By Stephanie D. Adams

In the mid 1970’s, the Bionic Woman, starring Lindsay Wagner, provided a fantasy account of a woman badly injured in a parachute accident who is reconstructed using bionic implants. Recently relaunched by NBC, the new Bionic Woman enters a very different landscape, where repair and replacement of damaged, diseased or aging body parts is no longer science fiction.

The Southeast is home to a number of internationally recognized research centers and companies, both public and private, developing new approaches to repairing and replacing cells, tissues and organs damaged by injury, disease, or aging. The range of products is vast, including cells (e.g., transplanted islet cells for diabetes), tissues (e.g., implants for cardiovascular, orthopedic and general surgical applications) and whole organs (e.g., kidney). The source materials are diverse, including human materials (from genetically distinct donors (allografts) or from the patient’s own tissues), animal materials and novel biomaterials.

North Carolina is the home of Dr. Anthony Atala, an internationally recognized expert in the field of regenerative medicine. Dr. Atala relocated to North Carolina in 2003 to become Director of the Wake Forest Institute for Regenerative Medicine. He is the founder of two companies, Tengion, Inc. and Plureon, Inc. Tengion is developing new human tissues and organs (such as bladders) derived from a patient’s own cells. The company recently announced a $33 million Series C financing in support of a phase III clinical trial for the neo-bladder. Investors include Deerfield Partners, Bain Capital LLC, Johnson & Johnson Development Corporation, HealthCap, Quaker BioVentures, Oak Investment Partners, and L Capital Partners. Tengion’s corporate headquarters is located in East Norriton, Pennsylvania, but the company maintains research offices, a development laboratory and a pilot manufacturing facility in Winston-Salem, NC. Dr. Atala’s other company, Plureon is based in Winston-Salem, and it is developing pluripotent stem cells obtained from amniotic fluid and placenta for a wide range of applications.

Virginia is home to Revivicor, Inc. (Blacksburg, VA), a regenerative medicine company developing transgenic animals as sources of cells, tissues and organs for human use (xenografts). Formed as a spinout of the Roslin Institute (which gained notoriety for Dolly the Sheep) and PPL Therapeutics plc, the company is producing pigs that have been genetically modified to remove the major xenoantigen (alpha-1,3-galactosyltransferase). The company’s current focus is the commercialization of treatments for diabetes (i.e., islet cells) and whole organ transplantation. Revivicor’s investors are the University of Pittsburgh Medical Center (UPMC) Health System, Highmark Health Ventures Investment Fund, L.P., and Fujisawa Investments for Entrepreneurship, LP. The University of Pittsburgh is one of the preeminent organ transplant centers in the country.

South Carolina is also on the regenerative medicine map. Cell & Tissue Systems, Inc. (Charleston, SC) is developing technologies to differentiate adult pancreatic stem cells in vitro, to provide a novel source of islets for transplantation.

The Atlanta area is home to several major allograft (same species, genetically distinct) companies. Cryolife, Inc. (NYSE: CRY) is a leader in the processing and distribution of implantable living human tissues for use in surgeries throughout the United States and Canada. Today, there are nearly 1,000 surgeons, at over 800 medical centers in the United States that routinely transplant CryoLife’s cryopreserved human heart valves. The company has also applied its technology to preserve a series of orthopedic tissues, including human meniscus tissue. In addition, Cell Dynamics, Inc., a private company based in Symyra, Georgia, specializes in the processing of human tissue, including organs, tissues and cells for research, transplantation and cell-derived therapeutics, with an emphasis on procuring and processing tissues from neonate donors.

Atlanta is also home to Salumedica, a private company developing products for soft tissue replacement, with a focus on novel biomaterials. The company’s unique biomaterial, Salubria, is a biostable hydrogel composition developed to behave similarly to human tissue, containing water in similar proportions, and known to be highly biocompatible. The company’s first product, the SaluBridge® nerve cuff, is an implant designed to restore function and sensation to patients with peripheral nerve injuries. It is available in the United States and European Union. A second product, SaluCartilage®, provides a less-invasive solution for patients suffering from pain and loss of mobility due to cartilage defects as a result of conditions such as arthritis and sports injury. SaluCarilage® is now available in the European Union. Salumedica’s founder and CEO, Dr. David Ku, is a Georgia Tech professor and serial entrepreneur who has been involved with at least four start-ups and raised over $20 million in financing. Salumedia recently licensed the Salubria® technology to SpineMedica, a private company, also in Georgia, developing the material as an artificial disc implant. SpineMedica raised over $10.6 million in a Series A offering in late 2005 that included FCA Venture Partners III, the Trelys Funds and A/B Partners III LP. The company also hired Lew Bennett, a veteran of the medical device industry, as CEO.

Another Georgia Tech professor, Dr. Barbara Boyan, has spurred commercial activity in the space as well. Dr. Boyan is the founder of Carticept, Inc., an emerging company developing products for cartilage deficits with funding from Domain Associates and New Enterprise Associates.

As a research institute, the Georgia Tech/Emory Center (GTEC) for the Engineering of Living Tissues has earned an international reputation in tissue engineering. GTEC was established in 1998 by the National Science Foundation and represents a unique partnership between a public engineering institution, Georgia Tech, and a private medical school, Emory University School of Medicine. GTEC’s maintains an active interface with industry, with industry educational partner members including Johnson & Johnson, Medtronic, Smith & Nephew, Boston Scientific and CR Bard.

Although the Bionic Woman possed remarkable strengths as a result of her restoration, patients currently suffering damaged, diseased or aging body parts will no doubt welcome a return to baseline function as promised by many of these new technologies and products. The Southeast will continue to be a leader in this important area.

Stephanie D. Adams, Ph.D., is the Executive Director, Southeast BIO. www.sebio.org