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OXFORD, England & BURLINGTON, Mass.--(BUSINESS WIRE)--Blue Earth Diagnostics, a molecular imaging diagnostics company, announced that the Trial Steering Committee recommended that further recruitment be stopped in the FALCON clinical study of fluciclovine (18F) PET/CT imaging, based on successful results of a pre-planned interim analysis. The FALCON trial, announced in March 2016, is a UK-based, open-label study (NCT02578940) to evaluate the clinical impact of fluciclovine (18F) PET/CT imaging on patient management decisions in men with biochemically recurrent prostate cancer. In 2016, the U.S. Food and Drug Administration approved Axumin™ (fluciclovine F 18), a novel molecular imaging agent for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. The primary endpoint of the FALCON study examines the percentage of men who have their management plan changed after a fluciclovine (18F) scan. The single, pre-planned interim analysis of the primary endpoint was performed based on the first 85 evaluable patients. Based on the interim analysis results, recruitment in the trial was to be stopped due to efficacy. The efficacy and safety of fluciclovine (18F) to impact patient management decisions is currently under clinical investigation. Blue Earth Diagnostics plans to present results of this interim analysis of the FALCON trial at an upcoming medical congress and subsequently publish full results in a peer-reviewed publication. “The primary aim of the UK multi-center FALCON trial of fluciclovine (18F) PET/CT imaging was to assess its clinical impact on treatment decisions in men with recurrent prostate cancer being considered for radical potentially curative treatment,” said Dr Fergus Gleeson, Professor of Radiology, University of Oxford, Oxford, UK, and Chief Investigator on the study. “Study recruitment has been stopped because of the significant numbers of changes to treatment made following the scan. In addition, we want to evaluate other criteria such as its diagnostic performance and the effect that PSA level may have on the probability of lesion detection by fluciclovine (18F). “We are pleased at the Trial Steering Committee’s recommendation for the FALCON trial, and we look forward to sharing the results with the medical community at an upcoming scientific congress,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “Axumin can provide actionable information for physicians treating patients with suspected recurrent prostate cancer, and Blue Earth is committed to continuing efforts that may benefit men with recurrent disease.” “Biochemically recurrent prostate cancer poses an important medical challenge, as it occurs in up to one third of men who have been previously treated, and current commercially available anatomical imaging techniques are limited in the amount of information they provide,” said Judd Moul, M.D., Professor of Surgery, Urology, at Duke University. “Information provided by an Axumin PET scan provides useful information about the location and extent of suspected recurrent disease and has the potential to provide information to facilitate the appropriate care of men with recurrent prostate cancer.” Blue Earth Diagnostics also announced that the LOCATE study (“The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment”), has completed patient enrollment earlier than anticipated. The LOCATE trial is a U.S. multi-center study designed to assess the impact on patient management of 18F fluciclovine PET imaging in patients with rising PSA after initial prostate cancer treatment. The clinical utility of 18F fluciclovine PET/CT imaging will be assessed by the change from initial to revised treatment plan. Additional information about the LOCATE trial is available at: www.clinicaltrials.gov (NCT02680041). The FALCON trial, “Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of prostate caNcer (FALCON),” is an open-label multi-center study in the U.K. designed to assess the clinical utility of fluciclovine (18F) PET imaging in the management of patients with prostate cancer with biochemical recurrence after initial treatment. The primary endpoint is to evaluate the clinical impact of fluciclovine (18F) in affecting treatment decision and is assessed by comparing records of the patient’s treatment plan after a fluciclovine (18F) PET scan with the treatment plan prior to the scan. Secondary endpoints include evaluation of the effect of treatment change in patients with positive fluciclovone (18F) PET imaging findings who had a treatment change involving radical salvage therapy; diagnostic performance; PSA threshold; safety assessment and comparison with choline PET (if performed). As stated in the protocol, a single, pre-planned interim analysis of the primary endpoint was to be performed based on the first 85 evaluable patients. If the number of treatment changes is greater than 45, the trial will stop recruitment early due to efficacy. If the number of treatment changes is 8 or fewer, the trial will stop recruitment early due to futility. The FALCON trial is jointly funded by Innovate UK and Blue Earth Diagnostics and is being conducted at six leading institutions in the UK: Oxford University Hospitals NHS Foundation Trust, University College London, Kings College London, The Royal Marsden NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, East and North Hertfordshire NHS Trust and Greater Glasgow Health Board. Additional information about the FALCON trial is available at: www.clinicaltrials.gov (NCT02578940). U.S. Indication and Important Safety Information About Axumin Axumin™ (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Full Axumin prescribing information is available at www.axumin.com. Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma. Prostate cancer is the second leading cause of cancer death in men in the United States. While most primary prostate cancer can be successfully treated, the disease recurs in approximately one-third of patients. In some patients recurrent disease is detectable only by a rise in prostate specific antigen (PSA) levels, yet the location of the recurrence cannot consistently be located by conventional imaging, potentially impacting subsequent management of these patients. Blue Earth Diagnostics is a molecular imaging diagnostics company focused on the development and commercialization of novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Formed in 2014, Blue Earth Diagnostics is led by recognized experts in the clinical development and commercialization of innovative nuclear medicine products. The company’s first approved and commercially available product is AxuminTM (fluciclovine F 18), a novel molecular imaging agent for use in PET imaging to detect and localize prostate cancer in men experiencing suspected biochemical recurrence. Blue Earth Diagnostics is funded by Syncona Limited, an investment company listed on the London Stock Exchange (LON: SYNC). For more information, visit www.blueearthdiagnostics.com.


