As filed with the Securities and Exchange Commission on January 30, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CHECK-CAP LTD. (Exact name of registrant as specified in its charter) ____________________ Israel 3844 Not Applicable (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 29 ...

Core Insights - GRAIL, Inc. has submitted the final module of its premarket approval application to the FDA for the Galleri multi-cancer early detection test, which has received Breakthrough Device designation since 2018, indicating its potential to enhance early cancer detection [2][5] - The PMA submission is based on data from the PATHFINDER 2 study and the NHS-Galleri trial, which collectively involved over 25,000 participants, aiming to improve cancer detection rates, especially for high-mortality cancers that lack routine screening options [3][7][11] Company Developments - The Galleri test is positioned to significantly impact public health by improving early cancer detection rates, particularly for cancers diagnosed at advanced stages [3][5] - GRAIL's stock has seen a substantial increase of 195.1% over the past six months, outperforming the industry and S&P 500 [4] - The company currently has a market capitalization of $3.94 billion [6] Clinical Studies and Data - The NHS-Galleri trial enrolled over 140,000 asymptomatic individuals aged 50-77, focusing on reducing stage III-IV cancer diagnoses and assessing the test's performance across multiple cancer types [8] - The PATHFINDER 2 study aims to evaluate the safety and performance of the Galleri test in 35,000 participants, with primary endpoints related to diagnostic procedures following a cancer signal detected result [9][10] Market Prospects - The cancer diagnostics market is projected to grow from $170 billion in 2025 at a CAGR of 8.6% through 2034, driven by increasing cancer patient numbers and the benefits of early diagnosis [12][14] - GRAIL's collaboration with Samsung to commercialize the Galleri test in Asian markets, supported by a $110 million equity investment, enhances its international expansion strategy [17]

Core Insights - The publication of a study confirms the clinical value of Cxbladder, emphasizing its importance for payers, providers, and patients who may avoid unnecessary invasive procedures [1][4] - The study's findings will be considered by the Contractor Advisory Committee (CAC) for Medicare reimbursement decisions regarding Cxbladder tests, with a meeting scheduled for February 19, 2026 [1][4] Study Findings - The study demonstrated that Cxbladder Triage significantly reduced cystoscopy and imaging procedures for low and intermediate-risk patients while increasing appropriate procedures for higher-risk patients [2][3] - A total of 3,353 risk-matched patients were evaluated, showing a cystoscopy rate of 3.8% for low probability patients compared to 46.5% in the risk-matched group, and a rate of 73.4% for high probability patients versus 45.7% in the standard care group [6] - Cancer detection rates were similar between Cxbladder Triage patients and standard care patients (0.6% vs 0.7%), indicating that unnecessary procedures were reduced without compromising cancer detection [6] Company Overview - Pacific Edge Limited is a global cancer diagnostics company focused on bladder cancer diagnostic and prognostic tests, headquartered in Dunedin, New Zealand [5] - Cxbladder tests are available in the US, Australasia, Israel, and various markets in Asia and South America, with over 5,000 urologists in the US having ordered more than 130,000 tests [10] - The company has a strong evidence portfolio with over 25 peer-reviewed publications supporting Cxbladder, which is included in the American Urological Association's Microhematuria Guideline [9]

FISCAL YEAR 2025, CONFIRMATION OF STRATEGIC TRANSFORMATION 9% increase in annual revenue to €168 millionDeployment of the Group's strategy: Proprietary products: 35% of revenueInternationalization: 42% of revenue generated outside France Strengthening of activities in Italy with the acquisition of Quimark and the assets of the Life Sciences unit of Voden Medical Instruments Spa Paris, January 27, 2026 - 5:40 p.m. - Eurobio Scientific (FR0013240934, ALERS), a leading French group in in vitro medical diagnos ...

ACTON, Mass., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical technology company developing rapid diagnostics on its Symphony platform to improve patient outcomes in critical care settings, today announced that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-4 (the “Reverse Stock Split”). The Reverse Stock Split will become effective at 12:01 a.m. Eastern Time on January 2 ...

Market Overview - U.S. equity markets in Q4 2025 were influenced by optimism regarding potential monetary easing and caution related to economic growth and valuations [1] - Early gains were attributed to strong AI-related earnings and a rate cut by the U.S. Federal Reserve in October, but sentiment cooled later due to mixed signals from the Fed [1] - Large-cap stocks rose 17.4% for the year and 2.4% in the quarter, while small caps gained 12.8% for the year and 2.2% in the quarter [1] - Value stocks outperformed growth stocks, returning 3.3% versus 1.2% for the quarter [1] Fund Performance - Meridian Growth Fund delivered a return of -0.39% (net) in the quarter, underperforming the Russell 2500 Growth Index's return of 0.33% [1] - The firm is monitoring factors affecting market returns, including potential changes in monetary policy and the sustainability of AI investments due to high valuations among hyperscalers [1] Company Spotlight: Exact Sciences Corporation - Exact Sciences Corporation (NASDAQ:EXAS) is recognized as a leading contributor to the Meridian Growth Fund, specializing in cancer screening and diagnostic test products [2][3] - As of January 26, 2026, Exact Sciences' stock closed at $102.51 per share, with a one-month return of 0.60% and an impressive 85.00% increase in value over the last 52 weeks [2] - The company has a market capitalization of $19.468 billion [2] - Exact Sciences is best known for its at-home colorectal cancer screening test, Cologuard, and saw stock performance improve due to signs of growth and the introduction of a new test [3] - The stock performance was further enhanced by Abbott's announcement to acquire Exact Sciences at a significant premium [3]

