A few interesting points:
- Wounding alone was more effective than Wounding + Lithium.
- The in-office procedure will take only 5 minutes!
- Follica's wounding method will be microneedling.
- Follica's topical drug will initially be Minoxidil, with a custom delivery device.
- The density of the needle wounds is important. In other words, when wounding a given area, you need a lot of needles placed close together. This maximizes follicle regeneration. This concept is known as 'quorum sensing'.
- NDA is expected to be filed in 2020.
Yes! Someone else who actually read everything, and understood what he read.
Also, they only wounded once. It is incredible that one five minute session was so effective, but also disappointing that they haven't tested varying frequencies.
The big questions I have are what depth do they wound, how many needles, and how fast does the device operate? Is it five minutes at fast speed? Their little graph on page 56 has FOL-004 at medium depth/density, and the Dhurat study at low depth/density. They lump density and depth together on the y-axis though, so is it actually less depth with a lot more density? They don't give the depth for FOL-004, but they give a depth of just 100-150 microns for the others. My guess is that this is going to be shallow needling with at least 12, maybe 36 needles at high speed.