Ocumetics Technology Corp. (TSXV:OTC, OTCQB:OTCFF, FRA:2QBO) focuses on a groundbreaking vision enhancement product - the Ocumetics Accommodating Lens. Leading the forefront of research and product development, Ocumetic's intraocular lens (IOL) is engineered to seamlessly shift the eye's focus from close to far distances without any noticeable lag. This process is called accommodation.
The eye's natural lens loses its flexibility to bend light rays accurately due to aging and injuries. This leads to the deterioration of eyesight and potential conditions like cataracts with or without astigmatism. Ocumetics has designed a very unique IOL that is surgically implanted to restore a patient’s vision. This lens is designed to harmoniously align with the eye's natural mechanisms, enhancing vision by appropriately bending light rays. Notably, it's designed to last a lifetime, presenting a significant potential advancement over other cataract technologies.
Ocumetics aims to solve the problem of eyesight degradation. The proposed solution is a surgically implanted lens that takes over the function of properly bending rays of light by working with the eye’s natural mechanisms, resulting in enhanced vision. Following a series of product enhancements, development of surgical procedure protocols, and animal testing for biocompatibility, the Ocumetics Accommodating Lens will soon begin human trials as the company works toward bringing the product to market.
This Ocumetics Technology profile is part of a paid investor education campaign.*
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Calgary, Alberta May 24, 2024 - TheNewswire . Â Ocumetics Technology Corp. (" Ocumetics " or the " Corporation ") ( TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO) announces that it has completed the first tranche of the private placement of debentures previously announced by the Corporation on May 15, 2024.
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Calgary, Alberta TheNewswire - February 29, 2024 - Ocumetics Technology Corp. ("Ocumetics") (TSXV:OTC) (OTC:OTCFF) (FRA:2QBO), is pleased to invite investors and other interested parties to attend an upcoming interview with Market Radius Research.
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Calgary, Alberta TheNewswire - December 21, 2023 - Â Ocumetics Technology Corp. (" Ocumetics " or the " Corporation ") (TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) is pleased to announce that the TSX Venture Exchange has granted a 15-day extension to close the Corporation's non-brokered private placement announced on November 15, 2023. Â The new closing deadline for the private placement is January 15, 2024.
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Ocumetics Technology Corp. (" Ocumetics ") ( TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) a pioneer in the field of ophthalmic innovation, announces a webinar to discuss the successful completion of its biocompatibility animal study and its upcoming first-in-human study, anticipated to commence in Q1 2024 in the Dominican Republic
Dean Burns, CEO of Ocumetics and 27-year Alcon veteran, will lead the presentation.
Click Image To View Full Size
Join the webinar to:
Learn more about the significance of the biocompatibility animal study;
Learn more about the upcoming first-in-human study; and
Ask questions regarding the Ocumetics Accommodating Lens and the company's plans.
Details are as follows:
Date: Â Â Â Â December 20, 2023
Time: Â Â Â Â 18:00 EST
RSVP: https://ocumetics.com/webinar-december-20-2023/
About Ocumetics
Ocumetics Technology Corp. ( TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO), headquartered in Calgary, Alberta, Canada, is an innovator in the field of ophthalmic technology, dedicated to developing and commercializing advanced vision correction solutions that enhance the quality of life for individuals worldwide.
Ocumetics is in the preclinical study stage of a game-changing technology for the ophthalmic industry. Â In its pursuit of a next generation interocular lens solution, Ocumetics has developed the Ocumetics Accommodating Lens, an expandable intraocular lens that fits within the natural lens compartment of the eye potentially to eliminate the need for corrective lenses. Â It is designed to allow the eye's natural muscle activity to seamlessly shift focus from distance to intermediate to near.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dean Burns
President and CEO
(817) 874-7564
Dayton Marks
Director
(778) 347-2500
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Copyright (c) 2023 TheNewswire - All rights reserved.
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Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline.
