The Commercial Availability.
The Strōma procedure is not currently available to the general public. We have completed a preliminary human study to test the safety and efficacy of the procedure and using what we’ve learned to design and build our next-generation device. Our next steps will be to complete our pilot and pivotal human clinical studies using our new device. Our plan is to treat about 20 patients in our initial pilot clinical study. Following the successful completion of that pilot study we will treat about 100 patients in multiple countries and follow them for a predetermined length of time.
We will release the product when we and the governing regulatory bodies are satisfied with the safety and efficacy of the procedure. Due to the relative cost and complexity of releasing a cosmetic medical device in the United States, we expect to release the procedure outside the United States first. The order of release in the non-U.S. territories will depend on upon the market demand and regulatory environment in each territory.