Hemostemix Announces Soft Lock of Database as Source Document Verification Completed

Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV:HEM; OTCQB:HMTXF; FSE:2VFO) is pleased to announce the source document verification process has been completed and the Company has soft locked the HS 12-01 database.  Next, each of the principal investigators will sign off the source documentation of the subjects they followed.  Following the sign off by all principal investigators, the HS 12-01 database will be locked.

The database includes a total of 65 subjects who were randomized on a 2:1 basis to receive ACP-01 or a placebo, respectively.  The Company is seeking the return of all of its intellectual property and assets from Aspire Health Sciences, LLC, including the randomization key(s) required to complete the statistical analyses of the trial.  

About Hemostemix
Hemostemix is a publicly traded autologous stem cell therapy company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other conditions of ischemia. ACP-01 has been used to treat over 300 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from amputation.

On October 21, 2019, the Company announced the results from its Phase II CLI trial abstract presentation entitled “Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Follow-up” which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.

The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy.