Published on November 16, 2007
Company Presentation: Company Presentation BioMed, 30 May 2006 Challenges in treating the Central Nervous System: Challenges in treating the Central Nervous System Stroke Third leading cause of death in the western world First cause of long term disability Annual worldwide direct cost of stroke-related care is over $100B Window for treatment is currently 3-6 hours Drug delivery for diseases of the brain Brain tumors Alzheimer Parkinson Lysosomal Storage Diseases (e.g. Gaucher type II, III) Brain infections … The Blood-Brain Barrier (BBB): The Blood-Brain Barrier (BBB) The BBB is formed by the brain capillary endothelium It excludes from the CNS Almost all large-molecules (MW > 500 Da) ~98% of small molecule drugs By far the biggest obstacle to CNS drug development Reference: Pardridge W., NeuroRx. 2:3-14, 2005 BrainsGate’s approach: BrainsGate’s approach The spheno-palatine ganglion (SPG): A small nerve mass residing behind the nose Heart shaped, about 6mm long In the last 10 years was found to controls vasodilatation of cerebral blood vessels In: rats, cats, dogs, monkeys and humans BrainsGate has developed a device to stimulate the SPG Access to the SPG : Access to the SPG The greater palatine canal: a natural approach Leads from SPG to a point near the third molar The NeuroPathTM implant is designed for insertion into the canal Procedure comparable to going to the dentist SPG stimulation through skin using electric coupling The system in use: The system in use The Neuropath system was used on 10 patients in clinical trials Application – Ischemic Stroke: Application – Ischemic Stroke Vasodilatation: Vasodilatation Increasing vessel diameter was observed during preclinical and clinical trials Vasodilation can play a major role in stroke treatment Stimulated Non Stimulated Dog brain Yarnitsky et al., Surg Neurol. 2005 Jul;64(1):5-11 Infarct size reduction : Infarct size reduction In pre clinical studies SPG stimulation caused Infarct size reduction Improved neuro-score Control Stimulation Improved mobility: Improved mobility Stroke SPG stimulation Memory improvement: Control SPG stimulated 1h SPG stimulated 6h SPG stimulated 10h Trial 1 Trial 2 Trial 3 Water Maze Test –time to platform Best improvement at 6 hours of stimulation Memory improvement Stroke - Summary: Stroke - Summary Preclinical evidence Vasodilatation Infarct size reduction Improved motor function Improved cognitive function Large window of opportunity Treatment initiation – up to 24h 3-6 hours of treatment a day for 7 days Clinical trials to begin in H2’06 Application – CNS Drug Delivery: Application – CNS Drug Delivery Affecting BBB permeability in rats: Affecting BBB permeability in rats Model: rat Marker: Evans Blue solution Treatment: Unilateral electrical stimulation applied to post SPG nerve fiber Endpoint: visual inspection of brain Affecting the BBB in dogs: Affecting the BBB in dogs Model: dog Marker: FITC-dextran Treatment: Unilateral SPG exposure and direct stimulation Endpoint: Analysis of marker levels ipsi- and contra-laterally Clinical data: Clinical data The NeuroPath system was implanted in a 10 pt Brain Tumor Study Conclusions: Implantation procedure – Safe and Feasible Stimulation - tolerable Efficacy Vasodilatation evidence Traces of chemotherapy in CSF Surrogate marker (S100) in plasma About Us: About Us BrainsGate – the company: BrainsGate – the company An Israeli medical device company, founded 2000 To date, has raised $23M from leading investors Boston Scientific, Pitango Venture Capital, Alice Ventures, Infinity Venture Capital, Elron Electronic Industries An integrated team of professionals Neurological & Neuro Surgical physicians CNS scientists Pre-clinical and clinical experts Electrical and mechanical R&D Extensive pre-clinical and clinical data gathered Comprehensive IP portfolio Summary: Summary SPG stimulation is a promising new modality for CNS therapy BrainsGate’s mission is to develop and commercialize this modality as a platform Based on current promising data our strategy is: Initiate clinical trials for Ischemic Stroke in H2’06 Seek collaborations with pharma companies targeting drug delivery to the CNS Thank you for your time!: Thank you for your time!