HINGHAM, Mass., June 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) today announced that it has entered into definitive agreements for the purchase and sale of 1,566,669 shares of the Company’s common stock at a purchase price of $1.50 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series F preferred investment options. The series F preferred investment options to purchase up to 3,133,338 shares of common stock have an exercise price of $1.50 per share and are immediately exercisable following issuance for a period of two years thereafter. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about June 4, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings. The gross proceeds to the Company from the offerings are expected to be approximately $2.35 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offerings for the continued development, commercialization and regulatory activities for the Company’s LIBERTY® Robotic System, expansion and development of additional applications derived from the Company’s existing IP portfolio, and for working capital and other general corporate purposes. The shares of common stock described above (but not the series F preferred investment options issued in the concurrent private placement or the shares of common stock underlying such series F preferred investment options) are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-275634) previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on December 4, 2023. The offering of the shares of common stock is 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 prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at placements@hcwco.com. The series F preferred investment options described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the series F preferred investment options, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the series F preferred investment options and underlying shares of common stock may not be offered or sold 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 shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, the completion of the offerings, the satisfaction of customary closing conditions related to the offerings, the intended use of proceeds from the offerings, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty +972-(0)52-3044404 IR@microbotmedical.com
Financial
HeartFlow AI Plaque Analysis Achieves Major Milestone Towards Medicare Coverage
MOUNTAIN VIEW, Calif., June 03, 2024 (GLOBE NEWSWIRE) — HeartFlow, a leader in cardiovascular healthcare technology, is pleased to announce a key Medicare policy development, which should allow for future expanded patient access to their Plaque Analysis product. Five Medicare Administrative Contractors (MACs), CGS, NGS, Noridian, Palmetto GBA, and WPS, released draft Local Coverage Determinations (LCD) for Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA). These draft LCDs recognize the importance of quantifying coronary artery plaque, which underscores the pivotal role HeartFlow technology plays in diagnosing and managing treatment for patients in need of cardiovascular care. HeartFlow’s accurate and actionable Plaque Analysis aligns with the Centers for Medicare & Medicaid Services (CMS) commitment to supporting technologies that enhance diagnostic accuracy and patient care: HeartFlow Plaque Analysis is the only FDA cleared plaque analysis with a reported 95% agreement prospectively compared to the gold standard, IVUS.¹Two out of three patients had their medical management changed and more precisely tailored with HeartFlow Plaque Analysis.² Plaque Analysis is a major function of the HeartFlow portfolio, which offers the only comprehensive, AI-driven, precision coronary care solution based on the guideline-directed cardiac CT pathway, backed by robust clinical evidence and guidelines. HeartFlow FFRCT has an established reimbursement pathway which is covered for 99% of people in the US with health insurance. Leveraging our expertise and proven success creating new AI reimbursement categories as done with HeartFlow FFRCT, similar coverage and adoption for Plaque Analysis is anticipated, ensuring it becomes an integral part of coronary care. “We are excited about this milestone, as it highlights the critical importance of accurately quantifying plaque in cardiovascular disease management,” said John Farquhar, chief executive officer at HeartFlow. “This recognition by the MACs in the draft policies is a testament to the clinical value of Plaque Analysis and its potential to revolutionize how cardiovascular disease is diagnosed and treated, for all.” The release of these draft LCDs mark the first step in integrating accurate plaque measurement into standard clinical practice. Next steps toward coverage include a period for input from clinicians and other stakeholders before policy is finalized and released. “We are confident that Plaque Analysis will not only meet but exceed the rigorous standards of Medicare,” added Cara Santillo, Senior Vice President of Market Access and Reimbursement at HeartFlow. “This nod of support from the MACs underscores the importance of access and equity in cardiovascular care by ensuring that all patients, regardless of background, receive the critical insights needed for treatment for cardiovascular disease.” About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media Contact Linly Ku Digital Marketing Manager media@heartflow.com Investor Contact Nick Laudico VP of Business Development and Investor Relations nlaudico@heartflow.com 1 Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound EHJ 2024. ² Rinehart et al. JSCAI 2024. https://doi.org/10.1016/j.jscai.2024.101296
UltraSight collaborates with Mayo Clinic to advance next generation cardiac care with AI
New collaboration formed to enhance detection and diagnosis of cardiovascular disease
TEL AVIV, Israel , June 3, 2024 /PRNewswire/ — UltraSight, a pioneer in digital health transforming cardiac imaging with artificial intelligence, is collaborating with Mayo Clinic on a new endeavor with the goal of enhancing cardiac care by harnessing the power of AI in point-of-care ultrasound.UltraSight and Mayo Clinic will jointly develop algorithms for analyzing and interpreting cardiac ultrasound images. This collaboration aims to create a new end-to-end solution and decision support to help healthcare providers make more informed diagnoses and treatment decisions using point-of-care ultrasound (PoCUS) devices. By gaining access to Mayo Clinic’s team of researchers, clinicians and data, UltraSight will be best positioned to enhance and scale its introduction of new cardiac solutions to the market.
