Key Highlights

  • Vitrafy Life Sciences Limited (ASX:VFY) entered a Partnership with Versiti Blood Health to advance development of its cryopreservation ecosystem for platelets.
  • The partnership follows an in-vitro platelet study with the United States Army Institute of Surgical Research, where Vitrafy’s protocol achieved 94.4% mean post-thaw platelet recovery.
  • Versiti will support verification and validation activities associated with Vitrafy’s planned U.S. medical device listing.
  • The company will initially place two cryopreservation freezing units at Versiti’s Blood Research Institute Facility in Milwaukee, Wisconsin.

Vitrafy Life Sciences Limited (ASX:VFY) is developing cryopreservation technologies designed to support the collection, preservation, storage and delivery of biological materials. The company’s shares were trading at AUD 3.760, up AUD 0.330 or 9.62% during the session. Vitrafy has announced a partnership with Versiti Blood Health to advance development of its cryopreservation ecosystem for platelets and support regulatory activities associated with its U.S. medical device listing.

Partnership With Versiti Blood Health

Vitrafy has entered into a partnership with Versiti Blood Health, a U.S.-based non-profit blood network, to support development of its platelet cryopreservation ecosystem.

The partnership follows Vitrafy’s Phase II in-vitro platelet study conducted with the United States Army Institute of Surgical Research (USAISR). The study reported that the 3% DMSO no-wash protocol achieved 94.4% mean post-thaw platelet recovery using Vitrafy’s cryopreservation ecosystem.

The platelet application remains under development and is subject to U.S. regulatory requirements.

Versiti represents Vitrafy’s third U.S. civilian blood partnership, following previous partnerships with Vitalant and Hoxworth Blood Center, which focused on red blood cell applications. The Versiti partnership is specifically focused on platelets.

Platelet Cryopreservation Development Program

Under the partnership, Vitrafy and Versiti will contribute resources to progress development of Vitrafy’s cryopreservation ecosystem for no-wash platelet cryopreservation within Versiti’s platelet workflows.

The collaboration is intended to support evaluation of the technology within blood processing environments and generate information relevant to further development activities.

Vitrafy’s ecosystem includes the Guardion cryopreservation freezing unit and LifeChain™, a cloud-based software platform designed to support management of biological materials through collection, cryopreservation, storage and delivery processes.

U.S. Medical Device Listing Activities

The partnership will also support verification and validation activities associated with Vitrafy’s planned U.S. medical device listing.

Blood products supplied through the partnership will support verification and validation activities for Vitrafy’s cryopreservation freezer for currently approved cryopreserved blood products, including plasma.

These activities are directed towards completing U.S. medical device listing for the Vitrafy cryopreservation freezer, targeted for FY2027.

Versiti will also explore potential applications of the Vitrafy cryopreservation ecosystem across other blood products, including red blood cells.

Placement of Cryopreservation Units at Versiti Facility

As part of the partnership, Vitrafy will initially place two cryopreservation freezing units at Versiti’s Blood Research Institute facility in Milwaukee, Wisconsin.

The units will be provided without charge, and the Placement will not generate Revenue for Vitrafy.

Vitrafy will fund certain verification and validation services undertaken by Versiti on behalf of the company as part of the FDA medical device listing process.

Versiti Blood Health Overview

Versiti Blood Health operates as a non-profit blood health organisation with 42 fixed collection centres and serves more than 400 hospitals across the Midwest United States.

The organisation collects, tests and distributes blood and blood products through donor centres and mobile blood drives across Illinois, Indiana, Michigan, Ohio and Wisconsin.

Versiti also operates the Versiti Blood Research Institute, which conducts research in hematology, transfusion medicine and cellular therapy.

Key Takeaways

Vitrafy’s partnership with Versiti expands its development activities in platelet cryopreservation and supports ongoing verification and validation work for its U.S. regulatory pathway. The collaboration follows encouraging in-vitro platelet study results and provides an opportunity to evaluate Vitrafy’s technology within a blood network environment. Further development and regulatory activities will determine the progress of the cryopreservation ecosystem.