HistoSonics Lands V.A. Contract for Histotripsy Systems

The Veterans Health Administration (VHA) and Strategic Acquisition Center (SAC) has awarded an exclusive $90 million contract to HistoSonics to provide U.S. Veteran’s Affairs hospitals with its non-invasive tumor liquefying technology. The VA contract is the culmination of a multi-year effort by HistoSonics to ensure meaningful value for U.S. veterans and their families, VHA clinicians, administrators, and caregivers.

“We are pleased that veterans suffering with tumors will soon have access to this non-invasive treatment at select VA facilities with interdisciplinary expertise,” said Patrick Malloy M.D., executive director of the VHA National Radiology Program.

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 its technology’s mechanism of action may provide significant advantages to patients, including the ability of the treatment site to recover and resorb quickly.

“Histotripsy is an innovative tool that will further enable VA specialists to continue to provide a full continuum of care to veterans,” stated Mark Wilson, M.D., VHA national director of Surgery.

Receiving U.S. Food and Drug Administration (FDA) De Novo clearance in October 2023, the Edison Histotripsy System is used in leading U.S. academic centers and integrated health systems, as well as many community hospitals seeking to offer histotripsy treatment for their patients. Michael Kelly M.D., 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.”

The Edison System is intended to non-invasively destroy liver tumors, including partially or completely destroying unresectable liver tumors through histotripsy. The FDA has not evaluated the Edison System for treating any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, five-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.

“Too frequently, veterans do not have early access to meaningful innovation in healthcare, so it has been a mission for our team to partner with the VA in bringing histotripsy to our veterans as soon as possible,” HistoSonics President/CEO Mike Blue said. “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 can enroll patients in HistoSonics’ prospective study and post market clinical program—BOOMBOX—which aims to collect data across a broad number of clinical use cases, and liver tumor pathologies, observing histotripsy’s use across all liver disease stages.

HistoSonics is teaming up with FIDELIS Sustainability as the SDVOSB partner and exclusive distributor of histotripsy systems to the U.S. government. “This is an absolute medical technology landmark for U.S. patient care, and we are honored to be a part of bringing the Edison System to the Veteran Hospitals and DoD medical centers around the world,” Fidelis President/CEO said Dustin Lee commented.

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 Histotripsy System in the United States and the HistoSonics Histotripsy System in select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Mich., and Minneapolis, Minn.