ANN ARBOR—HistoSonics Inc. announced that it had received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a clinical trial of its new technology, which is designed to use the science of histotripsy to mechanically destroy targeted liver tissue and tumors, from outside of the body.
The study is a multi-center, open label and single arm trial to evaluate the safety and efficacy in destroying liver tumors and will build upon the company’s first-in-humans study conducted in Barcelona, Spain. The company expects to begin enrolling patients in early 2021.
The number of patients in the United States who have primary liver tumors has increased 43 percent in the past 16 years and is expected to grow another 40 percent by 2030, company officials said.The liver is second only to lymph nodes as the most common site of metastatic tumors, those that spread from other organs, and estimated to be present in up-to 70 percent of patients with advanced disease from another site.
Patients eligible for the #HOPE4LIVER study will undergo non-invasive histotripsy in order to destroy up to three primary or metastatic liver tumors in a single session and will be followed by the trial investigators to evaluate the safety and efficacy of their treatments. The company intends to have up to seven enrolling sites in the United States comprised of experienced multi-disciplinary liver specialists. Successful completion of #HOPE4LIVER is expected to be used to support a U.S. regulatory submission, and the company plans to immediately expand the use of its platform in additional solid tumors after completion of the U.S. liver study.
“The approval of this study represents a significant milestone for our company and is the culmination of an incredible amount of work and dedication by a great number of people whose passion has been to make the science of histotripsy a reality for patients,” said Mike Blue, President and CEO of HistoSonics. “I also want to thank all of our investigators and partners for their overwhelming response to this study and being true pioneers in their field.”
Histotripsy uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. Earlier this year, the company raised $40 million in capital to continue to develop its Edison Platform, along with global clinical studies and new strategic projects. HistoSonics has offices in Ann Arbor and Minneapolis, Minn. More at www.histosonics.com/ .