Core Insights - Guardant Health, Inc. (GH) is expected to benefit from a collaboration with Quest Diagnostics (DGX), which will enhance access to Shield colorectal cancer screening [1] Group 1: Company Overview - Guardant Health is focused on innovative cancer screening solutions, particularly in colorectal cancer [1] - The collaboration with Quest Diagnostics provides Guardant access to over 650,000 patients, potentially increasing its market reach [1] Group 2: Investment Perspective - The analyst expresses a bullish outlook on Guardant Health due to the strategic partnership, which is anticipated to drive growth and improve financial performance [1] - The approach taken by the analyst emphasizes breaking down complex financial and technological problems to identify investment opportunities [1]

Core Insights - DiagnosTear Technologies Inc. announced promising interim results from its multi-center clinical study in Israel for the TeaRx™ Red Eye diagnostic platform, aimed at improving ocular diagnostics [1][6] Company Overview - DiagnosTear Technologies Inc. is a leader in rapid, point-of-care diagnostics for ocular diseases, focusing on multi-parametric tests that provide actionable insights based on tear-fluid analysis [8] Product Development - The TeaRx™ Red Eye device is designed to differentiate between three types of red eye conditions: Adenoviral conjunctivitis, Herpetic keratitis, and Allergic conjunctivitis, which collectively lead to millions of clinic visits annually [2][6] - The device addresses the current lack of rapid diagnostics, which contributes to misdiagnosis and inappropriate treatments [2] Clinical Study Details - The Israeli clinical program began in October 2023 and involves multiple leading health facilities, enrolling patients with suspected red eye conditions [3] - The study has recruited 130 subjects, with 66 samples evaluated for adenovirus, 60 for HSV-1/2, and 61 for total tear IgE [5] Interim Results - The TeaRx™ Red Eye assay showed high agreement rates: 92% positive and 100% negative for Adenovirus, 100% for HSV-1/2, and 73% positive and 93% negative for total tear IgE compared to reference methods [5] - These results indicate the device's reliability in identifying viral causes of red eye, which can lead to better point-of-care decisions [5][6] Future Plans - The Israeli study is expected to conclude by Q2 2026, with additional clinical programs in India and France also targeting completion by the same timeframe [6] - The company aims to compile a comprehensive dataset from these studies to support regulatory submissions and global commercialization of the TeaRx™ Red Eye [7]

Core Viewpoint - Veracyte is focused on enhancing the understanding and treatment of cancer through advanced molecular diagnostics, aiming to empower physicians and improve patient outcomes globally [2]. Group 1: Company Mission and Approach - The company aims to change cancer treatment by delivering actionable clinical insights and enabling deep research [2]. - Veracyte employs a platform approach that emphasizes generating more data than necessary for clinical questions, utilizing whole transcriptome and whole genome-based assays [3]. - This data-driven strategy creates a flywheel effect, enhancing clinical utility and adoption, thereby expanding the company's reach to more patients [3].

Core Insights - Biomerica, Inc. reported financial results for the second quarter of fiscal 2026, highlighting a strategic shift towards higher-margin diagnostic-guided therapy products and the commercialization of its inFoods IBS test [1][6]. Financial Performance - Net sales for the second quarter of fiscal 2026 were $1.21 million, down from $1.64 million in the prior year, primarily due to the absence of large initial distributor orders in the MENA region [9]. - For the six months ended November 30, 2025, net sales were $2.59 million, compared to $3.44 million in the prior year period [10]. - Gross margin for the six-month period was 18%, down from 21% in the prior year, reflecting the transition to higher-margin products [10]. - Operating expenses for the second quarter were $1.42 million, slightly down from $1.43 million in the same period last year [11]. - The net loss for the second quarter was $1.32 million, compared to $0.95 million in the prior year quarter, while the net loss for the six months improved to $1.31 million from $2.27 million in the prior year [12]. Strategic Developments - Biomerica entered a marketing services agreement with Henry Schein to support the commercialization of the inFoods IBS test in the U.S., enhancing awareness among healthcare providers [2]. - The company launched the AI-backed inFoods IBS Trigger Food Navigator, designed to improve dietary compliance for IBS patients by providing personalized meal suggestions [3]. - The Centers for Medicare & Medicaid Services established a national Medicare payment rate of $300 for the inFoods IBS test, effective January 1, 2026, which is expected to enhance patient access [4]. - The Egyptian Drug Authority authorized Biomerica's complete screening test portfolio, facilitating international expansion of its diagnostic products [5]. Management Commentary - The CEO emphasized a strategic pivot from lower-margin products to higher-value diagnostic-guided therapy products, indicating that current revenue softness is a result of this transition rather than a decline in business fundamentals [6]. - The CFO noted a 27% reduction in research and development expenses while continuing to invest in high-value diagnostic programs, indicating a focus on operational efficiency [8].