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November 20, 2015

AMNIOX Highlights Study Showing Eighty Percent Of Patients With Lower-Extremity Ulcers Achieve Healing When Treated With NEOX Wound Allograft

AMNIOX Medical, Inc., a TissueTech, Inc., company, announced the results of A Single-Center, Retrospective Study of Cryopreserved Umbilical Cord for Wound Healing in Patients Suffering From Chronic Wounds of the Foot and Ankle, a review of the effectiveness of NEOX® Wound Allograft in treating this patient population. The findings were presented at Desert Foot, a conference targeted to federal services healthcare professionals and designed to enable participants to improve clinical care for patients with diabetic foot ulcers. The study’s author, Mark Couture, DPM, Medical Director of the Central Texas Prevention of Amputations for Veterans Everywhere (PAVE) program,Temple, Texas, was among many top speakers on faculty at the conference.

Dr. Couture’s study focused on treatment of chronic, lower-extremity ulcers. The retrospective review was conducted on 57 patients presenting with 64 wounds and treated between November 2013 and March 2015. All wounds were debrided in an operating room or clinic before cryopreserved umbilical cord (NEOX® Wound Allograft) was placed directly over the wound.

The data revealed that 51 of the 64 wounds (79.7 percent) achieved complete healing. The average healing time was 5.53 weeks and the average number of applications of NEOX® Wound Allograft was 3.43. The author concluded that cryopreserved umbilical cord is effective in promoting the rapid healing of chronic, lower extremity ulcers, suggesting that it could be a useful advanced tissue treatment.

“The study findings are especially encouraging for this unique umbilical cord allograft as the wounds these patients suffered from can have devastating effects on their daily lives, including pain, restricted mobility and inability to work,” Dr. Couture said. “In addition to allowing patients to return to normal activity, this kind of treatment can reduce a significant burden on the healthcare system, because lower-extremity ulcers have become more common as the American population ages along with increased risk factors such as diabetes, obesity and smoking. These lower extremity ulcerations frequently lead to limb amputation when these wounds cannot be healed.”

“We’re encouraged that more studies are emerging to add to the body of clinical evidence regarding umbilical cord tissue in regenerative healing,” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Compare this 80 percent healing rate with the published rates for other treatment options like bioengineered skin substitutes and dehydrated amniotic membrane and you can see that using cryopreserved umbilical cord is proving itself a top choice in chronic wound healing. Along with demonstrating a higher rate of healing, cryopreserved umbilical cord is healing these wounds more rapidly than these other technologies.”

Amniox parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote regenerative healing. In utero, wound healing occurs rapidly and with minimal scar. This restorative ability is innate to these placental tissues and can be preserved and transplanted to adults. Heavy chain hyaluronic acid/pentraxin-3 is the key protein complex present in these tissues to orchestrate that regenerative healing process. Amniox Medical is the only provider of a human tissue allograft composed of both umbilical cord and amniotic membrane. Amniox utilizes its proprietary CRYOTEK process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues more effectively than other available technologies. Since the company’s inception, clinicians have performed more than 200,000 human transplants of its products and published more than 300 peer-reviewed studies supporting its technology platform.