October 22, 2015
Neox® Wound Allograft Study Reveals Highly Significant Healing Rate
ATLANTA – October 22, 2015 – Amniox Medical, Inc., a TissueTech, Inc., company, announced the results of the study, A Single Center Retrospective Study of Cryopreserved Umbilical Cord to Promote Healing of Complex Foot Ulcers in Patients with Underlying Osteomyelitis, a retrospective review of the effectiveness of Neox® Wound Allograft in treating this patient population. The presentation was highlighted at Superbones West, a conference that provides state-of-the-art evidence-based lower extremity workshops and lectures to support the continuing education of healthcare practitioners. The study’s author, Wayne Caputo, DPM, Chairman of the Department of Podiatric Surgery at Clara Maass Medical Center, Belleville, New Jersey, was one of a number of top national speakers on faculty at the meeting.
The clinical study focused on treating lower extremity ulcers with exposed bone, tendon, muscle, or joint capsule with underlying osteomyelitis. These wounds often present with multiple complex
comorbidities and patients are at risk for major limb amputation. A retrospective review was performed on 31 patients presenting with 33 wounds with a confirmed diagnosis of osteomyelitis and managed by the same surgeon between January 2013 and December 2014. All ulcers underwent sharp surgical debridement and resection as needed followed by treatment with Neox Wound Allograft.
Of 33 wounds identified in the analysis, 26 achieved complete healing, resulting in an overall wound healing rate of 78%. The mean time to wound closure was 16 weeks and the average number of
applications of Neox Wound Allograft was 1.24. Of the remaining seven wounds, six were lost to follow-up and one did not heal. The authors concluded that cryopreserved umbilical cord is effective in promoting wound healing of complex leg ulcers with exposed tendon, muscle, joint capsule and bone with underlying osteomyelitis to avoid or to reduce the extent of limb amputation.
“This study demonstrates the real-world effectiveness of this unique technology to treat a patient condition that frequently results in limb amputation and has a high mortality rate within five years of that amputation,” Dr. Caputo said. “In my practice, I have observed an improved healing rate and reduced rate of amputation in this patient population since this technology has become available. I am even more impressed with the low number of applications required, as fewer product applications may result in reduced cost of care for the patient.”
“This is the first of multiple studies underway to continue to expand the body of clinical evidence available regarding umbilical cord tissue to promote regenerative healing,” said Tom Dugan, Chief
Executive Officer of Amniox Medical. “These results compare very favorably clinically to the less than 50% healing rates demonstrated by bioengineered skin substitutes and dehydrated amniotic membrane in recent publications and economically to the two to three applications those technologies required to heal smaller less complex wounds over a longer period of time.”
Amniox parent TissueTech pioneered the commercialization and clinical application of human umbilical cord and amniotic membrane to promote the regenerative healing that occurs in utero, where wound healing occurs rapidly and with minimal scar. This restorative ability, which can be preserved and transplanted to adults, is due to the presence of the placental tissues and HC/HA-PTX3 is the key protein complex present in that tissue that orchestrates the 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.
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 the safety of its products. For additional information, please visit http://www.biotissue.com.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and BioTissue, Inc., 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) has supported TissueTech’s research with more than 25 continuous years of research grants. Since the company’s inception, clinicians have performed more than 200,000 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.