April 7, 2017
Amniox Highlights Three Studies Demonstrating Effectiveness of Umbilical Cord Tissue for Treating Chronic Wounds
Studies Document Healing Rates of 78% – 87%
ATLANTA, GA – April 7, 2017 — Amniox Medical, Inc., a TissueTech, Inc. company, highlighted the publication of three studies concerning Neox® 1K, its cryopreserved human umbilical cord tissue. In contrast to competitive offerings, these studies document the consistent effectiveness of the Company’s proprietary technology in the treatment of hard-to-heal chronic wounds.
The studies include:
- A Single-center, Retrospective Study of Cryopreserved Umbilical Cord/Amniotic Membrane Tissue for the Treatment of Diabetic Foot Ulcers in The Journal of Wound Care,
- A Single-center, Retrospective Study of Cryopreserved Umbilical Cord for Wound Healing in Patients Suffering From Chronic Wounds of the Foot and Ankle in Wounds,
- A Retrospective Study of Cryopreserved Umbilical Cord as an Adjunctive Therapy to Promote the Healing of Chronic, Complex Foot Ulcers with Underlying Osteomyelitis in Wound Repair and Regeneration,
The first study’s author, Dr. Allen Raphael, Northside Hospital, Atlanta, Georgia, conducted a retrospective review of 29 patients and the effectiveness of Neox 1K Wound Allograft in treating chronic diabetic foot ulcers. Twenty-eight of 32 wounds demonstrated complete healing, to achieve a rate of 87.5 percent.
The second study’s author, Dr. Mark Couture, Medical Director of the Central Texas Prevention of Amputations for Veterans Everywhere (PAVE) program, Temple, Texas, reviewed Neox 1K Wound Allograft in treating 57 patients with chronic, lower-extremity ulcers. Fifty-one of 64 wounds, or 79.7 percent, achieved complete healing.
The final study’s author, Dr. Wayne Caputo, Chairman of the Department of Podiatric Surgery at Clara Maass Medical Center, Belleville, New Jersey, conducted a retrospective review of Neox 1K Wound Allograft in treating lower extremity ulcers with exposed bone, tendon, muscle, or joint capsule with underlying osteomyelitis in 31 patients. Of 33 wounds, 26 achieved complete healing, resulting in a healing rate of 78 percent.
“The clinical evidence surrounding our proprietary cryopreserved umbilical cord tissue in regenerative healing continues to build on the work of leading physicians,” said Tom Dugan, Chief Executive Officer of Amniox Medical. “If one compares the healing rates found in these studies with rates published for multiple alternatively processed amniotic membrane products, including bioengineered skin substitutes and cryopreserved or dehydrated amniotic membrane, these results are all the more striking. This data combined with the ease of use and flexible storage that Neox 1K offers makes it a very compelling option.
In utero, wound healing occurs rapidly and with minimal scar. This restorative ability is innate to placental tissues, including umbilical cord and amniotic membrane. Heavy chain hyaluronic acid/pentraxin-3 is the key protein complex present in these tissues to orchestrate the healing process. Amniox Medical is the first 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 the native tissue and published studies have demonstrated that the CryoTek process more effectively preserves the structural and biological integrity of the tissue when compared to other technologies.
About Amniox Medical, Inc.
Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical is dedicated to developing and marketing regenerative therapies processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. This process has been proven to preserve the innate biological and structural properties of the matrix, which can then be transplanted to adult wound and surgical environments. Amniox Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and BioTissue® pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical develops and markets products for use in the musculoskeletal and wound care markets; BioTissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) have supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 250,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.