WALTHAM, Mass. – May 14, 2012 –  Regenerative medicine company Histogenics Corporation, announced today the presentation of intermediate data supporting the potential efficacy of the Company’s NeoCart Autologous Cartilage Tissue Implant (ACTI) for periods of up to five years with no evidence of severe treatment-related adverse events in patients with grade III chondral injury to the femur (cartilage damage in the knee). Dennis Crawford, MD., Ph.D., Assistant Professor and Surgical Director of Sports Medicine Programs in the Department of Orthopedics and Rehabilitation at Oregon Health Science University presented the findings in a poster session entitled, “An Autologous Cartilage Tissue Implant (ACTI) NeoCart^® for Treatment Grade III Chondral Injury to the Femur. Intermediate Term Results from Initial FDA Trials.” at the International Cartilage Repair Society (ICRS) 2012 Annual Meeting in Montreal Canada on Sunday, May 13, 2012. NeoCart is an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the repair of full thickness cartilage lesions.

“These results suggest that NeoCart may be able to play an important role as a potential first-line treatment option for focal cartilage renewal that does not surgically compromise the subchondral bone,” said Dr. Crawford. “For patients with knee cartilage injuries, duration of treatment response is very important, and in this study we saw improvements in patients treated with NeoCart from 6 months following surgery and sustained throughout a median study period of 48 months and, in some cases, up to five years. Improvements were seen across a wide spectrum of validated, ICRS-recommended outcome measures, including pain, function and associated activity of daily living performance.”

“This analysis continues to add to an already impressive NeoCart data set and further supports our ongoing Phase 3 study,” said Patrick O’Donnell, President and Chief Executive Officer of Histogenics. “There is clearly a need in the market for longer-term, effective solutions for cartilage injury and we are hopeful that NeoCart may be able to play a role in filling this treatment void.”

The primary purpose of the analysis was to summarize the safety and efficacy experience of all patients treated with NeoCart up to five years using ICRS-recommended patient reported scores, as well as general health assessments. Subjects were pooled from previously- completed, Company-sponsored Phase 1 and 2 multi-center clinical trials. Eligible patients were between the ages of 18-55 years of age and had one or two symptomatic ICRS grade III chondral lesion(s) on the femoral condyle. Validated and ICRS-recommended patient reported outcome measures were obtained at each follow up visit. These included the following: Knee injury and Osteoarthritis Outcome Score, Visual Analog Scale, Short Form Health Survey, and International Knee Documentation Committee subjective. Serious and adverse events were recorded for all patients. Data on twenty-nine patients was reported in the cohort, including eight patients through 60 months and 20 patients at a minimum of 36 months; one patient was lost to follow up after 12 months. The median follow up time period was 48 months.

Significant improvement (p<0.0001) was seen in the mean measures of all patient reported outcomes across all time points up to four years and at final follow up for each patient. Measures included the International Knee Documentation Committee, Short Form Health Survey, all five domains of the Knee injury and Osteoarthritis Outcome Score and the Visual Analog Scale (VAS) average and highest. Significant decreases from baseline (p<0.05) were reported for average VAS pain scores (17±18, p=0.031) at six weeks and for highest VAS pain scores at three months (23±31, p=0.004), and sustained through final visit (p < 0.0001) for both. Range of motion did not decrease in any patient and in fact improved with a mean change from baseline of 6±8 degrees at final follow-up (p < 0.001).

Serious adverse events were limited to four and not related to the implant. They included an ACL tear of the contralateral knee secondary to ski injury, a total joint arthroplasty of the contralateral knee as final treatment for septic arthritis, ovarian cancer and arthroscopy and microfracture of a separate lesion in the ipsilateral knee.

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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 a favorable safety profile was demonstrated.

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.

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“This advisory board represents some of the most prolific researchers, publishers and innovators in  regenerative medicine with an extensive range of expertise in cartilage and soft-tissue repair, biomaterial scaffolds, fibroblast growth factor variants and stem cell research,” said Patrick O’Donnell, President and Chief Executive Officer of Histogenics. “Each member will play a critical role in guiding our research and product development pipeline initiatives, including our next generation NeoCart On-DemandÔ single step cartilage tissue implant, as we continue to build Histogenics’ leadership position in articular cartilage and soft tissue regeneration.”

