CANTON, Mass. and ZUG, Switzerland, Aug. 4 MA-Organogenesis
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.
(iii) http://www.safw.ch
(iv) Annegret Czernotto -- Sprechstunde 1/2006, Jahrgang 36
(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
Chase Communications
(202) 955-4500
jchase@chasepr.com
SOURCE Organogenesis, Inc.
