Hemostemix Inc. (TSXV: HEM) (OTC: HMTXF) (FSE: 2VF0) and CytoImmune Therapeutics ("CytoImmune") have amended their Manufacturing Services Agreement, paving the way for accelerated global scale-up of Hemostemix's innovative ACP-01 therapies. The amendments, announced on January 9, 2025, include the addition of Regulatory Consulting and Engineering Services, as well as an optimized payment structure aligned with both the TSX Venture Exchange and Puerto Rico's ACT 60 Program.

CytoImmune's regulatory expert, with extensive experience at the FDA, is advising Hemostemix on regulatory strategy, protocol development, and Phase I-III clinical trials. This expertise will help Hemostemix navigate the complex regulatory landscape and increase the likelihood of successful clinical trials and approval. Additionally, CytoImmune's engineering team is advancing Hemostemix's patented Automated Cell Therapy System (ACTS), which has the potential to produce up to 23,040 ACP-01 therapies annually, each priced at USD $37,000.



The amended agreement also includes a feasibility study to determine the maximum production capacity of CytoImmune's 38,000-square-foot facility in San Juan, Puerto Rico. This will enable Hemostemix to maximize its production capabilities and meet the growing demand for ACP-01 therapies.

The optimized payment structure aligns with the policies of both the TSX Venture Exchange and Puerto Rico's ACT 60 Program. Payments to CytoImmune will be made in cash by Hemostemix PR Inc. to qualify for ACT 60 reimbursement, ensuring compliance with TSX Venture Exchange policies. CytoImmune will reinvest these proceeds into Hemostemix's equity at the then-market value, demonstrating their confidence in Hemostemix's growth potential.

The amendments to the Manufacturing Services Agreement between Hemostemix and CytoImmune will accelerate the global scale-up of ACP-01 therapies, transforming access to innovative treatments for cardiovascular diseases. With the support of CytoImmune's regulatory expertise and engineering capabilities, Hemostemix is well-positioned to bring its therapies to market more efficiently and generate substantial positive net cash flow from the treatment of no-option patients.