Vericel Corp (NSDQ:VCEL) shares soared 56% today after the Cambridge, Mass.-based company said the FDA approved its bioresorbable scaffold for cartilage repair. The product, Maci, is the 1st FDA-approved implant to use healthy cartilage tissue from a patient’s own knee to grow cells on the scaffold.
“Different cartilage defects require different treatments, so therapy must be tailored to the patient,” deputy director of the FDA’s Center for Biologics Evaluation & Research Dr. Celia Witten said in prepared remarks. “The introduction of Maci provides surgeons with an additional option for treatment.”
The Maci implant is made up of 500,000 to 1 million cells per square centimeter. The patient’s own cells are placed onto a bioresorbable porcine-derived collagen membrane that is implanted where damaged cartilage tissue was removed.
A 2 year clinical trial compared Maci to an alternative surgical procedure, microfracture, for cartilage repair. The trial enrolled 144 patients and a majority of the patients also participated in a 3 year follow-up study. The randomized, open-label study demonstrated a statistically significant improvement in pain and function scores for patients who received the Maci implant. Patients reported side effects associated with Maci such as joint pain, common cold-like symptoms, headache and back pain.
“The treatment of articular cartilage defects in the knee is challenging because articular cartilage in adults has minimal capacity to repair itself,” Vericel’s chief medical officer Dr. David Recker explained. “While orthopedic surgeons have long understood that autologous chondrocyte implantation can regenerate cartilage tissue, the previous surgical procedure was technically complex and time consuming, and the indicated patient population was limited. MACI is the first product to show a statistically significantly greater improvement in KOOS pain and function scores compared to microfracture, a commonly performed alternative surgical treatment for cartilage repair, in a well-controlled Phase III clinical study. With the introduction of MACI, orthopedic surgeons will have a simplified treatment option available for a broader patient population supported by solid clinical evidence.”
“Bringing an important new therapy to orthopedic surgeons and patients is a significant milestone for Vericel, and I would like to thank the FDA for working closely with us to make MACI available for these patients,” Vericel president & CEO Nick Colangelo added. “We believe that the introduction of MACI, along with investments to expand our commercial organization and implement new patient support programs, positions Vericel to generate significant growth in 2017 and beyond.”