HistoSonics Broadens Insurance Access to Histotripsy Therapy

HistoSonics Secures Major Payer Coverage Expansion for revolutionary Liver Tumor Treatment

Minneapolis-based HistoSonics has announced a significant expansion of insurance coverage for its innovative histotripsy treatment of liver tumors, following new positive medical policy decisions from Highmark Blue Cross Blue Shield. This growth promises to broaden access to the non-invasive therapy for an estimated 7 million members across New York, Delaware, Pennsylvania, and West Virginia.

The recent Highmark decisions represent a critical step forward for HistoSonics, building on an initial coverage nod received in May. This earlier win marked the company’s first major insurance buy-in for histotripsy, a groundbreaking treatment designed for both primary and metastatic liver tumors.

HistoSonics developed the FDA-cleared Edison system,a elegant platform that utilizes focused ultrasound energy to perform histotripsy. This advanced technique employs a robotic arm to mechanically destroy and liquefy targeted diseased tissue and tumors. A key advantage of histotripsy is its ability to achieve thes results without the invasiveness or potential toxicity associated with conventional treatment modalities. The company is also actively exploring the submission of histotripsy for kidney tumors, with ongoing studies in this area.

To date, HistoSonics reports that nearly 2,000 patients have been treated using its pioneering histotripsy therapy. Further underscoring the therapy’s efficacy, the company recently shared 12-month data showcasing histotripsy as a safe, effective, and non-invasive treatment option. This data suggests it could serve as a crucial alternative for patients who have not responded to or cannot tolerate standard-of-care treatments.

“This expanded Highmark coverage marks another critical step in delivering histotripsy to more patients who urgently need safe, non-invasive options,” stated mike Blue, President and CEO of HistoSonics. “Highmark’s decision not only reinforces the clinical value of our technology but also helps establish broader payer confidence as we continue working to expand access nationwide.”

The growing traction of HistoSonics’ technology has not gone unnoticed in the wider medtech industry. Earlier reports indicated significant interest from major players, with some of the largest medical technology companies reportedly considering HistoSonics for a potential acquisition, valuing the company at an estimated $2.5 billion. This expanded payer coverage undoubtedly strengthens HistoSonics’ position in the market and signals a promising future for its non-invasive cancer treatment solutions.

what specific clinical criteria must patients meet to qualify for Medicare coverage of histotripsy for hepatocellular carcinoma (HCC)?

Expanding Coverage for Non-Invasive Liver Tumor Treatment

HistoSonics, a medical technology company pioneering the use of histotripsy, has recently announced important strides in securing broader insurance coverage for its innovative therapy.This development marks a pivotal moment for patients with liver tumors, offering a non-invasive alternative to customary treatments like surgical resection, ablation, and liver transplantation. Histotripsy, a focused ultrasound technology, is increasingly recognized as a viable and effective option, and expanded insurance access will dramatically improve patient access to this cutting-edge procedure.

What is Histotripsy and Why the Increased Coverage?

Histotripsy utilizes focused ultrasound waves to mechanically destroy targeted liver tissue without the need for incisions or ionizing radiation. Unlike thermal ablation techniques (like radiofrequency or microwave ablation) which rely on heat, histotripsy creates a controlled zone of cavitation – microscopic bubbles – that breaks down the tumor cells.

Several factors are driving the increased insurance coverage:

Growing Clinical Evidence: Robust clinical trial data demonstrating the safety and efficacy of histotripsy in treating various liver tumor types. Studies have shown promising results in terms of tumor control, patient safety, and minimal impact on surrounding healthy tissue.

Non-Invasive Nature: The absence of incisions translates to reduced pain, faster recovery times, and lower risk of complications compared to surgical interventions. This is a major advantage for patients who may not be suitable candidates for more invasive procedures.

Preservation of Liver Function: Histotripsy’s precise targeting minimizes damage to healthy liver tissue, helping to preserve overall liver function – a critical consideration for patients with underlying liver disease.

Cost-Effectiveness: While the initial cost of the procedure might potentially be comparable to other treatments, the reduced hospital stay, faster recovery, and lower complication rates can lead to overall cost savings for healthcare systems.

Current Insurance Landscape & Key Payers

As of July 15, 2025, HistoSonics reports significant progress in securing coverage with both commercial and government payers.

Medicare: Medicare coverage for histotripsy is expanding, with increasing approvals for patients meeting specific clinical criteria. This includes patients with hepatocellular carcinoma (HCC) within established Milan criteria.

Commercial Insurers: Major commercial insurers, including Aetna, UnitedHealthcare, and Cigna, are now offering varying levels of coverage for histotripsy. coverage policies often depend on the specific tumor type, stage, and patient’s overall health.

Coverage Verification: Patients are strongly encouraged to verify their individual insurance coverage with their provider before scheduling a histotripsy procedure. HistoSonics provides resources on their website to assist patients in navigating the insurance process.

Benefits of Histotripsy: A Deeper Dive

Beyond the advantages already mentioned, histotripsy offers several unique benefits:

Image Guidance: The procedure is performed under real-time imaging guidance (typically MRI), allowing physicians to precisely target the tumor and monitor the treatment’s progress.

Repeatability: Histotripsy can be repeated if necessary,offering a potential advantage for patients with recurrent tumors.

Outpatient Procedure: In many cases, histotripsy can be performed as an outpatient procedure, further minimizing disruption to the patient’s life.

reduced Risk of Bile Duct Injury: Compared to surgical resection, histotripsy carries a significantly lower risk of injury to the bile ducts.

Patient Eligibility & Treatment Process

Determining candidacy for histotripsy involves a extensive evaluation by a multidisciplinary team, including a hepatologist, interventional radiologist, and oncologist.

Typical eligibility criteria include:

1. Liver Tumor Diagnosis: Confirmed diagnosis of a primary or secondary liver tumor.Common tumor types treated with histotripsy include HCC, colorectal liver metastases, and benign liver tumors.
2. Tumor Size & Location: Tumors must be appropriately sized and located for effective histotripsy treatment.
3. Liver Function: Adequate liver function is essential to ensure the patient can tolerate the procedure.
4. Overall Health: Patients should be in reasonably good overall health to minimize the risk of complications.

The treatment process generally involves:

Pre-Procedure Evaluation: Comprehensive medical history, physical exam, and imaging studies (MRI, CT scan).

Procedure: Performed under MRI guidance, the histotripsy device delivers focused ultrasound waves to mechanically destroy the tumor.

Post-Procedure Monitoring: Patients are typically monitored for a short period after the procedure and followed up with regular imaging studies to assess treatment response.

Real-World Impact: Case Studies & Emerging Data

While long-term data is still being collected, early case studies demonstrate the potential of histotripsy to improve patient outcomes. For example, a case series published in The Journal of Vascular and Interventional Radiology (JVIR) highlighted the prosperous treatment of several patients with HCC using histotripsy, with minimal complications and promising tumor control. Ongoing clinical trials are further evaluating the efficacy of histotripsy in various liver tumor types and stages.

Resources for Patients & Physicians

HistoSonics Website: https://www.histosonics.com/ – Provides detailed information about histotripsy, patient resources, and a physician finder tool.

National Cancer Institute (NCI): [https://wwwcancer[https://wwwcancer