HistoSonics Commences CAIN Trial of Histotripsy Platform to Treat Renal Tumors

April 5, 2023—HistoSonics recently announced that the first kidney patient has been treated using the company’s histotripsy platform. The procedure marks the initial treatment in the HistoSonics-sponsored CAIN trial, which is a phase I prospective, multicenter study designed to evaluate the safety and technical success of the histotripsy system in targeting and destroying primary solid renal tumors, completely noninvasively and without the need for incisions or needles.

The procedure was performed by Professor Tze Min Wah, MD, who is Senior Consultant Radiologist and Clinical Lead for the Interventional Oncology Program at Leeds Teaching Hospitals NHS Trust in Leeds, United Kingdom.

“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,” commented Prof. Wah in the company’s press release. “The CAIN trial represents a significant milestone for treatment of solid renal tumors with histotripsy as a needleless technology and is a paradigm shift from this point onwards.”

The company noted that the trial is named in honor of Charles Cain, PhD, coinventor of histotripsy and cofounder of HistoSonics, who died in March 2020. Dr. Cain was Chair of Biomedical Engineering at the University of Michigan in Ann Arbor, Michigan.

According to the company, HistoSonics’ image-guided sonic beam therapy system uses imaging and sensing technology to deliver noninvasive, personalized treatments with precision and control. Histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted tissue at subcellular levels. The noninvasive approach with histotripsy provides the potential to destroy targeted tissue without damaging nontargeted kidney tissue. Additionally, histotripsy’s purely mechanical mechanism of cellular destruction could preserve function of the kidney’s urine collecting system and eliminate certain complications seen with existing invasive approaches.

The HistoSonics Edison system is pending FDA review for an indication of destruction of liver tissue. The CAIN trial is expected to support a future expansion of the indication to include the destruction of kidney tissue.

In February 2023, HistoSonics announced FDA approval of the company-sponsored #HOPE4KIDNEY investigational device exemption trial, which is designed to evaluate the safety and technical success of the Edison system in targeting and destroying targeted primary renal tumors.

Also, the company recently submitted results to the FDA from its #HOPE4LIVER trials (one trial in Europe and one in the United States) in which both studies met the primary endpoints of safety and efficacy in destroying targeted liver tumors.

HistoSonics histotripsy systems are not currently available for sale; any use is limited to clinical investigations, advised the company.