News Release

ARTAS® System Receive FDA Clearance

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, CA – April 14, 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

"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.

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
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 .

1International Society of Hair Restoration Surgeons (ISHRS) website. http://www.ishrs.org/hair-loss/hairloss-male.htm . Accessed April 11, 2011.
2Journal of the American Academy of Dermatology
3ISHRS 2006 Consumer Hair Loss Survey

Rosemary Valenta
Pascale Communications, LLC

Print Page
E-mail Page
E-mail Alerts
Contact Us
Financial Tearsheet