Access and Timeframes

How soon will it be available in Australia?
The first Australian site is aiming for installation and initial treatments to begin in Oct/Nov 2025, pending final hospital approval and TGA regulatory steps.

Timeframes and cost?
If approvals proceed on track, patient access may begin Oct/Nov 2025. Costs for private access will be outlined soon; early procedures will not be covered by Medicare. This will be a subsequent process with a different timeline.

When will it be accessible to patients?
A patient registry will open shortly to begin collecting interest. The information collected is for Dr Chris Rogan and his team. Dr Rogan is an Interventional Radiologist who is committed to introducing Histotripsy—a non-invasive treatment option—to Australia. He is leading efforts to establish a clinical arrangement within a lead hospital.

To support the introduction of Histotripsy in Australia, we are collecting selected personal and health data from our forum community. This data will be de-identified and aggregated to create a compelling business case for presentation to Key Stakeholders involved in introducing Histotripsy to Australia. The goal is to demonstrate the potential demand and clinical relevance of Histotripsy as a treatment option for cholangiocarcinoma patients. 

Will trials begin in Australia?
At this stage, formal clinical trials are not required. However, compassionate or early access via Therapeutic Goods Administration (TGA) pathways (such as the Special Access Scheme) will apply initially.

Where in Australia will it be available?
Dr Chris Rogan will be the first interventional radiologist offering Histotripsy in Australia. The initial site will be in Sydney, with plans to confirm additional locations in Melbourne, Brisbane, Adelaide, and Perth over the coming months.

Will it be public or private access?
Initially, access is likely to be through private interventional radiology teams, but public access could follow pending Medicare item number development and broader rollout.

Who is installing the first machine?
Dr Chris Rogan will be leading the installation and clinical introduction of Australia’s first Histotripsy system.

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Clinical Questions

Can large tumours in the liver be eradicated?
Tumours up to 3–5 cm are most effectively treated. Larger tumours may be targeted in segments or require staged treatments.

Can multiple tumours be treated over time?
Yes, Histotripsy is repeatable, and multiple lesions can be treated across sessions depending on patient condition and tumour load.

Can large numbers of liver metastases be treated?
It depends. The best outcomes are seen when the number of lesions is limited , but suitability will be assessed case by case.

Can it be used with ALT >5x upper limit?
Caution is advised. Elevated liver enzymes may reflect underlying liver compromise. A multidisciplinary team will need to assess suitability individually.

Does Histotripsy destroy healthy liver cells?
Histotripsy is highly targeted. The technology uses focused ultrasound to create cavitation only in tumour tissue, sparing surrounding healthy tissue.

What happens to tumour debris?
The body’s lymphatic system and liver phagocytes naturally clear the destroyed tumour material. Risk of spread has not been observed in current data.

Is there a limit to how often it can be done?
There is no known upper limit, provided liver function remains adequate and tumour locations are treatable.

What are the side effects?
Most patients experience mild discomfort or fatigue. There is no radiation or chemotherapy-type toxicity.

Is it safe?
Early human trials and real-world use in the U.S. have shown high safety and low complication rates.

Can it be combined with chemotherapy or other systemic therapies?
Yes. It may complement targeted therapy, immunotherapy, or chemotherapy.

Is there an upper or lower tumour size limit?
Ideal range: 1 cm to 5 cm. Lesions <1 cm are hard to image; >5 cm may require staged treatments.

Is there a maximum number of tumours treatable?
No fixed limit, but best results occur with fewer than 10–15 lesions. High tumour burden will need to be reviewed individually.

Can it be used in widespread liver metastases or miliary spread?
Possibly, but less ideal. Histotripsy works best on discrete and imageable lesions.

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Suitability for Conditions

Neuroendocrine liver metastases (NETs)?
Yes, if lesions are visible and measurable on imaging, and are not diffuse. Suitability depends on tumour size and number.

METs with unknown primary and multiple liver lesions?
Possibly. Patient assessment will focus on growth rate, location, and systemic disease status.

Pancreatic cancer (including post-surgical liver mets)?
This is a developing indication. Currently off-label, but may be considered under individual review.

iCCA Stage 4 – Has anyone been cured?
Histotripsy is a new treatment, and long-term outcome data is still emerging. Some early patients have had complete ablations with no regrowth, but cure cannot yet be claimed.

