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UltraSight collaborates with Mayo Clinic to advance next generation cardiac care with AI

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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
SOURCE UltraSight

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Cadrenal Therapeutics Highlights Presentation of New Trial Data at ISHLT Conference Demonstrating the Importance of Anticoagulation Quality in LVAD Patients

Coronary/Structural Heart by Comments are Disabled

Tecarfarin, which recently received Orphan Drug Designation from the FDA for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, has the potential to improve the time in therapeutic range a factor correlated in the ARIES-HM3 trial with better patient outcomes
PONTE VEDRA, Fla., June 3, 2024 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, today highlighted a groundbreaking presentation at the International Society for Heart & Lung Transplantation (ISHLT) 44th Annual Meeting & Scientific Sessions.
These new findings from secondary analyses of the ARIES-HM3 trial were released in a presentation titled, “Impact of Vitamin K Antagonist (VKA) Therapy On Outcomes In a Randomized Controlled Trial of Aspirin Removal In Left Ventricular Assist Device (LVAD) Patients – A Pre-Specified Analysis From the Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure, or the ARIES-HM3, Randomized Clinical Trial.”
The ARIES-HM3 trial data demonstrated that lower time in therapeutic range, or TTR, translated directly to excessive bleeding events. The “average” patient in the ARIES-HM3 study had a 30% rate of serious bleeding events even after aspirin was eliminated as part of the antithrombotic regimen, and persistent bleeding was inversely correlated with TTR.
The ARIES-HM3 clinical study was sponsored by Abbott (NYSE: ABT), which evaluated a new clinical approach to patient management that included removal of aspirin as part of the antithrombotic regimen warfarin. The data is currently under review by the FDA. Labeling changes related to the antithrombotic regimen have not been approved by the FDA at this time.
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, holds the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and is Executive Director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital, commented, “This comprehensive analysis identifies adequacy of VKA use (as measured by TTR) as a significant risk marker for bleeding events and provides new clinical direction for further mitigation of bleeding to enhance hemocompatibility with the HeartMate 3 LVAD.” Mehra continued, “Each incremental improvement of 10% above the median of 56% TTR trends in a significant further reduction in bleeding rate. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anti-coagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”
“The ARIES-HM3 trial data underscores the deficiencies of warfarin and the need for a new VKA therapy for patients with LVADs. We believe our drug candidate, the next-generation VKA tecarfarin, with its unique retrometabolic design that provides for more stable anticoagulation than warfarin, is the much-needed replacement therapy. We intend to pursue a pivotal trial evaluating tecarfarin effectiveness for LVAD patients,” said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Cadrenal commends Abbott’s commitment to LVAD patients in sponsoring this important trial and analyses.”
On April 9, 2024, Cardenal Therapeutics announced that the United States Food and Drug Administration (FDA) had granted tecarfarin Orphan Drug Designation for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD).
The current market-leading direct oral anticoagulants (DOACs), such as Eliquis, are not indicated for patients with LVADs due to a lack of evidence of benefit, while the level of anticoagulation achieved with warfarin was achieved in the target range only 56% of the time in the ARIES-HM3 trial. Patients whose level of anticoagulation was in the therapeutic range > 56% had better outcomes than those with lower levels. This highlights the potential role for investigating new VKA agents in improving clinical outcomes in LVAD patients.
VKA anticoagulation is prescribed for the prevention of LVAD-related clotting. However, the only available VKA is warfarin, which was approved for human use in 1954. Tecarfarin has been shown to improve TTR, particularly in patients taking multiple medications, and be more stable in patients with renal dysfunction which is common in LVAD patients.
ABOUT CADRENAL THERAPEUTICS, INC.Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib) and just received orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is a next-generation Vitamin K Antagonist (VKA) specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.  
Safe Harbor StatementAny statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding tecarfarin having the potential to improve the time in therapeutic range which analysis of the ARIES-HM3 trial reveals is associated with better patient outcomes. TTRs as predicting increased risk for bleeding events, the VKA tecarfarin, filling the market void for a next-generation VKA, the Company pursuing a pivotal trial evaluating tecarfarin effectiveness for LVAD patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve the time in therapeutic range, the ability of the Company  to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics:Matthew Szot, CFO858-337-0766[email protected] 
Investors:Lytham Partners, LLCRobert Blum, Managing Partner602-889-9700[email protected] 
SOURCE Cadrenal Therapeutics, Inc.

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Microbot Medical Has Received FDA Approval to Proceed with its Pivotal Human Clinical Trial

Peripheral/Endo Regulatory by Comments are Disabled

BRAINTREE, Mass., June 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces that it has received the U.S. Food and Drug Administration’s (“FDA”) approval to proceed with its pivotal human clinical trial as part of its Investigational Device Exemption (“IDE”) application for its LIBERTY® Endovascular Robotic Surgical System. The study will be conducted in the U.S., and the Company has already signed a clinical trial service agreement with a leading academic medical center. The Company is also in the process of engaging additional leading centers to participate in the trial. In parallel to commencing the pivotal human clinical trial, the Company is completing its biocompatibility tests as required by its IDE application. “The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” commented Harel Gadot, CEO, President and Chairman. ”It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe”. 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, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the 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)52-3044404IR@microbotmedical.com

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

Peripheral/Endo by Comments are Disabled

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

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

Coronary/Structural Heart by Comments are Disabled

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

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

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.

Contacts:

Erika Winkels

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-526-8478

+1-763-505-4626

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

Financial by Comments are Disabled

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

Medienmitteilung PDF

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