 1, 2024. RENEWAL REQUIRED before expiration to maintain coverage through clinical study and launch. Action item: initiate renewal by August 2025.
M-026 | Phase 3: Clinical & Testing Strategy | LUMINA-US clinical study enrollment complete | September 15, 2025 | December 15, 2025 | 91 | Not Started | Veltrano Clinical Research Organization Inc. | Dr. Lisa Fontaine | M-024 | Yes | 14 weeks of enrollment
M-027 | Phase 3: Clinical & Testing Strategy | LUMINA-US clinical study completed (last subject last visit + data lock) | March 15, 2026 | 1 | Not Started | Veltrano Clinical Research Organization Inc. / Solstice Biomedical Inc. | Dr. Lisa Fontaine / Dr. Niamh Tierney | M-024 | Yes | 14-day sensor wear + 8 weeks data analysis. Approximately 6 months total study duration.
M-028 | Phase 4: 510(k) Submission Preparation | Draft 510(k) submission documents (cover letter, 510(k) summary per 21 C.F.R. § 807.92, Form 3881 IFU, SE comparison table, labeling) | January 15, 2026 | April 15, 2026 | 90 | Not Started | Calderwood & Harkness LLP / Pinnacle Regulatory Consulting Group LLC / Solstice Biomedical Inc. | Amy Whitfield / Dr. Sandra Ellison / Dr. Niamh Tierney | M-014, M-015, M-016, M-027 | Yes | Traditional 510(k) submission covering both C14 and R7 as a system. Product code QKQ. 21 C.F.R. § 862.1355. Primary predicate K211034, secondary predicate K230489.
M-029 | Phase 4: 510(k) Submission Preparation | Labeling review memo completed (21 C.F.R. Part 801 compliance) | February 1, 2026 | March 15, 2026 | 42 | Not Started | Calderwood & Harkness LLP | Amy Whitfield | M-028 (iterative) | No | IFU, package labeling, physician labeling. Warnings, contraindications, sensor insertion instructions.
M-030 | Phase 4: 510(k) Submission Preparation | Promotional claims memo completed | March 1, 2026 | April 1, 2026 | 31 | Not Started | Calderwood & Harkness LLP | Amy Whitfield | M-028 | No | Pre- and post-clearance promotional claims. Section 502 FD&C Act. Off-label promotion risks. Comparative advertising re NovaSense GlucoTrack.
M-031 | Phase 4: 510(k) Submission Preparation | U.S. Agent and Establishment Registration memo / FURLS submission (21 C.F.R. Part 807) | March 1, 2026 | April 15, 2026 | 45 | Not Started | Calderwood & Harkness LLP / Solstice Biomedical Inc. | Sean Morrissey / Marcus Hale | M-028 | No | SBI (Delaware File No. 7834291) as U.S. agent. Initial registration, annual renewal, device listing for Lumina CGM.
M-032 | Phase 4: 510(k) Submission Preparation | 510(k) submission to FDA CDRH | April 30, 2026 | 1 | Not Started | Solstice Biomedical Inc. / Calderwood & Harkness LLP | Dr. Niamh Tierney / Marcus Hale / Miriam Calloway | M-027, M-028, M-029 | Yes | 510(k) user fee: $22,417 (FY2025 rate; may adjust for FY2026). Applicant: Solstice Biomedical Inc.
M-033 | Phase 4: 510(k) Submission Preparation | FDA 510(k) review period (90-day statutory review + potential Additional Information request) | April 30, 2026 | Q3 2026 | ~90+ | Not Started | FDA CDRH | N/A | M-032 | Yes | 90-day review clock. AI requests may extend timeline. Original Solstice target was Q1 2026; revised to Q3 2026 per Calderwood & Harkness assessment.
M-034 | Phase 4: 510(k) Submission Preparation | Target FDA 510(k) clearance — Solstice Lumina™ CGM System | Q3 2026 | N/A | Not Started | FDA CDRH | N/A | M-033 | Yes | Clearance of traditional 510(k). Substantial equivalence to K211034 and K230489.
