Vitrafy Life Sciences (ASX: VFY) has completed Phase II in-vitro testing with the United States Army Institute of Surgical Research (USAISR), with all tested platelet cryopreservation protocols exceeding current regulatory and quality guidelines for platelet use.
The Texas-based study tested Vitrafy’s cryopreservation ecosystem across three protocols and delivered the strongest overall result from a 3% dimethyl sulfoxide (DMSO) no-wash protocol.
That protocol achieved 94% mean post-thaw platelet recovery and outperformed the other tested approaches across platelet recovery, clot strength and platelet receptor retention.
The result gives Vitrafy independent US military-authored validation for a potential no-wash frozen platelet solution in settings where fresh platelet supply remains logistically constrained.
With no commercially available frozen platelet product currently on the market, the study assessed all units against commonly accepted liquid-stored fresh platelet quality metrics, which were met or exceeded.
Largest Platelet Study
The Phase II program tested apheresis platelets from 20 donors, the largest blood platelet testing program completed to date using Vitrafy’s cryopreservation ecosystem.
The study assessed a no-wash 3% DMSO protocol, a no-wash trehalose-based protocol, and a 6% DMSO wash protocol.
The 3% DMSO no-wash protocol delivered 94% mean post-thaw recovery, compared with 84% from the 6% DMSO wash protocol and 78.9% from the trehalose protocol.
A wash-based protocol requires toxic levels of cryoprotectant to be added and removed through centrifuge-based washing and reconstitution—a process with limited use in time-critical or resource-constrained settings because it requires a specialised blood environment, sterile equipment, and trained personnel.
A no-wash protocol removes the need for specialised pre-freeze and post-thaw processing at the point of use.
Functional Performance Assessment
The Phase II study also assessed platelet function after thawing through clot strength and retention of key platelet surface receptors that support clotting.
The 3% DMSO no-wash formulation outperformed the wash protocol across both measures, retaining nearly twice the level of key platelet receptors after thawing—data that Vitrafy believes positions it to address a market gap with a differentiated offering supported by independent validation from the US Army.
“The ability to effectively utilize frozen platelets represents a vital advancement in addressing critical, growing needs across both civilian and military trauma response,” USAISR lead Dr Kristin Reddoch-Cardenas said.
“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.”
Independent Validation
“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,” Vitrafy chief executive officer Brent Owens said.
“Across 20 donors and at commercial volumes, we achieved 94% post-thaw recovery with superior clot strength and receptor retention — results that speak for themselves.”
Mr Owens said the milestone brought the company closer to addressing a persistent logistical challenge in transfusion medicine.
Vitrafy is progressing toward United States Food and Drug Administration (FDA) medical device registration in the first half of financial year 2027, and plans to present the Phase II findings with USAISR at international scientific conferences over coming months.
