MINNEAPOLIS--(BUSINESS WIRE)--May 12, 2025--
HistoSonics, the developer of the Edison Histotripsy System, today announced that Blue Cross Blue Shield of Michigan (BCBSM) and Blue Care Network have created a new medical policy for histotripsy of the liver. The policy covers non-thermal histotripsy using the Edison® Histotripsy System for the treatment of primary and metastatic liver tumors.
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As of February 1, 2025, histotripsy is a reimbursable procedure for the non-invasive mechanical destruction of liver tumors under CPT code 0686T, giving eligible patients in Michigan early access to this groundbreaking, non-invasive, incisionless treatment ahead of the broader policy effective date of July 1, 2025.
“Liver tumors are often a leading cause of death for patients with serious cancers, and it’s critical that they have access to safe, effective and non-invasive treatment options,” said Mike Blue, President and Chief Executive Officer, HistoSonics. “We applaud BCBSM for being the first to recognize the clinical value of histotripsy and for leading the way in ensuring their members have insurance coverage for this novel therapy. This milestone marks an important precedent, and we expect additional states and payers to follow in expanding access to histotripsy for patients with liver tumors across the U.S.”
The Edison System received De Novo authorization by the U.S. Food and Drug Administration (FDA) in 2023 and subsequently received two 510(k) clearances in 2024. The system uniquely employs high amplitude focused ultrasound to mechanically destroy targeted tumor tissue through acoustic cavitation, eliminating the need for heat, radiation, or incisions. The platform enables real-time image guidance, allowing the treating physician to continuously monitor treatment progress.
To date, the Edison Histotripsy System has been adopted at over 50 leading medical centers across the United States and has been used by surgeons, radiologists, and oncologists to treat more than 1,500 patients.
BCBSM’s coverage decision was based on compelling clinical evidence demonstrating that histotripsy is a safe, effective, and non-invasive treatment option for patients with primary or metastatic liver tumors who have not responded to, or are intolerant of, standard-of-care therapies. Histotripsy has shown to precisely target and destroy tumors while tending to spare critical structures such as blood vessels and bile ducts within and adjacent to the treated area. A key finding from the recently released 12-month #HOPE4LIVER trials follow-up analysis is a 90% local tumor control rate observed across all treated tumors regardless of tumor type or origin, which compares favorably to current standard of care local regional therapies at one year. The performance of these outcomes provides sufficient evidence to determine the technology’s impact on health outcomes.
In addition to commercial insurance recognition, the United Network for Organ Sharing (UNOS) recognizes histotripsy as an accepted loco-regional treatment option for patients needing bridging therapy for liver transplant. The addition of histotripsy to UNOS guidelines was made active in July 2024.
The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete ablation of unresectable liver tumors using histotripsy. The FDA has not evaluated the Edison System for the treatment of any specific disease, including cancer, nor has it assessed outcomes such as local tumor control, five-year survival, or overall survival.
The device should only be used by physicians who have completed HistoSonics-provided training, and its use should be guided by the clinical judgment of a qualified and appropriately trained physician. For a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events, please refer to the device’s Instructions for 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 liquify 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, Michigan 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 Edison Histotripsy System
WASHINGTON (AP) — Becky Pepper-Jackson finished third in the discus throw in West Virginia last year though she was in just her first year of high school. Now a 15-year-old sophomore, Pepper-Jackson is aware that her upcoming season could be her last.
West Virginia has banned transgender girls like Pepper-Jackson from competing in girls and women's sports, and is among the more than two dozen states with similar laws. Though the West Virginia law has been blocked by lower courts, the outcome could be different at the conservative-dominated Supreme Court, which has allowed multiple restrictions on transgender people to be enforced in the past year.
The justices are hearing arguments Tuesday in two cases over whether the sports bans violate the Constitution or the landmark federal law known as Title IX that prohibits sex discrimination in education. The second case comes from Idaho, where college student Lindsay Hecox challenged that state's law.
Decisions are expected by early summer.
President Donald Trump's Republican administration has targeted transgender Americans from the first day of his second term, including ousting transgender people from the military and declaring that gender is immutable and determined at birth.
Pepper-Jackson has become the face of the nationwide battle over the participation of transgender girls in athletics that has played out at both the state and federal levels as Republicans have leveraged the issue as a fight for athletic fairness for women and girls.
“I think it’s something that needs to be done,” Pepper-Jackson said in an interview with The Associated Press that was conducted over Zoom. “It’s something I’m here to do because ... this is important to me. I know it’s important to other people. So, like, I’m here for it.”
She sat alongside her mother, Heather Jackson, on a sofa in their home just outside Bridgeport, a rural West Virginia community about 40 miles southwest of Morgantown, to talk about a legal fight that began when she was a middle schooler who finished near the back of the pack in cross-country races.
