At Revalesio, we are dedicated to delivering safe and effective treatments. To achieve this, we collaborate with scientists, physicians, patients, and health authorities both in the US and internationally to conduct comprehensive clinical trials.
Clinical trials are the primary way patients can access our investigational therapies. We understand that some patients who do not qualify for clinical trial participation may seek access to these therapies before they receive regulatory approval. This type of access is often referred to as “expanded access,” “early access,” “compassionate use,” or a “named patient program.”
While we empathize with the urgent need for treatment options and have previously provided RNS60 for named patient programs and an institutional expanded access protocol, we have limited manufacturing supply for our acute ischemic stroke and ALS clinical development programs. For the time being, RNS60 can only be accessed by new patients via a clinical trial or for existing patients through the established ALS expanded access program.
We believe this approach best ensures the safety and efficacy of our treatments and the timely availability of our medicines to the largest possible number of patients.
