2017 Planned Milestones v Announce grant for se
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Posted On: 05/12/2017 6:54:45 AM
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.
10-Q https://www.sec.gov/Archives/edgar/data/15375...43_10q.htm
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
http://content.equisolve.net/archtherapeutics...460ea0.pdf
Some follow through would be excellent.
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.
10-Q https://www.sec.gov/Archives/edgar/data/15375...43_10q.htm
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
http://content.equisolve.net/archtherapeutics...460ea0.pdf
Some follow through would be excellent.
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