Professor Tze Min Wah, senior consultant radiologist and clinical lead for the interventional oncology program at Leeds Teaching Hospitals NHS Trust, performed the procedure. It marks the initial treatment in HistoSonics’ sponsored “CAIN” trial.
The Phase I prospective, multi-center study aims to evaluate the safety and technical success of the company’s histotripsy system. HistoSonics designed its system to target and destroy primary solid renal tumors in a completely non-invasive manner, without the need for incisions or needles. The company named its trial in honor of Charles Cain, its co-founder who passed away in March 2020. Cain also served as chair of biomedical engineering at the University of Michigan and co-invented histotripsy.
“This first treatment is a significant milestone for the company as it represents expansion into our second active clinical application (after liver) and supports our mission to deliver histotripsy to patients who may potentially benefit from its unique capabilities,” said Mike Blue, president and CEO of HistoSonics. “Our goal is to enable physicians to precisely target and destroy kidney tumors with our novel, noninvasive solution, avoiding the morbidity and complications seen with current invasive surgery or ablative techniques.”
About the HistoSonics renal tumor treatment
According to the Minneapolis-based company, invasive therapies like partial nephrectomy and thermal ablation exhibit complications. These come from bleeding and infection, which HistoSonics’ non-invasive histotripsy may avoid, the company said. Histotripsy’s purely mechanical mechanism of cellular destruction could preserve the kidney’s urine collection function, too.
The HistoSonics image-guided sonic beam therapy system uses advanced imaging and proprietary sensing technology. It delivers non-invasive, personalized treatments with precision and control. Scientifically, histotripsy uses focused sound energy to produce controlled acoustic cavitation. This mechanically destroys and liquified targeted tissue at sub-cellular levels.
HistoSonics believes its novel therapy provides significant advantages, including quick recovery and resorption of the treatment site. The platform also enables physicians to monitor the destruction of tissue under continuous real-time visualization and control.
Any use of the histotripsy systems is limited to clinical investigations. HistoSonics said its Edison system for liver tissue remains under FDA review. The company expects the CAIN trial to support future expansion to kidney tissue. Edison received FDA investigational device exemption in February.
“I was delighted to lead the clinical team in carrying out this world’s first kidney tumor treatment using histotripsy and a real privilege to have the trust of the patient and their family in translating this innovative technology into our clinic,” said Tze Min Wah. “The CAIN Trial represents a significant milestone for treatment of solid renal tumors with histotripsy as a needle-less technology and is a paradigm shift from this point onwards.”