Calgary, Alberta--(Newsfile Corp. - July 6, 2020) - Hemostemix Inc. (TSXV: HEM) (OTC: HMTXF) ("Hemostemix" or the "Company") is pleased to announce that the United States District Court for the District of Delaware has granted an order for the expedited briefing schedule on Hemostemix's Injunction application seeking the immediate return of all clinical trial data from Accudata Solutions, Inc. ("Accudata"). The Order directs Defendant Accudata to file an Answering Brief in response to Hemostemix's Motion for Preliminary Injunction on or before July 9, 2020. The Hemostemix Reply Brief in support of its Motion for Preliminary Injunction shall be filed on or before July 13, 2020. The Court scheduled a hearing on the preliminary injunction motion for July 15, 2020 at 8:30 a.m. ET.
Further to its July 3, 2020 news release, Hemostemix 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 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 has an absolute ownership right over its data and an absolute right to recover its data upon demand. Despite repeated requests, Accudata has failed and refused to return to Hemostemix its data.
Counsel for Hemostemix received a letter and a purported report on July 5, 2020 from the counsel for Aspire Health Science, LLC ("Aspire") at 10:42 p.m. ET on Sunday July 5, 2020. The document, dated April 30, 2020, is unsigned, was addressed to an individual that is neither a director nor officer of Hemostemix, nor acts for Hemostemix in any capacity, and is unverifiable as the underlying data was not included. Hemostemix cautions that Aspire's new release regarding the report is motivated by Aspire's own purposes and is potentially misleading.
Aspire is continuing to block Hemostemix from obtaining the return of its clinical trial data, and in its place has published a news release regarding the report. It is unclear to Hemostemix the scientific bases of the Aspire news release. Neither Aspire nor any of its agents or representatives have any ownership rights to Hemostemix's clinical trial data, nor do they have any rights whatsoever to publish any type of report or results purported to be related to Hemostemix's ACP-01 clinical trials. Similarly, Aspire has no right to continue to hold such data to the exclusion of Hemostemix.
Hemostemix requires its data to properly assess the midpoint analysis of its ACP-01 clinical trials. Hemostemix is seeking the Delaware Court's immediate intervention to obtain its complete clinical trial data from Accudata. Hemostemix will update the market once it has obtained its data and completed an analysis of its ACP-01 clinical trials including its midpoint analysis.
ABOUT HEMOSTEMIX
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, TSmeenk@Hemostemix.com 905-580-4170
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 dates for the various filings and the hearing in relation to the Verified Complaint and the Injunction Application; its ACP-01 clinical trials and the midpoint analysis, including the assessment of the midpoint analysis and updating the market in relation to its ACP-01 clinical trials; and 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: no applications or motions delaying the date of the filings or the hearing for Hemostemix's Injunction; no delays in the hearing due to the COVID-19 pandemic or other reasons which require a delay of the hearing; the timing of receipt of its full and complete clinical trials data; 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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