Q1 2025 Highlights:
Key Chief Executive Officer ("CEO") Commentary:
David Hochman, Chairman and CEO of Orchestra BioMed, stated: "We continued to make meaningful progress during the first quarter with significant inflection points for both our AVIM therapy and Virtue SAB programs. We believe the FDA's Breakthrough Device Designation for AVIM therapy signals meaningful recognition of its potential to meet the clinical needs of millions living with hypertensive heart disease, a population in which chronic high blood pressure can lead to various heart problems like left ventricular hypertrophy, diastolic dysfunction, heart failure, and coronary artery disease. We believe that AVIM therapy has the potential to provide a potent additional therapeutic option for these patients. We are focused on execution of the BACKBEAT global pivotal study alongside our strategic partner Medtronic as the critical pathway toward making AVIM therapy available to patients globally."
Mr. Hochman continued, "In parallel, we secured full IDE approval to conduct the Virtue Trial, a U.S. pivotal coronary study that will evaluate Virtue SAB, our investigational, non-coated drug-eluting balloon designed to deliver a large liquid dose of proprietary extended-release sirolimus, head-to-head against the commercially available AGENT paclitaxel-coated balloon. We believe the updated design of the trial, which we currently plan to initiate in the second half of the year, offers the most direct path to regulatory approval while showcasing the distinctive pharmacokinetic and therapeutic advantages of our proprietary technology. Taken together, these milestones mark tangible progress on multiple fronts. We continue to execute methodically and remain focused on advancing our pivotal trials, generating clinical evidence, and building long-term value for patients, physicians, shareholders and strategic partners alike."
Financial Results for the First Quarter Ended March 31, 2025
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is AVIM therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com , and follow us on LinkedIn .
References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.
About AVIM Therapy
AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk.
About Virtue SAB
Virtue SAB is an investigational therapeutic combination drug-device designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFRâ„¢ through a non-coated microporous AngioInfusionâ„¢ Balloon, protecting the drug in transit through the arteries and consistently delivering a large liquid dose, overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary in-stent restenosis ("ISR") in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. The FDA granted IDE approval for Orchestra BioMed to evaluate the efficacy and safety of Virtue SAB in the Virtue Trial, a pivotal trial that will randomize Virtue SAB against commercially available AGENT TM DCB, a paclitaxel-coated balloon.
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company's planned and ongoing pivotal trials and reporting of top-line results, including the timing of initiation of the Virtue Trial, the potential benefits of BDD, including its ability to expedite FDA reviews and allow access to add-on reimbursement, realizing the clinical and commercial value of AVIM therapy and Virtue SAB, the potential safety and efficacy of the Company's product candidates, and the ability of the Company's partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company's commercial product candidates and ongoing regulation of the Company's product candidates, if approved; the timing of, and the Company's ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading "Item 1A. Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025.
The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
Investor Contact
Silas Newcomb
Orchestra BioMed
Snewcomb@orchestrabiomed.com
Media Contact
Kelsey Kirk-Ellis
Orchestra BioMed
Kkirkellis@orchestrabiomed.com
| ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited) | ||||||||
| March 31, | December 31, | |||||||
| 2025 Â | 2024 Â | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 18,348 | $ | 22,261 | ||||
| Marketable securities | 31,536 | 44,551 | ||||||
| Accounts receivable, net | 89 | 92 | ||||||
| Inventory | 135 | 173 | ||||||
| Prepaid expenses and other current assets | 1,795 | 2,094 | ||||||
| Total current assets | 51,903 | 69,171 | ||||||
| Property and equipment, net | 1,413 | 1,384 | ||||||
| Right-of-use assets | 1,956 | 2,103 | ||||||
| Strategic investments, less current portion | 2,495 | 2,495 | ||||||
| Deposits and other assets | 1,284 | 1,020 | ||||||
| TOTAL ASSETS | $ | 59,051 | $ | 76,173 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 5,563 | $ | 5,134 | ||||
| Accrued expenses and other liabilities | 5,392 | 6,084 | ||||||
| Operating lease liability, current portion | 590 | 550 | ||||||
| Deferred revenue, current portion | 3,944 | 4,439 | ||||||
