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EmblemHealth Commits $2 Million To Combat Food Insecurity in New York City

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EmblemHealth Commits $2 Million To Combat Food Insecurity in New York City




EmblemHealth Commits $2 Million To Combat Food Insecurity in New York City

EmblemHealth partners with local food charities through its 15 Neighborhood Care centers to battle hunger in the Big Apple

NEW YORK, Sept. 25, 2025 (GLOBE NEWSWIRE) — New York City’s food pantries are struggling with dwindling funds while facing an increasing demand for their vital services. In response, EmblemHealth — a dedicated not-for-profit health plan with a strong community mission — has pledged $2 million to support food security in the diverse communities it serves. This substantial financial investment is focused on hunger, which has become a significant barrier to maintaining health or seeking healthcare services.

Food insecurity is now the most acute need for individuals and families visiting EmblemHealth Neighborhood Care centers. “We recognize that New Yorkers are currently facing significant challenges and need help feeding their families,” stated EmblemHealth’s Chief Financial Officer Heather Tamborino. “This investment demonstrates our deep commitment to uplifting the communities we serve and also aims to serve as a rallying call for others to join us in addressing this urgent need.”

Recent reports highlight the profound impact of budget cuts on crucial programs, like the Supplemental Nutrition Assistance Program (SNAP), that were compounded by challenges following the suspension of FEMA’s Emergency Food and Shelter Program in February. With these additional cutbacks, many essential programs are struggling to keep their shelves stocked, leaving countless families at risk of hunger.

Through partnerships with The Campaign Against Hunger, City Harvest, and The New York Common Pantry, EmblemHealth will increase its outreach efforts and strengthen its food security effort. By supporting these food justice organizations, EmblemHealth is actively promoting food security and advocating for equitable availability of nutritious food.

EmblemHealth’s funding will also support a variety of food distribution events in the community. At EmblemHealth Neighborhood Care centers, New Yorkers can receive free food at distribution events alongside additional health resources such as free nutrition, fitness, or stress relief classes and connections to community resources. EmblemHealth’s Community Affairs team will host pop-up food distributions and farmers markets in partnership with community-based organizations and local elected officials throughout New York City.

EmblemHealth hopes to inspire other organizations to create a lasting impact in the fight against food insecurity and ensure that New Yorkers can reliably receive essential nutrition during these challenging times. EmblemHealth remains committed to doing what is necessary to improve health outcomes for the communities it serves.

To find upcoming food distribution events and community pop-up events near you, visit emblemhealth.com/food.

Congressman Dan Goldman (NY-10) said, “With the cost of living at record highs, too many working families in New York are struggling just to put food on the table. EmblemHealth’s $2 million investment will make a real difference for our neighbors across the five boroughs, expanding access to healthy food and strengthening the community organizations on the frontlines of fighting hunger every day.” 

Assemblyman Steven Raga (AD-30) said, “No one should ever have to choose between going hungry or paying rent. Now more than ever, we need to work together and provide resources to families who are struggling to put food on the table. This $2 million investment represents an important step towards ensuring hungry New Yorkers have access to nutritious and fulfilling food. Thank you so much to EmblemHealth for leading this important initiative.”

“It’s heartbreaking that one in four children in New York City don’t always know where their next meal will come from. As a result of the immoral cuts that the federal government has made to SNAP and other vital safety net programs, that number is only going to increase – harming not only our children, but also older adults and vulnerable members of our communities,” said Mayor’s Office of Food Policy Executive Director Kate MacKenzie. “I am grateful to EmblemHealth for their generous commitment to food access in communities that need it most so that families have an easier time putting meals on the table.”

Dr. Melony Samuels, Founder and CEO, The Campaign Against Hunger, said, “EmblemHealth has been a valued partner in showing how access to food strengthens the foundation of resilient communities. Our continued partnership is about reaching more New Yorkers and ensuring that nutritious food isn’t out of reach for those who need it most.”

Jilly Stephens, CEO, City Harvest, said, “With EmblemHealth’s support, City Harvest is strengthening our ability to sustainably source and deliver nutritious food for free to New Yorkers at a time when visits to NYC soup kitchens and pantries are at a record high. This collaboration will make a real difference in the lives of our neighbors experiencing food insecurity.”

Stephen Grimaldi, Executive Director, New York Common Pantry, said, “At New York Common Pantry, we work tirelessly to reduce food insecurity through programs that provide meals and support long-term independence in the communities we serve. EmblemHealth’s support helps us meet urgent needs today while equipping families with the tools and support they need to strengthen their long-term well-being.”

