May New Products and Industry News

Study shows silver kills MRSA and other antibiotic-resistant infections

  ConvaTec (Skillman, NJ) released new in vitro study results showing that a wound dressing containing ionic silver is able to kill several strains of highly resistant bacteria, commonly referred to as superbugs. The study showed that bacteria found beneath the dressing died within 48 hours. The study results were presented at the 24th Annual Symposium on Advanced Wound Care and Wound Healing Society in Dallas, TX.   In the study, bacteria samples (including Acetobactor baumannii, Clostridium difficile, community-associated methicillin-resistant Staphylococcus aureus, or extended-spectrum beta lactamase-producing bacteria [ESBL]) were covered with a silver-containing sodium carboxymethyl cellulose wound dressing. The dressing was shown to be effective against emerging pathogens over a 7-day test period, including against re-inoculation. The dressing killed ESBL-producing bacteria and A. baumannii quickly and consistently, with an approximate 100,000-fold reduction of all pathogens within 24 hours. The rate of kill for C. difficile was rapid, with an approximate 100,000-fold reduction of all bacteria after 4 hours. The potency of silver-containing sodium carboxymethyl cellulose wound dressing against CA-MRSA was effective with a 100-fold reduction in bacterial population within 48 hours and no bacteria detected by day 7.

  For more information, visit www.convatec.com.

Fecal incontinence system receives FDA approval
  Oceana Therapeutics (Edison, NJ) announced the US Food and Drug Administration (FDA) has issued an Approvable Letter for Solesta® as a treatment for fecal (bowel) incontinence. The treatment is a biocompatible bulking agent consisting of dextranomer microspheres and stabilized sodium hyaluronate and has been developed as a minimally invasive treatment for fecal incontinence. It is the only injectable gel to be administered in an outpatient setting without the need for anesthesia. The treatment is injected in the deep submucosal layer in the proximal part of the anal canal. Although the exact mechanism of action has not been identified, it is hypothesized that injections may narrow the anal canal, allowing for better sphincter control.

  The FDA has determined that the treatment Premarket Approval Application (PMA) is approvable and subject to certain requirements relative to labeling and manufacturing. The company welcomes the opportunity to work with the FDA to satisfy the agency’s requests for final marketing approval. The company also will carry out a post-approval study to evaluate long-term treatment data.

  For more information, visit www.oceanathera.com.

Nerve stimulation therapy that aids fecal incontinence now FDA-approved
  Medtronic Inc (Minneapolis, MN) received Food and Drug Administration (FDA) approval for InterStim® Therapy for Bowel Control. The therapy, previously available for the treatment of overactive bladder and non-obstructive urinary retention systems, now is also approved for the treatment of chronic fecal incontinence among patients who have failed or are not candidates for more conservative treatments. The minimally invasive therapy is proven to improve or restore bowel control in more than 80% of patients who received the therapy in a multicenter clinical trial. The implantable system uses mild electrical stimulation of the sacral nerves to influence the behavior of the pelvic floor muscles and bowel. As a result, the therapy significantly reduced fecal incontinent episodes for a high percentage of clinical trial patients.

  The therapy is the only bowel control treatment option that allows patients and physicians to determine probable success of the therapy through a test stimulation procedure before committing to long-term therapy. Physicians who will implant the system for bowel control include colorectal surgeons, urologists, gynecologists, and urogynecologists who receive appropriate training. Originally approved by the FDA in 1997 for urinary urge incontinence, the therapy now can be used for both urinary control and bowel control in various geographical areas, including the US, Europe, Canada, and Australia. To date, more than 85,000 people have received the therapy worldwide.

  For more information, visit www.medtronic.com

. Wound care system patent issued
  The US Patent Office issued a patent that covers technology for assessment-driven selection and fabrication of personalized dressings produced by PolyRemedy (Concord, MA). The patent for invention number 7,448,186 covers selection algorithms and manufacturing methods that result in advanced antimicrobial dressings that are customized for optimal moisture control, vapor transfer, size, and shape to provide an optimal wound healing environment. Additionally, the Centers for Medicare and Medicaid Services (CMS) has confirmed reimbursement coding for the full customization of the company’s PolyFIT™ personalized advanced dressings. The prevalent method of wound treatment involves clinicians covering a wound with dressings selected from an inventory of stocked supplies, yet caregivers often select dressings with varying degrees of understanding of advanced wound healing principals, making treatment consistency and appropriateness difficult to maintain. The company’s Personalized Woundcare System (PWS™) ensures consistency of care by linking wound assessment to evidence-based protocols that address the functional needs of the patient’s wound at each point in the healing cycle. Furthermore, assessment data are leveraged to provide access to comprehensive analytics that allow for wound progress monitoring and resource utilization. The wound care system generates a personalized dressing optimized for a specific patient at a specific point in the healing cycle. At the same time, the system provides the treating nurse with a simplified one-step application, eliminating the adhoc customization that typically occurs. Ultimately, the company believes that the system will demonstrate improved clinical outcomes.

