Derma Sciences Presented Clinical Evidence And Data On Its Tissue Regeneration Products for Diabetic Foot Ulcers At Fall 2014 Symposium On Advanced Wound Care

PRINCETON, N.J., Oct. 23, 2014 /PRNewswire/ -- Derma Sciences, Inc., (Nasdaq:DSCI) a leading tissue regeneration company committed to the chain of discovery, manufacturing and distribution of novel advanced wound care products, presented clinical evidence and data on its tissue regeneration products for diabetic foot ulcers (DFUs) at the Fall 2014 Symposium on Advanced Wound Care (SAWC) in Las Vegas, Nev. The company's TCC-EZ® and AMNIOEXCEL® product lines were the subject of seven posters featured at the conference.

DFUs are a costly and potentially life-threatening complication of diabetes. Nearly 25%¹ of all people with diabetes will develop DFUs in their lifetime, and 1 in 15² of them will require amputation. Early and effective management of the wound is the safest route to preventing complications.

"Our portfolio has the most comprehensive line of evidence-based technologies across the continuum of care, providing clinicians with valuable integrated solutions to help remove barriers to healing, leading to better wound management and tissue repair," said Barry Wolfenson, Group President, Advanced Wound Care and Pharmaceutical Development. "The posters featured last week at SAWC further validate the growing clinical body of evidence in support of our products.  Notably, the clinical results achieved after real-world application on the worst of the worst wounds speaks volumes on the efficacy of our products."

The following posters with clinical evidence and data on TCC-EZ® and AMNIOEXCEL® were presented:

TCC-EZ®

• Introduction of an "Off the Shelf" Total Contact Casting (TCC) System in a Large Outpatient Diabetic Foot Ulcer Clinic (Puerta, J; Garcia Ramos, J; Moreno, H) The largest DFU clinic in Panama conducted a study of nine patients, ages 51-67 years, to evaluate the effectiveness of the Roll on Total Contact Cast (TCC) System for the treatment of DFUs. All nine patients achieved approximately 50% reduction in the surface area of the wound at 4 weeks. Results also showed that six patients achieved complete wound closure after an average of eight weeks of treatment with the Roll on TCC System.
  
• Total Contact Cast ‐ The Gold Standard for Off‐Loading and Healing Diabetic Foot Ulcers (Lien, M; Oliver, N; Moore, N; Greenstein, E; Lee, S; Fisher, N) This case study evaluated three patients with chronic foot ulcers varying in longevity. All of the patients' wounds were debrided and dressed according to advanced wound care evidence based practice, and each patient was placed in the TCC system to off-load pressure to the chronic foot ulcers. All three patients achieved complete wound closure. The average rate of healing with use of the TCC system was 45 days, ranging from as few as 35 days to as many as 62 days.
  
• Successful Implementation and Training of a Total Contact Cast System (Klinghard, C) Restorix Health's wound center engaged in a hands-on TCC certification training program including live demonstrations, didactic instructions and exams. All staff was required to both apply and remove the Roll on TCC System to a fellow staff member as per product guidelines for use. After completing the program, the staff was immediately able to demonstrate the clinical success of this educational program by comparing two cases, one that did not use TCC initially or early on in treatment and one that used the Roll on TCC System. The TCC certification training was key to increasing the staff's competence and confidence, allowing TCC to be a first line treatment rather than the last resort.
  
• A Busy Metropolitan Wound Care Setting has Successfully Incorporated the Gold Standard‐Total Contact Casting to Heal Challenging Foot Wounds (Applewhite, AJ) This case study included 14 patients with DFUs who were treated with the Roll on TCC System. Prior to participating in the study and being treated with the Roll on TCC System, the patients had wounds on their feet for 4 weeks to 1.5 years. The case study showed that all 14 patients achieved complete wound closure after treatment with the Roll on TCC System and that several wounds healed in 4-6 weeks.  

AMNIOEXCEL®

• Dehydrated Amniotic Membrane Allograft Therapy for Complicated Non‐Healing Wounds: a Promising Therapy Where Other Treatments Have Failed (Beless, DJ; Marcus, B) This case study demonstrated the effectiveness of Dehydrated Amniotic Membrane Allograft (DAMA) to heal chronic non-healing wounds that failed other advanced therapies. Two of the patients' wounds were present for more than two years and were treated with the standard of care for advanced therapies, including negative pressure wound therapy (NPWT), multiple skin equivalents and referrals to vascular specialists. Patients' wounds were deemed unable to heal due to co-morbidities. All three cases responded positively to DAMA. Patients were able to avoid additional surgery, and their wounds healed in an average of 12 weeks.
  