| Total current liabilities | 15,489 | 16,207 | ||||||
| Deferred revenue, less current portion | 10,752 | 10,989 | ||||||
| Loan payable | 14,338 | 14,292 | ||||||
| Operating lease liability, less current portion | 1,516 | 1,687 | ||||||
| Other long-term liabilities | 99 | 40 | ||||||
| TOTAL LIABILITIES | 42,194 | 43,215 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at March 31, 2025 and December 31, 2024. | — | — | ||||||
| Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 38,312,512 and 38,194,442 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively. | 4 | 4 | ||||||
| Additional paid-in capital | 345,449 | 342,780 | ||||||
| Accumulated other comprehensive income | 37 | 52 | ||||||
| Accumulated deficit | (328,633 | ) | (309,878 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 16,857 | 32,958 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 59,051 | $ | 76,173 | ||||
| ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue: | ||||||||
| Partnership revenue | $ | 732 | $ | 497 | ||||
| Product revenue | 136 | 123 | ||||||
| Total revenue | 868 | 620 | ||||||
| Expenses: | ||||||||
| Cost of product revenues | 44 | 34 | ||||||
| Research and development | 13,482 | 9,112 | ||||||
| Selling, general and administrative | 6,263 | 5,897 | ||||||
| Total expenses | 19,789 | 15,043 | ||||||
| Loss from operations | (18,921 | ) | (14,423 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 166 | 1,016 | ||||||
| Loss on fair value of strategic investments | — | (45 | ) | |||||
| Other expense | — | (11 | ) | |||||
| Total other income | 166 | 960 | ||||||
| Net loss | $ | (18,755 | ) | $ | (13,463 | ) | ||
| Net loss per share | ||||||||
| Basic and diluted | $ | (0.49 | ) | $ | (0.38 | ) | ||
| Weighted-average shares used in computing net loss per share, basic and diluted | 38,235,409 | 35,777,877 | ||||||
| Comprehensive loss | ||||||||
| Net loss | $ | (18,755 | ) | $ | (13,463 | ) | ||
| Unrealized (loss) gain on marketable securities | (15 | ) | 2 | |||||
| Comprehensive loss | $ | (18,770 | ) | $ | (13,461 | ) | ||
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-Â Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .
Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .
Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Events link at https://investorrelations.medtronic.com .
Looking ahead to fiscal year 2026, Medtronic plans to report its first, second, third, and fourth quarter results on Tuesday, August 19, 2025 , November 18, 2025 , February 17, 2026 , and Wednesday, May 20, 2026 , respectively. For these events, confirmation and additional details will be provided closer to the specific event.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , 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 more than 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. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts:
Erika Winkels
Public Relations
+1-763-526-8478
Ryan Weispfenning
Investor Relations
+1-763-505-4626
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-to-announce-financial-results-for-its-fourth-quarter-and-full-fiscal-year-2025-302449298.html
SOURCE Medtronic plc
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2025/07/c9900.html
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Star Jones , award winning television personality & women's heart health advocate, Â helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign
A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.
The survey, endorsed by WomenHeart and conducted by Wakefield Research, found that nearly half of women (45%) were more likely to discuss sensitive topics such as politics, money, or relationships with their mother or grandmother before discussing family heart health history, despite the fact that as much as half of the risk for heart disease is hereditary.
For more than a century, heart disease has remained the leading cause of death in women, accounting for more deaths than all cancers combined. Yet, when it comes to serious heart concerns, women are up to 35% less likely to be treated with proven, minimally invasive solutions for heart valve failure than men, and women account for more than half (52%) of deaths caused by high blood pressure. 1 Additionally, women often experience heart attack symptoms differently, and heart disease disproportionately impacts women of color, with 43% of Hispanic women and 59% of Black women experiencing some form of cardiovascular disease.
The Medtronic Letter to My Mother campaign encourages women to make heart health a priority, starting with a conversation with their mother, or a woman in their life, about family history, risk factors, and the signs and symptoms of heart disease. The campaign, part of the company's ongoing commitment to leading and advancing clinical research for women's health, seeks to close the gap in awareness of heart disease and risks—particularly heart valve failure and high blood pressure—in women.
