Medical device development
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Medical 21(MAVG) - Prospectus(update)
2026-03-20 19:17
As filed with the U.S. Securities and Exchange Commission on March 20, 2026. Registration Statement No. 333-293562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ––––––––––––––––––––––– AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ––––––––––––––––––––––– MEDICAL 21, INC. (Exact name of registrant as specified in its charter) ––––––––––––––––––––––– Minnesota 3842 81-1497154 (State or other jurisdiction of incorporation or organization) (Primary ...
Medical 21(MAVG) - Prospectus(update)
2026-03-12 00:45
As filed with the U.S. Securities and Exchange Commission on March 12, 2026. Registration Statement No. 333-293562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ––––––––––––––––––––––– AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ––––––––––––––––––––––– MEDICAL 21, INC. (Exact name of registrant as specified in its charter) ––––––––––––––––––––––– (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Class ...
Aethlon Medical Announces Fiscal Q3 2026 Financial Results and Corporate Update
Prnewswire· 2026-02-12 21:15
Core Insights - Aethlon Medical reported its fiscal Q3 2026 financial results, highlighting advancements in clinical and research programs, operational efficiencies, and ongoing technology development [1] Financial Performance - As of December 31, 2025, Aethlon had a cash balance of approximately $7.0 million [1] - Consolidated operating expenses for Q3 2026 were approximately $2.06 million, an increase of $250,000 or 13.6% from $1.81 million in Q3 2025, primarily due to higher payroll costs [1] - For the nine months ended December 31, 2025, consolidated operating expenses were approximately $5.36 million, a decrease of approximately $1.98 million or 26.9% compared to $7.34 million in the same period in 2024 [1] Operational Efficiency - The company maintained disciplined cost controls, resulting in a 26.9% decline in operating expenses year-to-date compared to the prior year [1] - Aethlon is actively progressing in its Australian oncology trial, with Cohort 2 enrollment and treatment underway, building on favorable results from Cohort 1 [1] Technology Development - Aethlon is evaluating the Hemopurifier® compatibility with a simplified blood treatment system under a Material Transfer Agreement, which may enhance its use in oncology units [1] - The company continues to advance its preclinical extracellular vesicle (EV) research platform, with recent findings on Long COVID published and submitted for peer review [1] Scientific Advancement - The R&D team is exploring the potential of the Hemopurifier to remove various EVs implicated in diseases beyond cancer, including Lupus and Cardiovascular Diseases [1] - Aethlon's research indicates that the Hemopurifier may serve as a "pipeline within a single device" for multiple therapeutic applications [1] Clinical Progress - The ongoing Australian oncology trial aims to evaluate the safety and feasibility of Hemopurifier treatments in patients with solid tumors [1] - The trial is designed to assess appropriate dosing in participants receiving anti-PD-1 agents [1] Nasdaq Compliance - Aethlon has maintained compliance with Nasdaq listing requirements, resolving all prior compliance matters [1]
Anteris Technologies Global Corp. Announces Pricing of $200 Million Public Offering
Globenewswire· 2026-01-21 03:53
Core Viewpoint - Anteris Technologies Global Corp. has announced a public offering of 34,782,609 shares at a price of $5.75 per share, aiming to raise approximately $200 million before expenses [1][2]. Group 1: Offering Details - The public offering consists entirely of shares sold by the Company, with underwriters granted a 30-day option to purchase an additional 5,217,391 shares [2]. - The Offering is expected to close on January 22, 2026, pending customary closing conditions [1]. - The shares are being offered under a shelf registration statement filed with the SEC, which was declared effective on January 8, 2026 [6]. Group 2: Private Placement - Anteris has agreed to sell up to $90 million of shares to Medtronic plc in a private placement, contingent on the completion of the public offering [3]. - The private placement will require a minimum purchase of 16% and a maximum of 19.99% of the shares outstanding after the public offering [3]. Group 3: Use of Proceeds - The net proceeds from the Offering and the Private Placement will support the growth and clinical strategy of the Company, including the DurAVR Transcatheter Heart Valve global pivotal trial [4]. - Funds will also be allocated to expand manufacturing capabilities and ongoing research and development for v2vmedtech, inc., with remaining proceeds for working capital and general corporate purposes [4]. Group 4: Company Overview - Anteris Technologies is focused on developing innovative medical devices for heart function restoration, with a significant presence in both Australia and the USA [10]. - The lead product, DurAVR THV, is designed to treat aortic stenosis and is the first biomimetic valve, utilizing patented ADAPT tissue technology [11].
SynCardia and Hydrix Enter into Development Collaboration to Advance the Emperor, SynCardia’s Next Generation Total Artificial Heart
Globenewswire· 2026-01-12 13:30
Core Viewpoint - Picard Medical, Inc. has entered into a development collaboration agreement with Hydrix Services Pty Ltd to advance the next-generation fully implantable Total Artificial Heart technology, known as the Emperor, which aims to enhance patient mobility and convenience by eliminating the need for an external driver [1][2]. Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is recognized for developing the only commercially available total artificial heart technology for patients with end-stage heart failure [5]. - SynCardia's Total Artificial Heart (STAH) is the first artificial heart approved by both the U.S. FDA and Health Canada, with over 2,100 implants performed across 27 countries, making it the most widely used artificial heart globally [5]. Collaboration Details - The partnership with Hydrix was chosen due to its expertise in complex critical engineering and a strong track record in developing regulated medical devices, particularly mechanical circulatory support systems [2]. - The development work under this agreement will continue through the end of 2026 as part of a broader multi-stage program, with progress contingent on technical performance and safety validation [3]. Financial Incentives - The collaboration may allow Picard to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure, subject to qualification and review [3]. Hydrix Overview - Hydrix Limited is a product innovation company focused on enhancing health and well-being through its services in design, engineering, and delivery of medical products, as well as investing in high-potential MedTech clients [4].
Envoy Medical(COCH) - Prospectus
2025-12-18 22:20
As filed with the U.S. Securities and Exchange Commission on December 18, 2025. Registration No. 333- (State or other jurisdiction of incorporation or organization) FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Primary Standard Industrial Classification Code Number) Delaware 3842 86-1369123 (IRS Employer Identification Number) 4875 White Bear ...
Envoy Medical(COCH) - Prospectus
2025-10-17 14:59
As filed with the U.S. Securities and Exchange Commission on October 17, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Envoy Medical, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3842 86-1369123 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification Number) 4875 White Bear P ...
ReShape Lifesciences (RSLS) - Prospectus(update)
2023-01-26 23:11
TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on January 26, 2023 Registration Statement No. 333-269207 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 RESHAPE LIFESCIENCES INC. (Exact name of registrant as specified in its charter) 3841 (Primary Standard Industrial Classification Code Number) 26-1828101 (I.R.S. Employer Identification Number) 1001 Calle Amanecer San Clem ...
ReShape Lifesciences (RSLS) - Prospectus
2023-01-12 22:07
Table of Contents As filed with the U.S. Securities and Exchange Commission on January 12, 2023 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 RESHAPE LIFESCIENCES INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3841 26-1828101 (I.R.S. Employer Iden ...