With CE Mark for Glaucoma Microsensor in Pocket, Implandata Looks to US
Now that the Implandata Ophthalmic Products has received approval to commercialize its implantable glaucoma-monitoring device in the European Union, it’s setting its sights on lining up funding to launch US trials in 2018, company managing director Max Ostermeier tells OIS Weekly in an exclusive podcast.
It’s no coincidence that the company’s initials – IOP – also are the abbreviation for intraocular pressure, which the firm’s implantable EYEMATE system monitors continually throughout the day. The EYEMATE system includes a permanent implantable microsensor that is placed in front of the artificial intraocular lens, posterior to the iris during cataract surgery.
The microsensor can measure the patient’s intraocular pressure at any chosen frequency, either continuously over the course of 24 hours or on demand at defined time points. Patients can perform measurement by themselves and under normal conditions. Collected data will be sent via a mobile phone module to the physician’s device, allowing remote monitoring and management of the patient’s disease and alerting of the physician to uncontrolled IOP.
For its US rollout, Implandata has already brought on renowned glaucoma specialist Robert N. Weinreb, MD, director of the Shiley Eye Institute at the University of California, San Diego, as scientific adviser. “Twenty-four-hour monitoring of intraocular pressure with an implantable sensor is transformative for management of glaucoma patients as it provides a plethora of data and deeper insight for enhanced management of their disease,” Dr. Weinreb says.
US trials also depend on financing and licensing, Ostermeier notes.
Implandata is also working on lining up Series C financing of up to 12 million Euros, part of which will fund activities in the US. The company is talking with strategic investors as part of its syndicate. “As small as we are right now, it would be really important for us to have a strategic partner to work within the US market,” he adds.
“Ideally we will close our funding round right at the summer of our funding rounds, and then we can start things in the US by end of the year and hopefully get our first study started in the US sometime in the second half of next year,” Ostermeier says.
In 2014, the company incorporated Implandata Ophthalmic Products Inc. in Delaware to gain a US foothold.
The current EYEMATE system version is CE marked for use in patients with primary open angle glaucoma. Implandata is also working on other versions to be used in other glaucoma conditions. The design team is also working on further miniaturization of the implant itself. “We want to get it very small so at the end you simply inject it into the anterior chamber or the posterior chamber into the sclera,” Ostermeier explains.
For the European market, Ostermeier says the company will focus on Germany, Austria, and Switzerland for commercial launch in the next 12 months.