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Associated Press
04-04-2025
- Business
- Associated Press
Royal Biologics Withdraws From the Alliance of Wound Care Stakeholders Over Support for Restrictive LCD Policies
Royal Biologics Takes a Stand Against Policies That Limit Patient Access, Suppress Innovation, and Drive Up Healthcare Costs HACKENSACK, NEW JERSEY / ACCESS Newswire / April 4, 2025 / Royal Biologics, a leader in regenerative biologic technologies and wound care solutions, today announced its formal decision to part ways with the Alliance of Wound Care Stakeholders. This move comes in response to the Alliance's continued support of newly adopted Local Coverage Determinations (LCDs) that Royal Biologics believes threaten fair competition, increase costs, and limit patient access to critical treatment options. The updated LCDs pertaining to Skin Substitute Grafts and Cellular and Tissue-Based Products (CTPs) drastically reduce the number of reimbursable products available, cutting over 200 therapies from coverage consideration. Royal Biologics views this as a significant setback for innovation and a direct blow to providers seeking effective, affordable wound care options for their patients. 'At Royal Biologics, we believe patients deserve access to the full spectrum of clinically effective wound care solutions, not just a narrow, high-cost selection that benefits a few legacy manufacturers,' said Royal Biologics CEO, Salvatore Leo. 'These policies threaten small businesses, limit innovation, and put vulnerable patients at risk-all while driving up costs across the system. That's a direction we cannot and will not support. We also believe the National Alliance of Wound Care Stakeholders did not work in the best interest of all its members, pushing unlawful policy forward without discussing with its full list of members.' The LCD changes not only consolidate market power among a select few companies but also place a disproportionate burden on Medicare and American taxpayers. Royal Biologics contends that such policies create a breeding ground for inefficiency, waste, and abuse; consequences that run counter to the goals of value-based healthcare. As a result, the company can no longer remain affiliated with an organization whose policy positions diverge so sharply from its mission of expanding access to biological innovation and advancing high-quality wound care for patients. 'It's time for CMS to take a step back and reconsider these flawed policies,' Leo continued. 'We urge CMS to engage with Congress on implementing thoughtful CTP pricing reform, reform that rewards value, curbs abuse, encourages real innovation, and most importantly, safeguards patient access.' Royal Biologics remains committed to its mission of delivering cutting-edge, accessible regenerative technologies while advocating for a marketplace that supports innovation, transparency, and choice for providers and patients alike. About Royal Biologics: Royal Biologics is a pioneering leader in orthobiologic and wound care research and development. Royal Biologics is committed to advancing the field of wound care with innovative solutions that enhance healing and improve patient outcomes. Dedicated to a patient-first approach, Royal has developed a broad range of products designed to address diverse wound care needs and improve quality of life. Media Contact
Yahoo
25-02-2025
- Business
- Yahoo
CORRECTION FROM SOURCE: Royal Biologics Announces Strategic Partnership With Coldplasmatech GmbH
This Press Release updates an error in the sub headline Strategic Partnership: Royal Biologics and Coldplasmatech Revolutionize Complex Wound Care HACKENSACK, NEW JERSEY / / February 25, 2025 / Royal Wound-X, a division of Royal Biologics committed to pioneering advanced wound care solutions, and Coldplasmatech GmbH, an innovator in medical cold plasma technology, today announce their strategic partnership aimed at transforming the treatment landscape for complex and chronic wounds worldwide. Chronic and acute wounds, including those complicated by multi-resistant infections, affect nearly one billion people globally and represent an annual healthcare cost of approximately $50 billion in the United States alone. Addressing this urgent medical challenge, Coldplasmatech's innovative Cold Atmospheric Plasma (CAP) technology, consisting of the CPT®cube (an automated control device) and CPT®patch (a specialized wound applicator), provides an effective, rapid, and safe therapy for complex wounds. It is registered as class IIb medical device in the European Union but is not yet approved in the United States. Dr. Carsten Mahrenholz, CEO of Coldplasmatech GmbH, states: "Our partnership with Royal Biologics marks a critical milestone. Chronic wounds remain a global healthcare burden, and our CPT® cold plasma therapy offers a transformative solution-combating multi-drug-resistant bacteria, and significantly improving patient outcomes." Salvatore Leo, CEO and founder of Royal Biologics and Royal Wound-X, who will join Coldplasmatech's board of directors, and serve as Chief Executive Officer of Cold Plasma U.S.A emphasizes the significance: "We are thrilled to announce our strategic partnership with Coldplasmatech GmbH. Chronic and acute wounds, with their known antimicrobial resistance, significantly impact society and healthcare costs. We are looking at a paradigm shift in the way health practitioners treat chronic wounds and anti-microbial resistance. CPT® cold plasma therapy will truly change the way we think about chronic wound care moving forward. Our partnership is a historic moment for patients suffering from chronic wounds." said Leo. Innovative Technology for Enhanced Wound Healing and Infection Management Inspired by science fiction's dermal regenerators, Coldplasmatech's patented CPT® system utilizes ionized gas to create a bioactive healing environment. The plasma effectively reduces bacterial burden, including antibiotic-resistant pathogens, and enhances cellular regeneration. With a simple two-minute application, the therapy integrates seamlessly into standard clinical workflows and can be combined with other advanced treatments, such as negative pressure therapy and skin substitute matrices. The technology is currently deployed at renowned medical institutions, including Hannover Medical School and University Heart Center Hamburg, and has been shown to help in successfully treating severe burns, surgical wounds, and chronic wounds. Prof. Dr. Markus Barten from the University Heart Center Hamburg summarizes: "The simple handling allows for quick and painless wound care with high effectiveness, to the delight of patients." About Coldplasmatech GmbH Founded in 2015 as a spin-off of the Leibnitz Institute for Plasma Research, Coldplasmatech GmbH is based in Greifswald, Germany. The company has earned international recognition for its CPT® cold plasma therapy, receiving multiple prestigious awards, including the German Innovation Award, Bavarian Innovation Award and IQ Innovation Award. Coldplasmatech is currently conducting the world's largest randomized controlled trial (RCT) on cold plasma therapy -the POWER Study- funded by the German Federal Ministry of Education and Research. For further information: About Royal Biologics Royal Biologics, headquartered in Hackensack, NJ, was founded in 2015 and specializes in the development, licensing, production, and distribution of orthobiologic products designed to enhance healing across various clinical settings, including orthopedics, sports medicine, spine surgery, wound care, and regenerative medicine. Their comprehensive product portfolio includes autologous advanced biologics, cellular bone grafts, traditional bone grafts, advanced synthetics, and specialized wound care products. Under the leadership of founder Salvatore Leo (CEO) and with backing from Granite Creek Capital Partners, Royal Biologics is committed to delivering innovative biologic solutions that improve patient outcomes. For further information: Contact Information Royal Support Team support@ SOURCE: Royal Biologics View the original press release on ACCESS Newswire Sign in to access your portfolio
