Derma Sciences to Present Clinical Data Demonstrating Efficacy in Tissue Regeneration at the Spring Symposium on Advanced Wound Care

PRINCETON, N.J., April 30, 2015 /PRNewswire/ -- Derma Sciences, Inc. (Nasdaq: DSCI), a leading tissue regeneration company at the forefront of research and innovation for the management of acute and chronic wounds and burns, will present 14 posters at the Spring Symposium on Advanced Wound Care (SAWC) in San Antonio, Texas this weekend. Data being presented on four of the company's products will feature tissue regeneration in advanced wound care.

Derma Sciences will also host a breakfast session titled "Giving New Life to Complex Wounds – The Dynamics of AMNIOEXCEL® Amniotic Tissue Supported by the TCC-EZ® Healing Chamber™." Dimitrios Lintzeris, DO, CWS, Medical Director of Wayne Memorial Wound Care Center will present features, clinical benefits and a challenging case series evaluating skin substitute AMNIOEXCEL® Amniotic Allograft Membrane to heal wounds of different etiologies, as well as how its use in conjunction with gold standard off-loading enhances healing for diabetic foot ulcers. The session will be held Saturday, May 2 from 7:30 a.m. – 9 a.m. To reserve seating, visit http://sawcspring.com/industry-supported-symposia/2015. Seating is limited.

Of the 29 million Americans¹ with diabetes, 15 percent will develop chronic foot ulcers. Neuropathic foot ulcerations precede 85 percent of all non-traumatic lower extremity amputations. There is a 68 percent mortality rate five years post lower extremity amputation.² These wounds require advanced modalities to facilitate closure and if not quickly treated, can cost patients their lives and represent an added cost burden on the healthcare system.

"Globally, there are about 50 million reported cases of patients suffering from hard-to-close wounds.³ Our product portfolio has the most comprehensive technologies across advanced wound care, and we look forward to a robust presence at the prestigious Spring SAWC," said Barry Wolfenson, Derma Sciences Group President, Advanced Wound Care. "As a leader in wound care, we will continue to build on the promising results from tissue regeneration products, alone and when used in conjunction with our other advanced wound care products."

A growing body of evidence is proving our tissue regeneration products to be effective options for wound care. The presentations demonstrate an impressive body of evidence that our products worked after patients failed with such treatments as collagens, silver dressings, foams, vacuum assisted closure devices and aggressive surgical debridement. The following posters on AMINOEXCEL® Amniotic Allograft, TCC-EZ® and MEDIHONEY® surgical dressings are being presented at the Spring SAWC:

AMINOEXCEL®

• Use of Dehydrated Amniotic Membrane Allograft and Off-Loading to Heal Diabetic Foot Ulcers (Peters, W): A case study of four patients with diabetes with wounds ranging in chronicity from six weeks to one year who were trending to amputation. They were treated with Dehydrated Amniotic Membrane Allograft (DAMA). Two patients were off-loaded with Roll On Total Contact Systems while two others were off-loaded with wheelchairs. Patients were able to avoid additional surgery; wounds healed in an average of six weeks.
• Using Dehydrated Human Amniotic Membrane to Support Wound Healing of Diabetic Foot Ulcers (Reuter, M): In this case study, DAMA was applied to three patients with chronic diabetic foot ulcers (DFUs). Chronicity in patients ranged from two months to one year and previous standards of care had failed to demonstrate a 50 percent reduction in wound size. Application of DAMA led to a statistically significant decrease in wound volume and area.
• Use of Dehydrated Amniotic Membrane Allograft to Facilitate Limb Salvage and Function in Patients At High Risk for Amputation (Doucette, M): This poster studied five military veteran patients who were given a DAMA application in chronic wounds in an attempt to prevent amputation and increase limb function.  As a result of the treatment, all patients either healed or regained some limb function.
• Dehydrated Human Amniotic Membrane Allograft for Wound Closure and Minimizing Advanced Wound Care Costs (Kamin, I): A case study of two male and one female patient with an average wound chronicity of 18 weeks that received applications of DAMA every other week in an outpatient setting. Wound closure was achieved after three to seven applications of DAMA. The total cost of product was $9,300 for all three patients. In a cost comparison (assuming 14 applications for each product), treating these patients with Dehydrated Human Amnion Chorion Membrane (DHACM) would have cost $17,606.34 (an additional $8,306.34) and Human Fibroblast Derived Dermal Substitute (HFDS) would have cost $19,040.00 ($9,740.00 more than DAMA) ^¥.

¥ Pricing based on Federal Government Supply Schedule 2014.

TCC-EZ® Roll On Total Contact Casting System (a one-piece, roll-on cast designed to off load weight from the bottom of the foot)

