HistoSonics, developer of a non-invasive platform and sonic beam therapy called histotripsy, has announced the treatment of the first patient in its pivotal #HOPE4KIDNEY trial.
The US Food and Drug Administration (FDA) approved the investigational device study earlier last year and it is designed to evaluate the safety and efficacy of the company’s Edison system to destroy targeted kidney tumours non-invasively and without the need for needles or incisions. The #HOPE4KIDNEY trial is a multicentre, open-label, single-arm trial, planned to enrol up to 68 patients.
The procedure was performed by urologist Michael McDonald (AdventHealth Celebration in Kissimmee, USA), a leader in advanced urologic procedures, including robotics. “At the start of my surgical career in the 1990’s, open surgical techniques were the primary method of medical operations. However, this quickly changed with the introduction of laparoscopic surgery in the late 1990’s and robotic surgery in the early 2000’s,” said McDonald.
“I’m excited about the potential of emerging technologies such as histotripsy to improve patient safety and outcomes.” The procedure was conducted under the auspices of the AdventHealth Research Institute, where physicians and researchers are currently conducting more than 650 studies and clinical trials.
In 2020, there were an estimated 628,355 people living with kidney and renal pelvis tumours in the USA, and an additional 81,000 people to be diagnosed with kidney tumours in 2023. Current kidney therapies such as partial nephrectomy and thermal ablation are invasive and exhibit complications from bleeding and infection that non-invasive histotripsy may avoid. While surgical intervention is the “gold standard” in removing kidney tumours, a non-invasive approach with histotripsy provides the potential to destroy targeted tumours without damaging non-targeted kidney tissue. Additionally, histotripsy’s purely mechanical mechanism of cellular destruction could preserve function of the kidney’s urine collecting system.
“We are extremely excited to have McDonald and his team at AdventHealth Celebration treat the first patient at part of the #HOPE4KIDNEY trial,” said HistoSonics president and CEO, Mike Blue. “Our goal is to enable physicians to precisely target and destroy kidney tumours with our novel, non-invasive solution, avoiding the morbidity and complications seen with current invasive surgery or ablative techniques,” added Blue. The company expects to take advantage of key learnings from its initial Phase I kidney study, called the CAIN trial, and technical enhancements with its Edison platform during the #HOPE4KIDNEY study.
