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HistoSonics Treats First Patients Evaluating the Edison® Histotripsy System for the Treatment of Benign Prostatic Hyperplasia (BPH)

Business

HistoSonics Treats First Patients Evaluating the Edison® Histotripsy System for the Treatment of Benign Prostatic Hyperplasia (BPH)
Business

Business

HistoSonics Treats First Patients Evaluating the Edison® Histotripsy System for the Treatment of Benign Prostatic Hyperplasia (BPH)

2026-03-30 20:00 Last Updated At:03-31 12:27

MINNEAPOLIS--(BUSINESS WIRE)--Mar 30, 2026--

HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced the successful treatments of the first patients in WOLVERINE, a prospective feasibility trial evaluating the Edison® Histotripsy System for the treatment of benign prostatic hyperplasia (BPH) at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong. The Edison System is a novel, non-invasive, image guided platform that uses the mechanical properties of focused ultrasound, called histotripsy, to destroy unwanted tissue without the need for invasive procedures, and with potentially fewer side effects than traditional, invasive therapies.

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WOLVERINE is a prospective, multi-center, single-arm feasibility trial designed to evaluate the safety of the Edison® Histotripsy System for the treatment of symptomatic benign prostatic hyperplasia (BPH). The trial is expected to enroll and treat up to 20 patients. Following treatment, participants will undergo imaging within 72 hours of the procedure to assess the immediate treatment effect. Patients will then be followed longitudinally to further evaluate safety and procedural outcomes.

“BPH affects millions of men worldwide and most of the existing treatment options require invasive procedures or lengthy recovery times,” said Mike Blue, Chairman and CEO, HistoSonics. “We believe histotripsy’s ability to mechanically destroy targeted tissue, completely non-invasively, has the potential to transform how BPH is treated. In addition, this milestone represents significant progress in our pursuit to expand the unique benefits of histotripsy over a significant number of serious clinical conditions throughout the body.”

“We are excited and extremely proud that Prince of Wales Hospital is the first center in the world to offer this novel treatment approach in a clinical trial and potentially benefit patients with BPH in the future,” said Dr. Peter Chiu, study investigator and Associate Professor of The Chinese University of Hong Kong. “If shown to be safe and effective, the non-invasive nature of histotripsy has the potential to change how BPH is treated for many patients suffering from lower urinary tract symptoms around the world.”

Benign prostatic hyperplasia is one of the most common urological conditions affecting aging men. Approximately 50 percent of men over the age of 50 and up to 80 percent of men over the age of 80 experience symptoms associated with BPH. Globally, more than 110 million men are affected by the condition, and its prevalence is expected to continue increasing as populations age.

The Edison Histotripsy System is currently cleared in the United States for the destruction of liver tumors. The use of the Edison System for the treatment of benign prostatic hyperplasia is currently limited to investigational use.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquefy unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, MI and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: www.histosonics.com. For patient-related information please visit: www.myhistotripsy.com.

HistoSonics Non-Invasive Edison Histotripsy System. Image credit: HistoSonics

HistoSonics Non-Invasive Edison Histotripsy System. Image credit: HistoSonics

UNITED NATIONS (AP) — The chief prosecutor of the International Criminal Court was removed from office on Friday, nearly two years after sexual misconduct allegations against him first emerged.

The ouster of Karim Khan comes at a time when the court is already facing daunting challenges, including a campaign by the United States to “dismantle” the ICC, which was established to prosecute people responsible for humanity’s worst crimes.

By a large majority, the ICC’s 125-member states voted to remove Khan, a British barrister, for “serious misconduct and serious breach of duty,” the court’s oversight body, the Assembly of States Parties, said in a statement.

“The ICC should hold itself to the highest standards. This includes ensuring a safe workplace with effective and credible mechanisms available to staff or others who experience abuse, including sexual violence or harassment,” Liz Evenson, international justice director at Human Rights Watch, said in a statement to The Associated Press.

