Histogenics – 2012 Fierce 15

Patrick O'Donnell, CEO of Histogenics

Based: Waltham, MA (a few employees are in Israel)
Founded: 2000
Website: http://www.histogenics.com

The Scoop: The company just completed a $49 million Series A financing that will allow it to complete the ongoing Phase III clinical program for lead product candidate NeoCart, which is currently enrolling patients. NeoCart could offer athletes and those who wish to continue an active lifestyle a much needed new option for the repair of knee cartilage damage. [Histogenics] is using a regenerative approach: A patient's own cells are used to create the cartilage implant. Thus far, clinical data have shown strong, long-lasting efficacy.

What Makes It Fierce: Histogenics is a regenerative medicine company, pure and simple. Its technology lands in both the medical device and biologics spaces. It combines cell-therapy and tissue-engineering technology with the hopes of taking articular cartilage repair to a whole new level beyond the current treatment options such as microfracture surgery, where surgeons create tiny fractures in the underlying bone in order to develop new cartilage. Getting there will be possible because of a $49 million all-new Series A financing the company nailed down in July in order to recapitalize, led by Sofinnova Ventures in an all-star round that also included Split Rock Partners, BioMed Ventures, ProChon Holdings BV, Altima Partners, Foundation Medical Partners, Inflection Point Capital and Boston Millennia Partners.

The funding infusion will propel two products to the regulatory finish line. Histogenics President and CEO Patrick O'Donnell says he envisions NeoCart's eventual FDA approval, designating it superior to the microfracture treatment, which can work for a short time but then deteriorate and leave the patient needing more aggressive treatment. NeoCart is now well under way enrolling up to 245 patients in a 2-to-1 randomized, Phase III trial at numerous sites around the country. The product is a cartilage tissue implant that uses the patient's own cells to regenerate cartilage for someone dealing with cartilage lesions in the knee. Another--VeriCart--is 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. Histogenics is working its way through the European regulatory process and hopes to submit VeriCart for a CE mark by mid-2013 and gain the regulatory approval designation by the end of that year. If all goes well, sales will launch in 2014, and the company plans to produce VeriCart through a contract manufacturer.

What To Look For: Beyond NeoCart and VeriCart, Histogenics touts 91 patents and related applications across the regenerative medicine spectrum. And O'Donnell doesn't mince words about the future and who he sees as ultimately bringing all of the company's technology to fruition.

"We are building this company to ensure that it is acquisition-ready in the next three years," he says. "If that doesn't happen, we are absolutely prepared to take it commercial ourselves. But we have a very focused exit strategy. And I am not afraid that we won't [sell]. This is our mission. We exist to be bought so I would rather be candid about it."

-- Mark Hollmer (Twitter | email) 

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Histogenics – 2012 Fierce 15