FAQs - CYTOTRON
Q. How is Shreis linked to the Cytotron/Dr.Kumar
Shreis Scalene Sciences LLC, Gaithersburg, MD, USA has an irrevocable and perpetual license from Dr. Rajah Vijay Kumar, the inventor of the device, through his company Scalene Cybernetics Limited, India, for the marketing, manufacture and distribution of the Cytotron for degeneration and regeneration. Shreis looks after the North and South American region including Mexico and the Caribbean, with open sales in any other country.
Q. What does it mean by the Cytotron being granted a ‘Breakthrough device designation’ by the U.S. Food and Drug ADMINISTRATION (U.S.FDA)?
According to the FDA, the Breakthrough Devices Program is a program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health. The FDA recognizes the Cytotron as a Breakthrough Device for the treatment of Breast, Pancreas and Liver Cancers, by conducting a clinical trial to establish that it is better than existing standards of care for these indications. This designation allows Shreis to Fast-track the path to market with FDA guidance, by conducting a clinical trial and establishing improvement in effectiveness of Cytotron therapy in these cancers. This breakthrough designation does not mean that the Cytotron is already an approved medical device for use in the US. Discussions are underway with the FDA to conduct clinical trials in the US for the treatment of a variety of solid tumors. See Resources for further details.
Q. Who invented the Cytotron?
The Cytotron was invented by Dr. Rajah Vijay Kumar, at Scalene Cybernetics Ltd. Bengaluru, India. Kumar’s Bio and background as an extraordinary scientist is detailed here...
Q. Is the Cytotron still experimental?
No. CYTOTRON therapy for the treatment of Musculoskeletal Disorders and terminal Cancer patients is not experimental. All required technical, safety and clinical requirements have been fulfilled to meet the device certification and approval criteria for the CE Mark (required Regulatory approval for clinical use of this technology in the European Union, like the US-FDA approval is required for clinical use in America. The Device is in clinical and commercial use in countries where the CE mark is adequate for treating patients. The Cytotron has been CE marked for clinical use since 2012. Domestic clinical trials and FDA approval is mandatory to get patients treated with the Cytotron here in this country. This being a platform technology, we are studying various disease indications with new protocols that are being developed fine tuned. Currently about 30 Cytotron installations are operating globally, for non-invasive tissue Degeneration (Cancer) and Regeneration (OA).
Q. Where can I get treated with the Cytotron?
With the breakthrough designation granted by the FDA, we are now in the process of starting clinical trials in the US. Currently there are no Cytotron Treatment Centers in the US, but we are in the process of initiating US-FDA approved Clinical trials to get underway shortly. For immediate needs for Cytotron treatment outside the US, please contact us here.
Q. How long is the duration of treatment with the Cytotron?
A typical treatment cycle using the Cytotron for Cancer treatment is for 1 hour/day for 28 days. For OA, the typical duration is for ½-1 hr per day for 21 days. For spine / disc problems it is 1 hr/day for 28 days. The rationale for the number of days and the duration of treatment is based on principles of radio-physics and a deep understanding of the science of non-invasive tissue degeneration or regeneration, beyond the scope of this Q &A. Please refer to the published literature here for more details.
Q. HOW much does the Cytotron treatment cost?
For accurate cost and pricing for treatment, please Contact Us for more information or the Cytotron treatment centers in your respective countries.
Q. Is insurance reimbursement authorized for Cytotron treatment?
Insurance covers the entire cost of Cancer and OA treatment on the Cytotron in India. We are not aware of the situation in any other countries that have their own formularies. In the United States, once FDA approved clinical trials will be initiated soon. Shreis has every intention to have discussions with various medical insurance and treatment reimbursement companies to ensure inclusion in their formularies, for treatment with the Cytotron once approved.