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Sound Blade Medical Appoints Neil Barman, M.D. as Chief Executive Officer
Sound Blade Medical Appoints Neil Barman, M.D. as Chief Executive Officer

Globe and Mail

time9 hours ago

  • Business
  • Globe and Mail

Sound Blade Medical Appoints Neil Barman, M.D. as Chief Executive Officer

Founder Jeremy Brown, Ph.D. to continue as Chief Technical Officer, driving scientific vision HALIFAX, NS, July 31, 2025 /CNW/ -- Sound Blade Medical, Inc., a leader in handheld histotripsy therapy, today announced the appointment of Neil Barman, M.D. as Chief Executive Officer. Dr. Barman, a physician-executive with more than two decades of medical technology leadership experience, previously served as the company's Chief Operating Officer and will now guide Sound Blade through its next phase of clinical development.

A Life on the Line and $250K in Debt Amid Insurer Denials
A Life on the Line and $250K in Debt Amid Insurer Denials

Medscape

time22-07-2025

  • Health
  • Medscape

A Life on the Line and $250K in Debt Amid Insurer Denials

The diagnosis came just as Nathan Kirkland and his wife were preparing for the birth of their second child in April 2024. Tests showed Kirkland, then 35 years, had intrahepatic cholangiocarcinoma, a rare form of cancer that develops in parts of the bile ducts housed within the liver. Kirkland's only chance for a cure was a liver transplant, but his tumor was too large to meet the criteria for the surgery. 'Cholangiocarcinoma just isn't a cancer most people come out on the other side of,' Kirkland told Medscape Medical News . 'The doctor said to me, 'Don't plan on seeing your daughter born in a few short months.'' Kirkland and his family Devastated, but determined to fight, Kirkland started a chemotherapy regimen that month to help shrink the tumor. To improve his chances for a liver transplant, his oncology team also recommended a noninvasive procedure, known as a histotripsy, that uses high-intensity sound waves to precisely target and eliminate liver tumors while avoiding the complications of surgery or radiation. The technique, which the FDA authorized in 2023, has shown a 95% success rate for treating liver lesions. Despite the data and FDA authorization, Kirkland's insurer, Anthem Blue Cross Blue Shield, denied a prior authorization request for the procedure in May. In July, Anthem approved a subsequent request, and Kirkland had his first histotripsy later that month. But this approval shift did not indicate better times ahead for Kirkland. The opposite. Starting in early August, Anthem denied approval for Kirkland's two subsequent histotripsy procedures, calling the procedure 'not medically necessary,' and, in November, reversed its July approval because of a coding issue. Anthem's medical policy considers histotripsy an 'experimental or investigational treatment for liver cancer,' Janey Kiryluik, staff vice president for corporate communications at Anthem's parent company Elevance Health, told Medscape Medical News in a statement. After numerous appeals in the fall of 2024, the insurer upheld its decision not to cover Kirkland's histotripsy procedures. Without coverage, the three procedures cost about $150,000 out of pocket, according to Kirkland. Although the exact frequency remains hard to pin down, coverage denials have become increasingly common among major health insurers, like Anthem, and the rise appears to be fueled, in part, by insurers' use of artificial intelligence (AI) algorithms to review prior authorization requests and then deny claims in batches. In some cases, rates of denials may be 16 times higher when reviewed by AI tools than by humans, according to figures from a recent American Medical Association report. While most denials are ultimately overturned, that can take days, sometimes weeks or months, and delay life-saving cancer care. In a 2024 survey of radiation oncologists, for instance, 30% reported that the prior authorization process harmed their patients, and 7% said it led or contributed to a patient's death. 'Every time insurers create a delay or a hurdle, it potentially complicates care,' said Kirkland's Oncologist, Laura Tenner, MD, MPH, an associate professor in the Division of Oncology and Hematology at the University of Nebraska Medical Center, Omaha, Nebraska. 'There have been some significant delays in prior authorizations and coverage by insurance companies that have delayed care to the point where patients missed out on curative intensive therapy for cancers.' To limit the delays, patients like Kirkland may be left with an impossible choice: Find a way to pay for their care and potentially fall into deep debt or delay their care while fighting the insurance company. Kirkland couldn't wait. In October and November 2024, he underwent two more histotripsies. To cover the cost, Kirkland and his wife exhausted their children's college funds and borrowed money from friends and family. In January 2025, Kirkland received some encouraging news: The procedures, plus the chemotherapy, had killed off enough of his cancer for his medical team to approve him for a liver transplant. 'I was on cloud nine once I got the good news from being cleared for transplant,' Kirkland said. 