M-035 | Phase 4: 510(k) Submission Preparation | Post-clearance regulatory obligations memo delivered | Q3 2026 | Q3 2026 | 14 | Not Started | Calderwood & Harkness LLP | Amy Whitfield / Sean Morrissey | M-034 | No | MDR reporting (21 C.F.R. Part 803), corrections/removals (Part 806), QSR (Part 820), annual registration, post-market surveillance. QSR-to-ISO 13485 harmonization transition.
M-036 | Phase 5: U.S. Commercial Launch | Target U.S. commercial launch — Solstice Lumina™ CGM System | Q4 2026 | N/A | Not Started | Solstice Biomedical Inc. | Marcus Hale / Dr. Eoin Gallagher | M-034, M-035 | Yes
[sheet: Dependency Map]
Milestone ID | Milestone Description | Predecessor Milestone IDs | Successor Milestone IDs | Lead Time / Lag (days) | Critical Path Segment | Risk if Delayed — Impact Description
M-001 | Calderwood & Harkness conflict check completed | None | M-002 | 0 | No | Delay prevents engagement opening; cascades to all downstream legal and regulatory activities
M-002 | Calderwood & Harkness engagement opened; engagement letter dated | M-001 | M-003, M-005, M-006, M-007, M-009, M-010 | 0 | No | Delay prevents commencement of all Calderwood & Harkness work products; cascades to Pre-Sub preparation
M-003 | $75,000 retainer received from Solstice Biomedical Inc. | M-002 | None | 0 | No | Administrative; non-payment could trigger engagement hold but unlikely to delay substantive work
M-004 | Crestline IP Advisory LLC — FTO preliminary assessment delivered | None | M-005, M-009 | 0 | No | Delay impacts regulatory strategy memo (M-005) and FTO/IP risk summary (M-009); could delay understanding of IP risk on predicate comparison
M-005 | Regulatory strategy memorandum — 510(k) pathway analysis, predicate selection, revised timeline | M-002, M-004 | M-011, M-017, M-018, M-022, M-023 | 0 | No | Key strategic document; delay cascades to Pre-Sub preparation, clinical strategy, and software/cybersecurity work streams
M-006 | Predicate device comparison table completed | M-002 | M-011 | 0 | No | Needed for Pre-Sub meeting request; delay pushes Pre-Sub timeline
M-007 | Device classification analysis memo (product code QKQ) | M-002 | M-008, M-011 | 0 | No | Classification confirmation required before Pre-Sub; delay pushes Pre-Sub request
M-008 | iCGM special controls memo | M-007 | M-012 | 0 | No | Informs Pre-Sub meeting package content; delay could reduce quality of FDA engagement
M-009 | FTO/IP risk assessment summary memo to Solstice | M-004 | None (informational) | 0 | No | Client needs IP risk summary for business decision-making; delay does not directly impact regulatory timeline but may affect design-around timing
M-010 | MDUFA small business qualification analysis memo | M-002 | M-032 | 0 | No | Determines user fee amount; delay does not impact timeline but needed before 510(k) submission fee payment
M-011 | Pre-Sub meeting request submitted to FDA | M-005, M-006, M-007 | M-012, M-013 | 0 | Yes | Delay pushes Pre-Sub meeting date and cascades to clinical study start; every week of delay here adds approx. 1 week to 510(k) submission target
M-012 | Pre-Sub meeting package submitted to FDA | M-011 | M-014 | 0 | Yes | Must be submitted exactly 60 days before scheduled meeting date (Aug. 14); late submission requires meeting reschedule
M-013 | Internal memo: Pre-Sub strategy and anticipated FDA feedback | M-011 | M-014 | 0 | No | Internal preparation document; delay reduces team preparedness for Pre-Sub meeting but does not directly gate FDA interaction
M-014 | Pre-Sub meeting with FDA | M-012 | M-015, M-016, M-017, M-024 | 60 days from M-012 | Yes | FDA feedback may alter biocompatibility testing scope, clinical study design, or predicate acceptance; key gating event for all downstream activities
M-015 | Biocompatibility testing complete (Whitmore Laboratories Inc.) | M-014 (feedback may alter scope) | M-024, M-028 | 0 | Yes | Biocompatibility data required for both clinical study commencement and 510(k) submission; delay cascades to study start and submission
M-016 | EMC / electrical safety testing complete (Whitmore Laboratories Inc.) | M-014 | M-028 | 0 | No | EMC data required for 510(k) submission; delay could impact submission preparation but not clinical study start
M-017 | IDE exemption analysis memo finalized (NSR determination) | M-005 | M-019, M-021 | 0 | Yes | NSR vs. SR determination dictates IRB submission pathway; if SR, full IDE application required which adds 3-6 months to timeline
