Navigation Links
Apligraf® Approved by Saudi Food and Drug Authority for Treatment of Chronic Wounds
Date:9/28/2010

CANTON, Mass., Sept. 28 /PRNewswire/ -- Organogenesis, Inc. announced that its Apligraf® bilayered living cellular construct has been approved for the treatment of diabetic foot ulcers and other chronic wounds by the Saudi Food and Drug Authority (SFDA) of the Kingdom of Saudi Arabia. Apligraf is a living cell based product used by physicians to heal chronic wounds in patients in the U.S. and around the world.

"With diabetes being a widespread and growing medical problem in Saudi Arabia and other Gulf States, the incidence of Diabetic Foot Ulcers is expected to increase," explained Dr. Damien Bates, M.D., Ph. D., F.R.A.C.S. (Plast.), and Chief Medical Officer at Organogenesis. "The prevalence of diabetes is now nearly 14% and expected to increase to 19% by 2030, the highest incidence in the Middle East nations."

The Kingdom of Saudi Arabia, with a population of more than 29 million, is the largest and most affluent of the Gulf Co-operation Council countries. It has built one of the most comprehensive healthcare systems in the Middle East.

Diabetic foot ulcers are open wounds that, for a variety of reasons, fail to heal by the body's own systems. The lifetime risk of a person with diabetes developing a foot ulcer could be as high as 25%. The International Diabetes Federation reports that 285 million people around the world suffer from diabetes.

Apligraf was the first bioengineered cell based product to receive U.S. FDA approval for chronic wounds. Clinical studies have shown that Apligraf in combination with a standard therapy is more efficient in healing diabetic foot ulcers or venous leg ulcers than standard therapy alone.(i,ii)

About Apligraf®

Apligraf® contains two layers of human living cells: an outer protective layer of differentiated keratinocytes and an inner layer of fibroblasts in a collagen matrix. When placed on a wound previously unresponsive to treatment, Apligraf provides cells, collagen matrix and other proteins that provide a covering that has been demonstrated to promote healing. In multiple controlled clinical studies, Apligraf has been shown to be an effective and safe wound care treatment, superior to conventional treatments.

About Organogenesis, Inc.

Having pioneered the field, Massachusetts based Organogenesis, Inc. is a leading regenerative medicine company focused in the areas of bioactive wound healing, oral regeneration and biosurgery. 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.

(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.


'/>"/>
SOURCE Organogenesis, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Oncology Drugs Development Update - Worldwide Markets and Forecasts of Approved EGFr/HEr2 Inhibitors, Treatment Costs, Pathway Analysis, Current and Expanded Clinical Indications, and Novel Agents in Development
2. Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome
3. Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome
4. Nexavar First FDA-Approved Drug Therapy for Liver Cancer
5. Newly Approved HIV Drug Shows Great Promise
6. Independent Physician Surveys Show if Approved, MF101 Could Become First-Line Treatment for Menopause Symptoms
7. Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine
8. Divigel(R) (estradiol gel) 0.1 Percent Offers Lowest Approved Dose of Estradiol for Treatment of Moderate to Severe Hot Flashes Associated with Menopause
9. FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
10. BRIDION(R) (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union
11. Pediatric Heart Transplants at Montefiore Approved by NY State Department of Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
(Date:10/2/2017)...  Eli Lilly and Company (NYSE: LLY ... quarter of 2017 on Tuesday, October 24, 2017. Lilly ... with the investment community and media to further detail ... will begin at 9 a.m. Eastern time. Investors, media ... of the conference call through a link that will ...
(Date:10/2/2017)... , Oct. 2, 2017 Halo Labs announces the European ... system called the HORIZON at MIBio 2017 in Cambridge, ... and visible particulate matter in biopharmaceutical samples with unprecedented speed and ... the novel technique Backgrounded Membrane Imaging. ... The HORIZON subvisible particle analysis system ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 ... characterized by frequent cessation in breathing. Oral appliances can offer significant relief to ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
(Date:10/12/2017)... ... , ... The American College of Medical Informatics (ACMI) will present the 2017 ... Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is ... pioneer in the field of medical informatics, this prestigious award is presented to an ...
Breaking Medicine News(10 mins):