Industry’s First Master Study Design Capturing All Histotripsy Use-Cases in the Liver
MINNEAPOLIS–BUSINESS WIRE–
HistoSonics, the developer and manufacturer of the Edison® Histotripsy System, announced today the first patients were enrolled in their novel prospective master protocol study, called BOOMBOX, designed to evaluate the real-world use of histotripsy for treatment of liver tumors. BOOMBOX is a comprehensive, post-market master study that will provide important data for up to 5,000 patients treated across a growing global base of multi-disciplinary histotripsy providers. This master study design is unique in the medical device industry, as it captures treatment data across diverse tumor types and disease stages in patients with varying interventional needs, and amongst multiple clinical specialties.
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“Traditionally, this complexity would require multiple individual study protocols over a prolonged period of time, delaying access to histotripsy for patients in need,” said Amanda Cafaro, VP of Clinical Affairs, HistoSonics. “We designed this post-market master protocol study and its accompanying sub-studies to accelerate our understanding of a wide range of clinically relevant research questions, expediting access to this innovative therapy.”
The primary endpoint for BOOMBOX will examine histotripsy’s capability as a versatile tool and the subsequent sub-studies will evaluate additional endpoints to demonstrate increasingly specific treatment goals: as a monotherapy, a combination therapy, for curative intent as well as priming for additional treatments. Enrollment has begun for the BOOMBOX study across multiple US histotripsy clinical treatment centers and the company expects participation from both US and global histotripsy sites.
“Histotripsy represents a novel treatment for my patients suffering with liver tumors and has already demonstrated an enhanced benefit-risk profile in a clinically meaningful way,” said Juan P. Rocca, M.D., MHA, surgical director for the New York-Presbyterian and Weill Cornell Medicine Liver Cancer Program, one of the centers around the country to offer histotripsy. “By participating in the BOOMBOX study, we are engaging in practical, real-world research that will drive the advancement of this innovative platform and explore new ways to utilize histotripsy in the future. Participating in BOOMBOX is exactly the type of practical research that will continue to advance this groundbreaking new platform and help us find new and innovative ways to use histotripsy going forward.”
“The depth and breadth of data we will capture as part of the BOOMBOX study will provide us and our histotripsy program partners with insight on how histotripsy may impact patients across many diseases and patient conditions. BOOMBOX is our long-term commitment to learning how histotripsy can best improve the lives of patients suffering from liver tumors and the debilitating symptoms these patients face,” said Joe Herman, MD, VP of Medical Affairs, HistoSonics.
The BOOMBOX study begins HistoSonics’ post-market evidence generation efforts in the liver after the recent publication of the company’s pivotal clinical #HOPE4LIVER trials which were submitted to the US Food and Drug Administration (FDA) as part of HistoSonics market access submission resulting in FDA De Novo grant in October 2023 for the non-invasive destruction of liver tumors using histotripsy. In addition to the BOOMBOX: Master Study, HistoSonics has established an ongoing Investigator Sponsored Research program designed to support independent research with histotripsy providers through grants, advancing the safe and effective use of histotripsy.
The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events.
About HistoSonics
HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.
