Mr. Thomas Smeenk reports
HEMOSTEMIX PROVIDES A CLINICAL TRIAL UPDATE AND ANNOUNCES THE RELEASE AND FILING OF 2020 YEAR-END AUDITED FINANCIAL STATEMENTS AND MANAGEMENT DISCUSSION AND ANALYSIS
With the last patient follow-up completed in April, Hemostemix Inc. is now focusing its efforts on completing the key areas of the trial, including, but not limited to, data entry, source document verification, database query management and validation as more fully described herein, biostatistical analyses, and final reporting documentation. This process is expected to take approximately three months.
The company has contracted a clinical data management service company to provide Hemostemix with clinical trial database management services, including database management plan adherence, database edit checks, database query management, database integration and validation, database reconciliations by events, database analysis readiness reporting, database hard lock, and database closeout and delivery. Hemostemix is continuing with the data entry and source document verifications. As announced on April 23, the 65th (final) subject has completed a last follow-up visit, and the company has contracted two additional clinical research associates to assist with the completion of the source document verification process.
Hemostemix filed on SEDAR its audited annual financial statements for the period ended Dec. 31, 2020, with a comparison with the year-earlier period, including the notes related thereto and also including management's discussion and analysis.
About Hemostemix Inc.
Hemostemix is a publicly traded autologous stem cell therapy company. 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 500 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 Oct. 21, 2019, the company announced the results from its phase 2 CLI trial abstract 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 per cent 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.
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