About EmblemHealth

EmblemHealth is one of the nation’s largest not-for-profit health insurers, serving members across New York’s diverse communities with a full range of commercial and government-sponsored health plans for employers, individuals, and families. With a commitment to value-based care, EmblemHealth partners with top hospitals and doctors, including its own AdvantageCare Physicians, to deliver quality, affordable, convenient care. At over a dozen EmblemHealth Neighborhood Care locations, members and nonmembers alike have access to community-based health and wellness guidance and resources. For more information, visit emblemhealth.com.

Contact: EmblemHealth Public Relations Office | Email: press@emblemhealth.com

Safety Shot Partners with Monarq Asset Management to Actively Manage BONK Holdings Treasury

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Safety Shot Partners with Monarq Asset Management to Actively Manage BONK Holdings Treasury




Safety Shot Partners with Monarq Asset Management to Actively Manage BONK Holdings Treasury

Institutional-Grade Asset Manager Retained to Monetize BONK Treasury, Generate Yield, and Preserve Shareholder Value

SCOTTSDALE, AZ, Sept. 25, 2025 (GLOBE NEWSWIRE) — Safety Shot, Inc. (Nasdaq: SHOT) today announced a strategic alliance with Monarq Asset Management, a leading multi-strategy digital asset investment manager, to oversee the active management of its BONK Holdings LLC subsidiary.

Monarq Asset Management will manage the Company’s digital asset treasury, which currently holds over $50 million in BONK tokens, with a clear three-pronged mandate designed to create a self-sustaining financial model and enhance shareholder value:

  • Active Treasury Management: Employ sophisticated, institutional-grade strategies to manage the Company’s significant BONK holdings.
  • Yield Generation & Accumulation: Actively monetize the BONK treasury through strategies such as staking and yield farming to generate new, non-dilutive revenue streams and strategically accumulate more BONK.
  • Wealth Preservation: Implement advanced hedging strategies to mitigate downside risk and protect the value of the treasury for shareholders.

This active management strategy is designed to generate sufficient yield to cover the Company’s public operating expenses, creating a self-sufficient model for growth. This new revenue stream from active treasury management is separate from and in addition to the Company’s 10% revenue sharing interest in the highly profitable memecoin launchpad, letsBONK.fun.

“Partnering with a firm of Monarq’s caliber is a pivotal step in our evolution,” said Jarrett Boon, CEO of Safety Shot. “This isn’t a passive treasury strategy; we are actively putting our digital assets to work to generate significant returns and protect shareholder value. Monarq’s expertise in quantitative trading and derivatives will allow us to monetize our BONK holdings in a sophisticated manner, with the goal of creating a self-funding engine for our growth.”

Mitchell Rudy (a.k.a. Nom), a BONK core contributor, added, “Bringing in a top-tier firm like Monarq Asset Management is a critical step in professionalizing our treasury and executing our vision at the highest level. Their deep expertise in quantitative strategies and risk management is exactly what we need to actively monetize our BONK holdings, generate sustainable yield, and protect our balance sheet. This isn’t just about holding an asset; it’s about making that asset productive for our shareholders. Partnering with Monarq ensures we have the institutional-grade horsepower to do just that.”

This alliance is expected to accelerate Safety Shot’s strategy of transforming into the premier public vehicle for investors to gain exposure to the growth of the BONK ecosystem, backed by real revenue and sophisticated, institutional-grade asset management.

About Safety Shot, Inc. Safety Shot, Inc. (Nasdaq: SHOT), is a company evolving bridge the gap between traditional public markets and the digital asset ecosystem. Following its strategic integration with letsBONK.fun, the Company is executing a new strategy focused on acquiring revenue-generating assets within the DeFi space to build a robust treasury of digital assets. The Company’s beverage division holds the patented Sure Shot beverage, designed to rapidly reduce blood alcohol content as well as Yerbaé’s plant-based, energy beverage.

Investor Relations: Phone: 561-244-7100 Email: investors@drinksafetyshot.com

Forward-Looking Statements: This press release contains forward-looking statements. Such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, and actual results could differ materially. Factors that could cause or contribute to such differences include, but are not limited to, the performance of BONK tokens, the successful integration and operational success with letsBONK.fun, the ability to execute on the Company’s treasury strategy, and other risks detailed in Safety Shot’s filings with the Securities and Exchange Commission.

Philips joins Optum Healthcare’s network as a preferred provider in the USA

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Philips joins Optum Healthcare’s network as a preferred provider in the USA




Philips joins Optum Healthcare’s network as a preferred provider in the USA

September 25, 2025

Philips’ ambulatory and diagnostic solutions and services are now available to 3.4 million Optum policyholders for enhanced outpatient cardiac monitoring

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has entered a national partnership in the USA with Optum Healthcare. The inclusion of Philips’ Mobile Cardiac Telemetry (MCOT) and Philips Extended Holter (ePatch) in the network is designed to enable earlier detection of cardiac conditions and timely clinical intervention. By expanding access to advanced cardiac ambulatory monitoring services for Optum members and streamlining the patient referral process, this collaboration supports proactive care and improved patient outcomes. Philips’ industry-leading solutions are now available to Optum Healthcare’s 3.4 million members in 22 U.S. states.

