NeuroSigma's Thin Film Nitinol Flow Diverting Stent Results Presented at the American Society of Neuroradiology Meeting

Pre-Clinical Study Conducted at Mayo Clinic

May 04, 2015, 07:00 ET from NeuroSigma, Inc.

LOS ANGELES, May 4, 2015 /PRNewswire/ -- NeuroSigma®, Inc. (NeuroSigma), a California-based life sciences company, today announced that results of an animal study of its Thin Film Nitinol (TFN) flow diverter were presented on April 30th by Mayo Clinic researchers at the 53rd Annual Meeting of the American Society of Neuroradiology in Chicago, Illinois. A copy of the study abstract can be accessed via the conference website.

The study at Mayo Clinic was primarily funded through a Small Business Technology Transfer (STTR) grant awarded to NeuroSigma by the National Institute of Neurological Disorders and Stroke (NINDS). Mayo Clinic is the partnering research institution on the grant, and Dr. David Kallmes Professor of Radiology at Mayo Clinic, led the study as the Principal Investigator. Dr. Kallmes is an expert on preclinical animal testing of novel neurovascular devices including flow diverting stents.

Thirteen simulated aneurysms in rabbits were treated with the TFN flow diverter. There were no acute complications associated with device deployment. Dramatically reduced intra-aneurysmal flow was observed on angiography immediately after device placement in all aneurysms treated. Additional results, including long-term follow-up, were presented at the conference.

"The animal data gathered by Dr. Kallmes and his team demonstrate several important benefits of NeuroSigma's TFN flow diverter, including substantial reductions in intra-aneurysmal blood flow immediately after device placement, and rapid establishment of an endothelial layer over the aneurysm neck region in the weeks following deployment," said David Johnson, Ph.D. Director of Advanced Materials at NeuroSigma.  

"The current first generation flow diverters typically take many weeks or months to achieve complete aneurysm occlusion, even after placement of multiple devices. In contrast, NeuroSigma's TFN flow diverter has thus far shown rapid aneurysm occlusion after placement of a single device," added Colin Kealey, M.D., Director of Advanced Development and Medical Affairs at NeuroSigma.

NeuroSigma's TFN technology is based on intellectual property exclusively licensed from the University of California, Los Angeles (UCLA) by NSVascular, Inc., a majority-owned subsidiary of NeuroSigma, and a portfolio of patents and trade secrets acquired by NSVascular from TiNi Alloy Company, founded by David Johnson, Ph.D., a pioneer in the fabrication of TFN. Dr. Johnson currently is Director of Advanced Materials at NeuroSigma and serves as the Principal Investigator of this Phase I grant.

Background – Thin Film Nitinol Flow Diverting Stent

Thin film nitinol (TFN) is a novel biomaterial produced on silicon wafers via NeuroSigma's unique sputter deposition process. NeuroSigma is a leader in TFN technology and has developed a high-throughput method to produce three-dimensional TFN constructs. NeuroSigma's TFN flow-diverter is composed of a porous TFN micromesh that is used to cover a stent backbone. The resulting device has a lower percent metal coverage and higher pore density (pores per mm2) than current-generation devices. Preclinical testing of the TFN flow diverter to date suggests that these physical characteristics may confer a substantially improved flow diversion effect.

About NeuroSigma, Inc.

NeuroSigma is a Los Angeles-based life sciences company established to develop technologies with the potential to transform medical practice and patients' lives. NeuroSigma is focused on its two product platforms: Trigeminal Nerve Stimulation (TNS) neuromodulation therapies and TFN-based endovascular devices. NeuroSigma's technologies are based on a portfolio of intellectual property that is both wholly owned, and licensed on an exclusive basis from the University of California, Los Angeles (UCLA). For more information about NeuroSigma, please visit www.neurosigma.com.

Research reported in this press release is supported by the National Institute Of Neurological Disorders And Stroke of the National Institutes of Health under Award Number R41NS074576. The content is solely the responsibility of NeuroSigma and does not represent the official views of the National Institutes of Health.

CAUTION: NeuroSigma's TFN-covered stents are investigational devices and are limited by Federal (or United States) law to investigational use.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our TFN and TNS systems.  These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.

 

SOURCE NeuroSigma, Inc.



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