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SYS-CON MEDIA Authors: Jnan Dash, Kevin Jackson, Peter Silva, Greg Wind, Glenn Rossman

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MiMedx at SAWC Spring 2014: Multiple Studies And Clinical Experience Demonstrate Clinical And Cost Effectiveness Of EpiFix Allograft For Treatment Of Hard-to-Heal Wounds

EpiFix® is shown to promote rapid healing and return to function for patients and provide a potential for significant cost savings.

MARIETTA, Ga., April 23, 2014 /PRNewswire/ -- EpiFix®, dehydrated human amnion/chorion membrane (dHACM) allografts, were shown to be clinically and cost effective in the treatment of multiple hard-to-treat wounds like diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and pressure ulcers (PUs), according to data and case experiences being presented at the Spring Symposium on Advanced Wound Care, the leading national wound healing conference now in its 27th year.  The symposium begins today, April 23, 2014, and concludes on April 27, 2014.

"We are pleased that two abstracts highlighting EpiFix® allografts were selected for oral presentation and one of them, authored by Charles M. Zelen, DPM, FACFAS, FACFAOM, FAPWCA; Thomas E. Serena MD, FACS and Robert J. Snyder, DPM, MSc, CWS, was selected as 3rd place for Best Oral Abstract," said Parker H. "Pete" Petit, CEO of MiMedx Group, Inc.  (NASDAQ: MDXG).

"Clinically, EpiFix® is associated with more rapid healing and prevention of longer term complications including infection and amputation," said Dr. Stephen Bergquist, Medical Director for Jackson-Madison County Hospital.  "From the cost-of-care perspective, EpiFix requires the use of fewer grafts leading to overall cost savings," he continued.

Abstracts presenting EpiFix® studies and cases are:

  • A Prospective, Randomized, Comparative Study of Weekly vs. Bi-weekly Application of Dehydrated Human Amnion/Chorion Membrane Allograft in the Management of Diabetic Foot Ulcers (Abstract #CR_055, Zelen, Serena, Snyder) demonstrated in a 12-week study period of 40 patients with a mean time to complete healing of 2.4 weeks for weekly application of EpiFix® vs. 4.1 wks for biweekly application of EpiFix®.  This shows using EpiFix® weekly heals DFUs almost twice as fast as biweekly applications of EpiFix®. Overall complete heal rate with EpiFix® in both arms was 92.5% (37/40) at 12 weeks.

 

  • A Multi-center Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Dehydrated Human Amniotic Membrane and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers (Abstract #CS_139,Serena,  Fetterolf , Harris, Doner, Patel, Connell, DeMarco, LE, McConnell , Lullove, Taffe.) 90 patients were enrolled to date in this ongoing trial. At time of interim analysis 68 patients had completed the study: 44 ulcers were randomized to receive dHACM (1 or 2 applications) and 24 received SOC alone. Outcomes were similar within the dHACM group.  At 4 weeks, 63.6% of wounds in the dHACM  group, and 25.0% of the standard of care group demonstrated greater than 40% wound closure at 4 weeks (p=0.0023). After 4 weeks ulcers treated with dHACM had reduced by 48.9% vs 12.0% for those treated with SOC only, p=0.003.

 

  • Treatment of Stage III and Stage IV Pressure Ulcers with Dehydrated Human Amnion/Chorion Membrane (Abstract #CS_014, Bergquist) evaluated the clinical and cost effectiveness of dHACM allografts as a treatment for Stage III and IV pressure ulcers (PUs).   In Stage III cases and Stage IV cases,  PUs of varying sizes were completely healed within weeks (from 1 week for  Stage III PUs with wound size of 8.6cm2 and 2.53 cm2, to 8 weeks for a Stage IV PU with an initial wound size of 9.2 cm2 ). Cost effectiveness of dHACM for treatment of PUs was influenced by increased healing rates, velocity of healing and subsequent reduction in risk for complications.  Wound size-appropriate grafts further reduce waste and cost per treatment. 

 

  • Human Amniotic Membrane Allograft to Treat Diabetic Foot Ulcers with Exposed Bone and Tendon   (Abstract# CS_117 Pougatsch, Shum, Belczyk, Rogers) 5 consecutive diabetic neuropathic patients exhibiting wounds with exposed bone and tendon were treated with EpiFix® with the intent to gain as much coverage over the exposed deep structures in as little time as possible in preparation for split-thickness skin grafting. All 5 patients had sufficiently developed granulation tissue overlying bone and tendon structures and were ready for split-thickness skin grafting in an average of 15 days (range 9-22). 4 patients healed the split-thickness skin grafts.

 

"These data support our previously published studies relating to the significant role for EpiFix® in advanced wound care," said Bill Taylor, President and COO of MiMedx. MiMedx is the leading developer and manufacturer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane.

MiMedx is exhibiting at the conference (booth 1506), and will host In-Booth Education with speakers Steve Bergquist, MD presenting on 'Complex wounds and pressure ulcer treatment with EpiFix', and Donna Becker, MSN, ACNP-BC who will discuss 'Clinical experiences with dHACM.'  Drs. Robert Snyder, Chuck Zelen, Matthew Garoufalis and Thomas Serena will be presenting about Wound Regeneration at a Company-sponsored symposium.

About EpiFix®

EpiFix® is a human amniotic allograft tissue offering uniquely processed through the Company's proprietary PURION® Process. EpiFix® dehydrated human amnion/chorion membrane (dHACM) can reduce inflammation and reduce scar tissue formation for enhanced healing. With a variety of sizes available, EpiFix® minimizes graft waste.  The Company's PURION® Process combines cleaning, dehydration and sterilization, making EpiFix® a safe, sterilized tissue that may be stored at ambient conditions for up to 5 years.

About MiMedx

MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 225,000 allografts to date for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

SOURCE MiMedx Group, Inc.

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