ROCKVILLE, MD. (PRWEB) JANUARY 30, 2023
NeuroCytonix, Inc. (the “Company” or “NeuroCytonix”) announced today that, on January 19, 2023, its subsidiary NeuroCytonix Mexico received a regulatory recognition letter from the Mexican regulatory authority COFEPRIS – reference number/memorandum 223300ES450795/2023 – following the submission of NeuroCytonix’s final report on its clinical trial for cerebral palsy, NCX-CP-01.
COFEPRIS is a member of the International Council for Harmonisation (ICH) and the Pharmaceutical Inspection Cooperation System (PIC/S). Furthermore, COFEPRIS is a Level IV National Regulatory Authority, competent and efficient in performing the health regulatory functions recommended by PAHO/WHO.
Recognition represents the legal and formal conclusion of the clinical trial, in accordance with the methodology authorized by COFEPRIS. The NCX-CP-01 clinical trial resolution provides safety and efficacy data on the experimental NeuroCytotron treatment for cerebral palsy. A manuscript detailing the results of this clinical trial is in preparation and will soon be submitted to several scientific journals.
The results of this clinical trial provide support for further studies that will continue to evaluate the ongoing application of NeuroCytotron therapies in larger groups of patients, which will be backed by a Standard Operating Procedure in which all cases will be recorded. This recognition confirms that NeuroCytonix is a company that has formally completed a clinical trial for its experimental treatment with NeuroCytotron and is now registered with the National Registry of Research Companies of Mexico.
About NeuroCytonix:
NeuroCytonix is an emerging biotechnology company founded in January 2017 by Dr. J. Roberto Trujillo to develop and explore transformative medical technologies for nervous system regeneration. The company’s technology and related protocols include the treatment of stroke, autism, cerebral palsy, and neurological consequences of traumatic brain injury (TBI) and Covid-19. The company’s flagship technology, NEUROCYTOTRON, utilizes a non-invasive and safe tissue engineering technology that stimulates proteins that aid in the regeneration of brain cells.
NeuroCytonix technology is based on the work of Dr. Rajah V Kumar, inventor of the Cytotron and a pioneer for over 30 years in the fields of biophysics, radiobiology, and regenerative tissue engineering.
The founder and CEO of NeuroCytonix, Dr. J. Roberto Trujillo, a physician and PhD from Harvard University, is a leader in clinical and basic research in neuroscience and molecular virology for brain diseases, and is transforming the status quo of healthcare for these conditions previously considered incurable.
NeuroCytonix built a Research Center in Monterrey, Mexico, where it trained and directed a clinical research team that successfully implemented its first clinical trial for cerebral palsy, evaluating the safety and efficacy of the treatment.
Access the full study at ClinicalTrials.gov .
For more information, visit http://www.neurocytonix.com .
Contact:
Laurent Lavigne du Cadet
, Chief Financial Officer
, llavigne@neurocytonix.com
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