Meet Edison® Histotripsy System – powerful bubbles

Please read this before asking questions

Histotripsy is a new treatment, but it’s an ablative technique rather than a drug.  It can be equated to liver embolization or conventional tumour ablation but uses what would appear to be a more effective targeted therapy.  It’s early days, the fact that it has been approved by FDA (see wording below) is about all we know but this blog will be kept live.

I get asked a lot of questions but some of the detail NET patients tend to ask is simply not available to me.  

1. Where can I get this treatment?  I do not know for sure which hospitals will be purchasing.  But the equipment manufacturer is now maintaining a commissioning database to keep us all updated with locations going live.   See link to that click here.

2. No, I don’t know the patient selection criteria, but I guess the original clinical trial for liver (primary or metastases) inclusion/exclusion criteria was a bit of a hint at the top level.  In reality, as an operational system, eligibility will be decided by healthcare professionals and hospitals, and this may differ from country to country, state to state and perhaps even hospital to hospital.  In Feb 2024, a doctor involved in Histotripsy treatment said “There are no set requirements and each center will have their own criteria. Currently liver is the only organ cleared by the FDA for treatment. The kidney mass trial is currently enrolling patients with other organs to come in the future. When the size of an individual tumor is very large other treatments (surgery or other liver directed therapies) are likely to have higher rates of destroying the lesion. Each patient is different and treatment plans are customized with the goal of the treatment in mind (treating every lesion or trying to treat a few lesions to obtain a systemic immune response)”.  Ask your specialist. 

3. Is it approved in my country? As of 12th Nov 2023, the treatment is only approved in USA. However there are hospitals in UAE and Hong Kong offering the treatment – see commissioned treatment centres click here.   Also see the UK Novel Innovation Program below for more info in UK (edit, at least one equipment is now formally approved and open for treatment in UK – click here).  Other approvals will follow but I have not seen anything yet. My ear is to the ground in Europe and Australia. 

5. Insurance Based Systems.  No, I do not know if your insurance will routinely approve. Although one (CMS) has suggested a price of $17,000 I have no idea what the breakdown of that cost is or what any extras will be, e.g. hospital fees etc.  Ask your treating hospital. (note as at December 2025, I have anecdotal evidence that Wellington Private Hospital in London UK is gearing up to install). 

6. Are there any clinical trials open? Firstly note that the locations used for the original liver trials no longer have the equipment.  Please note new trials for kidney and pancreatic tumours (to date) will have machines but only for those fitting the acceptance criteria for these trials (not for NET as far I can see).  Read more about open clinical trials click here.

7.  Any data confirming its utility in NET?   Yes although only covering a data period of 90 days so far.  Click here to read.

Is Histotripsy right for Neuroendocrine Cancer patients?

Firstly, you need to remember that this is not a treatment just for Neuroendocrine Cancer, it was developed to treat tumours no matter where they are and what type they are.  It is currently (as at 14th March 2025) only approved for liver tumours.

Secondly, you need to remember that because it is new, there’s a lot of hype surrounding the treatment – this will take time to settle as data starts to come out.  My advice for people in the NET community is to be cautious of the hype but also be optimistic that doctors will get better with experience of treating using this system and will be able to find the right balance via patient selection and the capabilities of the system.

Thirdly, remember that liver directed treatment is only the start, follow on trials have commenced to pancreas and kidney, with others to follow. It’s too early to say whether this will be suitable to these locations in NET but be optimistic.

Neuroendocrine Cancer is quite ahead of the game when you consider it’s the third most common cancer currently undergoing treatments (December 2025).  It’s also clear that the system has limits – it is not a systemic treatment, it is highly focused on individual tumours.  It follows that this treatment will not be for everyone.  But be cautiously optimistic at this point.  Check out this page and the questionnaires Histotripsy Tumor Treatment Information | MyHistotripsy;

Read about ALL Clinical Trials and ALL other information here

 

HistoSonics^®, (www.histosonics.com), the manufacturer of the Edison^® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.

The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

I first published this new treatment via the clinical trials information – you can read the background to that information by clicking here.   I want to use this new post to track deployment and updates as it becomes more well known.

FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe. Data pooled from both the US and European/UK trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumors.

