Vascular Therapies is a biopharmaceutical company committed to the development and commercialization of innovative new treatments to address major unmet clinical needs of patients requiring an AV fistula for dialysis.  To achieve this, we conduct clinical trials to assess the safety and efficacy of its investigational drug products, which if proven, will allow us to obtain the necessary approvals from regulatory authorities to provide patients with broad access to these drug products.

Under the 21st Century Cures Act,[1] manufacturers or distributors of an investigational drug indicated for a serious disease or condition are required to make publicly available their policy regarding the drug’s availability for expanded access, also known as compassionate use.

Currently, Vascular Therapies does not make its unapproved drug product available on an expanded access basis. Vascular Therapies is focusing its developmental efforts on its Phase 3 clinical study investigating the safety and efficacy of its drug product to improve the outcomes of arteriovenous fistulae (AVF) for hemodialysis.  The Company believes that participating in clinical trials is the best way for patients to access medicines prior to approval. Vascular Therapies encourages interested individuals to contact the company regarding potential participation in its clinical trial.

  • Contact Information. If you have any questions regarding potential participation in Vascular Therapies’ clinical trial, click here, or visit Clinicaltrials.gov and search “NCT02513303”.
  • Request Procedures. If you contact Vascular Therapies, please also include your contact information so Vascular Therapies may follow-up with you directly.
  • General Criteria. In the event Vascular Therapies decides to consider expanded access use in the future, we will evaluate and respond to each expanded access request that it receives on a case-by-case basis.
  • Anticipated Timing. If you contact Vascular Therapies as described above, Vascular Therapies anticipates that it will acknowledge receipt within ten business days.
  • Clinicaltrials.gov Hyperlink. If Vascular Therapies decides to make its products available on an expanded access basis in the future, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after such record becomes active.

Vascular Therapies may revise this expanded access policy at any time. Additionally, the posting of this policy by Vascular Therapies shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

 

[1] The 21st Century Cures Act is a United States law enacted in 2016. Section 3032, entitled “Expanded Access Policy,” requires a manufacturer or distributor of one or more investigational drugs “for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted … [for expand access] … for provision of such a drug.”