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INVESTMENT CASE

Restoring blood flow and quality of life. Restoring human potential.

Hemostemix is advancing ACP-01, an investigational autologous angiogenic cell therapy derived from a patient's own blood, supported by two decades of human clinical research across cardiovascular, peripheral vascular and neurological ischemic disease.

20+

years of clinical development

498

patients including 7 completed studies (318 subjects) 

11

peer-reviewed publications 

Multiple

ischemic indications 

TSXV: HEM | OTCQB: HMTXF | FSE: 2VF0 

WHY NOW

Two decades of science. A defined commercial inflection ahead.

Each milestone changes the company's risk profile. Regulatory decision de-risks market access. First patient converts a filing into an operating program. First 20 enrolled proves the funnel.

COMPLETED


  • Prior Phase I and Phase II clinical work 

  • Peer-reviewed cardiac and CLTI publications 

  • Manufacturing technology and IP 

  • FDA regulatory engagement

  • Bahamas commercial application filed Completed · Jul 8, 2026 

  • Manufacturing partner selected 

NEXT 5 TO 12 MONTHS


  • Bahamas regulatory decision Planned · September 

  • First commercial Phase I patient Planned · October 

  • Angina study commencement Planned · October 

  • Manufacturing batches released Planned · October 

  • First 20 patients enrolled Planned · December

  • Real-world evidence database activated Planned

CLINICAL EVIDENCE

The most published cell therapy in its class.

Seven completed clinical studies. Eleven peer-reviewed publications. Follow-up extending to 4.5 years. Each study links directly to its publication.

Study & indication 

Design & patients 

Plain language improvement

Source

Studies:

Mutirangura 2009
 CLTI 
Open-label pilot; 6 no-option patients; intramuscular 
83.3% meaningful improvement in circulation; 66.7% complete wound or stump healing. 
Link
Tresukosol 2006
Refractory angina 
Phase I open-label; 24 patients; intracoronary 
Walked 24.4% farther in 6 min. Angina severity down 50%. Perfusion defect down ~45%. 
Link
Szabó 2013
PAD/CLTI 
Phase II randomized; 13 treated / 8 control 
3-month amputations 0% vs 60%. At 2 years, 70% vs 40% amputation-free. 
Link
Arom 2008
Cardiomyopathy
Open-label; 41 patients; intramyocardial
Pumping function +18% overall, +26.3% ischemic. Walking distance +36.7%
Link
Chaithiraphan 2009
Ischemic CM & angina 
Open-label; 106 patients; transcoronary 
Angina severity down ~41.8%. Symptom severity down ~39%. 
Link
Schubart/Henderson 2023
Cardiomyopathy 
Retrospective; 53 patients; intracoronary 
Most severe subgroup nearly doubled pumping function (~94.5% relative). 
Link
Henderson et al. 2024
Wound / Ulcer Healing 
Phase II randomized; 21 treated / 8 control
Wound size down ~72.6% at 3 months. Event-rate differences not statistically significant. 
Link
Published investigational findings. ACP-01 has not received FDA or Health Canada marketing approval. Individual outcomes in future studies may vary. 

PATIENT IMPACT

The evidence has a human shape. It started with our founder.

Shared with each patient's consent. Every account is one person's experience, bounded and attributed. The science carries the case. These are why the case is being made.

Roger Bergersen
Founder & patient

Received an early version of ACP-01 in 2005 for critical heart disease. Credited it with saving his life and founded the company. Lived 15 more years.

Howie Lindeman
Ischemic cardiomyopathy

Chose ACP-01 over open-heart surgery in 2008 as one of the first ~50 patients. In his account, returned to a decade of touring and active diving. Now in his 70s.

Niem Malo
Post-infarction, EF 28%

Told he had a year to live at 47. In his account, ejection fraction improved from 28% toward near-normal, his defibrillator was switched off, and 16+ years on he still runs his restaurant.

Each account is the patient's own, published with consent. Individual outcomes vary and do not predict results for any other patient. ACP-01 is investigational. 
COMMERCIALIZATION & REVENUE MODEL

A defined operating model, separated from the science.

1-Blue

Patient inquiry

2-Blue

Physician screening

3-Blue

Blood collection

4-Blue

cGMP maunfacturing

5-Blue

Hospital Adminstration

6-inverse

Follow-up + RWE + revenue

REGULATORY ROADMAP

A jurisdictional strategy, stated plainly.

Jurisdiction 
Current status 
Permitted activity 
Next milestone 
The Bahamas
LARTA application filed; commercial Phase I 
Activities permitted following approval 
Approval and first treatment 
Florida
Limited state framework (SB 1768)
Wound care and pain management within physician scope
Counsel-confirmed compliant program
Canada
Investigational product
Special-access pathways as applicable
First Nations joint venture
Puerto Rico
Manufacturing and R&D structure
Manufacturing subject to applicable federal rules
Facility qualification
Hemostemix does not characterize any FDA discussion or feedback as approval or acceptance. The FDA recognizes that real-world evidence can contribute to regulatory decision-making, subject to data quality, study design and the specific regulatory question. LARTA authorization is a sovereign Bahamian framework and does not constitute FDA or Health Canada approval. 
Manufacturing & Intellectual Property

Built to scale, protected by IP.

