June New Products and Industry News

Pattern film dressing has comfort technology

  3M Skin and Wound Care (St. Paul, MN) launched 3M™ Tegaderm™ Diamond Pattern Film Dressing with Comfort Adhesive Technology. The dressing features transparent, breathable film; a frame delivery system; and new, comfort adhesive technology. Additionally, the breathable dressing is engineered with pressure-sensitive adhesive to conform to the skin’s irregular surface for a long, comfortable wear, even when environmental and patient conditions (including diaphoresis) have historically posed challenges for optimal dressing performance. The new dressing offers all the popular features of Tegaderm™ Transparent Film Dressings while adding adhesive technology to increase moisture management performance, which could lead to less-frequent dressing changes, a potential cost-savings option for healthcare facilities. The new dressing will be available in the US and in select international markets in June.   For more information, visit https://solutions.3m.com/wps/portal/3M/en_US/3MSWC/Skin-Wound-Care/ProductDirectory/Dressings/tegaderm-diamond/?WT.mc_id=pr_TegDiamond_5.

Trilayer matrix provides temporary ECM replacement

  Healthpoint Biotherapeutics (Fort Worth, TX) introduced Oasis® Ultra Tri-Layer Matrix, a natural extracellular matrix (ECM) material derived from three layers of porcine small intestinal submucosa (SIS). The three-layer construct of ECM was designed to incorporate increased structure into difficult-to-heal and chronic wounds. The product is indicated for surgical, partial- and full-thickness, traumatic (including second-degree burns) and draining wounds as well as venous, chronic vascular, diabetic, and pressure ulcers. The product should not be used in patients with known sensitivity to porcine material and is not indicated for use in third-degree burns. The company launched the product as an extension of their SIS product offerings.

  For more information, visit www.Healthpoint.com.

Total contact casting boot designed to treat diabetic foot ulcers

  MedEfficiency Inc (Wheat Ridge, CO) announced the availability of the new and improved TCC-EZ™ Boot. The boot is designed for use with the TCC-EZ Total Contact Cast System and now features an easy-to-use Velcro® closure system, side paddles that grip the cast, and a new sole tread design that enhances traction and is more resistant. Total contact casting is considered the gold standard for the treatment of diabetic foot wounds, distributing weight along the entire plantar aspect (sole) of the foot. It is applied to maintain intimate contact with the exact contour of the foot. The TCC, in conjunction with comprehensive wound care protocols, provides a dynamic approach to complete immobilization, which allows the tissue to heal without being disturbed or traumatized by repetitive injury or shear forces. This approach is considered the gold standard for the treatment of diabetic foot wounds.

  Additionally, the company recently announced the addition of the TCC-EZ Charcot Casting System, which includes a newly designed Charcot Boot that is available in sizes large and extra large.

  For more information, visit www.medefficiency.com.

Heel-specific hosiery available

  DM Systems Inc (Evanston, IL has introduced HeelSafe DVT Hose. Graduated compression hosiery can play a pivotal role in assisting patients prone to deep vein thrombosis (DVT). However, traditional compression hosiery exerts pressure on the heel of the foot and Achilles tendon, which can lead to heel pressure ulcers. The new hose include a patented window design that relieves pressure on the heel and Achilles tendon and facilitates easy visualization and palpation of the heel. The hose are indicated for patients at risk for venous pooling and thrombosis, patients with deep vein thrombosis, patients who have a history of heel pressure ulcers, patients who are restricted by limited mobility, and patients who need to sit or stand for long periods of time (eg, during long airline flights). Compression ratings ankle to knee for the knee-high hose are 20 to 12 mm Hg, while compression ratings from ankle to thigh for the thigh-high hose are 20 to 9 mm Hg. The hose are also available latex-free. The company also manufactures the Heelift® Suspension Boot.

  For more information, visit www.heelift.com/dvt.

Advanced wound care products debuted at symposium

  MediPlus™ advanced wound care products from MediPurpose® a distributor and manufacturer of medical products, were well-received at the 24th Annual Symposium on Advanced Wound Care (SAWC). The company chose to debut its products at the premier educational wound care program within the clinical field and the largest annual gathering of wound care clinicians in the US. Exhibit booth visitors and attendees were receptive to the new line of wound care products. The company established the price point for the line to provide its wound care product customers with the opportunity to remain competitive and grow their business in today’s formidable economic environment. Based on the reactions received from several booth visitors, the company is confident the line of products will be a success.

  For more information, visit www.medipurpose.com.