"The U.S. is at a tipping point when it comes to women's health, and heart health remains the deadliest concern of all," said Nina Goodheart , senior vice president and president, Structural Heart & Aortic, which is part of the Cardiovascular Portfolio at Medtronic. "At Medtronic, we're working relentlessly to ensure women receive personalized, evidence-based healthcare solutions, tailored to them. The launch of Letter to My Mother marks another step in our sustained commitment to improving health outcomes for all."
Results from the survey reveal a surprising disconnect between what women fear for their mothers or mother-figures as they age and the actual conversations happening around family health history:
"As women, we are our own best advocates, but without the confidence, knowledge, or resources to discuss our health history, we are missing out on potential life-saving conversations," said Star Jones , attorney, award-winning television personality & longtime women's heart health advocate. "I come from a family with a long history of heart disease, yet this was rarely a topic we talked about. If only I had acknowledged my risk for heart disease earlier, I could've potentially addressed my concerns with my cardiologist sooner before it led to needing open-heart surgery. That is why I am speaking out now to get all women talking about this disease and how addressing symptoms could save their life – like it did for me."
The survey also revealed that personal heart health is often overlooked by women in the sandwich generation, the population of women who bear the weight of making healthcare decisions for their children, parents, and family members. Almost all (94%) of women surveyed are responsible for making health-related decisions for loved ones, but over 60% of women find it hard to make their own health a priority.
"As physicians, we know heart health is not one size fits all. Women have a unique experience with heart disease and risk factors - like high blood pressure during pregnancy which may be the first sign of chronic high blood pressure persisting throughout their lifespan," said Dr. Raven Voora , hypertension specialist and nephrologist at UNC Health. "Too often, I've seen women present with risk factors or early signs of heart disease that they put on the backburner behind care for children and loved ones - or these signs and symptoms get brushed off as stress or anxiety. This survey shows us that patients need increased awareness and discussion surrounding heart health and to make sure they pay attention to their heart health."
This May, during Women's Health Month and timed to Mother's Day – Medtronic encourages people to take the pledge to talk to their mother or the women in their life about heart health today. For every pledge, Medtronic will make a donation to a cause that advances women's heart health.
Visit Alettertomymother.com to take the pledge and learn more.
About the Medtronic Letter to My Mother Survey: Â
Medtronic engaged Wakefield Research to conduct a nationally representative survey to gain insights into consumer perceptions and awareness of heart disease in women aged 30 through 50, targeted to the "daughters" who are sandwiched between taking care of their health, their children and parents. The survey was deployed among 1,000 U.S. women, ages 30 to 50, with a living mother and a living child, between March 13th and March 17th, 2025 , using an email invitation and an online survey.
Survey results are endorsed by WomenHeart: The National Coalition for Women with Heart Disease, the nation's leading voice for women living with or at risk of heart disease. WomenHeart is dedicated to promoting awareness, advocacy, and support for women with heart disease, empowering them to take charge of their heart health and improve outcomes.
About the Medtronic Letter to My Mother Campaign: Â
The Medtronic "Letter to My Mother" campaign aims to educate and close the gap in awareness of heart disease in women — the number one cause of death for more than a century. The campaign encourages people to start conversations with their mothers and loved ones about heart disease, including high blood pressure and heart valve failure, to better understand their family health history and risk factors. The campaign is part of the company's ongoing commitment to leading and advancing clinical research for women's health and was supported by the Medtronic Coronary & Renal Denervation and Structural Heart & Aortic businesses. To learn more about heart disease including signs, symptoms, treatment options and resources to start the conversation today, visit ALettertomyMother.com.