'I thought 'This is the best news ever! I'm going to be there for my kids.'' Kirkland and his family Kirkland started the transplant testing process. His brother agreed to be his donor, and a transplant date was tentatively set for February 14. But those plans halted abruptly. The family received a letter from Anthem denying coverage for the transplant. In the letter, dated February 6, 2025, Anthem claimed that the requested transplant was 'medically unnecessary.' 'Medical studies do not show that this surgery will improve your short- or long-term health,' Anthem officials wrote in the letter, which Kirkland shared with Medscape Medical News . 'It was a gut punch,' Kirkland said. 'This can't be real.' Denial-Fighting AI Enters the Scene Desperate to get the care he needed, Kirkland and his family turned to social media. By this point, Kirkland's out-of-pocket costs totaled about $250,000. Within days of sharing his story, Kirkland's posts on Facebook and LinkedIn garnered more than 6000 shares. The LinkedIn post even caught the attention of billionaire Mark Cuban who offered to help pay for the transplant. But it was a new AI startup called Claimable that turned the tables for Kirkland's insurance fight. The company, which launched in October 2024, is one of a growing crop of AI-based companies using the technology to help patients and providers analyze health insurance claim denials, uncover issues, and ultimately appeal and overturn denials. Health policy analysts say the new wave of companies is part of a growing 'battle of the bots' as health insurers increasingly use AI to deny claims. 'It's not surprising that new AI companies have sprung up,' said Michelle M. Mello, JD, a health law scholar at Stanford Law School who researches the effects of law and regulation on healthcare delivery. 'On the provider side, there are more denials than people to process them, and one of the things AI tools can do is help figure out which denials are most likely to be overturned if appealed. Often, the reason something is denied is just that information is missing. So having AI systems in place that can figure out, can learn, and can put in that additional information, that seems really valuable.' Claimable does not specialize in cancer cases, but when the company caught wind of Kirkland's story through social media, Warris Bokhari, MD, a former National Health Service physician behind the company, wanted to help. 'We probably spent a couple of hours on the phone with Nathan and then spent the rest of the day working with his brother and his sister to piece together the story,' said Bokhari, who previously led healthcare strategy and innovation across corporate America, including Anthem. 'We went through every test, every imaging result. We went through all of the evidence. And over the course of the day, we basically put together an appeal that was then elevated to visibility at the insurance company.' Bokhari discovered that Anthem had Kirkland's diagnosis wrong on the liver transplant denial. And it wasn't the first time. Anthem had initially misidentified Kirkland's cancer as neuroendocrine cancer, not intrahepatic cholangiocarcinoma, in a previous histotripsy denial. Although the original denial letters and initial appeal letter referred to liver cancer, Kiryluik told Medscape Medical News that the ''neuroendocrine cancer' term was inadvertently inserted by a medical director reviewer from a drop-down screen in place of 'liver cancer' which appears immediately above on the drop-down screen.' But 'this error did not impact the decision,' Kiryluik wrote. The second time occurred in the transplant denial letter from February 6, which listed Kirkland's cancer as hilar primary sclerosing cholangiocarcinoma — also a form of bile duct cancer, but one that develops outside the liver. The crux of Kirkland's appeal, however, was that Anthem was using data from 2004 to support its denial, Bokhari said. This is not unusual. Bokhari has found that many insurance companies rely on poor or out-of-date evidence or inconsistent enforcement of policies to make claim decisions. To unearth such issues, Claimable's AI platform analyzes patients' medical cases alongside clinical evidence, policy details, and appeal precedents in similar cases. The company charges patients about $50 fee for the service. In Kirkland's case, Claimable pointed to studies starting in 2018 that showed outcomes for patients with cholangiocarcinoma drastically improved following neoadjuvant chemotherapy and a liver transplant. The 5-year survival rate was close to 60%, according to a recent study. 'That was significant,' he said. 'And ultimately, our involvement was really to show that this should be a clinical decision between the transplant surgeon and Nathan.' Bokhari said it's unclear if Anthem used AI in Kirkland's claim denials — he becomes suspicious when denials include errors and incorrect terms — but the denials could have also been based on 'incompetent review,' he added. Anthem denies using AI in its coverage decisions. 'AI is not used in denial decisions,' Kiryluik told Medscape Medical News . 'Denial decisions are made by an appropriate medical director through our peer clinician review process.' 