The members of the Scientific Advisory Board are:

• Kyriacos A. Athanasiou, Ph.D., P.E., Distinguished Professor of Biomedical Engineering and Orthopaedic Surgery and Chair, Department of Biomedical Engineering at the University of California, whose research focuses on understanding and enhancing the healing processes of cartilage using scaffold-less or scaffold-based approaches in combination with suitable bioactive agents and biomechanical signals
• Bruno Peault, Ph.D. — Professor and Chair, Center for Cardiovascular Science at the University of Edinburgh and Queen’s Medical Research Institute; Professor, David Geffen School of Medicine and Orthopaedic Hospital Research Center at University of California at Los Angeles, whose research focuses on prospective identification, purification and functional characterization of multi-lineage stem cells present in human adult organs and tissues
• R. Lane Smith, Ph.D., Professor, Department of Orthopaedic Surgery at Stanford University, whose research focuses on understanding the fundamental biological and mechanical mechanisms influencing the differentiation, homeostasis and pathogenesis of bone, cartilage and dense connective tissues
• Chia Soo, M.D., Associate Professor, Department of Orthopaedic Surgery at University of California at Los Angeles, whose research focuses on bone and cartilage tissue engineering, stem cell-based approaches to regenerative medicine, and skin regeneration
• Laurence Tarrant, Ph.D., Founder and Chief Scientific Officer of Histogenics Corporation, with significant expertise in commercializing medical technologies and an innovator of three-dimensional scaffold technologies, the production of extracellular matrices and the use of hydrostatic pressure in the production of neocartilage tissue
• Avner Yayon, M.D., Ph.D., Founder and Chief Scientific Officer of ProChon Biotech, Ltd.; Founder and Chief Executive Officer of ProCore, Ltd, whose research focuses on the molecular mechanisms underlying FGF-related genetic and acquired skeletal disorders and led to the development of the advanced cartilage regeneration implant, BioCart™II

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 orthopaedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials of its NeoCart autologous tissue implant and is currently in a Phase 3 IND clinical study. Based in Waltham, Massachusetts, the company is privately held. For more information, visit www.histogenics.com.

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Sarah Cavanaugh or Jennifer Conrad
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“Bringing Michael and Peter onto our leadership team reflects the significant progress Histogenics has made as we advance NeoCart into a Phase 3 clinical trial for the treatment of knee cartilage injury and underscores our commitment to optimize the clinical and commercial success of both the NeoCart cartilage regeneration system and the VeriCart cartilage repair system,” said Patrick O’Donnell, President and Chief Executive Officer of Histogenics. “I look forward to working with Michael and Peter to continue to advance these promising programs.”

Dr. Lewis has more than 30 years of experience in orthopaedic surgery and in healthcare business. He has previously served as the Professor and Chairman of Orthopaedics and Chief of Staff at the Mount Sinai Medical Center in New York. He was the Medical Director of Vanderbilt University’s Rehabilitation Hospital and was the Senior Vice President (Clinical and Business Development) of Priority Healthcare Corporation, a publicly traded company. Dr. Lewis also has been a principal, advisor and consultant to different aspects of the healthcare and financial industries and taught healthcare and entrepreneurship at Vanderbilt’s Owen Graduate School of Management. He is a Senior Fellow at the Dartmouth Center for Health Care Delivery Science and is the inventor of a medical device that eliminated the need for amputation in many children with bone cancer. Dr. Lewis received his orthopaedic training at the Hospital for Special Surgery and was a fellow in Surgery at Memorial Hospital-Sloan Kettering Cancer Center. He received a B.A. degree from Tufts University, an M.D. degree from Cornell University and an M.B.A. degree with honors from Vanderbilt University.

