Ophthalmic company OptiMedica recently received FDA clearance for its Catalys precision laser system for capsulotomy and lens fragmentation. Catalys, which OptiMedica regards as an exciting breakthrough, combines a femtosecond laser, integrated optical coherence tomography imaging and the company's pattern scanning technology in an easy-to-use system that allows cataract surgeons to perform image-guided pre-operative laser lens conditioning.
Since its founding in 2004, Santa Clara, CA-based OptiMedica has been working on a reproducible, noninvasive technique to replace manual steps in cataract surgery with femtosecond laser technology. Roughly 19 million people worldwide undergo cataract surgery each year, and OptiMedica's offering represents a "tectonic shift" for cataract procedures, CEO Mark Forchette told FierceMedicalDevices.
Currently in cataract surgery, the physician makes a small corneal incision to allow manual formation of an opening in the anterior lens capsule. This is followed by the ultrasound-assisted emulsification and removal of the opaque lens and insertion of a synthetic intraocular lens. The procedure is regarded as safe, but complications are possible because of the manual steps involved. And that is where OptiMedica steps in, looking to replace the nonrepeatable, manual steps and provide higher levels of accuracy, Forchette explained.
According to clinical study results published in the Journal of Cataract & Refractive Surgery, Catalys produced capsulotomies that are within 30 microns of intended size and 80 microns of intended center with near perfect circularity. This level of precision has really impressed those doctors who have seen it in action, Forchette said.
So what's next for the company? Forchette told FMD that OptiMedica is "very focused" on satisfying market demand. Catalys has CE Mark clearance in Europe, where the company has seen incredible demand. Meanwhile, the company is seeing sites gearing up in Asia, particularly in Japan.
The company has identified and is continuing to look for ex-U.S. distributors that can satisfy expectations. It is using direct distribution in the U.S.
OptiMedica is viewing its technology as a platform for the future. It has an exciting R&D pipeline, although Forchette couldn't disclose anything further at this time.
- see the OptiMedica release