Industry News

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August 13, 2020 – The Center for Medicare and Medicaid Services this week released for comment its proposed CY 2021 updates to the Hospital Outpatient Prospective Payment System and Physician Fee Schedule. Below are several provisions the Alliance has identified as particularly impacting wound care clinicians, which the Alliance will be tracking and preparing comment on.

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The Wound Healing Foundation held their Awards Ceremony at the SAWC-WHS Virtual Meeting in July of 2020.

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Miami, FL – August 17, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company involved in the research of the clinical application of human birth tissue-based products, announced today that Yun Guan, MD, PhD, professor of anesthesiology and critical care medicine, and professor of neurological surgery at the Johns Hopkins University School of Medicine, has been awarded a 5-year R01 grant from the National Institutes of Health (NIH) for a study titled “Birth Tissue Products for Non-opioid Treatment of Post-surgical Pain.” Dr. Guan and his team will study the efficacy and molecular mechanism, thereby human birth tissue promotes wound healing and suppresses pain after surgical procedures. TissueTech will serve as a sub-contractor on the project.

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Early in the pandemic, the Alliance’s rapid response team developed a position statement calling for the protection of wound care as an essential service. That March statement was just the first step of their advocacy. Since that time, they’ve issued to HHS and CMS a series of letters and emails and participated in many calls to protect wound care. In their April letter to HHS/CMS, they detailed specific policies that, with regulatory relief, could remove barriers to treat wound care patients efficiently and effectively during the pandemic. While many of the Alliance’s recommendations were incorporated, many key ones were not – and they’ve been requesting and refining them in May recommendations and July requests to CMS's interim final rules to ensure that the Agency updates provisions impacting wound care based on Alliance members’ front-line experience.

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July 20, 2020 – Bethesda, MD – The Alliance of Wound Care Stakeholders called on the Centers for Medicare and Medicaid (CMS) to expand and increase reimbursement for wound-care related telehealth visits; provide flexibility in documentation requirements for continued need and refill of surgical dressings and other supplies; and permit medically necessary procedures to take place on the same date of service so that quality care to be provided to patients while minimizing their risk of COVID-19 exposure.

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San Antonio – July 2020 – EO2 Concepts® announced the release of an enhanced version of their full wound closure, at-home therapy system. The upgrade of the system consists of new and improved features for both the medical device, called the OxyGeni®, and the OxySpur® wound dressings.

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Toronto, CANADA – July 16, 2020 – MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of bacteria in wounds, announced the launch of its new i:X® Telemedicine Solution. The i:X Telemedicine Solution provides a synchronous link between the patient's bedside and the remote wound care clinician. With this secure solution, MolecuLight i:X imaging can be performed at any care location for accurate detection of wounds containing bacteria (> 104 CFU/g) and reviewed remotely and in real-time, enabling remote clinicians to obtain objective information on the status of bacterial burden in the wound and provide guidance on patient care.

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Toronto, CANADA – July 9, 2020 – MolecuLight Inc., creator of a device for point-of-care fluorescence imaging for real-time detection of bacteria in wounds, announces the launch of its new i:X Sterile Surgical Sleeve Convenience Kit for imaging bacteria in wounds using the MolecuLight i:X in a surgical and/or isolation setting. The convenience kit includes a unique disposable surgical sleeve that is fitted to neatly shroud the i:X device via an adapter to align the optics of the i:X to the sleeve. It is made of novel, optically-clear material so it doesn't interfere or degrade the fluorescence signal or image quality of the device. The surgical sleeve is now available to all customer sites in the US and Canada that want to perform bacterial imaging in these clinical settings and enables wound care practitioners to safely use the MolecuLight i:X to image wounds (both standard and fluorescence imaging) in a sterile field by providing a sterile barrier between the i:X device and the patient.

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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.