Mr. Hamilton has over 20 years of engineering and operating experience in the medical device industry. He previously served as Vice President Operations for Choice Therapeutics, Inc., a start-up wound care company specializing in antimicrobial dressings using silver nylon. He also served as Operations Manager at BioSphere Medical, where he managed production, quality control, sterilization, packaging and movement of inventory among U.S. and European facilities and developed two new methods of packaging for BioSphere’s lead product. Prior to BioSphere, Mr. Hamilton was a Senior Development Engineer at Boston Scientific, where he designed, developed and implemented production stents, snares and guide wires for non-vascular applications. He also served as a Design Engineer at Deknatel. Mr. Hamilton is the holder of six U.S. patents and received a B.S. degree in Mechanical Engineering from Wentworth Institute of Technology in Boston, Massachusetts and an M.B.A. degree from Anna Maria College in Paxton, Massachusetts.

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 orthopaedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials of its NeoCart autologous tissue implant. Based in Waltham, Massachusetts, the company is privately held. For more information, visit www.histogenics.com.

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Sarah Cavanaugh or Jennifer Conrad
MacDougall Biomedical Communications
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–Data at Two Years Post-Op Met Primary Endpoints –

WALTHAM, Mass. – July 27, 2011 – Histogenics Corporation, a privately held regenerative medicine company, today announced the presentation of positive Phase 2 data for the NeoCart Autologous Cartilage Tissue Implant (ACTI). The prospective randomized, controlled study, which was presented by Dennis Crawford, M.D., Ph.D. at the American Orthopaedic Society for Sports Medicine (AOSSM) Annual Meeting, compared NeoCart to microfracture (MF) for knee cartilage injury treatment at two years post-operation. NeoCart is a bio-engineered neo-cartilage implant containing an autologous chondrocyte population matured in a biodegradable collagen matrix. The Phase 2 results showed that ACTI treatment using NeoCart is associated with statistically significant improvements in knee and general health outcomes scores by six months, at the primary endpoint of twelve months, and that are then sustained for at least two years, and that NeoCart had a higher proportion of therapeutic responders in comparison to MF at one and two years. In addition, the study confirmed a favorable safety profile for NeoCart.

“These Phase 2 results demonstrate Histogenics’ continued progress with this product as we build a leading regenerative medicine company,” said Patrick O’Donnell, President and Chief Executive Officer of Histogenics. “Building on these results, Histogenics has advanced this program into a Phase 3 trial under a Special Protocol Assessment (SPA) with the FDA, moving us closer to addressing a significant opportunity – pain associated with cartilage injury – in the large and fast-growing global sports medicine market.”

Dennis Crawford, M.D., Ph.D., who led the Phase 2 trial and presented the results at AOSSM, stated: “Cartilage has a poor ability to repair itself, and, as a result, these injuries can persist indefinitely and often lead to pain and compromised joint function. These results strongly support the continued clinical development of NeoCart.” Dr. Crawford is Assistant Professor and Surgical Director of Sports Medicine Programs in the Department of Orthopedics and Rehabilitation at Oregon Health Science University.

About the Phase 2 Trial

The Phase 2 study of NeoCart evaluated 30 subjects, with a 2:1 randomization ratio of NeoCart treatment to MF treatment. Efficacy outcome measures applied included the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee (IKDC) Score.

According to results from the study, there were no serious adverse events related to treatment with NeoCart. Both cohorts demonstrated improvements in a measure of general health status at six, 12 and 24 months. NeoCart-treated patients demonstrated significant improvement for all outcome measures included in the study at 12 and 24 months, including knee function, pain (including maximum pain), activities of daily living, and sport and knee quality of life.

Surgeons who contributed to the Phase 2 trial include: Thomas Debarardino, M.D.; Aki Kusanagi, D.V.M., Ph.D.; CT Mooreman, M.D.; Suichi Mizuno, Ph.D.; Brad Nelson, M.D.; Hollis Potter, M.D.; Lane Smith, Ph.D.; Dean Taylor, M.D.; and Riley J. Williams, IIII, M.D.

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.

Media Contact

Sarah Cavanaugh or Jennifer Conrad

MacDougall Biomedical Communications

781.235.3060

scavanaugh@macbiocom.com or jconrad@macbiocom.com

HISTOGENICS ACQUIRES PROCHON BIOTECH
WALTHAM, Mass.—May 11, 2011— Histogenics Corporation, a privately held regenerative medicine company, announced today that it has acquired ProChon BioTech Ltd. in a stock-for-stock exchange. Histogenics new management team will be lead by President & CEO, Patrick O’Donnell, formerly CEO of ProChon BioTech, Ltd. Mr. O’Donnell will also participate as a member of the Board of Directors. The current investors provide for a strong investor syndicate that includes Altima Partners, Boston Millennia Partners, Foundation Medical Partners, and ProChon Holdings BV. Boston Equity Advisors, LLC served as the investment bank and was responsible for identifying and arranging the transaction.

