Core Viewpoint - Aethlon Medical, Inc. has received a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to advance its clinical trial of the Aethlon Hemopurifier without modifications, indicating a favorable safety profile for the device in oncology applications [1][3][4]. Group 1: Clinical Trial Details - The ongoing trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab," aims to evaluate the safety, feasibility, and optimal dosing of the Hemopurifier [2]. - The DSMB reviewed data from the initial cohort of three participants, each receiving a single 4-hour treatment, and found no safety concerns, confirming the Hemopurifier's favorable safety and tolerability profile [3]. - Enrollment for the second cohort is now open, where participants will receive two Hemopurifier treatments over a one-week period, with the trial aiming to enroll approximately 9 to 18 patients [4]. Group 2: Study Objectives and Endpoints - The primary endpoint of the trial is to monitor the incidence of adverse events and clinically significant changes in safety laboratory tests among Hemopurifier-treated patients [5]. - The study will also examine the number of Hemopurifier treatments needed to decrease the concentration of tumor-derived extracellular vesicles (EVs) and assess if these changes improve the body's ability to attack tumor cells [5]. Group 3: Device Information - The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation, utilizing a combination of plasma separation, size exclusion, and affinity binding [7]. - The device has received U.S. Food and Drug Administration Breakthrough Device designation and is being developed under an open Investigational Device Exemption for its oncology and infectious disease indications [8]. Group 4: Company Commitment - Aethlon Medical remains committed to advancing the Hemopurifier for oncology applications and will continue to provide updates as the clinical trial progresses [6].

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].