Updated: July 18, 2012 11:30 a.m.
OptiMedica Corp. is making waves and challenging the leaders in global eye care with its Catalys Precision Laser system for cataract surgery and CEO Mark Forchette isn’t shy about extolling his company’s potential.
The Catalys system, which won FDA clearance in December 2011 and CE Mark approval in the European Union in August 2011, performs key incisions during cataract removal using image-guidance and a next generation femtosecond laser clinically proven to be "an order of magnitude" more precise than manual cataract surgery. *
"In the cataract space this is an incredible breakthrough that ultimately has tremendous potential to change the procedure not only now but for the future as well," Forchette told MassDevice. "And that sort of disruptive change process is in our corporate DNA."
In an exclusive interview, Forchette told us about his extensive background in eye care, how femtosecond laser technology is changing the game and why he veered from steady path at the largest ophthalmology company in the world to join OptiMedica.
MassDevice: Tells us about your background, how you came to occupy the corner office at OptiMedica and why it was a good fit for you.
Mark Forchette: This August I will celebrate my 28th year in ophthalmology. I’ve had a fantastic career within this space. I started with a company called Grieshaber, a Swiss surgical instrument company that was in retina, glaucoma and cataract surgery. I started as a sales rep carrying a demo bag and I covered from Miami to Washington, D.C., all over the southeast.
That company was a tremendous place to start because we had a great track record of developing products with physicians. So I started as a sales rep and wound up ultimately in charge of the U.S. organization with Grieshaber. We built quite a reputation for ourselves. In 1998 Alcon Laboratories, the largest company in ophthalmology, acquired us to add to their retinaportfolio.
I integrated into the company to head panretinal/retinal sales, .a segment of their product portfolio. And I ultimately wound up as vice president of the retina division, in charge of the surgical sales in vitreoretinal and was starting to take over the marketing of their matching retinal pharmaceutical portfolio. And that was a fantastic experience. While I was there we experienced tremendous market-share growth. The company, in the retina space, took a leadership position.
And that was a fantastic experience for me. I thought I would finish my career there. I was having a blast, this company was so full of great people. But the opportunity to be considered for the OptiMedica CEO position came available through a friend of mine – he’s actually an advisor at Alcon – but I’d know him for many years, 23 years or so. And that’s Mark Blumenkranzhe’s the chair of the department of ophthalmology at Stanford. He told me I should consider OptiMedica and I just politely said yes because I thought I’d never leave Alcon.
But then I met some of the people here and I met Brook Byers, the chairman of our board from KleinerPerkins Caufield Byers. He and I share a South Georgia background. A really brief conversation that he and I were to have turned into about 2 hours, and the next thing you knew I was making a decision to come out here and lead OptiMedica. And I’ve never looked back since. It was a fantastic decision because the technology that we’ve developed and launched is really break-through in virtually everything that we’ve done. So it’s been a fantastic experience for me.
MassDevice: So give me the elevator pitch on what OptiMedica does and how it came to be.
MF: OptiMedica launched into ophthalmology looking at the space broadly. We originally launched the company in the retina, glaucoma and cataract space. We were quite successful in the retina space with the PASCAL pattern scanning laser. In just a few short years we sold 700 systems, treated a million patients successfully and delivered 40 million patterns successfully. Ultimately, that technology was acquired by TopconMedical Systems. This allowed us to focus on a project that we had been developing since the very beginning of the company in 2004, which was the femtosecond laser cataract surgery technology.
When I think about what OptiMedica does as a company, we have a very talented group of people and a rich process of innovation and development that we arrive at through a very collaborative relationship with physicians. And that has allowed us to launch disruptive and breakthrough technologies.
PASCAL totally changed retinal photocoagulation. And that sort of disruptive change process is in our corporate DNA and that’s what I think you see now with this femtosecond laser technology. In the cataract space this is an incredible breakthrough that ultimately, I think, has tremendous potential to change the procedure not only now but for the future as well.
MassDevice: What is the market opportunity and why did OptiMedica decide to hand off the retina and glaucoma businesses to focus on laser cataract surgery systems?
MF: The market opportunity in the cataract space is really significant. There are about 19 million procedures done per year in the world right now, with that growing dramatically if you think about the population with the aging population and cataract patients being older patients. This is a rapidly growing segment and a tremendous opportunity for us.
As for the reason why we transacted away the retina segment of our business, we were a new company and were being successful, but the retinal group of physicians is completely separate. They are really a referral base from the anterior segment group of physicians. And as we looked at what we were doing every day to manage those 2 segments, it was very logical for us to find a great home for the retinal technology, which we did with Topcon. Topcon is actually one of our distributors and had been very successful with the product so it matched up well to their product portfolio. It was a good transition for us and it allowed us to have a very pure focus on this huge cataract opportunity that we saw.