Pepper-Jackson has grown into a competitive discus and shot put thrower. In addition to the bronze medal in the discus, she finished eighth among shot putters.
She attributes her success to hard work, practicing at school and in her backyard, and lifting weights. Pepper-Jackson has been taking puberty-blocking medication and has publicly identified as a girl since she was in the third grade, though the Supreme Court's decision in June upholding state bans on gender-affirming medical treatment for minors has forced her to go out of state for care.
Her very improvement as an athlete has been cited as a reason she should not be allowed to compete against girls.
“There are immutable physical and biological characteristic differences between men and women that make men bigger, stronger, and faster than women. And if we allow biological males to play sports against biological females, those differences will erode the ability and the places for women in these sports which we have fought so hard for over the last 50 years,” West Virginia's attorney general, JB McCuskey, said in an AP interview. McCuskey said he is not aware of any other transgender athlete in the state who has competed or is trying to compete in girls or women’s sports.
Despite the small numbers of transgender athletes, the issue has taken on outsize importance. The NCAA and the U.S. Olympic and Paralympic Committees banned transgender women from women's sports after Trump signed an executive order aimed at barring their participation.
The public generally is supportive of the limits. An Associated Press-NORC Center for Public Affairs Research poll conducted in October 2025 found that about 6 in 10 U.S. adults “strongly” or “somewhat” favored requiring transgender children and teenagers to only compete on sports teams that match the sex they were assigned at birth, not the gender they identify with, while about 2 in 10 were “strongly” or “somewhat” opposed and about one-quarter did not have an opinion.
About 2.1 million adults, or 0.8%, and 724,000 people age 13 to 17, or 3.3%, identify as transgender in the U.S., according to the Williams Institute at the UCLA School of Law.
Those allied with the administration on the issue paint it in broader terms than just sports, pointing to state laws, Trump administration policies and court rulings against transgender people.
"I think there are cultural, political, legal headwinds all supporting this notion that it’s just a lie that a man can be a woman," said John Bursch, a lawyer with the conservative Christian law firm Alliance Defending Freedom that has led the legal campaign against transgender people. “And if we want a society that respects women and girls, then we need to come to terms with that truth. And the sooner that we do that, the better it will be for women everywhere, whether that be in high school sports teams, high school locker rooms and showers, abused women’s shelters, women’s prisons.”
But Heather Jackson offered different terms to describe the effort to keep her daughter off West Virginia's playing fields.
“Hatred. It’s nothing but hatred,” she said. "This community is the community du jour. We have a long history of isolating marginalized parts of the community.”
Pepper-Jackson has seen some of the uglier side of the debate on display, including when a competitor wore a T-shirt at the championship meet that said, “Men Don't Belong in Women's Sports.”
“I wish these people would educate themselves. Just so they would know that I’m just there to have a good time. That’s it. But it just, it hurts sometimes, like, it gets to me sometimes, but I try to brush it off,” she said.
One schoolmate, identified as A.C. in court papers, said Pepper-Jackson has herself used graphic language in sexually bullying her teammates.
Asked whether she said any of what is alleged, Pepper-Jackson said, “I did not. And the school ruled that there was no evidence to prove that it was true.”
The legal fight will turn on whether the Constitution's equal protection clause or the Title IX anti-discrimination law protects transgender people.
The court ruled in 2020 that workplace discrimination against transgender people is sex discrimination, but refused to extend the logic of that decision to the case over health care for transgender minors.
The court has been deluged by dueling legal briefs from Republican- and Democratic-led states, members of Congress, athletes, doctors, scientists and scholars.
The outcome also could influence separate legal efforts seeking to bar transgender athletes in states that have continued to allow them to compete.
If Pepper-Jackson is forced to stop competing, she said she will still be able to lift weights and continue playing trumpet in the school concert and jazz bands.
“It will hurt a lot, and I know it will, but that’s what I’ll have to do,” she said.
Heather Jackson, left, and Becky Pepper-Jackson pose for a photograph outside of the U.S. Supreme Court in Washington, Sunday, Jan. 11, 2026. (AP Photo/Jose Luis Magana)
Heather Jackson, left, and Becky Pepper-Jackson pose for a photograph outside of the U.S. Supreme Court in Washington, Sunday, Jan. 11, 2026. (AP Photo/Jose Luis Magana)
Becky Pepper-Jackson poses for a photograph outside of the U.S. Supreme Court in Washington, Sunday, Jan. 11, 2026. (AP Photo/Jose Luis Magana)
The Supreme Court stands is Washington, Friday, Jan. 9, 2026. (AP Photo/J. Scott Applewhite)
FILE - Protestors hold signs during a rally at the state capitol in Charleston, W.Va., on March 9, 2023. (AP Photo/Chris Jackson, file)
