Organogenesis Awarded a 5-Year Federal Supply Schedule Agreement with the Department of Veteran Affairs

Access to Apligraf® is Improved for Veterans with Chronic Diabetic Foot Ulcers and Venous Leg Ulcers

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Aug 04, 2014, 08:00 ET

CANTON, Mass., Aug 4, 2014 /PRNewswire/ -- Organogenesis Inc. announced today that it has been awarded Federal Supply Schedule Contract V797D-30288 with the Department of Veterans Affairs (VA) for Apligraf®, the only product with FDA approval for the treatment of both diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This five-year contract includes an option to extend its duration for an additional five years, for a total contract duration of up to 10 years. This award will streamline the purchasing process for Veterans Affairs Medical Centers to gain easier access to Apligraf.

Apligraf(R), a living cellular technology that is FDA-approved to treat diabetic foot ulcers and venous leg ulcers. (PRNewsFoto/Organogenesis Inc.) (PRNewsFoto/Organogenesis Inc_)

The VA Federal Supply Schedule program is managed by the VA under delegated authority by the General Services Administration (GSA). The VA manages Schedule programs for medical equipment, supply, pharmaceutical, and service contracts.

"This is a positive event for veterans and patients within the VA system who suffer from DFUs and VLUs, as they will have improved access to Apligraf, which is now on contract within the VA Medical Centers and Community-Based Outpatient Clinics," said Geoff MacKay, President and CEO of Organogenesis Inc. "Apligraf has been proven to close these chronic wounds faster than standard care alone, and lower amputation rates have been observed, which is especially important in the VA system. Research has shown that closing wounds rapidly is critical in preventing complications such as amputations or osteomyelitis."

Diabetic foot ulcers and venous leg ulcers are among the most frequently occurring chronic wounds, affecting millions of people in the United States every year, including many U.S. veterans. Research has shown that the majority of patients with VLUs or DFUs fail to heal with conventional therapy alone. These low success rates contribute to both the costs and risks associated with chronic wounds.

With Apligraf, clinicians have a bioengineered living cell-based treatment for wounds that fail to adequately respond to conventional therapy. Recent findings highlighting the significant burden of these debilitating chronic wounds underscore the urgent need for improved identification, prevention and aggressive treatment. ^[1],[2]

Diabetes affects about 1 million veterans within the VA health care system, which is nearly 20% of the patients the Department sees each year (compared to 8% of the total U.S. population).^[3],^[4] Diabetes is also the leading cause of blindness, end-stage renal disease, and amputation for VA patients. ^[5] A recent retrospective study found that VA patients with a new diagnosis of a diabetic foot ulcer had significantly higher amputation rates compared to patients treated in adjacent private and public hospitals (6.8% private, 12% public and 23.5% VA, p< 0.001). ^[6]

About Apligraf
Apligraf 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 wound previously unresponsive to treatment, Apligraf provides cells, collagen matrix, and other 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. Clinical studies of Apligraf application were based on up to 5 treatments, comprising weekly assessments and/or applications, over a 12-week period. Over 650,000 Apligraf units have been shipped for patient application. The product is covered by Medicare, Medicaid and more than 1,500 private insurers.

About Organogenesis Inc.
Having pioneered the field, Massachusetts-based Organogenesis Inc. is a world leading regenerative medicine company focused in the areas of bio-active 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.

^[1] Rice JB, U Desai, AK Cummings, HG Birnbaum, M Skornicki, N Parsons. Medical, drug, and work-loss costs of diabetic foot ulcers [ISPOR abstract A12]. Value in Health. 2013; 16(3): A12.
^[2] Rice JB, U Desai, AK Cummings, HG Birnbaum, M Skornicki, N Parsons. Medical, drug, and work-loss costs of venous leg ulcers [ISPOR abstract A73]. Value in Health. 2013; 16(3): A73.
^[3] American Diabetes Association. http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed April 5, 2013.
^[4] Understanding the complex link between diabetes and cognitive health. http://www.research.va.gov/news/features/diabetes_cognition.cfm. July 11, 2012. Accessed April 5, 2013.
^[5] Ibid.
^[6] Blumberg SN, Warren SM. Disparities in initial presentation and treatment outcomes of diabetic foot ulcers in a public, private and VA hospital. J Diabetes. 2013. doi:10.1111/1753-0407.12050.