ProChon Biotech has reported that the patient enrollment in the Phase II study of the BioCart Autologous Cartilage System is nearing the halfway point and is expected to be completed within the next three months.
The randomized, double-arm, open-label, multicenter Phase II study compares the safety and efficacy of the BioCart System to microfracture for the treatment of symptomatic cartilage defects.
ProChon also reported that it will provide educational information on the BioCart System to attendees at the Annual Meeting of the American Academy of Orthopaedic Surgeons, at the Morial Convention Center in New Orleans.
ProChon continues to execute on its business plan of advancing the clinical progress of the BioCart System and developing collaborative agreements for the company’s Fibroblast Growth Factor (FGF) platform technology.
The company has recently entered into a research collaboration with a West Coast-based company that specializes in orthopaedic repair/regeneration applications. The objective of the development program is to define new solutions to critical orthopaedic issues for patients, such as the development of an injectable ceramic/polymer formulation to carry growth factors for the purpose of bone repair/regeneration applications.
ProChon said that its BioCart autologous cartilage system is a minimally invasive, high-quality implant that is currently being investigated for long-term articular cartilage regeneration stemming from joint cartilage defects and injuries. The BioCart System is commercially available in Greece and Israel.
The system is undergoing a Phase II multicenter clinical study in the US. To date, over 87 patients have received the BioCart implant with some patients over five years post-implantation.
Patrick Donnell, chief executive officer of ProChon, said: “We look forward to exhibiting at such a prestigious gathering of orthopaedic surgeons, nurses and global orthopaedic corporations. Until recently, very few surgeons have been aware of our next generation cartilage regeneration technology, the BioCart System. The AAOS conference is an ideal venue at an ideal time for ProChon to raise the level of awareness.
“The BioCart system has the potential to advance cartilage regeneration and in doing so, change the paradigm in the rehabilitation protocol associated with cartilage injuries.We expect that the ongoing clinical research of the BioCart system will demonstrate a strong correlation between the quality of cartilage regeneration and successful long-term clinical outcomes.”