HistoSonics, the developer and manufacturer of the Edison® Histotripsy System, announced today the publication of the company’s pivotal clinical trials data in Radiology. The prospective, international, multi-center, single arm #HOPE4LIVER Trials were designed to evaluate the safety and efficacy of histotripsy for the non-invasive destruction of primary (hepatocellular carcinoma) and metastatic liver tumors. Safety and efficacy were measured against performance goals established using extensive real-world evidence from ablative therapies. The analysis included 49 targeted tumors in 44 patients: 18 with primary liver tumors and 26 with metastatic tumors from the colon, rectum, breast, pancreas, and other primary origins.

HistoSonics announced today that the first patient has been treated as part of the company’s #HOPE4LIVER Europe Trial, which was approved by German authorities earlier in the year. The study is designed to evaluate the safety and efficacy of the HistoSonics’ platform technology, which uses the novel science of histotripsy and the mechanical properties of therapeutic focused ultrasound, to destroy unwanted tissue, including targeted primary and metastatic liver tumors, without the need for incisions or invasiveness. The #HOPE4LIVER Europe Study is a multi-center, open label, single arm trial planned to enroll up-to 45 patients throughout sites in Spain, Italy, UK, and Germany, and is being run in parallel with a similar US trial.

HistoSonics’ non-invasive platform combines advanced imaging and proprietary software to deliver patient specific treatments and uses the science of histotripsy to mechanically destroy targeted tissues at sub-cellular levels. The company believes that the novel mechanism of action of their proprietary technology, intended to avoid thermal necrosis and ionizing radiation, may provide significant advantages to patients, including the ability of the treatment site to recover and resolve quickly, as well as provides physicians the unique ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

The procedure was performed at the Otto von Guericke University Clinic Magdeburg by Professor Dr. med. Maciej Pech, Interventional Radiologist, Director of University Clinic for Radiology and Nuclear Medicine and Principal Investigator of the #HOPE4LIVER site in Magdeburg, Germany. Professor Pech commented, “The first treatment in the #HOPE4LIVER was successful in destroying the targeted tumor and the patient performed well both during and after the procedure. We will follow up with the patient per the trial protocol and look forward to enrolling more patients that may be good candidates for histotripsy therapy. The ability to use histotripsy to destroy tumors completely and non-invasively could represent a tremendous advantage for many patients.”

Only 20%-30% of patients with liver tumors are eligible for surgical resection due to the presence of multiple tumors, underlying poor liver function, or general health issues limiting the success of surgery. Primary liver tumors were the third leading cause of tumor related death worldwide in 2020, with approximately 906,000 new cases and 830,000 deaths globally, and 5-year survival rates less than 18%. Additionally, 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% of patients with advanced disease from another site. Histotripsy may provide benefits to these patients due to its unique non-invasive, non-thermal, and non-ionizing destructive capabilities.

HistoSonics’ Vice President of Medical Affairs, Joe Amaral, M.D., added, “It is extremely exciting to be working with Professor Pech and the team at Otto con Guericke University Clinic in Magdeburg to build upon the company’s initial success of the THERESA Study conducted in Spain. We believe our non-invasive platform and novel therapy has the potential to change the experience for patients with solid liver tumors, and our aim is to continue to build this evidence with the #HOPE4LIVER Trials. We are very thankful to Professor Pech and the entire team in Magdeburg for their continued commitment to clinical research and providing leadership in this important trial.”

The HistoSonics device is investigational and is not available for sale in the United States or Europe. It is limited to investigational use in the approved IDE and European studies.

HistoSonics announced today the treatment of the first patient in the #HOPE4LIVER US Study. The investigational device study was approved by the FDA in the fourth quarter of 2020. The study is designed to evaluate the safety and efficacy of the company’s platform technology, which uses the novel science of histotripsy, a form of therapeutic focused ultrasound, to mechanically destroy targeted primary and metastatic liver tumors, without invasive incisions or needles entering the patient’s body. The #HOPE4LIVER US Study is a multi-center, open label, single arm trial planned to enroll up-to 45 patients.

The procedure was performed at Tampa General Hospital by Cliff Davis, M.D., assistant professor and director of the Interventional Radiology Residency Program in the USF Health Morsani College of Medicine and principal investigator of the #HOPE4LIVER trial at the TGH site, and represents the first histotripsy procedure performed in the #HOPE4LIVER US Study. Dr. Davis commented, “We are extremely excited to have successfully performed the first non-invasive histotripsy tumor treatment in the United States. The patient tolerated the procedure well and will continue to be followed up by our team per the study protocol. We are eager to continue participating in the study and help the promise of histotripsy to be realized.”