 
95

Patents protecting the platform

 

 
7 days
 
Blood draw to release
cGMP process.
 
 
2
 
Facilities modeled
20 to 40 treatments each per month.
 

LEADERSHIP & GOVERNANCE

The people and the governance behind the platform.

Thomas Smeenk

Director, CEO, Co-Founder

A chief executive who structures, negotiates and has closed eight figure contracts. A dynamic business development and management team leader who delivers timely profitable results domestically and internationally. An adept communicator who succeeds at collaborative and interpersonal relationships with management, prospects, clients and suppliers.

Peter Lacey

Chairman

Chairman of Cervus Equipment Corporation (CERV.TO), from inception to date.

President and Chief Executive Officer of Cervus Equipment Corporation and its predecessor entities from 1982 to April 2012.

Cervus is a company he and his partners started in 1999 and built from five John Deere dealerships to 63 dealerships selling six brands in three countries with revenues of $1.1 Billion.

Graduate of the Institute of Corporate Directors Education Program at the University of Toronto.

Dr. Ronnie Hershman

Director

Graduated Magna Cum Laude from Sophie Davis Center for Biomedical Research in 1980.

Practicing Cardiologist since 1987 and Medical Director of NYU Langone Long island Cardiac Care.

Pioneer in performing laser assisted coronary angioplasty.

Entrepreneur and investor for more than two decades and director and/or officer of over 9 life science companies.

Track record of investing in companies that commercialize technologies quickly and globally.

Advisor to late stage life science VC that has funded 24 companies.

Loran Swanberg

Director

Part owner and a director of a private company, Landsman Properties Ltd. since 2005. Landsman owns and leases out shop and office space in North East British Columbia and Alberta.

From 1992 to 2005, Mr. Swanberg was a director of the family owned oilfield transportation company, Swanberg Bros. Trucking Ltd., which was purchased by Producers Oilfield Services Inc. in 2005.

Director of privately held Swanberg Air Inc. from 2000 to 2012, and was a director of the Northern B.C. Truckers’ Association for 10 years, 1992 to 2002.

Most recently, Mr. Swanberg was a partner and director of Vieworx Geophoto Inc. from 2012 until Q1 2020.

Dr. Desirée Cox

Director

Dr. Desirée Cox (MD, MPhil, PhD) is a physician, scientist, bioethicist, and Rhodes Scholar whose work spans medicine, ethics, public policy, and regenerative medicine with degrees from McGill University (BSc), Oxford (MD, as a Rhodes Scholar), and Cambridge (MPhil, PhD).

For more than a decade, Dr. Cox has led regenerative medicine ethics and governance in The Bahamas, chairing the National Stem Cell Ethics Committee and helping build the legislative framework behind the country's Longevity and Regenerative Therapies Act (LARTA) — positioning The Bahamas as a hub for responsible longevity science. She is the founder of HEALinc, a global health innovation platform working to make regenerative, longevity-enhancing technologies more accessible.

FINANCIALS

Easy to find, complete.

Here are the quarterly and annual Financials Statements and Management Discussion & Analysis together in one file for each year. Additionally, a link to the company profile on Sedar+ is included..

FAMILY OFFICE DATA ROOM

Where interest becomes diligence.

🔒 

NDA-controlled, password protected

The public site creates interest. The data room converts interest into diligence. Access requires NDA execution and credential issue.

WHY FAMILY OFFICES INVEST

Purpose, return and protection.

 

Purpose

Capital supports a patient-derived therapy intended to restore blood flow, mobility, independence and meaningful family life. Buy two TCDs and donate one, invest in the equity, or invest in the SPV. 

Return

Large patient populations, a defined price per treatment, a modeled contribution margin, scalable manufacturing, clinic-level economics and the regulatory value of the resulting real-world evidence. 

Protection

Insider capital per SEDI, management equity ownership, milestone-based deployment, quarterly reporting, independent governance, secured manufacturing, scenario-based dilution and clearly stated risks. 

 

IMPORTANT NOTICE
ACP-01 is an investigational therapy and has not been approved by the U.S. Food and Drug Administration or Health Canada. Information provided on this website is for educational purposes only and does not constitute medical advice. Patients should consult a qualified healthcare professional regarding diagnosis and treatment decisions.
 
FORWARD-LOOKING STATEMENTS
This website contains forward-looking statements regarding clinical, regulatory, manufacturing and commercial plans. These reflect current expectations and are subject to risk and uncertainty. Actual results may differ materially. Investors should review all public disclosures on SEDAR+ before making investment decisions.  
 
FLORIDA NOTICE
This notice is provided in accordance with Florida law. One or more physicians referenced may perform stem cell therapies that have not been approved by the United States Food and Drug Administration. Patients are encouraged to consult with their primary care provider before undergoing any stem cell therapy.