SOURCE: Aesculap

Aesculap

September 03, 2014 11:30 ET

Aesculap Biologics, LLC Announces First Human Implantation of NOVOCART® 3D Autologous Chondrocyte Product

CENTER VALLEY, PA--(Marketwired - September 03, 2014) - Aesculap Biologics, LLC, a division of Aesculap, Inc. focused on biological approaches to the repair and regeneration of diseased or damaged tissues, is pleased to announce that the first clinical study patient was implanted with the company's NOVOCART® 3D product in August 2014. NOVOCART 3D, part of an FDA Investigational New Drug (IND) Phase 3 randomized, partially blinded multi-center study, is a matrix induced autologous chondrocyte product designed to repair articular cartilage defects of the knee.

Kenneth R. Zaslav, M.D., a board-certified orthopedic surgeon with Advanced Orthopedics in Richmond, Virginia, performed the first implantation during a knee surgery to repair diseased articular cartilage. He implanted NOVOCART 3D's cartilage scaffold that was regenerated from the patient's chondrocytes, the basic cell of articular cartilage.

"I am very excited to be one of the first entities in the U.S. to implant NOVOCART 3D," said Dr. Zaslav, a founding member of the Cartilage Restoration Center at Advanced Orthopedics and a Clinical Professor of Orthopedic Surgery at Virginia Commonwealth University. "The product is easy to implant, there is no potential for leakage of cells out of the defect area as the cells are equally distributed within the implant [due to the nature of the scaffold]. The hope is that NOVOCART 3D will promote a hyaline-like repair of the cartilage to mimic the natural joint and provide homogenous ingrowth of articular cartilage for good long term results."

Articular cartilage gives synovial joints friction-free movement with even load distribution to minimize peak stress on the bone. The loss or damage of articular cartilage can lead to osteoarthritis, the leading cause of chronic disability in the US.1 NOVOCART 3D aims to stop or slow down the deterioration of articular cartilage. NOVOCART 3D places healthy cartilage cells on a collagen-based scaffold grown from a small cartilage biopsy harvested from the patient. After a 21 - 25 day growth cycle, the final cell-scaffold is implanted into the cartilage defect, positioning the cells to grow into new cartilage tissue, with the intention of relieving pain and restoring normal function of the joint.

"This is a major milestone for Aesculap and the NOVOCART 3D technology," said Chuck DiNardo, Aesculap, Inc. President. "The NOVOCART 3D technology offers great potential to provide cutting edge biologic solutions for our surgeons and their patients and will greatly enhance their quality of life."

To learn more about the NOVOCART 3D clinical trial contact the Aesculap Biologics Study Coordinator at cathy.dawson@aesculap.com or visit: http://clinicaltrials.gov/show/NCT01957722

Learn more about Aesculap's other offerings at aesculapusa.com

1 http://www.cdc.gov/chronicdisease/overview/index.htm

About Aesculap Biologics, LLC
Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body's own regenerative power to improve the quality of patients lives.

Aesculap, Inc., a B. Braun company, is part of a 175-year-old global organization focused on meeting the needs of an ever-changing healthcare community.

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