Glaukos yesterday registered for an initial public offering worth as much as $86.2 million.
The iStent made by Laguna Hills, Calif.-based Glaukos was the 1st micro-invasive glaucoma surgery device to hit the U.S. market. It’s a tiny titanium stent designed to alleviate the intra-ocular pressure caused by glaucoma.
Pre-market approval from the FDA for the iStent came in June 2012, clearing the device for use during cataract surgeries. Glaukos, which said it plans to trade on the New York Stock Exchange under the "GKOS" symbol, reported slightly narrower 2014 losses of -$14.1 million on sales growth of 118.2% to $45.6 million, compared with 2013.
The company said it has 3 main devices in its pipeline and 18 clinical trials under way to evaluate their safety and effectiveness. The iStent Inject consists of a pair of pre-loaded stents and has 2 versions, Glaukos said, with the 2nd capable of making a self-sealing corneal incision. That opens the potential for an outpatient procedure, the company said. Both versions are in investigational device exemption studies, with the 1st version’s trial examining treatment along with cataract surgery and the 2nd as a stand-alone treatment, the company said.
Glaukos said the iStent Supra is designed for an alternative drainage space "where we estimate 20% of aqueous humor outflow occurs. The iStent Supra is also in a U.S. pivotal IDE trial.
The 3rd device, iDose, is a drug-device combination designed to deliver a sustained dose of prostaglandin, the company said.
Glaukos sells via direct sales forces in the U.S. and Germany and via distribution in Europe, Asia-Pacific, Canada and "other targeted international geographies," it said. The U.S. sales force has 52 reps, according to the IPO filing.