GE Healthcare signs up to distribute HistoSonics' soundwave therapy for liver cancer

GE Healthcare is teaming up with the developer of a non-invasive platform for destroying liver tumors with sound waves. 

HistoSonics’ investigational Edison treatment uses guided sonic beams to deliver vibrations into the organ without breaking the skin and causes the targeted tissue to break down and liquify at the cellular level without the use of ionizing radiation or heat. Dubbed histotripsy, the therapy is not unlike lithotripsy procedures used to break apart large kidney stones using ultrasound.

Pending the FDA’s approval, HistoSonics’ hardware will be paired up with GE’s cart-based hospital ultrasound system, the Logiq E10 series, to provide treatment planning and real-time visualization during the procedure. The financial terms of the distribution agreement were not disclosed.

"We've developed a very collaborative relationship with GE Healthcare and look forward to expanding our efforts to realize the full potential of histotripsy across clinical applications, specialties, and care settings," HistoSonics R&D Vice President Josh Stopek said in a statement.

Last October, the FDA granted HistoSonics a breakthrough designation for its system including the device and software for planning patient-specific treatments. 

According to the company, early clinical and preclinical studies have shown histotripsy largely preserves nearby structures such as the fibrous layer that encompasses the lobes of the liver as well as larger blood vessels and bile ducts. In addition, the procedure allows physicians to monitor the destruction of tissue in real-time.

Last year, HistoSonics also announced it treated its first patients in clinical trials based in Europe and the U.S.. The aim of the single-arm, open-label studies is to mechanically destroy primary and metastatic liver tumors, and each trial hopes to enroll about 45 patients.

HistoSonics estimates that only about 20% to 30% of patients with liver tumors are eligible for surgery, whether due to the presence of multiple tumors, poor liver function or other limiting health issues. At the same time, the company expects the number of patients in the U.S. with primary liver tumors to grow by 40% by 2030, while the liver is also a common site for metastases from other cancers.