December New Products & Industry News

Therapeutic surface enhances pressure ulcer prevention and management

  Kinetic Concepts Inc ([KCI] San Antonio, TX) recently launched the Skin IQ™ Microclimate Manager (Skin IQ™ MCM). The product is a for-sale, powered waterproof, vapor-permeable coverlet with bacterial barrier that uses the company’s proprietary Negative Airflow Technology to actively reduce excess moisture and the temperature of the skin’s surface. This moisture and temperature reduction is intended to help reduce the risk of maceration, friction, and the shear forces that twist and tear underlying blood vessels. Used in combination with a pressure redistribution mattress such as the AtmosAir™ 9000 MRS, the product provides an alternative to conventional low-air-loss therapy. Acute and long-term care facilities can benefit from the coverlet use to manage patients’ skin integrity. When used with a facility-owned pressure redistribution mattress, the single-patient-use product design enables facilities to stock product on site, offers considerable workflow benefits and fewer steps to initiate therapy, allows nurses to spend more time in the direct treatment of their patient, provides streamlined surface and protocol selection, and potentially aids in reducing nosocomial risk as the result of earlier therapy initiation.

  For more information, visit www.kci1.com.

Antimicrobial foam dressing introduced

  Mölnlycke Health Care US LLC (Norcross, GA) recently introduced their newest product, Mepilex® Border Ag antimicrobial bordered foam dressing with Safetac® technology. The dressing represents the next generation of antimicrobial wound dressings that offer an all-in-one dressing that effectively absorbs and retains exudate and maintains a moist wound environment. The new dressing has powerful silver performance that inactivates wound-related pathogens within 30 minutes and sustains antimicrobial effect for up to 7 days.   The Safetac® layer seals the wound edges, which allows exudate to pass into the absorbent core and minimizes the risk of maceration. The dressing features a multi-layered absorbent foam pad that consists of compressed foam with silver and a fiber layer for maximum fluid retention. This combination absorbs, spreads, and retains exudate while allowing the silver to be released. The dressing is ideal for medium to high exuding wounds that require a moist environment, exudate management, gentle fixation, and antimicrobial action, including leg and foot ulcers, pressure ulcers, superficial and partial-thickness burns, traumatic wounds, and surgical wounds.

  For more information, visit www.molnlycke.us.

>Re-launched products address skin damage prevention

  3M Skin & Wound Care (St. Paul, MN) has re-launched the 3M™ Cavilon™ Professional Skin Care line, a full range of products to help prevent skin damage from moisture, friction, and adhesive trauma. Following extensive research and surveys of caregivers and clinicians, the Cavilon brand has been updated with new packaging to help easily identify the right product for a specific need. Widely known for its Cavilon No Sting Barrier Film, the company also plans to introduce new Cavilon products starting later this year with Cavilon Antifungal Cream. This new product relieves redness, irritation, scaling, itching, discomfort, and burning due to athlete’s foot, jock itch, and ringworm. It also offers barrier properties to protect against moisture, and an easy-to-spread formula to soothe affected areas. In 2011, the company will add enhanced product formulations, sizes, and new patient-friendly delivery systems to the product line, which includes a full range of comfort and convenient products such as an extra dry skin cream, hand moisturizer, a no-rinse skin cleanser, and lotion for incontinence care.

  For more information, visit www.3M.com/healthcare.

Medical supplier enters wound care sector

  Teva UK Limited (Castleford, England), a medicine supplier of the NHS, entered the wound care sector with the launch of PolyHeal™ at the Wounds UK conference. This product for hard-to-heal wounds has been clinically proven to cause a significant reduction in wound size after just 1 month of treatment, even in wounds with exposed bones and tendons. The product consists of negatively charged polystyrene microspheres, suspended in a nutrient medium, that interact with cellular components within the wound bed to activate the inflammatory and proliferation phases of wound healing. It has been shown effective in treating hard-to-heal wounds across a variety of wound types, achieving granulation coverage in 63% of wounds after 4 weeks, 40% wound size reduction after 4 weeks, and 36% of wounds closed within 12 weeks. The results of two open-label studies of chronic wounds of multiple etiologies including venous, diabetic, and ischemic ulcers showed that 87% of patients treated with the product achieved significant wound improvement after 4 weeks. All exposed bones and tendons were covered after 4 weeks.

