Hair Loss: A Breakthrough in Hair Growth
The HairMax LaserComb® laser hair treatment is a breakthrough in hair growth technology. FDA Cleared*, Clinically Proven and Doctor Recommended, the HairMax LaserComb® hair loss treatment makes baldness and thinning hair an option rather than an unavoidable reality.
The HairMax LaserComb® FDA Approved Non Drug Option
NetWideSales recommend The HairMax LaserComb®, FDA Approved for both men and women!
The HairMax LaserComb® is the First and Only FDA Cleared home-use medical device that utilizes laser phototherapy to effectively promote hair growth and treat hair loss.* At last, both men and women can combat hair loss with a scientifically backed, clinically proven treatment in the privacy of their own homes.
The HairMax LaserComb® represents over two decades of research and development culminating in a low level laser therapy medical device that is safe, effective and easy to use. Seven double blind, device controlled, clinical studies with 460 subjects have been conducted at top medical research centers such as the Cleveland Clinic, the University of Miami and the University of Minnesota. Subjects used the HairMax LaserComb® for an average of 8-15 minutes, 3 times per week for 26 weeks.
*The HairMax Advanced 7, Premium, Lux 9, and the Professional 12 models are indicated to treat Androgenetic Alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V and in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and who both have Fitzpatrick Skin Types I to IV.
FDA approved HairMax LaserComb®
FDA approved HairMax LaserComb®
In June 2011, HairMax received FDA Clearance for the treatment of hair loss in females with androgenetic alopecia (pattern hair loss*).
In January 2007, the HairMax LaserComb® became the first and only medical laser device for home use to receive FDA Clearance for the treatment of hair loss in males with androgenetic alopecia (pattern baldness).*
The HairMax LaserComb® a Unique Non-Drug Hairloss Treatment Option
The FDA clearance of the HairMax LaserComb® has significant implications for the Hair Loss Treatment industry. To date, there are only two other FDA accredited hair loss treatments available, 5%Minoxidil and Propecia® for males and 2% minoxidil for females. With the addition of the HairMax LaserComb, there is now an effective, non-drug, non-topical treatment available. HairMax, has an excellent safety record, with no serious side effects. It is a one time purchase, with no ongoing costs.
Continue reading: HairMax LaserComb ®Studies
Note that while the HairMax works well as a stand-alone treatment, it is possible to use it in conjunction with the other approved therapies of your choosing. We know that fighting hair loss is an uphill battle and the FDA clearance to market of the HairMax* now makes you one step closer to winning your battle with hair loss.
HairMax Hair Loss Treatment FDA Clearance Process
In 2010, Lexington Int’l completed its six-month, multi-center device controlled clinical trials for the treatment of (androgenetic alopecia)female pattern hair loss and submitted data to the FDA. The data from the trial indicated that 100% of participants, all 25-60, experienced hair growth. Further, subject assessment of thickness and fullness of hair was statistically significant for the HairMax over the control device. No serious side effects were reported.
In June 2011 the FDA granted marketing Clearance for the HairMax for the treatment of androgenetic alopecia (female pattern hair loss)* based in part on the results of the 2010 clinical studies.
In August 2011, the FDA granted marketing Clearance for the HairMax Dual 12 device and for 3 new HairMax models, the HairMax Professional 12, HairMax Lux 9 and HairMax Advanced 7.
After years of extensive research and randomized clinical studies, Lexington International submitted the results of its initial six-month, multi-center placebo controlled clinical trials to the FDA. The data from the trials indicated that 93% of the participants had a medically significant increase in hair growth. No serious side effects were reported. Based on part of the results of this study, the FDA granted initial marketing for the treatment of androgenetic alopecia, (pattern hair loss)* in males.
All of the clinical trials conducted since 2006 have provided conclusive evidence that the HairMax is consistently effective and safe for the treatment of male and female pattern hair loss*. The HairMax is a viable treatment option for those wishing not to use drugs and/or topicals.
The results of the key clinical study in 2006 which led to the original FDA clearance was published in the May 2009 Issue of Clinical Drug Investigation. The article entitled, HairMax LaserComb Phototherapy Device in the Treatment of Male Androgenetic Alopecia, is indexed as Clin Drug Invest 2009: 29 (5): 283-292 in most of the biomedical databases such as MEDLINE, EMBASE/Excerpta Medica, etc. The studies also showed that there were no serious adverse effects in any of the trial participants.
During these six month studies, subjects treated their hair once per day, three times a week. The number of hairs in the target area were counted at the beginning of the studies and then again at 16 weeks and 26 weeks. 93% of clinical study participants experienced significant hair growth with 149 additional hairs per square inch, average increase in hair count.
Continue reading: HairMax LaserComb ®Studies
