Tune in this morning at 8am for an update on the causes of hair loss and baldness with hair loss expert, Dr. Alan J. Bauman 'live' in-studio on FOX29 Palm Beach WFLX TV. Along with health reporter, Dr. David Soria, Dr. Bauman will discuss the genetic link to hair loss in men and women and what can be done to slow, stop and reverse the process. Advances in diagnosis and testing, fda-approved medications, treatments and procedures mean that you don't have to live with hair loss--if you don't want to! For more info, tune in today at 8am or visit http://www.baumanmedical.com
According to their own press release...
April 14, 2011 09:00 AM Eastern Daylight Time
ARTAS System Receives FDA Clearance for Ground-Breaking Technology Treating Hair Loss
Restoration Robotics, Inc., a medical device company that pioneered the first robotic follicular unit harvesting system, today announced that it has received FDA 510K clearance for its revolutionary ARTAS System
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Restoration Robotics, Inc. a privately-held medical device company, today announced that its revolutionary technology, the ARTAS™ System, has received 510K clearance from the Food & Drug Administration (FDA) for harvesting hair follicles from the scalp in men diagnosed with androgenetic alopecia (male pattern hair loss) with black or brown straight hair. The ARTAS™ System was developed in close collaboration with several leading hair restoration physicians to enhance the quality of follicular unit harvesting for the benefit of physicians and their patients.
“Hair loss is a very real issue for millions of men in the United States. We’re pleased to offer a powerful new technology for patients who are interested in a safe new way to enhance their quality of life.”
“We are thrilled to receive FDA clearance, and look forward to rolling out the ARTAS™ System to leading hair restoration physicians,” said Jim McCollum, Chief Executive Officer, Restoration Robotics. “Hair loss is a very real issue for millions of men in the United States. We’re pleased to offer a powerful new technology for patients who are interested in a safe new way to enhance their quality of life.”
ARTAS™ is a physician-controlled, state-of-the-art, interactive, computer-assisted system that enables harvesting of hair follicles during hair restoration procedures. It combines several features including an image-guided robotic arm, special imaging technologies, small dermal punches, and a computer interface. The ARTAS™ System is capable of identifying and harvesting individual follicular units to implement the follicular unit extraction (FUE) technique.
“Many patients are seeking less invasive alternatives to the current hair restoration techniques,” said Miguel Canales, MD, Medical Director, Restoration Robotics. “There is growing interest in FUE because of its many patient benefits, such as less discomfort and a quicker return to normal activities. The ARTAS™ System solves many of the technical challenges experienced by physicians currently attempting the FUE procedure which gives physicians and patients an exciting new choice.”
Hair restoration is performed as an office-based procedure. Implanted hairs develop their own blood supply, begin to grow and new hairs are seen a few months after the procedure. New hair continues to grow over the course of a full year, making the change in the patient’s appearance gradually noticeable to others.
“I believe the ARTAS™ system will make hair restoration more attractive to a broader group of patients,” said James Harris, MD, of the Hair Sciences Center in Denver, CO. “In my practice, I have seen a significant increase in patients asking for FUE because of its minimally invasive approach. They really liked the rapid healing and lack of a linear scar, which makes this procedure different from the strip method.”
Hair Loss By The Numbers
According to the International Society of Hair Restoration Surgery (ISHRS)1, at least 35 million men in the United States are affected by male pattern baldness or androgenetic alopecia. By age 50, approximately 50% of men will experience some degree of appreciable hair loss. Approximately one in four men suffer from male pattern baldness (MPB), which has psychological, professional and social consequences for these patients, such as:
• 68% of men feel helpless about their hair loss
• 73% of balding men feel they are less attractive than they were when they had hair2
• 77% of balding men would feel very or somewhat concerned if they were in their 20s, just starting their career and experiencing hair loss3
While prescription remedies, such as Propecia® and Rogaine®, offer some benefits to existing hair, hair restoration moves healthy, functioning follicles to the areas of the patient’s scalp most impacted by baldness for more dramatic results. Hair restoration is a popular cosmetic procedure, with an estimated number of procedures exceeding 100,000 in the U.S. in 2009. Hair restoration is the only permanent solution for hair loss and can result in a natural, undetectable outcome.
