July 29, 2014
AMNIOX® Medical Announces Initiation of Prospective, Randomized, Controlled Clinical Study of Chronic Wounds
ATLANTA – July 29, 2014 – Amniox Medical, Inc., a developer and marketer of restorative therapies processed from amniotic membrane and umbilical cord, announces the initiation of a randomized, controlled clinical trial of its proprietary product in patients with chronic wounds. The multi-center, randomized, parallel, crossover design study of non-healing diabetic foot ulcers compares Cryopreserved, Umbilical Cord Allograft (NEOX® CORD 1K) versus standard of care. The study is designed to demonstrate the Company’s technology is a clinically effective and cost-efficient option for patients.
Amniox is the only provider of a human tissue matrix composed of both amniotic membrane and umbilical cord. These placental tissues have innate regenerative properties that can be preserved and transplanted to other environments. The Company’s amniotic membrane/umbilical cord matrix comprises key proteins, cytokines and growth factors that have been shown to modulate inflammation and promote regeneration of normal tissue. Amniox utilizes its patented CryoTek™ process, a cryopreservation technology, to preserve the natural biological and structural integrity of these tissues.
“The regenerative healing capabilities of placental tissues are well documented in peer reviewed studies,” said David Armstrong, DPM, MD, PhD, Director of Southern Arizona Limb Salvage Alliance and Co-Developer of the protocol for the CONDUCT 1 study. “Furthermore, the anti-inflammatory properties and decreased scar tissue formation offered by this technology in ophthalmic procedures are also well documented. We look forward to see whether or not we can observe similar outcomes in the treatment of chronic wounds. This could offer us a much needed tool in our efforts to heal wounds and prevent amputations in people with diabetes.”
Patients are being recruited nation-wide in Georgia, California and Arizona. It is anticipated that 30 patients with non-healing diabetic foot ulcers will be enrolled.
“We are very pleased to initiate this important study,” said Aaron Smith, General Manager of Amniox Medical. “Since our inception, this technology has been rapidly adopted in the wound care market and clinicians have been very pleased with the outcomes obtained, particularly in patients that have failed other wound healing modalities. This study was designed to validate in a controlled setting what physicians are currently observing in practice.”
Amniox Medical, Inc.
Founded in 2011 to serve the orthopedic and wound care markets, AMNIOX Medical is dedicated to developing and marketing restorative therapies processed from amniotic membrane and umbilical cord matrix 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 the safety of its products. For additional information, please visit http://www.biotissue.com.
TissueTech, Inc. is a leader in regenerative amniotic tissue-based products for use in the ophthalmology, optometry, musculoskeletal and wound care markets. The National Institutes of Health (NIH) has supported TissueTech’s research with more than 25 continuous years of research grants. Since inception, more than 130,000 human implants have been conducted using the Company’s patented CryoTek™ process and 300 peer-reviewed scientific publications have been produced supporting the technology platform. The Company has pioneered the clinical application of human amniotic membrane and its role in stem cell research. 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.
For Amniox Medical, Inc.
Amy Phillips, 412-327-9499