News About Histogenics
2008
2007
Histogenics NeoCart Cartilage Therapy Found Promising in OHSU Study
Crawford to Report Data at ICRS Meeting
2006
__________________________________________________________________________
Histogenics Appoints Ken Andrews President and CEO
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.
Histogenics NeoCart Cartilage Therapy Found Promising in OHSU Study
Crawford to Report Data at ICRS Meeting
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.
__________________________________________________________________________
OHSU Doctors Test Disc to Repair Knee Cartilage Damage
(Oregon Health & Science University News Release)
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.
To access all OHSU news releases, visit www.ohsu.edu/news/
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.
__________________________________________________________________________
Boston Millennia Partners Invests in Histogenics Corporation
(Boston Millennia Partners News Release)
BOSTON, MA, Auguset 22, 2006 — Boston Millennia Partners is pleased to announce the recent closing of a $13.1 million preferred stock equity financing of Histogenics Corporation. Histogenics is focused on the repair of articular cartilage damage utilizing advancements in cell biology, tissue culture, engineering, and materials science to affect tissue repair. The Company’s technology is based on the work of Dr. Shuichi Mizuno of Brigham and Women’s Hospital, a Harvard Medical School affiliated teaching hospital, in collaboration with Takagi Industrial Co., Ltd., a Japanese firm specializing in computer-controlled machinery.
Boston Millennia Partners led the round, originally investing in the Company in January of 2006. Also participating in the financing round were Foundation Medical Partners, a venture firm, and Stryker Corporation (NYSE: SYK), one of the leading orthopedic companies in the world. As part of the round, Patrick J. Fortune, Ph.D., Partner with Boston Millennia Partners, joined the Company’s Board of Directors.
“Histogenics’ technologies have the potential to provide an alternative to joint replacement in treating injuries to weight bearing joints. Such injuries can result from trauma or from a lifetime of wear and tear, so that the Histogenics technology is expected to be good news for people over the age of thirty just beginning to suffer from joint pain. We believe Histogenics is uniquely positioned to address this growing market opportunity with an effective cartilage repair technology,” stated Dr. Fortune.
Articular cartilage lines the articulating joints of the body and serves to provide a smooth and low friction surface. This cartilage can be injured as a result of trauma or general wear and tear. When injured, a lesion forms in the surface of a joint leading to pain and reduced function. These lesions are not naturally repaired by the body and can progress to osteoarthritis. Once osteoarthritis has developed, the gold standard therapy is joint replacement. Joint replacement is not, however, generally practical until the patient reaches the age of 50 or so.
Histogenics’ NeoCart System enables a surgeon to extract a sample of a patient’s native chondrocytes, culture them and then re-implant them into a lesion using a proprietary collagen matrix and glue. This System also includes the biopsy and implantation instrument set. In addition, the Company also plans to test a single step procedure that involves use of the matrix without the addition of any cells, as well as a single step procedure that uses the matrix with growth factors but no extracted cells.
About Histogenics Corporation
Histogenics Corporation’s approach to cartilage regeneration is to use a technology platform that employs advances in cell biology, tissue culture, engineering, and materials science to affect tissue repair. Histogenics uses biomechanical stimulation, novel materials, and the patient's own cells to produce cartilage outside the body for re-implantation. A second product, currently in development, will utilize an acellular version of the same technology to produce cartilage inside the body. Histogenics has assembled a portfolio of patents that protect the Company’s investment in technology and its position in the tissue engineering field. The Company holds 15 applications on the structure and function of NeoCart and related products. It holds a series of 3 issued US patents and 12 applications on the processor. In addition, it licenses a pressure algorithm series which thus far includes one US patent and eight additional applications from Stanford University. More information can be found at www.histogenics.com.
About Stryker Corporation
Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. Stryker also provides outpatient physical therapy services in the United States.
©2007 Histogenics Corporation