· We have raised $1.4M of our $1.5M raise to conduct our clinical trial and submit our FDA DeNovo 510(k). This is a priced round with Series Seed Preferred Equity at a $4.2M pre-money valuation. Tech Coast Angels (TCA) is our lead investor. The BOD has approved limited oversubscriptions for this round.
· Research is done. The device has been tested in 4 Animal studies (pigs) and 1 human cadaver study which shows the technology works. This includes use by 10 anesthesiologists who had never seen the device before.
· We did a pre-submission with the FDA and met with them 3 times. We have negotiated the DeNovo 510(k) requirements with the FDA, including a short clinical trial expected to last ~90 days.
· We have submitted our clinical trial application to the University Hospital Cleveland (UHC) Institutional Review Board (IRB) for review and anticipate approval the week of July 25. We anticipate we will treat our first patients in late August or early September at UHC.
· We are manufacturing commercial use product for the FDA testing now.
· The USPTO has issued an office action to us stating that they will allow our first patent claim. No patents granted to others which would interfere with our device. This means that any other company that sells a similar (me too) product will violate our patent.
· Three separate marketing focus groups conducted with 21 anesthesiologists. Very positive response. Product developed based on physician feedback. Every single physician stated they would try the product when available.
· Hospital For Special Surgery (HSS). We have a Letter of Intent (LOI) from HSS for a Clinical Collaboration Agreement to evaluate the BrightPointTM Epidural system and develop new platform technology products for orthopedic use. We are working on the final agreement and expect to close soon. The agreement also includes a $250K direct investment into Lumoptik. HSS is the #1 orthopedic hospital in the US.