Histogenics, a biotech developing an implantable tissue repair platform for cartilage damage to the knee, filed on Tuesday with the SEC to raise up to $65 million in an initial public offering.
The company's lead candidate, NeoCart, uses a patient's own cartilage cells and creates a scaffold to engineer tissue growth, and then implants NeoCart at the injured knee. Histogenics expects to complete enrollment of a Phase 3 trial for its regenerative medicine platform by the 1H16. Its trial has been designed under a Special Protocol Assessment from the FDA in hopes of proving efficacy and superiority over the current standard of care, microfracture, which creates tiny holes underneath injured cartilage to spur blood clotting and regeneration.
Primary shareholders include Sofinnova Ventures, Director Michael Lewis Split Rock Partners, Altima Partners and Boston Millennia Partners. The three largest shareholders intend to purchase $15 million worth of shares on the offering and Intrexon Corporation, which holds $10 million worth of convertible notes, also intends to purchase $15 million on the offering.
Another company developing implantable tissue, Innocoll (INNL), raised $59 million in a July IPO, but has traded down nearly 40% after pricing below the range. Among competitive products, it lists Zimmer’s (ZMH) DeNovo NT, Arthrex’s BioCartilage, Osiris’ (OSIR) Cartiform, Genzyme’s Carticel and Sanofi’s (SNY) MACI.
The Waltham, MA-based company, which was founded in 2000, plans to list on the NASDAQ under the symbol HSGX. Histogenics initially filed confidentially on February 14, 2014. Cowen & Company, Needham and Canaccord Genuity are the joint bookrunners on the deal. No pricing terms were disclosed.
