IntraLase is based on the concept of using low-energy femtosecond laser pulses to create precise resection planes and focal vaporizations inside the cornea (and other transparent structures of the eye), without damaging overlying or adjacent tissue. This concept had occurred to several researchers in the early 1990s, including myself in 1993, after I examined a researcher who had suffered an accidental retinal injury from a laboratory femtosecond laser. At the time, I was a resident at the University of Michigan and was looking for an interesting case for Grand Rounds. I began learning about femtosecond laser technology, and subsequently began working with a group at the University of Michigan called the Center for Ultrafast Optical Science, led by Gerard Mourou, PhD, and funded by the National Science Foundation. This group was just beginning to look at material processing applications with the femtosecond laser, and I was able to collaborate with them using various tissues as target materials.
Interestingly, my future cofounder at IntraLase, Tibor Juhasz, PhD (a laser physicist with a long history in short- pulse laser-tissue interactions), was in his fifth year of conducting similar work at the University of California at Irvine. We met at a conference in 1994, and soon began working together. In our initial series of experiments, we discovered that the femtosecond laser had a number of unique properties that allowed for very precise material processing. These observations led to a successful patent application from the University of Michigan.
TESTING AND MARKETABILITY
The cornea was a particularly attractive experimental target because of its transparency, which allowed us to focus the laser inside the tissue bulk and monitor the effects optically. At that time, refractive surgery was growing steadily, and the potential clinical and commercial opportunities for laser refractive technology were obvious.
The idea for a laser microkeratome had originally been developed several years earlier using the picosecond laser. Dr. Juhasz, Vincenzo Marchi, MD (Rome, Italy), Arturo Chayet, MD (Tijuana, Mexico), and Mark Speaker, MD (New York, NY), were all involved in this research. However, the larger energies per pulse required for the picosecond laser produced much poorer-quality tissue resections for flaps. Our proof-of-concept studies of femtosecond laser flaps performed in animal eyes in 1996 and 1997 demonstrated this as one of the most promising potential surgical applications for this technology. These studies were conducted with Christopher Hovarth, PhD, a physicist from the University of Heidelberg who, with Dr. Juhasz, designed both the laboratory and commercial versions of our laser.
PURSUING THEIR OWN STRATEGY
One of the key factors that determines if an idea or concept can be commercialized is the potential market opportunity for the product. For us, the popularization of LASIK made it feasible to raise money for developing our femtosecond laser from a laboratory experiment into a clinical tool. With IntraLase, we were also able to combine key patents from different sources under one umbrella, again justifying the large capital investment required for development. Whether an existing company or a new venture undertakes a project, nobody wants to spend a lot of money on a product that a competitor can copy easily. Our decision to begin our own company (rather than license the idea to another company) was also based on our belief that the femtosecond laser was a platform surgical technology, with a number of potential products.
TURNING A CONCEPT INTO A COMPANY
In 1997, we made a series of presentations to venture capital firms to request funding to develop the technology commercially. Ultimately, we settled on a Michigan-based company, Enterprise Development Fund (and one of its general partners, Tom Porter, MBA), because of that firm's experience with early-stage projects and their willingness to assist us with hands-on management. Of course, beginning a business with venture funding always involves negotiations regarding the percentage of the company that investors will own. However, their ownership percentage turns out to be much less important than how much value you can create with the money and time you are given. A critical concept to understand and believe is that it is much better to own a small percentage of a successful company than a large percentage of a failure. Since its inception, IntraLase has benefited greatly from its quality investors. (In addition to Enterprise Development Fund, our current investor group includes Brentwood Venture Capital, InterWest Partners, Domain Partners, Versant Ventures, Venture Investors Management, and Meritech Capital Partners.)
With initial funding, IntraLase was able to build its first femtosecond machine and conduct early proof-of-concept clinical studies in Europe in 1998 and 1999. We worked with Imola Ratkay-Traub, MD, in Hungary, and Vincenzo Marchi, MD, in Italy. It is critical to work out the basic principles of any product as early as possible, because this becomes much more difficult to do as the organization grows. Our promising early results enabled us to raise additional funding to apply for US FDA clearance, and to begin building a company infrastructure. In a start-up company, there is not enough time or money to conduct on-the-job training, so an experienced, professional team is critical to success. Early on, we were lucky enough to attract several of the best people from the medical device industry, many with decades of experience in ophthalmology and refractive surgery. This team, including Randy Alexander, President and CEO; Eric Weinberg, Vice President of Sales and Marketing; Judy Gordon, DVM, Vice President of Regulatory and Quality; Scott Schoeller, Vice President of Operations; and Shelley Thunen, CFO, has brought the technology to its present stage.IntraLase was also fortunate to have a dedicated and experienced group of US clinical advisors, including Lee Nordan, MD (Carlsbad, CA), Stephen Slade, MD (Houston, TX), and Jon Dishler, MD (Denver, CO) who demanded the technology attain a very high level of performance.
INTRALASE: PRESENT AND FUTURE
IntraLase is in the second phase of its initial product introduction of the IntraLase FS surgical system and IntraLASIK software for laser flap creation. There are approximately 15 laser systems now being used by surgeons across the country, and our goal is to make this safe and precise technology available to surgeons and patients as widely and as quickly as possible. In addition to creating LASIK flaps, surgeons will ultimately be able to offer a number of other procedures using the IntraLase FS. If we think of this technology as a remote-controlled, high-precision, subsurface scalpel, then its uses are only limited by our collective imagination. Novel therapeutic keratoplasty procedures, the creation of channels and pockets for corneal implants, as well as new refractive procedures that utilize only the IntraLase FS are all currently in development. Beyond the cornea, there are a number of other applications on which we are working for several common ophthalmic conditions and diseases.
As an ophthalmologist, I would like to comment on the great resources our discipline enjoys in industry—scientists, engineers, regulatory and quality specialists, sales and marketing professionals, and yes, even venture capitalists, are as proud to be a part of the ophthalmic community as we are. It is critical to our own professional success that we acknowledge and reward their contributions, skills, and integrity, so that we continue to drive innovation in our field.