Product News

Wound Dressing Wins Innovation Award

Imbed Biosciences, a privately held medical device company based in Madison, WI, has won the inaugural 2016 Wound Care Innovation Award at the European Wound Management Association (EWMA) for the product Microlyte™ Ag wound dressing. The product is described as an ultra-thin polymeric film with metallic silver coating that absorbs wound fluid, forms a soft gel, and intimately conforms to the underlying wound surface to maintain a moist healing environment. According to company officials, the product kills 99.99% of bacteria on its surface for several days while using up to 100 times less silver than competitive dressings. It also reportedly reduces the risk of silver toxicity and staining, making it safe for use at the onset of any wound-management plan, including burns, donor sites, diabetic ulcers, and pressure sores. The device is in review by the U.S. Food and Drug Administration and has not been cleared for human clinical use. Imbed was one of five finalists invited to present at the Wound Care Innovation Symposium for the grand prize, which was sponsored by CMC Consulting Group, EWMA, and Lohmann & Rauscher. Company representatives received 10 minutes to present their respective technological innovations before a panel of industry judges. Other finalist included Kerecis Ltd. (Iceland), Birken AG (Germany), Inotec AMD Ltd. (United Kingdom), and NuTech Medical (United States).

The product was also showcased at the Biotechnology Industry Organization International Convention in San Francisco, June 6-9. Visit www.imbedbio.com for more information.

Wound Care Company Products Distributed for Clinical Trials

Officials with AlloSource,^® Centennial, CO, a provider of cartilage, cellular, bone, skin, and soft tissue allografts for use in surgical procedures and wound care, have announced the distribution of investigational bioengineered blood vessels for Humacyte, a regenerative medical technology company based in Morrisville, NC, conducting a phase 3 clinical trial. The first shipment of vessels will be used in an upcoming trial that will reportedly investigate the potential of blood vessels to improve vascular access for hemodialysis patients living with end-stage renal disease. The clinical trial will compare the efficacy of the vessels to the current standard of care, synthetic blood vessel replacement with polytetrafluoroethylene grafts, according to company officials. The investigational bioengineered vessels are produced using donated human vascular cells that are decellularized to remove the donor identity from the newly created vessels. This process results in the production of investigational human vascular grafts with the potential for implantation into any patient at the time of medical need. In 2014, the U.S. Food and Drug Administration gave the technology a fast-track designation to help facilitate development and expedite review. Visit www.allosource.org for more information.

Wound Imaging Device Changes Chronic Wound Treatment

MolecuLight, a fluorescence-guided wound imaging technology company based in Toronto, Canada, has developed a handheld fluorescence imaging device that can allow clinicians to easily visualize and target bacterial presence and distribution in skin and chronic wounds in real-time at the point-of-care, according to company officials. The i:X^TM device uses a special light to identify germs in and around the wounded area — even if there are no symptoms of an infection. The device is being tested in two hospitals based in the United Kingdom (UK) and in in two Canadian trials. Company officials said they plan to introduce the device within UK hospitals during the next three months. For more information, visit www.moleculight.com.

Companies Develop 3-D Wound Care Measurement Tool

A device that’s expected to provide accurate and convenient 3-D wound measurement and documentation at the point of care for pressure ulcers, diabetic foot ulcers, and other chronic wounds has been developed through a partnership between eKare Inc. Fairfax, VA, and Daewoong Pharmaceutical, Rockville, MD. The inSight™ will reportedly help clinicians to obtain a full set of 3-D wound measurements, including depth and volume, by taking a photo of the wound without direct patient contact. The product is also designed to provide the latest sensing technology to customers with easy-to-use interfaces. Under the terms of the partnership, Daewoong will work with eKare to obtain regulatory approvals and to manage marketing, sales, and distribution activities of the product in the territory, officials said. Visit www.ekareinc.com for more information.  

Commercializing Dermal Regeneration Matrix

Integra LifeSciences, Plainsboro, NJ, a global medical technology company, has received approval from the U.S. Food and Drug Administration to package Integra^® Omnigraft™ Dermal Regeneration Matrix, according to company officials. The product is designed for ease of handling and application in the outpatient wound care setting and is indicated for use in the treatment of partial- and full-thickness neuropathic diabetic foot ulcers (DFUs) lasting more than six weeks with no capsule, tendon, or bone exposed when used in conjunction with standard diabetic ulcer care. The company’s FOot Ulcer New DErmal Replacement (FOUNDER) study on the product is the largest published DFU study to date, officials said. The study evaluated a cellular- and/or tissue-based product (CTP) that demonstrated significantly improved healing compared to conventional therapy, with a median of one application. Visit www.integralife.com for more information.

Silicone-Free Wound Care Adhesives Launched

Lohmann Corporation, Orange, VA, a wholly owned division of Lohmann GmbH & Co KG, has launched its newest custom adhesive solution specifically designed for manufacturers of wound care products — the DuploMED Soft-Stick™ Series. The product series features gamma-sterilization, stable, gel-like PSAs with all the advantages of traditional silicone adhesives for pain-free, easy-off adhesion, which is important for patients with fragile skin, company officials said. It is painless, permeable to water vapor, and residue-free. Dressings can be contoured to the wound and sealed around the edges. This product was also a featured at the 2016 Symposium on Advanced Wound Care Spring in Atlanta. Visit www.lohmann-tapes.com for more information.

Wound and Infection Molecular Test Available

Officials at Granger Diagnostics, Richmond, VA, a division of Al Bio Tech, have announced immediate availability of the first commercially available, next-generation sequencing test for wounds and infections — Wound~Seq. This test reportedly ensures discovery of all bacteria, fungi, parasites, and select viruses and requires only a simple swab of the wound or infected area. A molecular diagnostic test using up-to-date reference databases for identification of bacteria/fungi and determination of antibiotic resistance genes, it is the second “next-generation” test in the company’s pipeline, following Gynecologene, the first commercially available laboratory test for bacterial vaginosis that incorporates this novel technology, officials said. Visit www.grangerdiagnostics.com for more information.

Research Highlights Positive Effect of Wound Care Products  

Organogenesis Inc., an advanced wound care technology company based in Canton, MA, has released results of research highlighting the role of PuraPly™ and PuraPly Antimicrobial in managing bioburden and supporting wound healing across a variety of wound types. These highlights appeared in three new research abstracts that were presented at the 2016 Symposium on Advanced Wound Care (SAWC), April 13-17. Visit www.organogenesis.com for more information.