Novel system to treat hair loss receives CE Mark approval

Restoration Robotics, Inc., a privately-held medical device company, today announced its revolutionary ARTAS^® System received CE Mark Certificate (Conformité Européenne) to market in the European Union. The ARTAS System is the first physician controlled, computer assisted technology that allows harvesting individual follicular units directly from the scalp. This minimally invasive solution utilizes sophisticated digital mapping and precision robotics to deliver permanent and natural looking results.

“We have seen strong interest in bringing the ARTAS System to Europe, and we can now move forward with our expansion plans.”

"Receiving the CE Mark for Europe is a major milestone that indicates our FDA-cleared solution also meets the quality and safety standards required by the international healthcare marketplace," said Jim McCollum, President and Chief Executive Officer, Restoration Robotics, Inc. "We have seen strong interest in bringing the ARTAS System to Europe, and we can now move forward with our expansion plans."

Hair Loss By The Numbers

Hair loss affects approximately 50% of all men and over 25% of all women worldwide. Over 35 million men are affected by male pattern baldness (androgenetic alopecia) in the United States alone. Approximately two-thirds of American men will experience appreciable hair loss by age 35; by age 50, 85% will see significant loss in hair thickness. Genetic hair loss, which typically begins between late adolescence and before or during middle age, is largely untreatable outside of surgery.