About Medtronic Â
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, 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 90,000+ passionate people across more than 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. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts:
Kimberly Powell
Public Relations
+1-202-498-2601
Ryan Weispfenning
Investor Relations
+1-763-505-4626
1 Caoimhe T Rice, Sophie Barnett, Shea P O'Connell, Enoch Akowuah, Clare E Appleby, John B Chambers, Benoy N Shah, Daniel J Blackman - Impact of gender, ethnicity and social deprivation on access to surgical or transcatheter aortic valve replacement in aortic stenosis: a retrospective database study in England: Open Heart 2023;10:e002373. |
View original content to download multimedia: https://www.prnewswire.com/news-releases/new-survey-1-in-3-women-have-not-talked-to-their-doctor-about-heart-health-the-1-killer-of-women-302448627.html
SOURCE Medtronic plc
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Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Afferaâ„¢ family of technologies, including the next-generation Sphere-360â„¢ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9â„¢ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .
Sphere-360 Study Safety and Performance
Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.
"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."
Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.
Sphere-9 for Linear Ablation
Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .
"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."
Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelectâ„¢ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.
AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .
For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , 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 more than 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. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
References
Dr. Reddy is a paid consultant for Medtronic.
Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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SOURCE Medtronic plc
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Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery  in the U.S. presented as a late-breaker at the American Urologic Association annual meeting
Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration
Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugoâ„¢ robotic-assisted surgery (RAS) system.
The data, described by the American Urologic Association (AUA) as a "practice-changing, paradigm-shifting (P2) clinical trial in urology", was presented today at the AUA annual meeting in Las Vegas by Michael R. Abern , M.D., the study's national principal investigator and a urologic surgeon at Duke University Hospital in Durham, N.C.
"The study demonstrated that the Hugo RAS system met the safety and effectiveness endpoints, and the outcomes are consistent with published literature for robotic-assisted urologic surgery," said Dr. Abern. "Having performed the first case in the Expand URO clinical study, it's incredibly rewarding to see the results of this rigorous and important study in the field of robotic surgery."
About the Expand URO clinical study:
Expand URO study primary endpoint data:
"The Expand URO clinical study provides important clinical evidence about the Hugo RAS system and is an exciting milestone that brings us closer to our goal of offering surgeons in the U.S. long-awaited choice in robotic technology," said James Porter , M.D., chief medical officer, Robotic Surgical Technologies and Digital Technologies within the Surgical business, part of the Medical Surgical portfolio at Medtronic, and a urologic surgeon at Swedish Medical Center in Seattle, WA. "Surgeons want to deliver the best care to our patients and robotic technology is key to making that possible today by enabling minimally invasive surgery and leveraging technology that is shaping the future of surgery."
U.S. FDA submission for the Hugo RAS system
Medtronic also announced today that it submitted the Hugo RAS system to the U.S. Food and Drug Administration (FDA) for a urologic indication in the first quarter of calendar 2025.
The FDA submission is the company's latest milestone toward a planned entrance into the U.S., the world's largest robotic surgery market. In February, the company shared that it completed enrollment in both its hernia and benign gynecology (GYN) studies and received approval to start a new clinical study including oncologic GYN procedures — all in support of planned submissions to the FDA for additional indications beyond urology for the Hugo RAS system in the U.S.
Outside the U.S., the Hugo RAS system is in clinical use in more than 25 countries across 5 continents, with a growing body of evidence including more than 200 independent papers published to date.
Medtronic thoughtfully designed the Hugo RAS system — through collaboration with hundreds of surgeons and hospital leaders globally — with the goal of expanding access to minimally invasive care to more patients around the world. The Hugo RAS system delivers the benefits of RAS in a flexible, modular form factor and open surgeon console that supports communication among the surgical team. Paired with the Touch Surgery™ ecosystem, the Hugo RAS system offers a smart, connected surgical experience that is shaping the future of surgery. ‡
The Hugo RAS system is not cleared or approved in all markets. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the U.S., the Hugo RAS system is an investigational device not for sale.
For more information, visit medtronic.com/hugo .
†The evaluation did not include assessment of outcomes related to the treatment of cancer or any specific treatment of any underlying disease or condition.
