Hemostemix Submits FDA Filing 1517 for ACP-01 (VesCell™) Basket Protocol Targeting Multiple Ischemic and Vascular Indications

“`html

Hemostemix (OTCQB: HMTXF) has filed FDA Pre-IND Application 1517 for a basket protocol Phase I clinical trial of its lead therapy ACP-01 (VesCell™). The trial aims to evaluate safety, feasibility, and early efficacy of ACP-01 across multiple conditions including vascular dementia, peripheral arterial disease, angina, cardiomyopathy, and congestive heart failure.

The company plans to integrate real-world evidence from Florida, where ACP-01 is legally available under SB 1768, to support IND advancement and expedited regulatory designations. Hemostemix has completed 498 safe treatments to date and has 11 peer-reviewed publications demonstrating safety and efficacy.

Positive

Filing of FDA Pre-IND Application 1517 enables evaluation of multiple indications under one unified trial design
Company has completed 498 safe treatments and published 11 peer-reviewed papers demonstrating safety and efficacy
Real-world evidence from Florida treatments can support expedited regulatory designations
Basket protocol approach could accelerate development timeline and expand addressable markets

Negative

Multiple indications still require Phase I clinical trials, indicating early development stage
Success of basket protocol strategy depends on pending FDA feedback
Complex regulatory pathway across multiple therapeutic areas may increase development risks

`;
summaryContainer.insertAdjacentHTML(‘beforeend’, translationDropdownHTML);

document.querySelectorAll(‘.dropdown-item.item-translation’).forEach(item => {
item.addEventListener(‘click’, function(event) {
event.preventDefault();
const lang = this.getAttribute(‘data-lang’);
switchLanguage(lang);
});
});
}
}

fetchTranslations();
}

function switchLanguage(lang) {
// Hide all summaries
document.querySelectorAll(‘.rhea-summary, #summary’).forEach(element => {
element.classList.add(‘d-none’);
});

// Show the selected language summary
const summaryElement = document.getElementById(‘summary-‘ + lang) || document.getElementById(‘summary’);
if (summaryElement) {
summaryElement.classList.remove(‘d-none’);
}

// Save the selected language to localStorage
localStorage.setItem(‘preferredLanguage’, lang);
}

09/23/2025 – 12:22 PM

Calgary, Alberta – Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), a company focused on autologous stem cell therapies, is advancing its lead therapy, VesCell™ (ACP-01). The company announced it has filed FDA Pre-IND Application 1517 to initiate a basket protocol Phase I clinical trial. This trial aims to evaluate the safety, feasibility, and preliminary efficacy of ACP-01 in individuals suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia. Notably, ACP-01 is currently available in Florida under Florida’s SB 1768.

The proposed basket protocol is designed to evaluate safety, feasibility, and early efficacy signals of ACP-01 in patients with:

Vascular dementia (earliest medically validated subtype)
Peripheral arterial disease (PAD)
Angina
Ischemic cardiomyopathy
Non-ischemic dilated cardiomyopathy
Congestive heart failure (CHF)
Total body ischemia

Strategic Importance of FDA Filing 1517
This filing marks Hemostemix’s formal engagement with the FDA to align on the regulatory path for ACP-01 in multiple high-unmet-need conditions. By pursuing a basket protocol, the Company aims to:

Accelerate development by studying multiple indications under one unified trial design;
Maximize the breadth of ACP-01’s therapeutic potential in ischemia-related diseases;
Generate pivotal safety and exploratory efficacy data across cardiology, neurology, and vascular medicine.

Incorporating Real-World Evidence (Florida SB 1768)
Hemostemix intends to leverage the real-world evidence (RWE) generated from patients receiving ACP-01 (VesCell™) treatments in Florida under SB 1768. The company plans to capture data from these treatments and present it to the FDA. This comprehensive data set, collected using standardized endpoints and monitoring, will serve as supportive evidence for IND advancement and potential expedited regulatory designations, such as RMAT (Regenerative Medicine Advanced Therapy).

Implications for Shareholders

Regulatory Pathway Clarification: Filing 1517 is the essential first step in securing FDA guidance on ACP-01’s accelerated development pathway, including RMAT designation, Fast Track, or Breakthrough Therapy eligibility.
Expansion Potential: A successful basket protocol enables Hemostemix to pursue multiple billion-dollar markets in parallel, significantly expanding the Company’s addressable market.
Value Creation: Positive FDA feedback could shorten timelines to pivotal trials and eventual commercialization, positioning Hemostemix as a first-mover in autologous stem cell therapies for ischemia and vascular dementia.

Management Commentary
According to Thomas Smeenk, CEO of Hemostemix, the FDA filing marks a significant turning point for the company’s ACP-01 development. Smeenk stated that the basket trial, spanning cardiology, vascular disease, and vascular dementia, seeks to establish ACP-01’s regenerative potential. Additionally, the real-world evidence gathered in Florida is expected to bolster the company’s pursuit of expedited regulatory pathways, which is expected to yield shareholder value.

Hemostemix highlighted that it has completed 498 safe treatments with its therapy to date. Its claims are backed by 11 peer-reviewed publications demonstrating safety and efficacy in treating no-option patients with severe angina, ischemic and non-ischemic dilated cardiomyopathy, and related co-morbidities, including congestive heart failure, peripheral arterial disease (PAD), and chronic limb-threatening ischemia (CLTI).

Market and Technology Analysis

The filing of the Pre-IND application signals a critical step in Hemostemix’s efforts to bring ACP-01 to a broader market. The basket trial approach, if approved by the FDA, would allow for a more efficient and cost-effective evaluation of ACP-01’s efficacy across a range of ischemic and vascular conditions.

Furthermore, the inclusion of real-world evidence from Florida is a strategic move to accelerate regulatory approvals. The ability to demonstrate the therapy’s benefits in a real-world setting, rather than solely relying on traditional clinical trial data, could provide a significant advantage in the approval process.

The RMAT designation, which Hemostemix seeks to obtain, is designed to expedite the development and review of regenerative medicine therapies intended to treat serious or life-threatening conditions. Receiving this designation could significantly reduce the time to market for ACP-01.

Hemostemix’s autologous stem cell therapy platform represents a potentially disruptive approach to treating ischemic and vascular diseases. While the field of stem cell therapy is still relatively nascent, the company’s focus on a personalized approach, using the patient’s own cells, could offer advantages in terms of safety and efficacy compared to allogeneic therapies.

FAQ

What is the significance of Hemostemix’s FDA Pre-IND Application 1517?

The FDA Pre-IND Application 1517 allows Hemostemix to pursue a basket protocol clinical trial for ACP-01 across multiple conditions including vascular dementia, PAD, and heart conditions, potentially accelerating development timelines.

How many treatments has Hemostemix (HMTXF) completed with ACP-01?

Hemostemix has completed 498 safe treatments with ACP-01 (VesCell™) and has published 11 peer-reviewed publications demonstrating safety and efficacy.

What medical conditions will Hemostemix’s ACP-01 basket trial target?

The basket trial will target vascular dementia, peripheral arterial disease (PAD), angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure (CHF), and total body ischemia.

How does Florida’s SB 1768 law benefit Hemostemix’s development strategy?

Under Florida’s SB 1768, Hemostemix can collect real-world evidence from ACP-01 treatments, which can support IND advancement and expedited regulatory designations such as RMAT.

What is the current development stage of Hemostemix’s ACP-01 therapy?

ACP-01 is entering Phase I clinical trials through a basket protocol, while also being available in Florida under SB 1768. The company has completed 498 treatments and published 11 peer-reviewed studies.