MINNEAPOLIS– HistoSonics, the developer and manufacturer of the Edison Histotripsy System, announced today they have been awarded an exclusive contract to provide Veteran’s Affairs hospitals across the United States access to their novel non-invasive tumor liquefying platforms. The contract, the work of the Veterans Health Administration (VHA) and the Strategic Acquisition Center (SAC) , establishes a $90 million ongoing schedule to develop histotripsy programs at key VA Hospitals. The announced VA contract is the culmination of a multi-year effort by HistoSonics, the company called Project Hero, to ensure meaningful value for Veterans and their families, VHA clinicians, administrators, and caregivers.
Histotripsy is a novel form of focused ultrasound that uses high amplitude, very short pulses to create a “bubble cloud” that is designed to mechanically destroy and liquefy targeted liver tumors. These bubble clouds form and collapse in microseconds, creating mechanical forces strong enough to destroy tissue at cellular and sub-cellular levels in a non-invasive and non-thermal method. Histotripsy is a single-setting, outpatient procedure for most patients and offers a promising treatment option for patients with liver tumors, avoiding complications like infection and toxicity which are common for invasive surgical and radiation procedures. The company believes that the novel mechanism of action of their proprietary technology may provide significant advantages to patients, including the ability of the treatment site to recover and resorb quickly.
“We are pleased that Veterans suffering with tumors will soon have access to this innovative, non-invasive treatment at select VA facilities with interdisciplinary expertise,” said Patrick Malloy MD, Executive Director of the VHA National Radiology Program. Mark Wilson, MD, VHA National Director of Surgery, added, “Histotripsy is an innovative tool that will further enable VA specialists to continue to provide a full continuum of care to Veterans.”
Receiving FDA “De Novo” clearance in October 2023, the Edison Histotripsy System has been successfully put into clinical practice at leading US academic centers and integrated health systems, as well as many community hospitals seeking to offer breakthrough histotripsy treatment for their patients. Michael Kelly MD, Executive Director of the VHA National Oncology Program, acknowledged the promise histotripsy has within the VA system and in conjunction with ongoing Federal oncology initiatives, “As the largest integrated oncology provider in the United States, Veterans Affairs remains committed to improving the lives of Veterans and supports the goals of collaborative programs like the Cancer Moonshot Initiative,”
“Too frequently, Veterans do not have early access to meaningful innovation in health care, so it has been a mission for our team to partner with the VA in bringing histotripsy to our Veterans as soon as possible,” said Mike Blue HistoSonics CEO and President. Blue adds, “Histotripsy’s unique mechanism of action and non-invasive approach have demonstrated a patient friendly procedure for destroying liver tumors allowing many patients to return home and, ideally, to their lives quickly after the procedure. We believe that histotripsy is especially well-suited as a therapy for those who served with honor and are due the best healthcare we can provide.” All participating VA hospitals will be eligible to enroll patients in HistoSonics’ prospective study and post market clinical program, called BOOMBOX, which aims to collect data across a broad number of clinical use cases, and liver tumor pathologies, observing the use of histotripsy across all stages of liver disease.
HistoSonics is proud to partner with FIDELIS Sustainability as the SDVOSB partner and exclusive distributor of histotripsy systems to the federal government. “This is an absolute medical technology landmark for US patient care, and we are honored to be a part of bringing the Edison System to the Veteran Hospitals & DoD medical centers around the world,” said Dustin Lee Fidelis President & CEO.
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.
