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Month: June 2023

AVITA Medical Submits FDA PMA Supplement for RECELL GO

VALENCIA, Calif., June 29, 2023 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced its submission of a premarket approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for RECELL GO™. The supplement follows the original PMA of its RECELL Autologous Cell Harvesting Device and subsequent PMA supplements. With its innovative capabilities, RECELL GO revolutionizes the current, manually operated RECELL device by eliminating the need for manual management of skin samples. RECELL GO will utilize single-use processing cartridges integrated into a durable AC powered processing device. The automated workflow streamlines the critical...

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FDA Grants De Novo Marketing Authorization for KidneyIntelX.dkd to Assess Risk of Progressive Kidney Function Decline in Adults with Diabetes and Early-Stage Kidney Disease

Simple Blood Test Aids Risk Assessment for Approximately 14 Million Eligible Patients in the United States Diabetic Kidney Disease is the Leading Cause of End Stage Kidney Disease in the United States LONDON and SALT LAKE CITY, June 29, 2023 (GLOBE NEWSWIRE) — Renalytix plc (LSE: RENX) (NASDAQ:RNLX) announces that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for its KidneyIntelX.dkd ™ prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease. Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international...

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Friedman Industries, Incorporated Announces Fourth Quarter and Fiscal Year 2023 Results and Provides Near-Term Outlook

LONGVIEW, Texas, June 29, 2023 (GLOBE NEWSWIRE) — Friedman Industries, Incorporated (NYSE American: FRD) announced today its results of operations for the quarter and fiscal year ended March 31, 2023. March 31, 2023 Quarter Highlights:Net earnings of approximately $6.3 million Sales of approximately $124.2 million 152% increase in sales volume over prior year quarter volume 17% increase in sales volume over the preceding third quarter volumeFiscal Year March 31, 2023 Highlights:Most profitable fiscal year in Company history with net earnings of approximately $21.3 million Acquisition of steel processing facilities in East Chicago, Indiana and Granite City, Illinois Completion of newly constructed steel processing facility in Sinton, Texas Sales of approximately $547.5 million 134% increase in sales volume over prior fiscal...

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Essential Energy Services Issues Inaugural ESG Report

CALGARY, Alberta, June 29, 2023 (GLOBE NEWSWIRE) — Essential Energy Services Ltd. (TSX: ESN) (“Essential” or the “Company”) is pleased to announce the release of its inaugural Environmental, Social and Governance (“ESG”) Report. While Essential has been reporting its ESG highlights through the Company’s Annual Information Form since 2019, this formalized report is a significant milestone for Essential as it demonstrates to shareholders and other stakeholders its commitment to meeting evolving ESG reporting expectations. The ESG Report showcases the work of Essential’s employees who provide services in an ESG responsible manner to meet the expectations of customers and communities in which the Company and its employees live and work. The Report provides enhanced transparency regarding the Company’s ESG efforts and approach to managing...

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First Bank Announces Second Quarter 2023 Earnings Conference Call

HAMILTON, N.J., June 29, 2023 (GLOBE NEWSWIRE) — First Bank (Nasdaq Global Market: FRBA) invites participation in a conference call to discuss the Company’s financial and operating performance during its second quarter ended June 30, 2023.Event: Earnings Conference Call – Second Quarter 2023     When: Thursday, July 27, 2023 at 9:00 a.m. Eastern Time     Access: Conference Call Dial-In: (888) 330-3273 (toll free)       Conference Call Access Code: 7660423     Patrick L. Ryan, President and Chief Executive Officer, Andrew L. Hibshman, Executive Vice President and Chief Financial Officer and Peter J. Cahill, Executive Vice President and Chief Lending Officer will provide an overview of second quarter 2023 results. The management presentation typically lasts approximately fifteen to thirty minutes, followed...

