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Elastin Biosciences Announces Positive Preclinical In Vivo Data Demonstrating Elastin Preservation and Restoration in Models of Abdominal Aortic Aneurysm and Williams Syndrome

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Mice treated with Elastin Restoration Platform demonstrated five-fold increase in elastin expression, improved metabolic profile, reduced pro-inflammatory markers, and significant improvement in aorta arterial tensile strength
LONDON, June 3, 2024 /PRNewswire/ — Elastin Biosciences, an emerging biotechnology company focused on developing small molecule therapies to address diseases and conditions linked to elastin deficiency, today announced promising preclinical data from its in vivo mouse model studies.. The studies highlight the efficacy of the company’s Elastin Restoration Platform in enhancing elastin expression and improving arterial tensile strength, offering a potential breakthrough for conditions such as abdominal aortic aneurysm and Williams syndrome.
The Elastin Restoration Platform, which utilizes a combination of proprietary molecules, resulted in a five-fold increase in elastin expression and significantly improved arterial tensile strength of the aorta in mouse models. The therapy improved the overall metabolic profile and reduced pro-inflammatory markers without adverse effects, indicating a favorable safety profile and potential for broad therapeutic application. Additionally, treated mice showed a marked increase in elastin deposition biomarkers.
These results align with data from a prior proof-of-concept in vivo mouse study in which mice treated with the Elastin Restoration Platform showed significant improvements compared to untreated mice, such as enhanced coat color (from spotted gray to all black), better coat quality with less damage, and improved behavioral markers in tests assessing mobility and anxiety.
“These positive preclinical findings highlight the potential of our Elastin Restoration Platform to address critical conditions associated with elastin deficiency,” stated Sherif Idriss, Ph.D., CEO of Elastin Biosciences. “Our approach has demonstrated both therapeutic efficacy and potential for tissue recovery and regeneration, bringing us closer to developing effective treatments for numerous age-related diseases including those associated with the skin, lungs, and blood vessels. Notably, our treatment produced initial indications of efficacy in Williams syndrome, recovering the expression of five genes that are partially deleted in the aorta.”
Dr. Idriss continued, “Based on these data, our next step is to have our molecule combination advance to IND-enabling studies later this year, with the aim to initiate Phase 1 clinical trials by January 2026. Additionally, the Company is exploring other indications and therapies to maximize the benefits of our Elastin Restoration Platform.”
About Elastin:Elastin is a crucial protein in the human body, providing elasticity and resilience to tissues such as skin, lungs, and blood vessels. Its degradation due to aging leads to reduced tissue function and is associated with various age-related diseases. By mitigating elastin loss, therapies can potentially improve patients’ quality of life and longevity.
About Elastin Biosciences:Elastin Biosciences is an emerging biotechnology company developing small molecule therapeutics to address diseases linked to elastin deficiency. The Company’s Elastin Restoration Platform leverages a combination of proprietary molecules designed to fortify the structural integrity of crucial tissues, including those in the cardiovascular and epidermal systems.  Elastin’s lead development program has demonstrated an ability to increase elastin expression and arterial tensile strength in models of abdominal aortic aneurism and Williams syndrome, a rare a multisystem disorder characterized by elastin arteriopathy.  Elastin Biosciences emerged from Longaevus Technologies and is based in London.  For more information, please visit www.elastin-biosciences.com
Investor and Media Contact:Tiberend Strategic Advisors, Inc.
David Irish[email protected]231-632-0002
Eric Reiss[email protected]
SOURCE Elastin Biosciences

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HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation

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HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation Paris, June 3rd 2024 – HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe Mitral Regurgitation (MR), announced today that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to initiate a US Pivotal Study with its technology. The Pivotal Study is a single-arm, multicenter, prospective study assessing the safety and effectiveness of the HighLife TSMVR solution in patients with moderate to severe Functional Mitral Regurgitation (FMR), unsuitable for surgery or transcatheter repair treatment. This patient population lacks approved therapeutic options, leading to a poor prognosis with many recurrent hospitalizations and reduced life expectancy. The pivotal study is expected to enroll patients at clinical sites in the United States, Europe and APAC. Over 100 patients have been treated with the HighLife technology within different clinical programs in the USA, Europe and APAC. Study results have been presented at conferences globally and published in JACC (Journal of the American College of Cardiology) – Cardiovascular Interventions1. Prof. Gregg W. Stone, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai (New York, USA) will be the Principal Investigator of the Pivotal study. “I am honored to lead the HighLife pivotal study. There is still a significant unmet clinical need for patients suffering from mitral regurgitation and TMVR is a promising treatment option. The HighLife TMVR solution offers the potential to provide important clinical benefits for these high-risk patients. We are gratified that FDA has granted approval for this pivotal study that will further advance the management of patients with MR” commented Prof. Stone. Georg Börtlein, Founder and Chief Executive Officer of HighLife, said, “We are extremely pleased with the FDA IDE approval for our US pivotal study, marking a significant milestone in our US clinical strategy. This approval aligns with the maturity of our extensive clinical dataset generated over multiple sites across three continents. We are also making great progress towards CE mark readiness, eagerly anticipating the market introduction of our technology in Europe.” The HighLife technology will be featured at NY Valves annual meeting on Thursday, June 6th   at 11am in the session “Innovation at NYV: Transfemoral TMVR – Technology and Clinical Updates” – Room: Innovation & FDA, 504, Level 5, Jacob K. Javits Convention Center, North. About HighLife HighLife SAS, headquartered in Paris, France, with facilities in Irvine, California, is a pre-commercial stage company. It is focused on the development of a novel transcatheter replacement system for treating mitral regurgitation. The TSMVR solution developed by HighLife consists of a valve-in-ring concept, both ring and valve being implanted percutaneously. The technology is implanted in a simple, 3-step procedure. The valve is deployed in a beating heart, reducing trauma to the patients. It is currently evaluated in clinical studies across three continents. For more information, visit https://www.highlifemedical.com/ Caution: The HighLife Valves are investigational devices and not for sale in any geography. About Mitral Regurgitation Mitral Regurgitation is a growing public health concern, affecting over 2% of the total population2. It refers to a condition in which the valve between the heart’s left chambers (the mitral valve) does not close completely, allowing blood to leak back across it, rather than continuing to supply the organs with oxygenated blood. Without proper treatment, severe Mitral Regurgitation can cause major heart problems or even lead to heart failure. Limited treatment options are available for many patients at high surgical risk, TSMVR solutions offer a less invasive alternative to traditional open-heart surgery. Contact: HighLife MedicalAmina Benkabouabenkabou@highlifemed.comTel : +33 (0)1 72 32 21 25 1 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study. J Am Coll Cardiol Intv. 2023 Dec, 16 (23) 2854–28652Burden of valvular heart diseases: a population base study. Nkomo VT et al.
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030624_HighLife_PR FDA Pivotal Trial_

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Medtronic announces closing of public offering of €3.0 billion of senior notes