Can it be combined with systemic therapy (e.g. chemo or targeted therapy)?
Yes, it can be safely combined with other treatments and may help synergise with immunotherapy or targeted agents.

Colorectal cancer liver mets – abscopal effect data?
Early data suggests potential immune stimulation, but abscopal effect rates are not yet established.

Minimum or maximum tumour size?
Typically 1 cm to 5 cm. Below 1 cm is difficult to image; above 5 cm would require staged treatment.

Ovarian cancer with liver mets?
Case-by-case. Liver metastases from other primaries may be eligible depending on tumour biology and treatment response.

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Logistics and Access

Will a referral be required?
Yes. As with all specialist medical treatments a referral from a treating oncologist, GP, or specialist will be required.

Can you approach the Interventional Radiology team privately?
Yes, early access is expected to be through private consults with IR specialists.

Can patients self-initiate contact with a private IR team?
Yes. Early access will likely be managed through private IR consultations.

How will patients be prioritised?
Consistent with current practices, this is determined by the Specialist and availability of the clinical environment.

Cases will be reviewed by your chosen doctor.

Will it be covered by Medicare or insurance?
With regards to Medicare, not initially.  This is a separate process that requires the procedure to be registered with Medicare. Medicare coverage is not yet in place.

With regards to insurance, patients would need to confirm with their own private insurance whether it is covered. You may find that your insurance may partially cover consults, imaging or hospital stays etc.

Expect out-of-pocket costs.

What will it cost in Australia?
Expected cost per treatment is $20,000–$50,000 AUD, depending on the facility, number of lesions, and whether hospitalisation is required. This is a guide only and subject to change.

Travel to Florida – waiting time and cost?
Estimated $80,000–$200,000 AUD including treatment and travel. Wait times are 4–8 weeks depending on the site.

Can it be used when primary has spread?
Yes, especially if the liver disease is dominant or symptomatic.

Is there a free trial or subsidy option?
No. However, philanthropic funding may be available and reduce costs for some patients.

How does the cost compare overseas (e.g., California or Hong Kong)?
Treatment abroad can range from $80,000–$200,000 AUD excluding flights, visas, and accommodation.

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Awareness and Education

Will there be efforts to educate doctors and advocate for access?
Yes. An advocacy group is working with hospitals and specialists to train staff, share data, and engage with regulators.

Will there be public awareness campaigns?
Yes. Plans are underway to educate oncologists, GPs, and patients through webinars, conferences, and social media.

Does the TGA need to approve the machine and the treatment?
Yes. The HistoSonics Histotripsy System requires TGA registration or access via the Special Access Scheme (Category B) or Authorised Prescriber Pathway.

Are doctors being educated about this?
Yes. Interventional radiologists, oncologists, and surgeons are being trained and briefed on patient selection.

What else is required to bring Histotripsy to Australia?
There are a number of processes that need to be completed including, but not limited to, TGA compliance, approval by the Sponsoring Hospital Board, assessing patient demand, setting up hospital infrastructure, clinical approval, training.

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Implementation & Eligibility

What has to happen to get Histotripsy into Australia? Will it be a free trial? Will the company look at other organs like the pancreas and spleen to treat? General cost of treatment?
The system must either be approved by the TGA or accessed under compassionate use pathways.

There will be no free trial, but early access will be privately funded through select interventional radiology teams.

The company is already exploring Histotripsy for use in pancreas, spleen, kidney, and prostate.

General treatment costs in Australia are expected to be $20,000–$50,000 AUD, and $80,000–$200,000 AUD overseas (e.g. in Hong Kong or the U.S.).

Cost and age group eligibility?
Cost: $20,000–$50,000 AUD per treatment.

Age eligibility: There is no strict age limit. Patients are considered based on overall health, liver function, and tumour characteristics. Cases in patients ranging from 30s to 80s have been assessed.

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ℹ️Additional Information

Age eligibility?
There’s no strict age limit. Cases have included patients aged 30s–80s, based on liver function and goals of care.

Will it treat other organs (e.g., pancreas, kidney, spleen)?
Yes. Trials are already exploring pancreas, kidney, prostate, and spleen applications. Liver is the first step in Australia.