AcuFocus Inc. is banking on a recent cash infusion and a tiny device implanted in the eye to spur big growth.
The Irvine-based startup is working off a $21 million round of fresh venture funding it landed this month. Several of its existing investors participated in the round, including Versant Venture Management LLC, a Menlo Park-based venture capital firm with an office in Newport Beach.
AcuFocus has raised a total of $86 million—it got $65 million three years ago from Versant and six other investors.
The privately held company, which doesn’t disclose financials, has sales in Japan, Europe and Latin America.
Now it is seeking Food and Drug Administration approval to go to market in the U.S.
AcuFocus has had a veteran of Orange County’s medical device sector—Chief Executive James Mazzo—as a key to the effort for the past year or so. Mazzo is also an operating partner at Versant.
AcuFocus is setting the stage for “once we get U.S. approval, which we’re hoping for the first part of next year,” Mazzo said last week before flying to London for a meeting of the European Society of Cataract and Refractive Surgery.
AcuFocus makes intraocular lenses that are implanted in the eye to treat presbyopia, or age-related loss of near vision. Its lead device is known as the Kamra inlay and is implanted in a patient’s cornea to correct presbyopia. The company competes with Santa Ana-based Abbott Medical Optics and Valeant Pharmaceuticals International Inc. in Canada.
Mazzo said AcuFocus will use a portion of the latest round of financing to build up its domestic commercial effort. The company recently named Darin Dixon, who worked with Mazzo at Abbott Medical, as its director of commercialization for the Americas.
Recruiting
Dixon “is in the midst right now of recruiting a sales force, as well as some clinical staff to help execute” the process of getting Kamra on the market here, Mazzo said.
AcuFocus will start recruiting in the fourth quarter and should have its sales and clinical staffs ready in the U.S. by April, when the company anticipates being able to start selling Kamra, according to Mazzo.
AcuFocus has about 70 workers, most in OC (see Medical Device Makers’ list, page 24).
The recently raised funds allow us “to continue to execute outside the United States, where we’re approved in most of the major countries,” Mazzo said.
Mazzo, who has been with the company for about a year, said he has noticed a shift in Kamra’s main market.
“I would say that when we came on board, Japan was actually our largest market, but now, since then, we have more inlays implanted [in other countries], and I would say that’s predominantly in major European markets,” he said.
It uses a mix of distributors and senior managers tied directly to the company to distribute devices outside the U.S.
R&D
AcuFocus is also planning to “accelerate some key R&D projects” with the money, according to Mazzo.
“We’re very thrilled because we’re in the middle of the development of a new presbyopic-correcting intraocular lens that we’re going to be planning to introduce in Europe,” he said. That lens, IC-8, will contain the Kamra technology, he added.
The IC-8 small aperture intraocular lens received European regulatory approval late last week.
Mazzo called IC-8 “transformational” for AcuFocus and said it gives the company a product for patients 60 years old or older. Kamra is mainly for people from the age of 40 to 60; many people begin to develop presbyopia in their 40s.
AcuFocus aims to remain independent for now, although “we do anticipate that down the road because this is an extremely interesting first-of-its-kind, small aperture inlay and IOL, and heavily patent-protected product, I’m sure we’re going to be receiving a lot of attention,” Mazzo said.
AcuFocus wants “obviously to continue to build this innovation, and now, especially with the intraocular lens, we believe we know it and we can execute it best,” Mazzo said, although he added that the company has several products that fit “with larger firms that can take it to the next level.”
AcuFocus also produces the AcuTarget, which is an instrument that doctors use in diagnostics and surgical planning.
Fixture
Mazzo is a fixture in Orange County’s device industry. He spent 22 years with Allergan Inc. in Irvine, where he led the 2002 spinoff of its medical device division into Advanced Medical.
Mazzo was Advanced Medical’s chairman and chief executive. He sold it in 2009 to Chicago-based Abbott Laboratories for $2.8 billion.
Mazzo also is executive chairman of Cumberland, R.I.-based Neurotech Pharmaceuticals Inc., another Versant portfolio company. Neurotech is developing a genetically engineered implant for delivering drugs that treat retinal diseases such as wet and dry age-related macular degeneration.
