Melgisorb® Ag Claims Receive FDA Clearance

     Mölnlycke Health Care (Norcross, Ga) recently received FDA clearance to support two new claims for Melgisorb® Ag, a highly absorbent, antimicrobial dressing. The dressing absorbs up to 45% more than leading silver hydrofiber dressings and the high fiber strength allows for removal in one piece. The dressing may be used under compression bandages and offers sustained release of silver for up to 14 days and is now indicated for use on partial-thickness burns. This is in addition to the management of moderate to heavily exuding partial-thickness wounds such as surgical wounds, trauma injuries, leg ulcers, pressure ulcers, diabetic ulcers, and graft/donor sites.

     Visit www.molnlycke.com for more information.

Clinician Reports Rapid Healing of Intractable Wounds After Using Medihoney®

     Derma Sciences (Princeton, NJ) recently announced that Jason R. Hanft, DPM, Director of Medical Education at Baptist Health South Florida, revealed details of a recently concluded 11-patient venous leg ulcer (VLU) case series involving the use of the company’s Medihoney® at the 22nd annual Symposium on Advanced Wound Care and Wound Healing Society Meeting (SAWC/WHS). The study was a confirmatory case series following a positive, 108-patient, randomized controlled study that was published in 2008 on a similar patient population—all of whom suffered from non-healing VLUs.

     In the recent case series, 11 patients were enrolled with VLUs that had not healed with other advanced wound care modalities including the gold standard multi-layered compression as well as silver antimicrobial dressings, hyperbaric oxygen therapy, and antibiotic therapy for at least 4 months’ duration. The study was designed to measure the percentage of wounds that healed in the standard timeframe of 12 weeks, but all 11 wounds healed within 6 weeks and more than half healed within 4 weeks.

     Visit www.dermasciences.com for more information.

Excellarate™ Indicates Promising New Formulation Enhancements

     Cardium Therapeutics (San Diego, Calif) and its subsidiary Tissue Repair Company (TRC) announced significant new formulation enhancements for its Excellarate™ product candidate that is designed to simplify and broaden the use of the product for diabetic ulcers. The enhancements will expand the potential applicability into a number of additional wound healing market opportunities, including pressure and venous stasis ulcers, as well as major surgical and serious trauma wounds.

     Excellarate is a collagen-based topical gel employing TRC’s Gene Activated Matrix™ (GAM) technology to stimulate a patient’s cells to produce a sustained micro-release of platelet-derived growth factor-β (PDGF-β) protein directly within the patient’s wound where it is needed. PDGF-β is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of cells such as monocytes, fibroblasts, and endothelial cells—all of which are critical for the effective stimulation of a variety of wound healing processes.

     On May 6, 2009, Cardium announced the completion of recruitment for the Phase 2b MATRIX clinical trial to evaluate the safety and efficacy of Excellarate for the treatment of nonhealing diabetic foot ulcers. The MATRIX Data and Safety Monitoring Board has reviewed safety data collected from study participants as of April 21, 2009 and reported that Excellarate appears to be both safe and well tolerated, with no serious adverse events attributable to the study product.