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DUBLIN, June 3, 2024 /PRNewswire/ — Medtronic plc (the “Company”) (NYSE: MDT) announced today that its wholly-owned indirect subsidiary, Medtronic, Inc., has closed a registered public offering (the “Offering”) of €850,000,000 principal amount of 3.650% senior notes due 2029, €850,000,000 principal amount of 3.875% senior notes due 2036, €600,000,000 principal amount of 4.150% senior notes due 2043, and €700,000,000 principal amount of 4.150% senior notes due 2053 (collectively, the “Notes”). All of Medtronic, Inc.’s obligations under the Notes are fully and unconditionally guaranteed by the Company and Medtronic Global Holdings S.C.A., a wholly-owned subsidiary of the Company and the indirect parent of Medtronic, Inc., on a senior unsecured basis.
The net proceeds from the Offering are approximately €2.97 billion, after deducting underwriting discounts and estimated expenses related to the Offering payable by Medtronic, Inc. The net proceeds of the Offering are expected to be used for general corporate purposes, which may include repayment of outstanding commercial paper and other indebtedness.
Citigroup Global Markets Limited, J.P. Morgan Securities plc, Merrill Lynch International and Mizuho International plc were the joint book-running managers for the Offering, Barclays Bank PLC, Deutsche Bank AG, London Branch, Goldman Sachs & Co. LLC and HSBC Bank plc were the senior co-managers for the Offering, and Drexel Hamilton, LLC, Guzman & Company, Independence Point Securities LLC and Siebert Williams Shank & Co., LLC were the co-managers for the Offering.  The Offering was made by means of a prospectus dated March 3, 2023 and prospectus supplement (together, the “Prospectus”), copies of which may be obtained for free by visiting EDGAR on the U.S. Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the Prospectus may be obtained by contacting Citigroup Global Markets Limited, toll-free at +1 800 831 9146, J.P. Morgan Securities plc at +44-20 7134-2468 (non-U.S. investors), or J.P. Morgan Securities LLC collect at +1-212-834-4533 (U.S. investors), Merrill Lynch International, toll free at +1 800 294 1322 and Mizuho International plc, at +44 20 7248 3920.
About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.
Forward-Looking Statements
This press release may be deemed to contain forward-looking statements regarding future events that are subject to the safe harbor created under Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act and the Securities Exchange Act of 1934. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including but without limitation, statements relating to the expected use of proceeds from the Offering.
You should pay particular attention to the important risk factors and cautionary statements referenced in the “Risk Factors” section of the prospectus related to the offering referenced above, as well as the risk factors and cautionary statements described in Medtronic plc’s filings with the SEC, including the risk factors contained in Medtronic plc’s most recent Annual Report on Form 10-K. Medtronic plc does not undertake to update its forward-looking statements.

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Erika Winkels

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Public Relations

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SOURCE Medtronic plc

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Half Moon Medical Announces 15 Patients Treated in Pilot Study with Transcatheter Mitral Valve Repair System

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Clinical progress to be highlighted in key presentations at New York Valves
MENLO PARK, Calif., May 31, 2024 /PRNewswire/ — Half Moon Medical today announced the treatment of 15 patients with its second generation Half Moon transcatheter mitral valve repair technology (TMVr) as part of an ongoing pilot study. Half Moon Medical also announced two upcoming presentations by leading physicians at the New York Valves conference in June 2024.
The investigational Half Moon mitral valve repair device is designed to restore mitral valve function in patients with severe symptomatic mitral regurgitation (MR), a disease where blood leaks backwards within the heart due to the mitral valve’s inability to close properly. The device is deployed using a percutaneous (from the leg) delivery catheter, which is navigated through the vasculature to the diseased native mitral valve. The Half Moon device has been shown to produce significant, sustained reduction in MR without an increase in pressure gradient across the valve in a wide range of valve anatomies not addressable by other percutaneous therapies.
Leading interventional cardiologists in the US and Australia have implanted the Half Moon device in the ongoing pilot study. “The Half Moon device allowed us to successfully treat a patient with severe mitral regurgitation who had no other meaningful treatment options. We are very excited about the opportunity to expand our percutaneous toolbox for the treatment of mitral valve disease” said Dr. Stan Chetcuti, Director of the Cardiac Catheterization Laboratory at University of Michigan, who treated the 15th patient with the Gen 2 Half Moon device along with his team consisting of Dr. Neal Duggal, Director of Anesthesia for Structural Heart Interventions, and Dr. Matthew Romano, Associate Professor of Cardiac Surgery.
Two physician-led presentations highlighting the Half Moon device will be featured at the New York Valves Conference in New York City, June 5-7th, 2024. Dr. Azeem Latib, System Director of Interventional Cardiology at Montefiore Health System in Bronx, NY, will be presenting interim data from the Half Moon pilot study on Wednesday June 5th, 2024. On Thursday June 6th, 2024, Dr. Hemal Gada, President of UPMC Heart and Vascular Institute in Harrisburg PA, will present a case he performed with the Half Moon device in a patient with complex mitral valve pathology that could not be addressed by transcatheter edge to edge mitral valve repair or transcatheter mitral valve replacement.
“We are encouraged by the promising results we have seen to-date with the Gen 2 Half Moon device significantly reducing mitral regurgitation in a wide range of challenging anatomies” said Matt McLean, CEO and Co-Founder of Half Moon Medical. “We are also thankful to our physician partners who are bringing this innovative therapy to patients in need.”
About Half Moon Medical
Half Moon Medical (Menlo Park, CA) is privately held company that was founded in 2017 at The Foundry LLC (Menlo Park, CA), a leading medical device incubator that rapidly transforms concepts into companies. Half Moon Medical is developing a minimally invasive technology to treat mitral regurgitation, a disease affecting an estimated four million people. Half Moon Medical is enrolling patients in a pilot study in the US, Canada and Australia.
Contact: Matt McLean, [email protected] 
SOURCE Half Moon Medical

