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Check-Cap(CHEK) - Prospectus
2026-01-30 22:28
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 ...
GRAIL Submits FDA PMA for Galleri Multi-Cancer Early Detection Test
ZACKS· 2026-01-30 19:35
Key Takeaways GRAIL submitted the final PMA module to the FDA for its Galleri multi-cancer early detection blood test.The Galleri test holds FDA Breakthrough status, backed by U.S. PATHFINDER 2 results and the NHS-Galleri trial.The PMA includes data from 25,490 participants in PATHFINDER 2 and the first round of the NHS-Galleri trial.GRAIL, Inc. (GRAL) announced the submission of the final module of its premarket approval application to the FDA for the Galleri multi-cancer early detection (MCED) test. The F ...
Kaiser Study Backs Cxbladder Triage Ahead of Medicare Panel
PRWEB· 2026-01-28 00:00
"The study publication provides powerful, independent confirmation of Cxbladder's value in daily clinical practice. That is a compelling message for payers, providers, and most importantly, for patients who may otherwise face an invasive procedure they do not need." said Pacific Edge CEO Dr Meintjes Post this This publication comes at an important time for Pacific Edge, because peer-reviewed publications can be considered by the Contractor Advisory Committee (CAC) that Novitas, our Medicare Administrative ...
Eurobio Scientific: 2025 FY revenue
Globenewswire· 2026-01-27 16:45
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 ...
Bluejay Diagnostics Announces 1-for-4 Reverse Stock Split
Globenewswire· 2026-01-27 13:00
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 ...
Exact Sciences Corp. (EXAS) Rose Following the Acquisition Announcement
Yahoo Finance· 2026-01-27 12:46
Meridian Funds, managed by ArrowMark Partners, released its “Meridian Growth Fund” fourth-quarter 2025 investor letter. A copy of the same can be downloaded here. U.S. equity markets experienced a quarter shaped by optimism around potential monetary easing and caution related to economic growth and valuations. Early gains were driven by strong AI-related earnings and the US Federal Reserve’s rate cut in October. However, market sentiment cooled later in the quarter due to mixed signals from the Fed regardi ...
Guardant Health: Shield Colorectal Cancer Screening To Sustain Growth
Seeking Alpha· 2026-01-18 09:32
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]
DiagnosTear Announces Interim Clinical Results Indicating High Efficiency from TeaRx(TM) Red Eye
TMX Newsfile· 2026-01-17 00:00
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]
Veracyte, Inc. (VCYT) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-15 20:16
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].
Biomerica Reports Second Quarter Fiscal 2026 Financial Results
Globenewswire· 2026-01-14 22:17
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].