  For more information, visit www.tevauk.com.

Cephalosporin fights against bacterial and skin infection

  Forest Laboratories Inc (New York, NY) announced that ceftaroline fosamil (Teflaro™), a broad-spectrum bactericidal cephalosporin with activity against both Gram-positive and Gram-negative micro-organisms, was approved by the US Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

  The product is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. The efficacy and safety of the cephalosporin was established in pivotal trials including 1,219 patients treated with the drug. The company eagerly anticipates the commercial launch of the product and remains committed to bringing additional new treatments to market that target infectious diseases; it recognizes the enormous burden of disease associated with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. The product will be available to wholesalers by January 2011.

  For more information, visit www.frx.com.

Urological medical supply company launches website

  UroMed (Suwanee, GA) officially launched its new website (https://www.uromed.com), providing patients with a variety of catheter, urological, and incontinence products, along with health education resources. The website includes the company’s medical supply catalog that features intermittent catheters, external catheters, and pediatric catheters. The site also offers medical updates on catheter use and educational videos plus reference materials on spinal cord injury, spina bifida, and multiple sclerosis. The company partners with healthcare professionals across the country to provide their patients with the best urological and incontinence products available. The new website is designed to help urology and continence care patients learn more about their condition and ongoing catheter use while ordering their catheters and urologic medical supplies quickly and easily.

  For more information, visit www.uromed.com.

Reimbursement code granted for SUI treatment device

  Novasys Medical Inc (Newark, CA), a developer of women’s health therapies, recently announced that CPT Code 53860, specific to the nonsurgical Renessa treatment for women with stress urinary incontinence (SUI), will be in effect in January 2011. Establishing a Category I CPT Code is a tremendous milestone for women suffering with SUI and has been a long awaited event for customers, employees, and investors. The company anticipates by January many payors will include this treatment in their list of covered services, enabling more women affected by the debilitating and embarrassing effects of SUI access to this safe and effective nonsurgical therapy. Currently, the treatment is covered by Medicare in 31 states, by Aetna nationwide, by Blue Shield of California, and by several other large regional commercial plans across the country. The company is expanding commercial operations in response to the growing demand for the treatment procedure based on current insurance coverage, and expects to increase these efforts as additional coverage and demand result from the implementation of the new CPT code.

  For more information, visit www.novasysmedical.com.

Prosthetic limbs shipped to aid Haitian children

  Just 3 months after the Knights of Columbus (Hialeah, FL) announced that it would donate $1 million to Project Medishare to provide prostheses to Haitian children who lost limbs in the January 2010 earthquake, a large shipment of the prosthetic devices have been shipped to Port-au-Prince. An estimated 1,000 children underwent amputations after suffering severe injuries in the earthquake. Project Medishare, which operates a critical care, trauma, and rehabilitation hospital in Port-au-Prince and clinics in the Central Plateau, is equipped to fit prostheses and to provide physical therapy once patients have been fitted with the devices. The Knights of Columbus agreed to underwrite the cost of both the prostheses and therapy for children in need. The children will be supplied with up to three prostheses (as they outgrow them) and 2 years of physical therapy.

  For more information, visit www.kofc.org/en//index.html.

Medical device and pharmaceutical company awarded government research grant

  Derma Sciences Inc (Princeton, NJ) has been awarded a research and development grant of $244,479 from the US government under HR: 3590, Patient Protection and Affordable Care Act (the “Act”) in immediately available funds. Under the Act, $1 billion was earmarked for qualifying therapeutic discovery projects that treat areas of unmet medical need or prevent; detect or treat chronic or acute diseases and conditions; and/or reduce the long-term growth of US healthcare costs. In addition, allocation of the credit took into consideration which projects show the greatest potential to create and sustain high-quality, high-paying US jobs and to advance US competitiveness in life, biological, and medical sciences.

