Monitor GMED's remaining MDR conformity assessment timeline and any updates on CE marking. The ability to manufacture now reduces one risk, but revenue generation depends on regulatory approvals and commercial adoption, which remain uncertain.
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Executive Summary
Profusa received ISO 13485:2016 certification from GMED, a key step toward EU MDR certification and CE marking for its Lumee Oxygen Platform. The certification allows manufacturing to begin but does not guarantee MDR approval or market entry. This regulatory milestone is overshadowed by recent auditor dismissal and a dilutive convertible note financing, raising concerns about financial stability.
Key Facts
- ISO 13485:2016 certificate issued by GMED for design, development, and manufacture of Lumee Oxygen Platform at Berkeley facility.
- Certification follows positive certification decision announced September 24, 2026.
- Profusa can now begin manufacturing the Lumee Oxygen Sensor Platform.
- CE marking and MDR certification remain contingent on completion of remaining conformity assessment activities.
- No assurance on timing or outcome of MDR certification or market entry.
- Recent cross-filings include auditor dismissal (Oct 9) and $700K convertible note financing (Oct 15).
Financial Impact
No financial figures disclosed; regulatory milestone with uncertain commercial impact.
Risk Factors
- MDR certification and CE marking not guaranteed; timing uncertain.
- Recent auditor change and convertible note financing indicate financial and reporting stress.
- No revenue or sales guidance provided; pre-commercial stage company.
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3381457 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 12d ago | Press Release | $1.07 $1.02 | ▼ −4.67% | ▼ −3.66% | $0.7800 (−27.10%) |
Oct 15, 2026 12d ago | 8-K | $1.07 $1.02 | ▲ +4.67% | ▲ +3.66% | $0.7800 (+27.10%) |
Oct 9, 2026 17d ago | 8-K | $1.30 $0.9002 | ▲ +30.75% | ▲ +29.26% | $0.7800 (+40.00%) |
Oct 5, 2026 22d ago | 8-K | $1.75 $1.30 | ▼ −25.71% | ▼ −26.14% | $0.7800 (−55.43%) |
Sep 24, 2026 4w ago | Press Release | $3.03 $1.87 | ▼ −38.28% | ▼ −37.87% | $0.7800 (−74.26%) |
Sep 16, 2026 5w ago | 8-K | $1.78 $2.05 | ▼ −15.17% | ▼ −12.61% | $0.7800 (+56.18%) |
Sep 15, 2026 6w ago | 8-K | $1.83 $1.91 | ▲ +4.37% | ▲ +3.55% | $0.7800 (−57.38%) |
Sep 1, 2026 7w ago | 8-K | $2.88 $2.47 | ▲ +14.24% | ▲ +14.32% | $0.7800 (+72.92%) |
Aug 31, 2026 8w ago | 8-K | $3.00 $2.88 | ▼ −4.00% | ▼ −3.86% | $0.7800 (−74.00%) |
Aug 20, 2026 9w ago | 8-K | $7.57 $4.24 | ▲ +43.99% | ▲ +45.10% | $0.7800 (+89.70%) |
US Market Status
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