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Jul 27, 2023

FDA approves HistoSonics IDE trial for sonic beam therapy

February 13, 2023 By Sean Whooley Minneapolis-based HistoSonics designed its

February 13, 2023 By Sean Whooley

Minneapolis-based HistoSonics designed its Edison system to target and destroy targeted primary renal tumors. It achieves this in a non-invasive manner without the need for incisions or needles. Edison uses a novel sonic bean therapy called histotripsy.

HistoSonics has backing from some major players in the medtech space. In May 2022, it entered into an agreement with GE HealthCare to use its ultrasound imaging to power the novel sonic beam therapy. In December 2022, HistoSonics raised $85 million in a financing round led by Johnson & Johnson Innovation.

The company said FDA approval for the Hope4Kidney trial follows recent results from its Hope4Liver trials. Both trials met primary endpoints of safety and efficacy in destroying targeted liver tumors.

"This approval represents a substantial milestone for our company as we continue to expand histotripsy and its potential benefits into diseases that impact the lives of so many people," said Mike Blue, president and CEO of HistoSonics. "We are excited to expand on our experiences in successfully targeting and treating in the liver using our enhanced Edison platform that combines advanced imaging and targeting capabilities with real-time treatment monitoring.

HistoSoncis said current therapies for renal tumors include partial nephrectomy and thermal ablation. These invasive procedures demonstrate complications from bleeding and infection that non-invasive histotripsy may avoid, the company said.

This therapy could potentially destroy targeted tissue without damaging non-targeted kidney tissue. Histotripsy's mechanism of cellular destruction could preserve the function of the kidney's urine-collecting system, too.

HistoSonics’ image-guided sonic beam therapy uses advanced imaging and proprietary sensing. The therapy uses focused sound energy to produce controlled acoustic cavitation, mechanically destroying and liquefying targeted liver tissue at sub-cellular levels.

According to the company, the platform can also offer quick recovery and resorption and monitoring capabilities.

Edison isn't currently for sale as it awaits FDA review for a liver tissue indication. The company hopes the coming trial can support expansion to a kidney tissue indication.

"The kidney is a logical next application as treating in the kidney has very similar procedural and anatomical considerations as the liver, and Edison was specifically designed to treat anywhere in the abdomen, as a starting point," Blue said. "In addition, the prevalence of kidney disease remains high with many patients kept in active surveillance or watchful waiting."

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Imaging, Oncology, Regulatory/Compliance Tagged With: HistoSonics Inc.