Nipro Corp.

Sudbury, Massachusetts-based Gentuity received approval for the technology for use both before and after percutaneous coronary intervention (PCI). The company said this makes it the only intravascular imaging platform specifically indicated for the assessment of the coronary vessel pre- and post-intervention. According to a news release, recent studies showed that pre-PCI imaging with OCT led to changes in procedural strategy of 80% of lesions. That includes lesion assessment (45%), vessel preparation strategy (27%), stent diameter (37%) and stent length (36%). Building on this, Gentuity developed and commercialized its Vis-Rx micro-imaging catheter. The company says that, at 1.8 F, it represents the world’s smallest imaging platform. Its low crossing pro enables essential pre-PCI imaging, reducing the need for pre-dilation. The system also streamlines the procedural workflow and enhances intervention accuracy by allowing clinicians to assess coronary arteries in their native state. “We are excited to receive this FDA clearance, which marks a major milestone for the Gentuity HF-OCT imaging system,” said Desmond Adler, president of Gentuity. “The ability to image pre-PCI where it is most needed—without pre-dilation—offers clinicians unparalleled opportunities to optimize treatment plans and obtain previously unavailable insights throughout the entire procedure. “Combined with our AI-guided analysis tools, best-in-class scan range for left main and bifurcation assessment, and seamless device setup, the Gentuity HF-OCT Imaging System is truly an indispensable tool for advancing patient care.” Nipro serves as the global distribution partner for Gentuity.

Intravascular Imaging Technology Featuring the World's Smallest Imaging Catheter Now FDA Cleared for Pre- and Post-Intervention Use. SUDBURY, Mass., Oct. 22, 2024 /PRNewswire/ -- Gentuity, LLC, a global leader in advanced intravascular imaging technologies, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Gentuity HF-OCT Imaging System, featuring the Vis-Rx Micro-Imaging Catheter, for use both before and after percutaneous coronary intervention (PCI), making it the only intravascular imaging platform specifically indicated for the assessment of the coronary vessel pre and post intervention. Intravascular imaging has long been recognized for its ability to improve patient outcomes during PCI. Recent studies, such as the LightLab initiative, have shown that pre-PCI imaging with OCT led to changes in procedural strategy in 80% of lesions, including lesion assessment (45%), vessel preparation strategy (27%), stent diameter (37%), and stent length (36%).1 Building on these insights, Gentuity has developed and commercialized the Vis-Rx Micro-Imaging Catheter, which at 1.8 F is the world's smallest imaging platform. The low crossing profile of the Vis-Rx Micro-Imaging Catheter makes it uniquely capable of performing essential pre-PCI imaging, reducing the need for pre-dilation, streamlining the procedural workflow, and enhancing intervention accuracy by allowing clinicians to assess coronary arteries in their native state. "We are excited to receive this FDA clearance, which marks a major milestone for the Gentuity HF-OCT Imaging System," said Desmond Adler, President of Gentuity, LLC. "The ability to image pre-PCI where it is most needed—without pre-dilation—offers clinicians unparalleled opportunities to optimize treatment plans and obtain previously unavailable insights throughout the entire procedure. Combined with our AI-guided analysis tools, best-in-class scan range for left main and bifurcation assessment, and seamless device setup, the Gentuity HF-OCT Imaging System is truly an indispensable tool for advancing patient care." Dr. Hiram Bezerra, Medical Director of TGH Interventional Cardiology Center of Excellence at Tampa General Hospital, emphasized the significance of this advancement: "The expanded indication for the Gentuity HF-OCT Imaging System, particularly for pre-PCI imaging, represents a major step forward in coronary intervention. The ability to assess coronary arteries comprehensively before and after intervention enhances procedural planning and post-procedural assessment, ultimately improving patient outcomes. The high-speed pullback, 100 mm in 1 second, coupled with a very small catheter profile, 1.8 F, position HF-OCT as the ideal system for pre-intervention imaging." Key Benefits of the Gentuity HF-OCT Imaging System: Smallest Imaging Catheter: The 1.8 F Vis-Rx Micro-Imaging Catheter is the smallest intravascular imaging device in the world, designed with a low crossing profile to streamline image acquisition without the potential need for pre-dilation. Pre- and Post-Intervention Use: Designed to streamline workflow and enhance decision-making in PCI procedures, the Vis-Rx Imaging catheter, integrated with advanced AI-driven software, enables physicians to access real-time, actionable insights in as little as one second. The innovative system improves procedural efficiency while also minimizing contrast utilization.2 Improved Clinical Outcomes: Pre-PCI imaging with OCT has been shown to enhance procedural planning, reduce MACE, and improve stent deployment.3,4 For more information about the Gentuity HF-OCT Imaging System and its expanded indications, please visit Gentuity's website or contact Gentuity's global distribution partner Nipro Corporation. The Gentuity HF-OCT Imaging System will be featured during an industry sponsored symposium at the upcoming TCT (Transcatheter Therapeutics) Conference in Washington D.C. on Monday October 28th . Visit the Nipro booth (#3005) during the conference to learn more. About Gentuity, LLC Based in Sudbury, MA, Gentuity is a commercial-stage medical technology company with a global presence focused on developing next-generation intravascular imaging devices using best-in-class technologies. The company's mission is to advance patient care, improve outcomes, and expand the utility of intravascular procedural guidance tools in cardiovascular disease. 1 Bergmark, B. et al: Decision-Making During Percutaneous Coronary Intervention Guided by Optical Coherence Tomography: Insights From the LightLab Initiative. Circ Cardiovasc Interv. 2022;15:e011851. DOI: 10.1161/CIRCINTERVENTIONS.122.011851. 2 Uemura, Shiro, et al. "Abstract 11731: Efficacy of a new generation fast-pullback, high-frequency intracoronary optical coherence tomography imaging on the reduction of contrast medium in clinical practice." Circulation, vol. 148, no. Suppl_1, 7 Nov. 2023, . 3 Holm, Niels R., et al. "OCT or angiography guidance for PCI in complex bifurcation lesions." New England Journal of Medicine, vol. 389, no. 16, 19 Oct. 2023, pp. 1477–1487, . 4 Hong, Sung-Jin, et al. "Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): An investigator-initiated, multicentre, randomised, open-label, Superiority Trial in South Korea." The Lancet, vol. 404, no. 10457, Sept. 2024, pp. 1029–1039, (24)01454-5. Media Contact: Candace Copher [email protected] SOURCE Gentuity, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