MassDevice: Tell me a little more about the Catalys system and how it differs from existing methods of cataracts surgery.
MF: Let me start with what I think is really the unmet need in cataract surgery. If you think about this procedure, 19 million of them performed per year, it’s a fantastic procedure. However, there are still opportunities for us to take it to higher levels of precision and accuracy. And the reason that’s important is because there is a number of things occurring with this technology and this space that are driving patient expectations to a higher level.
Part of that is the increasing level of sophistication of the intraocular implants. These implants now have the ability – when properly delivered and precisely placed – have the ability to greatly improve a patient’s vision. Many patients, post the procedure, function without using glasses. And they’re willing to pay a premium to have that higher-level technology.
But this technology is very sensitive to placement in effective lens position. And what our system does is it delivers 4 steps of a procedure that allow the precision and accuracy to be enhanced. We do a perfectly size, shaped and positioned capsulotomy, which creates an opening to the natural human lens that the physician can go in and remove the cataract. Traditionally, they removed the cataract with an ultrasound probe. However, our technology, once it does that capsulotomy opening, also segments and softens the nucleus by using image guidance to go in and map all the surfaces in the eye. And then the laser is driven by the image to fragment and segment the nucleus, which allows that nucleus to be more easily removed – a great percentage of them without ultrasound at all.
And then we also have the ability to make incisions in the cornea to address astigmatism as well as multi-plain incisions to enter the eye. So there is really 4 things that we do and every one of them is aimed at allowing the implant that is ultimately delivered in a procedure to be more precisely placed and positioned. And we also allow for the nucleus to be removed in a way that addresses some of the traditional safety issues of the procedure.
There are some differentiating characteristics of the system that I think are important for you to understand. The patient interface is very important in this procedure because it’s the window to the patient’s eye to be able to treat. Ours is a very novel Liquid Optics interface. Liquid Optics essentially eliminates corneal folds that can interfere with the treatment beam and the imaging beam during the procedure. And that’s really a key piece of our system that drives the precision and accuracy. But it’s not just that piece. There are multiple elements of the system that combine to deliver the precision. In addition to the Liquid Optics interface, we have a very precise, ultrafast femtosecond laser.We made a decision to have an integrated bed to ensure the stability of the patient and their interface with the system, which is critical. In addition, the image guidance of the system – ours is called Integral Guidance – is really the driver of the laser throughout the procedure. All of those elements together combine to create the precision that we deliver.
This type of product innovation is a key part of what makes us different. And it didn’t happen by chance. If I think about OptiMedica and some of the things that we do that are unique and special, we had physicians involved in the design of our product from the very beginning. We had a medical advisory board that spent many, many days with our R&D teams over a period of years to make sure that we delivered something that hit the opportunities in this segment.
Medical advisory boards often don’t participate as deeply as they could. Ours has essentially been embedded with our teams. Along with the medical staff we had nursing staff and operating room staff integrated into the design process as well. This collaboration really makes a difference in making sure that the product is right.
MassDevice: How does the Catalys system compare with manual procedures or other laser-based procedures?
MF: I think there are a couple of critical factors that are important to note. Physicians measure the success of this by the patient outcome and the data really represents that. So you’ve heard me speak about the precision of the capsulotomy. In our data that we submitted to the FDA we did a head-to-head comparison of the Catalys capsulotomy versus the manual capsulotomy – and manual capsulotomy done by a very talented group of surgeons in the clinical trial. We measured the size, shape and position against the intended target, and Catalys was an order of magnitude more precise than manual. So that was a critical data piece. The capsulotomies were also very precisely centered against the target.
And then lastly there is the reduction in the use of ultrasound that Professor BurkhartDick demonstrated at our very first Catalys site in Germany. In his first 400 patients using our 350 micron grid pattern, he demonstrated a 99% reduction in the use of ultrasound. These were some pretty amazing outcomes. I think it’s a really breakthrough moment for ophthalmology when you see that performance.
Another element is that Professor Dick, through the design elements of the system and the user-friendliness and patient-friendliness of it, was able to treat all comers in his patient series. So the technology allowed a broader patient population to be treated, even difficult-to-treat patients. And that was a pretty amazing thing because some patients have cloudy corneas, they might have small pupils, some have very mature cataracts that you might typically steer away from. But he found that the precision and accuracy of our system allowed him to be able to treat those patients. I think if you were to look at his patient series and the ones that might have something that would fall into the difficult-to-treat segment, I’d say maybe 25% to 30% of the cataract patient population in that first 400 procedures that he recorded on had some difficult-to-treat element. And so that’s remarkable when you look at the different issues that he was able to address with our technology
MassDevice: And what is the cost in terms of patient results and financial expense or complications associated with having an imprecise cataract surgery?
