Revolutionizing CLI Treatment: Insights from VesCell HealthTalks #10

On September 11, 2025, Hemostemix hosted its 10th VesCell HealthTalks webinar, led by Chief Commercial Officer Croom Lawrence and featuring CEO Thomas Smeenk. The session explored chronic limb-threatening ischemia (CLTI), a severe form of peripheral arterial disease (PAD), and introduced ACP-01, an investigational autologous stem cell therapy offering hope for no-option patients. This blog post summarizes the key points from the webinar and accompanying presentation, highlighting the burden of CLTI, the potential of ACP-01, and pathways to access care, tailored for patients, healthcare professionals, and investors.

The Burden of CLTI: A Call for Early Action

CLTI, the most severe form of PAD, affects over 12 million Americans and 200 million people worldwide. Caused by narrowed arteries due to atherosclerosis, it leads to reduced blood flow, resulting in rest pain, non-healing wounds, or gangrene. Risk factors include age, smoking, diabetes, and high blood pressure. Alarmingly, 40% of PAD patients are asymptomatic, underscoring the need for early detection to prevent severe outcomes like amputations (150,000 annually in the U.S.) and cardiovascular complications.

• Key Statistics (Slide: "The Epidemiology and burden of CLI"):
  • PAD affects 6.5 million Americans over 40; CLTI comprises 11% of PAD cases (2 million in the U.S.).
  • 6-month amputation rates: 10–40% (50% for diabetics).
  • Mortality: 15–20% at 6 months, 50% at 5 years; 40% one-year mortality post-major amputation.
• Warning Signs (Slide: "Understanding CLTI"):
  • Leg pain or cramping during walking (claudication) that stops with rest.
  • Non-healing wounds, rest pain, or gangrene in severe cases.
• Action: If you experience leg pain, have risk factors like diabetes or smoking, or notice wounds that won’t heal, consult your healthcare provider for PAD/CLTI screening. Early intervention can prevent complications and improve quality of life.

ACP-01: A Breakthrough in Regenerative Medicine

ACP-01 (VesCell™) is an investigational autologous stem cell therapy developed by Hemostemix, derived from a patient’s own blood to treat ischemic diseases like CLTI. With over 20 years of development and 90+ patents, ACP-01 targets no-option patients—those ineligible for standard treatments like angioplasty or bypass surgery—by promoting new blood vessel growth, reducing inflammation, and enhancing tissue repair.

How ACP-01 Works

1. Cell Isolation: A 50mL blood draw isolates angiogenic cell precursors (ACPs) using proprietary technology, avoiding invasive procedures like bone marrow aspiration.
2. Angiogenesis Activation: ACPs stimulate new blood vessel formation to improve circulation.
3. Inflammation Reduction: Cells create an optimal healing environment.
4. Paracrine Signaling: ACPs release growth factors and cytokines to activate natural repair mechanisms.
5. Targeted Delivery: Intramuscular injection into the calf or foot ensures precise administration.

Clinical Evidence 

Hemostemix has treated 498 patients across seven trials, with 318 subjects in CLTI studies:

• Mutirangura et al. (2009): Phase I open-label study (n=6) showed no procedural complications, 83% improved distal circulation, and 80% complete ulcer healing.
• Randomized Phase I: Zero mortality in the treated group vs. 20% in placebo; 70% limb salvage vs. 75% amputation in placebo over 2 years.
• Randomized Phase II (Hsiang et al., 2023): Significant ulcer size reduction by month 3 (p=0.005, n=25 treated vs. n=9 control); 4.8% amputation and mortality rates in treated group vs. 25% in placebo at 12 months. At 4.5 years, 83% of subjects experienced ulcer healing, pain cessation, and no amputation.
• Safety Profile: No complications from ACP-01 across 298 patients (one death due to unrelated myocardial infarction). The outpatient procedure avoids anesthesia, tainted blood risks, and ethical concerns associated with fetal tissue.

• The blood draw, an office procedure,

             - Avoids anesthesia

             - No complications associated with bone marrow harvest

             - Public perception of safety of Autologous cells

  Autologous cells have no risk of

             - Tainted blood or blood products,

             - No parasite, no virus, no pathogen

             - No risk of  neoplasia from pluripotential cells

             - No ethical concerns as with fetal tissue

  Transmissible spongiform encephalopathy

                  eg prion disease Jacob Creutzfeldt-

             - No risk to medical providers

ACP-01 also shows promise for other conditions, including angina, ischemic/dilated cardiomyopathy (with up to 27–47% improvement in left ventricle ejection fraction), and emerging applications like vascular dementia and brain-computer interfaces.

Economic Impact: Breaking the Cost Cycle

The webinar and presentation emphasized the high costs of traditional CLTI management, particularly amputations, compared to the potential savings with ACP-01 (Slides: "Amputation: The Last Resort," "Cost-Effectiveness Analysis," "Breaking the Cost Cycle").

