2017 Planned Milestones v Announce grant for self-assembling peptidomimetics patent v Raise Capital
Submit 510(k) filing for external use to US FDA ~mid-year 2017 File CE Mark for EU commercialization File IDE for internal surgical clinical trial (for planned PMA application) File additional patent application(s) Establish commercialization strategy Provide data from multiple preclinical programs in pipeline
As of May 1, 2017, 150,769,042 shares of the registrant’s common stock were outstanding.
Clinical-Regulatory Plan for AC5 Adding 510(k) to US regulatory strategy
Medical device pathway EU and US Regulatory interactions begun Device met primary and secondary endpoints of EU clinical (human) trial 46 pts. with 10 on antiplatelet therapy (blood thinner) Safety outcomes comparable between AC5 and control; no serious adverse effects 41% improvement in median time to hemostasis (TTH) versus control TTH ≤30 seconds in groups of AC treated wounds (+/- antiplatelet therapy) Regulatory filings US 510(k) for external topical use Advanced filing plans to mid-2017 Internal resources focused Benefits include business opportunities, technology validation PMA for internal use File IDE for surgical trial in 2017 EU CE Mark – file application as soon as possible in 2017 Potential use of US surgical data for internal use application
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