Just wanted to bring this info to attention of forum members. Looks like there are now 3 things FDA approved for hair loss, Rogaine, Propecia and now Hairmax. Guess all the claims were backed up with proof good enough for the FDA. Don't everyone run out and get one now!



FDA Clears the HairMax LaserComb for the Promotion of Hair Growth

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BOCA RATON, FL, January, 2007 – Lexington International LLC is proud to announce the landmark achievement of US Food & Drug Administration (FDA) clearance for their medical laser device, the HairMax LaserComb. Through years of extensive research and clinical studies in the science of hair growth, Lexington has developed an affordable and convenient, hand-held laser device, clinically proven to promote hair growth in males with androgenetic alopecia (Norwood II A to V with Fitzpatrick skin types I to IV).

For the FDA submission, Lexington conducted an extensive clinical study in four different locations around The United States. The study concluded that 93% of the participants (ages 30-60) using the HairMax LaserComb had an increase in the number of terminal (thick) hairs. The average number of terminal hairs per square centimeter increased by 19 hairs/cm² over a six-month period. During the study, there were not any reports of serious adverse events. The number and types of adverse events were similar in both the active and placebo groups.

Lexington's clinical study demonstrating the efficacy of the HairMax LaserComb in females is concluding and we will be submitting the data to the FDA shortly.

David Michaels, Managing Director, shares his thoughts on this momentous announcement, "I believe the results of this study are far more significant than any other product on the market today. We are very excited about having reached a major milestone in hair care and science. Laser hair therapy is the talk of the hair restoration industry and with our FDA clearance behind us, we are now soundly positioned to dominate this emerging Laser treatment segment."

It is estimated that 55 million men are suffering from hair loss in the United States alone. Until recently, the FDA has only approved two other products as solutions to combat hair loss. The clearance of the HairMax LaserComb offers an exciting new modality for the stimulation of hair growth in males. Compliance is a key factor in the efficacy of any hair growth treatment. Fortunately, The HairMax LaserComb is very easy to use in the comfort and convenience of your own home, treatments last 10 to 15 minutes three times per week. The HairMax LaserComb is also the only drug-free option available thus allowing many who were previously unable or weary of drug based solutions new found hope in their battle against hair loss.

Dr. Matt Leavitt, Chief Medical Advisor to Lexington, expresses his enthusiasm on news of the clearance, "The HairMax LaserComb is a method of treatment that can be of great help to men of all ages suffering from hair loss. I am impressed with the protocol and results from the clinical trials that Lexington has conducted. With the FDA clearing the HairMax LaserComb as a medical device, it offers an attractive option for hair growth for medical practitioners. We can now deliver a new modality to our patients and achieve strong user satisfaction".

Randy Veliky, Lexington COO, comments, "The HairMax LaserComb will revolutionize the hair growth industry, but we are not stopping there. Lexington is dedicated to continuing research into laser technology. We will be expanding our offering of laser hair growth solutions to include freestanding clinical units, affordable laser panel arrays for the home market and broadening the features of our current products."

For over 20 years, the directors of Lexington have been at the forefront of laser hair growth research. Born from this passion for innovation, The HairMax LaserComb uses a patented technology to part the hair allowing the focused laser energy to reach the scalp. The laser is most effective when it has an unobstructed path directly to the hair follicle. Extensive research has also allowed Lexington to determine the optimal wavelength and energy level to deliver maximum results. Lexington's continued dedication to consistent innovation ensures that users are always receiving the latest in Laser hair technology.

About Lexington International, LLC
Based in Boca Raton, Florida Lexington International manufactures and distributes the HairMax LaserComb® (www.hairmax.com) to more than 80 countries and has provided new hope and satisfaction to tens of thousands of customers since 2001. The HairMax LaserComb is based on 20 years of international research and studies on the effects of Low Level Laser use. Both the press and users alike have universally taken to the HairMax LaserComb. Coverage has included Dateline NBC, TIME Magazine, as one of their "Inventions of the Year", as well as the November 2004 issue of Good Housekeeping Magazine.

Lexington is a proud member of "Team Florida" and has participated in high-level, overseas trade missions with Governor Jeb Bush. Additionally, the company was awarded by the U.S. Department of Commerce for "Commercial and Export Achievement".

Dr. Leavitt?????

Well, I am sold now, for sure.

Anytime the founder of MHR throws his support behind a product, I will support it wholeheartedly.

As we know, he has nothing but the patients best interests in mind.

Please.

Anyway, I think laser treatments DO help..... to a certain extent.

