Skye® Biologics Announces WoundEx® Membrane Recent Study Reveals Accelerated Wound Closure Rates

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Skye Biologics announces just completed study shows 98% complete heal rate achieved at 12 weeks in patients treated with WoundEx® FastActing™ Membranes. This demonstrates successful use of Skye's proprietary dHAM Amniotic Tissue Allograft in the Treatment of Lower Extremity Wounds, with significant clinical results.

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I utilize WoundEx® with my diabetic patient population, and it performs remarkably well to advance and progress these wounds to healing - said Dr. Eric Lullove

98% complete heal rate achieved at 12 weeks in patients treated with WoundEx® FastActing™ Membranes.

Skye Biologics announces the results of the study, Use of proprietary dHAM Amniotic Tissue Allograft in the Treatment of Lower Extremity Wounds, with significant clinical results. This 20 patient pilot study conducted by Dr. Eric Lullove, DPM CWS FACCWS, Medical Director, West Boca Center for Wound Healing, observed the effectiveness of WoundEx Membranes for the treatment of chronic diabetic foot ulcers and venous leg ulcers. This study shows the real-world efficacy of WoundEx Membranes in chronic difficult-to-treat wounds, in patients with significant co-morbidities.

20 male and female patients with chronic non-healing wounds were selected. This patient cohort exhibited an average wound size of 7.4 sq cm (ranging from 2.0 sq cm to 14.5 sq cm), which is significantly larger than the average diabetic ulcer size of 1.5 sq cm. Patients underwent a two-week run-in period where standard of care was used to clear the wound of bioburden. WoundEx was applied at week 1, 3, and 5 if necessary. At only 4 weeks there was an average reduction in wound size of 46% with 98% wound closure at 12 weeks. The average closure rate for all wounds was 9.94 weeks.

“These are patients I see every day in my office,” said Dr. Eric Lullove. “Their health is poor; from diabetes to vascular disease to venous disease, and their wounds are challenging to heal. I utilize WoundEx with this patient population, and it performs remarkably well to advance and progress these wounds to healing.  I have used various types of tissue biologics in my practice, and this is now my go-to tissue for advanced wound healing.”

Chronic non-healing wounds are debilitating and costly to the healthcare system. Diabetic foot ulcers alone cost the US $245 billion dollars in 2012 and are the leading cause of non-traumatic lower extremity amputation. Even more prevalent, venous leg ulcers are the most common wound type in the United States, with almost 2 million people affected annually. Traditional treatments for these kinds of wounds may include surgical and non-surgical debridement, collagens, foams, venous compression, off-loading, and pressure-relief support. Treatment with WoundEx Amniotic Membranes has shown to be a viable solution to treat this patient population. 

“As a company, our mission is to create the most viable biologic solutions so patients have the best opportunity for a good outcome,” said Chris Sharp CEO, Skye Biologics. “We are committed to developing new, innovative product formulations to meet the various needs of physicians and the patients they treat. We pride ourselves on our HydraTek Process and how well we preserve the biologic integrity of these tissues. Historically this has not been a consideration by many biologic and tissue processors. This study is part of an on-going effort to validate the outstanding clinical results of our products across multiple specialties.” 

FastActing WoundEx Amniotic Membranes are part of Skye's extensive line of amniotic and placental products designed to help support proper tissue formation while reducing scarring and controlling pain and inflammation. Skye products are processed with the next-generation HydraTek® Technology that has been independently validated to maintain the majority of natural collagens, growth factors, and BioActive® molecules found in natural, unprocessed placental tissues. HydraTek, utilizing its proprietary BioAware™ System is designed to better preserve the products' natural biomechanical structure by scientifically controlling moisture levels versus traditional heat-baking or lyophilization systems and avoids the use of harsh chemical rinses.

About Skye® Biologics
Skye Biologics® is an innovative biomedical processor and marketer of specialized human tissue biologics for numerous clinical settings. Our proprietary HydraTek® technology was developed to produce the most extensive line of placental tissue grafts, providing optimized configurations for surgical and in-office applications. HydraTek is validated with leading efficacy on processing quality, safety and performance. Over 100,000 placental tissue grafts have been utilized in various specialties including wound care, orthopedics, sports medicine, foot and ankle and ocular.

For more information, visit our website at skyebiologics.com.

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Chris Sharp
Skye Biologics, Inc.

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