WALTHAM, Mass., May 11, 2015 /PRNewswire/ – Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced the creation of its new Scientific Advisory Board (SAB) comprised of internationally renowned scientists and researchers. The SAB’s mission will be to provide strategic scientific and technical oversight as Histogenics brings NeoCart®, Histogenics’ lead product candidate, through its Phase 3 clinical trial, leverages its recent biomaterials manufacturing experience, and advances its product pipeline which may include next-generation therapies and additional indications of NeoCart®.
“Histogenics is entering a new phase of technology optimization, both in its NeoCart® and biomaterials manufacturing processes as we prepare for potential commercialization,” stated Stephen Kennedy, Senior Vice-President, Technical Operations, and Chair of Histogenics’ SAB. “Our goal as a collective team is to translate innovative technologies within our product portfolio and intellectual property estate into safe, effective, and approvable products,” continued Mr. Kennedy. “The combined expertise in biologics, biomaterials, orthopedics and manufacturing technology possessed by the highly accomplished members of our SAB will be leveraged in a way that may be transformative for the Company, and we look forward to their contributions to this important field of cartilage regeneration in orthopedics.”
Histogenics Scientific Advisory Board (SAB) is comprised of the following individuals:
Dr. Kyriacos A. Athanasiou: Distinguished Professor of Biomedical Engineering and Orthopaedic Surgery, the Child Family Professor of Engineering, and the immediate past Chair of Biomedical Engineering at the University of California Davis. His research interests include healing of musculoskeletal defects with particular emphasis on hyaline articular cartilage and fibrocartilage. Central to his group’s efforts is a scaffold-free tissue engineering approach, termed the self-assembling process, for fabricating large sections of articular cartilage. He has served as president of the Biomedical Engineering Society. Additionally, he is the Editor-in-Chief of the Annals of Biomedical Engineering, the flagship journal of BMES. His list of awards includes the Nemitsas Prize (Cyprus’ largest award presented by the President of Cyprus), HR Lissner Medal from the American Society of Mechanical Engineers, Distinguished Service Award from BMES, Wall Street Journal’s 2008 Innovation Award, Thomas A. Edison Patent Award from ASME, Hershel Rich Outstanding Invention Award, Marshal Urist Award for Excellence in Tissue Regeneration Research from the Orthopaedic Research Society, and the Van Mow Medal from ASME. He is a Fellow of BMES, AAAS, AIMBE, and ASME; recently he was elected to the National Academy of Inventors. In addition to his academic interests, he has been involved with effecting the translation of devices and instruments into clinical use and commercialization. He obtained his PhD in Bioengineering (Mechanical Engineering) from Columbia University in 1989.
Dr. Charles L. Cooney: Robert T. Haslam (1911) Professor of Chemical Engineering, Emeritus; MIT Department of Chemical Engineering. Faculty Director, Emeritus; Deshpande Center for Technological Innovation. A consultant to multiple biotech and pharmaceutical companies, Cooney sits on the boards of Polypore International, Biocon, Ltd. (India) and multiple private companies (GreenLight Bioscience, Mitra Biotech , Pronutria Biosciences, Boyd Technologies, enEvolve, Inc., Levitronix). His research and teaching interests span many aspects of biochemical engineering and pharmaceutical manufacturing and accelerating technological innovation. Dr. Cooney received his B.S. in chemical engineering from the University of Pennsylvania, and the S.M. and Ph.D. in biochemical engineering from MIT. After a short post-doc at the Squibb Institute for Medical Research, he joined the MIT faculty as an assistant professor in 1970, becoming full professor in 1982.
