Expanded
Access Policy

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.

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 upcoming Phase 3 clinical study investigating the safety and efficacy of its drug product. The Company believes that participating in clinical trials is the best way for patients to access medicines prior to approval.

If you have any questions regarding potential participation in Vascular Therapies’ upcoming clinical trial, contact Vascular Therapies. Please also include your contact information so we may follow up with you directly. In the event we decide to consider expanded access use in the future, we will evaluate and respond to each expanded access request that we receive on a case-by-case basis.

The posting of this policy shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

CAUTION: THE SIROLIMUS-ELUTING COLLAGEN IMPLANT (SIROGENTM) IS AN INVESTIGATIONAL PRODUCT THAT IS NOT AVAILABLE FOR SALE IN ANY COUNTRY. READ OUR Expanded Access Policy.