The access to Philips technology within the network offers several significant benefits for patients, providers and payers:

  • Reduced delays in specialist referrals: Streamlined processes help to minimize waiting times for cardiac condition referrals.
  • Enhanced diagnostic insights: Improved access to diagnostic data supports more informed clinical decision-making for cardiac issues.
  • Seamless care coordination: Ensures smooth transitions throughout the patient journey, from the initial visit to post-discharge.
  • Increased patient compliance: User-friendly monitoring and diagnostic devices can encourage better adherence to treatment plans.

These components are crucial in managing chronic conditions effectively.

“Today marks a great step forward in Philips’ ability to reach even more patients and help them receive the care they deserve,” said Julia Strandberg, Chief Business Leader, Connected Care, at Royal Philips. “As a preferred in-network provider, Philips’ cardiac ambulatory monitoring services empower primary care physicians and cardiologists with actionable data that enables them to build stronger collaboration across care teams and can ultimately improve patient outcomes.”

Through this partnership with Optum, Philips is expanding access to its MCOT and ePatch cardiac monitoring solutions across commercial, Medicare, Medicare Advantage or Managed Medicare, and Medicaid plans. These wearable technologies empower clinicians with insights to accelerate clinically smart cardiac care [1], while enabling patients to maintain their daily routines with confidence. This collaboration helps to support providers in delivering efficient care and helps payers advance value-based models. 

[1] Data on file.


For further information, please contact:
Allison Johnson
Business Communication Director, Philips
Tel: +1 617-631-7305
E-mail: allison.johnson@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.

Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2024 sales of EUR 18 billion and employs approximately 67,300 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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HealthEquity Strengthens Executive Leadership Team with Strategic Appointments to Drive Growth and Innovation

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HealthEquity Strengthens Executive Leadership Team with Strategic Appointments to Drive Growth and Innovation




HealthEquity Strengthens Executive Leadership Team with Strategic Appointments to Drive Growth and Innovation

New CMO and Sales Executive Join from Mastercard and EverQuote to Capitalize on Historic HSA Market Expansion

DRAPER, Utah, Sept. 25, 2025 (GLOBE NEWSWIRE) — HealthEquity, Inc. (Nasdaq: HQY), the nation’s largest Health Savings Accounts (HSAs) and consumer-directed benefits administrator, today announced the appointment of new senior executives to accelerate the company’s strategic vision and capitalize on expanding market opportunities. Mukund Ramachandran joins as Chief Marketing Officer and Garett Kitch as Senior Vice President of Client Sales & Relationship Management, effective September 29, 2025.

The appointments come as HealthEquity continues to execute against record financial performance, alongside the largest HSA eligibility expansion in 20 years following recent federal legislation.

The legislation represents significant market expansion opportunities, allowing Direct Primary Care arrangements, low-cost telehealth services, and all individual Bronze and Catastrophic ACA plans to be coupled with HSAs beginning January 1, 2026. With over 7M people currently enrolled in bronze plans and approximately 90% of these plans previously ineligible for HSAs, HealthEquity is uniquely positioned to capture this expanded market through its broad partner network and enhanced consumer enrollment experience.

Mukund Ramachandran Appointed Chief Marketing Officer
Ramachandran brings more than 25 years of B2B marketing and communications leadership across fintech, adtech, and martech. Most recently, he served as SVP, Head of B2B Marketing for Commercial & New Payment Flows at Mastercard, where he shaped global messaging, advanced sales enablement, and executed integrated marketing programs that fueled significant growth. Prior to Mastercard, he was a senior marketing leader at Dynamic Yield (later acquired by Mastercard), where he helped transform the company from a startup into a recognized category leader. Earlier in his career, he held marketing and strategy positions across the media and technology sectors, further broadening his expertise in scaling brands and driving market adoption.

In his new role, Ramachandran will be responsible for developing and executing HealthEquity’s enterprise-wide marketing strategy. He will lead product marketing and go-to-market execution, while overseeing execution and strategies to strengthen brand reputation and engagement across both B2B and B2C audiences.

Garett Kitch Named SVP, Client Sales & Relationship Management
Kitch joins HealthEquity with two decades of experience building and leading high-performing sales teams in tech-enabled businesses. As Chief Sales Officer at EverQuote, he led revenue-generating functions for the publicly traded insurtech company. Previously, Kitch served in progressive leadership roles at eHealth, Inc., where he led Medicare sales operations with P&L responsibility for $420M in revenue and managed teams of over 2,200 members. He also held senior positions at Vivint, where he established the Channel Partner division from startup to major acquisition channel.

