AMNIOX Study Confirms Benefits of CLARIX FLO for Plantar Fasciitis


AMNIOX Medical, Inc., a TissueTech, Inc. company, announced today the results of a study demonstrating the application of its unique cryopreserved human umbilical cord tissue for the treatment of patients with plantar fasciitis. The findings were recently presented at the American College of Foot and Ankle Surgeons in Las Vegas.

In this study, forty-three patients received injections of CLARIX FLO human amniotic membrane and umbilical cord matrix, and were followed for 18 weeks. The authors concluded that injections of CLARIX FLO significantly decreased pain from baseline and improved overall functional recovery. Increasing dose resulted in better therapy outcomes.

The study, Particulate Umbilical Cord/Amniotic Membrane for the Treatment of Plantar Fasciitis, was authored by Dr. Ryan Scott of The CORE Institute in Phoenix, and Dr. David Garras of Midwest Orthopaedic Consultants and an Assistant Professor at University of Illinois at Chicago. Plantar fasciitis is the most common cause of debilitating heal pain. It affects up to 1 million patients annually in the United States and as many as 30 percent of those patients fail conservative therapy. The condition is characterized by an accumulation of small tears in the plantar fascia, causing the structure to weaken and become irritated, often to the point of interfering in daily activities. Previously available therapies have demonstrated inconsistent outcomes or have negative side effects.

“These study results continue to demonstrate the compelling therapeutic benefits of a human tissue matrix composed of both umbilical cord and amniotic membrane,” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Furthermore, Amniox Medical is the only provider of an injectable form of umbilical cord, allowing for the non-invasive delivery of the biological components of umbilical cord, which have proven regenerative properties.”

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.

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. For additional information, please visit http://www.amnioxmedical.com

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue®, 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; Bio-Tissue 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170330005905/en/

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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  1. Have there been any reported cases of contaminated umbilical cord/amniotic membrane — by contaminated I am not referring to the handling, preserving or packaging, but from the donors in forms of viruses or disease? I understand there have not been any such cases reported in the United States — but what about outside of the U.S.? A representative today came into our office, and I wanted to ask this question — but also, I did not wish to interrupt the discussion between the rep and one of our doctors. Additionally, I would like to know what studies have been done, if any, showing the injectable form of this product’s benefits for inflammation in shoulders — frozen shoulder, torn rotator cuff, etc. or in hips and knees.

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