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Cook Biotech Incorporated Release: Doctors Share Interim Findings, Results Offer Promise That Ulcers Treated With OASIS(R) Wound Matrix May Be "More Likely To Heal"


10/19/2005 5:10:45 PM

FORT WORTH, Texas, Nov. 13 /PRNewswire-FirstCall/ -- Jeffrey A. Niezgoda, M.D., F.A.C.E.P., and Eliot N. Mostow, M.D., M.P.H., physicians participating in two separate clinical studies designed to evaluate products and standards of care in the management of hard-to-heal wounds, announced interim analysis on the performance of HEALTHPOINT's innovative wound care product, OASIS Wound Matrix, where over 1,000 clinicians attended a recent clinical symposium in Chicago.

(Logo: http://www.newscom.com/cgi-bin/prnh/20030430/HEALTHLOGO )

The two physicians independently presented findings related to their studies at the October 16-18 Clinical Symposium on Advances in Skin and Wound Care in Chicago, Illinois, an annual meeting held for sharing information and continuing education for doctors, nurses, podiatrists, and other healthcare providers from around the world.

"These studies validate the intended use of OASIS as a product beneficial to wound treatment," said Dwayne Dixon, Director, Marketing for Tissue Management, HEALTHPOINT. "The results demonstrate that OASIS creates an environment conducive to healing."

Dr. Eliot Mostow's study included patients from a variety of care settings, focusing on the affects of Small Intestine Submucosa (SIS), the technological basis for OASIS Wound Matrix, on full-thickness pressure ulcers. The study was conducted with the cooperation of physicians at 12 medical facilities around the country.

Dr. Jeffrey Niezgoda's study, a randomized, prospective study also conducted at 12 medical sites, was designed to evaluate SIS as part of a treatment regimen for hard-to-heal venous ulcers.

The results of the Niezgoda and Mostow's studies will be published in 2004. A third study, also to be published in 2004, will feature the results of OASIS use on diabetic foot ulcers.

In addition to diabetic, pressure, and venous ulcers, OASIS is indicated for management of partial and full-thickness skin loss injuries such as surgical and trauma wounds, second degree burns, abrasions, and autograft donor sites.

"Thanks to its remarkable strength and flexible handling, OASIS is also easy to use," added Mr. Dixon.

Interim results for Dr. Niezgoda's study were positive. "In my own opinion, hard-to-heal ulcers are more likely to heal using SIS extracellular matrix compared to standard-of-care treatment," said Niezgoda, Medical Director of Hyperbaric and Wound Care Associates, S.C. and The Center for Comprehensive Wound Care and Hyperbaric Oxygen Therapy, St. Luke's Medical Center, Aurora Health Care, Milwaukee, Wisconsin.

As of mid-October, 71 of the Venous ulcer study's patients had completed the 12-week evaluation period. Of that group, 73 percent of the patients receiving OASIS treatments had healed. Only 53 percent of the control patients receiving standard wound care had healed by the 12th week.

Dr. Mostow, whose study focused on management of full-thickness pressure ulcers with SIS extracellular matrix, has also seen promising results. With 83 patients past the 12-week mark, Dr. Mostow reported that 61 percent of the SIS group had healed. Only 44 percent of the basic wound care group had healed.

OASIS Wound Matrix, manufactured by Cook Biotech is comprised of intact porcine Small Intestine Submucosa which is freeze-dried and terminally sterilized to form an acellular, extracellular matrix which is characteristically unique amongst the wide variety of wound preparation, management, and healing products available today, according to the company.

Submucosa (a complex biomaterial found between the mucosal and muscular layers in the wall of the small intestine) provides strength to the intestine through a complex organization of structural and functional proteins and molecules that forms a three-dimensional matrix. Extracted in a manner that leaves the complex matrix intact, the result is a naturally derived, extracellular matrix material. This natural matrix supports the body's healing process by providing an acellular scaffold that accommodates remodeling of host tissue.

Since its inception in 1992, HEALTHPOINT has established a U.S. presence in the research, development, and marketing of branded pharmaceuticals, over the counter drugs, and medical devices for tissue management, dermatology, and surgical. An aggressive research and development effort has brought HEALTHPOINT's unique technologies to the market, setting the pace for its highly trained field sales organization of direct sales representatives. HEALTHPOINT, with over 250 employees, is a DFB Pharmaceuticals, Inc. affiliate company. HEALTHPOINT is based in Fort Worth, Texas. Visit HEALTHPOINT's web site at http://www.healthpoint.com/ .

Also headquartered in Fort Worth, DFB provides technology-driven products, outsourcing services and licensing opportunities to the healthcare industry worldwide through its affiliate companies, contract partners, and branded marketing organizations.

Cook Biotech (http://www.cookbiotech.com/ ) is actively developing extracellular matrix (ECM) technology and biological scaffolds for numerous medical purposes. Medical products utilizing Cook's licensed and patented ECM technology are currently marketed worldwide for use in wound management and surgical repair of soft tissues. Together with a network of medical practitioners, Cook Biotech is identifying the medical needs most compatible with ECM technology and developing products to meet these needs.

Photo: http://www.newscom.com/cgi-bin/prnh/20030430/HEALTHLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.comHEALTHPOINT

CONTACT: Dwayne Dixon of HEALTHPOINT, +1-800-441-8227, ordwayne.dixon@healthpoint.com ; or Madia Milks of Cook Biotech,milks@cookbiotech.com


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