Biotherapeutic Cell-based Product from Organogenesis Meets Switzerland's Highest Clinical and Safety Standards
CANTON, Massachusetts and REINACH, Switzerland, Nov. 2, 2015 /PRNewswire/ -- Organogenesis Inc. today announced that its Apligraf® wound-healing technology has become the first transplant product in Switzerland to receive marketing authorization from Swissmedic for the treatment of venous leg ulcers (VLU) and diabetic foot ulcers (DFU). In Switzerland, the classification of "transplant products" includes cell therapies such as Apligraf.
With marketing approval of Apligraf, Switzerland has become the first country in Europe to grant marketing authorization for a bioengineered transplant product. Swissmedic applies a rigorous, pharmaceutical-like premarket regulatory review process to the approval of transplant products. The Swissmedic approval is another validation of the safety and efficacy of Apligraf by a leading regulatory agency. Apligraf is already FDA-approved in the United States for the treatment of VLUs and DFUs.
"Organogenesis is thrilled that Apligraf has received marketing approval to continue helping Swiss patients living with chronic, non-healing wounds," said Stefan Kaelin, Managing Director for Organogenesis in Europe, the Middle East and Africa. "We applaud the Swiss government's decision for marketing authorization and to provide full reimbursement for the use of Apligraf, which will help ensure patients across the country have access to clinically advanced treatment options for previously unresponsive diabetic foot ulcers and venous leg ulcers."
Apligraf is a biotherapeutic wound-healing technology that contains two layers of human living cells: a layer of differentiated keratinocytes and a layer of fibroblasts in a collagen matrix. When placed on a chronic wound previously unresponsive to treatment, Apligraf provides cells, collagen matrix, and other bioactive proteins and has been demonstrated to promote healing.
In controlled clinical studies, Apligraf has been shown to be an effective and safe wound care treatment, superior to conventional treatments alone. A recent study published in the peer-reviewed Journal of Medical Economics found that Apligraf patients had a 28% lower amputation rate, 33% fewer days hospitalized, and 32% fewer emergency department visits than their respective matched controls.(1)
All registered and marketed products in Switzerland must follow stringent criteria for reimbursement set forth by the Federal Office of Public Health. Products granted marketing authorization by Swissmedic - including Apligraf - must demonstrate clinical efficacy, safety, and cost effectiveness.
"Swissmedic's approval, and the reimbursement by the Federal Office of Public Health, of Apligraf demonstrates a commitment to patient health and an understanding of the economic benefits of investment in clinically advanced technology," said Gary S. Gillheeney, Sr., President & CEO of Organogenesis. "Research shows the use of Apligraf can lower health costs by cutting healing time, reducing the number of days hospitalized and lowering amputation rates.(1) This is good news for both clinicians and patients needing proven therapies, and for payors looking to contain health costs."
Recent data suggests health costs associated with diabetic foot ulcers are on the rise in Switzerland. From 2003 to 2008, the number of Swiss patients hospitalized for diabetic foot ulcers rose by 112%, and the number of patients hospitalized for amputations due to diabetic foot ulcers rose by 26%.(2) Roughly 30,000 patients(3) in Switzerland live with a chronic, non-healing wound. It is estimated that more than 1,000(4) amputations occur every year among Swiss patients with diabetic foot ulcers.
"The approval of Apligraf in Switzerland is part of an ongoing effort to expand patient access to our products across the globe," added Gillheeney.
Organogenesis' products currently have regulatory approval in United States, Canada, Mexico, Saudi Arabia, Kuwait, South Africa, Singapore and Switzerland.
Apligraf is FDA-approved for the treatment of venous leg ulcers and diabetic foot ulcers lasting longer than one month that have not adequately responded to conventional therapy. It contains living cells, proteins produced by the cells, and collagen. Complications may include suspected wound or non-wound infection, skin inflammation, wound drainage, swelling, a skin tear or cut, pain, a new ulcer, red, flaky skin, bone infection, rash, low or high blood sugar, bruising, swelling, worsening ulcer, and dry skin. Apligraf should not be used if your wound is infected or if you are allergic to cow collagen or the agarose shipping medium. For more information, please read the complete prescribing information available at Apligraf.com [http://apligraf.com/].
About Organogenesis Inc.
Having pioneered the field, Massachusetts-based Organogenesis Inc. is a world leading regenerative medicine company focused in the areas of bioactive wound healing and soft tissue regeneration. The company's mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care. For more information, visit www.organogenesis.com [http://www.organogenesis.com/].
CONTACT:Angelyn Lowe+1 (781) firstname.lastname@example.org [mailto:email@example.com]
________________(1 )Rice JB [http://www.ncbi.nlm.nih.gov/pubmed/?term=Rice%20JB%5BAuthor%5D&cauthor=true&cauthor_uid=25786331], Desai U [http://www.ncbi.nlm.nih.gov/pubmed/?term=Desai%20U%5BAuthor%5D&cauthor=true&cauthor_uid=25786331], Ristovska L [http://www.ncbi.nlm.nih.gov/pubmed/?term=Ristovska%20L%5BAuthor%5D&cauthor=true&cauthor_uid=25786331], Cummings AK [http://www.ncbi.nlm.nih.gov/pubmed/?term=Cummings%20AK%5BAuthor%5D&cauthor=true&cauthor_uid=25786331], Birnbaum HG [http://www.ncbi.nlm.nih.gov/pubmed/?term=Birnbaum%20HG%5BAuthor%5D&cauthor=true&cauthor_uid=25786331], Skornicki M [http://www.ncbi.nlm.nih.gov/pubmed/?term=Skornicki%20M%5BAuthor%5D&cauthor=true&cauthor_uid=25786331], Margolis DJ [http://www.ncbi.nlm.nih.gov/pubmed/?term=Margolis%20DJ%5BAuthor%5D&cauthor=true&cauthor_uid=25786331], Parsons NB [http://www.ncbi.nlm.nih.gov/pubmed/?term=Parsons%20NB%5BAuthor%5D&cauthor=true&cauthor_uid=25786331].( Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers.) J Med Econ. [http://www.ncbi.nlm.nih.gov/pubmed/25786331] Rev Med Suisse. [http://www.ncbi.nlm.nih.gov/pubmed/22730618]( 2012 June 6;8(344):1215-6, 1218-20.3 Baumgartner M, Tanner D, Hunziker T et al Therapeutische Umschau 2011; 68 (3)4 Czernotta A et al Sprechstunde 1/2006EndFragment)
Web site: http://organogenesis.com//