“This acquisition positions the new Histogenics as a leading regenerative medicine Company with products in the clinic, with solid intellectual property, and with experienced commercial and technical management. Merging these two companies will have a significant positive impact on the adoption of regenerative medicine, beginning with cartilage regeneration and extending to other applications in the near term” said Mr. O’Donnell. “We will leverage each company’s distinctive capabilities to develop a broad regenerative medicine pipeline that will address surgical applications in orthopedics, vascular, and neurosurgery. We are excited and very enthusiastic about the results we have seen to date and the opportunities that lie ahead.”

Presently the Company has very positive Phase II clinical data on its NeoCart™ autologous cartilage regeneration technology and the pivotal clinical trial is presently underway. The Company also has promising clinical data on products that augment cartilage repair in microfracture procedures and has promising preclinical results in soft-tissue regeneration based on a combination of proprietary growth factor, stem cell, scaffold, and bioadhesive technologies. The initial focus of the Company will be to complete the NeoCart™ Phase III clinical study and expedite the process of bringing this exceptionally promising cartilage regeneration product to market in the United States, Europe and Israel.

The sports medicine market is one of the fastest growing segments in the orthopaedic market and the cartilage repair/regeneration segment has long been seen as the next major opportunity in the industry. Surgeons and patients have long awaited technologies that would address the pain associated with cartilage defects, predominately in the
knee, so as to avoid the more aggressive implantation of a metal prosthesis. Over 550,000 cartilage repair procedures on patients between the ages of 10 and 60 years of age will be performed in the United States.

Osteoarthritis is the most prevalent articular disease, affecting nearly 28 million people in the U.S., and predominantly involves the weight-bearing joints including the knee. An estimated 6.7 million Americans suffer from symptomatic chondral and osteochondral lesions of the knee and nearly 100,000 have osteochondritis dissecans (an osteochondral fracture).

About Histogenics
Histogenics develops and manufactures products that improve the body’s ability to regenerate healthy cartilage, improve joint function and prevent degenerative disease. Formed in 2000, 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 I and Phase II 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. Major investors include Boston Millennia Partners, Foundation Medical Partners, Altima Partners, Stryker Corporation, Inflection Point Partners, Takagi Sangyo and a private investor. For more information, visit www.histogenics.com.

About ProChon Biotech, Ltd.
ProChon is a privately held biotechnology company focused on modulating the fibroblast growth factor system to enable it to create more effective solutions for tissue regeneration. ProChon’s products combine cell regeneration technologies with proprietary growth factors and biocompatible scaffolds to restore injured or chronically damaged tissues to normal. ProChon has filed patent applications, licensed patents for core technologies and products, and has been granted patents in the United States, Europe, Israel and Australia.

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WALTHAM, MASSACHUSETTS, July 8, 2010 — Histogenics Corporation, a privately held tissue engineering company, announced that it has launched the pivotal Phase III study to evaluate the effectiveness of the NeoCart® autologous tissue implant in repairing knee cartilage injury.

This Phase III clinical program is the largest active study of cartilage repair in the US, comprising 245 patients at about 25 sites across the country. This prospective randomized study is the only large-scale study in the US to evaluate the potential clinical superiority of a neocartilage repair tissue implant (NeoCart) over the current standard, microfracture surgery. In microfracture surgery, small holes are made in the bone to allow a blood clot to fill the defect. With the NeoCart technique, the defect is repaired using neocartilagenous tissue made from the patient’s own cells. The Phase III Study outcomes include pain relief and restoration of knee function.

“This is a condition that we see frequently, and we believe NeoCart offers the potential for an improved treatment option for our patients,” said principal investigator Riley J. Williams III, M.D., Associate Attending Orthopedic Surgeon and Director of the Institute for Cartilage Repair, Hospital for Special Surgery, New York, who enrolled the first patient in late June. “We are pleased to participate in a study that could lead to a new standard therapy for a growing medical problem: cartilage injuries.”