‡Touch Surgery ecosystem is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition; Live Stream and performance insights are only intended for education and training purposes.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, 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 more than 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. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts:
Gary Jeanfaivre
Public Relations
+1-203-556-0777
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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SOURCE Medtronic plc
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Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle
Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, received U.S. Food and Drug Administration (FDA) approval for the OmniaSecureâ„¢ defibrillation lead for placement within the right ventricle. The lead, built on the highly reliable SelectSecureâ„¢ Model 3830 pacing lead and delivered via catheter, builds on the Medtronic portfolio of lead solutions designed for precise delivery and placement. The lead connects to an implantable defibrillator, and treats potentially life threatening ventricular tachyarrhythmias, ventricular fibrillation (VTVF) and bradyarrhythmias. As the world's smallest defibrillation lead (4.7 French, or 1.6mm), the OmniaSecure lead represents a meaningful innovation in electrophysiology, and is indicated for stimulation in the right ventricle for adults and adolescent pediatric patients ages 12 and up, including those with smaller anatomies.
Separately, the company is also studying placing the novel, small-diameter OmniaSecure defibrillation lead in the left bundle branch (LBB) area, which has the potential to enable physiologic pacing to more closely mimic the heart's natural conduction system. Investigational outcomes of this study were presented at Heart Rhythm 2025 in San Diego . The results from the study demonstrate high defibrillation success of 100% at implant when the lead is implanted in the LBB area. Globally, the OmniaSecure defibrillation lead is investigational for use in LBB area and requires FDA approval in the future.
Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are the standard for preventing sudden cardiac death. The ICD/CRT-D connects to a defibrillation lead (insulated electrical wire) that forms the electrical conduit between the device and the heart. The lead senses the heartbeat, and transmits signals to the implanted device, which then delivers therapy to correct or interrupt abnormally fast rhythms. The lead must flex with millions of heart contractions over a lifetime.
Existing defibrillation leads are larger in diameter than the OmniaSecure lead. A larger-diameter lead may increase the potential for downstream complications, such as venous occlusion or tricuspid valve regurgitation.
"FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimize complications−including vascular complications and valve interaction−with strong, reliable lead durability. We engineered the OmniaSecure lead based on the trusted SelectSecure Model 3830 pacing lead, which has been the lead of choice for many physicians for more than 20 years," said Alan Cheng , M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "This milestone underscores our commitment to driving clinical innovations that help patients today while paving the way for future innovations that will usher in the next era of electrophysiology."
Previously, researchers presented late breaking data from the global Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal Trial showing the OmniaSecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals when placed within the right ventricle. The results were presented during Heart Rhythm 2024, simultaneously published in Heart Rhythm , and are the basis of FDA approval for the traditional right ventricular lead placement indication.
Late-Breaking LEADR LBBAP Results Presented at Heart Rhythm 2025
Researchers presented late-breaking results at Heart Rhythm 2025 for the LEADR LBBAP (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing) study that showed the OmniaSecure defibrillation lead demonstrated high defibrillation success when placed in the LBB area for patients indicated for an ICD or CRT-D. Placing the defibrillation lead in the LBB area is being evaluated as an alternative to right ventricular stimulation for sensing, pacing, cardioversion and defibrillation.
Defibrillation testing conducted in 162 patients at device implantation was successful in 100% of cases, with the study meeting the prespecified efficacy goal of 88%. Of the first 193 patients implanted in the study, the OmniaSecure lead was successfully implanted per protocol in 95.8% of the procedures as reported by physician investigators. There were no procedure-related major complications such as early helix or lead fracture, system revision, or death.
"The left bundle branch area is emerging as an option for more physiologic pacing for patients who receive an ICD or CRT-D to treat dangerous heart rhythms," said Pugazhendhi Vijayaraman, M.D., cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa. , who presented the data at the meeting. "The option to place a lead in the left bundle branch area may provide for physiologic pacing by engaging the heart's natural conduction system. These positive preliminary results for the LEADR LBBAP study are encouraging and highlight the potential versatility of the OmniaSecure defibrillation lead."
The LEADR LBBAP trial is a global, prospective, non-randomized, multi-center study. The study has enrolled approximately 300 patients at 24 sites in 11 countries in North America , Europe , Asia and Australia . Patients enrolled in the study indicated for an ICD are being followed out to 3 months while patients indicated for CRT-D are being followed out to 6 months post-implant.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, 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 more than 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. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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SOURCE Medtronic plc
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