M-018 | Clinical study agreement with Veltrano CRO reviewed and executed | M-005 | M-019, M-024 | 0 | Yes | CRO agreement must be executed before IRB submission and study commencement; delay cascades directly to study start
M-019 | IRB submission to Clearwater Institutional Review Board LLC | M-017, M-018 | M-020 | 0 | Yes | IRB submission is prerequisite for approval; delay pushes IRB approval and study commencement dates
M-020 | IRB approval received for LUMINA-US | M-019 | M-024 | 0 | Yes | Clinical study cannot commence without IRB approval; delay directly delays study start
M-021 | Informed consent form finalized | M-017 | M-019 | 0 | No | ICF needed for IRB submission package; delay could impact IRB submission completeness
M-022 | Software documentation checklist and gap analysis completed | M-005 | M-028 | 0 | No | Software documentation needed for 510(k) submission; delay impacts submission preparation timeline
M-023 | Cybersecurity premarket submission checklist completed | M-005 | M-028 | 0 | No | Cybersecurity documentation needed for 510(k) submission; delay impacts submission preparation timeline
M-024 | LUMINA-US clinical study commenced | M-014, M-015, M-018, M-020 | M-026, M-027 | 0 | Yes | Depends on Pre-Sub feedback, biocompatibility completion, CRO agreement execution, and IRB approval. Any delay in these four predecessors delays study start.
M-025 | Atlas insurance policy expiration | None | None (action item) | N/A | No | Policy expires Sept. 30, 2025; clinical study runs through March 2026. Failure to renew creates coverage gap during active clinical study and pre-launch activities.
M-026 | LUMINA-US clinical study enrollment complete | M-024 | M-027 | 91 days | Yes | Enrollment delays directly extend study duration and delay data lock, cascading to 510(k) submission
M-027 | LUMINA-US clinical study completed (last subject last visit + data lock) | M-024 | M-028, M-032 | ~6 months | Yes | Study completion is the longest-duration critical path task; delay directly delays 510(k) submission
M-028 | Draft 510(k) submission documents | M-014, M-015, M-016, M-027 | M-029, M-030, M-031, M-032 | 0 | Yes | Submission document drafting depends on all testing and clinical data; delay cascades to submission date
M-029 | Labeling review memo completed | M-028 (iterative) | M-032 | 0 | No | Labeling must be finalized before 510(k) submission; delay could hold submission
M-030 | Promotional claims memo completed | M-028 | M-036 | 0 | No | Needed for commercial launch planning; delay does not directly impact 510(k) submission but affects marketing readiness
M-031 | U.S. Agent and Establishment Registration memo / FURLS submission | M-028 | M-036 | 0 | No | Registration required before commercial distribution; delay could impact launch timing
M-032 | 510(k) submission to FDA CDRH | M-027, M-028, M-029 | M-033 | 0 | Yes | Submission cannot occur until clinical data analyzed, all submission documents finalized, and labeling reviewed
M-033 | FDA 510(k) review period | M-032 | M-034 | ~90 days | Yes | 90-day statutory review; AI requests could extend by 30-90+ days; directly determines clearance date
M-034 | Target FDA 510(k) clearance | M-033 | M-035, M-036 | 0 | Yes | Clearance is prerequisite for U.S. commercial distribution; delay directly delays launch
M-035 | Post-clearance regulatory obligations memo delivered | M-034 | M-036 | 0 | No | Informational memo; delay does not prevent launch but could create compliance gaps in post-market obligations
M-036 | Target U.S. commercial launch — Solstice Lumina™ CGM System | M-034, M-035 | None (end milestone) | 0 | Yes | Final milestone; delay represents overall program delay and impacts revenue projections, competitive positioning
[sheet: Budget Tracker]
Cost Item | Vendor / Provider | Contact Person | Related Milestone IDs | Estimated Cost (USD) | Actual Cost to Date (USD) | Remaining Budget (USD) | Source / Reference | Notes
FDA 510(k) user fee (FY2025) | FDA CDRH | N/A | M-032 | $22,417 | $0 | $22,417 | FDA MDUFA FY2025 fee schedule | Standard fee; SBI does not qualify as small business (consolidated parent revenue €187.4M ≈ $204.3M exceeds threshold)
Biocompatibility testing (ISO 10993 series) | Whitmore Laboratories Inc. | Dr. James Haverford | M-015 | $485,000 | $0 | $485,000 | Whitmore quote dated March 3, 2025 | C14: cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity, implantation, hemocompatibility, genotoxicity. R7: cytotoxicity, sensitization, irritation. A2LA Cert. 3847.01.