  The company submitted an application for DSC127, its pharmaceutical product currently completing Phase 2 trials in diabetic foot ulcer healing. The company looks forward to reporting top-line efficacy results of these trials in late December or early January in addition to furthering the development of this drug either alone or with a partner.

  For more information, visit www.dermasciences.com.

Medical device and pharmaceutical company awarded government research grant

  Derma Sciences Inc (Princeton, NJ) has been awarded a research and development grant of $244,479 from the US government under HR: 3590, Patient Protection and Affordable Care Act (the "Act") in immediately available funds. Under the Act, $1 billion was earmarked for qualifying therapeutic discovery projects that treat areas of unmet medical need or prevention; detect or treat chronic or acute diseases and conditions; and/or reduce the long-term growth of US healthcare costs. In addition, allocation of the credit took into consideration which projects show the greatest potential to create and sustain high-quality, high-paying US jobs and to advance US competitiveness in life, biological, and medical sciences.

  The company submitted an application for DSC127, its pharmaceutical product currently completing Phase 2 trials in diabetic foot ulcer healing. The company looks forward to reporting top-line efficacy results of these trials in late December or early January in addition to furthering the development of this drug either alone or with a partner.

  For more information visit www.dermasciences.com.

Life sciences company awarded project grant to advance technology

  The US government has awarded a grant under its Qualifying Therapeutic Discovery Project (QTDP) to Quick-Med Technologies Inc (Gainesville, FL) to advance the development of the company's Nimbus technology for wound dressing and wound drains. The technology offers highly effective, nontoxic, long-lasting, nonleaching, and affordable antimicrobial protection. The QTDP grant program provides support for projects determined by the US Department of Health and Human Services (HHS) to have reasonable potential to result in a new therapy, reduce healthcare costs, or significantly advance the goal of curing cancer.

  For more information visit www.quickmedtech.com.

Regenerative medicine company implements urinary conduit in clinical trial

  Tengion Inc (East Norriton, PA) a leader in regenerative medicine, announced that surgeons at the University of Chicago have implanted its Neo-Urinary Conduit^TM in the first patient as part of the ongoing clinical trial evaluating the company's lead product candidate in bladder removal. The patient is being treated at the University of Chicago Medical Center by the study's principal investigator, Gary D. Steinberg, MD, professor of surgery and director, urologic oncology. The trial is also going to be conducted at The Johns Hopkins Hospital in Baltimore, MD.

  This implantation marks a significant milestone for bladder cancer patients and physicians eager for a treatment alternative to the current standard of care. For many patients who have had their cancerous bladders removed, the current standard of care is the surgical creation of a urinary diversion using a segment of the patient's own bowel tissue to carry tissue from the kidneys to a plastic bag on the abdominal wall. The company's neo-urinary conduit is built from a patient's own cells obtained from a fat biopsy. The product is designed to catalyze regeneration of native-like bladder tissue, eliminating the need to use bowel tissue as a replacement for the cancerous bladder. The conduit is designed to avoid many of the complications associated with the use of bowel tissue, including bowel obstructions, bowel leakage, systemic absorption of urine via the bowel tissue, recurrent infections, stone formations, and mucus secretions in the urine.

  Imaging will be performed at 3-month intervals for the first year to examine the neo-organ's structure, patency, and identify any obstructions or other abnormalities. This frequent evaluation and the open-label nature of this study will provide significant ongoing feedback throughout the study. The study, which initially will enroll up to five patients with bladder cancer following bladder removal, is designed to provide data on the safety profile for the conduit as well as to optimize the surgical technique and the ideal post-surgical patient care before proceeding into larger trials. The surgical procedure may be modified in subsequent patients based on the experience gained by the prior patients enrolled.

  For more information visit www.tengion.com.

Free AAWC memberships available

  Through a grant from a corporate member, Healthpoint (Fort Worth, TX), and through support from individual donors, AAWC has been able to offer nearly 150 free patient/caregiver memberships in 2010. Any wound care patient or personal caregiver who wishes to take advantage of the free opportunity should email Patient_Advocacy@aawconline.org or call (800) 237-7285, EXT 113.

  For more information visit www.aawconline.org.