'Battle of the Bots' Claimable sits alongside a small but growing number of companies using AI to help physicians and patients fight health coverage denials. In June 2024, Flight Health Insurance launched a platform to help patients appeal denials and, in April 2025, expanded its reach to providers with a platform called Fight Paperwork. In November 2024, Cofactor AI introduced an AI-powered platform called Cofactor Denial Suite that supports claim appeals for providers. In January 2025, payment software company Waystar announced the launch of Waystar AltitudeAI™ to help providers appeal denied medical claims. And in April 2025, Red Sky Health unveiled its new AI-solution, Daniel, which helps providers identify and correct claims errors. Holden Karau, a software development engineer who created Flight Health Insurance, has been thinking about insurance coverage issues since being hit by a car in 2019. While the insurer paid for her 'bones to be fixed,' Karau said nearly every other aspect of the process ended in a payment dispute. Only recently has the technology gotten to a point where it made sense to work on a platform to help fight denials, Karau said. Like Claimable, Karau's company keeps the process simple and the costs low for patients and providers. 'The hope is to keep the prices low because we think that there's just so many denials out there that aren't being appealed,' Karau said. A Hard-Won Transplant That Didn't Come to Pass Six days after the February 6 transplant denial, Kirkland learned that Anthem had reversed its decision based on 'new information.' According to Bokhari, Claimable is currently beating about 85% of health coverage denials. Kiryluik told Medscape Medical News via email that the initial coverage request was 'denied due to lack of medical necessity based on the provided information.' 'After Mr Kirkland contacted us on February 9, we initiated an appeal process, which included further discussions between our oncology medical director and his transplant surgeon,' Kiryluik said in a statement. 'It was during this review that new details were provided, including an updated diagnosis and data on the transplant center's success rates for patients with similar diagnosis,' Kiryluik explained. Claimable's letter, for instance, corrected Kirkland's cancer diagnosis and cited data from Kirkland's transplant team showing that all 10 patients with intrahepatic cholangiocarcinoma who had received a liver transplant at their institution had survived. 'With this new information, Anthem approved coverage for Mr Kirkland's liver transplant and informed him of the decision,' Kiryluik said. But time was not on Kirkland's side. After Anthem reversed its denial, Kirkland's medical team immediately rescheduled his transplant. Physicians knew it was urgent he received his transplant before his cancer metastasized . Kirkland was prepped and headed into surgery on February 14, which he called 'fitting' because the date happened to be National Organ Donor Day. Surgeons opened him up. Before the transplant, his team first wanted to biopsy a retroperitoneal lymph node. The biopsy came back positive for cancer, indicating the tumor had metastasized. Because the lymph node was outside the surgical resection field, Kirkland's cancer would not have been fully removed, even with a liver transplant, explained Tenner. The transplant procedure was cancelled. Kirkland and his family were crushed. A curative liver transplant is now off the table for Kirkland and the goal is to explore palliative therapies to extend his life and give him the best quality possible, Tenner said. His oncology team is also looking into clinical trials for him, she said. But there's a lingering question: Did Kirkland miss the slim window he may have had for curative intent therapy because Anthem's prior authorization process and coverage denials delayed his care? 'There is a chance that had things been approved quicker and a biopsy obtained, the cancer would not have spread at that time, but I can't give you a definitive 'yes' or 'no' on that,' Tenner said. Ultimately, Anthem also reversed its denials of Kirkland's histotripsy procedures after Claimable got involved. Kirkland also believes the social media attention surrounding his case contributed to Anthem's shift. But the insurer told Medscape Medical News that 'Anthem approved coverage of the histotripsy following an external review by an independent peer review organization. Consideration was given to several factors, including the member's unique clinical circumstances and documentation by the treating facility that the member had exhausted all evidence-based therapies, and other alternative medical services were not available outside of a clinical trial.' In late May, Kirkland finally received his first reimbursement check for $97,000 of the $250,000 he had paid. Even the reimbursement process was 'slow and messy,' he said. He is still waiting for the remaining amount, and his surgeon is still waiting to be paid by Anthem, he said. Despite his outcome, Kirkland said he's 'not done fighting.' He hopes his story will draw attention to unfair insurance denials and lead to changes in company policies. In February, he filed an ERISA appeal to Anthem, urging the insurer to make changes in its policies for patients who need liver transplants and FDA-backed histotripsy procedures. 'At this stage, it's more about making sure other people get the opportunity and the care they need to have a better outcome,' he said. 'It shouldn't be such a burden to get treatment.'