Only 20%-30% of patients with liver tumors are eligible for surgical resection due to the presence of multiple tumors, underlying poor liver function, or general health issues limiting the success of surgery. The number of patients in the US who have primary liver tumors has increased 43% in the past 16 years and is expected to grow another 40% by 2030. Additionally, 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% of patients with advanced disease from another site.  Histotripsy may provide benefits to these patient due to its unique non-invasive, non-thermal, and non-ionizing destructive capabilities.

HistoSonics President and CEO Mike Blue added, “Treating the first patient in the #HOPE4LIVER US Study is a tremendous milestone for our company, and we are very grateful to Dr. Davis and the Tampa General team for their commitment to clinical research and leadership in this important trial.  We believe our non-invasive solution combined with the potential benefits of histotripsy’s novel mechanism of action, have the potential to change the experience for patients with solid tumors, and this study is the next step in building that evidence.  We look forward to continuing our strong partnership with Tampa General Hospital, as well as enrolling patients in our other US sites in the very near future.“

The HistoSonics device is investigational and is not available for sale in the United States. It is limited to investigational use in the approved IDE and European studies.

HistoSonics announced today that it has received approval to initiate the company’s second European clinical trial of its new platform technology, which is designed to use the science of histotripsy to mechanically destroy targeted liver tumors, from outside of the body. The study, similar to HistoSonics’ recent FDA approved #HOPE4LIVER U.S. Study, is a multi-center, open label, single arm trial to evaluate the safety and efficacy in destroying liver tumors and will build upon the company’s first-in-man THERESA Study recently conducted in Barcelona, Spain. The company expects to begin enrolling patients in early 2021.

In Europe, the outlook for patients with primary liver tumors remains dismal with the 3-year survival rates estimated to be between 47.3% for patients under surveillance, and as low as 21.8% for those found while not already under surveillance.

The company intends to have up-to seven enrolling sites in select European countries. Each site will be led by experienced clinical investigators and multi-disciplinary liver specialists. Patients eligible for the #HOPE4LIVER European study will undergo non-invasive histotripsy in order to destroy up-to 3 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. Successful completion of #HOPE4LIVER is expected to be used to support a European regulatory submission, and the company plans to immediately expand the use of its platform in additional solid tumors after completion of the US and European liver studies.

Dr. Luigi Solbiati of Humanitas Research Hospital in Milan, Italy, and co-Principal Investigator of #HOPE4LIVER Trial, commented, “I am particularly glad to be the principal investigator of this trial, given that all the participating centers across Europe have outstanding reputations for clinical medicine and research.” Solbiati added, “Histotripsy’s non-invasive approach and novel mechanical destruction of tumors provide potential for this procedure to become a leading technology in interventional therapies.”

Joe Amaral, MD, HistoSonics’ Vice President of Medical Affairs, also commented, “I am excited to work with our co-Principal Investigators, Dr. Solbiati, a true pioneer of ablative locoregional therapy, and Dr. Guido Torzilli, world-renowned liver surgeon. These experts, as well as the other leading European cancer centers participating in the trial provide extensive liver treatment experience and have been innovators in locoregional therapies.” In addition, Dr. Amaral commented, “The successful completion of the European #HOPE4LIVER Clinical Trial will bring us one step closer to achieving Histosonics promise of providing patients with revolutionizing interventional care.”

HistoSonics announced today that it has received approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a clinical trial of its new platform 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-man THERESA Study recently conducted in Barcelona, Spain. The company expects to begin enrolling patients in early 2021.

The number of patients in the US who have primary liver tumors has increased 43% in the past 16 years and is expected to grow another 40% by 2030. 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% 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 3 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 US regulatory submission, and the company plans to immediately expand the use of its platform in additional solid tumors after completion of the US 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,” commented 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.”

Dr. Joseph Amaral, FACS, Vice President of Medical Affairs, added, “Histotripsy is a uniquely differentiated treatment platform that has great promise to transform the care of patients. We are humbled to have such exceptional investigators and leaders in the field involved in our first US study. They, together with the patients who enroll in the study, will potentially pave the path to improved care in the future.”

The company also expects to initiate a similar European based clinical trial in early 2021.