Author: Ken Dropiewski

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

Financial by Comments are Disabled

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

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-526-8478

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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

Coronary/Structural Heart by Comments are Disabled

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

Coronary/Structural Heart by Comments are Disabled

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.
Anhang

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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

Peripheral/Endo by Comments are Disabled

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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BioSig Announces Closing of $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

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Westport, CT, May 30, 2024 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules of an aggregate of 1,570,683 shares of its common stock at a purchase price of $1.91 per share and concurrent private placement unregistered warrants to purchase up to 1,570,683 shares of common stock at an exercise price of $1.78 per share. The unregistered warrants are immediately exercisable and will expire five years from the date of issuance. H.C. Wainwright & Co. acted as exclusive placement agent for the offering. The gross proceeds to the Company from the offering were approximately $3 million, before deducting placement agent fees and other offering expenses payable by the Company. BioSig intends to use the net proceeds of this offering for working capital and general corporate purposes. The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants or the shares of common stock underlying such unregistered warrants) described were offered and sold by BioSig pursuant to a shelf registration statement on Form S-3 (File No. 333-251859) that was previously filed with the Securities and Exchange Commission (“SEC”) on December 31, 2020, and subsequently declared effective on January 12, 2021. The offering of the shares of common stock were made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at placements@hcwco.com. The offer and sale of the unregistered warrants issued in the concurrent private placement were made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About BioSig Technologies, Inc. BioSig Technologies is a medical technology company focused on deciphering the body’s electrical signals, starting with heart rhythms. By leveraging a first of its kind combination of hardware and software, we deliver unprecedented cardiac signal clarity, ending the reliance on ‘mixed signals’ and ‘reading between the lines.’ Our platform technology is addressing some of healthcare’s biggest challenges—saving time, saving costs, and saving lives. The Company’s product, the PURE EP™ Platform, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy. Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Such statements include, but are not limited to, statements related to the intended use of proceeds from the offering. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) BioSig’s ability to regain compliance with and meet the continued listing requirements of the Nasdaq Capital Market to maintain listing of its common stock; (ii) our cost reduction plan and associated workforce reduction or other cost-saving measures not reaching the targeted reduction of cash burn by 50%; (iii) the geographic, social, and economic impact of pandemics or worldwide health issues on BioSig’s ability to conduct its business and raise capital in the future when needed; (iv) BioSig’s inability to manufacture its products and product candidates on a commercial scale on its own, or in collaboration with third parties; (v) difficulties in obtaining financing on commercially reasonable terms; (vi) changes in the size and nature of BioSig’s competition; (vii) loss of one or more key executives or scientists; (viii) difficulties in securing regulatory approval to market BioSig’s products and product candidates; and (ix) market and other conditions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause BioSig’s actual results to differ from those contained in forward-looking statements, see BioSig’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in BioSig’s Annual Report on Form 10-K, filed with the SEC on April 16, 2024. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise, except as required by law.

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InnovHeart Announces First-In-Human Trans-Septal Implantation of Saturn Mitral Valve Replacement

Coronary/Structural Heart by Comments are Disabled

NEWTON, Mass. and MILAN, May 30, 2024 /PRNewswire/ — InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral regurgitation (MR), announced today the first trans-septal clinical trial implant with the proprietary Saturn Transcatheter Mitral Valve. Excellent hemodynamic results are reported for the patient, a 79 year old female suffering from severe mixed (degenerative and functional) mitral regurgitation. The Trans-Septal TMVR procedure was performed as part of the on-going European clinical trial, the CASSINI-EU study, on May 8th, 2024 at Santaros Klinikos University Hospital in Vilnius, Lithuania with the Heart Team of Kęstutis Ručinskas, MD1; Giedrius Davidavičius, MD1; Agnė Drąsutienė, MD1; Vilhelmas Bajoras, MD1; supported by Torsten Vahl, MD2; Lauren Ranard, MD2; Paolo Denti, MD3; and Stefano Stella, MD3.
“We were honored to work with this outstanding international team providing life-changing novel TMVR therapy for this high surgical-risk patient. It is particularly rewarding to support the InnovHeart progression from trans-apical to trans-septal delivery of the Saturn Valve at our Institute,” said Dr. Giedrius Davidavičius. “This first case is a critical step to validate that the Saturn valve can be successfully delivered via a fully percutaneous, transfemoral transseptal approach. The Saturn prosthesis has a unique modular design comprising an annular ring and low-profile valve that can reverse remodel the native annulus, avoid LVOT obstruction and eliminate MR” said Dr. Torsten Vahl.  
“Overall, this important case demonstrates that the Saturn valve can be successfully implanted with either retrograde or antegrade approaches. It is exciting to add trans-septal delivery and begin to expand the clinical experience for the Saturn valve beyond the initial trans-apical study, now in long-term follow-up. I continue to believe that Saturn will become a valuable new therapy with fewer anatomical exclusions than other technologies, with the potential to treat a wider range of patients,” said Dr. Paolo Denti who is the Principal Investigator for the CASSINI-EU study. “We are very grateful for the skilled physicians who successfully completed our first trans-septal CASSINI study case and for our Founder and CTO, Giovanni Righini, for realizing this very important milestone for patients and the company,” said David Wilson, InnovHeart CEO. The CASSINI-EU study will expand to multiple countries and enroll up to 30 patients with moderate to severe or severe MR.
1 Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania2 Structural Heart and Valve Center, New York-Presbyterian Hospital, Columbia University Irving Medical Center, New York, USA 3 San Raffaele University Hospital, Milano, Italy
About InnovHeart
InnovHeart is a medical device company dedicated to providing new treatment options for people suffering from moderate to severe or severe mitral regurgitation (MR) and who need a mitral valve replacement. The InnovHeart proprietary Saturn Transcatheter Mitral Valve Replacement (TMVR) System is designed to eliminate mitral regurgitation and restore normal valve function. InnovHeart is a privately held company located in Colleretto Giacosa, Italy and Newton, Mass, USA. For more information, please visit www.InnovHeart.com and follow us on LinkedIn and X (@InnovHeart).
Caution: The SATURN Transcatheter Mitral Valve Replacement (TMVR) System is limited to investigational use and is not commercially available in any country.

SOURCE InnovHeart

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