Could tiny bubbles be the future of cancer care? Singapore's new clinical trial says 'yes'
Could tiny bubbles be the future of cancer care? Singapore's new clinical trial says 'yes'

Independent Singapore

time01-07-2025

  • Health
  • Independent Singapore

Could tiny bubbles be the future of cancer care? Singapore's new clinical trial says 'yes'

SINGAPORE: In a quiet but potentially trailblazing move, Singapore is slated to introduce medical trials in the second half of 2025 for a novel, nonintrusive treatment that utilises bubbles. However, these are not ordinary bubbles; these are microbubbles designed to destroy liver tumours without taking out a single layer of skin. According to a recent Healthcare Asia article, this next-generation treatment, known as histotripsy, employs intensive ultrasound to generate microscopic bubbles in the liver. These bubbles quickly inflate and collapse, crashing tumours reflexively — not thermally — which could lessen problems and protect adjacent healthy tissues. 'This technique may also enhance other treatment strategies such as immunotherapy,' said Dr. Glenn Bonney, senior consultant at the National University Hospital and National University Cancer Institute, Singapore. A first for Southeast Asia The clinical trial, involving 40 patients at the Singapore General Hospital (SGH) and the National Cancer Centre Singapore (NCCS), specifically targets individuals over the age of 21 with lumps smaller than three centimetres who are not candidates for surgical procedures. The trial will evaluate the tumour's reaction over six months and keep a close eye on possible complications and aftereffects. If the outcomes are encouraging, regulatory endorsement will be pursued, said Dr. Brian Goh, head of hepatopancreatobiliary and transplant surgery at SGH and NCCS. A decade in the making The expertise behind this invention came from the University of Michigan, where a team led by biomedical engineering professor Zhen Xu has spent over a decade finalising the science. 'Histotripsy uses microsecond-length ultrasound pulses at very high pressure,' Xu explained. 'This requires new instrumentation that did not exist commercially.' In contrast to high-intensity focused ultrasound, which scalds tissue employing heat, histotripsy functions more like an infinitesimal jackhammer, mildly disruptive, yet highly targeted. Xu, who co-developed the platform and co-founded the company HistoSonics, said the team had to build their equipment from nothing to bring this idea to life. Backed by big philanthropy Singapore's entry into this turf is boosted by a substantial $12 million contribution from the Li Ka Shing Foundation and Temasek Trust, which financed the city-state's first histotripsy system. This pioneering machine was bestowed upon NCCS and the National University Cancer Institute as part of a larger push to fast-track cancer innovation in the region. Histotripsy's future is not confined to liver tumours. Researchers are exploring the same platform as a possible treatment for haemorrhagic strokes, epilepsy, and even cardiovascular ailments. Scientists are also trying an all-in-one transcranial device that can 'awaken' the brain through the cranium, a sci-fi-sounding application that's getting closer to reality. A hopeful future With national recruitment projected to complete within the year, all eyes are now on the trial outcomes. If the results are satisfactory, Singapore may soon become a regional — or even global — leader in steering this next wave of cancer treatment. As Dr. Goh put it simply: 'If the results are positive, we will apply for the necessary approvals for treatment.' And just like that, the unassuming microbubble may rise as the improbable hero in the fight against one of the most fatal diseases of this era.