  For more information, visit www.polyremedy.com.

Wound bandage heals wounds, fights infection
  Medtric Biotech (West Lafayette, IN), based out of Purdue University, developed a bandage that both heals wounds and fights infection. The company won the Wake Forest University School of Business annual Elevator Competition from among 35 participating teams and is now automatically entered in the Venture Labs Investment Competition, which could yield up to $500,000 in investment from the Piedmont Angel Network.

  For more information, visit medtricbiotech.com/technology.html.

Company launches new wound care implant and elects new executive
  MiMedx Group Inc (Marietta, GA) announces the national launch of their latest product, EpiFix™, a biologic implant specifically processed to offer a wide variety of wound healing and wound care options. The implant is a branded tissue resulting from the company’s proprietary Purion® process. The amniotic tissue produced using the process has generated a growing demand for easy to use, minimally manipulated allografts and has experienced increased growth in the areas of ophthalmology, dental, spine, and sports medicine. The company’s tissues have been used in over 30,000 implants to date.

  The company also recently hired Frank Burrows to the newly created position of Vice President of Wound Care. Burrows brings more than 20 years of experience and expertise at companies including J & J Wound Management, Smith & Nephew, Advanced Tissue Sciences, and Histogen Aesthetics, developing and implementing sales and marketing programs that have created growth for numerous medical devices and pharmaceuticals in the areas of wound closure, wound healing, tissue engineering, and bioactive therapeutics.

  The company’s wound care initiative serves both civilian and military and will focus on wound care clinics, hospitals, general practice clinics, physicians, and private label opportunities.

  For more information, visit www.mimedx.com.

Pharmaceutical company highlights the efficacy of anti-infective solution
  NovaBay Pharmaceuticals Inc (Emeryville, CA) is developing its anti-infective Aganocide® compounds for the local treatment and prevention of antibiotic-resistant infections. The company presented a poster on the efficacy of NeutroPhase® solution (NVC-101) with the hydrophobic mesh Sorbact® in healing chronic nonhealing wounds at the 24th Annual Symposium on Advanced Wound Care (SAWC) in Dallas, TX.

  Written by researchers from the company and San Francisco Center for Advanced Wound Care at the Seton Medical Center (Daly City, CA), the poster reported multiple case studies in which a combination of 0.01% NeutroPhase with Sorbact as a wound mesh dressing was capable of reducing maceration of adjacent skin and binding and inactivating pathogenic micro-organisms, in conjunction with negative pressure wound therapy (NPWT) administered to 26 patients with chronic nonhealing wounds. The researchers demonstrated the solution was capable of destroying biofilm in the wounds without damaging the surrounding tissues and was an effective topical antimicrobial that improved wound healing. Moreover, the hydrophobic mesh was found to help reduce tissue maceration. The company has two FDA 510(k) clearances for the solution and has begun moving forward toward larger-scale manufacturing and eventual marketing by its Hospital Business Unit.

  For more information, visit www.novabaypharma.com.

Medical technology company achieving its milestones
  Sanuwave Health Inc (Alpharetta, GA) has made significant progress toward its goal of becoming a leading regenerative medicine company serving the wound care, orthopedics, and plastic surgery markets. The company completed its dermaPACE® pivotal Phase III clinical trial to treat diabetic foot ulcers (DFU) and reported safety and efficacy results during the fourth quarter. The company also submitted the first of three modules of their Premarket Approval (PMA) application to the US Food and Drug Administration (FDA), which included preclinical data and the results of prior clinical testing. By completing this rigorous Phase III clinical trial and immediately initiating their modular PMA submission process, the company has surpassed a key milestone for transforming the brand from a development stage entity in to a commercial company. As demonstrated by results from the DFU clinical trial, the product has the potential to help a large number of patients who suffer with foot ulcers. Pending FDA approval, the company looks forward to bringing the product to medical professionals and patients alike, while aiming to make a significant impact on wound healing and quality of life. Business highlights from 2010 include the completion of the dermaPACE Phase III, prospective, randomized, double-blinded, sham-controlled, multicenter, 206-patient, Investigational Device Exemption (IDE) clinical trial in DFU in 24 centers in the US and Europe.