The 56-year-old Khan was accused of sexual misconduct with a female aide, as outlined by the AP in a series of stories, allegations he has steadfastly denied. According to documents seen by the AP, Khan engaged in a sexual relationship with the woman and tried to prevent her from pursuing her allegations.

The oversight body will now need to hold elections for a new prosecutor, someone who is likely to face sanctions by the Trump administration, which has already brought the force of financial penalties and travel bans on 13 members of staff, including Khan.

Khan's lawyers criticized the process leading to his ouster, complaining that he was blocked from addressing the session Friday and arguing the regulations had been rewritten to disadvantage him.

Khan's “removal was determined by a process in which he was never given a fair opportunity to be heard, and in defiance of the conclusions of the independent judges who examined the full evidential record,” attorney Tayab Ali said in a statement. He said Khan's legal team would challenge the decision “through all available legal mechanisms."

The decision comes at a time when the global tribunal is under enormous pressure.

In a statement last week, Secretary of State Marco Rubio said the U.S. was launching a “sweeping campaign to dismantle the threat posed by the International Criminal Court to U.S. sovereignty.”

Rubio said he will pressure member states to withdraw from the institution, sanction organizations that work with the court and ban staff from traveling to the United States. Countries that “enjoy the benefits of the U.S. security umbrella” will be called upon to reject the court’s jurisdiction over U.S. citizens.

Hours after the vote, Venezuela announced it would withdraw from the court. “Venezuela considers that the Court’s actions reflect a demonstrated geographical bias, which has disproportionately concentrated its work on African and Latin American countries, to the detriment of the Global South,” Félix Plasencia, the country’s foreign affairs minister announced in a statement.

Earlier this year, prosecutors at the court announced they were dropping an investigation into whether U.S. sanctions against Venezuela qualified as crimes against humanity, citing a lack of evidence. A separate investigation into possible crimes committed by Venezuelan security forces under former Venezuelan President Nicolás Maduro will continue.

Trump’s administration already has brought sanctions against Khan and a dozen other ICC staff in retaliation for warrants the court has issued for top Israeli officials, including Prime Minister Benjamin Netanyahu, over the war in Gaza and investigations into U.S. personnel in Afghanistan.

The allegations against Khan have become entwined with the court’s investigation into the war in Gaza, experts said.

“Political considerations have been folded into this, especially as it is the first time a prosecutor has pursued warrants against a Western ally,” Iva Vukusic, a researcher at Utrecht University who has been following the process, told the AP.

Khan's removal will have no immediate impact on the arrest warrants in 2024 for Netanyahu and former Defense Minister Yoav Gallant for crimes against humanity, which can only be withdrawn by ICC judges.

Before ending the closed session, Kaukoranta called for the international community to respect “the dignity and privacy of all those involved” in the case regarding Khan.

“I expressed my deep appreciation to the assembly of states parties for the diligent consideration of this difficult matter, and for the spirit of unity shown in upholding the integrity of the court,” she said.

Quell reported from The Hague, Netherlands,. Amiri reported from New York.

FILE - Chief Prosecutor Karim Khan talks before convening the International Criminal Court (ICC) in The Hague, Netherlands, March 14, 2025. (AP Photo/Peter Dejong, Pool, File)

FILE - Chief Prosecutor Karim Khan talks before convening the International Criminal Court (ICC) in The Hague, Netherlands, March 14, 2025. (AP Photo/Peter Dejong, Pool, File)

FILE - Karim Khan, Prosecutor of the International Criminal Court, looks up prior to a press conference in The Hague, Netherlands, July 3, 2023. (AP Photo/Peter Dejong, File)

FILE - Karim Khan, Prosecutor of the International Criminal Court, looks up prior to a press conference in The Hague, Netherlands, July 3, 2023. (AP Photo/Peter Dejong, File)

FILE - The International Criminal Court (ICC) is seen on Dec. 9, 2025, in The Hague, Netherlands. (AP Photo/Peter Dejong, Pool, File)

FILE - The International Criminal Court (ICC) is seen on Dec. 9, 2025, in The Hague, Netherlands. (AP Photo/Peter Dejong, Pool, File)

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