Zero Candida Announces Plans to Complete Preclinical Studies for FDA Submission by Q3 2025

Zero Candida Technologies, Inc. (TSXV: ZCT), (FSE: 9L2) (the "Company" or "ZCT"), an Israeli FemTech medical device company focused on revolutionizing women's health, announces plans to complete preclinical studies for FDA submission by Q3 2025. In accordance with FDA requirements, the company is preparing to conduct a full preclinical study of its final human-use device in up to 24 additional sheep.

The company has successfully completed a two sheep protocol pilot trial in November 2023, and is now preparing to expand the study. The ZC-1-A device was confirmed as 100% safe for use, with findings concluded from the Shamir Medical Center.

Conclusions from the Shamir Medical Center: two healthy, naïve sheep were exposed to intravaginal pulsating blue light for 3 hours using the Zero Candida ZC-1-A device. After the illumination procedure, both animals were examined postmortem and autopsy showed no abnormal findings. Pathological evaluation of the relevant harvested organs showed no signs of thermal lesions or other pathological changes. The pathology laboratory declared the Zero Candida ZC-1-A blue light illumination device safe to use.

The ZC-1-A device combines a therapeutic light source with a selected wave-length and intensity to not only destroy Vulvo-Vaginal Candidiasis ("VVC") at record speed, but is also AI-driven to transmit data in real-time to the attending physician for hybrid medicine and personalized treatment consulting. More commonly known as yeast infections, VVC affects 3 out of 4 women globally, and ZCT is providing a solution that addresses the root cause, without chemicals or side effects, breaking down barriers in this space. Zero-Candida technology (ZCT) is FemTech developing an AI smart tampon-like device based on therapeutic light source with a selected wave-length and intensity that can treat the Candida fungus successfully of 99.999% an POC overnight. Vulvo-Vaginal Candidiasis ("VVC") affects about 75% of women globally, ZCT device is a Game changer that has the potential to change the treatment of women and the FemTech industry in the world. The first of its kind technology using a controlled "Blue Light," destroys the vagina fungus at record speed and without side effects. The treatment is Safety & carried out by a tampon-like medical device which, according to medical experts, provides an optimal solution for removing the fungus altogether and preventing the recurrence of the disease.

Zero Candida is working on creating a technology to enable the hybrid medicine services to be provided by gynecologists to populations that until now received no treatment at all, including, among others, in the developing countries. The ZCT device is Collect and transmits treatment data to the attending physician in real time, for assessment, treatment personalization and monitoring. Seamless data transfer through Wi-Fi chip and VoIP, allows for the convenience of remote care and treatment consulting. Another significant advantage of the Zero Candida device is treatment without side effects, supporting growing demand from women to improve their health without the use of chemicals.

Eli Ben Haroosh, Founder & CEO stated: "Zero Candida is a groundbreaking and game-changing company in the world of women's medicine & women's health and non-drug treatments technology, I believe that in 2025 we will present to investors the completion of the sheep animal study with full success. From there, the path to clinical research in women will be very close".

Dr. Asher Holzer CTO & Director added: "As the company's chief scientist, Zero Candida is a world leader in technology that includes hybrid medicine, we are a team of highly senior researchers leading unique research into a solution and remedy for hundreds of millions of women around the world who suffer from vaginal yeast infection".

About Zero Candida:

Zero Candida (ZCT) is a publicly traded FemTech company pioneering innovative solutions in women's health. The company is developing an AI-driven, tampon-like device that uses a therapeutic light source with a selected wave-length and intensity to effectively treat the Candida fungus with a demonstrated 99.999% success rate in POC. Vulvo-Vaginal Candidiasis ("VVC") affects about 75% of women globally, with 138witheach year 138 million women are affected world-wide and 492 million over their lifetime. Recurrent VVC (4 or more episodes per year) is increasingly documented to become drug resistant to existing treatments, since the root cause is poorly understood and addressed. ZCT has successfully completed a safety trial using its pre-clinical device in large animals (sheep), and is finalizing their device for human use in preparation for an upcoming clinical trial, that they secured both funding and agreements with leading hospitals in Israel and Europe for. The Company continues to grow it's global patent portfolio with applications filed in the United States, Brazil and Europe, and was recently granted a final patent in South Africa. With hybrid medicine and technology-based diagnostics, ZCT is addressing unmet needs in women's healthcare and expanding access to underserved populations, bringing the field of gynecology into the 21st century. To learn more visit www.zero-candida.com

ZCT has signed pre-clinical agreements with hospitals in Israel and Europe and the company has successfully completed a safety trial for the use of a pre-clinical device in large animals (sheep) ZCT continues the development of the final product for human use in preparation for a clinical trial that will take place in June 2025.

