Core Viewpoint - Anteris Technologies reported its financial results for Q1 2025, highlighting significant clinical milestones and ongoing preparations for the PARADIGM Trial, which is crucial for the commercialization of its DurAVR Transcatheter Heart Valve (THV) [1][2]. Business & Operations - The company successfully submitted its Investigational Device Exemption (IDE) application to the FDA for the PARADIGM Trial, which is designed to assess the safety and effectiveness of the DurAVR THV [4][6]. - Over 100 patients have been treated with the DurAVR THV, marking a significant clinical milestone and demonstrating growing physician confidence in the technology [3][8]. - The PARADIGM Trial is set to commence in Q3 2025, pending FDA approval, and aims to provide robust clinical evidence for FDA Premarket Approval (PMA) [4][5]. - Anteris is expanding its global manufacturing capacity to support the PARADIGM Trial, with production facilities being scaled to at least three times the 2024 capacity levels [13]. Clinical Milestones - The company achieved a major clinical milestone with 100 patients treated with the DurAVR THV, including complex cases such as bicuspid aortic valve patients and valve-in-valve patients [8][9]. - One-year clinical data for DurAVR THV patients showed sustained favorable hemodynamic outcomes and a strong safety profile, with no valve or cardiovascular-related mortality reported [15][11]. Financial Results - For Q1 2025, net sales were $0.6 million, a decrease of 27% compared to $0.8 million in Q1 2024, primarily due to lower demand for tissue products [16]. - The loss after income tax for the quarter was $21.9 million, an increase of 36% from $16.2 million in the same period last year [17]. - Research and development expenses rose to $16.5 million, a 42% increase from $11.6 million in Q1 2024, driven by upscaling manufacturing capabilities and preparatory activities for the PARADIGM Trial [24]. Corporate and Financing Activities - Anteris was included in the FTSE Russell 2000 Index as of March 24, 2025, reflecting its position in the small-cap segment of the US equity market [20]. - The company raised an additional $0.47 million through the partial exercise of a green shoe option related to its December 2024 IPO [19].

REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on September 8, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Code Number) 3513 Brighton Blvd, Suite 410 Denver, CO 80216 (844) 427-8100 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices) Eric Schlorff Chief Executive Officer 3513 Brighton Blvd. Suite 410 Denver, CO 80216 UNDER THE S ...

As filed with the Securities and Exchange Commission on August 18, 2023. Registration Statement No. 333-273346 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1/A REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PRECISION OPTICS CORPORATION, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Massachusetts 3845 04-2795294 (Primary Standard Industrial Classification Code Number) (I. ...

Table of Contents REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on July 20, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-3681132 (Primary Standard Industrial Classification Code Number) (I.R.S ...

As filed with the Securities and Exchange Commission on July 20, 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 PRECISION OPTICS CORPORATION, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Massachusetts 3845 04-2795294 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identifi ...

Table of Contents REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on April 24, 2023 Registration No.333-271215 UNITED STATES SECURITIES AND EXCHANGE COMMISSION 3513 Brighton Blvd, Suite 410 Denver, CO 80216 (844) 427-8100 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices) Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation ( ...

Table of Contents REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on April 11, 2023 Registration No. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-3681132 (Primary Standard Industrial Classification Code Number) (I.R.S. Em ...

Table of Contents REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on January 20, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-3681132 (Primary Standard Industrial Classification Code Number) (I. ...

Table of Contents Index to Financial Statements REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on January 4, 2023 Registration No. 333-268503 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 SeaStar Medical Holding Corporation (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 6770 85-3681132 (Prima ...