Kitch will define and implement HealthEquity’s multi-year sales strategy focused on organic growth, new logo acquisition, and expansion across direct and partner-assisted channels. He will lead efforts to build executive-level relationships with key clients, brokers, and strategic partners while developing differentiated engagement strategies by client segment.

Driving Strategic Vision and Innovation
The new leadership appointments support HealthEquity’s strategic focus on leveraging technology innovation to enhance member and client experiences. The company continues to advance its AI-powered solutions, including expedited claims processing that has automated millions of dollars in reimbursements while improving member satisfaction and reducing costs. HealthEquity’s Assist portfolio and Member First Secure Mobile Experience, which now boasts 1.7M downloads, demonstrate the company’s commitment to technological excellence.

“These key additions to our executive team strengthen our ability to execute against our vision of helping Americans better save, spend, and invest for health. As we capitalize on the largest HSA expansion in 20 years and continue innovating with AI-powered solutions, Mukund and Garett will bring the expertise and leadership needed to drive our next phase of growth,” said Michael Fiore, Chief Commercial Officer. “Mukund’s proven track record of building high-performance marketing organizations and driving measurable pipeline growth makes him the ideal leader to elevate our brand and accelerate customer acquisition, while Garett’s exceptional track record of scaling sales organizations aligns perfectly with our mission to expand market leadership. Their combined experience in financial services, insurance, and both B2B and B2C marketing will be invaluable as we modernize our approach and expand our reach to new consumer segments through recent legislative changes.”

Both Ramachandran and Kitch will report to Fiore, strengthening HealthEquity’s go-to-market capabilities as the company pursues new consumer-driven strategies while maintaining its leadership position with employers and partners.

About HealthEquity
HealthEquity and its subsidiaries administer HSAs and other consumer-directed benefits for more than 17 million accounts in partnership with employers, benefits advisors, and health and retirement plan providers who share our mission to better save and improve lives by empowering healthcare consumers. For more information, visit www.healthequity.com.

Media Contact
Atiya Easterling
pr@healthequity.com

Femasys Accelerates European Growth for FemBloc® with Kebomed Partnership

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Femasys Accelerates European Growth for FemBloc® with Kebomed Partnership




Femasys Accelerates European Growth for FemBloc® with Kebomed Partnership

— Femasys leverages Kebomed’s pan-European distribution strength to drive adoption of FemBloc permanent birth control in France and Benelux, unlocking significant market access —

ATLANTA, Sept. 25, 2025 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today a partnership with Kebomed, a leading European distributor of medical devices and equipment, to commercialize FemBloc Permanent Birth Control in France and the Benelux region (The Netherlands, Belgium, and Luxembourg). With France representing the largest single-market opportunity for FemBloc in Europe, this collaboration significantly expands access to the only non-surgical permanent birth control option and represents a major milestone in Femasys’ European growth strategy following recent CE mark approval.

“We are thrilled to partner with Kebomed, a leading distributor with deep expertise in women’s health and strong market access in key markets across Europe,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “France is a large market opportunity for FemBloc in the region, and Kebomed’s established infrastructure and gynecology-focused portfolio, make them the ideal partner to expand access, accelerate adoption, and unlock significant growth potential.”

Søren Dalmark Kornerup, Chairman of Kebomed Europe AG, stated, “FemBloc represents a revolutionary advancement in women’s health. With our strong presence in gynecology and established European network, we are well positioned to drive adoption in France and Benelux. Adding this permanent contraceptive solution further strengthens our women’s health portfolio and reinforces our leadership in this important field.”

FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control, addressing a significant unmet need in women’s reproductive health. It uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue for permanent occlusion. In contrast to surgical sterilization, FemBloc eliminates the risks of anesthesia, infection, and recovery downtime, making it safer, more accessible, and significantly more cost-effective. With no comparable alternatives on the market, FemBloc represents a disruptive advancement with broad global potential. Learn more at www.FemBloc.com.

About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1

FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.

Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

About Kebomed
Kebomed Europe AG is a leading independent distributor of medical devices with more than 30 years of heritage and a strong footprint across Europe. Founded in 1995 in Scandinavia, the company expanded through acquisitions in the UK, Benelux, Norway, followed by France, Switzerland, Germany, and Austria, establishing itself as one of the few truly pan-European platforms.

Women’s health has long been a strategic focus for Kebomed, supported by its close relationship with LiNA Medical, an innovator in minimally invasive gynecology owned by the same family. Through this connection, Kebomed distributes LiNA products in select European markets, strengthening its portfolio and reinforcing its leadership and deep clinical expertise in this important therapeutic area.

More information on Kebomed can be found at www.kebomed.com.        

References
1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.

2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.

Forward-Looking Statements 
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.

