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Hemostemix Welcomes Shaune Harding, OStJ, RN as Director of Patient Care & Clinical Operations

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Hemostemix (OTCQB: HMTXF) appointed Shaune Harding, OStJ, RN (non-practicing) as Director of Patient Care & Clinical Operations effective December 4, 2025. Harding will oversee patient onboarding, comprehensive medical-records transfer, multi-year health-journey mapping, continuous wearable-data monitoring (e.g., Fitbit Sense 2), monthly follow-ups, and adverse-event tracking with escalation and formal reporting.

The role covers patient programs in The Bahamas, Florida, and Canada and is described as supporting long-term continuity of care, enabling patient data capture to advance regulatory approval of ACP-01/VesCell.

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Positive

  • Experienced clinical lead with 30+ years of hands-on care
  • Role covers patient programs in The Bahamas, Florida, and Canada
  • Wearable data capture (Fitbit Sense 2) integrated into monitoring
  • Adds monthly follow-up and formal adverse-event reporting

Negative

  • None.

News Market Reaction – HMTXF

+9.95%
+9.95% Session move

In the trading session that priced this news, HMTXF gained 9.95%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +9.9% in the session following this news. A strong positive reaction aligns with man...
Analysis

The stock moved +9.9% in the session following this news. A strong positive reaction aligns with management’s emphasis on building a patient-centric delivery model around ACP-01/VesCell. The appointment of a Director of Patient Care & Clinical Operations reinforces long-term follow-up and data capture across multiple regions. However, past news often saw price divergence despite favorable content, and prior financings introduced dilution. Investors monitoring such a move could have weighed whether operational upgrades and low-priced shares near $0.06364 supported sustained strength.

Historical Context

5 past events · Latest: Dec 03 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Dec 03 Conference presentation Positive -8.9% Showcased ACP-01/VesCell limb salvage and ulcer reduction data at wound meeting.
Dec 02 Conference & financing Positive -3.2% Announced DFCon participation plus TSXV-approved private placement with warrants.
Nov 26 Practice acquisition Positive -3.2% Binding LOI to acquire two cardiology practices and extend financing timeline.
Nov 18 Conference data update Positive +6.6% Reported Phase II wound-healing data and market size at Florida conference.
Nov 13 Clinical data presentation Positive -3.2% Presented ACP-01 safety, efficacy signals, and Florida access pathway at grand rounds.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive clinical, conference, and transaction news often saw negative next-day price reactions, with only one of five events aligning positively with the news tone.

Recent Company History

Over the last month, Hemostemix has highlighted ACP-01/VesCell clinical data, conference presentations, and strategic steps to commercialize its therapy. Events on Nov 13, Nov 18, and Dec 3 emphasized safety, efficacy, and wound-healing outcomes. On Nov 26 the company advanced a roll-up of cardiology practices alongside financing, and on Dec 2 it closed a private placement. Despite broadly positive themes, four of these five news days saw negative 24-hour price reactions.

Key Terms

hipaa-compliant, autologous stem cell therapeutics, ischemic diseases, adverse event
4 terms
hipaa-compliant regulatory
"Comprehensive medical records review and HIPAA-compliant transfer of patient records"
HIPAA-compliant means that a product, service, or organization follows the U.S. Health Insurance Portability and Accountability Act’s rules for protecting patients’ private health information, including technical controls, physical safeguards, and record-keeping. For investors, compliance matters because it reduces risks of costly fines, lawsuits and reputational damage, and it can be a requirement to sell into healthcare markets — like having a certified lockbox and an audit trail that reassures customers and regulators.
autologous stem cell therapeutics medical
"a leader in autologous stem cell therapeutics for ischemic diseases"
Therapies that harvest a patient’s own stem cells, process or modify them, and then return them to the same person to repair or replace damaged tissue. Think of it like using your own spare parts for a repair job, which can reduce immune rejection and regulatory hurdles but often requires individualized manufacturing and higher upfront costs. Investors watch these factors because they affect safety, pricing, scalability, and the speed at which treatments can reach the market.
ischemic diseases medical
"a leader in autologous stem cell therapeutics for ischemic diseases"
Ischemic diseases are conditions caused by reduced blood flow that starves tissues of oxygen and nutrients, like a kinked garden hose limiting water to a plant; common examples affect the heart, brain and limbs. They matter to investors because they drive demand for diagnostics, drugs, devices and procedures, influence healthcare spending and clinical trial activity, and can materially affect the revenues and regulatory risks of companies in medical and biotech sectors.
adverse event medical
"Adverse event monitoring, documentation, and reporting, including:"
An adverse event is any unwanted or harmful medical occurrence experienced by a person during a clinical trial or after using a product, whether or not it is caused by the treatment. Investors watch these reports because they can signal safety problems that delay approvals, trigger additional testing, reduce sales, or harm a company’s reputation — similar to how a series of car breakdowns can cut value and future sales for an automaker.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Calgary, Alberta--(Newsfile Corp. - December 4, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company"), a leader in autologous stem cell therapeutics for ischemic diseases, is pleased to announce the appointment of Shaune Harding, OStJ, RN non-practicing, as Director of Patient Care & Clinical Operations. In this senior clinical role, Ms. Harding will oversee:

