Vitrafy Life Sciences (VFY) Study result summary

Study overview and objectives

• Phase II results focused on U.S. Army collaboration for blood platelet cryopreservation, conducted under a Cooperative Research and Development Agreement.

• Achieved 94% post-thaw recovery using a 3% DMSO no-wash protocol, validated independently by the U.S. Army Institute of Surgical Research.

• Study included over 20 donors and 60 samples across three protocols, representing the largest commercial-scale platelet testing program to date.

• Main goal was to validate the cryopreservation ecosystem for operational, rapidly deployable platelet products for critical response use.

• Results support FDA medical device registration and future publication in military and civilian journals, delivering on a key IPO commitment.

Protocols and regulatory benchmarks

• Three protocols tested: wash (aligned with European guidelines), no-wash (operational benefit), and a comparison to fresh platelets.

• No-wash protocol with 3% DMSO demonstrated high recovery and functionality, reducing toxicity and operational complexity.

• All protocols exceeded regulatory and quality standards for platelet recovery; European EDQM guideline requires 50% post-thaw recovery, FDA/AABB guidance for fresh platelets is 75%.

• No-wash protocol enables rapid deployment and stockpiling for trauma response.

• No study was conducted with 3% DMSO plus wash, as the focus was on operational and toxicity benefits.

Functional outcomes and market impact

• Platelets preserved with the no-wash protocol showed strong clotting function and rapid response, with high post-thaw functionality including clot strength and receptor retention.

• Lower DMSO concentration reduces toxicity, eliminating the need for complex wash steps.

• Enables scalable, sustainable supply for both military and civilian needs, addressing 20% wastage in the U.S. market and a critical market gap.

• Medical device registration and further validation are underway, with FDA registration and publication of results targeted for H1 FY27.

• Ongoing collaboration with the U.S. Army and proactive engagement with FDA, military, and civilian blood networks.