Celavet Inc. Plans Submission of Equine Tendinitis Study to FDA’s Center for Veterinary Medicine and Announces Ashlee E. Watts, DVM, PhD, DACVS as Principal Investigator

Celavet has previously collaborated with Dr. Watts to evaluate OK100 stem cells for treatment of equine tendon injuries

OXNARD, Calif.–(BUSINESS WIRE)–#equine—Celavet Inc., a regenerative medicine company developing stem cell-based therapies for the treatment and prevention of orthopedic injuries and diseases in large and small animals, and a subsidiary of Celavie Biosciences, LLC, today announced Ashlee E. Watts, DVM, PhD, DACVS as principal investigator for a new equine tendinitis study being submitted to the FDA’s Center for Veterinary Medicine (CVM).

Celavet is submitting the study protocol to the CVM for Investigational New Animal Drug (INAD) status. The tentative double-blind, randomized, placebo-controlled pivotal trial aims to test the safety and efficacy of Celavet’s undifferentiated allogeneic pluripotent equine (OK100) stem cells for the treatment of equine tendinitis.

Dr. Watts is Director of the Comparative Orthopedics and Regenerative Medicine Laboratory at Texas A&M University, as well as Associate Professor of Equine Orthopedics and the Linda and Dennis H. Clark 68’ Chair of Equine Studies. Ashlee’s clinical and research experience and specialized focus in regenerative medicine, osteoarthritis prevention and innovative techniques to improve musculoskeletal healing lend strength to Celavet’s expertise.

Previously, Dr. Watts was lead author on an article describing a double-blind, placebo-controlled study of Celavet’s OK100 stems cells in a large animal flexor tendonitis model published in 2011 in Stem Cell Research & Therapy. Additionally, she was key investigator in a controlled study of Embryonic Stem Cells for the Treatment of Tendonitis involving OK100 stem cells at Cornell University in 2009 that demonstrated the ability of OK100 cells to restore tendon lesions to anatomical normality with no scar formation.

“We’re thrilled to have Dr. Watts as principal investigator for our study to test the safety and efficacy of OK100 stem cells for the treatment of equine tendinitis,” said Sandy Solmon, CEO and President of Celavie Biosciences and Celavet. “We successfully worked with Dr. Watts previously to study our OK100 cells in equine tendon injuries and believe our collaboration is a crucial next step towards obtaining INAD approval from the CVM.”

Celavet builds upon the work of Celavie Biosciences to develop proprietary, pluripotent allogeneic stem cells for treatment of a range of diseases and conditions. To date, Celavet’s OK100 stem cells have been used to treat over 400 horses with tendon and ligament injuries in multiple trials at more than 35 veterinary centers around the U.S. and represent the first application of undifferentiated stem cells in musculoskeletal veterinary injuries. In these trials, OK100 stem cells demonstrated potential to repair connective tissues in acute and chronic injuries in horses. No tumor formation, infection or any other lasting adverse events have been observed.

About Celavie Biosciences

Celavie Biosciences is a privately-held company whose mission is to improve lives and restore hope by advancing regenerative stem cell therapies for the treatment of Parkinson’s disease and other disorders of the central nervous system (CNS). The company develops undifferentiated, unmodified allogeneic pluripotent stem cell-based therapies, holds a strong IP portfolio, including 18 issued patents, and has an experienced management team blending expertise in concept and cell technology, product scalability and entrepreneurship. Celavet, a subsidiary, applies the same proprietary technologies for the treatment and prevention of serious veterinary diseases. More information is available at https://www.celavie.com/.

About Celavet

Celavet Inc., a subsidiary of Celavie Biosciences, LLC, is a regenerative medicine company developing stem cell-based therapies for the treatment and prevention of orthopedic injuries and diseases in large and small animals, with an aim to restore health and mobility. Celavet uses the same standardized and controlled production methods as used in human cell manufacture to establish equine, canine and feline stem cell lines. Stem cell lines from different species all express standard stem cell characteristics and are available to address pathologies in their respective species. More information is available at https://www.celavie.com/celavet/.

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