  • On-boarding of all new patients entering Hemostemix treatment programs;
  • Comprehensive medical records review and HIPAA-compliant transfer of patient records to the treating physician team;
  • Patient health-journey mapping, from initial assessment through treatment and multi-year follow-up;
  • Continuous patient data monitoring, including heart rate, activity, exercise, and sleep metrics captured through approved wearable devices such as Fitbit Sense 2;
  • Monthly follow-up meetings to support goal setting, healthcare journey adherence, and improvements in functional status;
  • Adverse event monitoring, documentation, and reporting, including:
    • Real-time tracking of patient-reported issues;
    • Immediate escalation protocols to the treating physician;
    • Formal reporting to Hemostemix's clinical operations team and regulators.
    • Ensuring compliance with regulatory, clinical, and safety obligations.

Ms. Harding brings more than three decades of patient-hands-on clinical and management experience to her role, which will be leveraged it to advance Hemostemix's personalized care experience in The Bahamas, Florida, and Canada. This integrated role strengthens Hemostemix's hands-on, patient-centric healthcare model. It ensures long-term continuity of care for all who are treated with VesCell. Equally important, it enables patient data capture, which will be used to advance regulatory approval of ACP-01.

"I've known Shaune since 1967," said Thomas Smeenk, President & CEO of Hemostemix. "Shaune has always been one of the best-hearted friends anyone could have. Hemostemix's patients are going to love working with her, as she will help them get assessed, onboard, treated, and followed-up monthly. Shaune is the perfect person to guide patients throughout their health journey, and I'm thrilled to welcome her to head our patient care team," Smeenk said.

ABOUT HEMOSTEMIX

Hemostemix is an autologous stem cell therapy platform company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the Company has developed, patented, is scaling and selling autologous (patient's own) blood-based stem cell therapy, VesCell™ (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in eleven peer reviewed publications. ACP-01 is safe, clinically relevant and statistically significant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure, and angina. Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science. As compared to a five year mortality rate of 50% in the CLTI patient population, UBC and U of T reported to the 41st meeting of vascular surgeons: 0% mortality, cessation of pain, wound healing in 83% of patients followed for up to 4.5 years, as a midpoint result. For more information, please visit www.hemostemix.com.

For further information, please contact: Thomas Smeenk, President, CEO EM: tsmeenk@hemostemix.com / PH: 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 in relation to the Phase I clinical trial of ACP-01 as a treatment for Vascular Dementia, and the treatment of pain related to CLTI in Florida and other jurisdictions related to angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia with Angiogenic Cell Precursors (ACP-01) in furtherance of sales of VesCell™ (ACP-01), and the commercialization of ACP-01 via the sale of compassionate treatments under Florida SB 1768. There can be no assurance that such forward-looking information will prove to be accurate. 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 underlying value of Hemostemix and its Common Shares; the successful resolution of any litigation that Hemostemix is pursuing or defending (the "Litigation"); the results of ACP-01 research, trials, studies and analyses, including the analysis being equivalent to or better than previous research, trials or studies; the receipt of all required regulatory approvals for research, trials or studies; 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, Hemostemix obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies, and any Litigation. 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 clinical trials, complete a satisfactory analyses and file the results of such analyses to gain regulatory approval of a phase II or phase III clinical trial of ACP-01; potential litigation 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 Hemostemix'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, disruptions to economic activity and financings, disruptions to supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession or depression; the potential impact that the COVID-19 pandemic may have on Hemostemix which 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.sedarplus.ca. 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, it 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/276823

FAQ

Who is Shaune Harding and what role did Hemostemix (HMTXF) announce on December 4, 2025?

Hemostemix named Shaune Harding, OStJ, RN (non-practicing) as Director of Patient Care & Clinical Operations.

What responsibilities will Shaune Harding have at Hemostemix (HMTXF)?

She will manage patient onboarding, HIPAA-compliant records transfer, multi-year health-journey mapping, wearable-data monitoring, monthly follow-ups, and adverse-event reporting.

Which regions will Hemostemix's new Director of Patient Care oversee for HMTXF programs?

The role will support Hemostemix patient programs in The Bahamas, Florida, and Canada.

How will Hemostemix (HMTXF) use wearable devices under the new clinical operations role?

Wearable devices such as Fitbit Sense 2 will capture heart rate, activity, exercise, and sleep metrics for continuous patient monitoring.

Will Shaune Harding's role affect Hemostemix's regulatory efforts for ACP-01 (VesCell)?

The company says patient data capture from Harding's role will be used to advance regulatory approval of ACP-01/VesCell.

Does the announcement for HMTXF disclose financial impacts or changes to guidance?

No financial figures or guidance changes were disclosed in the appointment announcement.