Ultrasound Liver Cancer Therapy Set for NHS Launch
Ultrasound Liver Cancer Therapy Set for NHS Launch

Medscape

time16-06-2025

  • Health
  • Medscape

Ultrasound Liver Cancer Therapy Set for NHS Launch

A new ultrasound-based treatment that destroys liver cancer tumours without surgery or radiation will be offered to NHS patients this summer in a European first. The therapy, called histotripsy, is a non-invasive and non-thermal technique that uses focused sound waves to break down cancerous tissue. It causes minimal damage to surrounding organs and may be delivered in a single 30-minute session. It is being hailed as a breakthrough by clinicians, patients, and academics. Bubble Cloud Destroys Tumours Without Heat or Blades Histotripsy works by generating high-amplitude, short ultrasound pulses via a platform known as the Edison System. These pulses create a "bubble cloud" from gases naturally present in targeted tissue. These bubbles form and collapse in microseconds, generating mechanical forces strong enough to destroy and liquefy targeted tumour tissue at cellular and sub-cellular levels. The remnants are absorbed by the body within one to two months, leaving minimal scarring. Treatment can be used both for primary liver cancer and metastatic disease in the liver. The treating physician can monitor the bubble cloud continuously and observe the treatment effect in real time. Animal research also suggests that the treatment may stimulate an immune response and induce abscopal effects – shrinkage of untreated tumours elsewhere in the body. NHS Access Through Fast-Track Innovation Scheme The technology was developed by ultrasound researchers at the University of Michigan and commercialised by US-based company HistoSonics. Health and Social Care Secretary Wes Streeting approved early access to the treatment under an unmet clinical need authorisation. A joint announcement on 10 June from the Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency confirmed its authorisation for controlled early access use through the Innovative Devices Access Pathway (IDAP). The government described the move as part of its 'blitz on red tape' to support innovation in the NHS. First Patients to Be Treated in Cambridge The first patients will receive histotripsy at Addenbrooke's Hospital in Cambridge this summer. The treatment is expected to reduce complications, shorten recovery time, and free up beds and surgical capacity. It will be available for both NHS and private patients. The technology was procured and installed using a donation from the Li Ka Shing Foundation, which has a longstanding history of funding projects at the University of Cambridge. Roland Sinker, chief executive of Cambridge University Hospitals, described histotripsy as 'an exciting new technology that will make a huge difference to patients'. Liver Cancer Survival Remains Low According to Cancer Research UK, liver cancer is the 17th most common cancer in the UK. On average, over 6500 cases are diagnosed annually, and more than 5800 people die from the disease each year. Current treatment modes include surgery, chemotherapy, thermal ablation, targeted drugs, and radiotherapy. Fiona Carey, co-chair of the Cambridge Cancer Research Hospital patient advisory group, who has advanced kidney cancer, said the announcement was "seriously good news." She added, 'for patients for whom ordinary surgery is no longer an option, this could make all the difference.' Histotripsy is also being explored as a potential treatment for other hard-to-reach cancers, including kidney and pancreatic tumours.

