Recognition & research
What's proven, what's promising, and what isn't settled yet.
The approvals and designations the Cytotron® holds, what each one means in practice, and where the research stands today — set out clearly, so you can weigh it up for yourself.
CE marked since 2012
Assessed by an independent notified body and in continuous clinical use across the EU for more than a decade.
FDA Breakthrough Device Designation, 2019
Granted for solid tumours of the breast, liver and pancreas. A priority review pathway — the beginning of the FDA process, not the end of it.
In use in around nine countries
Approved for clinical use in Saudi Arabia and Mexico, with roughly thirty installations worldwide.
The FDA designation
What it means — and what it doesn't.
On 31 October 2019 the FDA's Center for Devices and Radiological Health granted the Cytotron® Breakthrough Device Designation for solid tumours of the breast, liver and pancreas. The programme is intended for devices that treat serious or life-threatening conditions and may offer a meaningful advantage over the options currently available. Receiving it means the FDA reviewed the early data and judged the technology promising enough to warrant priority attention.
The designation marks the beginning of the FDA pathway rather than the end of it. The clinical work supporting the next stage is ongoing, and until it concludes the device isn't marketed in the United States.
We spell this out because you may see it described inaccurately elsewhere, and we'd rather you heard the precise position from us. The correct description is: granted Breakthrough Device Designation by the US FDA. We'll update this page as the programme progresses.
Around the world
Where the device is recognised
| Country / region | Status | What it means |
|---|---|---|
| European Union | CE marked since 2012 | Certified for safety and performance; in clinical use across the EU. |
| United States | US FDA Breakthrough Device Designation, 2019 | Recognised as addressing a serious condition with potential advantages; on the FDA's priority review pathway. |
| Saudi Arabia | SFDA approved | Approved for clinical use. |
| Mexico | COFEPRIS approved | Approved for clinical use. |
| India | [CDSCO status — insert exact status and licence number] | [Insert accurate description once verified against CDSCO records.] |
Last verified [MONTH YEAR]. We review this table every quarter.
The 2016 clinical study, in detail
The study you'll find if you go looking.
The most substantial clinical publication on Cytotron® therapy in cancer is a 2016 peer-reviewed paper by Kumar and colleagues, reporting a four-year pilot study run from 2006 to 2010 in India with ethics committee approval under Indian Council of Medical Research guidelines. Because it's the study most patients eventually find, we'd rather walk you through it properly.
Who was in it. Ninety-eight patients aged 15 to 84 from India, Europe, South East Asia, the US and Africa. All had solid tumours confirmed on pathology, and all but three had been declared terminally ill by their treating oncologist, with conventional options exhausted. Eighty-six completed the full course.
What treatment involved. One hour daily for 28 consecutive days, with each patient's dose computed individually from the proton density of their own MRI scans. Progress was measured against RECIST v1.1 imaging criteria alongside the Karnofsky Performance Scale and the FACT-GP quality-of-life questionnaire, with twelve months of follow-up.
| Measure | Before / predicted | Observed |
|---|---|---|
| Survival (n=86) | Predicted mean 117 days from a standard palliative prognostic model; 0% predicted to reach 12 months | Actual mean 377 days; 47% alive at 12 months, and 31 still alive when the study closed |
| Quality of life (FACT-GP) | 71 ± 22 | 78 ± 18 at completion, held at one month (p = 1.71 E-08) |
| Day-to-day function (Karnofsky) | 74 ± 15 | 80 ± 12 at completion (p = 7.25 E-06) |
| Tumour status at one month (51 imaged) | — | 71% stable disease · 8% partial response · 22% progression |
| At twelve months (of 36 stable patients) | — | 8 remained stable and 2 showed complete resolution on imaging |
| Safety | — | No serious adverse events. Occasional mild, passing effects. Every patient completed the course. |
Kumar R, Augustus M, Nair AR, Ebner R, Nayar GS, Kumar RV. Quantum Magnetic Resonance Therapy: Targeting Biophysical Cancer Vulnerabilities to Effectively Treat and Palliate. J Clin Exp Oncol 2016;5:2. doi:10.4172/2324-9110.1000156. We'll gladly share the full paper with you or your oncologist.
If you research this yourself
Two things worth knowing.
Much of the published RFQMR work concerns knee osteoarthritis, not cancer, because the same platform is used for both. When you search, a good proportion of what you find will be orthopaedic.
The oncology literature is at an earlier stage. The 86-patient study is its most substantial entry; around it sit case reports and smaller series. That work is genuinely valuable for describing safety and identifying who tends to do well. The larger comparative studies that build on it are in progress.
The most substantial registered study is NCT03577600 on ClinicalTrials.gov, covering compassionate treatment in children with brain tumours. Registration means a study's design, endpoints and sponsor are recorded publicly in advance.
What this means for your decision
Cytotron® therapy is a promising, well-tolerated technology with real international recognition, at a stage where the research is still maturing. Individual responses vary, and no clinic can promise you a particular outcome.
What we can do is look at your specific situation, tell you honestly what we think is reasonable to expect, and give you what you need to decide with your family and your oncologist.
Cancer brings enough uncertainty without a clinic adding to it. You're going to research this carefully, and you should — so we'd rather you found an accurate, complete picture here than pieced one together from elsewhere at midnight.
Medically reviewed by [NAME, QUALIFICATION, REGISTRATION NO.] · Last reviewed [MONTH YEAR]
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