The product is approved in Israel and the EU. It is shortly awaiting reimbursement in both areas. Comically, the device and procedure are reimbursed but not approved in the U.S.
The company is negotiating with distributors and expects to finalize a deal by the end of the third quarter for the U.S. market. The Israeli and EU launches, meanwhile, may have a significant impact on the share price.
The company is preparing to initiate their U.S.-based clinical study. The study will include 90 patients randomized to either BST or a sham device, meaning that this is not a long or complicated trial to run. The study will be complete within 12 to 15 months, but interest will build in front of this important catalyst.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.