To request financial study support from HistoSonics, investigators must submit a study concept to the HistoSonics ISR Portal. If HistoSonics determines the study concept is of interest, the investigator will be invited to submit a full study proposal. Please note that HistoSonics does not contemplate providing product or systems as part of our support for ISR studies at this time and can only support studies conducted in a country where the Edison System has regulatory authorization.

Before creating your submission, please note:

• HistoSonics can only support studies conducted in a country where the Edison System has regulatory authorization, which is currently limited to the United States.
• HistoSonics does not contemplate providing product or systems as part of our support for ISR studies.
• HistoSonics is interested in supporting clinical studies of histotripsy in the liver.
• The treating physician must have prior experience with histotripsy in the liver before HistoSonics will review the proposal.

A full study proposal is required for funding approval and includes:

1. A draft protocol containing the background, study objective(s), study design, inclusion/exclusion criteria, treatment details, follow-up visit schedule, and statistical method.
2. An itemized budget outlining specific items for which support is sought.  The budget may include, but is not limited to, research activity-related personnel costs (e.g., research assistant, statistician, medical writer), data management expenses, and IRB review fees.
3. Sponsor organization’s W-9 form.

Complete proposals will be reviewed and assessed by the ISR Committee based on scientific merit, strategic fit, the investigator’s qualifications, histotripsy experience, research experience, and requested monetary support. There is no guarantee of funding. Funding will be provided only with a fully approved grant agreement.

The investigator is responsible for complying with all applicable laws and regulations regarding human clinical studies.  The Edison System’s indications for use are for the destruction of liver tumors, including unresectable liver tumors, using a non‑thermal, mechanical process of focused ultrasound. Note that all human clinical studies in the US must be evaluated against 21CFR Part 812 to determine if an FDA Investigational Device Exemption is required.

Our team is bringing the power of histotripsy to patients and physicians around the world.