Autologous skin spray improves outcomes

  Avita Medical Ltd (Northridge, CA and Cambridge, UK) introduced its ReCell® Spray-On-Skin™ to clinicians from six countries of the Arabian Peninsula: Saudi Arabia, Kuwait, Bahrain, Qatar, United Arab Emirates and Oman. The skin spray allows in‐theater preparation of a spray‐on suspension consisting of cells derived from a small (2 cm x 2 cm), thin (0.15 to 0.20 mm) biopsy of a patient’s own skin that is sufficient to cover an area up to 80 times the size of the biopsy. The spray’s suspension contains basal keratinocytes, melanocytes, fibroblasts, and Langerhans cells. The metabolically responsive epithelial cells migrate across the wound surface, leading to regeneration of skin of normal color and texture. The spray requires only a minimal donor site and is immediately available as a cell‐based spray at the patient’s bedside. Patented, CE-marked for Europe, TGA-registered in Australia, and SFDA-cleared in China, the spray is not available for sale in the US because it is limited by federal law to investigational use.

  Dr. Khaled Alkandari of the International Health Services (Kuwait) introduced the product launch and workshop, which was attended by approximately 45 surgeons. More than 3,500 patients have been treated with the spray for treatment of burns, hypo- and hyper-pigmentation (eg, vitiligo, a common skin pigmentation disease), scar revisions (eg, acne), and aesthetic skin rejuvenation procedures (eg, wrinkle removal). The spray has been demonstrated to improve outcomes, reduce morbidity, and reduce length of hospital stay and patient care costs.

  For more information, visit www.avitamedical.com.

FDA application for collagen wound healing product filed

  Uluru Inc (Addison, TX) has filed a 510(k) application with the US Food and Drug Administration to obtain marketing authorization for Altrazeal® Collagen.

  Collagen-containing wound care products represent a growing segment of the advanced wound care market. Collagen stimulates cellular migration and contributes to new tissue development; collagen dressings encourage the deposition and organization of newly formed collagen, creating an environment that fosters healing. Biomaterials with collagen stimulate the wound healing cascade, recruiting specific cells during this process and ultimately, enhance wound healing.

  For more information, visit www.uluruinc.com.

Clinical development program for new hydrogel initiated

  BioTime Inc (Alameda, CA) will seek regulatory approval of HyStem® Rx as an implantable cell delivery vehicle that can be used to improve outcomes in reconstructive surgery and potentially a wide array of other cell-based therapies. The product is a biocompatible hydrogel that mimics the extracellular matrix in which cells reside. As an injectable product, the gel has the potential to address an immediate need in cosmetic and reconstructive surgery and other procedures by improving the process of transplanting adipose cells or other adult stem cells. Such applications may include numerous cell transplant procedures currently being developed in which a patient’s own adult stem cells are utilized. Similarly, once newer cell replacement products derived from human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells become available for medical use, the gel may provide the best means of implanting those cells in patients.

  Filing for regulatory approval of the gel as a medical device in Europe may begin within approximately 14 months, which is the estimated time for completing nonclinical studies and performing manufacturing and assay validations. Regulatory approval may take as little as 2 years, after which the product may be sold for use in existing cell transplant therapies.

  For more information, visit www.biotimeinc.com.

Pharmaceutical company reports ongoing healing rates among patients in clinical trial

  Derma Sciences Inc (Princeton, NJ), announced findings from the follow-up portion of its Phase 2 clinical trial concentrating on patients with diabetic foot ulcers using DSC127, a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated upon tissue injury. The percentage of patients treated with the therapeutic (0.03%) dose of DSC127 with complete healing at 24 weeks following trial enrollment was 73% in the intent-to-treat (ITT) population and 85% in the per-protocol population (PP), a difference of 27 and 33% points, respectively, compared with patients treated with placebo/standard of care (placebo). Healing was defined as 100% epithelialized with no drainage. The company previously announced that the 0.03% dose of DSC127 exceeded the trial’s initial goal of an improvement of 15% points in complete healing of wounds at 12 weeks for both the ITT (21% point increase) and PP (27% point increase) populations, compared with placebo. The improvement at 24 weeks between patients treated with DSC127 0.03% and patients treated with placebo is even more pronounced.

  The double-blind, placebo-controlled, multicenter Phase 2 clinical trial randomized 80 patients to receive one of two dose strengths of DSC127 (0.03% or 0.01%) or vehicle placebo control. After 14 days of best standard of care to evaluate ulcer healing and ensure the wounds were chronic, patients randomized into the study received 4 weeks of active treatment followed by 8 weeks of observation and assessment. Although the primary endpoint of the trial was healing at 12 weeks, patients continued to be followed for an additional 12 weeks to gain further information on the drug and its effects. Consistent with what was seen at week 12, the 0.01% dose of DSC127 continued to be comparable to placebo at week 24, and therefore nontherapeutic. No drug-related adverse safety events occurred during the entire 24-week study period.

