New Products and Industry News

Portable NPWT System Provides Enhanced Features

  Kinetic Concepts, Inc (San Antonio, TX) announced the next generation V.A.C. Via Negative Pressure Wound Therapy System received Food and Drug Administration clearance. This single patient-use, ultra-portable system simplifies wound care for patients with moderate- to low-exudating wounds. It features a diaphragm pump for faster draw down, longer battery life, and higher leak rate threshold than the original device. These enhancements make the system both effective and convenient for patients.

  In addition to providing all the benefits of the therapy, patients can enjoy a discreet, portable device; clinicians can benefit from the convenience of having easy access to an off-the-shelf, single patient-use device; and hospitals will appreciate the potential cost savings of reduced length of stay.   The system can be used in the acute setting for patients transitioning home who are in need of continued therapy. The product is now available in the United States.

  For more information visit www.KCI1.com.

New Distribution Agreement for Diagnostics Business

  WOUNDCHEK™ Laboratories (Gargrave, England) successfully completed the spin-out of the diagnostics business from Systagenix (San Antonio, TX) and has signed a non-exclusive global distribution agreement with Kinetic Concepts, Inc (San Antonio, TX), the acquirers of the Systagenix advanced wound care business.

  The newly formed WOUNDCHEK™ Laboratories business, owned by One Equity Partners LLC, is based principally in the United Kingdom and will continue to focus 100% on the development of novel wound diagnostics products to help improve therapeutic outcomes in wound care. Note: WOUNDCHEK™ Protease Status is not currently cleared by Food and Drug Administration for sale within the United States market.

  Current development efforts are centered on three critical questions, identified by clinical experts as the primary pieces of diagnostic information needed to direct treatment pathways in the majority of chronic wounds: 1) Does the wound have elevated protease activity? 2) Is there an active infection? 3) Is there adequate tissue oxygenation?

  For more information, visit www.woundchek.com.

Distribution Agreement Signed for Antimicrobial Wound Care Dressing

  Mölnlycke Health Care (Norcross, GA) signed a licensing agreement with Covalon Technologies (Mississauga, Ontario) to market and distribute antimicrobial film dressings using the Canadian company’s technology.

  The dressings, which will be marketed as Mepitel Film AM and Mepitel® Film IV AM, are the only antimicrobial clear silicone adhesive film dressings that combine Safetac Technology with chlorhexidine and silver. The products will provide broad-spectrum antimicrobial activity for up to 7 days, killing 99.99% of bacteria with which they come in contact.

  The dressings initially will be launched during the first quarter of 2014 in North America and in the Middle East, followed by other markets in subsequent months.

  For more information, visit www.molnlycke.com.

FDA Clears Fish-Skin Technology for Human Wounds

  Kerecis Limited (Isafjordur, Iceland) announced a 510(k) clearance has been received from the US Food and Drug Administration to market a proprietary fish-skin, omega-3, tissue-regeneration technology for the treatment of chronic wounds in the United States.

  The technology, marketed under the name MariGen Omega3, is indicated for the management of chronic wounds, including diabetic, vascular, and other hard-to-heal wounds. The product is produced in Iceland from fish locally harvested in the North Atlantic waters. The treatment products are intact, decellularized fish skin sheets that have had all cells and antigenic materials removed. Fish skin is largely made from the same material as human skin, with the addition of omega-3 polyunsaturated fatty acids. When the product is inserted into or onto damaged human tissue, protease activity is modulated, the fish skin is vascularized and populated by the patient’s own cells, and ultimately converted into living tissue.

  For more information, visit www.kerecis.com.

Program Raising Awareness of Diabetic Foot Ulcers

  Organogenesis Inc (Canton, MA) is launching Fight4MyFeet, an educational program and online resource focused on proper foot hygiene within the diabetic community. Fight4MyFeet offers patients and clinicians tools and strategies to help ensure the best chance of healing a diabetic foot ulcer.

  The program is designed to help people with diabetes fight for their feet by providing them with easy-to-understand information about the prevalence of diabetic foot ulcers among people living with diabetes, simple measures they can take to ensure their feet are protected, and an opportunity to gain comfort from real patients who have dealt with a diabetic foot ulcer.

  For more information, visit www.Fight4MyFeet.com.

Dressing Contours to Body, Helps Prevent Pressure Ulcers

  Mölnlycke Health Care US (Atlanta, GA) announced the release of Mepilex Border Flex, a new dressing designed to fit the challenging contours of the body, aid in the prevention of pressure ulcers, and treat wounds in difficult-to-dress areas of the body.

  The dressing is an evolved design with improved flexibility and conformability. The dressing combines Flex technology, an oval shape, and newly engineered borders. It retains the proven, five-layer construction consisting of Safetac technology, Mepilex foam, a nonwoven spreading layer, a superabsorbent layer, and a highly breathable backing film, making it versatile, easy-to-use, and cost effective.

  The dressing is suitable for acute and chronic wounds on all areas of the body. The Flex technology allows the dressing to conform to the shape of the body and adapt as the patient moves. This is especially important on challenging areas such as joints and skin folds. It comes in two sizes.

  For more information, visit molnlyckeusa.com.

Licensing Agreement Forged for Advanced Wound Care Products

  Alliqua, Inc (Langhorne, PA) entered into a licensing agreement with Celgene Cellular Therapeutics, a subsidiary of Celgene Corporation (Summit, NJ) whereby Alliqua received the right to develop and market the advanced wound care products Biovance and Extracellular Matrix (ECM).

  Biovance is a collagen-based decellularized and dehydrated topical wound covering produced from human amniotic membrane that is indicated for the management of non-infected, partial- and full-thickness wounds. The product, which is ready for commercial use, is expected to be launched during the latter part of the second quarter 2014.

  ECM is a suite of advanced wound management products made from extracellular matrix derived from the human placenta.

  For more information, visit www.alliqua.com. This article was not subject to the Ostomy Wound Management peer-review process.