Histotripsy was noted to have achieved both primary safety and efficacy endpoints in the pooled data where 44 subjects were evaluated for safety and 44 tumors treated were evaluated for efficacy. Important to note was the heterogeneity of the treated subjects, 18 of which had hepatocellular carcinoma (HCC) tumors and 26 had metastatic tumors to the liver from the colon, rectum, breast, and other primary origins. As recently presented at the annual CIRSE Congress in Copenhagen, a technical success rate of 95.5% was achieved indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumors. Also, only 3 procedure related CTCAE Grade 3 or higher adverse events through 30 days post-histotripsy were observed across all 44 subjects treated, representing a complication rate of 6.8% with each event being common to focal liver therapies and not specific to histotripsy.

HistoSonics Edison System Recognized With BioTech Breakthrough Award For “MedTech Innovation Of The Year”

BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe today announced that HistoSonics®, the manufacturer of the recently FDA cleared Edison® Histotripsy System and developer of novel, non-invasive sonic beam therapy platforms, is the recipient of the “MedTech Innovation of the Year” award in the third annual BioTech Breakthrough Awards program.

Mike Blue, President, and CEO of HistoSonics. Blue added, “We are very grateful to our early clinical partners who are in the process of being trained on the platform and will be the first ever to deliver histotripsy in routine clinical care, offering its unique benefits to the patients suffering from significant liver disease.” The Company noted it has expanded its commercial and operational capacity over the previous year in preparation for commercial activities. Premier medical centers like The University of Rochester Medical Center, The University of Michigan Medical Center, The University of Wisconsin Medical Center, The University of Chicago Medicine, and other top clinics are on their way to being the very first in the world to institute histotripsy programs for the many patients they serve.

In addition to an FDA Grant for the system’s use for liver tumors, HistoSonics is also conducting an ongoing clinical trial for histotripsy of the kidney in the UK, called the CAIN Trial. The company expects to initiate additional liver and kidney trials in 2024, along with early research into pancreas and prostate to follow.

How does it work?

The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue, including tumors, at sub-cellular levels. HistoSonics’ Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control. The company believes that the novel mechanism of action of their proprietary technology may provide significant advantages to patients, including the ability of the treatment site to recover and resorb quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

“As a surgeon, it’s rewarding to be able to offer a procedure where we can precisely destroy liver tumors without using a scalpel or needles, hopefully enabling the patient’s quick recovery while avoiding certain complications like surgical site infections or radiation illness common with other modalities,” commented Joe Amaral MD, VP Medical Affairs for HistoSonics. “Based on the data and patient experiences in our studies we are confident histotripsy will have a meaningful impact for patients suffering from unresectable liver disease, including liver tumors, and we look forward to the role histotripsy will play in treatment strategies going forward,” added Amaral.

The video below is courtesy of HistoSonics^® Meet Edison^®

https://ronnyallan.net/wp-content/uploads/2023/10/MKT2641_Meet_Edison_with_FDA_language_for_launch.mp4#t=2

What happens next?

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 tumours.

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, and others. (Note: Clinical Trials have been added for Primary Solid Renal Tumours).

Please note:

The Edison^® System is intended for the non-invasive mechanical destruction of liver tumours, including the partial or complete destruction of unresectable liver tumours 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 tumour 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.

Where can I get this as an approved treatment if I am eligible?

Can I get this in UK?

 

 

Resources used

1. FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System – HistoSonics
2. Tumor-destroying sound waves receive FDA approval for liver treatment in humans | University of Michigan News (umich.edu)
3. HistoSonics | Leader in Histotripsy

Disclaimer

I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.

Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.

Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.

 

Select of category of posts you’d like to see

• A spotlight on NENs
• A spotlight on NENs – Syndromes
• A Spotlight on NENs – Testing Series
• A spotlight on NENs – Types
• Awareness
• Clinical Trials and Research
• Diet and Nutrition
• Fundraising
• General
• Humour
• Inspiration
• Latest ENETS Guidelines
• Living with Neuroendocrine Cancer
• Newsletters
• Patient Advocacy
• Ronny Allan’s “The Trouble with the NET Series”
• Sometimes you gotta climb that hill!
• Spotlight on NENs – Types Series
• Survivorship
• The NET Effect Series
• Travel with Ronny
• Treatment

• Facebook
• X
• Bluesky
• Mail
• WhatsApp
• Pinterest
• Threads
• LinkedIn

Disclaimer

I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.

Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional. Some content may be generated by AI which can sometimes be misinterpreted.  Please check any references attached.

Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.

Click here and answer all questions to join my private Facebook group


Facebook – Neuroendocrine Cancer


X (twitter) – Ronny Allan


Website


Instagram

Thanks for reading.

Ronny

Check out my WEGO Health Awards

Check out my Glossary of Terms – click here

 

Please Share this post for Neuroendocrine Cancer awareness and to help other patients