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Early Feasibility Clinical Study of the VitalFlow Stimulator, an Emergency Treatment for Ischemic Stroke

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4U44NS094307-02
Agency Tracking Number: U44NS094307
Amount: $2,534,753.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 105
Solicitation Number: PAR14-299
Timeline
Solicitation Year: 2014
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-15
Award End Date (Contract End Date): 2022-08-31
Small Business Information
526 S MAIN ST STE 801-A
Akron, OH 44311-4403
United States
DUNS: 962561762
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 EMILIO SACRISTAN
 (330) 752-6002
 esacristan@nervive.com
Business Contact
 TAMARA HEATON
Phone: (330) 752-6002
Email: heatontamara@yahoo.com
Research Institution
N/A
Abstract

Stroke is the world’s greatest healthcare burden for which few treatment options are available. The long-term
objective of the applicant, Nervive, Inc., is to bring to market a non-invasive medical device, the VitalFlow
stimulator, as an emergency treatment for ischemic stroke. The VitalFlow is a novel technology that activates
the autonomic components of the facial nerve using pulsed magnetic energy, thereby dilating the arteries of
the brain and increasing cerebral blood flow (CBF). Delivery of intravenous tissue plasminogen activator (rtPA)
to the site of an obstructing blood clot will be improved by increasing CBF, and endovascular clot retrieval
catheter navigation will be facilitated by dilation of the cerebral arteries. Thus, the VitalFlow stimulator is highly
relevant to the mission of the NINDS because it seeks to improve clinical outcomes in stroke patients and
reduce the burden of stroke.
With CREATE Devices grant support, we intend to test a clinical prototype VitalFlow stimulator that can be
used in the emergency department for the treatment of acute ischemic stroke. The following Specific Aims are
proposed:
In Phase I of the CREATE Devices project, Nervive will achieve the following:Specific Aim 1: Write the Early Feasibility Clinical Study protocol.Specific Aim 2: Establish a Quality Control System and freeze VitalFlow device design.Specific Aim 3: Complete a Pre-IDE meeting with FDA.
In Phase II of the CREATE Devices project, Nervive will achieve the following:Specific Aim 4: Complete external performance testing of the VitalFlow stimulator.Specific Aim 5: Receive FDA IDE clearance and hospital IRB approval.Specific Aim 6: Conduct an Early Feasibility Clinical Study in 8 acute ischemic stroke patients.
Nervive is pursuing Expedited Access Pre-Market Approval (PMA) regulatory clearance for the VitalFlow. In
the U.S. alone, the commercial opportunity for the VitalFlow includes the sale of device hardware to 5700
hospitals and the sale of consumable components for more than 400k patient treatments each year.Our device, the VitalFlow stimulator, will increase blood flow to the brain during ischemic stroke, thereby
preventing injury to the brain that leads to life-long disability. We now propose to test the VitalFlow device as
an emergency treatment for ischemic stroke in the emergency department setting in a small group of patients.
As a safe, effective, and simple-to-use emergency treatment for ischemic stroke, the VitalFlow stimulator will
have an important impact on patient outcomes and long-term disability.

* Information listed above is at the time of submission. *

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