Dennis Crawford, M.D., Ph.D. (Surgical Director of Sports Medicine, Oregon Health & Science University, Portland OR), a principal investigator in the Phase I, II and III NeoCart trials, notes the relative simplicity of the NeoCart procedure and the clinical performance after NeoCart treatment. “The technique of surgically applying the Neocart is performed in less than an hour and without sutures. As such, it is completed as an outpatient procedure and has a recovery time analogous to simple knee arthroscopy. Physicians are anxious for new clinical tools with which to treat the problem of articular cartilage damage, and we are pleased to be a part of a large-scale study to further evaluate the potential of NeoCart.”

Also participating in the trial is the OrthoCarolina Research Institute, led by James Fleischli, M.D., Chief of Orthopaedic Surgery at Mercy Hospital, and Dana Piasecki, M.D., Charlotte, North Carolina.

“Enrolling the first patients in this study is a milestone,” said F. Ken Andrews, Histogenics President and Chief Executive Officer. “Demonstrating superiority of NeoCart over microfracture would open the door for potentially thousands of patients each year to take advantage of this new therapy.” Based on numerous studies of knee arthroscopies, it is estimated that more than 500,000 severe cartilage lesions are treated each year in the US.

NeoCart® is an autologous engineered neocartilage implant created outside the body using the patient’s own cartilage cells (chondrocytes) that are integrated into a three-dimensional collagen matrix. It has the biological characteristics of native articular cartilage.

About Histogenics
Histogenics develops and manufactures products that improve the body’s ability to regenerate healthy cartilage, improve joint function and prevent degenerative disease. Formed in 2000, 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 I and Phase II 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. Major investors include Boston Millennia Partners, Foundation Medical Partners, Altima Partners, Stryker Corporation, Inflection Point Partners, Takagi Sangyo and a private investor. For more information, visit http://www.histogenics.com.

Other participants include existing investors Foundation Medical Partners, Altima Partners, Stryker Corporation, Inflection Point Partners and one private investor.

The financing will be used to further the development and clinical trials of its NeoCart® neocartilage implant and VeriCart™ auto-regenerative cartilage matrix. The NeoCart implant will finish Phase II clinical trials this fall where it is showing promise for use as a treatment for repairing knee joints.

“This funding reflects the strong confidence well-respected investors have in the technology Histogenics has developed to encourage the generation of true hyaline cartilage,” said F. Ken Andrews, President and Chief Executive Officer. “Histogenics products yield strong, long-lasting cartilage, and can offer a more desirable alternative to microfracture surgery and other traditional methods.”

Dominic Redfern, managing partner of Altima Partners, said, “We are delighted to be associated with Histogenics, and to support its innovative approaches for restoring joint function.”

Boston Equity Advisors, LLC acted as placement agent. Boston Equity Advisors is a FINRA member broker/dealer firm focusing on the private placement of equity securities for medical device and biotech companies.

About Histogenics
Histogenics develops and manufactures products that improve the body’s ability to regenerate healthy cartilage, improve joint function and prevent degenerative disease. Formed in 2000, 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 I clinical trials, and has nearly completed Phase II trials in which the NeoCart® implant’s effectiveness is compared to that of standard microfracture surgery. Trials for the VeriCart™ matrix began in 2008. Based in Waltham, Massachusetts, the company is privately held. Major investors include Boston Millennia Partners, Foundation Medical Partners, Altima Partners, Stryker Corporation, Inflection Point Partners, Takagi Sangyo and a private investor. For more information, visit http://www.histogenics.com.

WALTHAM, MASSACHUSETTS, May 30, 2008 — Histogenics Corporation, a cartilage regeneration company whose NeoCart® neocartilage implant shows promise in clinical trials as a long-lasting treatment for knee joint repair, has named F. Ken Andrews as President and Chief Executive Officer.

“Ken’s rich experience in a range of biomedical areas, especially tissue regeneration, will serve Histogenics well,” said Laurence Berlowitz Tarrant, Ph.D., Histogenics Chairman, Chief Scientific Officer and Founder. “His impressive record of achievement makes him an ideal leader as we progress through clinical trials and strive to bring our products to market.”

