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Beta Bionics to Announce Second Quarter 2025 Financial Results on July 29, 2025
GlobeNewswire· 2025-07-02 11:30
Company Announcement - Beta Bionics, Inc. plans to release its second quarter 2025 financial results after the market closes on July 29, 2025 [1] - A conference call and webcast will be hosted on the same day at 4:30 pm Eastern Time [1] Webcast Information - The link to the webcast will be available on the company's website in the "Investors—Events & Presentations" section and will be archived for future replay [2] - A personal pin and dial-in details for the live call can be accessed through a provided registration link [2] Company Overview - Beta Bionics is a commercial-stage medical device company focused on developing innovative solutions for insulin-requiring individuals with diabetes [3] - The iLet Bionic Pancreas is highlighted as the first FDA-cleared insulin delivery device that autonomously determines insulin doses, aiming to improve health outcomes for people with diabetes [3]
CytoSorbents Provides U.S. FDA and Health Canada Regulatory Update for DrugSorb-ATR
Prnewswire· 2025-07-02 11:00
PRINCETON, N.J., July 2, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada. DrugSorb-ATR is an FDA-designated Breakthrough Device designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting ...
CVRx: Sell-Off Ignores Its True Potential
Seeking Alpha· 2025-07-02 08:02
Core Insights - CVRx is a pioneering medical device company focused on treating advanced heart failure with its FDA-approved therapy [1] - The company is currently unprofitable due to significant investments in US sales and support infrastructure [1] Company Overview - CVRx operates in the medical device industry, specifically targeting advanced heart failure treatment [1] - The company has received FDA approval for its therapy, indicating regulatory validation of its product [1] Financial Performance - Despite its innovative approach, CVRx has not yet achieved profitability [1] - Heavy investments in infrastructure are a key factor contributing to the company's current financial status [1]
Penumbra, Inc. Schedules Second Quarter 2025 Earnings Release and Conference Call for July 29, 2025
Prnewswire· 2025-07-01 20:30
ALAMEDA, Calif., July 1, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN) today announced that it will host a conference call to discuss financial results for the second quarter 2025 after market close on Tuesday, July 29, 2025 at 4:30 PM Eastern Time. A press release with second quarter 2025 financial results will be issued after market close that day.Webcast & Conference Call InformationThe conference call can be accessed live over the phone by dialing (888) 596-4144 (conference id: 6572573), or the webcas ...
First Clinical Results from MAGiC Catheter Study Published in the Journal of Interventional Cardiac Electrophysiology
Globenewswire· 2025-07-01 13:00
Core Insights - Stereotaxis has published initial clinical results of the MAGiC catheter in a peer-reviewed journal, demonstrating its efficacy and safety for minimally invasive endovascular interventions [1][2]. Company Overview - Stereotaxis is a pioneer in surgical robotics for minimally invasive endovascular interventions, with a mission to develop robotic systems and solutions that enhance patient care and operating room efficiency [6]. Clinical Study Details - The study involved a prospective multi-center, single-arm design, treating 67 patients with various arrhythmias, including atrial fibrillation and ventricular tachycardia, with ongoing enrollment expected to reach around 100 patients [2][3]. - The acute efficacy of the MAGiC catheter was reported at 94%, with an average procedure time of 83 minutes and a procedure-related adverse event rate of 1.5% [3]. Product Features - The MAGiC catheter is designed for cardiac ablation procedures, enhancing treatment precision and control while maintaining safety through its soft flexible design [4]. - The catheter has shown improved stability, not requiring sheaths for support, and maintaining steady temperatures during ablation, which benefits patients with compromised cardiac and renal function [3][4]. Market Presence - Stereotaxis' robotic technologies have been utilized in over 100 leading hospitals globally, treating more than 150,000 patients [4].
ReShape Lifesciences® Granted U.S. Patent Related to an Intragastric Balloon System
Globenewswire· 2025-07-01 12:31
Core Insights - ReShape Lifesciences announced the issuance of U.S. Patent 12,350,179 for an intragastric device, enhancing its intellectual property portfolio [1][2] - The patent covers a swallowable capsule with a self-sealing fill valve and a degradable release valve, designed for natural excretion after deflation [1] - The patent protection extends to at least January 2031, potentially longer with a Patent Term Extension [1] Intellectual Property Development - The company has secured over 50 patents related to its intragastric balloon technology since its initial filing in 2011, contributing to a total of over 160 issued and pending patents [2] - This robust patent portfolio positions the company to defend its competitive edge and support its innovation pipeline [2] Company Overview - ReShape Lifesciences specializes in weight loss and metabolic health solutions, offering products like the FDA-approved Lap-Band systems and the non-surgical Obalon balloon technology [3] - The company aims to provide integrated solutions for managing obesity and metabolic diseases [3] Recent Transactions - ReShape has entered into an asset purchase agreement with Biorad Medisys, agreeing to sell substantially all of its assets, including the Lap-Band and Obalon systems [4]
Vivos Therapeutics Receives Medicare Approval for VidaSleep™ Oral Appliance
Globenewswire· 2025-07-01 12:30
Important Milestone Clears the Way for Millions of Medicare Beneficiaries with Sleep Apnea to Access Vivos’ Patented and FDA-Cleared Oral Appliance TreatmentLITTLETON, Colo., July 01, 2025 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (NASDAQ: VVOS) (“Vivos” or the “Company”), a pioneering medical technology company revolutionizing the treatment of obstructive sleep apnea (OSA) and snoring, today announced that its VidaSleep™ oral appliance, featuring Vivos’ patented and U.S. Food and Drug Administration (FD ...
Kestra Medical Technologies, Ltd. to Report Fourth Quarter and Fiscal Year 2025 Results on July 15
GlobeNewswire News Room· 2025-07-01 12:00
KIRKLAND, Wash., July 01, 2025 (GLOBE NEWSWIRE) -- Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced that it will report fourth quarter and fiscal year 2025 financial results on Tuesday, July 15. Management will host a corresponding conference call at 4:30 p.m. Eastern Time. A live and archived webcast of the conference call will be available in the "Events" section of the investor relations website. Participants are encouraged to reg ...
New Evidence Supports the Value of Elutia’s Antibiotic-Eluting Platform for Implantable Devices
GlobeNewswire· 2025-07-01 12:00
To learn more, visit www.elutia.com/products/elupro/. About Elutia — The EluPro BioEnvelope findings demonstrate the bioactive properties and superior healing response compared to synthetic materials for cardiac implantable electronic devices (CIEDs) — GAITHERSBURG, Md., July 01, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix technologies, today announced the publication of a new study describing the bioinductive effects of its antibiotic ...
EDAP Announces Transition from Foreign Private Issuer to U.S. Domestic Filer Status
GlobeNewswire News Room· 2025-07-01 11:00
Core Points - EDAP TMS SA will transition to U.S. reporting status effective January 1, 2026, ceasing to qualify as a foreign private issuer under SEC rules [1] - This change reflects the company's commitment to transparency and regulatory best practices, aiming to strengthen relationships with shareholders and attract institutional investors [2] Company Overview - EDAP TMS SA is a leader in robotic energy-based therapies, developing and distributing minimally invasive medical devices using ultrasound technology [2] - The company has introduced the Focal One® system, a leading prostate focal therapy, with potential applications beyond prostate cancer [2]