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New Member Spotlight: Histogenics

Histogenics is a microcosm of ARMI/BioFabUSA in the regenerative medicine area of cartilage and musculoskeletal tissues,” said Steve Kennedy, Chief Operating Officer. “Our platform includes the process, manufacturing, regulatory, QC and clinical supplies for our industry,” he continued.

Histogenics, incorporated in 2000 and headquartered in Waltham, Massachusetts, has a goal to become the leading regenerative medicine company developing, marketing and commercializing products in the musculoskeletal segment of the marketplace.

“We’ve been through the unique tech hurdles many companies in regenerative medicine will face and we are looking forward to the collaboration among our peers that ARMI/BioFabUSA will provide.”

In May 2011, Histogenics acquired ProChon Biotech, Ltd. (ProChon), a privately-owned biotechnology company based in Israel, which enabled a synthesis of products, technology and materials science by establishing a robust scientific and technology platform targeting tissue repair solutions.

Asked when he thought the general population would see the benefits of regenerative medicine, Kennedy said, “Although our tissue engineered cartilage product, NeoCart, will hopefully be available soon, the real impact will begin to be felt five to ten years from now,” adding “Some things are happening now with 3-D printing reaching milestones in successfully printing stem cells that multiply and differentiate into a material very similar to human cartilage material.”

The Histogenics platform combines expertise in cell processing, scaffolding, tissue engineering bio adhesives and growth factors to provide innovative treatments that may be used individually or in concert to treat musculoskeletal conditions.

The company, listed on the NASDAQ (HSDXL), completed Phase 3 clinical enrollment recently for its first product, NeoCart®, specifically for damage to the knee.

“Tissues are very complex so we need to ‘weave’ the right biomaterials with the right systems while overcoming any issues that could arise from viral or bacterial complications. Detecting any adventitious agent is a real challenge,” he said.

Histogenics would like to see, and be a part of, developing good regulations to protect the entire manufacturing process.

“We are looking forward to the collaboration, the debates, and the solutions where ARMI/BioFabUSA acts as the catalyst for the entire industry.”