Vitrafy Announces Positive Phase 2 USAISR Platelet Results
Key points
- USAISR results confirm Vitrafy's cryopreservation ecosystem outperforms regulatory standards
- 94% post-thaw recovery achieved with no-wash protocol
- Largest blood platelet testing program using Vitrafy's ecosystem
- Positioning the company to address a critical market gap
Full summary
Vitrafy Life Sciences Limited announced successful results from Phase 2 USAISR platelet testing, demonstrating that their cryopreservation ecosystem outperforms regulatory and quality standards across all tested platelet protocols. The study, conducted under a Cooperative Research and Development Agreement (CRADA) with the U.S. Army, evaluated the system's capability to cryopreserve critical response blood platelets. The no-wash protocol using 3% DMSO achieved a 94% post-thaw recovery, surpassing the regulatory standard and quality guidelines. This milestone positions Vitrafy to address a significant market gap and paves the way for FDA medical device registration and further engagement with military and civilian blood networks.
Guidance
FDA medical device registration expected in H1 FY27
Outlook
Vitrafy plans to engage with FDA, military, and civilian blood networks in the first half of FY27, following the publication of Phase II results.
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