Histogenics Corporation (NORTHAMPTON, Mass.), a tissue-engineering company developing tissue replacements for cartilage, ligament, and other tissues, announced that it has raised $13.1 million in Series A-1 financing to be used to advance NeoCart®, its lead investigational product, into phase II clinical trials. The therapeutic focus of NeoCart is the repair of articular cartilage defects in the knee. The company's technology includes a novel cell growth matrix, implantation system, and computer-controlled processors, and 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 and an early investor in Histogenics.

The process of making NeoCart is initiated by taking an arthroscopic cartilage biopsy from a non–weight-bearing area of the femoral condyle. The biopsy is transported to the Histogenics facility where the chondrocytes are isolated, expanded, seeded into a three-dimensional honeycomb-like type-I collagen gel matrix, and cultured under cyclic hydrostatic pressure (0.5 MPa, 0.5 Hz) in a specialized apparatus that mimics conditions normally encountered while walking, and which cause the chondrocytes to produce the extracellular matrix of native hyaline cartilage. Within 6 weeks, a discrete three-dimensional piece of the patient's own neocartilage, having early-stage characteristics of native articular cartilage, is sent to the physician and implanted through a mini-arthrotomy into the defect. Following debridement, the NeoCart is secured in place with a novel collagen/polyethyleje glycol-based tissue adhesive, and the incision is closed.

NeoCart is being tested by researchers at Oregon Health & Science University, the University of California, San Francisco, and the Hospital for Special Surgery in New York. 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.

In 2005 Angiotech Pharmaceuticals, Inc, entered into a nonexclusive license agreement with Histogenics to provide Histogenics access to their proprietary biomaterial ChondroGELâ„¢, for use in the field of cartilage, ligament, meniscus, and/or tendon repair. ChondroGEL is a self- polymerizing hydrogel specially modified with collagen which, in preclinical studies, has been shown to contribute to the support of healthy tissue growth and cartilage regeneration while anchoring cartilage implants such as NeoCart in place. As part of the license agreement, Angiotech agreed to supply Histogenics with 1000 ChondroGEL kits and to facilitate transfer of ChondroGEL biomaterial product manufacturing to Histogenics.

— A. Techman

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