Cybernaut

Have never personally used it, but it case you've been taken in by all of the FDA hype, see http://www.hairrestorationnetwork.com/eve/showthread.php?t=154198?

Dr Feller Your old friends Lexington have posted again on Rassman's blog http://www.baldingblog.com/2008/05/02/reader-adds-to-the-lasercomb-fda-debate/ Do leave a response. It should make an interesting read!

Bill Do I take it from what you say that they actually called it an FDA "approval"? That would be interesting to know because it's further proof that they're abusing their clearance.

Somehow I just know that you're not being serious!

When did you receive this? Was it subsequent to my thread on the FDA clearance? I would like to see any response to this. How come you didn't publish it upon receipt as a new thread, in the same way that Dr Rassman has done on his blog? Did they instruct you not to?

I still find it strange that she's covering her face on the first photo. Makes me wonder whether it's even the same person.

Lexington has been to Dr. Rassman's blog to defend their position, as recently as March http://www.baldingblog.com/2008/03/24/response-from-lex...critical-statements/ http://www.baldingblog.com/2008/03/18/critical-of-the-l...ms-and-fdas-rulings/ And also back in 2006 http://www.baldingblog.com/2006/08/24/email-response-fr...f-hairmax-lasercomb/ Why not post a response to your old comrade Mr. Michaels!

Also see http://www.hairrestorationnetwork.com/eve/showthread.php?t=154198 to dispel the myth that the FDA Clearance of HairMax constitutes some kind of official approval.

Anyone who believes that the FDA Clearance of HairMax constitutes some kind of official approval, please see my thread on http://www.hairrestorationnetwork.com/eve/showthread.php?t=154198 It also includes links to Dr Rassman's blog where he disputes their hair counts on the before & after pictures, and one actually had less hair. There are comments from physicians and clinical investigators describing just how unusual Lexington's decision is to not make full details of the available to the public and for peer-review, questioning the motive behind this. There are also 2 very lengthy responses from Lexington.

I'm afraid these before & after photos do nothing except fill me with skepticism. Even if we accept that she's not covering her face to disguise the fact that they're different people, the hair styles are completely different, meaning that it is impossible to glean anything at all ... other than the fact that we're being presented with photos that prevent anyone from making a valid comparison.

More great stuff on Dr Rassman's website, criticizing Lexington's failure to make details of their clinical trials public or have them peer reviewed, as would normally happen in such circumstances. Critical of the LaserComb's Claims and FDA's Rulings "As a physician, I'd like to amplify on a previous blog, which emphasized that detailed data on the benefits of the LaserComb is not available and thus makes it difficult to evaluate its benefit beyond anecdotal experiences. In addition, the manufacturer makes claims likely to be criticized as unsupportable if similar claims were made for a drug and, to me, employs classic marketing techniques designed to give as little information as possible. When the manufacturers of the LaserComb report their claims in peer-reviewed, scientific journals where the data can be evaluated by the public, it will allow me to better evaluate the risk/benefit is. In addition, claims made by the manufacturer ("greater than 90% user satisfaction reported!") are the type of marketing statements that are impossible to evaluate without context." "As an experienced clinical investigator, it is misleading for Lexington to argue that they "had to prove to the FDA, under the same statistical scrutiny as both Propecia and Minoxidil, that the HairMax was effective in increasing ??Hair Counts' in men with Androgenetic Alopecia." ... One wonders why this data was not submitted for puyblication immediately upon completion of the study or at least submission of the regulatory filing (as is common practice by biopharmaceutical companies)." "There are a couple of things that I find odd about this study, for one, the study was completed in November of 2005, yet they didn't submit it to the FDA until September of 2006." Continuing the LaserComb Debate... "Great that the single pivotal study is being written up for publication. This should have taken 1 week and been done a long time ago. It is highly atypical that a device or drug is approved without the study being published (before approval) in a peer-reviewed, scientific journal. This is truly the only way for physicians and patients to understand the effectiveness and safety profile, and make an educated decision. It is so atypical not to publish such data that the absence creates skepticism, whether deserved or not." That last comment refers to Lexington's "promise" We are currently drafting a medical review of the study to be submitted to a peer-reviewed journal. We have every intention of publishing the study and making the full results available for public scrutiny. Well we all look forward to that. But even if they did this today, why it has taken them so long!

