NINDS awards NeuroSigma Phase I grant to develop TFN-covered stents

NeuroSigma, Inc., a Los Angeles-based medical device company, today announced it has been awarded a Phase I NIH-STTR grant from the National Institute of Neurological Disorders and Stroke (NINDS) for the further development of its Thin-Film Nitinol (TFN)-covered stent for the potential treatment of brain aneurysms.  Mayo Clinic is the sponsored research institution in this STTR grant.  The TFN-covered stent technology was developed at the University of California, Los Angeles (UCLA) and is exclusively licensed by UCLA to NSVascular, Inc., a majority-owned subsidiary of NeuroSigma.

NeuroSigma's Phase I grant of approximately $680,000 (two tranches) extends over a period of more than a year, with the second tranche of funding subject to the availability of funds and satisfactory progress made using the first tranche.  The NINDS STTR program may provide up to an additional $3 million of follow-on Phase II funding for additional clinical studies.  The major focus of the project is further development and pre-clinical testing of NeuroSigma's TFN-covered stent for the potential treatment of brain aneurysms. 

David Johnson, Ph.D., Director of Advanced Materials at NeuroSigma, is the Principal Investigator of the STTR grant.  He recently joined NeuroSigma and is widely regarded as a pioneer and one of the leading authorities in the world on the fabrication of TFN.  "Proposals for NIH grants go through a rigorous peer-review process and we are very pleased to have been awarded this funding.  I have been working for many years on the development of TFN-covered neurovascular stents and I am delighted to have this opportunity at NeuroSigma to make my dream a reality," said Dr. Johnson.  Co-Investigators on the project are David Kallmes, M.D., Colin Kealey, M.D. and Antonio De Salles, M.D., Ph.D.

Dr. Kallmes, an experienced interventional neuroradiologist, is spearheading the pre-clinical trials, which will be performed by his team at Mayo Clinic.  Dr. Kealey is Manager of Product Development at NeuroSigma.  Before joining NeuroSigma, Dr. Kealey, a vascular surgeon, was a key member of the UCLA team that developed the TFN technology.  Dr. De Salles is a Professor of Neurosurgery at UCLA and co-founder and Senior Medical Advisor at NeuroSigma.

 "We are very pleased to have received this important funding from the NIH and that very qualified and experienced teams at NeuroSigma and Mayo Clinic are working together on this project," said Lodwrick Cook, Chairman of NeuroSigma.

In July 2011, NeuroSigma announced the formation of its majority-owned subsidiary, NSVascular, Inc. and the signing of an exclusive worldwide license with UCLA covering its TFN-covered stent technology.  Nitinol is a superelastic nickel and titanium alloy with unique properties that allow deformation and subsequent full recovery of the original shape upon exposure to body heat.  NSVascular will initially focus on developing and commercializing TFN-covered stents for endovascular applications, with its first two applications being flow-diverting stents for intracranial aneurysms and stents for treating peripheral artery disease.