At 20 weeks, nearly twice as many venous leg ulcer patients achieved complete would healing with bi-weekly Talymed plus standard care versus standard care alone
DANVERS, Mass.--(BUSINESS WIRE)-- Marine Polymer Technologies, Inc. today announced that positive clinical trial results of Talymed, an advanced bio-active wound-healing technology, for the treatment of patients with hard-to-heal venous leg ulcers (VLUs) were published in the Journal of the American Academy Dermatology. The study compared the proportion of patients who achieved complete wound healing at 20 weeks using Talymed plus standard care versus those who received standard care alone. Study investigators reported that nearly twice as many patients who received biweekly Talymed in addition to standard care achieved complete wound healing at 20 weeks, compared to patients who received standard care alone (86.4% versus 45.0%, p<0.01). An abstract of the published article entitled, “A randomized, investigator-blinded, controlled pilot study to evaluate the safety and efficacy of a poly-N-acetyl glucosamine-derived membrane material in patients with venous leg ulcers,” is available at the journal’s website at http://www.eblue.org/article/S0190-9622(11)00303-3/abstract.
The newly published study enrolled adult patients with VLUs who sought treatment at wound care clinics. The primary endpoint, the proportion of patients who achieved complete VLU healing at 20 weeks, compared healing rates of patients who received Talymed in addition to standard care to those of patients who received standard care alone. Data obtained from all randomized patients were included in the analysis (intent-to-treat analysis). At enrollment into the study, the average patient age was 61.5 years, average ulcer size was 11.2 cm2, mean VLU duration was 3 months, and the most common comorbid conditions were hypertension (74%), diabetes (61%), arthritis (46%), class III obesity (45%), and blood clotting disorders (23%). At 20 weeks, 86.4% of patients who received Talymed every other week (10 applications) achieved complete healing, versus 45.0% of patients who received standard care alone; findings were highly statistically significant (p<0.01). No significant treatment-related adverse events or reactions occurred during the study and none of the subjects experienced increased pain or edema.
“VLUs, which affect more than a half a million people in the US, are very challenging and potentially serious wounds that are caused, in part, by poor venous circulation” said Teresa Kelechi, PhD, lead investigator and Chair, College of Nursing at the Medical University of South Carolina. “Patients with VLUs often experience considerable pain and swelling, poor functioning and quality of life, and are at risk for developing dangerous wound site and systemic infections. These wounds are notoriously difficult to heal. After 20 weeks of treatment with standard care, which consists of compression bandaging and moist dressings, only about half of VLUs are usually completely healed. We were therefore surprised to find that at 20 weeks, the proportion of patients who achieved complete healing with the bi-weekly addition of Talymed was nearly double that of patients who received standard care alone. By virtue of its significant wound healing benefits, Talymed may also decrease the risk for infection, improve patient functioning and well-being, and ultimately reduce health care costs.”
Talymed is a bio-active matrix that is cleared by the US Food and Drug Administration (FDA) for the management of wounds, including diabetic ulcers, venous ulcers, pressure ulcers, ulcers of mixed vascular causes, partial- and full-thickness wounds, second-degree burns, surgical wounds, and other bleeding surface wounds and abrasions. The active ingredient in Talymed is poly-N-acetyl glucosamine (pGlcNAc),nanofiber technology. The mechanism of action of pGlcNAc nanofiber-based matrix has been investigated in vitro and in vivo. Increased wound-healing rates may occur in response to enhanced angiogenesis and granulation tissue formation, in concert with rapid epithelialization.
Marine Polymer Technologies (MPT) is a privately-held medical device company that researches, develops and markets technologies for patient hemostasis and wound healing based on a proprietary microalgae-based polymer. In addition to Talymed, MPT products include Syvek Excel® Vascular Access Hemostasis System for use following femoral catheterization procedures to assist in obtaining and maintaining hemostasis; the Syvek® NT for use in the local management of bleeding wounds such as vascular access sites, percutaneous catheters or tubes and surgical debridement; and the MRDH™ trauma dressing intended for the temporary control of severely bleeding wounds such as surgical wounds (operative, post-operative, donor sites, dermatological, etc.) and traumatic injuries.
Marine Polymer Technologies
Sergio Finkielsztein, +1 781-270-3200
President and CEO
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