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SS Innovations Engages BDO as its new Auditor

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FORT LAUDERDALE, Fla., May 31, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global population, today announced that it has engaged BDO India LLP (“BDO”) as its independent registered public accounting firm. The Company believes that the selection of BDO will facilitate SS Innovations’ strategy to uplist its common stock to a National Securities Exchange. In addition, the engagement of BDO reflects the Company’s commitment to transparent financial and accounting practices and regulatory compliance. SS Innovations has demonstrated significant operational success, reporting 32 successful installations of its flagship SSi Mantra Surgical Robotic System in medical facilities across India. This innovative robotic surgical system has been integral to the launch of four cardiac surgery programs, broadening the spectrum of robotic cardiac surgeries available in India. For the quarter ended March 31, 2024, SS Innovations sold 8 SSi Mantra Surgical Robotic Systems and reported revenues of approximately US $7 million, which exceeds revenues reported for the entire year ended December 31, 2023. “SS Innovations is committed to democratizing access to quality healthcare while ensuring transparency for our shareholders,” stated SS Innovations’ Founder, Chairman and Chief Executive Officer, Dr. Sudhir Srivastava. “The engagement of an audit firm of the caliber and reputation of BDO is a crucial component of this commitment, serving as a bridge to our uplisting strategy and reflecting our dedication to open and transparent financial and accounting practices. This initiative is part of our broader mission to bring advanced, precise surgical solutions to every corner of the globe and to make top-tier medical care accessible to all.” Barry Cohen, COO of the Americas for SS Innovations, added, “Engaging BDO as our auditor is a strategic move which we believe will facilitate our journey to uplist our common stock to a National Securities Exchange. Our operational achievements, demonstrated by over 1,200 operations performed using the SSi Mantra, showcase our readiness for sustained, long-term growth. This is not just a procedural step but an instrumental one, which will help prepare us for the next phase of expansion, and help solidify our market position.” Mr. Cohen further noted, “The SSi Mantra has been clinically validated in 70 types of surgical procedures, demonstrating mitigation of R&D risk. We are targeting a global market, beginning with India, which alone has a population of 1.4 billion people and about 70,000 hospitals. We have begun to capture market share in India with our 32 SSi Mantra installations. We look forward to continuing to showcase SSi Mantra’s affordability, reliability and unique capabilities in a diverse and demanding healthcare environment.” About SS Innovations International, Inc. SS Innovations International, Inc. (OTC: SSII) is a developer of innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger part of the global population. SSII’s product range includes its proprietary “SSi Mantra” surgical robotic system, and “SSi Mudra”, its wide range of surgical instruments capable of supporting a variety of surgical procedures including robotic cardiac surgery. SSII’s business operations are headquartered in India and SSII has plans to expand the presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, globally. For more information, visit SSII’s website at ssinnovations.com or LinkedIn for updates. About SSi Mantra Supporting advanced, affordable, and accessible robotic surgery, the SSi Mantra Surgical Robotic System provides the capabilities for multi-specialty usage including cardiothoracic, head and neck, gynecology, urology, general surgery and more. With its modular arm configuration, 3D 4K vision open-console design and superior ergonomics, the system engages with the surgeon and surgical teams to improve safety and efficiency during procedures. The SSi Mantra has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 60 different types of surgical procedures. The Company has initiated the regulatory approval process in the United States and the EU, with approvals anticipated in 2025. Forward-Looking Statements This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations International’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. For more information: PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com

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Data from the PRECISION study of aprocitentan to be presented at the European Society of Hypertension Annual Meeting 2024

