HistoSonics Announces FDA Approval of its Pivotal IDE #HOPE4KIDNEY Trial

February 13, 2023 |

HistoSonics announced today the US Food and Drug Administration (FDA) has approved the company sponsored #HOPE4KIDNEY Trial which is designed to evaluate the safety and technical success of the Edison System in targeting and destroying targeted primary renal tumors, completely non-invasively and without the need for incisions or needles. FDA approval of the #HOPE4KIDNEY IDE Trial comes after the company recently submitted results to the agency from their #HOPE4LIVER Trials where the studies met both primary endpoints of safety and efficacy in destroying targeted liver tumors.

“We are very pleased with the FDA’s approval of our #HOPE4KIDNEY Trial and appreciative of the agency’s prompt review process. 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,” commented Mike Blue, President and CEO of HistoSonics.  Blue added, “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. 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. In addition, the prevalence of kidney disease remains high with many patients kept in active surveillance or watchful waiting.”

In the United States, there are an estimated 600,000 people living with tumors of the kidney and renal pelvis with rates of new cases increasing since the 1990’s. Current 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 tumors, a non-invasive approach with histotripsy provides the potential to destroy targeted tissue 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 and eliminate certain complications seen with existing invasive approaches.

HistoSonics’ image guided sonic beam therapy system uses advanced imaging and proprietary sensing technology to deliver non-invasive, personalized treatments with precision and control. The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue at sub-cellular levels. The company believes that the novel mechanism of action of their proprietary technology provides significant advantages to patients, including the ability of the treatment site to recover and resorb quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

The Edison System is not currently available for sale. It is pending FDA review for a destruction of liver tissue indication. The #HOPE4KIDNEY trial is expected to support a future expansion of the indication to include the destruction of kidney tissue.

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Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by persons who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions and a summary of clinical trial results, including reported adverse events.

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