Mr. Andrews was most recently Vice President of Marketing and Sales, and Chief Commercial Officer at Alkermes. Previously, he was founding CEO at Medicalis Corporation. Among his senior executive positions at biotechnology, pharmaceutical and device companies, he was Vice President of Marketing and Sales of the Tissue Repair Division of Genzyme Corporation.

He was Senior Vice President of Commercial Operations at Alteon Pharmaceuticals and Vice President of U.S. Operations for Seikagaku Corporation. He began his career with American Hospital Supply as a sales representative and rose in the ranks to Director of Sales and Marketing. He helped lead the creation of the initial sales and marketing organizations at both Genentech, Inc. and Centocor, Inc. He has also been a consultant with Synergy Partners, assessing new technologies and products in the life science industry.

He graduated from the University of Tennessee with a B.A. degree in business administration.

About Histogenics
Histogenics develops and manufactures products that improve the body’s ability to regenerate healthy cartilage, improve joint function and prevent degenerative disease. Formed in 2000, 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 I clinical trials, and has nearly completed Phase II trials in which the NeoCart® implant’s effectiveness is compared to that of standard microfracture surgery. Trials for the VeriCart™ matrix began in 2008. Based in Waltham, Massachusetts, the company is privately held. Major investors include Boston Millennia Partners, Foundation Medical Partners, Takagi Sangyo and Stryker Corporation. For more information, visit http://www.histogenics.com.

WALTHAM, MASSACHUSETTS, September 26, 2007– Histogenics’ NeoCart® neocartilage implant is safe and shows promise, according to Dennis Crawford, MD, PhD, of Oregon Health & Science University (OHSU) in a presentation at the International Cartilage Repair Society Annual Meeting (ICRS) in Warsaw, Poland on September 30, 2007.

Crawford, assistant professor of orthopaedics and surgical director for Sports Medicine & Cartilage Reconstruction, OHSU, will report on an FDA Phase I safety trial of seven patients treated with NeoCart at OHSU and followed for two years. All patients showed good cartilage fill and integration with surrounding cartilage, and all experienced pain relief. Knee joint function was improved in six of the seven patients. Advanced MRI techniques showed that the NeoCart treatment had resulted in the formation of true hyaline cartilage in four of the seven patients.

NeoCart is a novel autogenous neocartilage implant grown using the patient’s own cartilage cells seeded onto a collagen matrix. A patented, high-pressure tissue engineering processor is said to produce more natural neocartilage than other techniques. In addition, the NeoCart system includes a novel bioadhesive which makes implantation quick and easy.

“This novel therapy may very well replace microfracture to become the next primary treatment for cartilage injury to the knee,” said Crawford. “Patients are getting pain relief for at least two years, the technology can be applied via a simple out-patient procedure and it appears by our best radiographic methods to mature and stabilize over time.”
Crawford is a member of the Histogenics Scientific Advisory Board.

About Histogenics
Histogenics develops and manufactures products that improve the body’s ability to regenerate healthy cartilage, improve joint function and prevent degenerative disease. Formed in 2000, 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 I clinical trials, and begun Phase II trials in which the NeoCart® implant’s effectiveness is compared to that of standard microfracture surgery. Trials for the VeriCart™ matrix are planned to begin in early 2008. Based in Waltham, Massachusetts, the company is privately held. Major investors include Boston Millennia Partners, Foundation Medical Partners, Takagi Sangyo and Stryker Corporation. For more information, visit http://www.histogenics.com.

Patient’s own cells used to build bio-bandage for injury commonly associated with ACL tears

PORTLAND, OR, November 28, 2006 — Oregon Health & Science University is leading a national effort to test a novel treatment for a little-known, but debilitating type of knee injury common among athletes and active individuals.

NeoCart, manufactured by Histogenics Corp. of Boston, is an investigational biological implant formed from a patient’s own cells to replace cartilage damage resulting from a variety of knee injuries. One common injury associated with cartilage damage is tearing of the anterior cruciate ligament, or ACL, the central band of collagen tissue that stabilizes the shinbone, or tibia, and keeps it from sliding beneath the thighbone, or femur.

