Tag: EpiFix®

MiMedx Announces Statistically Significant Results

     In New Multicenter Clinical Study Of Healing Of Diabetic Foot Ulcers Using EpiFix®

 

MARIETTA, Ga., Aug. 24, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ : MDXG ), a leading developer and marketer of regenerative and therapeutic biologics, today announced that a new study regarding the use of EpiFix® in the treatment of diabetic foot ulcers (DFUs) has been published in the peer-reviewed journal, International Wound Journal.

 

The paper is entitled “A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane dHACM Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics.” The paper was authored by: William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M Caporusso, DPM; and Patrick S. Agnew, DPM. The electronic publication of the article in International Wound Journal can be found at https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.12976.

 

This multi-center randomized and controlled trial was led by William Tettelbach, MD, principal investigator and former Executive System Medical Director of Wound Care and Hyperbaric Medicine Services for InterMountain Healthcare. Dr. Tettelbach is now Associate Chief Medical Officer for MiMedx, a position that postdated the completion of the study.

 

Clinical Study Design and Results

The objective of the study was to determine the safety and effectiveness of EpiFix as compared to standard of care (SOC) therapy for the treatment of non-healing DFUs. The primary efficacy endpoint was the incidence of complete wound closure over a 12-week period. Data from 110 patients meeting study inclusion and exclusion criteria were analyzed in the Intent-to-Treat (ITT) cohort. A total of 98 patients completed the study Per Protocol (Per-Protocol cohort).

 

ITT analysis requires patients to be included even if they did not fully adhere to the protocol. In comparison, in a Per-Protocol analysis, only patients who completed the entire clinical trial according to the protocol are counted towards the final results.

 

In the current study on an ITT basis, 70% of patients who received weekly EpiFix had complete healing by 12 weeks versus 50% of patients only receiving weekly SOC (EpiFix 70% vs. SOC 50%, p=0.0338) … read more

MiMedx to Highlight Efficacy of Its Allografts

in Presentations at SAWC Spring Conference
Breakfast Symposium to Underscore Statistically Significant Evidence of EpiFix® in Healing DFUs and VLUs

 

MARIETTA, Ga., April 23, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced the Company’s participation in the 2018 Symposium on Advanced Wound Care Spring | Wound Healing Society (SAWC Spring/WHS) meeting being held April 25-29, 2018 in Charlotte, North Carolina.

During the five-day conference, the clinical and cost-effective healing results of the Company’s allografts will be highlighted in a Breakfast Symposium, two dinner presentations, five clinical poster presentations, and in-booth education sessions. MiMedx will be exhibiting in booth #830 from April 26, 2018 through April 28, 2018.

 

Now in its 31st year, the SAWC Spring/WHS conference is the leading national wound healing forum connecting the foremost experts with your entire wound care team to improve patient outcomes through education.  No other wound care conference offers the level of education, advanced state-of-the-art clinical reviews and emerging research findings.

 

MiMedx will sponsor a Breakfast Symposium entitled “EpiFix® – First and Only Amnion/Chorion Allograft with Statistically Significant Level I Evidence for healing in DFUs and VLUs” on Friday morning, April 27, 2018 from 7:30 am to 9:00 am. The Company will also host two dinner presentations on Thursday, April 26th and Friday, April 27th entitled “Using MiMedx Placental Tissues in the Lower Extremity“, which will review the use of various products in wound and surgical applications.

 

Hands-on product demonstrations will be provided by expert physicians during booth hours on April 26th and April 27thin the MiMedx booth.

 

The poster presentations will report on the clinical effectiveness of MiMedx EpiFix dHACM (dehydrated Human Amnion/Chorion Membrane) placental tissue allografts in the healing of diabetic foot ulcers, venous leg ulcers, pressure ulcers and refractory non-healing wounds, as well as the use of AmnioCord umbilical cord allografts for reducing Achilles tendon pain. These independent case studies and respective conclusions will include:

 

  • Abstract: “EpiFix VLU Study Group: A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane Allograft for the Treatment of Venous Leg Ulcers”
    Authors: Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Dosluoglu, MD, FACS; Gregory Tovmassian, DPM
  • Abstract: “EpiFix DFU Study Group: A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane (dHACM) Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study”
    Authors: William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M. Caporusso, DPM; Patrick S. Agnew, DPM
  • Abstract: “The Application of Dehydrated Human Amnion Chorion Membrane dHACM Allografts to Expedite Healing in Patients with Six Major Types of Refractory Non-Healing Wounds, 157 Patients”
    Authors: Aamir Mahmood, DPM; Justin Goldsmith, DPM; Anna Tien, DPM; Mike Czurylo, DPM; Laith Shaman, DPM; Kelda Beachy, DPM; Neal Patel, DPM; Shayan Alamgir, DPM; Matthew Garoufalis, DPM, FASPS, FACFAOM
  • Abstract: “Use of Umbilical Cord Allograft for Pain Reduction in Achilles Tendon Pathologies: A Case”
    Authors: Brandon Brooks, DPM; Kevin Pham, DPM; Bradley Brooks, DO; Brady Brooks, MS-1; James Henry, MS-1; Terria Madison, DPM
  • Abstract: “Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane in the Treatment of Pressure Ulcers: a Case Series”
    Authors: Chi Chi Berhane, MD, MBA; Kimberly Brantley, BSN, RN, CRRN; Sandra Williams, NP-C, APN, WCN; Erica Sutton, MA; Carlyn Kappy, RD, LD, CCRP

 

“For more than 30 years, SAWC and WHS have been dedicated to continuous advancements in wound care and have worked tirelessly toward their goal of decreasing the number and severity of wounds of all types.” said Parker H. “Pete” Petit, MiMedx Chairman and CEO. “We are honored to be a part of this year’s meeting, and MiMedx will continue to work with SAWC and other organizations to raise the level of scientific and clinical expertise and the professional processes within the wound care sector of healthcare.”

 

Bill Taylor, President and COO of MiMedx, added, “We are pleased that our EpiFix, AmnioCord and AmnioFill allografts will be so prominently demonstrated at this year’s SAWC. We look forward to participating in the conference and highlighting the significant investments made in the science and clinical study of placental technology.”

 

About MiMedx

 

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to give physicians products and tissues to help the body heal itself.  The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Press release from PR Newswire