Organogenesis Inc. Announces Apligraf(R) Cell Therapy Reimbursed in Switzerland
CANTON, Mass. and ZUG, Switzerland, Aug. 4 /PRNewswire/ -- Organogenesis, Inc., the world's leading regenerative medicine company, announced today that Apligraf(R), its living bi-layered cell therapy product used to treat non-healing wounds, has gained Swiss reimbursement, beginning August 1.
"Swiss patients with non-healing wounds are the first in Europe to benefit from a fully reimbursed regenerative medicine therapy with Apligraf," said Geoff Mackay, CEO of Organogenesis. "As pioneers in the translation of regenerative medicine technology from visionary science to treatments used in everyday medical care, Organogenesis is proud to lead the way in introducing living cell therapies to patients around the world."
Organogenesis is the first company to successfully mass produce living regenerative medicine products -- reaching hundreds of thousands of patients in the U.S. and around the world. Its signature product, Apligraf, is the first living cell therapy to have received U.S. Food and Drug Administration (FDA) approvals to close diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).
Clinical studies have shown that Apligraf in combination with a standard therapy is more efficient in healing diabetic foot ulcers than standard therapy alone(i,ii). Over 200,000 patients around the world have been treated with Apligraf to date.
"Patients suffering from diabetes or from circulatory (venous) insufficiencies often have long-lasting open wounds. Those may last over several years, and they significantly lower the quality of life," said Dr. Fiorenzo Angehrn, surgeon and head of the clinic Piano in Biel, Switzerland, who has successfully treated patients with Apligraf for several years. "Many chronic wounds need to be treated with an active wound healing product, and therefore we welcome Apligraf as a true medical advancement."
Apligraf(R) re-entered the Swiss market in October 2006. As of August 1, 2008 treatment costs will be fully reimbursed according to appendix 1 of the Swiss reimbursement regulations for the treatment of chronic, poorly healing ulcers and for the treatment of soft tissue defects. Health insurers in Switzerland fully reimburse the product if treatment applies to the user-guidelines and to the certification process(iii) issued by the Swiss Association for Wound Care (SAfW) and the Swiss Association for Dermatology and Venerology SGDV.
Diabetic foot ulcers and other chronic wounds are a substantial burden for health care systems around the world. Untreated open wounds which get infected often cause long- lasting hospitalization, and sometimes even lead to amputation. In Switzerland alone there are approximately 1,000 diabetic foot amputations every year, due to non-healing wounds(iv).
"Allogeneic skin transplantations to close open wounds (including mesh-skin-grafts) necessitate a surgical intervention, and they cause a second wound, which may again poorly heal," said Stefan Kaelin, Managing Director, Organogenesis Switzerland. "A Swiss health economics study showed a cost reduction of 22.7 percent in the first year for treatments of chronic wounds with Apligraf compared to standard wound therapy. Apligraf was shown to be cost-efficient largely due to reduced hospitalization time, the potential for decreases in amputation, and subsequently improvements in the quality of life."(v)
About Apligraf(R)
Like human skin, Apligraf contains two layers of living cells: an outer (or epidermal) layer of protective skin cells, and an inner (or dermal) layer of cells that produce more than 40 substances such as cytokines and growth factors that are important for healing. When placed on a wound previously unresponsive to treatment, Apligraf starts to stimulate the body's own healing capabilities by releasing cytokines and growth factors into the neighboring tissue. Apligraf has been used in over 200,000 patients with an excellent safety profile, and is covered extensively by Medicare, Medicaid and by 350 private payers in the U.S.
In Switzerland Apligraf(R) is delivered to the treating certified specialist within 72 hours after subscription. The application handling is simple and can be done in an out-patient setting. The treatment has shown sustainable healing results and is well tolerated. For more information, visit http://www.apligraf.com.
About Regenerative Medicine
A new frontier in healthcare, regenerative medicine utilizes living human cells, including stem cells, to repair or replace body tissue damaged by injury, disease or even the natural aging process.
Regenerative medicine is a multidisciplinary field which brings together biology, medicine, and engineering to empower scientists to grow living cells, tissues and organs in the laboratory, and to safely implant them into the human body for the purposes of healing.
About Organogenesis, Inc.
Massachusetts based Organogenesis, Inc. is the world's most successful regenerative medicine company and is focused in areas of bio-active wound healing, bio-surgery and bio-aesthetics. Organogenesis delivers living tissue "on demand," and its mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care.
Organogenesis is in the midst of a large expansion, both in the U.S., as well as overseas. As the world's leading Regenerative Medicine company, Organogenesis has broadened its international scope and ties over the past few years. The company has recently established European headquarters located in Switzerland. In addition, last December the company announced an agreement with China's National Tissue Engineering Center (NTEC), a leading stem cell and regenerative medicine consortium, headquartered in Shanghai, for the commercialization of Organogenesis, Inc. technology within the Chinese market, and potentially throughout Asia. For more information, visit http://www.organogenesis.com.
(i) Veves A, Falanga V, Armstrong DG, Sabolinski ML. Diabetic Foot Ulcer Study Group. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care 2001; 24: 290-5.
(ii) Falanga V, Sabolinski M. A bilayered living skin construct. (APLIGRAF) accelerates complete closure of hard-to-heal. Venous Ulcers. Wound Rep Reg 1999; 7:210-207.
(v) Roger-Axel Grenier, Jean-Phillipe Assal, Bettina Peter, Kornelia Lovas, Zoltan Kalo. Cost of Diabetic Foot Ulcer in Switzerland in Relationship with the Erasmus Health Economic Model of Apligraf(R). Available from HealthEcon Ltd., Steinentorstrasse 19, PO Box 1510, CH-4051 Basel, Switzerland
CONTACT: Julie Chase of Chase Communications, +1-202-955-4500,
jchase@chasepr.com, for Organogenesis, Inc.
Web site: http://www.organogenesis.com/
http://www.apligraf.com/