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.

“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.”

“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 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