Histogenics Closes $49 Million Series A Fundraising to Support Commercial Development of Transformational Cartilage Repair Products

--Proceeds to Drive Completion of Phase 3 NeoCart® Clinical Trials and EU Regulatory Clearance of VeriCart™--

WALTHAM, Mass.--()--Regenerative medicine company Histogenics Corporation, announced today the completion of a $49 million round of financing. The syndicate was led by Sofinnova Ventures with participation from additional 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 in the financing. Proceeds will be used to complete the ongoing Phase 3 clinical program for lead product candidate NeoCart®, which is currently enrolling patients. NeoCart is an autologous neocartilage tissue implant that utilizes the patient’s own cells to regenerate cartilage in patients suffering from cartilage lesions in the knee. Funds will also support efforts to obtain regulatory clearance in the European Union for product candidate VeriCart™, a single-step, cell-free collagen scaffold uniquely designed to be used in conjunction with the patient’s own stem cells, to repair small cartilage defects frequently observed in meniscal and anterior cruciate ligament repair procedures. Garheng Kong, MD, PhD of Sofinnova Ventures and Josh Baltzell of Split Rock Venture Partners will join Histogenics’ Board of Directors. Arnold Freedman of Boston Equity Advisors served as the exclusive placement agent.

Patrick O’Donnell, President and Chief Executive Officer of Histogenics, commented, “We believe the quality of the investors and the significant level of commitment demonstrated in this financing speak to the potential of our product candidates 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 our Phase 3 product candidate, 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 successful clinical and regulatory execution.”

Garheng Kong, MD, PhD, General Partner of Sofinnova Ventures added, “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.”

About NeoCart
NeoCart® is an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the regeneration of cartilage lesions. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met, and NeoCart was found to be generally well tolerated.

About VeriCart
VeriCart™ is a single step, off-the-shelf, cell-free collagen scaffold, specifically designed for cartilage applications, which when reconstituted with the patients own bone marrow or augmenting marrow stimulation procedures, is intended for the improved repair of cartilage tissue. VeriCart is currently in development.

About Histogenics
Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company ProChon BioTech. Histogenics’ flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implant’s effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visit www.histogenics.com.

About Sofinnova Ventures
Sofinnova Ventures has over 40 years of experience building start-ups and later stage companies into market leaders. With $1.4 billion under management, the firm applies capital and expertise to build companies from inception to exit. Sofinnova closed its life science-focused $440M, SVP VIII, in late 2011. The firm’s investment team of MDs and PhDs has significant scientific, operational and strategic experience, and specializes in financing later stage clinical products. The Sofinnova team partners with entrepreneurs to address patients’ unmet medical needs—and has had a string of recent exits through companies, including Movetis, Preglem, Amarin, Vicept and Intellikine.

About Split Rock Partners
Split Rock Partners, with offices in Minneapolis and Menlo Park, seeks emerging opportunities in healthcare as well as software and internet services. Since 2005, Split Rock has raised $575 million over two funds. Representative companies backed by Split Rock's team include Ardian, Atritech, DFine, Entellus, eBureau, Evalve, Guardian Analytics, HireRight, Intacct, LowerMyBills, MyNewPlace, QuinStreet (Nasdaq: QNST), SPS Commerce (Nasdaq: SPSC) and Tornier (Nasdaq: TRNX). Additional information about the firm can be found at www.splitrock.com.

Contacts

MacDougall Biomedical Communications
Cory Tromblee, 781-235-3060
ctromblee@macbiocom.com

Release Summary

Regenerative medicine company Histogenics Corporation, announced today the completion of a $49 million round of financing. Funds will be used to advance NeoCart for treatment of knee cartilage injury.

Contacts

MacDougall Biomedical Communications
Cory Tromblee, 781-235-3060
ctromblee@macbiocom.com