Have found some great stuff on Dr Rassman's website http://www.baldingblog.com/index.php?s=lasercomb Analyzing the Results of the HairMax Laser Comb Dr Rassman has performed an analysis of the before/after photos of the clinical trial patients. http://www.lasercomb.net/beforeafter.htm The first set are normal headshots. I struggled to see any real difference in many, and in some the head was tilted more forward in the after photo, an old trick to make the hairline appear more advanced. Dr R's observations are "I looked carefully at these, and there is a real question in my mind as to what I am seeing. A few of these pictures have longer hair that is possibly responsible for the changes that I can see. I wanted to get an enlarged version of the photos to see the details that would tell me what I was looking at, but they are not available on the site. The first before/after set in the group are a good example to start with. There is a suggestion that the scalp has coloring to it (Dermatch or something similar), but as I can't enlarge the photos, I can't try to determine what it might be. Could the difference be lighting or combing style? I don't know, honestly. Many of the photographs suggest styling differences. In no case was there any significant change in the hair coverage, though. Either the person had plenty of hair when they started or there was not enough hair when they finished treatment. " The second set are the clinical trial macro photos. Dr R's observations are "We analyzed two sets of the before/after high-powered magnification photos, which also includes the data that they based their research upon. The actual hair counts as they did them are well presented and can be seen by magnifying the circular areas of hair density assessments. Each hair grouping was identified, numbered, and the authors put the actual count on each follicular unit as they made the measurement. They did not separate or identify those hairs that were miniaturized. Because all of the information is present in the material presented on their website, it was easy for us to repeat their measurements and to ascertain if their numbers corresponded to an independent assessment. " He gives full counts on his website, and disagrees with the count claimed by the clinical trials on each of the before/after photos. Dr R concludes "Statistically, the percent difference between the before and after photos (according to my count) is insignificant. Therefore, in the first set of photos the LaserComb made no real difference. In the second sequential set of photos, I discovered that the after photo actually had less hair than the before photo" Whose count should we believe. Dr R claims his because "I am comfortable saying that I am one of the world's experts in hair densitometry. I can prove this as I am the inventor of this technology and hold the U.S. Patent on the instruments used by HairMax (or Lexington International) to demonstrate their findings (see: USPTO.gov). With that being said, I reviewed our findings and agree with our counts. I believe that HairMax's photos do not show any objective evidence of hair growth on the first two sets of data and that the numbers that they derived do not correspond to the assessments made by us. Lots of good hype if you're into it."

Anyone wishing to read this particular blog from Tony Pearce is too late. It has just been removed whereas all of his other posts still remain! Maybe he had threats of legal... But there's other good stuff on the link http://www.hairlossclinic.com.au/blog/. Have a read of Setting The Record Straight ... http://www.hairlossclinic.com.au/blog/2008/02/26/setting-the-record-straight/ It's a scream!

Hair expert Tony Pearce says Having previously been requested to become involved in a clinical trial for laser therapy FDA approval, I know how manipulated these ??clinical trials' can be. You pre-select your subjects in age, minimal hair thinning, total health check, supplement them with protein and nutrients until it comes out their ears ??“ and you're ready to go. ??98% success rate' can mean ONE additional hair has been counted within a one centimeter-square designated area of the subject's scalp ... In my opinion this is statistical crap that means nothing to the everyday consumer. He writes some good stuff on http://www.hairlossclinic.com.au/blog/

Thanks for your comments all. Would still love to hear from anyone who has been through the 510(k) process, or who knows about lasers and how they can possibly be effective in hair growth, or who knows anything about Lexington's trials.