News Article | May 19, 2017
Site: www.prnewswire.com

Wells Financial Corp. is the bank holding company for Wells Federal Bank, a Minnesota-chartered, FDIC-insured bank. Wells Federal Bank, originally chartered in 1934, operates nine full-service offices in Faribault, Blue Earth, Martin, Nicollet, Freeborn, Steele and Watonwan Counties, Minnesota. This communication is for informational purposes only and is neither an offer to purchase, nor a solicitation of an offer to sell, any securities in any jurisdiction pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of any applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Additional Information About The Proposed Transaction and Where To Find It This press release does not constitute a solicitation of any vote or approval. In connection with the merger, Citizens will be filing with the Securities and Exchange Commission ("SEC") a Registration Statement on Form S-4 and other relevant documents. STOCKHOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT ON FORM S-4 TO BE FILED BY CITIZENS WHEN IT BECOMES AVAILABLE AND ANY OTHER RELEVANT DOCUMENTS FILED BY CITIZENS WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The Registration Statement, including the proxy statement/prospectus, and other relevant materials (when they become available), and any other documents filed by Citizens with the SEC, may be obtained free of charge at the SEC's website at www.sec.gov. Documents filed by Citizens with the SEC, including the registration statement, may also be obtained free of charge from Citizens' website http://www.snl.com/IRWebLinkX/corporateprofile.aspx?iid=4091023 by clicking the "SEC Filings" heading, or by directing a request to Citizens' CEO, Stephen Bianchi at sbianchi@ccf.us. The directors, executive officers and certain other members of management and employees of  the Company may be deemed to be "participants" in the solicitation of proxies for stockholder approval. Information regarding the persons who may, under the rules of the SEC, be considered participants in the solicitation of stockholder approval will be set forth in the proxy statement/prospectus and the other relevant documents to be filed by Citizens with the SEC. Certain statements contained in this press release are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words or phrases such as "anticipate," "believe," "could," "expect," "intend," "may," "planned," "potential," "should," "will," "would" or the negative of those terms or other words of similar meaning. Such forward-looking statements in this press release are inherently subject to many uncertainties arising in the Company's operations and business environment. These uncertainties include the timing to consummate the proposed transaction; the risk that a condition to closing of the proposed transaction may not be satisfied and the transaction may not close; the risk that a regulatory approval that may be required for the proposed transaction is delayed, is not obtained or is obtained subject to conditions that are not anticipated; the combined company's ability to achieve the synergies and value creation contemplated by the proposed transaction; the effects of governmental regulation of the financial services industry; industry consolidation; technological developments and major world news events; and general economic conditions, in particular, relating to consumer demand for the Company's products and services. Shareholders, potential investors and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to make any revisions to the forward-looking statements contained in this press release or to update them to reflect events or circumstances occurring after the date of this press release. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/wells-financial-corp-declares-cash-dividend-300460671.html


