Mantel Technologies announces that the US Food and Drug Administration (FDA) has completed its review of Mantel's canine freeze-dried plasma (cFDP), a pooled allogeneic canine freeze-dried plasma intended for the treatment of hypovolemia and control of hemorrhage in dogs, and decided the product met the criteria for low-risk determination, thereby allowing Mantel to introduce the product to the market.
FORT COLLINS, Colo., Jan. 8, 2026 /PRNewswire-PRWeb/ -- Mantel Technologies (Mantel, www.manteltechnologies.com) today announced that the U.S. Food and Drug Administration (FDA) has completed its review [1] of Mantel's canine freeze-dried plasma (cFDP) and decided the product met the criteria for low-risk determination, thereby allowing Mantel to introduce the product to the market. The FDA review process involved extensive evaluation of cFDP by the Center for Veterinary Medicine (CVM) and it was concluded that Mantel has appropriately identified and mitigated potential risks associated with cFDP and identified no additional safety concerns.
Mantel's cFDP is a pooled allogeneic canine freeze-dried plasma intended for the treatment of hypovolemia and control of hemorrhage in dogs. The product is administered intravenously and is regulated as an animal cell, tissue, and cell- and tissue-based product (ACTP).
As part of its review, the FDA, under the ACTP program, evaluated the product characterization and manufacturing controls, determining that the coagulation times and clotting factors used to characterize potency are relevant to the product's intended function. The agency also found that the manufacturing process includes appropriate controls, that contamination risks are adequately mitigated, and that the product's properties are consistent with other plasma products, without raising new safety concerns.
The FDA further reviewed Mantel's donor screening and disease mitigation protocols. Donor dogs undergo annual screening, disease testing, and evaluation prior to each donation. Plasma is pooled and the pooled sample is also tested for disease agents. The FDA determined these procedures appropriately mitigate the risk of disease transmission to recipient animals, other animals, and people who may handle or be exposed to the product.
Target animal safety was supported by both historical data and new studies conducted by Mantel. FDA-reviewed scientific literature documents the safe historical use of freeze-dried plasma in both human and veterinary medicine, with infrequent and generally non-serious adverse events. In addition, Mantel conducted three studies involving a total of 46 dogs administered cFDP intravenously at 20 mL/kg. These studies evaluated safety across different blood groups, the ability to control hemorrhage in dogs with induced coagulopathy, and treatment of hypovolemia following blood loss. Reported adverse events were limited and included cutaneous hypersensitivity reactions and vomiting. Based on these data, the FDA determined there is a low likelihood of harm to canine recipients.
The FDA also concluded that product labeling adequately mitigates risks to people who handle or administer cFDP, and that the environmental risk associated with the product is low given that plasma is a naturally occurring biological material, its characteristics are unchanged, and use is limited to dogs.
"The FDA's conclusion represents a significant milestone for Mantel and for the veterinary community," said Mike Cushman, President & CEO of Mantel Technologies. "cFDP is designed to provide veterinarians with a shelf-stable, field-deployable plasma product to rapidly address hemorrhage and hypovolemia in dogs, when time and access to fresh or frozen plasma are limited. We're proud to have one of the few ACTP products that have been reviewed by the FDA and to receive this determination. Development of the product wouldn't have been possible without the support provided by our sponsors at DHA OPMED [Defense Health Agency Operational Medical Systems] and the U.S. Special Operations Command. We're grateful for the partnerships forged within the special operations, first responder and critical care communities that allowed us to arrive at a product that is safe, efficacious and meets the needs of practitioners in both hospital and field settings."
Based on its comprehensive review, the FDA concluded that Mantel has properly identified and mitigated potential risks associated with cFDP and has no additional safety concerns. Mantel looks forward to making cFDP available to support veterinarians, emergency responders, and working dog teams in critical care situations.
Launch of the product is planned for early 2026. Parties interested in receiving details on purchasing the product are encouraged to contact [email protected].
Acknowledgement
Development of Mantel's canine freeze-dried plasma product was supported by the U.S. Army Medical Research Acquisition Activity under Contract No. W81XWH22C0127.
About Mantel Technologies
Mantel Technologies is a diversified defense technology company focused on delivering products and services to the National Security and dual use markets. Among its applications domains, Mantel has a robust product pipeline and service offerings in the working dog and general veterinary fields. A major emphasis of its canine products is bridging logistics and care challenges through delivery of point-of-need products and tools to monitor and ensure health and quality of life for working dogs. https://www.manteltechnologies.com
Media Contact
Michael Cushman, Mantel Technologies, 1 (720) 310-0179, [email protected], https://manteltechnologies.com
SOURCE Mantel Technologies
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