• Cost Analysis of Implementing Roll On TCC System Versus Felt and Foam Off-Loading By Nursing Staff for Diabetic Foot Ulcer Treatment In Brazil (Tolentino, A): Researchers created a cost-analysis model of implementing Roll On TCC for patients with diabetic foot ulcers (DFUs). Using data from the International Diabetes Federation for 2014 and studies as to application times, frequency of changes and mean healing times, adopting a Total Contact Casting (TCC) system would save $188,219,626 USD annually over the cost of foam off-loading, considering only the nursing time involved and not product costs.
• Cost Analysis of Implementing Roll On TCC System Versus Felt and Foam Off-Loading By Nursing Staff for Diabetic Foot Ulcer Treatment in Australia (Tolentino, A): Total Contact Casting is recognized as the gold standard for off-loading diabetic foot ulcers (DFUs), but barriers include application time, complexity and costs. Researchers examined data from 495,120 patients with DFUs obtained from the International Diabetes Federation in Australia. Using that data and studies as to application times, frequency of changes and mean healing times, the analysis determined that adopting the new Roll On TCC system would save $46,396,705 USD annually over the cost of foam off-loading, considering only the nursing time involved and not products costs.
• Effects of Off-Loading Chronic Plantar Pedal Ulcerations Using Total Contact Casting (Oliver, M and Rose, E): This case study evaluated three patients with non-healing ulcerations of greater than one year. A Roll On TCC system was applied in all patients and changed weekly with concurrent serial debridement. Two of the three patients achieved complete wound healing in 11 and 15 weeks respectively. The third patient's total wound area decreased more than one half of the initial measurements.
• A Busy Metropolitan Wound Care Center Has Successfully Incorporated A Roll On Total Contact Cast System to Heal Challenging Foot Wounds (Applewhite, A): Baylor Comprehensive Wound Care conducted a case study of 14 patients to demonstrate how a scientifically proven modality like TCC-EZ® can deliver positive outcomes in healing. Wounds chronicity ranged from one to 18 months prior to treatment with Roll On TCC. Patient wounds took an average of six weeks to heal, which is in line with the current literature.
• Successful Implementation and Training of A Roll On Total Contact Cast System (Klinghard, C): Restorix Health wound center developed a total contact casting (TCC) certification and training program. The program included live demonstrations, didactic instructions and exams. The program increased staff competence and confidence in Roll On TCC System application. As a result, TCC moved from being a last resort to a first line treatment, improving patient outcomes and wound healing.

MEDIHONEY®   

• A Case Series Illustrating the Effect of Active Leptospermum Honey on Early Vs. Late Presentation Wounds (Sheikh, E): This retrospective chart determined ALH dressings are viable treatment options for both early and late presenting wounds. Review of ten patients demonstrated the effectiveness of active Leptospermum honey (ALH) to promote timely healing and wound closure. All early presenting wounds, <3 weeks from injury or surgery, closed within two to six weeks. Late presentation wounds, >5 months, and up to 12 years since initial injury, closed within 10-16 weeks.
• Palliative Management of Malodorous Squamous Cell Carcinoma of the Oral Cavity with Manuka Honey (Drain, J): Manuka honey was used in the case study of an 80-year old woman with a wound relating to her squamous cell carcinoma of the oral cavity. The woman presented with complaints of distress related to extreme malodor. After three months of using Manuka honey, it was reported the patient's external wound had decreased in size, with no signs or symptoms of infection noted, and no odor noted.
• Use of Active Leptospermum Honey to Treat Difficult Post Operative Pediatric Pilonidal Cyst Wounds (Amaya, R): Data from five teen patients (aged 14-17) with chronic, reoccurring pilonidal cysts, and histories of surgical excisions were referred for wound management. Due to lack of normal healing, ALH was initiated to reduce necrotic tissue, facilitate granulation and reduce risk of infection. Among the five patients, four wounds closed. One patient did not return for follow-up but showed marked improvement. Wound closure with ALH occurred in 4-11 weeks.
• Cost-Analysis of Active Leptospermum Honey Calcium Alginate Dressing versus Silver Hydrofiber Dressing for Chronic Leg Ulcer Treatment Under the Brazilian Public Payer Perspective (Tolentino, A): A cost analysis model of ALH Calcium Alginate versus silver hydrofiber (Ag) for chronic leg ulcers in adults was conducted using data from Brazilian Hospital Information System from October 2013–September 2014. Estimated costs for inpatient period assumed one dressing change every 3 days for ALH and Ag. Overall treatment costs per patient were $329.12 USD for ALH compared to $623.46 USD for AG, representing a $303.34 US cost saving for ALH per patient/per treatment.
• Cost-Analysis of Active Leptospermum Honey Calcium Alginate Dressing versus Silver Hydrofiber Dressing for Chronic Leg Ulcer Treatment in Australia (Tolentino, A): Based on a 2013-2014 cohort of Australian cases of chronic leg ulcers, a cost-analysis of ALH Calcium Alginate versus silver hydrofiber (Ag) found savings of $210.63 USD per patient/per treatment. Clinical benefits for use of ALH over Ag include: an optimally moist environment conducive to wound healing, optimal conditions for granulation tissue formation, and decreased risk of hypersensitivity to compounds.

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. Both products were launched in 2014, and both are included within the Veterans Administration Federal Supply Schedule. AMNIOEXCEL® is currently the focus of a randomized clinical trial on the management of diabetic foot ulcers. Derma Sciences' 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 a 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, a patented active pharmaceutical ingredient (API) which is currently in Phase 3 clinical trials for the healing of diabetic foot ulcers. DSC127 is also in preclinical testing for scar prevention/reduction and is part of a BARDA grant program for the healing/prevention of tissue damage due to ionizing radiation exposure. The Company also offers a full product line of traditional dressings.

For more information please visit http://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 development and commercialization of DSC127, product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, 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. "Diabetes Latest." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 17 June 2014.

2. Armstrong DG et al. Guest editorial: Are Diabetes Related Wounds And Amputations Worse Than Cancer? Int Wound J. 2007; 4 (4): 286-287.

3. "Overlooked Advanced Wound Care Market Catches Attention of Healthcare Analysts, Investors." Forbes. Forbes Magazine. 3 February 2014.

SOURCE Derma Sciences, Inc.