Core Insights - NLS Pharmaceutics Ltd. and Kadimastem Ltd. announced the continuation of the ITOL-102 cell therapy program for Type 1 Diabetes under the merged entity NewCelX Ltd. following their merger [1][3][4] Group 1: Company Overview - NLS Pharmaceutics is a biopharmaceutical company focused on innovative therapies for central nervous system disorders [5] - Kadimastem is a clinical-stage cell therapy company developing treatments for neurodegenerative diseases and diabetes [6] Group 2: ITOL-102 Program - The ITOL-102 program aims to develop a functional, stem-cell-derived pancreatic islet cell therapy to cure Type 1 Diabetes without lifelong immunosuppression [3] - The BIRD Foundation, which has invested over $300 million in joint projects since 1977, will continue to support the ITOL-102 program under NewCelX [2][4] Group 3: Strategic Focus - The merger allows NLS to leverage Kadimastem's advanced stem-cell platform, expanding its pipeline into regenerative and metabolic medicine [4]

Core Viewpoint - Hemostemix Inc. has completed the drafting of a clinical trial protocol for the treatment of refractory angina using its ACP-01 stem cell therapy, aiming to provide new options for patients who do not respond to standard treatments [1][3][15] Company Overview - Hemostemix Inc. is a leading autologous stem cell therapy company that offers VesCell™ (ACP-01) for various conditions including angina and chronic limb threatening ischemia [1][15] - The company has a history of over two decades in developing and scaling autologous blood-based stem cell therapies and has completed seven clinical studies involving 318 subjects [15][16] Clinical Trial Details - The Phase 1 clinical trial will enroll 20 to 100 adults aged 40–90 years with recurrent or refractory severe angina, focusing on feasibility and safety as primary endpoints [9][10] - ACP-01 will be administered via intracoronary injection, with secondary endpoints including improvement in chest pain frequency, quality of life, and left-ventricular ejection fraction (LVEF) [9][10] Scientific Rationale - ACP-01 cells are derived from the patient's own blood and are designed to promote new blood vessel formation and micro-circulatory repair, potentially improving heart function [6][7] - Previous studies indicated that patients receiving ACP-01 therapy experienced improved heart function and reduced emergency treatment needs [8][6] Mechanism of Delivery - The delivery of ACP-01 will be performed through an intracoronary route under fluoroscopic guidance, allowing precise localization to ischemic areas [11][12] - The procedure is expected to be safe and feasible in outpatient settings, with no reported serious complications in prior trials [11][14] Safety Oversight - The clinical trial will be monitored by qualified interventional cardiologists and a Data Safety Monitoring Board (DSMB) to ensure patient safety during the procedure [13][14]

Hemostemix Files for Ethics Approval of its Study of Vascular DementiaOctober 09, 2025 9:03 AM EDT | Source: Hemostemix Inc.Calgary, Alberta--(Newsfile Corp. - October 9, 2025) - Hemostemix (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") is pleased to announce it has filed its Institutional Review Board (IRB) application for approval of its Phase 1 clinical trial titled "Treatment of Vascular Cognitive Impairment and Dementia with Angiogenic Cell Precursors (ACP-01)." Th ...