Minneapolis-based HistoSonics developed their Edison system to target and kill targeted primary kidney tumors. He does it non-invasively, without incisions or needles. Edison used a new sound therapy called histology.
HistoSonics is backed by some of the big players in the medical technology industry. In May 2022, the company entered into an agreement with GE HealthCare to use its ultrasound imaging technology to provide a new type of sound beam therapy. In December 2022, HistoSonics raised $85 million in a funding round led by Johnson & Johnson Innovation.
The company said the FDA approval of the Hope4Kidney study is based on the latest findings from the Hope4Liver study. Both trials achieved their primary safety and efficacy endpoints in targeting liver tumors.
“This approval is an important milestone for our company as we continue to expand the application of tissue slicing technology and its potential benefits to the treatment of diseases that affect the lives of so many people,” said Mike Blue, President and CEO of HistoSonics. We are pleased to expand our experience. successful targeting and therapy in the liver using our advanced Edison platform, which combines advanced imaging and targeting capabilities with real-time therapy monitoring.
Current treatments for kidney tumors include partial nephrectomy and thermal ablation, HistoSoncis said. These invasive procedures demonstrate bleeding and infectious complications that can be avoided with non-invasive tissue biopsy, the company said.
This therapy potentially destroys the target tissue without damaging non-target kidney tissue. The mechanism of destruction of cells in tissue sections may also preserve the function of the urinary system of the kidneys.
HistoSonics Image Guided Sound Beam Therapy uses advanced imaging and patented sensor technology. The therapy uses focused acoustic energy to create controlled acoustic cavitation to mechanically disrupt and liquefy the target liver tissue at a subcellular level.
The platform can also provide rapid recovery and takeover, as well as monitoring capabilities, the company said.
Edison is not currently marketed, pending FDA review for liver tissue indications. The company hopes that upcoming trials will help expand indications for kidney tissue.
“The logical next application was the kidney, because kidney therapy is very similar to liver therapy in terms of procedural and anatomical considerations, and Edison is specifically designed to treat any part of the abdomen as a starting point,” Blue said. “In addition, the prevalence of kidney disease remains high, and many patients are under active surveillance or waiting.”
Filed Under: Clinical Trials, Food and Drug Administration (FDA), Imaging, Oncology, Regulatory Compliance / Tag Compliance: HistoSonics Inc.
Sean Wooley is an Associate Editor writing for MassDevice, Medical Design & Outsourcing and Business News for drug delivery. He holds a bachelor’s degree in multiplatform journalism from the University of Maryland at College Park. You can reach him via LinkedIn or email shooley@wtwhmedia.com.
Copyright © 2023 · WTWH Media LLC and its licensors. All rights reserved. The materials on this site may not be reproduced, distributed, transmitted, cached or otherwise used except with the prior written permission of WTWH Media.
Post time: Feb-14-2023