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Allschwil, Switzerland – May 31, 2024 Idorsia Ltd (SIX: IDIA) today announced that data from the Phase 3 study of aprocitentan, Idorsia’s endothelin receptor antagonist, will be presented by Prof. Krzysztof Narkiewicz, MD, PhD, at the European Society of Hypertension’s 33rd European Meeting of Hypertension and Cardiovascular Protection, taking place in Berlin, Germany, May 31 – June 3, 2024. An oral presentation is scheduled for Sunday, June 2 (09:05 – 09:15 CEST) in Convention Hall I C, as part of the “Clinical Studies” session, entitled “Blood pressure control with aprocitentan in resistant hypertension”. The presentation focuses on a pre-planned analysis evaluating the efficacy of aprocitentan on the percentage of patients with controlled blood pressure according to hypertension guidelines at different timepoints during the Phase 3 PRECISION study. The abstract can be found here. A poster presentation is scheduled for Saturday, June 1 (18:50 – 18:55 CEST) as part of the session “Moderated E-poster session 7 – Clinical studies”, entitled “Effect of high dose aprocitentan in patients with resistant hypertension not controlled by low dose”. The presentation focuses on a post-hoc exploratory analysis evaluating the observed long-term benefit of increasing to a higher dose of aprocitentan (25 mg) in patients not achieving a blood pressure control after 4 weeks on the lower dose (12.5 mg). The abstract can be found here. Notes to the editor About aprocitentanAprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. In May 2022, Idorsia announced positive top-line results of the Phase 3 PRECISION study with aprocitentan for the treatment of patients with resistant hypertension. Detailed results were published in The Lancet and presented as a Late-Breaking Science presentation during the American Heart Association (AHA) Scientific Sessions in November 2022. More details and commentary can be found in the dedicated press release and an investor webcast featuring Prof. Markus Schlaich, an investigator in PRECISION. On March 19, 2024, aprocitentan was approved as TRYVIO in the US, with availability planned for H2 2024. On April 25, 2024, Idorsia received a positive opinion for aprocitentan (as JERAYGO™) from the Committee for Medicinal Products for Human Use (CHMP) as a treatment of resistant hypertension. A CHMP positive opinion is one of the final steps before marketing authorization can be granted by the European Commission; a final decision is expected approximately two months after publication of the CHMP opinion. About Prof. Krzysztof Narkiewicz, MD, PhDProfessor Krzysztof Narkiewicz is the Head of the Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland. His research has been focused on the role of the sympathetic nervous system and metabolic factors in regulation of cardiovascular function in physiological and pathological states, and on prevention and treatment of cardiometabolic diseases including hypertension, diabetes, coronary artery disease, congestive heart failure and obstructive sleep apnea. He has published over 700 full-text publication; ( > 39 000 citations; h-index: 69). He was the President of the Scientific Council of the European Society of Hypertension (2009-2011). He was a member of the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) preparing the 2007, 2013 and 2018 Guidelines for the Management of Arterial Hypertension. He also contributed to the 2023 ESH hypertension guidelines. Prof. Krzysztof Narkiewicz serves as a consultant to Idorsia. About IdorsiaIdorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contactAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.commedia.relations@idorsia.com www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
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Noah Medical and CEO Dr. Jian Zhang Named Finalists in Surgical Robotics Technology (SRT) Industry Awards

