Scalene Cybernetics Limited, the medical technology company, has bagged the CE certification from Underwriters Laboratories (UL) for its product Cytotron used to control pain in cancer and osteoarthritis. The certification was awarded under Annexxe II, Section 3, of the Medical Devices Directive, 93/42/EEC as class II A Medical Devices. The company has already bagged 53 orders from the European Union for Cytotron installation. Efforts are also on to introduce the same under the National Cancer Care Programme of the Government of India. Scalene is looking at private public partnership for the same.
Cytotron is developed by Centre for Advanced Research and Development, the research arm of Scalene Cybernetics. The product which is claimed to be only one-of-its-kind in the world has several global patents. Cytotron is developed using the Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR) technology. It is used to relieve pain in cancer and osteoarthritis patients. The technology is used to alter the 'tran-membrane potential' (TMP) which is the potential difference between the inside and outside of the cell membrane in human tissue. The TMP pathways can stimulate the specific proteins resulting in tissue regeneration or degeneration.
While there are 14 installations in India, the product has also undergone clinical trials for 140 terminally ill cancer cases. Of these, the one year survival range was 52 per cent while 92 per cent of the patients had improved quality of life. The technology has a proven track record as 52 per cent of the end-stage cancer patents who were expected to live more than a month have survived for over a year. The technology has been able to arrest the cancer growth, stop its spread from organ to organ and provide better quality of life, said Dr Rajah Vijay Kumar, chairman, Scalene Cybernetics at a press conclave.
With the CE certification, Cytotron is now accepted as one of the therapeutic modality for cancer and osteoarthritis. There is considerable interest evinced from Europe, Middle East, Austrialia, Malaysia, Canada, New Zealand, South Africa and Mexico. By 2015, we are gearing up to install over 1000 Cytotron devices, he added.
The device bears strong resemblance to MRI scanner with a big bore and has 864 guns or radiating antennae each of which produces radio frequency radiation simultaneously with high instantaneous magnetic field.
While the price of the machine is around Rs 2.5 crore, the treatment cost for the patient is around Rs 1.2 lakh.
The company invested Rs 25 crore and funds have been raised through internal accruals. It is looking at increasing the offering of Cytotron to treat diabetes by stimulating the pancreas. But only extensive clinical trials are required to support this evidence. Scalene has already in the process of seeking approval from the Ethics Committee of the DCGI for the same.