Histogenics said it raised another $49 million for its regenerative cartilage treatments, as it proceeds with a clinical trial for its NeoCart treatment and pursues CE Mark approval for its VeriCart system.
The round was led by Sofinnova Ventures and including backing from new investors Split Rock Partners, BioMed Ventures and FinTech GIMV Fund. Prior backers ProChon Holdings BV, Altima Partners, Foundation Medical Partners, Inflection Point Capital and Boston Millennia Partners also kicked in.
The NeoCart device uses patients’ cells to regenerate knee cartilage. Histogenics launched the 245-patient NeoCart trial in July 2010 to compare use of the implant with standard microfracture surgery to repair damaged knee cartilage. Microfracture surgery involves drilling small holes in bone to fill the defect with blood clots. The NeoCart device uses neocartilagenous tissue developed from patients’ chondrocyte cells, which are integrated into a 3-dimensional collagen matrix.
Emphasizing that several companies, including Genzyme (NSDQ:GENZ), have taken a run at the regenerative medicine market for knee repair, president & CEO Patrick O’Donnell told MassDevice.com today that the round is enough to carry Histogenics through to CE Mark approval for NeoCart by mid-2015 "if the stars align."
"This is a really tough study, from an enrollment standpoint, so you really need to put a lot of resources into it. Almost all cartilage studies include lengthy exclusivity criteria – it makes it tough to find candidates that fit into the rigorous criteria. It’s so precise, there are so many things that could keep someone from being in the study. That’s not unique to us, that’s part of the risk," O’Donnell told us, citing positive Phase II study results for what he termed a "4th-generation" technique. "We hope to mimic that caliber of data in the Phase III study. If we do so – and a lot of companies have died on this mountain – this is truly a disruptive technology, to be used to treat patients upstream from more invasive, bridge-burning metal implant procedures."
O’Donnell said Histogenics hopes to submit data from the trial by the end of 2014 and to win CE Mark approval 6-9 months later. The NeoCart device is also undergoing a U.S. trial under the auspices of an investigational drug exemption from the FDA, he said.
As for VeriCart, Histogenics will wait until "there’s greater clarity around the 510(k) program" to pursue U.S. market clearance from the federal watchdog agency, O’Donnell said. In the meantime, Histogenics will use part of the $49 million round to fund the pursuit of CE Mark approval for VeriCart, he said.
The VeriCart system is a collagen scaffold designed to be used with patients’ stem cells to repair small defects during meniscal and anterior cruciate ligament repair procedures, according to a press release.
Soffinova’s Dr. Garheng Kong and Josh Baltzell of Split Rock Venture will join the Histogenics board, according to the release.