EMC / electrical safety testing | Whitmore Laboratories Inc. | Dr. James Haverford | M-016 | $175,000 | $0 | $175,000 | Whitmore quote dated March 3, 2025
Clinical study (LUMINA-US, Protocol SBD-LUM-CL-001) | Veltrano Clinical Research Organization Inc. | Dr. Lisa Fontaine | M-018, M-024, M-027 | $4,200,000 | $0 | $4,200,000 | CRO budget estimate | 350 subjects × $12,000/subject = $4,200,000. 175 T1D + 175 T2D. 6 U.S. sites.
Regulatory consulting fees | Pinnacle Regulatory Consulting Group LLC | Dr. Sandra Ellison / Thomas Greenbaum | M-005 through M-032 | $380,000 | $0 | $380,000 | Pinnacle SOW dated January 15, 2025 | Engaged January 15, 2025. 9500 Medical Center Dr., Suite 210, Rockville, MD 20850.
Freedom-to-operate analysis | Crestline IP Advisory LLC | Dr. Raymond Cho | M-004, M-009 | $215,000 | $0 | $215,000 | Crestline engagement letter dated February 2025 | FTO re NovaSense patent portfolio. 75 Federal St., Suite 1800, Boston, MA 02110.
Legal fees (FDA regulatory strategy) | Calderwood & Harkness LLP | Miriam Calloway (Responsible Partner) / Joel Strauss (Billing Partner) | All | $650,000 | $0 | $650,000 | Engagement letter 1037-00002 dated April 22, 2025 | Hourly basis. Blended effective rate ~$725/hr. Retainer $75,000 received April 28, 2025. Expense cap $15,000 without prior client approval. Monthly billing.