This report assesses future trends in molecular imaging equipment revenues as well as growth in the number of unit shipments over the next few years. This will provide value to market participants that design and manufacture molecular imaging equipment. Market participants will also be provided insights on recent industry and technology trends that are shaping the molecular imaging market. Radiopharmaceutical manufacturers will be provided with key insights on the evolving usage trends of workhorse FDG and Tc-99m radiopharmaceuticals and the increasing adoption of new radiopharmaceuticals across new clinical areas. Companies that are in the process of developing software to improve quantitation accuracy, lower dosages, and reduce scan times for both PET and SPECT will be provided with key insights on how the molecular imaging market is growing as well as the factors that are required to facilitate greater adoption of PET and SPECT technologies. Key Topics Covered: 1. Research Methodology 2. Executive Summary-Molecular Imaging 3. Executive Summary-Radiopharmaceuticals 9. Key Products and Participants 10. Latest Trends Among the Big Three Competitors-Philips Healthcare 11. GE Healthcare 12. Siemens Healthineers 13. Companies to Look Out For 14. Other Issues Impacting Growth Of Molecular Imaging 15. Key Technology and Industry Trends 16. Drivers and Restraints-Total Radiopharmaceuticals Market 17. PET Radiopharmaceuticals Segment 18. SPECT Radiopharmaceuticals Segment 19. Key Products and Participants 20. Key Companies to Look Out For 21. Key Industry Trends 22. Role of New Radiopharmaceuticals in Oncology 23. The Last Word 24. Appendix 25. Medicare Hospital Outpatient Prospective Payment System (HOPPS) Companies Mentioned - Advanced Accelerator Applications - Bio-Nucleonics - Blue Earth - Bracco - Cardinal - Eckert & Ziegler Nuclitec - Eli Lilly - GE - IBA Molecular - Jubilant Draximage - Kimberley-clark - Lantheus - MDS Nordion - Mallinckrodt - Mayo Clinic - Molecular Dynamics - Navidea - NeuSoft - PETNET - Pharmalucence - Philips - Piramal - Siemens Healthineers - Spectrum - Toshiba - UltraSPECT For more information about this report visit http://www.researchandmarkets.com/research/5mxv25/analysis_of_the Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/united-states-molecular-imaging-equipment-and-radiopharmaceuticals-market-2017-2023---research-and-markets-300440832.html


A stabilized mixed oxidant solution may be produced by flowing a starting solution (e.g., salt brine, hypochlorous acid, and/or sodium hypochlorite) through a flow-through electrochemical module including first and second passages separated by an ion permeable membrane while electric power is applied between an anode and cathode in electrical communication with the first and second passages, respectively. An initially acidic anolyte solution received from the first (anode) passage is stabilized by elevating pH to yield a stabilized mixed oxidant solution. Methods of using the mixed oxidant solution are further provided.


The present invention relates to a process for removing surface contaminants from water filtration media contained in a water filtration bed including granular activated carbon (GAC). This process comprises the steps of:applying a cleaner in granular form onto said water filtration media, while the filtration media is located within the filtration bed;applying an active oxygen donor in liquid form to said water filtration bed, to initiate at least one chemical reaction between the cleaner, the active oxygen donor, and the surface contaminants on the water filtration media, causing at least one of suspension and dissolution of contaminants received from the water filtration media;after initiating of said at least one chemical reaction, rinsing the filtration media in the water filtration bed with water for removing any of residual cleaner, residual active oxygen donor, suspended contaminants, and dissolved contaminants from the water filtration media.


A stabilized mixed oxidant solution may be produced by flowing a starting solution (e.g., salt brine, hypochlorous acid, and/or sodium hypochlorite) through a flow-through electrochemical module including first and second passages separated by an ion permeable membrane while electric power is applied between an anode and cathode in electrical communication with the first and second passages, respectively. An initially acidic anolyte solution received from the first (anode) passage is stabilized by elevating pH to yield a stabilized mixed oxidant solution. Methods of using the mixed oxidant solution are further provided.


Compositions and methods for removing surface deposits in situ from filtration media contained in water filtration beds may include a solid acid component, a solid oxidizer, low temperature activator, a dessicant, an anti-caking agent, a pH indicator, a corrosion inhibitor, a surfactant, a chelating agent, and/or a defoaming agent. A granular acid component may include sodium bisulfate, and a granular oxidizing component may include at least one of sodium percarbonate, sodium perborate, potassium percarbonate, and potassium perborate. Compositions may be applied to top surface and/or subsurface regions of a filter bed, in wetted or dry form. A kit includes a container with dry composition and instructions or indicia for cleaning water filtration media using the composition.


Methods and compositions for improving water quality by reducing chlorine demand, decreasing disinfection by-products and controlling deposits in water systems include adding low concentrations of supplemental oxidants, for example, RE-Ox to the systems.


Methods and compositions for improving water quality by reducing chlorine demand, decreasing disinfection by-products and controlling deposits in drinking water distribution systems include adding low concentrations of supplemental oxidants, for example, RE-Ox to the systems.


Methods and compositions for improving water quality by reducing chlorine demand, decreasing disinfection by-products and controlling deposits in water systems include adding low concentrations of supplemental oxidants, for example, RE-Ox to the systems.

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