Calgary, Alberta--(Newsfile Corp. - July 3, 2020) - Hemostemix Inc. (TSXV: HEM) (OTC: HMTXF) ("Hemostemix" or the "Company") is pleased to announce on June 29, 2020, it filed a Verified Complaint and, on July 2, 2020, Motions for a Preliminary Injunction and Expedited Scheduling seeking to compel the immediate return of all clinical trial data from Defendant Accudata Solutions, Inc. ("Accudata") and enjoining Accudata from continuing to divulge and disclose such highly sensitive and confidential information to third parties who have no ownership or custodial right to it.
Hemostemix engaged the services of Accudata to conduct, pursuant to a Consulting Agreement executed in August 2019, a statistical analysis of the clinical trial midpoint data. All clinical trial data and, in particular, the clinical trial midpoint analysis and supporting data are, and always have been, the property of Hemostemix. Hemostemix has an absolute ownership right over that data and an absolute right to recover the data upon demand. Despite repeated requests, Accudata has failed and refused to return the midpoint data to Hemostemix.
Hemostemix also recently learned that, while refusing to return the clinical trial midpoint data to Hemostemix, Accudata produced a copy of the midpoint data and report to an agent of the former Contract Research Organization ("CRO"), Aspire Health Science, LLC ("Aspire") and Aspire is now blocking Hemostemix from obtaining the return of its clinical trial data. Neither Aspire nor any of its agents or representatives have any ownership or any other right to have, maintain, or withhold such data, or to hold such data to the exclusion of Hemostemix. Hemostemix seeks the Court's immediate intervention to enjoin Accudata's continued breaches of the parties' agreement.
Hemostemix filed in the United States District Court for the District of Delaware.
On June 25, 2020 counsel for Hemostemix presented oral argument to the 9th Circuit Court in and for Orange County, Florida on its motion to dismiss Aspire's lawsuit on grounds that, among other things, Hemostemix's threshold challenge that it is not subject to jurisdiction in Florida. A decision on Hemostemix's motion is pending. In the meantime, the presiding judge has stayed a hearing on Aspire's Motion for a Speedy Hearing previously set for June 29, 2020 pending a decision on Hemostemix's motion to dismiss.
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 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 entitled "Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup" 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. For more information, please visit www.hemostemix.com.
Contact: Thomas Smeenk, President, CEO & Co-Founder
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information regarding: the commercialization of ACP-01. There can be no assurance that such forward-looking information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: the results of ACP-01 research, trials and studies being equivalent to or better than previous research, trials or studies as well as management's expectations of anticipated results; Hemostemix's general and administrative costs remaining constant; the receipt of all required regulatory approvals for research, trials or studies as well as any required or desired financings of Hemostemix, including TSX Venture Exchange acceptance and any third party consents; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages; and obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete its current CLI clinical trial, complete a satisfactory futility analysis and the results of such and future clinical trials; litigation and potential litigation that Hemostemix may face; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in the Company's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession; the potential impact that the COVID-19 pandemic may have on Hemostemix may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at www.sedar.com. Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, is subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.
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