Vitrafy Reports Consistent Phase II Platelet Cryopreservation Outcomes Across Wash and No-Wash Protocols
Vitrafy Life Sciences has announced the completion of Phase II testing of a platelet cryopreservation study with the U.S. Army Institute of Surgical Research, showing consistent results for the legacy wash-based protocol and encouraging outcomes for an innovative no-wash approach.
- Phase II study expanded sample size to over 60 platelet samples
- Wash-based protocol results consistent with Phase I benchmarks
- No-wash protocol showed comparable or improved outcomes
- Final report and analysis expected in Q4 FY2026
- Ongoing discussions for commercialisation and partnership expansion with U.S. Army
Phase II Study Completion and Scope
Vitrafy Life Sciences Limited (ASX:VFY) has announced the completion of Phase II testing in a platelet cryopreservation study conducted by the U.S. Army Institute of Surgical Research (USAISR). This study forms part of a Cooperative Research and Development Agreement (CRADA) between Vitrafy and the U.S. Army, aimed at developing rapid response platelet solutions for trauma settings.
The Phase II study expanded on earlier Phase I work by increasing the number of platelet samples tested to over 60, making it Vitrafy’s largest third-party testing program to date. The testing evaluated two protocols using Vitrafy’s cryopreservation ecosystem: the legacy wash-based protocol, which is the current global benchmark, and a next-generation no-wash protocol designed to simplify and accelerate platelet preservation and transfusion.
Legacy Wash-Based Protocol Validated
The wash-based protocol involves adding and then removing cryoprotectants to reduce toxicity, a process that can reduce workflow efficiency and delay patient transfusion. Phase II results for this protocol were consistent with those observed in Phase I, supporting the reproducibility and robustness of Vitrafy’s cryopreservation ecosystem. These findings reinforce the company’s progress toward medical device registration and commercialisation milestones.
Promising No-Wash Protocol Outcomes
The no-wash protocol, which eliminates the manual washing step, was tested using formulations with reduced cryoprotectant concentrations, including a 3% DMSO formulation and a trehalose-based formulation. Indicative Phase II results showed that this approach delivered outcomes comparable to or exceeding the legacy benchmark. This protocol could enable platelet deployment in emergency, regional, and resource-constrained environments by reducing handling time and operational complexity, potentially improving patient outcomes.
Next Steps and Commercial Outlook
Final analysis and validation of the Phase II data are underway, with the full report expected to be published in the fourth quarter of FY2026. Vitrafy and USAISR plan to present the findings at international scientific conferences later this year. Discussions are ongoing regarding commercialisation pathways and potential expansion of the partnership with the U.S. Army.
These developments follow Vitrafy’s recent strategic progress, including a 12-month commercial agreement with IMV Technologies and expansion of its U.S. operations, which have been detailed in the company’s earlier updates on its commercialisation efforts and U.S. military collaborations.
Managing Director Brent Owens highlighted the significance of the collaboration, noting that the relationship with the U.S. Army continues to strengthen and supports Vitrafy’s trajectory toward key commercial and regulatory milestones.
Bottom Line?
Vitrafy’s Phase II results reinforce the potential of its cryopreservation technology, but final validation and regulatory progress will be critical to its commercial impact.
Questions in the middle?
- How will the final Phase II report influence regulatory approval timelines for Vitrafy’s medical device registration?
- What are the potential commercialisation models being considered with the U.S. Army partnership?
- How might the no-wash protocol affect adoption in civilian trauma and emergency care settings beyond military use?
