U.S. EXPANDED ACCESS POLICY

U.S. Expanded Access Policy

Carthera® is a medtech company committed to developing innovative ultrasound-based medical devices used in association with different medicinal products to treat a wide range of serious and life-threatening brain diseases. Our most advanced clinical-stage product (SonoCloud-9) is for the treatment of patients suffering from glioblastoma.

Expanded Access is a U.S. regulatory pathway in which patients may gain access to an investigational treatment outside of the context of participation in clinical trials. At Carthera®, we recognize and understand the need for an expanded access for patients who have serious or immediately life-threatening disease and have limited available treatment options.

The decision to establish an expanded access will be made by Carthera® on a case-by-case basis and will be dependent on several key factors and conditions. These include, but are not limited, to the following:

• The patients suffer from glioblastoma, and are either no longer responsive to or no longer able to tolerate any available treatment options;
• The potential patient benefit justifies the potential risks of using the investigational treatment and those potential risks are not unreasonable in the context of the disease;

• The patients are eligible for the SonoCloud-9 device implantation by neurosurgeons who are already trained and well experienced in the implantation procedure, or have already been implanted with the SonoCloud-9 device as part of a previous trial they have since exited;
• The requested use for expanded access will not interfere with the conduct or completion of our ongoing clinical trials;
• Adequate supply of the investigational drug/device is available.

Carthera® believes that participation in our ongoing clinical trials is the best way to access our investigational products.

Public Information about our recruiting clinical trials, including eligibility criteria and locations is available at www.clinicaltrials.gov, searching for “SonoCloud®” and selecting “Recruiting” in Study Status. Information on the Carthera®-sponsored Phase 3 trial “Sonobird” is available at sonobird.eu.

If you are a physician who is interested in learning more about our products, or is seeking access to Carthera® investigational products for your patients, please submit a request to contact@carthera.eu. We will use our best efforts to respond within 10 business days after receipt of your request.

Additional information on Expanded Access Policies may be obtained by visiting the U.S. Food and Drug Administration at: Expanded Access: Information for Physicians.