Year: 2023

– Completion of the European Union Medical Device Regulation (MDR) final audit is the last step in obtaining an MDR certificate and CE marking, confirming Femasys’ compliance with the highest required regulatory standards – – Femasys continues to fulfill its commitment to bring innovative solutions to women around the world –ATLANTA, Oct. 26, 2023 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has successfully completed the Stage 2 European Union (EU) Medical Device Regulation (MDR 2017/745) onsite audit resulting in zero nonconformances and no findings. This is the final...

—  Clinical responses with TransCon IL-2 β⁄γ demonstrated as monotherapy or in combination with checkpoint inhibitor, including in two of three small cell lung cancer patients treated with combination therapy — TransCon IL-2 β⁄γ administered every three weeks was generally well tolerated as a monotherapy or in combination with pembrolizumab, with no meaningful effect on Tregs and eosinophils — Enrollment continues in indication-specific cohorts for Phase 2 portion of the IL-Believe Trial COPENHAGEN, Denmark, Oct. 26, 2023 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) reported updated and new data from its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β⁄γ in a poster presentation at ESMO 2023, the annual meeting of the European Society of Medical Oncology held in Madrid, Spain. The data included longer-term follow...

SYFORME NAKANOSYFORME NAKANOTOKYO, Japan, Oct. 26, 2023 (GLOBE NEWSWIRE) — SYLA Technologies Co., Ltd. (NASDAQ: SYT) (“SYLA” or “the Company”), operator of the largest membership real estate crowd-funding platform in Japan, Rimawari-kun, announced its subsidiary, SYLA Co., Ltd. (“SYLA Co.”) has begun selling the SYFORME NAKANO condominium units (“Property”) for investors as of Wednesday, October 11, 2023.SYFORME NAKANO is centrally located in the evolving Nakano area in convenient proximity to public transport stations that is one stop away from the heart of Shinjuku city center. The nine-story, 25 unit condominium was collaboratively developed by SYLA Co.’s in-house development, construction, sales, and management teams synergistically working together, resulting in the Company’s first sale of its own fully constructed...

PKP2 Mutations Are the Leading Cause of ARVC, a Dangerous Condition Linked to Sudden Cardiac Arrest in Young People Estimated to Affect 70,000 People in the US TN-401 Preclinical Studies Demonstrated Robust Reduction of Ventricular Arrhythmias and Extended Survival in Knockout Models of Disease After a Single Dose SOUTH SAN FRANCISCO, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of the company’s Investigational New Drug (IND) application to initiate clinical testing of TN-401. TN-401 is Tenaya’s adeno-associated virus serotype 9 (AAV9)-based...

The Company will also hold an investor conference call on Monday, October 30ᵗʰ to provide a business update SAN ANTONIO, Oct. 26, 2023 (GLOBE NEWSWIRE) — C-Bond Systems (the “Company” or “C-Bond”) (OTC: CBNT), a developer and marketer of glass strengthening solutions for enhanced safety, announced it was featured on the Stock Day podcast today, October 26, 2023. The interview with C-Bond’s CEO, Scott R. Silverman, can be found by clicking here. The Company plans to hold a conference call at 4:15 pm ET on October 30, 2023, to provide an update on its Patriot Glass Solutions division and new events within the Company. To listen to the live call, please dial (605) 313-5939 and use conference ID 1855758. To access a playback of the call, please dial (605) 313-4101 and use conference ID 1855758. The Company plans to conduct three additional...

BARTLETT, Tenn., Oct. 26, 2023 (GLOBE NEWSWIRE) — SurgePays, Inc. (Nasdaq: SURG) (“SurgePays” or the “Company”), a multiproduct company focused on the underbanked and underserved, announced the hiring of Gary Chekan as Director of Revenue Assurance and Financial Technology. Mr. Chekan, a seasoned telecom executive, has over 25 years of experience in leading finance organizations at large and small telecom organizations. He will oversee wireless revenue assurance, forecasting, business intelligence reporting, and margin efficiencies. Additionally, Gary will oversee reporting consolidation across multiple company software platforms, creating centralized sales revenue and back-office visibility for executive management. Gary Chekan commented on his new opportunity, “I am honored and tremendously excited to join the SurgePays team....