Groundbreaking cancer treatment which ‘destroys tumours with sound' to be rolled out on NHS
Groundbreaking cancer treatment which ‘destroys tumours with sound' to be rolled out on NHS

The Independent

time10-06-2025

  • Health
  • The Independent

Groundbreaking cancer treatment which ‘destroys tumours with sound' to be rolled out on NHS

NHS patients will be the first in Europe to benefit from a pioneering new cancer treatment which uses ultrasound to destroy tumours. The technology, known as histotripsy, offers a non-invasive treatment capable of breaking down liver cancer tissue without surgery, radiation or chemotherapy, with minimal damage to the surrounding organs, according to the Department for Health and Social Care (DHSC). First approved by US regulators in October 2023, histotripsy uses pulsed sound waves to create 'bubble clouds' from gases present in the targeted tissue and tumour. When these bubbles pop, within microseconds, a shockwave is released which is capable of breaking up a mass and killing cancerous cells, while avoiding the harms of radiation and reducing the risks of bleeding, infection, and damage to surrounding non-targeted tissue. Treatment is delivered via a single session – potentially taking just 30 minutes – with limited or no pain, a quick recovery, and can be performed as a day case, according to the DHSC. The first NHS patients are set to be treated this summer at Addenbrooke's Hospital in Cambridge, where the technology – which uses a device called an Edison System, created by US firm HistoSonics – is being debuted after a donation from the Li Ka Shing Foundation. Cancer Research UK describes liver cancer as the 17th most common cancer in the UK and the 8th most frequent cause of cancer death. More than 8,000 people received a new diagnoses in 2022, with liver cancer incidence across the UK having surged by 42 per cent over the past decade, according to the British Liver Trust. So far, more than 1,500 patients worldwide have received treatment using histotripsy, mainly in the United States – following approval by the US Food and Drug Administration in late 2023. According to 12-month follow-up data from HistoSonics' previous clinical trials, which involved patients for whom other treatments had been either unsuccessful or unavailable, overall survival rates after one year were 73.3 per cent for primary liver cancer, and 48.6 per cent for those with secondary tumours. The paper, published in the Annals of Surgery journal in April, noted that both tumour control and survival rates were similar to those among other current treatments. The UK's new device is expected to be fully installed in Cambridge later this year, where it will be used initially to treat patients with primary and secondary liver tumours. Wider research on how this could potentially treat tumours in other organs – such as the pancreas and kidneys – is underway. The technology has been approved in the UK via the innovative devices access pathway, which aims to enable faster approvals of medical devices and treatments which evidence shows are safe, efficient and can fill unmet need. 'This is a strong example of smart, agile regulation in action,' said James Pound, of the Medicines and Healthcare products Regulatory Agency (MHRA). 'It's a major step forward for patients with liver cancer and shows how the UK can be a frontrunner in supporting responsible innovation that meets real clinical need.' While 'regulation is vital to protect patients', the government is 'slashing red tape, so game-changing new treatments reach the NHS front line quicker – transforming healthcare', said health secretary Wes Streeting. Hailing histotripsy as 'an exciting new technology that will make a huge difference to patients', Roland Sinker, chief executive of Cambridge University Hospitals, said: 'By offering this non-invasive, more targeted treatment we can care for more people as outpatients and free up time for surgeons to treat more complex cases. 'The faster recovery times mean patients will be able to return to their normal lives more quickly, which will also reduce pressure on hospital beds, helping us ensure that patients are able to receive the right treatment at the right time.' Fiona Carey, a kidney cancer patient who co-chairs Cambridge's patient advisory group, added: 'This is seriously good news. A new, non-invasive option to treat these cancers is very welcome indeed. 'For patients for whom ordinary surgery is no longer an option, this could make all the difference.'

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