Am I Eligible for ACP-01? What Patients Need to Know

After reading about ACP-01, most patients arrive at the same question: does this apply to me?

It is the right question to ask, and this article is here to answer it as honestly as possible. ACP-01 is investigational, which means access is through specific regulated pathways and eligibility is assessed individually. Not every patient who contacts us will be a candidate. But understanding who has been studied, and what the evaluation involves, tells you whether it is worth taking the next step.

Who Has Been Studied in ACP-01 Clinical Research

The clinical trials of ACP-01 have focused on patients with the following characteristics. This is not a checklist for automatic eligibility. It is a description of the patient populations that have been evaluated and shown the most meaningful clinical signals.

• Leg artery disease: Advanced Peripheral Artery Disease (PAD) or Chronic Limb-Threatening Ischemia (CLTI)
• Prior failed revascularization attempts, including bypass surgery, angioplasty, or stenting that did not provide durable benefit
• Classification as no-option CLTI: no viable target vessel for further surgical or catheter-based intervention
• Active non-healing wounds on the foot or lower leg
• Rutherford Class 5 or 6 disease (the most advanced stages, characterized by active tissue loss and gangrene)
• Cardiac patients: Refractory angina that has not responded to medications, stenting, or bypass surgery
• Ischemic or dilated cardiomyopathy (weakened heart muscle from poor circulation)

What the Evaluation Process Involves

No patient is accepted into an ACP-01 program without a thorough individual evaluation. Here is exactly what that process looks like.

• An initial conversation with the Hemostemix clinical team, either by phone or email, to discuss your history and current condition
• A review of your existing medical records, imaging, and prior treatment history
• A determination by the Hemostemix clinical physician team of whether your anatomy, disease stage, and medical status suggest you may be a candidate
• If you are considered a potential candidate, a detailed discussion of the treatment process, realistic expectations, risks, access pathway, and costs
• Informed consent and physician consultation before any treatment proceeds

You can stop the process at any point. If the clinical team determines you are not a candidate, they will tell you that directly, along with any other options they are aware of that may be relevant to your situation.

Where ACP-01 Is Currently Available

Because ACP-01 remains investigational, access is through specific regulated pathways:

• Florida, USA, under Senate Bill 1768, which permits physician-supervised access to investigational therapies for eligible patients
• Toronto, Canada, through compassionate access pathways
• The Bahamas and Dominican Republic, through international research and access programs

The Honest Answer to the Eligibility Question

Not every patient who contacts us is a candidate. The clinical team evaluates each case individually and will give you an honest answer based on your specific situation.

What we can say is this: if you have advanced PAD, CLTI, a non-healing wound, refractory angina, or heart failure that has not responded to standard treatment, the conversation is worth having. The evaluation costs you nothing but time.