Stemcis (Hybrigenics): green light from the FDA to market its medical devices – 06/27/2022 at 18:21


(AOF) – Stemcis, a subsidiary of Hybrigenics SA, specializing in the treatment of adipose tissue, mesenchymal stem cells and their uses in plastic and reconstructive surgery, has announced that it has received the clearance letter from the FDA (Food and Drug Administration ) authorizing it to market its medical devices in the United States.

“Obtaining authorization from the American health agency FDA is a major step that will allow the company to expand its market and thus consolidate its position as a pioneer in the market for single-use devices intended for the community. of specialized surgeons”, specifies the company.

The “Adipose Treatment Kit” range has been authorized in the United States for the following specialties: neurosurgery, gastrointestinal surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery and surgical arthroscopic.

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immuno-oncology, the specialty that has been driving this market for ten years, supports research. GlobalData estimates that this segment could reach 180 billion in 2026. The major players are looking to strengthen themselves in this niche. Pfizer recently acquired Canadian biotech Trillium Therapeutics for $2.3 billion. Following this operation, the American group got hold of two promising molecules in the treatment of blood cancer.



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