  For more information, visit www.sanuwave.com.

Company presents at annual symposium
  Derma Sciences Inc (Princeton, NJ), offered both poster and expert presentations featuring Medihoney® and Xtrasorb® at the Symposium on Advanced Wound Care (SAWC) Spring, April 14 -17, 2011 in Dallas, TX. Their two posters included “Use of Active Leptospermum Honey to Heal Pressure Ulcers — A Case Series of Pressure Ulcer Patients” by Cynthia Bridgman, BSN, RN, CWOCN, and Carol Hall, BSN, RN, CWOCN, CFCN of The University of Texas Southwestern Medical Center at Dallas; and “Protease Modification by Super Absorbent Polymer Dressings” by Marcy Turkos, PT, DPT, CWS and Kimberly Stallo, BS, RN, CWOCN. Presentations highlighting the products took place at the company’s booth and included “The Versatility of Medihoney® for Use on a Variety of Stalled Wounds and Wounds of Atypical Etiologies” and “Medihoney® and Xtrasorb®: The Value of an Osmotic Gradient on Chronic Wounds: A Combination Therapy.”

  For more information, visit www.dermasciences.com.

Leading health insurer announces coverage of wound care system
  Spiracur Inc (Sunnyvale, CA), which recently developed an ultraportable and disposable negative pressure wound therapy (NPWT) device, and Highmark Inc (Pittsburgh, PA), an independent licensee of the Blue Cross and Blue Shield Association, announced new coverage for Spiracur’s SNaP® (Smart Negative Pressure) Wound Care System and related supplies. The wound care system eliminates the electric or battery powered pump used to deliver NPWT; it is completely silent and lightweight, (2.2 oz). The wound care system will benefit the insurer’s members suffering from diabetes, circulatory problems, and additional conditions.

  For more information, visit www.spiracur.com.

NAFC names first medical center in Western US as award recipient
  The National Association For Continence [(NAFC) Charleston, SC] designated the Virginia Mason Medical Center’s Pelvic Floor Center as a Center of Excellence (COE): Continence Care. Virginia Mason is the first medical center in the western US to receive this honor and joins only one other medical center in the country that has achieved this status. Drs. Fred Govier, Kathleen Kobashi, Alvaro Lucioni, and Ksenija Stefanovic are the principal physicians in the COE. Recognized nationally for their expertise in prostate cancer, incontinence, erectile dysfunction and sexual dysfunction, the Virginia Mason urologists have played a vital role at the medical center for more than 80 years.

  The NAFC’s National Centers of Excellence: Continence Care program was established to offer consumers seeking solutions to their bladder and bowel control problems and related pelvic floor dysfunction (PFD) a reliable, trustworthy means of finding an experienced and credentialed expert. The COE designation is based on evidence of extensive training, clinical experience, interdisciplinary resources and patient satisfaction statistics that meet established standards. Healthcare institutions seeking to apply for this designation must first meet prequalification requirements set by the NAFC and its COE Review Committee. A complete list of requirements can be found on NAFC’s website.

  For more information, visit www.nafc.org.

Number of Medicare patients covered under New England carrier increased
  Uroplasty Inc (Minneapolis, MN) has added most of New England to its roster of Medicare carriers after NHIC Corp. agreed to cover its UrgentPC treatment for urinary incontinence. The decision, effective May 22, 2011, puts 1.8 million Medicare patients in Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont under the company’s coverage umbrella for a total of 31 million within 35 states. The United Healthcare decision added its 33 million-patient roster to the more than 30 million Medicare patients already under the coverage umbrella for the company’s Urgent PC neurostimulation device to treat urinary incontinence. The company’s system is a posterior tibial nerve stimulation device that, unlike competing devices is minimally invasive. The company’s decision expands the total pool of patients with private insurance coverage for the procedure to nearly 70 million.

  For more information, visit www.uroplasty.com.