  For more information, visit www.dermasciences.com.

Top industrial research and development award presented

  Quick-Med Technologies Inc (Gainesville, FL) received the Wound Healing Society’s (WHS) top Industrial Research and Development Award in recognition of scientific research. This is the second time in the past 6 years that the company has earned the society’s top Industrial R&D recognition as the overall first-place winner among all research abstracts and the fifth Industrial R&D Award within that timeframe.

  The award is presented by the WHS to recognize the best product-oriented research and development performed within the corporate world. Formerly known as the Blue Ribbon Industrial Research and Development Award, the award recognizes corporate research and development teams that are working to show mechanisms of action or efficacy for their company’s products and technologies. The company’s award-winning abstract, “Improved Healing in Weanling Pig Model of Vesicant Injury Shown by High Feature Antimicrobial Dressing” can be viewed at: https://www.globenewswire.com/newsroom/ctr?d=222760&l=4&u=http%3A%2F%2Fcontent.stockpr.com%2Fqmdt%2Fmedia%2F41b86d772b9ee310df5928d03e48ddb6.pdfhttps://content.stockpr.com/qmdt/media/41b86d772b9ee310df5928d03e48ddb6.pdf.

  For more information, visit www.quickmedtech.com.

Acquisition of intellectual property for medical mattress completed

  Joerns Healthcare LLC (Charlotte, NC) announced the acquisition of all intellectual property for the Dolphin Fluid Immersion Simulation Mattress Systems from Biologics Inc. Joerns is adding the Dolphin product portfolio to an ever-expanding offering of wound prevention and healing products and services.

  The technology simulates the effects of a body floating in a fluid, alleviating vertical shear forces that deform soft tissue, and thus supports optimized skin integrity and wound healing. The mattress and its patented technology have been adopted by leading healthcare providers throughout the healthcare continuum to prevent and treat pressure ulcers, which are both clinically complex and costly to manage. The mattress product portfolio complements the company’s existing proprietary therapeutic and preventative mattress solutions. The company’s national service team delivers the mattress and other important products to hospitals and nursing homes to support immediate clinical needs.

  For more information, visit www.joerns.com.

Women’s pelvic healthcare program introduced

  SRS Medical (Redmond, WA) announced the formation of Restore Continence™, a women’s pelvic health program based on the use of a comprehensive suite of medical devices for diagnosing and treating urinary incontinence. The program was officially launched at the Annual Clinical Meeting of The American College of Obstetricians and Gynecologists on May 2–May 4, 2011, in Washington, D.C.

  The new program starts with first-line therapies such as the StepFree™ vaginal weights to help improve pelvic muscle tone at home. The next line of treatments are performed in the office and include the Aware™ EMG biofeedback and stimulation instruments for developing voluntary control of pelvic muscles. In cases where conservative procedures are not sufficient, the company provides physicians with the latest diagnostic tools, including the UroScan® bladder ultrasound and EasyPro™ urodynamics to help inform the next course of treatment and medically justify surgical procedures. For women with prolapse-related incontinence who are not candidates for surgery, the company also offers the EvaCare® line of pessaries.

  For more information, visit www.restorecontinence.com or www.srsmedical.com.

Poster abstract honored at the SAWC Spring

  Four of SteadMed® Medical LLC’s (Ft. Worth, TX) poster abstracts were accepted for review at the Symposium on Advanced Wound Care (SAWC), held April 14-16, 2011 at the Gaylord Texan Convention Center in Grapevine, TX. One of the abstracts, “Drawtex®: The Effect of Accelerated Exudate Removal on the Bioburden of Venous Leg Ulcers,” received first-place honors. Authored by Randall Wolcott, MD, of the Southwest Regional Wound Care Center and Scot Dowd, PhD, the abstract was the highest scoring abstract in the clinical research category. The competition was judged by the North American Center for Continuing Medical Education, LLC (NACCME).

  The three other poster abstracts accepted for review were: “Detoxification of Venous Ulcers with a Novel Hydroconductive Wound Dressing That Transfers Chronic Wound Fluid Away From the Wound,” “Hydroconductive Debridement: A New Perspective in Reducing Slough and Necrotic Tissue,” and “Clinical Practice Evaluation and Usage of a Novel Absorbent Dressing.”

  For more information, visit www.SteadMed.com.

This article was not subject to the Ostomy Wound Management peer-review process.