Dennis Crawford, M.D., Ph.D., assistant professor of orthopaedics and surgical director for Sports Medicine, OHSU School of Medicine, is the first surgeon in the country to successfully perform the NeoCart procedure in the first phase of a U.S. Food and Drug Administration clinical trial. Now, one year after all these research subjects have achieved return to activities, a second trial will be launched comparing this new technology to commonly performed micro-fracture surgery.

The NeoCart implant is a disc created by growing cartilage cells within a three-dimensional honeycomb matrix. The disc, or tissue bandage, is then sealed within the injury of the cartilage using a biologic glue. NeoCart replaces the damaged cartilage surface on the end of the bone inside the knee. The procedure is designed to allow the knee joint to resume gliding across the smooth area and, ultimately, absorb impact forces of activity.

Crawford, who serves as the lead investigator for the FDA trial, says the Neocart procedure has the potential to provide a substantial new clinical benefit.

“The aim of this technology is to restore normal hyaline cartilage on the joint surface, in areas where tissue has been damaged and otherwise does not heal,” he said. “In contrast, the microfracture technique creates a scar cartilage. Using the NeoCart technology, the damaged cartilage is actually replaced by engineered tissue with the potential to heal. The intent of our study is to test whether Neocart allows joint healing, avoids joint degeneration and prevents future arthritis in comparison to microfracture, which appears to have only short-term, limited benefit.”

The study now involves surgeons and researchers at the United States Military Academy at West Point; University of California, San Francisco; Hospital for Special Surgery in New York; and the Duke University Sports Medicine Center.

“There are several exciting aspects of this investigational technique that make it a significant advance from available surgical practices. This procedure can now be performed on an out-patient basis. One reason this is possible is the development and application of the bio-glue that eliminates the need for suturing the patch,” Crawford added. “This seems to act a like a biologic Band-Aid.”

Cartilage injuries often accompany ACL tears when sudden blows or twists to the knee can damage the joint. This is common among athletes in such sports as football, soccer, basketball, snowboarding and skiing. This type of cartilage injury appears as a small chip or tear in the joint surface that can feel mildly painful with standing or activity. Over time, the damage can scar, creating a rough surface on the cartilage that may manifest as degenerative joint disease or arthritis later in life.

Crawford says the function of normal cartilage is essential. “It’s a thousands times slicker than ice,” he said. “If it’s injured, it doesn’t heal well. If there’s even a small defect, it may expand over time to become a painful, debilitating problem.”

If a cartilage injury is detected through examination and a unique MRI process, patients can undergo a joint arthroscopy surgery. During this procedure, a micro-camera is used to examine the knee and evaluate the damaged cartilage. A pea-sized cartilage tissue sample is taken and sent to a laboratory, where the cells are grown into a NeoCart patch for six to nine weeks.

All study participants must meet several criteria, including passing an examination for the absence of arthritis as well as tests to determine whether they’re allergic to a collagen used to grow the cartilage disc. After the cartilage patch is implanted during a similar outpatient surgery, subjects are directed to limit use of the joint and follow a specific rehabilitation program for several months. Subjects are evaluated periodically for improvements in knee function, and pain. MRI is used intermittently to monitor the healing process.

This randomized, controlled trial is designed to help doctors learn more about the application of this type of technology for the surgical management of knee joint injuries. One specific aim of the five-year study is to demonstrate that early treatment, in younger persons, is important in preventing future degenerative joint disease. Crawford said. “If NeoCart, or other technology like it, is proven safe and effective in clinical trials and approved by FDA, this could change the way we treat something once commonly thought of as simply a ‘knee sprains.’”

Crawford emphasized the procedure is limited, still experimental, not an alternative to knee replacement, and is only designed for certain knee injuries and for injuries of certain sizes. As with any investigational product, there are potential risks, including risks associated with joint surgery, lower-than-expected cartilage cell function, and loosening of the implant.

NeoCart is limited by federal law to investigational use and is not available for sale.

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Dr. Crawford has an interest in Histogenics, the company that sponsors this study. Dr. Crawford and the sponsor may financially benefit if the study is successful. This potential conflict was reviewed, and a management plan approved by the OHSU Conflict of Interest in Research Committee was implemented. Contact the OHSU Research Integrity Office at 503 494-7887 for more information.