Unfortunately, I have never heard of ONE person using a laser comb to combat baldness. (in lieu of Propecia or Rogaine)and making a substantial gain.

So why the laser comb offers SOME help to us baldy's, offering the laser comb as a "drug free solution" to baldness just shows how ignorant and corrupt the FDA is.

I would buy one to check it out, but I would not be tossing my propecia/rogaine/Dut out the window any time soon.

Your Thoughts....?

B Spot,

I couldn't agree more. In my time surfing around various forums in order to find hairloss treatments, I've never heard anyone have success at regrowing any hair but use of laser treatments. It appears to have a purpose, but as you stated, not to combat baldness with any gain. I wouldn't throw it in the mix with finasteride or minoxodil. Anyway...I'll be willing to keep an open mind, however, I can't see myself recommending it, not until somebody has miraculous results with it...seems like a waste to me.

Falc

Wonder if any FDA members got a few kickbacks out of this?? HHHmmmmm

I remain sceptical.

Hi guys

I've been saying the same for many posts.. I wouldn't waste a dime on it and unfortunately, my brother did without results. I did too without results..

I say use it to grow your fern instead

I would have to go along with you guys, plenty of junk out there, even when the FDA approves it. Personally I tried Propecia for one year, found it did nothing for me despite the hype, did not even slow down my hair loss. My friend also used it, the only thing he grew were breasts, not hair. Haven't really heard of anyone getting good results from it so far, all I hear on various boards is how it is ruining everyones sex life and nothing else. On the other hand Rogaine has been pretty effective for me so far, though it seems to be pretty worthless to many others, so I guess I should be thankful. I am giving the laser a try, maybe it will end up in the junk heap with empty bottles of propecia, only time will tell. Grow well.

We obviously keep having the same debate about alternatives to the big 2. Now however people can't use the FDA approved only arguement to critique against the laser. Who knows? I have never put much credence in the FDA though.

I personally think that from everything that I have read, it does have some merit, but how many of us are going to use it as diligently as it is prescribed? It is so much easier to swallow a pill or slap some shit on our head before we go to bed.

JohnS--I think that there probably are some legitimacies to there tests so why don't you give it a try and document with photos. You can be our lab rat.

I agree.......

I'd definitely need to see PROOF that it works before investing in it. Anyone know where we can see the detail for the actual studies that were done? The statements they're making say that it increased the "average number of terminal hairs per square centimeter by 19 hairs/cm2 over a six-month period".

So............in this statement are they saying that it is thickening existing hair, or regrowing new hair? I guess I'm still somewhat confused by the statement and what is claimed to have been accomplished. Since Lexington International, LLC, appears to have been created to produce and sell this product, it would be nice to hear some comments (or see statistics) produced by an unbiased third party................this is Lexington's press release so of course it will make them look good.

Too bad it still appears to be lacking credibility.............if it worked I'd buy one!

It sounds like it says they are growing new hair. Dang, 19 new hairs per sq cm. That's like a mini transplant. I find it all very difficult to believe.

I think this might be a case of presenting this in such a way that it looked very impressive to the FDA. Sales is sometimes all in the presentation.

I used the hairmax laser comb (bought off e-bay for $200). Unfortunetly I tried it before propecia (which I wish I had started earlier). The only thing I ever thought from it, was that it makes my hair look better when I use it regularly. I had in fact pretty much stopped using, except sparingly, until roughly 4 weeks after my HT. I was a little frustrated with the continuing pink hue my scalp had. I started using it once/twice a week the last few weeks. Don't know if it was a factor, but the pink quickly faded. It also reminded me of how it does make my hair look better when I use it. But then again, my hair might look better if I slowly combed my hair backward three times for 15 min.

I seriously doubt anyone had 19 h/cm grow b/c of this comb. I am amazed it got FDA approval. At the same time, some folks respond well to Propecia (I did), some to Rogain (I hat that Sh#$#t), and maybe some to the lasercomb.

Toad

IMO, a double blind independent study is the only way to go. Half the people go in so many times a week and get treated with the real laser brush, the other half gets the non laser brush (without knowing of course) It's the only way to make sure. It's expensive but the manufacturers who trust their products invest in such studies, it was done for Rogaine, Propecia ....
When they don't do such studies it means to me that they do not want the public to see the results.

HK500,

I will have to give a big AMEN on the need for a double blind study. I use the lasercomb for cosmetic reasons but I do not believe that it causes me to have MORE hair. It makes it look better, but that is it. I have one, so I use it, but would much rather have $500+ that they cost new to spend on my next 100 grafts.

Toad