Dr. Jennifer Elisseeff: Jules Stein Professor; Wilmer Eye Institute and Biomedical Engineering, and Director; Translational Tissue Engineering Center, Johns Hopkins University. Dr. Elisseeff was a Fellow at the National Institute of General Medical Sciences Pharmacology Research Associate Program where she worked in the National Institute of Dental and Craniofacial Research. In 2001, Dr. Elisseeff became an assistant professor in the Department of Biomedical Engineering at Johns Hopkins University. In 2004, Elisseeff cofounded Cartilix, Inc., a startup that translated adhesive and biomaterial technologies for treating orthopedic disease, acquired by Biomet Inc in 2009. In 2009, she also founded Aegeria Soft Tissue and Tissue Repair, new startups focused on soft tissue regeneration and wound healing. Dr. Elisseeff has received several awards including the Carnegie Mellon Young Alumni Award, Arthritis Investigator Award from the Arthritis Foundation, Yasuda Award from the Society of Physical Regulation in Medicine and Biology, and was named by Technology Review magazine as a top innovator under 35 in 2002 and top 10 technologies to change the future. In 2008, Dr. Elisseeff was elected a fellow in the American Institute for Medical and Biological Engineering and a Young Global Leader in the World Economic Forum. Dr. Elisseeff received a bachelors degree in Chemistry from Carnegie Mellon University and a PhD in Medical Engineering from the Harvard-MIT Division of Health Sciences and Technology.
Dr. Shuichi Mizuno: Assistant Professor, Orthopedic Surgery; Harvard Medical School. Co-founder of Histogenics Corporation. His research interests has focused on dynamic roles of extracellular matrix in musculoskeletal system, encompassing development of functionally instructed cell constructs for promoting tissue repair and manipulation of chondrocyte behavior by changes in physicochemical factors. Dr. Mizuno provided technical leadership when Histogenics was in its infancy to develop the state-of-the-art NeoCart technology and to conduct preclinical studies. This technology provided the foundation for the NeoCart we use today in our phase III clinical trial. Dr. Mizuno is extending his research program to manipulate a lineage of stem cells for diverse applications of cell-based therapy, to model regeneration of articular cartilage in vitro and in silico, and to develop new diagnostic tool and treatments for post-traumatic early osteoarthritis. He earned his Ph.D. in Biomedical Engineering from University of Tsukuba in Japan.
Dr. Lonnie Shea: Professor and Chair; Biomedical Engineering, University of Michigan. He joined the faculty at the University of Michigan in 2014 bringing his active research group working at the interface of tissue engineering, gene therapy, and drug delivery. He received an NSF CAREER Award in 2000, which helped start the work on developing new technologies based on combining biomaterials and gene/drug delivery. The overall objective is to create controllable microenvironments for directing or molecularly dissecting tissue growth. These systems are being applied to clinical problems such as ovarian follicle maturation for treating infertility, islet transplantation for diabetes therapies, nerve regeneration for treating paralysis. More recently, he research has moved into cancer diagnostics, autoimmune disease, and systems biology applied to regenerative medicine. He received his BS and MS degrees at Case Western Reserve University in Chemical Engineering. He received his PhD in Chemical Engineering and Scientific Computing from the University of Michigan. He joined the faculty of Northwestern University in 1999 within the Department of Chemical and Biological Engineering, and retains an appointment in that department as well as in Obstetrics and Gynecology at Feinberg School of Medicine.
Dr. R. Lane Smith: Professor of Orthopedic Surgery; Stanford University School of Medicine. His research focuses on the mechanisms of cartilage degradation in inflammation and sepsis and the stimulation of cartilage growth and repair by growth factors and hormones in serum-free culture. His research also focuses on the effects of adherence and deposition of glycocalyx on bacterial resistance to antibiotic treatment. He received his B.A., M.A. and Ph.D. from the University of Texas at Austin. He conducted his postdoctoral training at Stanford University School of Medicine and Friedrich Miescher Institut, Basel, Switzerland.
About Histogenics Corporation
Histogenics is a regenerative medicine company focused on developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions that can be utilized individually or in concert to treat musculoskeletal-related conditions. Histogenics’ first investigational product candidate, NeoCart®, leverages its platform to provide an innovative treatment in the orthopedic space, specifically cartilage damage in the knee.
Forward –Looking Statements
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart® Phase 3 clinical trial, including, without limitation, possible delays in enrolling the NeoCart® Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart® or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart® raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and needs for additional financing; Histogenics’ ability to attract or retain key personnel; the technologies on which Histogenics’ channel partnering agreement with Intrexon Corporation is based are currently in preclinical and clinical stages of development; Histogenics will incur additional expenses in connection with its exclusive channel collaboration agreement with Intrexon Corporation and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2014 filed with the SEC on March 27, 2015 and Quarterly Report on Form 10-Q for the three months ended March 31, 2014 to be filed with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.
There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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