• Standard Care Costs (Farber et al., NEJM 2022):
  • Surgical bypass: $25,000–$30,000 initially, $35,000–$40,000 total over 2.7 years.
  • Endovascular therapy: $15,000–$20,000 initially, $38,000–$45,000 total due to 31% re-intervention rate.
  • Amputation: $50,000–$70,000 per procedure; 5-year costs range from $278,000–$500,000+, with lifetime estimates up to $794,000 including societal costs (e.g., lost productivity).
• ACP-01 Costs: Approximately $37,000–$50,000 upfront (out-of-pocket, not typically insured), with 5-year totals of $50,000–$100,000, offering 50–70% savings by reducing hospitalizations, amputations, and complications.

By addressing the root cause—impaired blood flow—ACP-01 reduces readmissions, enhances quality of life, and lowers long-term healthcare costs, with a break-even point within 1–2 years due to fewer interventions (Slide: "Breaking the Cost Cycle").

Patient Journey: Amputation vs. ACP-01 (Slide: "CLI Patient Journey")

The presentation contrasted the patient journeys for CLTI management:

• Amputation Path:
  1. Diagnosis: Rest pain, ulcers/gangrene confirmed via ABI, angiography.
  2. Initial Management: Risk control, wound care, pain relief, antibiotics.
  3. Revascularization: Angioplasty or bypass (often fails in advanced CLTI).
  4. Amputation: Below-knee or above-knee surgery.
  5. Post-Surgery: Recovery, rehabilitation, prosthetics, monitoring.
  • Outcomes: 25–40% amputation rate in 1 year, 20–25% mortality in 1 year, 50% at 5 years, 30% risk of secondary amputation.
  • Costs: $278,000–$500,000+ over 5 years.
• ACP-01 Path:
  1. Assessment: Eligibility via MRI/CT for no-option CLTI.
  2. Blood Collection: 50mL blood drawn.
  3. Processing: Lab isolation of ACPs.
  4. Treatment: Outpatient intramuscular injection.
  5. Monitoring: Follow-ups at 3, 6, 12 months.
  • Outcomes: 50%+ ulcer reduction by 3 months, 80% limb salvage, 4.8% amputation/death rate.
  • Costs: $50,000–$100,000 over 5 years.
• Key Contrast: Amputation focuses on damage control, while ACP-01 aims for limb salvage and recovery.

Accessing ACP-01: Pathways for Patients 

ACP-01 is not FDA-approved but will be available starting December 2025 under compassionate use and special access programs at Hemostemix’s U.S. facility, in partnership with CytoImmune. Access options include:

• Treatment Convertible Debentures: Reserve therapy in advance to align with cell manufacturing schedules ($37,000–$50,000 MSRP).
• Financing: Low monthly payments (~$800/month) through bank partnerships.
• 501(c)(3) Foundation: Supports patients unable to afford treatment, encouraging donations to fund care for others.
• Clinical Trial Enrollment: Available via Hemostemix.com or VesCellHealth.com.

The care workflow involves physician referral, diagnostic review, patient qualification, blood draw, treatment, and follow-up monitoring, with dedicated navigators to assist with scheduling, travel, and payment options.

Why It Matters

CEO Thomas Smeenk highlighted the human impact: “Imagine being pain-free every day for 5 years.” ACP-01 offers hope for no-option patients facing debilitating pain or limb loss, with significant cost savings and improved outcomes. The therapy’s potential extends to other ischemic conditions, positioning Hemostemix as a leader in regenerative medicine (Slide: "Hope, Healing, and a New Future for CLTI Patients").

For healthcare professionals, ACP-01 complements multidisciplinary care, integrating with first-line therapies like antiplatelet drugs, statins, and wound care protocols. For investors, it represents a revolutionary opportunity to reduce healthcare costs and improve patient lives.

Get Involved

Hemostemix invites patients, physicians, and investors to join the mission:

• Patients: Consult your physician about ACP-01 and contact Croom Lawrence (clawrence@hemostemix.com) for trial enrollment or compassionate use details.
• Physicians: Reach out to Dr. Fraser Henderson (fhenderson@hemostemix.com) for clinical study information.
• Investors: Connect with Thomas Smeenk (tsmeenk@hemostemix.com) to explore partnership opportunities.

The webinar slide set is available via email and YouTube. Join VesCell HealthTalks weekly at Hemostemix.com or VesCellHealth.com for updates on this transformative journey.

Important Disclosures:

• ACP-01 is an investigational therapy under development and is not approved by the FDA.
• Access may be available globally and in some U.S. states (e.g., Florida) under specific state guidelines and FDA regulations for eligible patients.
• Patients must provide informed consent and be advised of the investigational nature of the treatment.
• Patients may need to travel for treatment, either within the U.S. or abroad.
• Treatments are generally out-of-pocket expenses and may not be covered by insurance.
• Consult your physician before seeking treatment to discuss risks, benefits, and eligibility.

Sources:

• Farber A, et al. N Engl J Med. 2022;387:2305-2316.
• Henderson FC, et al. J Biomed Res Environ Sci. 2024;5(2):092-010.
• Mutirangura P, et al. J Med Assoc Thai. 2009;92(3):320-7.
• Norgren L, et al. J Vasc Surg. 2007;45(Suppl S):S5-67.
• Barnes JA, et al. Arterioscler Thromb Vasc Biol. 2020;40:1808-1817.