• Case Series Demonstrating the Impact of Dehydrated Human Amniotic Membrane Allograft on Would Healing in Acute and Chronic Wounds (Lintzeris, D; Yarrow, K; Johnson, L; White, A; Hampton, A; Strickland, A; Albert K; Cook, A) This case study illustrated the use of DAMA in a variety of wounds – It includes 2 acute wounds and 4 chronic wounds in patients with diabetes and/or vascular disease. The acute wounds were present for an average of 1.5 weeks (1-2 weeks) and the chronic wounds were present for an average of 17.8 weeks (9-35 weeks), before application of DAMA. In both acute and chronic cases, all wounds showed marked improvement, including a decrease in wound size, within two weeks following the first application of DAMA. At 6 weeks following the first application, a mean decrease of 91.3% and 86.28% was demonstrated for wound volume and area respectively. In the acute wounds, the wounds closed in an average of 1.5 weeks (1-2 applications) and in the chronic wounds after a mean of 7.5 weeks (3-4 applications). All wounds were closed by 8 weeks.
  
• Case Series Demonstrating the Healing Capabilities in Diabetic Foot Ulcers Using Dehydrated Human Amniotic Membrane (Rosenblum, BI) This case study included eight patients who had non-healing foot ulcerations where amputation was being considered as the next treatment option. Having failed healing with a variety of treatments, including bi-layer skin grafts, silver dressings, NPWT, aggressive debridement and TCC, the patients were chosen to have DAMA applied to their wounds. The patients' wounds healed in an average of 8.2 weeks after an average of 2.75 DAMA applications. The largest wound healed in only 28 days after being present for three years.

"As an organization we are committed to building the body of evidence for treatments that advance the healing of diabetic foot ulcers. As part of this commitment, we continue to advance our pharmaceutical wound care product DSC127, which is currently in Phase 3 trials for the healing of DFUs," said Edward J. Quilty, Derma Sciences Chairman and Chief Executive Officer.  "Our goal is to be leader in the DFU space."

About Derma Sciences, Inc.
Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It offers a line of products with patented technologies to help better manage chronic and hard-to-heal wounds, many of which result from diabetes and poor vascular functioning. The company recently entered the $500 million market for skin substitute products with its licensing of AMNIOEXCEL® and AMNIOMATRIX® in the first quarter of 2014. AMNIOEXCEL® was launched to customers in March 2014 and AMNIOMATRIX® was launched in the second quarter. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. TCC-EZ® is its gold-standard total contact casting system for diabetic foot ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants. Its pharmaceutical wound care products include DSC127, which is currently in Phase 3 clinical trials for the healing of diabetic foot ulcers. The drug candidate is also part of a BARDA grant program for the healing/prevention of tissue damage due to ionizing radiation exposure. The patented API peptide used in DSC127 is also in preclinical testing for scar prevention/reduction. The company also offers a full product line of traditional dressings.

For more information please visit www.dermasciences.com.

Forward-Looking Statements
Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release or that are otherwise made by or on behalf of the company. Factors that may affect the company's results include, but are not limited to, product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the company's actual results and forward-looking statements include but are not limited to, those discussed in the company's filings with the U.S. Securities and Exchange Commission.

References

1. Boulton, AJ. "Comprehensive Foot Examination and Risk Assessment: A Report of the Task Force of the Foot Care Interest Group of the American Diabetes Association, with Endorsement by the American Association of Clinical Endocrinologists." Diabetes Care 31.8(2008): 1679.

2. Brem, H.; Tomic-Canic, M. "Cellular and molecular basis of wound healing in diabetes." Journal of Clinical Investigation 117.5 (2007): 1219–1222.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/derma-sciences-presented-clinical-evidence-and-data-on-its-tissue-regeneration-products-for-diabetic-foot-ulcers-at-fall-2014-symposium-on-advanced-wound-care-749178549.html

SOURCE Derma Sciences, Inc.

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