Vitrafy Life Sciences (ASX:VFY) has announced that an independent Phase 2 in vitro study led by the United States Army Institute of Surgical Research (USAISR) has validated the company's cryopreservation ecosystem as capable of delivering near-fresh platelet quality at commercial volumes.
The study tested apheresis platelets from 20 donors across three cryopreservation protocols and found that a no-wash 3 per cent DMSO (the standard agent for freezing cells) protocol produced a mean post-thaw platelet recovery of 94 per cent, outperforming a 6 per cent DMSO wash protocol at 84 per cent and a trehalose no-wash protocol at 78.9 per cent.
The comparative functionality data shown in the chart on page 3 demonstrates superior clot-forming strength and substantially greater retention of key platelet surface receptors for the 3 per cent DMSO no-wash formulation, with receptor retention nearly twice that of the wash protocol.
The Phase 2 program is the largest blood platelet testing exercise completed to date using the Vitrafy system and provides US military-authorised validation that cryopreserved platelets can be produced at scale while meeting or exceeding commonly accepted liquid-stored platelet quality metrics.
Vitrafy and USAISR emphasised the operational implications of a no-wash solution. A wash-based protocol requires centrifugation and reconstitution with freshly thawed plasma, using specialised equipment and trained personnel, thereby restricting its use to specialised settings. A decentralised no-wash protocol that delivers near-fresh post-thaw quality could enable stockpiling for event preparedness and extend access to rural hospitals and battlefield and emergency-response settings, where the current platelet supply is logistically constrained.
The USAISR research lead, Dr Kristin Reddoch Cardenas, said, "The ability to effectively utilise frozen platelets represents a vital advancement in addressing critical, growing needs across both civilian and military trauma response. We are proud of the scientific achievements resulting from this Phase II work and look forward to developing these findings into a peer-reviewed publication. Our ongoing collaborative research with Vitrafy offers a valuable scientific pathway toward implementing these essential capabilities."
Vitrafy Managing Director and CEO Brent Owens added, "The final Phase II report from USAISR delivers independent validation that our decentralised, no-wash platelet preservation platform exceeds regulatory and quality guidelines on every meaningful measure. Across 20 donors and at commercial volumes, we achieved 94 percent post thaw recovery with superior clot strength and receptor retention — results that speak for themselves. This milestone brings us firmly within reach of addressing one of transfusion medicines most persistent logistical challenges, and we look forward to building on our partnership with USAISR as we progress toward FDA medical device registration in the first half of FY2027."