Nervive, Inc.

<p>An animal prototype VitalFlow has been successfully tested in more than 170 large animal experiments, including 3 animal models of stroke. &nbsp;The results of some of these studies have been published in Stroke and Brain Research, and 4 manuscripts are currently in review.&nbsp; The results of preclinical testing of the VitalFlow as a magnetic facial nerve stimulator are consistent with nearly a century of research evaluating the effect of electrical stimulation of the facial nerve as a means to increase cerebral blood flow, as well as the ongoing development program for an invasive facial nerve stimulator as a subacute treatment for stroke (BrainsGate;&nbsp; www.brainsgate.com).</p> <p>Ongoing preclinical testing in the rabbit ischemic stroke model is showing the VitalFlow to be as effective as intravenous tissue plasminogen activator on improving neurological outcome measures. &nbsp;What is more, using the VitalFlow in conjunction with tissue plasminogen activator appears to have a synergistic effect. &nbsp;Thus, we expect the VitalFlow will not compete with existing treatments for stroke, and instead will augment their effectiveness.</p> <p>A clinical prototype VitalFlow based on a proprietary design has been assembled and has passed internal safety and performance testing. &nbsp;The clinical prototype VitalFlow was evaluated in 35 normal subjects, in whom no major safety findings were identified. &nbsp;Stimulation for a period of 3 minutes was found to be safe and tolerable in normal subjects up to the highest stimulation powers, and an increase in cerebral blood flow was reliably observed on contrast perfusion MRI. &nbsp;Subsequently, the clinical prototype VitalFlow is being evaluated as a treatment for a stroke-like condition, cerebral artery vasospasm, which develops several days after&nbsp;some types of brain hemorrhages.&nbsp; VitalFlow stimulation has been shown to reverse arterial constriction in vasospasm patients with no adverse events. &nbsp;The results of our preclinical and clinical studies can be found at www.nervive.com/vitalflow_scientific_background and&nbsp;www.nervive.com/preprints.</p> <p>Preclinical testing in conditions that mimick ischemic stroke&nbsp;(hemorrhagic stroke, active seizures) have shown that the VitalFlow does not make these conditions worse. &nbsp;Accordingly, we will develop the VitalFlow for use&nbsp;in the treatment of ischemic stroke in the emergency department and ambulance settings where diagnostic capabilities are scarce. &nbsp;Indeed, Nervive plans to develop future versions of the VitalFlow linked to artificial intelligence equipped with natural language capabilities so as to diagnose stroke and make treatment decisions where stroke diagnostic expertise is not available.</p>