5 months 3x per week and no results to date

[JC]

Lexington:

Can you please post an update on your FDA trial? In addition is there one person in the controlled group that you can explain the results for us in detail after six months in positive haircount. Also how does this result compare against someone in you placebo group? I do want to continue to use but in looking over your board there would seem to be more positive testimonials if 20K of these units have been sold. I appreciate any further scientific data you can provide.

[Randy]

Dear JC,

Thank you for your forum posting and expression of interest in our HairMax LaserComb.

FDA Clearance of New devices and new ‘indications of use’ is an in-depth process with many factors considered. Lexington initially filed a 510K submission with the FDA. A 510K submission assumes that there are ‘predicate device’ and ours was submitted on the basis of there being substantial equivalence of other light based devices (non hair related) in the market.

At this stage the FDA has stated that they have not found other predicated devices cleared for 510k acceptance, they suggested that we need a ‘De Novo’ filing. They also requested a second phase study for OTC use from a further research site. It is common for the FDA to make this request especially for devices with new indications of use. This does not take away any merit of the strength and statistical significance of the clinical data we presented.

Since our clinical results were statistically significant and superior to any other product on the market we thought we would have clearance on our first attempt.

We are continuing in our communications with the FDA to qualify each and every one of their requirements, beyond any reasonable doubt, and will continue and proceed with additional studies.

As we hope everyone could appreciate FDA approvals and device clearance take years and require extensive scientific data, comprehensive FDA compliance documents and regulatory advisors to present a strong submission. Most rulings are through a panel decision with some variables based on objective and subjective information.

Additional clinical data will be published when the FDA process is complete.

With regards to your comment about more positive postings - please keep in mind, most people view the LaserComb as a private item. They do not choose to post their comments in a public forum.

The LaserComb has been demonstrated to be effective. We encourage you to continue using it and see the benefits for your self. After all - isn't that what counts the most?

Regards
Randy

[Anonymous]

good results

I am now in my 6 month of use. I am beginning to see new hairs. They are small, but they are growing. Even my wife saw them and now she understands even more.