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Bionano Announces the Stratys™ System for OGM and VIA™ Software for Hematologic Malignancies

The Stratys™ instrument for optical genome mapping (OGM) will enable a four-fold increase in raw data generation rate compared to the Saphyr® instrument. Our plan is to eventually enable labs to develop work-cells comprised of multiple Stratys instruments to reach an increase in data generation rates of up to 13-fold over Saphyr. Approximately 10 Stratys instruments will be available as part of an early access program in the second half of 2023 as our manufacturing capacity increases. The VIA™ software replaces NxClinical™ software with a completely new platform for visualization, interpretation and reporting for hematologic malignancies across the main data types used in cytogenomics today – OGM, microarray and NGS. VIA software installations will begin at the end of July.SAN DIEGO, June 29, 2023 (GLOBE NEWSWIRE)...

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CryptoBlox Closes Acquisition of Crypto Mining Facility

Vancouver, B.C, June 29, 2023 (GLOBE NEWSWIRE) — CryptoBlox Technologies Inc. (the “Company” or “CryptoBlox”) (CSE: BLOX), is pleased to announce, further to its news release dated June 19, 2023 (the “Prior Release”), that it has completed its acquisition (the “Acquisition”) of Red Water Acquisition Corp. (“Redwater”), a company specializing in crypto mining technology. As discussed in the Prior Release, Redwater’s air-cooled data centers and advanced heat recapture products have obtained development rights in Sturgeon County, Alberta, Canada, for its operations. This site will serve as the foundation for Redwater’s state-of-the-art crypto mining facility, designed for efficiency and cost-effectiveness. Both CryptoBlox and Redwater share a common commitment to sustainable and responsible practices in the crypto-mining industry....

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Unicycive Therapeutics Provides Regulatory Update on Lanthanum Dioxycarbonate Program

LOS ALTOS, Calif., June 29, 2023 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today provided an update based on recent interactions with the U.S. Food and Drug Administration (FDA or Agency) concerning the Company’s New Drug Application (NDA) for lanthanum dioxycarbonate (LDC), previously known as Renazorb. LDC is an investigational new drug being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. In preparation for its anticipated NDA filing for LDC, the Company requested a pre-NDA meeting with the FDA to align on the contents of the NDA. As previously noted, the Agency had requested a 6-month toxicity study in mice comparing LDC and lanthanum...

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Advanced Health Intelligence Ltd Announces Implementation of ADS Ratio Change

NEW YORK, June 29, 2023 (GLOBE NEWSWIRE) — Advanced Health Intelligence Ltd (ASX/NASDAQ:AHI) (“Advanced Health Intelligence”, “AHI” or the “Company”) announces today that its planned ratio change of the Company’s American Depositary Shares (ADSs) to its non-traded ordinary shares from the previous ratio of one (1) ADS representing seven (7) ordinary shares to the new ratio of one (1) ADS representing twenty-eight (28) ordinary shares shall become effective on June 30, 2023. The ratio change will have the same effect as a reverse split of the existing ADSs of 1 new ADS for every 4 old ADSs. The effective date for the ratio change is June 29, 2023, and the Company’s ADSs will continue to be traded on the Nasdaq Capital Market (“Nasdaq”) under the symbol “AHI” with a new CUSIP Number 00777C 203. Today, trading of the ADSs on Nasdaq...

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VitalHub Corp. Announces Results of Annual General Meeting of Shareholders

TORONTO, June 29, 2023 (GLOBE NEWSWIRE) — VITALHUB CORP. (TSX: VHI) (OTCQX: VHIBF) (the “Company” or “VitalHub”) today reported a summary of the voting results of its Annual General Meeting of Shareholders (the “Meeting”). Results of the Meeting The Company is reporting the voting results of its Meeting held virtually on June 28, 2023. The summary of the results are as follows:Total Shares Voted: 17,794,108Total Shares Issued and Outstanding: 43,629,921Total Percentage of Shares Voted: 40.784%   1. Election of Directors Each of the nominee directors listed in VitalHub’s management information circular dated May 25, 2023 was elected as a director as set forth in the table below:Name of Nominee Vote For % Withheld Vote %Barry Tissenbaum 15,919,133 89.603 1,847,248 10.397Roger Dent 14,730,793 82.914 3,035,588 17.086Stephen...

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