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SAN CARLOS, Calif., May 30, 2024 (GLOBE NEWSWIRE) — Medical robotics innovator Noah Medical announced today that it has been named a finalist in the prestigious Surgical Robotics Industry Awards 2024 alongside its founder and CEO Dr. Jian Zhang. This joint recognition highlights Noah Medical’s groundbreaking work in endoluminal robotics and Dr. Zhang’s visionary leadership within the industry. Noah Medical is a finalist in the Innovative Start-up category, which honors companies under six years old that have demonstrated significant potential and introduced innovative solutions to enhance surgical procedures and patient outcomes. Dr. Zhang is a finalist in the Industry Leadership category, awarded to those who have demonstrated outstanding business or commercial success, highly effective management, and a track record as a thought leader. Since the beginning of 2023, Noah Medical has announced $150 million in Series B funding, secured FDA clearance for The Galaxy System™, its fully image-integrated solution for robotic navigated bronchoscopy, and launched the platform to commercial and industry acclaim. The company’s proprietary technology is transforming the early identification and diagnosis of lung cancer by making it possible for physicians to overcome traditional imaging and navigation limitations to confidently reach nodules in the outer periphery of the lung. New white paper data from partner hospitals has shown the Galaxy System’s ability to consistently achieve a diagnostic yield as high as 96% in the field, including the 75% or more that were found in the outer third of the lung. In addition to reaching early adoption milestones faster than any other robotic platform, the technology was named a “2023 Fierce 15 Company” by Fierce MedTech and the “2023 Best Healthcare Robotics Company” in the 7th Annual MedTech Breakthrough Awards Program. About Noah Medical Noah Medical is building the future of medical robotics. Our next-generation robotic platforms and technologies target early diagnosis and treatment of patients across multiple indications. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top robotics, medical device, and healthcare companies in the world. Learn more at noahmed.com. About the Galaxy SystemDesigned in collaboration with physicians, the Galaxy System features a groundbreaking combination of innovative new technologies and features, including proprietary integrated tomosynthesis (TiLT+ Technology™) with augmented fluoroscopy, a disposable single-use bronchoscope with always-on vision, and a small, compact footprint that allows for easy integration into most bronchoscopy suites. Recent results have shown Galaxy Systems’ ability to achieve 100% successful navigation to lesion, 100% diagnostic yield, and 95% tool-in-lesion accuracy in a preclinical trial, and 100% tool-in-lesion accuracy and 90-95% diagnostic yield in a human trial. Media Contact:Jennifer SipeNoah Medical513-313-1403press@noahmed.com

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First Irish patient implanted with innovative heart failure management system from Irish Company FIRE1

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DUBLIN–(BUSINESS WIRE)–Dublin-based FIRE1 today announced that the first Irish patient has been successfully implanted with its FIRE1™ System for remote heart failure monitoring. The innovative system has the potential to positively impact thousands of people living with heart failure in Ireland every year and alleviate the burden on hospital emergency rooms. The […]

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Favorable Oncocyte VitaGraft Kidney Study Results Published in the New England Journal of Medicine