TOTAL ESTIMATED EXTERNAL REGULATORY COSTS | $6,127,417 | $0 | $6,127,417 | Sum of all line items
[sheet: Key Contacts]
Organization | Organization Type | Role in Program | Key Contact Name | Title | Address | Engagement / Effective Date | Reference Numbers
Solstice Biomedical Devices Ltd. | Private limited company (Ltd.) — Ireland | Client (parent entity) | Dr. Eoin Gallagher, CEO; Dr. Niamh Tierney, VP Regulatory Affairs; Dr. Aisling Burke, CTO; Fiona Drennan, QA Director | See name field | Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland | N/A | CRO No. 648231; ISO 13485:2016 (Meridian NB 0483); EU MDR CE Cert. MCA-2024-07319 (Sept. 12, 2024); Prior 510(k) K192847 (Nov. 14, 2019)
Solstice Biomedical Inc. | Corporation — Delaware | U.S. subsidiary; intended 510(k) holder and U.S. agent | Marcus Hale, VP of U.S. Operations | VP of U.S. Operations | 220 Westbrook Drive, Suite 400, Cambridge, MA 02142 | N/A | Delaware File No. 7834291; FY2024 U.S. revenue $22.8M; ~95 employees
Calderwood & Harkness LLP | LLP — District of Columbia | Engaged law firm — FDA regulatory strategy | Miriam Calloway (Responsible Partner); Joel Strauss (Billing Partner); Amy Whitfield (Lead Associate); Sean Morrissey (Working Associate) | See name field | 1401 K Street NW, Suite 900, Washington, D.C. 20005 | April 22, 2025 | Engagement Ref. 1037-00002
Pinnacle Regulatory Consulting Group LLC | LLC — Delaware | Regulatory affairs consultancy | Dr. Sandra Ellison, Managing Director; Thomas Greenbaum, Senior Regulatory Specialist | See name field | 9500 Medical Center Drive, Suite 210, Rockville, MD 20850 | January 15, 2025 | SOW dated January 15, 2025
NovaSense Medical Technologies Inc. | Corporation — Delaware | Predicate device manufacturer (primary K211034, secondary K230489) | David Reinhardt, CEO; Dr. Karen Nishimura, VP Regulatory Affairs | See name field | 4800 Innovation Parkway, San Diego, CA 92121 | N/A | Delaware File No. 5429876; FY2024 revenue $1.24B; Patents: U.S. 10,847,221; 11,234,567; 11,502,893
Marlowe Asset Management Patent Group LLP | LLP — Virginia | Patent counsel for NovaSense | Patricia Langford, Partner | Partner | 2200 Wilson Boulevard, Suite 1100, Arlington, VA 22201 | N/A
Crestline IP Advisory LLC | LLC — Delaware | FTO / patent counsel (retained by Solstice) | Dr. Raymond Cho, Patent Attorney | Patent Attorney | 75 Federal Street, Suite 1800, Boston, MA 02110 | February 2025 (engagement letter) | FTO preliminary assessment delivered April 10, 2025
Hargrove & Endicott LLP | Partnership — Ireland | Irish corporate & regulatory counsel | Ciara Brennan, Partner | Partner | 38 Fitzwilliam Square East, Dublin D02 NH85, Ireland | N/A | Advising on EU MDR compliance interface with FDA strategy
Whitmore Laboratories Inc. | Corporation — Delaware | Contract testing laboratory (biocompatibility, EMC) | Dr. James Haverford, Director of Biocompatibility Testing | Director of Biocompatibility Testing | 1625 Shady Grove Road, Suite 300, Gaithersburg, MD 20878 | March 3, 2025 | A2LA Certificate No. 3847.01; ISO 17025 accredited
Meridian Conformity Assessment GmbH | GmbH — Germany | EU notified body (ISO 13485, CE marking) | Dr. Henrik Vogt, Lead Auditor | Lead Auditor | Landsberger Allee 44, 10249 Berlin, Germany | N/A | NB 0483; EU MDR CE Cert. MCA-2024-07319 issued Sept. 12, 2024
Atlas Underwriting Partners Ltd. | Limited company — United Kingdom | Product liability / clinical trial insurer | N/A | N/A | 25 Fenchurch Avenue, London EC3M 5AD, United Kingdom | October 1, 2024 (policy inception) | Policy No. AUP-PL-2024-00893; $25M occurrence / $50M aggregate; expires Sept. 30, 2025
Broadleaf Accounting Partners LLP | LLP — Ireland | External auditors for Solstice | Declan Murray, Audit Partner | Audit Partner | 12 Harcourt Street, Dublin D02 P890, Ireland | N/A
