Charles Sternberg, Associate Editor01.11.23
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has announced an accelerated launch timeline for MACI arthroscopic delivery, which is now anticipated to be launched in 2024.
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.
The company expects 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.
Total net revenue for full-year 2022 is expected to be approximately $164 to $165 million.
MACI net revenue for full-year 2022 is expected to be approximately $132 million.
“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.”
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.
The company expects 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.
Preliminary, Unaudited Q4 and Full-Year 2022 Financial Results
The company also shared preliminary, unaudited financial results for the fourth quarter and year ended December 31, 2022.Total net revenue for full-year 2022 is expected to be approximately $164 to $165 million.
MACI net revenue for full-year 2022 is expected to be approximately $132 million.
“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.”
