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
April 2011
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.
“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.”
The ARTAS™ System is capable of identifying and
harvesting individual follicular units to implement the follicular
unit extraction (FUE) technique.
The Benefits
“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
Source
.gif)