Veltrano Clinical Research Organization Inc. | Corporation — Indiana | CRO for LUMINA-US clinical study | Dr. Lisa Fontaine, VP of Clinical Operations | VP of Clinical Operations | 500 North Capitol Street, Suite 700, Indianapolis, IN 46204 | TBD (MSA under review)
Clearwater Institutional Review Board LLC | LLC — Florida | IRB for LUMINA-US clinical study | N/A | N/A | 3200 Bayshore Boulevard, Tampa, FL 33629 | TBD (submission planned) | IRB Registration No. IRB-2019-04821
[sheet: Device Technical Summary]
Parameter | Solstice Lumina C14 Sensor | Solstice Lumina R7 Reader/Transmitter | Primary Predicate: NovaSense GlucoTrack NX-500 (K211034, cleared June 18, 2022) | Secondary Predicate: NovaSense GlucoTrack NX-700 (K230489, cleared March 7, 2024) | Solstice GlucoStrip RX-200 (K192847, cleared Nov. 14, 2019)
Product Code | QKQ (anticipated) | QKQ (anticipated) | QKQ | QKQ | NBW
Device Class | Class II (anticipated) | Class II (anticipated) | Class II | Class II | Class II
Regulation Number | 21 C.F.R. § 862.1355 (anticipated) | 21 C.F.R. § 862.1355 (anticipated) | 21 C.F.R. § 862.1355 | 21 C.F.R. § 862.1355 | N/A (different regulation)
Device Type | Subcutaneously implantable CGM sensor | Wearable reader/transmitter (arm-worn) | Enzymatic electrochemical CGM sensor | Enzymatic electrochemical CGM sensor (enhanced) | Glucose test strip reader
Sensor Technology | Fourth-generation enzymatic electrochemical biosensor; PtIr-4G platinum-iridium electrode coating | N/A (receives data from C14) | Enzymatic electrochemical; platinum electrode | Enzymatic electrochemical (enhanced) | Test strip reader (not CGM)
Sensor Wear Duration | 14 days (336 hours) | N/A | 10 days | 14 days | N/A
Wireless Protocol | BLE 5.2 | BLE 5.2 | BLE 5.0 | BLE 5.0 | N/A
Reader Form Factor | N/A | Arm-worn integrated reader/transmitter | Handheld receiver | Handheld receiver (updated) | Handheld reader
Algorithm | LuminaPredict v2.1 (proprietary glucose prediction) | Embedded in reader | NovaSense proprietary | NovaSense updated algorithm | N/A
Measurement Range | 40–400 mg/dL | Displays C14 data | 40–400 mg/dL | 40–400 mg/dL | N/A
MARD Target | ≤ 9.0% | N/A | Per cleared labeling | Per cleared labeling | N/A
Warm-Up Time | ≤ 60 minutes | N/A | Per cleared labeling | Per cleared labeling | N/A
Alert Latency | N/A (sensor only) | ≤ 5 minutes from sensor reading to user notification | Per cleared labeling | Per cleared labeling | N/A
Display Features | N/A | Real-time glucose values, trend arrows, 8-hour trend graphs, configurable hypo/hyperglycemia alerts | Per cleared labeling | Per cleared labeling | Glucose value display
Mobile App | N/A | Solstice Lumina™ mobile app (iOS/Android) v1.0.3 via BLE | Per cleared labeling | Per cleared labeling | N/A
Firmware / Software Versions | Firmware v3.4.2 | Reader OS v2.1.0 | N/A | N/A | N/A
Intended Population | Persons aged 18+ with Type 1 or Type 2 diabetes mellitus | Same (system component) | Per cleared labeling | Per cleared labeling | General glucose testing
Submission Type | Traditional 510(k) (single submission covering C14 + R7 as a system) | Same submission | 510(k) | 510(k) | 510(k)
Predicate Role | Subject device | Subject device | Primary predicate | Secondary predicate (reference device) | Referenced for corporate pedigree only; not a predicate for substantial equivalence
EU MDR Status | CE-marked; EU MDR Certificate MCA-2024-07319 (Sept. 12, 2024, Meridian NB 0483) | Same CE certificate | N/A | N/A | N/A
Key Differences from Primary Predicate | 1) 14-day vs. 10-day wear; 2) PtIr vs. Pt electrode; 3) BLE 5.2 vs. 5.0; 4) Arm-worn vs. handheld reader; 5) Different algorithm | See C14 differences | N/A (is the primary predicate) | Aligned on 14-day wear; updated BLE and algorithm | Different product code and technology
[sheet: Risk Register]
Risk ID | Risk Description | Related Milestone(s) | Likelihood | Impact | Overall Risk Rating | Mitigation Strategy | Risk Owner | Status
