Posts Tagged ‘HairMax LaserCombs’
In June, Lexington Intl, LLC (“Lexington”), a Hair Foundation partner, received FDA Clearance to market its HairMax LaserComb® Lux 9 for the treatment of androgenetic alopecia (female pattern hair loss) and the promotion of hair growth.
On Aug. 4, CBS Philadelphia ran a story about this HairMax LaserComb. It featured a 53-year-old woman with hereditary hair loss and included Hair Foundation’s Vice Chair, Dr. Ken Washenik, as a hair loss medical expert.
Here’s a link to the video and some background on the story.
In an additional story about the LaserComb Lux 9, here’s one from Univision.
Want to learn more about the HairMax LaserComb Lux 9 for women? Check out this June 10 Hair Foundation blog post.
In this video from New York’s PIX11 , Dr. Ken Washenik, Hair Foundation’s vice chairman, discusses causes of hair loss and offers treatment suggestions. He mentions Hair Foundation’s partner, Lexington Intl, which recently received FDA clearance for its HairMax Laser Comb.
To learn more about women and hair loss as well as treatments, please visit the Hair Foundation’s new physician video series.
On June 6, Lexington Intl, LLC (“Lexington”), a Hair Foundation partner, announced in a press release that it received FDA Clearance to market its HairMax LaserComb® Lux 9 for the treatment of androgenetic alopecia (female pattern hair loss) and the promotion of hair growth.
It is the first time in over twenty years that a new home-use treatment for female hair loss has been available, according to Lexington. The HairMax Lux 9 has indicated it treats androgenetic alopecia (female pattern hair loss), and promotes hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I-IV.
The HairMax was the subject of a double-blind, device-controlled clinical study of females which showed that 100% of subjects on the HairMax LaserComb Lux 9 experienced hair growth at six months. In addition, over the same time period, subjects using the HairMax experienced a mean increase in hair count of 20.5 hairs per centimeter squared, which is considered medically and scientifically significant.
Most importantly, over 79% of the subjects using the HairMax Lux 9 reported improvement in thickness and fullness of their hair. No serious side effects occurred and there were no other side effects caused by the HairMax Lux 9 in the study.
The results of this study of efficacy and safety were a key part of the FDA 510(k) submission, and the subsequent decision of the Agency to grant marketing clearance for the treatment of female AGA.
In Lexington’s press release, Dr. Matt Leavitt, Chairman and President, the Hair Foundation, and Lexington Medical advisor, made the following comment regarding the news:
“Hair loss amongst women is a growing concern”, says Dr. Matt Leavitt, Medical Advisor to Lexington. “In the past, women had only one FDA Approved drug ingredient to treat their hair loss. Now they have a clinically proven viable alternative. Upon review of Lexington’s extensive clinical studies on female hair loss, the FDA has granted Clearance to this exciting new treatment option. I believe the HairMax will be able to offer help to the millions of women suffering from hair loss.”
Here is a copy of the FDA clearance letter.
To learn more about female hair loss and treatments, please see the Hair Foundation’s new video series.
Lexington International, LLC recently announced that it successfully completed two clinical studies of its HairMax LaserComb and its results proved the efficacy and safety of three new devices for the treatment of androgenetic alopecia (hereditary hair loss).
Their studies showed that 95 percent of participants using the HairMax LaserComb experienced hair growth and that average increases in hair count for participants in the HairMax LaserComb group was 20.4 hairs per centimeter squared; this is considered medically and scientifically significant.
The company also disclosed that none of the studies’ participants suffered from any serious side effects. From the clinical results, according to the press release, “the FDA Granted Class II Clearance 510(k) K103368 of these medical devices for sale in the USA for the ‘Treatment of Hair Loss and Promotion of Hair Growth’ in males.” This validates that the HairMax is a non-drug option for the treatment of herditary hair loss in males.
The Hair Foundation’s Dr. Zoe Draelos was involved in the studies and the HairMax LaserComb is a partner of the Hair Foundation.
These clinical trials are posted on www.clinicaltrials.gov and the submission of the data was a major component of the FDA filing; it was a key factor in the agency’s decision to clear the HairMax LaserComb.
In response to the new devices, Lexington said the following:
“The new devices, which are designed for mass market appeal, will greatly expand the treatment options for people suffering from thinning hair,” said Randy Veliky, Lexington COO. “The combination of our patented technology, state of the art design and the proven efficacy will better satisfy the needs of the millions of men suffering from this condition”
To learn more about the LaserCombs and the impact of the FDA approval, here’s a link to the press release.