Gallant Advances Stem Cell Therapy for Canine Osteoarthritis with FDA Expanded Approval Pathway

Gallant Advances Canine Osteoarthritis IV-Delivered Stem Cell Therapy with Promising Pilot Data and Expanded FDA Conditional Approval Pathway Eligibility. 

Gallant, an animal health biotechnology company pioneering off-the-shelf mesenchymal stromal cell therapies for pets, today announced that its canine osteoarthritis MSC therapy program has been granted eligibility to use the U.S. 

 Food and Drug Administration Center for Veterinary Medicine's expanded conditional approval pathway. The company also announced positive results from a randomized, placebo-controlled pilot study evaluating intravenous (IV) UMSCs in client-owned dogs with naturally occurring OA. 

According to Towards Healthcare, the veterinary regenerative medicine market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 1.6 billion in 2026 to approximately USD 4.74 billion by 2035, representing a compound annual growth rate (CAGR) of 12.8% from 2026 to 2035. Growth is driven by the increasing number of pet owners, which is leading to higher spending on veterinary medicines and advanced treatments. The growing incidence of conditions like osteoarthritis, hip dysplasia, tendon injuries, and spinal disorders in companion and livestock animals is driving demand for regenerative treatments. 

About Gallant

Gallant is an animal health biotechnology company creating a new category of veterinary care with a pipeline of off-the-shelf, ready-to-use stromal cell therapies targeting the root cause of disease in pets. Led by pioneers in veterinary regenerative medicine with deep expertise in development, manufacturing, and commercialization, it is making regenerative medicine accessible, moving beyond symptom management to restoring health at the source.  

The FDA granted Gallant expanded conditional approval eligibility for both its canine and feline OA programs, a regulatory designation expected to bring these therapies to market earlier, meeting a well-established unmet medical need with potential conditional approval targeted for 2028. 

Dr. Linda Black, DVM, Ph.D., CEO of Gallant, said We’re encouraged by the pilot data, and it moves us closer to making regenerative medicine a real and practical option for all veterinarians treating dogs suffering from OA. 

A recent report by Towards Healthcare highlights that the veterinary regenerative medicine market is witnessing growth due to rising demand for advanced therapies in companion animals and livestock, including stem cell treatments and platelet-rich plasma therapies. This demand is supported by the increasing prevalence of orthopaedic, musculoskeletal, and chronic conditions in pets. There is increasing awareness among pet owners and veterinarians about the benefits of regenerative medicine in treating various animal conditions. This acceptance is driving the demand for regenerative medicine applications.