July 2004 Industry News

Healthpoint, Cook Biotech to Aid Children in Afghanistan

HEALTHPOINT Ltd. and Cook Biotech, Inc. are sending critically needed bioengineered tissue for burn and wound care to Afghanistan to help children injured during the war and its aftermath.

Enough of the product, OASIS® Wound Matrix, has been shipped to Children’s Hospital in Kabul to treat hundreds of young patients.

The OASIS Wound Matrix acts as a framework to support the remodeling of host tissue. This Purdue University-licensed ECM technology is a tissue-engineered medical device derived from a natural organically intact animal source and developed into strong, sterile, pliable sheets that provide a rich environment or “scaffold” for cell attachment and growth.

“We wanted to recognize that, though media attention may be focused elsewhere, there are still a lot of children with burns who are in need of help,” said Dwayne Dixon, Director of Marketing for Tissue Management at HEALTHPOINT. “We wanted to do our part to respond to that need and acknowledge all of the efforts being made on behalf of Afghanistan’s children.”

For information visit www.healthpoint.com [2].

Mölnlycke Health Care, Inc. Awarded Contract with MedAssets

Mölnlycke Health Care, Inc. has been awarded a three-year contract by MedAssets HSCA of St. Louis, Missouri, for their Tendra® wound management products, which feature Safetac® technology effective May 1, 2004.

The products will be placed into a new dressing category termed “Soft Silicone Dressings.” Safetac is a patented soft silicone adhesive technology designed specifically for wound management dressings. The products in the Safetac range are: Mepitel® soft silicone wound contact layer; Mepilex® soft silicone foam dressing; Mepilex Border soft silicone adhesive bordered foam dressing, Mepilex Lite soft silicone thin foam dressing, Mepilex Transfer soft silicone exudate transfer dressing, and Mepiform thin flexible self-adherent dressing for scar management.

The products can be used on numerous wound types, including skin tears, venous leg ulcers, pressure ulcers, burns, radiation therapy skin reactions, cancer wounds, and scar management. In addition, the products with Safetac technology have been proven very helpful with the dermatological condition epidermolysis bullosa (EB).

All of the products with Safetac technology are designed to minimize trauma and pain during dressing changes. The unique medical-grade soft silicone provides gentle, but secure, adhesion to intact dry skin, while the hydrophobic nature prevents the dressing from adhering to moist wounds.

For more information, visit www.molnlycke.net [3].

RegeneRx Receives Orphan Drug Designation

RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com [4]) announced that it has received Orphan Drug designation from United States Food and Drug Administration’s Office of Orphan Products Development (OOPD) for its drug, Thymosin beta 4 (Tb4), for the treatment of epidermolysis bullosa (EB). Orphan drug designation results in seven years of market exclusivity upon FDA approval of a marketing application for that use, the waiver of certain FDA user fees, tax credits of up to 50 percent of qualified U.S. clinical trial expenses, and eligibility for FDA research grants for clinical trials.

“This designation,” explains J.J. Finkelstein, RegeneRx’s President and CEO, “offers us a number of opportunities that would not otherwise have been available. It is an important milestone—the result of the growing body of scientific data supporting Tb4’s development for this debilitating disease. Recent experimental studies in animal models have documented the ability of Tb4 to stimulate the production of laminin-5, a key adhesive protein missing or diminished in certain EB patients. We now look forward to establishing Tb4’s safety and efficacy in clinical trials in patients with EB in order to obtain FDA marketing approval.”

Tb4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. It is a drug that promotes endothelial cell differentiation and keratinocyte cell migration, down-regulates a number of inflammatory cytokines, and chemokines and has a very low molecular weight, allowing it to diffuse relatively long distances through tissues. A key mechanism of action is Tb4’s ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton. Additionally, Tb4 directly influences the production of laminin-5, a protein necessary for proper adhesion of certain types of mammalian cells. Tb4 has been the subject of a significant amount of research at the National Institutes of Health (NIH) and several other academic institutions.

For more information, visit the company’s website at www.regenerx.com [4].

Stratus Pharmaceuticals Acquires Contract with Novation

Stratus Pharmaceuticals Inc., a minority owned pharmaceutical distributor and manufacturer, announced recently that it has been awarded a three-year contract with Novation for all Stratus products, including Stratus papain and urea debriding ointments Kovia and Ziox.

Mr. Alberto Hoyo, President of Stratus commented, “For over three years we have supplied Novation members with our products, and this award represents a vote of confidence to our company and products by Novation.” Mr. Hoyo added, “We are very proud of being a key contributor to the cost containment of pharmaceuticals,"

Stratus products are also contracted with most of the major GPOs nationwide, including Amerinet, Broadlane, Consorta, Innovatix, Med-Assets, MHA, Premier, PACT, the FSS (V.A.), and others.

The company’s target focus remains based on direct promotion to dermatologists, wound care specialists, plastic surgeons, and physician associated estheticians with emphasis on promoting the wound care products to podiatrists, general practice, and geriatric physicians.

National Healing Corporation Adds Specialist to its Team

Diane L. Krasner, PhD, RN, CWOCN, CWS, FAAN, has been named clinical manager of the Wound Healing Center at York Hospital in Pennsylvania, a National Healing Wound
Center.

President of the Association for the Advancement of Wound Care (AAWC), Krasner also serves as a member of the board of directors of the American Academy of Wound Management and the National Pressure Ulcer Advisory Panel. She is co-editor of the third edition of Chronic Wound Care: A Clinical Source Book for Healthcare Professionals (HMP Communications) and sits on the editorial board of the peer-reviewed journal, WOUNDS. Past awards include the AAWC Distinguished Member Award and the ET Nurse of the Year Award from the Mid-Atlantic Region Wound Ostomy Nurses Association.

National Healing Corporation (NHC) CEO James E. Patrick said, “We are pleased to add Diane to our team. She is a dedicated specialist who is committed to staying on the leading edge of new wound care therapies and options. I feel confident she will make a valuable contribution to the evolution of our clinical pathway and the above average healing rates NHC centers continue to achieve.”

A board certified Wound Ostomy Continence Nurse, a Diplomat of the American Academy of Wound Management, and a Fellow of the American Academy of Nursing, Krasner will be responsible for all clinical aspects of the York center. Responsibilities include providing continuity of care for patients, integrating new therapies into care and training new personnel, reviewing and reporting on patient outcomes and ensuring quality of care.

Krasner received her bachelor’s degree, master’s, degree, and doctorate in nursing from the University of Maryland School of Nursing. At John Hopkins University in Baltimore, she earned a master’s degree in adult and continuing education from the School of Continuing Studies and held the post of Johnson & Johnson Medical Postdoctoral Fellow at the Center for Nursing Research in the School of Nursing.

DERMAGRAFT™ Approved for DEB Patients

Smith & Nephew is pleased to announce that the FDA has approved a Humanitarian Device Exemption for the use of DERMAGRAFT® on patients with dystrophic epidermolysis bullosa (DEB). Dystrophic epidermolysis bullosa is a rare genetic disease characterized by the presence of extremely fragile skin and recurrent blister formation, resulting from minor mechanical friction or trauma. Current treatment for DEB patients is directed toward the symptoms and is largely supportive.

DERMAGRAFT, a human fibroblast-derived dermal substitute currently indicated for treatment of diabetic foot ulcers, stimulates wound healing, and decreases healing time in the most severe form of its approved indication. Along with a wide range of wound care products, DERMAGRAFT is available from Smith & Nephew Wound Management Division. For more information call Customer Care at 800-876-1261.