WIXOM, Mich.--( BUSINESS WIRE )--Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that the Company executed a distribution agreement with Nipro Medical Corporation ("Nipro"), as part of Nipro Corporation Japan, a leader in the global healthcare and medical device industry. Under the terms of the agreement, Rockwell Medical will supply Nipro with the Company's liquid and dry acid and bicarbonate hemodialysis concentrates, as well as its dry acid concentrates mixer, for which Nipro has the right to distribute the Company's products globally, excluding the United States. The agreement will remain in effect for two years with the option to extend the agreement for an additional one-year period and includes product purchasing minimums of $5.0 million for the first year and incremental increases each subsequent year. "Nipro is globally renowned for its high-quality medical devices and healthcare solutions specifically in the renal and cardiovascular therapeutic areas," said Mark Strobeck, Ph.D. , President and CEO at Rockwell Medical. "There continues to be increasing market demand for our hemodialysis portfolio of products. We are excited by the opportunity this partnership continues to offer Rockwell Medical and the patients who will be positively impacted by our hemodialysis concentrates worldwide." “Rockwell Medical has been a longtime partner, and we are pleased to be able to extend our relationship with them and in turn, expand accessibility to their products for dialysis patients around the world," said Manny Zapata, Renal Division Manager Latin America, Nipro Medical Corporation. "As we've stated previously, we continue to see continued growth in the number of patients undergoing hemodialysis treatments and are happy to partner with Rockwell Medical to support these patients with its high-quality life sustaining renal products." About Rockwell Medical Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell Medical's mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Rockwell is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed at freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or in a patient’s home. Rockwell Medical's products are vital to vulnerable patients with end-stage kidney disease, and the Company is relentless in providing unmatched reliability and customer service. Rockwell Medical is the second largest supplier of acid and bicarbonate concentrates for dialysis patients in the United States and has the vision of becoming the leading global supplier of hemodialysis concentrates. Certified as a Great Place to Work ® in 2023 and 2024, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis Solutions TM . For more information, visit www.RockwellMed.com . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend," "look forward to," "remain confident," “are determined,” “are on track,” “are resolute in our vision,” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. There can be no assurance that Rockwell Medical will become the leading global supplier of hemodialysis concentrates. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2023, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.