IntraLase
IntraLase began as a technology transfer licensed startup company from the University of Michigan, Ann Arbor in the mid-1990's. IntraLase was led by University of Michigan ophthalmologist Ronald Kurtz and physicist Tibor Juhasz of the University of California, Irvine. The IntraLase and UM teams developed a novel diode-pumped 1um wavelength laser engine that was sufficiently compact and robust to enable practical femtosecond laser medical applications.
First commercial prototype of IntraLase femtosecond corneal refractive laser in the laboratory at the Kellogg Eye Center (University of Michigan, Ann Arbor), circa 1999. Gain Consulting managed performance testing of the IntraLase prototype to support the successful regulatory submission for the company's first several 510[k]'s.
The laser engine was co-developed at UM's CUOS and at IntraLase's original Orange County, CA location. Combined with a modified scanning laser delivery system that itself was descended from the Intelligent Surgical Lasers picosecond system for corneal vision correction surgery. The result was the world's first femtosecond laser for performing corneal refractive surgery. The company began conducting international clinical evaluations with a "breadboard" system. Ron Kurtz tells the story of how IntraLase began here.
While those first-in-human clinical evaluations were underway, the company's first commercial prototype was shipped to the University of Michigan, Kellogg to perform pre-clinical animal studies in preparation for commercialization. Greg Spooner of Gain Consulting assisted the IntraLase team in that effort, receiving the prototype, arranging for the laboratory "shake down" of the prototype, preparing, debugging, qualifying and operating the instrument for animal studies and performance data in support of the first (and successful) regulatory submission for the company.
Microscope image of a glass slide with a femtosecond laser scan pattern scribed inside (mag ~100X). Gain personnel assisted in evaluating, characterizing and troubleshooting IntraLase's first commercial femtosecond laser prototype.
Gain provided technical and scientific analyses in support of the first successful FDA 510[k] for a femtosecond laser medical application and helped write, land and manage several SBIR Phase I and SBIR Phase II grants that fueled the initial development of the IntraLase prototypes.
From those early days, IntraLase went on to a successful IPO, followed by an acquisition by Advanced Medical Optics (a division of Abbott Labs), and has now completed over 5 million femtosecond procedures., including the branded iLASIK procedure and the generally known IntraLasik procedures. Gain Consulting is proud to have participated at key early moments in the development of a large and successful new sector of the medical device industry, with a number of corneal refractive and cataract applications and many ophthalmic device manufacturers.