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Shares of Organogenesis Holdings Inc. (ORGO) jumped 7% after hours on Monday after the company said that it met with the U.S. Food and Drug Administration (FDA), and now plans to initiate seeking approval for its experimental treatment ReNu before the end of December.
The company is seeking approval for ReNu in the treatment of knee osteoarthritis pain, a degenerative joint disease that is estimated to affect nearly 31.1 million Americans.
ReNu is a cryopreserved, amniotic suspension allograft. It provides anti-inflammatory, growth factor, and cellular components, offering a non-surgical alternative to reduce inflammation, alleviate pain, and enhance joint function.
The company decided to initiate a rolling application for ReNu following the completion of a meeting with the FDA.
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