Contacts: 
David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com

Silexion Therapeutics Regains Compliance with Nasdaq Listing Requirements

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Silexion Therapeutics Regains Compliance with Nasdaq Listing Requirements




Silexion Therapeutics Regains Compliance with Nasdaq Listing Requirements

Company Successfully Meets Both Minimum Bid Price and Shareholders’ Equity Requirements, Securing Continued Listing on the Nasdaq Capital Market

GRAND CAYMAN, Cayman Islands, Sept. 25, 2025 (GLOBE NEWSWIRE) — Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company“), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced that it has received written notification from The Nasdaq Stock Market LLC (“Nasdaq“) confirming that the Company has regained compliance with both Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), concerning the minimum bid price and shareholders’ equity requirements.

The letter, dated September 23, 2025, confirmed that the Company has successfully met the minimum bid price requirement of $1.00 per share. Additionally, Nasdaq confirmed that Silexion has regained compliance with the $2.5 million minimum shareholders’ equity requirement. Accordingly, the Company will continue to be listed on the Nasdaq Capital Market.

“We are pleased to have regained full compliance with Nasdaq’s listing requirements,” said Ilan Hadar, Chairman and CEO of Silexion Therapeutics. “This milestone reinforces our strong financial foundation as we advance toward our planned Phase 2/3 clinical trials for SIL204 in the first half of 2026. With our recent preclinical data demonstrating up to 97% inhibition rates with activity across multiple KRAS-driven cancer types and our strategic CRO collaboration now in place, we remain focused on executing our clinical development strategy and working to deliver transformative RNAi therapies to patients with difficult-to-treat cancers.”

About Silexion Therapeutics

Silexion Therapeutics is a pioneering clinical stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer. For more information please visit: https://silexion.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including statements regarding Silexion’s business strategy, clinical development plans, timeline for Phase 2/3 trials, and expectations regarding SIL204’s therapeutic potential, are forward-looking statements. These forward-looking statements are generally identified by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion’s ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion’s strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion’s future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) Silexion’s ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed or to be filed with the SEC by the Company, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 18, 2025. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.

Company Contact:
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com

Capital Markets & IR Contact:
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com

Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025

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Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025




Pfizer Highlights Momentum in Redefining Standards of Care in Cancer at ESMO 2025

More than 45 abstracts, including five late-breaking presentations and recognition in Presidential Symposium, showcase impact of approved medicines and potential of next-generation pipeline

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany. Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer’s core scientific modalities and key tumor areas.


“At ESMO, Pfizer is demonstrating how earlier interventions with our innovative medicines have the potential to deliver greater impact to even more patients,” said Jeff Legos, Chief Oncology Officer, Pfizer. “The survival benefits we’re seeing across certain cancer types reinforce our commitment to accelerating innovative medicines that bring new hope to patients everywhere, while pipeline data highlight the next wave of potential breakthroughs that could transform care for even more people living with cancer.”

Pfizer will share highlights from its leading Oncology portfolio at ESMO, including:

  • In a Presidential Symposium, unprecedented survival results from the Phase 3 EV-303 trial (KEYNOTE-905) evaluating PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate (ADC), plus KEYTRUDA® (pembrolizumab)* in patients with muscle-invasive bladder cancer who are ineligible for or declined cisplatin-based chemotherapy, showing potential to redefine standard of care in these patients (Presentation #LBA2)
  • Final overall survival results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide)** in combination with leuprolide and as monotherapy in non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence, highlighting the benefit of XTANDI in this earlier line of treatment (Presentation #LBA87)
  • Updated overall survival data from the Phase 2 PHAROS study of BRAFTOVI® (encorafenib) plus MEKTOVI® (binimetinib)*** in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC), reinforcing this combination as a potential key treatment option for these patients (Presentation #1849MO)

Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here.

Presentation Title

Details

Genitourinary Cancer

 

Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study [Merck/MSD-led]

 

Vulsteke et. al

Presidential Symposium (Presentation #LBA2)

Saturday, October 18, 2025, 4:30 PM CEST

 

Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression [Remegen-led]

 

Sheng et. al

Presidential Symposium (Presentation #LBA7)

Sunday, October 19, 2025, 4:30 PM CEST

 

Overall survival with enzalutamide in biochemically recurrent prostate cancer

 

Freedland et. al

Oral Presentation (Presentation #LBA87)

Sunday, October 19, 2025, 10:55 AM CEST

 

Randomised phase 3 trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303)****

 

Nguyen et. al

Oral Presentation (Presentation #LBA86)

Sunday, October 19, 2025, 10:15 AM CEST

Thoracic Cancer

 

Updated overall survival analysis from the phase 2 PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC)

 

Johnson et. al

Mini Oral Presentation (Presentation #1849MO)

Sunday, October 19, 2025, 8:30 AM CEST

 

Enfortumab vedotin plus pembrolizumab (EV + P) as first-line (1L) treatment in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): results from a cohort of the EV-202 trial [Astellas led]

 

