Skye® Biologics & Human Regenerative Technologies Complete Major Milestones For Product Launch into Advanced Wound Care

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WoundEx has gained high cost reimbursement and achieved publication of an impactful study showing 98% complete heal rate achieved at 12 weeks in patients treated with WoundEx® FastActing™ Membranes. These advancements will provide a turn-key solution to existing and future private label partners of Skye and Human Regenerative Technologies in the Advanced Wound Care market.

As a leading OEM processor of high quality tissue biologics we are thrilled to offer a turn key solution with our FastActing™ biologic for Advanced Wound Care.

WoundEx has gained high cost reimbursement and achieved publication of an impactful study showing 98% complete heal rate achieved at 12 weeks in patients treated with WoundEx® FastActing™ Membranes. These advancements will provide a turn-key solution to existing and future private label partners of Skye and Human Regenerative Technologies in the Advanced Wound Care market.

Published January 25th in WOUNDS Journal online ahead of print, this study demonstrates successful use of Skye's proprietary Amniotic Tissue Allografts in the treatment of lower extremity wounds, with significant clinical results. This 20 patient retrospective 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), 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.

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. 

This study follows the Centers for Medicare & Medicaid Services approval of these membranes for high-cost reimbursement status under Q4163. This status allows for enhanced reimbursement at ambulatory and hospital outpatient facilities, expanding patient access to this next-generation biologic.

“As a company, our mission is to create the most viable biologic solutions so patients have the best opportunity for a good outcome as shown in this study with our proprietary FastActing™ membranes,” said Chris Sharp CEO, Skye Biologics. “ As a leading and proven OEM processor of high quality amniotic and placental tissue biologics we are thrilled to be providing a turn key solution for those companies looking to add an innovative FastActing™ amniotic membrane product line for Advanced Wound care.”

“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, and we are thrilled to see this paper published in one of the most well respected journals in wound care.” 

FastActing WoundEx Amniotic Membranes are part of HRT’s & 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 150,000 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 & http://www.humantissue.com

The full paper can be found here: http://www.woundsresearch.com/article/use-dehydrated-amniotic-membrane-allograft-treatment-lower-extremity-wounds-retrospective

Skye & HRT continue to expand its national and international distribution network and private label opportunities with synergistic medical companies.

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