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The HistoSonics system targeting a tumor

HistoSonics Announces Milestone As AMA Issues Unique Category III CPT® Code For Histotripsy Of Liver

July 12, 2021

HistoSonics is pleased to announce that the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) code for histotripsy of the liver. Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy tissue in the liver without incisions, ionizing radiation or heat. The new […]
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A close up on the HistoSonics device

HistoSonics Announces First Patient Treated in European Clinical Trial

June 7, 2021

HistoSonics announced today that the first patient has been treated as part of the company’s #HOPE4LIVER Europe Trial, which was approved by German authorities earlier in the year. The study is designed to evaluate the safety and efficacy of the HistoSonics’ platform technology, which uses the novel science of histotripsy and the mechanical properties of […]
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The HistoSonics team celebrating their 1st patient treated

HistoSonics Announces First Patient Treated in US Clinical Study of Novel Sonic Beam Therapy for Liver Tumors

February 3, 2021

HistoSonics announced today the treatment of the first patient in the #HOPE4LIVER US Study. The investigational device study was approved by the FDA in the fourth quarter of 2020. The study is designed to evaluate the safety and efficacy of the company’s platform technology, which uses the novel science of histotripsy, a form of therapeutic […]
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HistoSonics #Hope4Liver

HistoSonics Receives Approval To Begin European #HOPE4LIVER Clinical Study

January 11, 2021

HistoSonics announced today that it has received approval to initiate the company’s second European clinical trial of its new platform technology, which is designed to use the science of histotripsy to mechanically destroy targeted liver tumors, from outside of the body. The study, similar to HistoSonics’ recent FDA approved #HOPE4LIVER U.S. Study, is a multi-center, […]
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Signature Bank Venture Banking Group

HistoSonics Announces $15M Debt Facility Agreement with Signature Bank

November 25, 2020

HistoSonics Announces $15M Debt Facility Agreement with Signature Bank. HistoSonics is proud to partner with Signature Bank and plans to use proceeds to accelerate strategic projects and growth of the Edison Platform.
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Red Herring 100 Winner Award

HistoSonics Selected as 2020 Red Herring Top 100 North America Winner

November 19, 2020

HistoSonics was chosen as a 2020 Red Herring Top 100 North America Winner. “What has excited me most is to see so many people forging niches in high-tech and cutting edge sectors,” added Alex Vieux, Red Herring's publisher. “Some of the technical wizardry and first-rate business models showcased at the conference has been fantastic to […]
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HistoSonics #Hope4Liver

HistoSonics Announces Approval of its #HOPE4LIVER US Clinical Study

October 5, 2020

HistoSonics announced today that it has received approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a clinical trial of its new platform technology, which is designed to use the science of histotripsy to mechanically destroy targeted liver tissue and tumors, from outside of the body. The […]
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Three doctors review a procedure together

HistoSonics Announces $40 Million Financing

June 8, 2020

HistoSonics announced today that it has closed $40 million in an oversubscribed Series C-1 financing. The round was led by Yonjin Venture, LLC, who specializes in innovative early and mid-stage life science companies, and included additional new strategic investors. Also participating were existing investors Varian Medical Systems, Inc., Johnson & Johnson Innovation - JJDC, Inc. […]
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Joe Amaral profile

HistoSonics Appoints Dr. Joe Amaral to Vice President of Medical Affairs

June 5, 2020

HistoSonics announced today the appointment of Joe Amaral, MD, to the newly created position of Vice President of Medical Affairs, where he will oversee global clinical development initiatives for the company. Dr. Amaral brings with him more than 35 years of significant clinical and executive leadership in the healthcare space. Most recently, Dr. Amaral was […]
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Observer's 2020 List of The Hottest "Flyover Tech" companies in Digital Health

HistoSonics Wins Top Honors in The Observer’s List of Top Healthcare Start-ups

January 13, 2020

HistoSonics was named by The Observer as one of the nation’s most influential healthcare companies during the 38th J.P. Morgan Healthcare Investment Conference in San Francisco, CA. The company’s platform, Edison, integrates imaging, and proprietary sensing technology, and uses the science of histotripsy and the mechanical properties of focused ultrasound to destroy and liquify targeted […]
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Last updated on February 14, 2024

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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