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Up Front | Jun 2002

ThinOptX: The Story of a Start-Up IOL Company

How ThinOptX overcame years of adversity to bring a promising new IOL technology to market.

How do you start a new IOL company in this day and age? First, you need experience and the knowledge it affords. Second, it helps to have a technology that has a defined application and a clear advantage over what is currently available. Then, you must make sound business decisions, surround yourself with people who believe in you and your concept, and receive some breaks along the way. The story of ThinOptX has all of these elements.

The very beginnings of ThinOptX date back into the mid- 1970s, when I was working as Vice President of Manufacturing for California Intraocular Lens Corporation. At that time, the company deviated from manufacturing iris-fixated lenses and began producing posterior chamber lenses. They were using jeweler's journal-bearing lathes and steel tooling. In the winter of 1977, I met with the optical engineer and the instrument maker to design the first air-bearing lathe to be used in the IOL industry. The air-bearing lathe did not have moving parts in contact, and therefore was free of vibrations that could spoil the lens surface.

We had difficulty polishing those early lenses. Their edges were hand-polished, and although polishing was necessary to break the lenses' sharp edges, the optics of the lenses were better after cutting and before polishing. We hired an engineer from a competing company that had been developing a tumble polishing process. Our Quality Control Manager, Harold Koch, undertook the challenge of developing this technology, and approximately 3 months later, he implemented the tumble polishing process. This process dramatically improved the quality of the lenses we produced. It was almost 3 years before any competitor implemented air-bearing lathes and tumble polishing.

Because the tumble polishing process produced such excellent quality lens optics and surfaces, we began work on developing a one-piece lens with haptics. At first, the draftsman laughed at me when I asked him to draw such a lens; he told me that no one could ever cut such thin haptics into one piece of material. By the fall of 1980 at the American Academy of Ophthalmology meeting in Chicago, Illinois, surgeons were standing in line to see the new one-piece, all-PMMA lenses.

In 1994, I began to work independently, along with my son, Scott, on developing an inexpensive way to manufacture lenses. We were successful, and decided to raise funding to return to the IOL business. Our fundraising efforts were unsuccessful until we learned that the market wanted an all-PMMA lens that would insert through a small incision. We began learning to cut PMMA material thin enough to roll. We were able to cut PMMA into a rollable wafer, but we did not know how to apply optics to this wafer. It was approximately 3 years later when I hit on a theory of how to create this thin lens. Scott and I wrote the initial patent for the thin lens, and then developed and patented the haptic designs.

By this time, the IOL business was crowded, so we decided to raise money to start a refractive lens company. Scott and I had proven that the PMMA wafer would roll and filed patents on the optic, but no lens had ever been made with a design that included rings on the back of a lens. I met with Kenneth J. Hoffer, MD, for his advice, and he did not believe such a lens would work. However, Dr. Hoffer gave us money to purchase time on an air-bearing lathe to determine if the concept would work. When I met with the owner of the small lens company that had the lathe and explained what I wanted, he told me to save my money. I promised to pay for a week's worth of work with the lathe, whether it successfully cut optics or not. On the second day, I received a phone call that to their surprise, the design was working, and the lathe was successfully cutting optics into our PMMA lens. ThinOptX, Inc. was born.

In the fall of 2000, I spoke with Jack Dodick, MD, who recommended we make a cataract lens from a thin, flexible material that could be inserted through a 1-mm incision. We began this development immediately, and we were able to take samples to the 2001 ASCRS meeting a few months later. By the fall of 2001, our cataract lenses were being implanted (Figure 1); over 75 were implanted by the spring of 2002, and one-third of those had been implanted for over 6 months. All the patients are doing well. ThinOptX is currently working to obtain a CE Mark and FDA approval for both the cataract and refractive lenses.

We are currently in the process of signing with and receiving purchase orders from international distributors. We expect to have our CE Mark in 3 months, and foresee growing rapidly once that is obtained. Although our current lens can be inserted through a 1.45-mm incision, we are still working on inserting the hydrophilic cataract lens through a 1-mm incision. We are also experimenting with a 5-mm optic, and are expecting results on that soon. In addition, Geuder AG (Heidelberg, Germany) has made us an insertion instrument for incisions less than 1.5 mm. Later this year, we are planning to reintroduce our refractive lens made of the same hydrophilic acrylic material, and this will be intended for a sub–2-mm incision. We will ask surgeons to implant this lens by the end of this year.

The best advice I could give someone trying to start their own company is to determine every component of the business plan, identify your own strengths, and then hire people who can competently handle the areas in which you are not as strong, so that all your bases are covered. My biggest regret is not working with a good financial advisor to better manage the money. We always raised funding in small pieces, and it would have been better if we could have raised much larger amounts of investment money to speed the development process.

Wayne B. Callahan is founder and President of ThinOptX in Abingdon, Virginia. Mr. Callahan may be reached at (276) 623-2258; thinoptx@aol.com
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