A THIRD-PARTY COMPETITIVE ANALYSIS performed by world-leading medical product consulting firm, Simbex, determined there are NO EXISTING COMPETITORS IN THE STROKE MARKET.
No existing drug or medical device is capable of achieving improved clinical outcomes, reduction of vasospasm, reduction of hydrocephalus, and reduction of infection. AURENAR’S V-LINK PRODUCT ACHIEVED REDUCTION OF EACH MAJOR STROKE-RELATED COMPLICATION IN A RANDOMIZED CONTROLLED CLINICAL STUDY. Additionally, V-Link significantly reduced hospital length of stay and medical costs.
No existing medical device is capable of addressing key challenges for use in the intensive care unit. Specific challenges include fast and easy placement by nursing staff, elimination of infection caused by re-use, reduction of capital equipment costs, and burden of maintenance. AURENAR’S V-LINK PRODUCT SOLVES EACH CHALLENGE FOR USE IN THE INTENSIVE CARE UNIT. V-Link is easy to place on the ear by nursing staff, is pre-programmed to apply a self-timed 20 minute stimulation therapy, is single use and disposable to eliminate risk of infection, and has no capital equipment cost or maintenance.
The third-party competitive analysis identified two existing medical device products that activate the vagal nerve via minimally-invasive neural stimulation for non-stroke related applications. Neither device is suitable for use within the intensive care unit.
The first product identified, GammaCore, non-invasively stimulates the vagus nerve through the neck, requiring the hand-held device to be held in place for approximately 30 minutes to treat migraines. This technology is not FDA-approved for stroke, requires careful placement to target the vagus nerve, is impractical for intensive care nursing staff to hold in place for extended periods, introduces risk of infection through re-use, and requires capital equipment cost and maintenance.
The second product identified, Masimo Bridge, stimulates the auricular nerve branch in the ear using penetrating needle electrodes inserted into the ear to treat opiod withdrawal symptoms. This technology is not FDA-approved for stroke, requires tedious placement using transillumination of the ear with a flashlight tool to locate hidden nerve branches, is impractical for intensive care nursing staff administer, introduces risk of infection through re-use, and requires capital equipment cost and maintenance.