About Restoration Robotics
Restoration Robotics, Inc., a privately held medical device company, is dedicated to revolutionizing the field of hair transplantation by developing and commercializing its state-of-the-art image-guided ARTAS™ System. This interactive, computer assisted system uses image-guided robotics to enhance the quality of hair follicle harvesting for the benefit of physicians and their patients. To learn more about Restoration Robotics and its unique technology, visit www.restorationrobotics.com. To learn more about hair loss and restoration, please visit the International Society of Hair Restoration Surgeons (ISHRS) at www.ishrs.org.
1 International Society of Hair Restoration Surgeons (ISHRS) website. http://www.ishrs.org/hair-loss/hair-loss-male.htm. Accessed April 11, 2011. 2 Journal of the American Academy of Dermatology 3 ISHRS 2006 Consumer Hair Loss Survey
Pascale Communications, LLC Rosemary Valenta, 917-701-3246 firstname.lastname@example.org
It will be interesting to see if patients want their hair transplant performed by a Robot... --Dr. Bauman.
ARTAS is based on the FUE technique, although most of the press coverage compares it to the traditional linear harvesting. Basically, it's an FUE Harvesting Robot. Still need an artistic person (surgeon) to design the hairline and make the incisions where the hair follicles are going to be implanted and a team for implanting them (for now)... although they're working on that part too. What most of the press has failed to realize is that the FUE alternative to linear/strip harvesting as a no-scalpel/no-stitch/no-linear scar option has been available for years already. It's just that very few doctors specialize in the FUE technique and have mastered it. NeoGraft is actually the missing link between linear and robotic hair transplants. If the robot uses NeoGraft harvesting techniques... wow! The robot won't hold your hand during the surgery, like my surgical technician do though! LOL --Dr. B. 4/27/2011
Colleagues and Friends,
There is no question that this recent report appears shockingly erroneous to anyone who regularly prescribes propecia. I agree that Merck should prepare some formal response to this report, sharing what they know. However, it is also our responsibility as Hair Restoration Physicians to individually communicate what we know from our clinical experience to our patients and the general public.
Having prescribed finasteride to thousands of patients dating back prior to the fda approval, I completely agree with those who regard this report of the incidence of persistent side effects as "shocking." Over the past 15 years, I've prescribed Propecia to thousands of patients as a stand-alone therapy and also in combination with other medications like minoxidil, laser therapy and hair transplantation. Less than two-percent have had sexual side effects, which is in accordance with the original Propecia studies. In the cases of side-effects, discontinuing the medication resolved the side-effects in approximately one week.
Again, in over 15 years as a full-time Hair Restoration Physician, I haven't seen persistent side effects from propecia... Not a single case! I know many of my colleagues have prescribed propecia in even higher volumes to your patients. From my communications with a good number of them, I know they have NOT seen persistent side effects either.
My concerns with this highly flawed retrospective 'study' that made the rounds last month include the fact that they did not physically meet with many or most of the patients, they did not perform lab tests, they relied on these patients' own recall prior to treatment and they did not take into account the well-established psychological impact of continued hair loss.
Not to mention that the majority of the so-called 'patients' in this study were recruited through anonymous internet message boards and the interviews were conducted by phone or skype... adding new dimension to the terms "selection bias" and "interview bias."
Personally, I'm compiling my finasteride side-effect data for publication... if anyone else would like to collaborate, shoot me an email.
FYI, A link to the original journal article was posted here last month: http://www.linkedin.com/groupItem?view=&gid=3122721&type=member&item=48297823
and comments are open for ISHRS Members.
Alan J. Bauman, M.D.
Bauman Medical Group, P.A.
Follow me @DrAlanBauman
Certified, American Board of Hair Restoration Surgery
19th Annual World Congress on Anti-Aging and Aesthetic Medicine / American Academy of Anti-Aging
Orlando FL April 7-9 2011
Friday April 8, Morning Session 7am Crystal Ballroom H
7:00AM - Photobiomodulation in Anti-Aging: Harnessing the Power of Low Level Laser Therapy (LLLT) for Healing and Regeneration - Michael Hamblin, PhD [Harvard/MIT/Wellman Center for Photomedicine]
7:25AM - The Use of Low Level Laser Therapy in the Medical Management of Androgenetic Alopecia (Hereditary Hair Loss) - Alan J Bauman, MD [Bauman Medical Group]