R-001 | FDA rejects primary predicate K211034 (NovaSense GlucoTrack NX-500) during Pre-Sub or 510(k) review | M-014, M-032, M-034 | Low | High | Medium | Prepare contingency predicate analysis using K230489 as primary; address in Pre-Sub questions; develop fallback argument for substantial equivalence | Miriam Calloway / Amy Whitfield | Open
R-002 | FDA determines device requires PMA instead of 510(k) | M-014, M-032 | Low | Critical | High | Pre-Sub question addresses classification; have De Novo contingency strategy; iCGM pathway analysis prepared | Miriam Calloway | Open
R-003 | FDA requires additional clinical endpoints or larger study population beyond 350 subjects | M-014, M-024, M-027 | Medium | High | High | Include Pre-Sub question on clinical study design acceptability; budget contingency for expanded enrollment; discuss protocol flexibility with Veltrano CRO | Amy Whitfield / Dr. Niamh Tierney | Open
R-004 | Biocompatibility testing reveals concerns with PtIr-4G electrode coating (novel material) | M-015 | Medium | High | High | Early engagement with Whitmore Laboratories on PtIr-4G testing scope; gap analysis against FDA biocompatibility guidance; leverage EU MDR testing data where acceptable | Sean Morrissey / Dr. James Haverford | Open
R-005 | FTO analysis identifies high infringement risk for NovaSense U.S. Patent 10,847,221 (enzyme coating) | M-004, M-009 | Medium | High | High | Design-around efforts underway (alternative electrode deposition process); Crestline completing full claim chart analysis; monitor for any design-around impact on regulatory data | Dr. Raymond Cho / Dr. Aisling Burke | Open
R-006 | FDA determines clinical study is significant risk (SR) rather than NSR, requiring full IDE application | M-017, M-024 | Low-Medium | High | Medium | IDE exemption analysis underway; Pre-Sub question to confirm NSR determination; prepare abbreviated IDE as contingency | Amy Whitfield | Open
R-007 | IRB approval from Clearwater delayed beyond September 2025 | M-019, M-020, M-024 | Low | Medium | Medium | Submit IRB application by August 1, 2025; maintain regular communication with Clearwater IRB; prepare complete submission package well in advance | Dr. Niamh Tierney / Amy Whitfield | Open
R-008 | Atlas Underwriting Partners Ltd. product liability policy expires September 30, 2025 — coverage gap during clinical study | M-025 | Low | High | Medium | Initiate renewal discussions by August 2025; ensure renewed policy covers U.S. clinical study activities through March 2026 and beyond to launch | Marcus Hale | Open
R-009 | Pre-Sub meeting date delayed beyond August 14, 2025 due to FDA scheduling constraints | M-014 | Medium | Medium | Medium | Submit meeting request as early as June 2, 2025; indicate flexibility on meeting format (teleconference); prepare all materials well in advance of 60-day deadline | Miriam Calloway / Dr. Niamh Tierney | Open
R-010 | Clinical study recruitment delays at one or more of the 6 U.S. sites | M-024, M-026, M-027 | Medium | Medium | Medium | Veltrano CRO to identify backup sites; enrollment contingency plan; consider expanding to 7-8 sites if needed | Dr. Lisa Fontaine / Dr. Niamh Tierney | Open
R-011 | FDA Additional Information (AI) request during 510(k) review extends timeline beyond Q3 2026 | M-033, M-034 | Medium | Medium | Medium | Ensure 510(k) submission is comprehensive and addresses all Pre-Sub feedback; prepare team for rapid AI response; build 4-week buffer into launch planning | Miriam Calloway / Amy Whitfield | Open
R-012 | Cybersecurity documentation gaps identified that require additional engineering effort | M-023, M-028 | Medium | Medium | Medium | Complete cybersecurity checklist early (by June 2025); engage Solstice engineering team to address SBOM, threat modeling (STRIDE), and patch management gaps proactively | Sean Morrissey / Dr. Aisling Burke | Open