Swiecicki et. al

Mini Oral Presentation (Presentation #1329MO)

Sunday, October 19, 2025, 4:30 PM CEST

 

 

Breast Cancer

 

Health-Related Quality of Life (HRQoL) from the PATINA Trial (AFT-38): Impact of Adding Palbociclib to HER2 and Endocrine Therapy (ET) after Induction in HR+/HER2+ Metastatic Breast Cancer (MBC)

 

Ines Vaz-Luis et. al

Mini Oral Presentation (Presentation #485MO)

Monday, October 20, 2025, 10:15 AM CEST

 

 

Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)−advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial*****

 

Campone et. al

Mini Oral Presentation (Presentation #489MO)

Monday, October 20, 2025, 10:15 AM CEST

Gastrointestinal Cancer

 

Circulating tumor (ct) DNA analysis of BRAF V600E dynamics and changes in genomic landscape in patients (pts) with first-line (1L) BRAF V600E-mutant metastatic colorectal cancer (mCRC) treated in BREAKWATER******

 

Kopetz et. al

Mini Oral Presentation (Presentation #729O)

Monday, October 20, 2025, 08:30 AM CEST

 

Cancer-Related Conditions

 

Efficacy and safety of ponsegromab in patients with cancer-associated cachexia: Results from the open-label extension of a randomized, placebo-controlled, Phase 2 study

 

Crawford et. al

Oral Presentation (Presentation #LBA102)

Friday, October 17, 2025, 4:00 PM CEST

 

* Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in patients with previously untreated metastatic urothelial cancer.

** XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States.

*** The PHAROS trial is conducted with support from Pierre Fabre.

**** Led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP) with Astellas funding

***** Pfizer and Arvinas have a global collaboration for the co-development and co-commercialization of vepdegestrant.

****** The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company.

Prescribing Information for Pfizer Medicines

Please see full Prescribing Information, including BOXED WARNING, for PADCEV® (enfortumab vedotin).

Please see full Prescribing Information for XTANDI® (enzalutamide).

Please see full Prescribing Information for BRAFTOVI® (encorafenib).

Please see full Prescribing Information for MEKTOVI® (binimetinib).

Please see full Prescribing Information for IBRANCE® (palbociclib) tablets and IBRANCE® (palbociclib) capsules.

About Pfizer Oncology

At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of September 25, 2025. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer Oncology, Pfizer’s Oncology portfolio of marketed and investigational therapies, including combinations, and an investigational therapy for a cancer-related condition; expectations for our product pipeline, in-line products and product candidates, including their potential benefits, clinical trial results and other developing data; potential breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; and other statements about our business, operations and financial results that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Contacts

Media Contact: PfizerMediaRelations@Pfizer.com

Investor Contact: IR@Pfizer.com

Marginum HIVEN® for Neurosurgery Is Cleared for CE Mark at Record Speed

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Marginum HIVEN® for Neurosurgery Is Cleared for CE Mark at Record Speed




Marginum HIVEN® for Neurosurgery Is Cleared for CE Mark at Record Speed

KUOPIO, Finland–(BUSINESS WIRE)–#hiven–Marginum announces a significant milestone as its flagship device, HIVEN®, is cleared for the CE mark. The underlying MDR certification signifies an important regulatory milestone.




Marginum, a Finnish medical technology company, made rapid strides in validating the aspirate tissue monitoring (ATM) technique and received the MDR certificate at a record-breaking speed, just over 4.5 years. Marginum’s team successfully developed a breakthrough class IIb medical device that addresses an unmet clinical need to accurately detect tumorous tissue during surgery, without compromising existing workflows.

New era of precision in cancer surgery

HIVEN® is a novel device for assisting in intraoperative margin assessment that provides near real-time feedback to support surgeons in achieving a safer and more complete tumour resection. By providing surgical teams with immediate insight into the tumour margins while resecting, the device aims to improve patient outcomes and reduce the likelihood of reoperations. HIVEN® is designed to detect fluorescent cancer tissue from aspirated tissue during surgery without disrupting standard workflow.

“Achieving clearance for the CE mark is a pivotal step in bringing the HIVEN® into clinical practice and improving outcomes for patients in Europe. This certificate reflects the hard work of our team and the strength of our scientific and clinical foundations,” says Juho Leskinen, CTO and co-founder of Marginum.

Clinical Benefits & Indications

The aspirate tissue monitoring technology aims to overcome surgical challenges that may damage healthy tissues and leave tumour cells undetected. Incomplete removal, damage to healthy tissues, and reoperations exacerbate patient suffering, compromised standard of care, and long-term complications – all directly escalating healthcare costs.

Critical structures like blood vessels often create blind spots – behind corners and tissue ridges – where cancerous tissue can be difficult to detect. The HIVEN® aspirate tissue monitoring device addresses this challenge by allowing resected tissue to be transported directly for fluorescence analysis. This provides surgeons with more comprehensive information about the surgical site.