With cardiovascular disease affecting approximately 130 million people globally, according to the American Heart Association, the demand for timely cardiac diagnosis and access to consistent cardiac care is on the rise.
“According to the American Heart Association, the prevalence of cardiovascular disease is more than 75 percent in individuals over 60,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota. “Early detection may prevent the progression of heart disease or stroke. The addition of AI to point-of-care ultrasound, widely available and inexpensive, stands to eliminate significant barriers to adoption by guiding users in image acquisition and supporting image interpretation – making the approach highly scalable for early diagnosis and periodic cardiac monitoring.”
“UltraSight Real-time Guidance software harnesses the power of AI to allow more medical practitioners to capture images with confidence,” said Davidi Vortman, CEO of UltraSight. “However, obtaining diagnostic quality cardiac images at the patient point of care is only the first step needed to increase patient access to quality care. We firmly believe that point-of-care ultrasound, when enhanced by the capabilities of AI, holds potential to optimize patient care. Through this collaboration, we plan to enhance our solution to detect and manage cardiac conditions in a more scalable and cost-effective way, ultimately helping more patients receive timely treatment.”
“We know that over the next decade, training programs around the world will not graduate enough specialists and technologists to meet the demands of an aging population,” said John Halamka, M.D., President of Mayo Clinic Platform. The best option in our toolkit is to embrace AI in a way that democratizes access to knowledge. Mayo Clinic and UltraSight will work together to enable a wider spectrum of caregivers to obtain cardiac ultrasound data and understand the results, serving many more patients globally.”
Mayo Clinic is now an investor at UltraSight and has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
For more information about UltraSight, visit www.ultrasight.com. For more information about Mayo Clinic, visit www.mayoclinic.org
About UltraSightUltraSight’s mission is to make diagnostic imaging more accessible by empowering medical professionals to successfully acquire timely and accurate cardiac ultrasound images anywhere. UltraSight’s AI-driven software offers real-time guidance, making cardiac ultrasound accessible and efficient, which may lead to quicker diagnoses and improved patient care. The company was awarded a patent for its real-time guidance solution for ultrasound devices. UltraSight’s software has FDA 510(k) Clearance, is UKCA and CE Marked, and has Israeli AMAR Clearance to assist medical professionals in performing cardiac ultrasound scans. For more news and information, visit our website or follow UltraSight on LinkedIn and Twitter
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Medtronic announces closing of public offering of €3.0 billion of senior notes
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.
Contacts:
Erika Winkels
Ryan Weispfenning
Public Relations
Investor Relations
+1-763-526-8478
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Johnson & Johnson Completes Acquisition of Shockwave Medical
NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson (NYSE: JNJ) today announced it has completed its acquisition of Shockwave Medical. Shockwave is now part of Johnson & Johnson and will operate as a business unit within Johnson & Johnson MedTech. “Through Innovative Medicine and MedTech, Johnson & Johnson is transforming the trajectory […]
SS Innovations Engages BDO as its new Auditor
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
Noah Medical and CEO Dr. Jian Zhang Named Finalists in Surgical Robotics Technology (SRT) Industry Awards
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
BioSig Announces Closing of $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
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.
BioSig Announces $3 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
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 that it has entered into definitive agreements for the issuance and sale of an aggregate of 1,570,683 shares of its common stock at a purchase price of $1.91 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, BioSig has also agreed to issue and sell to the same purchasers 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 will become immediately exercisable upon issuance and will expire five years from the date of issuance. The closing of the offering is expected to occur on or about May 30, 2024, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as exclusive placement agent for the offering. The gross proceeds to the Company from the offering are expected to be 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 above are being offered 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 shares of common stock to be issued in the registered direct offering are being offered 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 will be filed with the SEC and will be 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, when available, 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 are being 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 timing and completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of proceeds therefrom. 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.
Medtronic announces pricing of €3.0 billion of senior notes
DUBLIN, May 29, 2024 /PRNewswire/ — Medtronic plc (the “Company”) (NYSE: MDT) announced today that its wholly-owned indirect subsidiary, Medtronic, Inc., has priced an 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 will be 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 of the Offering are expected to be used for general corporate purposes, which may include repayment of outstanding commercial paper and other indebtedness. The Offering is expected to close on June 3, 2024, subject to customary closing conditions. The joint book-running managers for the Offering are Citigroup Global Markets Limited, J.P. Morgan Securities plc, Merrill Lynch International and Mizuho International plc.
The Offering is being made only by means of a prospectus dated March 3, 2023, and prospectus supplement (together, the “Prospectus”). You may get these documents 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 Offering and the expected use of proceeds therefrom, and the expected closing date of 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.
Contacts:
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Public Relations
Investor Relations
+1-763-526-8478
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SOURCE Medtronic plc



