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| Histogenics President and CEO Patrick O'Donnell--courtesy of Histogenics |
Histogenics--a tissue engineering company--has nailed down $49 million in new Series A financing intended to bring its two signature products to the regulatory finish line.
The enormous cash infusion is designed to recapitalize the Waltham, MA company following its acquisition of Israeli cell therapy outfit Prochon BioTech in May 2011, explains President and CEO Patrick O'Donnell. He ran Prochon before it became part of Histogenics, and noted to FierceMedicalDevices that both new and existing investors took part in the company's Series A recapitalization round, which he said in the current sluggish investor market "is a very big deal."
"This is absolutely a very difficult time, a challenging climate to raise money of this caliber and the level of scrutiny is greater than it has ever been in terms of raising money. So we're extremely gratified by the level of support from new and existing investors," O'Donnell said. "I am very enthusiastic about being able to focus all of our attention on the clinical and regulatory strategy we have in place."
Sofinnova Ventures led the round, which included new investors Split Rock Partners, BioMed Ventures and FinTech GIMV Fund, L.P. Existing investors ProChon Holdings BV, Altima Partners, Foundation Medical Partners, Inflection Point Capital and Boston Millennia Partners also participated.
Histogenics, which first launched in 2000, plans to use the money to advance two programs. In part, the funds will support the company's push for a CE mark for VeriCart, a cell-free collagen scaffold designed to be used with a patient's own stem cells to repair small cartilage defects in meniscal and anterior cruciate ligament repair procedures. That submission will take place toward the end of 2013, with plans to pursue U.S. approval once the company obtains "greater clarity" regarding the 510(k) program.
Separately, the cash infusion will support enrollment in a Phase III clinical trial for NeoCart, a cartilage tissue implant that uses the patient's own cells to regenerate cartilage for someone dealing with cartilage lesions in the knee. The multicenter trial will eventually enroll 245 patients in a 2-to-1 randomization. The FDA granted NeoCart a special protocol assessment, which should enable a more stable regulatory pathway, O'Donnell said. Histogenics hopes to complete enrollment and follow the patients a year after, with plans to submit the data to the FDA for approval by the end of 2014, under a biologics license application.
O'Donnell said that NeoCart will stand out because it takes a tissue engineering approach to cartilage regeneration rather than a cell therapy technique, using cells directly from the patient that are placed inside a scaffold, which is placed inside a proprietary bioreactor in which the unit grows new cartilage tissue. The substance is tested before implantation to make sure it has evolved into "neocartilage" tissue that's on its way to becoming full-blown cartilage tissue.
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