LSI USA

Regulatory clearance solved one challenge, but not the broader question of clinical evidence. Blue acknowledged that medical oncologists are accustomed to extensive long-term data, while HistoSonics reached the market through a Class II De Novo pathway and a more focused safety and effectiveness study. The company is now investing in the evidence needed to support broader adoption. “We are committed,” Blue said. “We’ve got an incredible group of investors who are very committed and convicted to building the clinical evidence we need to create a paradigm-changing new category in healthcare.” Holste sees a larger lesson in that journey. More data can be important, but entrepreneurs should not assume another clinical study will automatically solve funding, adoption, or commercialization. For more information visit here: https://www.pearltrees.com/lsiusasummit/item830115553  

At LSI USA ’26, Hannes Holste, Director, Life Science Investments & Data Science at Thiel Capital, joined Michael Blue, Chairman and CEO of HistoSonics, for a keynote to discuss the origins of histotripsy, the skepticism surrounding the technology, and what its trajectory could teach the medtech industry about building new categories. From Discovery to a New Category Histotripsy originated at the University of Michigan, where ultrasound researchers were looking for a way to non-invasively create a small opening in the cardiac septum. Because thermal energy was unsuitable, they began experimenting with extremely high-amplitude, short-duration ultrasound pulses that could mechanically destroy targeted tissue. “They ultimately created the way to liquefy targeted tissue and then coined the phrase in 2002, histotripsy,” Blue said. “We’re mechanically destroying and ultimately creating a liquefaction that then gets naturally absorbed by the body.” The technology was explored across appl...