|Treating acne with Sebacia Gold Microparticles--Courtesy of Sebacia|
Georgia-based startup Sebacia hopes to gain FDA approval for the first physician office treatment to offer acne patients relief. It has raised $22 million, which includes a $12 million Series C round and a $10 million credit facility, to complete its U.S. pivotal trial, submit to the FDA and even start its U.S. launch. Some of the cash will also go to supporting European marketing, where the company already has a CE mark.
Sebacia has a topical treatment that includes microparticles made of gold and silica. This is massaged into the pores and sebaceous glands and then heated by dermatologists using a hair removal laser that is already commonly in use in their offices. The laser pulse creates a photothermic, heating effect in the sebaceous glands that is intended to reduce their activity and the subsequent inflammatory lesions that result in acne.
"We are grateful to our returning investors for their continued support as we complete our U.S. pivotal clinical trial and FDA application and prepare for U.S. and European commercial launches of Sebacia Treatment, an innovative dermatology product that is designed to significantly improve acne treatment," said Sebacia CEO Anthony Lando in a statement.
"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," he added.
The Sebacia Gold Microparticles are in a 300-patient, ongoing randomized pivotal trial with final primary endpoint data completion slated for July. The trial is of moderate to severe acne vulgaris patients aged 15 to 45 with roughly 25 to 75 facial inflammatory lesions.
It has three arms: three Sebacia/laser treatments over two weeks; the non-active vehicle suspension used with the laser; and three Sebacia treatment over two weeks without laser. The primary endpoints represent mean percent change in inflammatory lesion count from baseline to week 12 and number of adverse events during that period. In May, the company reported positive study results.
"Our clinical data so far has shown that the Sebacia Treatment can deliver a robust and significant reduction in acne, which we believe will have tremendous benefit to the many who struggle for years with the condition," said Lando. "The newest round of financing will also support commercialization as we recruit talent and bring multiple manufacturing options online."
The startup raised the equity portion from existing investors Accuitive Medical Ventures, Domain Associates, Versant Ventures, and Partners Innovation Fund, while the credit facility is from Square 1 Bank. Sebacia also appointed Pedro Medrano into the new role of VP of engineering and program management. He was previously director of the project management office for Royal Philips' ($PHG) nuclear medicine and imaging business.
- here is the release