Industry News

By Industry News

Miami, FL – June 30, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today the initiation of the first of two planned multi center randomized controlled Phase 3 Clinical Trials that will be conducted at 20 investigational sites across the U.S. with an enrollment of 220 patients in each trial. These trials, titled AMBULATE DFU and AMBULATE DFU II, will study the benefits and risks of using TTAX01 to achieve complete wound closure of complex non-healing DFUs with high-risk factors of ulcer depth indicating exposed bone, tendon, muscle, and/or joint capsule, and clinical suspicion of osteomyelitis.

By Marcia Nusgart, RPh; Lee C. Rogers, DPM; Mark D. Iafrati, MD, FACS; Paul J. Kim, DPM, MS, FACFAS; Karen Ravitz, JD; Stephanie Woelfel, PT, DPT, CWS, FACCWS; and Emily Greenstein, APRN,CNP, CWON

On May 7, 2020, the Alliance of Wound Care Stakeholders presented a round table discussion with frontline experts to discuss the challenges and opportunities clinicians are facing during the COVID-19 pandemic. The discussion reviewed the significant changes wound care professionals are undergoing, a review of relevant regulatory flexibilities, and the Alliance's role in ensuring that wound care is identified as "essential" care, rather than "elective." A question and answer session followed the panels' discussion; the following represents some of the most frequently asked questions.

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Edison, N.J. – June 25, 2020 – MTF Biologics, a global nonprofit organization providing tissue and organ donation, transplantation, and research, today announced that new positive coverage decisions by Aetna, Centene Corporation, WellCare and Tufts Health Plan will provide greater access to its human placental and dermal allografts, AmnioBand® and AlloPatch®, for the treatment of diabetic foot ulcers (DFUs).

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Toronto, Canada– June 15, 2020 – MolecuLight Inc., a provider of point-of-care fluorescence imaging for real-time detection of bacteria in wounds, announces the availability of its MolecuLight i:X® platform to 9,000 healthcare facilities in the US through its new commercial arrangement with MAGNET GROUP GPO.

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Toronto, CANADA – June 11, 2020 – MolecuLight Inc., the creator of a point-of-care fluorescence imaging device for real-time detection of bacteria in wounds, announces that the Centers for Medicare & Medicaid Services (CMS) has assigned an Ambulatory Payment Classification (APC) code 5722 for the MolecuLight i:X imaging procedure for point-of-care real-time fluorescence wound imaging for bacterial presence, location and load (CPT® code 0598T (Category III)). The new APC code is effective July 1, 2020 and enables facility reimbursement under the Medicare Hospital Outpatient Prospective Payment System (OPPS), with a 2020 hospital outpatient payment rate of approximately $253.10 USD. This is in addition to the two category III CPT codes (0598T and 0599T), which also become active on July 1, 2020, that enable physicians to request payment from payers for their work providing the MolecuLight i:X imaging procedure.

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The Wound Healing Fondation shares news on the Thomas K Hunt lecture, their COVID-19 patient tips, and new Board of Directors members.

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June 2, 2020 – Smith+Nephew, the global medical technology business, announced the publication of a health economic study in Wound Management and Prevention, which states that the use of PICO◊ Single Use Negative Pressure Wound Therapy System (sNPWT) is estimated to be highly cost effective when compared with traditional NPWT (tNPWT), and may therefore provide opportunity to reduce the economic burden of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs).

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Miami, FL – June 1, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company, announced today the results from the one-year follow-up study to their Phase 2 open label, multicenter pilot study of Cryopreserved Umbilical Cord allograft TTAX01. The objectives of the study were to examine the safety and efficacy of TTAX01, plus standard of care, in achieving complete wound closure of complex non-healing Diabetic Foot Ulcers (DFUs) with evidence of exposed bone, tendon, muscle and/or joint capsule and clinical suspicion of osteomyelitis. Results of this one-year study are published in the peer-reviewed journal Wound Repair and Regeneration.

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Miami, FL – February 24, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today the results from a single-center, retrospective case-controlled series authored by Christopher M. Stewart, MD. The study, titled “The Use of Cryopreserved Umbilical Cord in Open Reduction and Internal Fixation of Calcaneus Fractures,” was published in the SunKrist Journal of Trauma, Emergency Medicine and Acute Care. Analysis found that the overall complication rate in a controlled group of 20 consecutive patients was 35 percent, compared to a complication rate of 10 percent in the cUC group of patients when CLARIX was used as an adjunct to help decrease wound complications, re-operations, and infection rates.

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March 30, 2020 – As the COVID-19 pandemic continues to evolve, focusing on mitigating the disease and maintaining a stock of personal protective equipment (PPE) has changed standard procedures. Many institutions have reportedly closed wound clinics preventing wound patients from obtaining much needed services, procedures and surgeries. Chronic wound patients often present with other comorbidities such as older age, diabetes, hypertension, lung disease, peripheral arterial disease, venous insufficiency and obesity, any of which increases their susceptibility to COVID-19. The unintended consequence of losing access to wound care can increase the risk of the wound deteriorating which could require hospitalization and possible amputation. Wound care is essential to the health of wound patients. For this reason, the Alliance for Wound Care Stakeholders drafted a letter that wound care clinicians may use to justify ongoing care.