Early Access to TriSalus™ Investigational Products Policy

TriSalus Life Sciences, Inc. is dedicated to improving outcomes for patients with liver and pancreatic tumors and is studying therapeutic regimens aimed at accomplishing this commitment. Regulatory requirements associated with the development of new therapies mandate that TriSalus demonstrate the new therapeutic or regimen meets health authority (HA) standards of safety and effectiveness. This is done through gathering outcome data from clinical trials and submitting these results to HAs for evaluation and approval or licensing.  Clinical trials are the best mechanism for efficiently getting a new therapeutic to the most patients in a population with an unmet medical need.

TriSalus recognizes that there are patients with serious or life-threatening conditions that are ineligible or are unable to participate in one of our clinical trials who may potentially benefit from a TriSalus investigational therapeutic. Requests for access for these patients are commonly referred to as a request for “Early Access” or “Compassionate Use” or a therapy issued on a “Named Patient” basis, depending on the HA/jurisdiction. These patients often have no remaining treatment options and do not qualify for any appropriate clinical trial. Under these circumstances, TriSalus welcomes a patient’s physician to submit a request for pre-approval access to the therapeutic.1

Eligibility for Pre-Approval Access Consideration

For TriSalus to consider an early access request, the following criteria must be met:

  • The request is for a patient suffering from a serious or life-threatening condition
  • There are no viable options for the patient – either through currently approved therapies or clinical trials
  • There is sufficient evidence that the potential benefit of the drug will outweigh the potential risks of the drug for the patient, based upon current knowledge
  • TriSalus has definite plans to license and commercialize the drug in the region associated with the request
  • The access program is compliant with local law
  • TriSalus has adequate supplies of investigational product to meet the needs of the request, without negative impact to the clinical trials program
  • The access program must be discontinued as soon as feasible when approval of the drug is achieved in the country from which the request is received
  • The patient can receive treatment at a site with sufficient expertise in managing immunotherapy agents and interventional radiology infusions

Process for Requesting Pre-Approval Access

A patient with interest in obtaining access to a TriSalus investigational drug should discuss their eligibility for a TriSalus clinical trial with their physician or health care provider. Information about our company’s clinical trials may be obtained here.

If the physician does not believe that the patient is eligible for a clinical trial, there are no other options available to patient, and the physician believes the investigational therapeutic may be appropriate for the patient, the physician should contact TriSalus to make a request on the patient’s behalf. Physicians seeking to discuss access with TriSalus may contact TriSalus at clinical@trisaluslifesci.com.

It is important to remember that without a regulatory approval, possible safety risks and benefits for the investigational therapy have not been established. Therefore, patients and physicians should consider all possible safety risks and benefits when seeking access to an investigational drug.

The federal Right to Try Act was signed into law on May 30, 2018, by former President Trump (now codified as section 561B of the Federal Food, Drug and Cosmetic Act, 21 USC 360bbb(b)). TriSalus believes that its Early Access to Investigational Products Policy fulfills the mandates of this act.

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