Histogenics Corporation, a regenerative medicine company, has completed a $49 million round of financing that will enable the company to complete the ongoing Phase 3 clinical trial for NeoCart. NeoCart is an autologous neocartilage tissue implant, grown outside the body that utilizes the patient’s own cells to regenerate cartilage in patients suffering from cartilage lesions in the knee. Management entered the Phase 3 clinical trial after reporting positive Phase 2 data in which all primary endpoints were met and NeoCart found to be generally well tolerated.
Histogenics Lands $49 Million Cartilage Financing
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The investments will also support efforts to obtain regulatory clearance in the European Union for VeriCart which is a single-step, cell-free collagen scaffold to be used in conjunction with the patient’s own stem cells to repair small cartilage defects. These are frequently observed in meniscal and anterior cruciate ligament repair procedures.
Patrick O’Donnell, president and CEO of Histogenics, said,
We believe that the significant level of commitment demonstrated in this financing speaks to the potential of our products to transform the treatment of cartilage injury with the goal of returning patients to their pre-injury level of activity.
“Each year, 1.8 million active adults and elite athletes undergo arthroscopy for the diagnosis and treatment of painful cartilage defects in the knee. With continued positive clinical results, we believe NeoCart, has considerable potential as a much-needed treatment alternative for a significant portion of these patients. The successful completion of this financing fully funds the company to reach key clinical and commercial milestones for NeoCart and VeriCart and allows us to focus our full attention on continued clinical and regulatory execution.”
Garheng Kong, MD, PhD, general partner of Sofinnova Ventures which is one of the financial backers said, “NeoCart has the potential to dramatically change the way knee cartilage injuries are treated. Current treatments for knee cartilage damage frequently do not produce the lasting effects that individuals need to avoid serious knee pain and improve function—preventing them from getting back to their active, daily lives. Published data have shown that patients treated with NeoCart experienced a very durable response that is sustained throughout a period of four years or more. Sofinnova is pleased to support Histogenics’ efforts to receive approval for NeoCart and address this unmet clinical need.” Histogenics is based in Waltham, Massachusetts and is privately held.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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