Zero Candida's device will bring the field of gynecology into the 21st century with hybrid medicine and technology-based diagnostics. At the same time as developing the treatment procedure, Zero Candida is working on creating a technology to enable the hybrid medicine services to be provided by gynecologists to populations that until now received no treatment at all, including, among others, in the developing countries.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this press release.

Forward-Looking Statements

This news release includes certain statements and information that constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, are forward-looking statements. The Company provides no assurance that forward-looking statements and information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements or information. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company does not undertake to update any forward-looking statements, other than as required by law. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by Zero Candida. Readers are cautioned not to place undue reliance on forward-looking statements.

Contacts:
VictoriaGamble
victoria@zero-candida.com
(647) 874 3767

Eli Ben Haroosh
CEO & Founder
info@zero-candida.com

Source

Click here to connect with Zero Candida Technologies, Inc. (TSXV: ZCT), (FSE: 9L2) to receive an Investor Presentation

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Zero Candida Technologies Inc. Opens the Market

Eli Ben-Haroosh, Co-Founder and Chief Executive Officer, Zero Candida Technologies Inc. (TSXV: ZCT) ("Zero Candida" or the "Company"), joined Dani Lipkin, Managing Director, Global Innovation Sector, Toronto Stock Exchange, to open the market to celebrate the Company's new listing on the TSX Venture Exchange.

Zero Candida Technologies, Inc. (ZCT), is a medical device company bringing female healthcare into the 21st century. They are transforming the treatment of Vulvo-Vaginal Candidiasis ("VVC"), which affects 75% of women worldwide, often recurrent and increasingly drug-resistant with current treatments failing to address the root cause effectively. Free from chemicals and side effects, their AI-driven tampon-like device enables real-time data collection and transmission to physicians for personalized, at-home treatment. Beyond VVC, ZCT aims to revolutionize gynecology, improving access for underserved populations and advancing hybrid medicine.

Please refer to the Company's website here.

MEDIA CONTACT:
Victoria Gamble
Corporate Development Consultant
victoria@zero-candida.com
416-706-0332

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/231280

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Zero Candida Applies to List its Shares on the TSX Venture Exchange

Zero Candida Technologies Inc. (the "Company" or "Zero Candida") (TSXV: ZCT), a technology company focused on development and commercial exploitation of a number of patents and patent applications with respect to an AI smart tampon-like device, designed to treat Candidiasis and transfer the medical information via Wi-Fi to the doctor, is pleased to announce that it has filed its application to list the Company's common shares (the " Common Shares ") on the TSX Venture Exchange (the " TSXV "). The application is available under the Company's profile on SEDAR+.

Zero Candida (formerly 1319743 B .C. Ltd.), has recently completed its business acquisition of Zero Candida Ltd., an Israeli private company ("ZC" and "Acquisition" respectively). In connection with the completion of the Acquisition, the Company changed its name to Zero Candida Technologies Inc. and split its share capital on a fifty-five thousand five hundred fifty five (55,555) common shares for one (1) common share basis, so that 36 common shares of the Company, without par value which were issued and outstanding immediately before completion of the Acquisition, were split into 2,000,000 common shares without par value. Pursuant to the terms of the Acquisition, the Company issued a total of 17,533,037 common shares (9.6165 common shares in the capital of the Company for each ordinary share in the capital of ZC) (the " Payment Shares "). Following completion of the Acquisition, ZC became a wholly-owned subsidiary of the Company. In addition, in connection with closing of the Acquisition, the Company issued 1,450,643 incentive stock options to employees of ZC (9.6165 incentive Options in exchange for each currently outstanding ZC Option). The terms of the exercise of the Options shall be consistent with the terms of the originally issued underlying ZC securities.

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Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

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 Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ 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 PulseSelect™ 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

Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

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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Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

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 Hugo™ robotic-assisted surgery (RAS) system.

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

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, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

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Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

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 it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.

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Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

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 that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

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Investing News NetworkYour trusted source for investing success

Zero Candida Announces Plans to Complete Preclinical Studies for FDA Submission by Q3 2025

Moore Market analysis: Zero Candida potential market will reach over $2 Billion by 2030

Zero Candida Technologies Inc. Opens the Market

Zero Candida Applies to List its Shares on the TSX Venture Exchange

Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

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