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Vericel expects MACI arthroscopic commercial launch in 2024
The Fly

Vericel expects MACI arthroscopic commercial launch in 2024

Recent Business Highlights and Updates: Following a Type C meeting with the FDA, the Company is planning to initiate a human factors validation study to support expanding the MACI label to include arthroscopic administration of MACI for the treatment of cartilage defects of the knee and now anticipates an accelerated potential commercial launch of arthroscopic MACI in 2024; Announced FDA approval of NexoBrid on December 28, 2022 for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns, with U.S. commercial availability expected in the second quarter of 2023; Expect to hold a pre-IND meeting with the FDA in the first half of 2023 to discuss the MACI development program for the treatment of cartilage defects in the ankle. "We made tremendous progress advancing our pipeline and expanding our business in 2022, highlighted by an accelerated regulatory pathway for the MACI arthroscopic delivery program and the recent approval of NexoBrid," said Nick Colangelo, President and CEO of Vericel. "We also had very strong MACI performance to close the year and we look forward to building on this momentum in 2023 across both of our franchises, as we expect accelerating total revenue growth this year and further acceleration in 2024 driven by a full year of NexoBrid on the market and the planned launch of arthroscopic MACI."

Published first on TheFly

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