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Late-breaking presentation of data at American Transplant Congress on Monday, June 3Data show potential to monitor for therapeutic efficacy and recurrencePotential repeat testing opportunities with claims expansion IRVINE, Calif., May 30, 2024 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced that favorable data regarding its lead product VitaGraft™ Kidney was published in the New England Journal of Medicine. Oncocyte’s Drs. Ekke Schuetz and Julia Beck, inventors of the technology, are among the authors of the study. VitaGraft Kidney was used to monitor graft injury in a phase 2 double-blind, placebo-controlled study (NCT05021484) of the investigational drug felzartamab, a fully human CD38 monoclonal antibody, for antibody-mediated rejection (AMR), a leading cause of kidney allograft failure. VitaGraft Kidney measures the amount of DNA in transplant patients’ blood that comes from the donor organ, a key biomarker for assessing graft health. This process is commonly referred to as donor-derived cell-free DNA (dd-cfDNA) testing and is widely used in clinical practice today. In this study, Oncocyte’s proprietary diagnostic test using droplet-digital PCR was able to identify responders and non-responders to felzartamab, showing, “a decrease in dd-cfDNA fractions at week 12 (0.33% [0.25−0.40] versus 0.95% [0.37−1.63]; mean difference: −0.75%; 95% CI: −1.41, −0.09) and week 24 (0.31% [0.21−0.49] versus 0.82% [0.34−2.90]).” The study points to new clinical utilities for VitaGraft Kidney beyond the Company’s currently approved and reimbursed indication of for cause testing. Both therapeutic efficacy and recurrence monitoring are potential new use cases for dd-cfDNA testing. Both utilities would be expected to require multiple tests during the active management phase, when a drug is being given, and long-term to help doctors watch for AMR recurrence. “The results of the phase 2 trial suggested that monitoring of dd-cfDNA could be useful to accurately detect responsiveness to felzartamab therapy, also uncovering disease recurrence after stopping treatment,” said Dr. Georg Böemig, Medical University of Vienna, senior author of the publication. “Therefore, the assay could have high potential as a tool to individually guide dosing intervals and duration of anti-rejection therapy.” Up to 20.2% of kidney transplant patients will develop AMR within 10 years of transplant and up to 70% of those patients will progress to graft failure.1 Currently, there are no FDA approved drugs that have indications for the management of AMR. Results of the phase 2 trial suggest that the combination of felzartamab drug therapy and VitaGraft Kidney testing may have significant potential to address this key unmet need in transplant management by enabling detection, management, and monitoring of AMR. “We congratulate the research teams on this groundbreaking study and its potential to lead to a treatment option for kidney transplant patients suffering from AMR around the world,” said Josh Riggs, Oncocyte CEO. “We are grateful for the support from our research partners and their inclusion of our test in this study. It is exciting to see a new opportunity for Oncocyte’s technology to serve the clinical market and patients in need. This study, combined with earlier results showing that our test can detect AMR up to 10 months earlier than protocol, points to new opportunities to improve care and outcomes for these high-risk patients. In the future, we expect that VitaGraft will be there to support physicians looking to detect AMR as early as possible and then effectively manage this disease.” “Our recent partnership with Bio-Rad, gives us the scale we need to support the global transplant research community with easy-to-use dd-cfDNA monitoring tools,” continued Mr. Riggs. “Use cases like this will help drive adoption of our combined technology around the world.” The results of this publication will be discussed as a Late Breaking Abstract at the 2024 American Transplant Congress on June 3rd 2024 at 9:15 ET by Dr. Katharina Mayer from the Medical University of Vienna. Oncocyte will be exhibiting at the conference at Booth #430. Oncocyte will be hosting a conference call to discuss the results of the clinical trial with study authors, Dr. Klemens Budde, Head of Transplantation at Charite, and Dr. Ekke Schuetz, Chief Science Officer at Oncocyte. Dr. Schuetz developed the dd-cfDNA technology as CEO and CSO of Oncocyte subsidiary Chronix Biomedical alongside Dr. Julia Beck. The clinical presentation will be followed by an operational update and Q&A focused on the commercial launches of VitaGraft Kidney and GraftAssure by Josh Riggs. Investors may submit questions for the Q&A by emailing them to the contact information listed below. The date and time of the call will be announced in due course. 1 Mujtahedi, S.S., Yigitbilek, F., Ozdogan, E. et al. Antibody-Mediated Rejection: the Role of Plasma Cells and Memory B Cells. Curr Transpl Rep 8, 272–280 (2021). https://doi.org/10.1007/s40472-021-00342-1 About Oncocyte Oncocyte is a precision diagnostics company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a clinical blood-based solid organ transplantation monitoring test. GraftAssure™ is a research use only (RUO) blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. For more information about Oncocyte, please visit https://oncocyte.com/. For more information about our products, please visit the following web pages: VitaGraft Kidney™ – https://oncocyte.com/vitagraft-kidney/VitaGraft Liver™ – https://oncocyte.com/vitagraft-liver/GraftAssure™ – https://oncocyte.com/graftassure/DetermaIO™ – https://oncocyte.com/determa-io/DetermaCNI™ – https://oncocyte.com/determa-cni/ VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation. About Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure, with late AMR affecting approximately 23,000 patients total in the U.S. There is no effective treatment for AMR and patient options are highly limited. Donor-specific antibody (DSA) production by plasma cells, and tissue infiltration of Natural Killer (NK) cells presumed to be involved in DSA-dependent microvascular inflammation, are both linked to AMR. Observations that both plasma cells and NK cells express high levels of CD38 have motivated the approach of targeting CD38 to deplete these cell populations to address AMR. About Felzartamab Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority. Forward-Looking Statements Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to, among other things, the future of VitaGraft Kidney, the anticipation that Oncocyte and Bio-Rad’s combined technology will be adopted around the world, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on Oncocyte or its subsidiaries’ financial and operational results, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. CONTACT: Jeff RamsonPCG Advisory(646) 863-6893jramson@pcgadvisory.com

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