Sebacia, which already markets its gold-and-silica microparticle acne treatment in Europe, raised $36 million to finish a U.S. pivotal trial ahead of an FDA submission expected in 2018. The new funding includes a $20 million series D and a $16 million debt facility.
The microparticle treatment aims to treat moderate to severe acne. A topical suspension containing the microparticles is massaged into the skin’s pores and sebaceous glands and then heated with a hand-held laser device. The heat causes the treatment to reduce the glands’ activity and decrease the inflammatory lesions that cause acne, the company said.
Such lasers are common in dermatologists’ offices, where they are used to remove hair or pigmented lesions, such as sunspots. The Sebacia treatment is designed to be an in-office procedure that could be an alternative to current treatments, such as oral antibiotics, the company said.
"If approved, the Sebacia treatment would be the first procedure performed by a dermatologist that is intended to provide relief from acne without use of daily pills, lotions and creams," said Sebacia CEO Anthony Lando in 2015, when the Duluth, Georgia-based company picked up $22 million to bankroll its pivotal trial and to support marketing efforts in Europe.
The company expects to report pivotal data by mid-2018 and anticipates an FDA response to its submission by the end of 2018, according to a statement. Sebacia is also recruiting for a pair of European trials, to take place in Denmark, Switzerland and Poland. The first will study the use of microparticles in patients with facial inflammatory acne, while the second is a multiple-arm study evaluating the safety and efficacy of the microparticle-and-laser system in patients with acne.
"At this pivotal time, we are grateful for the continued support of our top-tier venture capital syndicate and energized by the addition of Salem Partners and other new investors," Lando said in the statement. "From intellectual property to extensive clinical experience and a defined clinical path to approval, we believe we have all the pieces to bring Sebacia's breakthrough treatment for acne to market in Europe and the United States."
Existing backers Versant Ventures, Domain Associates, Accuitive Medical Ventures and Partners Healthcare Innovation Fund led the series D round, while Sebacia closed the debt facility with Hercules Capital.