“In glioma surgery, our ability to distinguish tumour from healthier tissues is limited by anatomical constraints, blood and compromised visibility, particularly in deep-seated areas. We wanted HIVEN® to provide critical feedback beyond sensory limitations; you can consider it a sixth sense for tumour detection,” comments docent Antti-Pekka Elomaa MD PhD, a consultant neurosurgeon and one of Marginum co-founders.

The HIVEN® is approved for fluorescence-guided neurosurgery of high-grade gliomas, where precise margin identification is critical. HIVEN® enhances surgical accuracy by enabling objective tissue detection in hard-to-reach areas and simplifying the procedure workflow.

About Marginum:

Marginum, a leading innovator in fluorescence-guided oncological surgery, is a medical technology company developing fluorescence-based tissue detection systems. HIVEN® by Marginum enables safe and efficient monitoring of tumour tissues during cancer surgery. www.marginum.com

Contacts

Media contact:
Samu Lehtonen, CEO & Co-Founder

Email: samu.lehtonen@marginum.com
Mobile: +358405797890

https://www.marginum.com

Corstasis Therapeutics and U.S. Heart and Vascular® Collaboration Will Seek to Improve Heart Failure Care with ENBUMYST™ (Bumetanide Nasal Spray)

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Corstasis Therapeutics and U.S. Heart and Vascular® Collaboration Will Seek to Improve Heart Failure Care with ENBUMYST™ (Bumetanide Nasal Spray)




Corstasis Therapeutics and U.S. Heart and Vascular® Collaboration Will Seek to Improve Heart Failure Care with ENBUMYST™ (Bumetanide Nasal Spray)

The collaboration will seek to foster the adoption of appropriate protocols and pathways for the integration of ENBUMYST™ (bumetanide nasal spray) into clinical care with the goal of reducing readmissions, improving fluid management and enhancing outcomes through the novel delivery of diuretic therapy.


HENDERSON, Nev.–(BUSINESS WIRE)–#chf–Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, today announced a strategic collaboration with U.S. Heart and Vascular® (USHV), the nation’s premier cardiovascular management services organization, seeking to enable earlier intervention and enhance outcomes for heart failure patients. Corstasis and USHV will co-develop, and seek to optimize, value-based care pathways for the outpatient treatment of fluid overload in patients with congestive heart failure, liver disease and chronic kidney disease with ENBUMYST™ (bumetanide nasal spray).

“ENBUMYST was developed with the goal of giving providers a new, self-administered outpatient option,” said Brian Kolski M.D., Chief Medical Officer of Corstasis Therapeutics. “Our collaboration with USHV reflects a shared commitment to health system innovation, value-based care delivery and patient-centered outcomes.”

The collaboration between Corstasis and USHV will seek to:

  • Develop and validate protocols and clinical workflows that are consistent with approved labeling and enable adoption of early intervention via nasal spray diuresis when clinically indicated
  • Develop associated provider and staff training to ensure seamless integration of this important new intervention into clinical care
  • Capture outcomes and healthcare economic data to support payer engagement and future reimbursement strategies

“At USHV, we are continuously seeking new tools that empower our affiliated physicians and deliver measurable value to patients and payers,” said Emily Rash, Chief Value-Based Care Officer, USHV. “We believe an outpatient-friendly alternative represents a meaningful step forward in ambulatory heart failure care and we’re proud to work with Corstasis to bring this innovation into practice.”

The U.S. Food and Drug Administration (FDA) recently approved ENBUMYST for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults.

This effort is intended to put Corstasis and USHV at the forefront of improving outpatient heart failure management, with the goal of enabling the option of earlier intervention, reduced escalation of care and a more cost-effective path to euvolemia. Fluid overload associated with CHF, liver disease and chronic kidney disease is responsible for driving millions of hospitalizations and readmissions annually.

About ENBUMYST

ENBUMYST is a nasal spray loop diuretic indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ENBUMYST™ (BUMETANIDE NASAL SPRAY).

INDICATION

ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

IMPORTANT SAFETY INFORMATION

ENBUMYST is contraindicated in patients with anuria, who are in hepatic coma and have a history of hypersensitivity to bumetanide.

ENBUMYST is a diuretic that may cause fluid, electrolyte, and metabolic abnormalities. Excessive fluid loss can lead to dehydration, decreased blood volume, and increased risk of blood clots. Abnormalities may include changes in blood electrolytes, nitrogen, glucose, and uric acid. The chance of getting these abnormalities is higher in people who are elderly, use higher doses or who do not get enough electrolytes by mouth.

If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide.

Although unlikely at the recommended doses, the potential for ototoxicity must be considered a risk of intravenous therapy, at high doses, repeated frequently in the face of renal excretory function impairment.

Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause.

Advise lactating women treated with ENBUMYST to monitor their infants for excessive urine output, dehydration, and lethargy.

Most common adverse reactions are hypovolemia, headache, muscle cramps, dizziness, hypotension, nausea and encephalopathy (in patients with pre-existing liver disease).

These are not all of the possible side effects of ENBUMYST. To report suspected adverse reactions, contact Corstasis Therapeutics at 1-877-300-5339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for ENBUMYST.

About Corstasis Therapeutics

Corstasis Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on transforming the treatment of fluid overload in patients with heart failure, liver disease, and kidney disease. Its lead asset, ENBUMYST™ (bumetanide nasal spray), was approved by the FDA on September 12, 2025 and is designed to offer rapid, reliable diuresis outside the hospital setting. For more information, please visit www.corstasis.com.

About U.S. Heart and Vascular (USHV)

Formed in 2021 in Nashville, TN, US Heart and Vascular is a physician-led management platform enabling independent cardiologists to expand patient access, improve outcomes, and reduce costs to the healthcare system. USHV builds collaborative partnerships with best-in-class cardiovascular practices, providing non-clinical management solutions and resources that allow practices to expand access to compassionate and comprehensive care, improve patient outcomes, and strategically reduce costs to the healthcare system. Currently investing in practices across five states, USHV is actively seeking new partnerships with quality cardiovascular practices and entrepreneurial physicians across the U.S. Visit https://usheartandvascular.com/.

Contacts

Media Contacts:
Ben Esque, CEO

Corstasis Therapeutics Inc.

Phone: 702-541-9222

Email: Info@corstasis.com

Carrie Moore, VP Communications

U.S. Heart & Vascular

Email: carrie.moore@usheartandvascular.com

ClearNote Health Receives In Vitro Diagnostic Approval in United Kingdom for Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test

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ClearNote Health Receives In Vitro Diagnostic Approval in United Kingdom for Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test




ClearNote Health Receives In Vitro Diagnostic Approval in United Kingdom for Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test

SAN DIEGO–(BUSINESS WIRE)–#5hmC—ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received a United Kingdom Conformity Assessed (UKCA) marking for its Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test. Part of the UK’s independent product safety framework following its departure from the European Union, this designation confirms compliance with UK medical device regulations and is a prerequisite for selling products in the UK. The company’s Avantect Pancreatic Cancer Test received the same certification in July 2025.


The Avantect Multi-Cancer Detection Test is a simple blood test designed to screen for several types of cancer simultaneously in asymptomatic, generally healthy persons. It targets some of the deadliest cancers by analyzing both the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) and genomic features in circulating cell-free DNA. Unlike conventional methods, ClearNote Health’s 5hmC-based approach measures changes in active biology, offering a highly specific signal of early cancer development and identifying the likely tissue of tumor origin.

This test was one of only two assays recently selected for the critical Vanguard Study funded by the National Cancer Institute, part of the National Institutes of Health, following a thorough evaluation of 23 emerging multi-cancer detection technologies. The Vanguard Study implemented a stringent, multi-stage selection process to evaluate multi-cancer detection assays based on sensitivity, specificity, tissue of origin prediction accuracy, and assay failure rates. Key selection criteria included early-stage detection performance for at least three cancer types. The study includes nine geographically diverse clinical trial hubs and will enroll up to 24,000 total participants to assess the implementation of multi-cancer detection testing.

The Avantect Ovarian Cancer Test was designed to aid in earlier diagnosis of cancer in women at elevated risk, particularly those with inherited genetic mutations, such as BRCA1 and BRCA2, Lynch syndrome, or a strong family history of ovarian, breast, uterine, or colorectal cancer, as well as other significant risk factors. The test uses ClearNote Health’s underlying Virtuoso™ epigenomics platform to measure the presence or absence of an abnormal signal associated with ovarian cancer in cell-free DNA.

“By achieving UKCA markings for all three of our Avantect cancer tests, ClearNote Health is well poised to deliver on our mission of helping to eradicate the deadliest forms of cancer through early detection,” said Dave Mullarkey, CEO at ClearNote Health. “These regulatory milestones are a testament to the dedication of our cross-functional team as we expand into new international markets and bring our innovative, life-saving technology to more patients worldwide.”

For more information on the Avantect cancer tests, please visit www.avantect.com.

About ClearNote Health

ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company’s patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. Its highly sensitive, noninvasive Avantect® pancreatic and ovarian diagnostic tests may identify cancers in high-risk patient populations earlier than conventional approaches, when patients may be more likely to benefit from treatment. ClearNote Health’s headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on LinkedIn.

ClearNote Health, the ClearNote Health logo, and Avantect are registered trademarks of ClearNote Health.

Contacts

Media Contact
Andrew Noble

415-722-2129

andrew@bioscribe.com