MF: There are many different ways that the precision may not be optimal. One thing that can occur during the procedure when using ultrasound to remove the nucleus is the ultrasound gets too close to the posterior capsule and creates a capsular rupture. That makes it difficult to place the lens where you want it to be. It also creates interaction with the vitreous in the back of the eye.
If the capsulotomy is improperly performed manually, this can potentially result in a capsular tear which could split the bag and not leave the right platform for the lens to be implanted. And if it’s not precisely aligned where the physician wants it to be, ultimately the lens position post the procedure may not be optimal.. The implant that’s being left in the eye, the intraocular lens, really should be a precisely aligned optical system. The natural process that occurs when the intraocular lens is implanted in the patient’s capsular bag is that the bag sort of shrink wraps around the implant. And if that shrink wrapping doesn’t occur precisely, it can shift or de-center the lens and take that optical system out of alignment.
A factor in the precise and accurate “shrink wrapping” is where that capsulotomy is placed. And that’s why what we are doing is so important to ensuring that you wind up with the right result at the end of the procedure.
MassDevice: So how much of this system is automated and how much is physician-controlled?
MF: The system is driven by the physician. The physician makes the strategic decisions about what occurs during the procedure, including the dimensions and the placement of the incisions and all the key elements that need to be delivered to each specific patient. So essentially they’re selecting custom elements of the procedure for each patient.
But once they make those selections, the Catalys system then maps all the ocular surfaces and identifies all the key tissues plains, and automatically places the customized procedure on that patient’s specific anatomy. And then at the command of the physician, the system delivers the laser treatment according to the customized plan.
MassDevice: So the Catalys system just won FDA clearance in December.
MF: That’s correct.
MassDevice: So what’s the market response been since then?
MF: It’s been fantastic, although we had actually already started getting some tremendous market response. because we received our CE clearance in the third quarter of last year. The CE mark clearance allowed us to begin shipping outside of the United States, which we did. And then we received the FDA clearance in the U.S. in December, and now we’re shipping in the U.S. So we now have multiple systems in the United States, Germany, Spain, Switzerland, Australia and Japan, and our placements are occurring rapidly.
The response has been tremendous, and I think that’s for a particular reason. I think physicians see the promise of this technology and then they see how we execute against that promise. And they find that very compelling and are stepping up to add Catalys to their practice. That’s really rewarding for us because we’ve been working for a long time to make sure the technology was absolutely top notch when it came time for broad commercialization.
MassDevice: So how do you intend to keep that momentum going?
MF: Well I think the thing that drives momentum is that, when we ship a system into a physician’s hands and allowed them to treat their patient, we deliver on our promise. The way that we are wired as a company is to deliver the very best technology with patients in mind. If we meet patient expectations and we deliver the very best technology, then I think the momentum takes care of itself.
And I think that’s what we’re seeing. All of the physicians and ophthalmologists are a great big community of interlinked individuals, they talk among themselves quite a bit. And I think if we’re meeting their expectations when someone buys the system, they tell their friends and that word gets out. That’s clearly happening with us. And I think that’s driving the momentum for us in a really robust way not just in the United States but globally. The orders that we have right now are from all over the world, and that’s really satisfying for us.
MassDevice: So what is your competition like in this market?
MF: We have competitors in this market. One is Alcon Surgical. They have a system that they acquired called LensX. LenSx is cleared in the U.S. and around the world. There are 2 other competitors that have not entered the space commercially. Their systems have been described but they’re not shipping to my knowledge in the world yet.
So right now it’s LenSx and OptiMedica shipping systems. LenSxcame to market before us but we really made a very conscious decision that we needed to have the strongest technology possible. And I think we’ve really fulfilled against that objective. There are a number of differentiating elements of our system that were really important decision points in our corporate history to make sure that we addressed all the opportunities in the best way.
MassDevice: And what is the reimbursement status for the Catalys procedures?
MF: It depends on where you are in the world. In the U.S. market, physicians right now of course make their own decisions about how they do this within their practice. Most cataract patients in the U.S. are covered by Medicare so most of these are Medicare-reimbursed procedures. But there are rulings by CMS to address astigmatism that allow patients to opt to pay for treatment of astigmatism. Many practices leverage that ruling as the way in which they provide the laser procedure to patients. So there is a patient-pay element of this procedure that may be part of a premium refractive cataract procedure paradigm.
MassDevice: So what’s next for OptiMedica, not that you don’t have your hands full already with launching and everything.
MF: I’d say there are 2 things: number 1 is we worked very diligently to get to this position. So what’s next for us right now is to make sure that we deliver this technology to the customers that want it and that are stepping up to acquire it and that we deliver the absolute best experience that they can possibly have. We are very focused on doing that and scaling the company to do that, which is going to be an incredible future for us just by itself.
But as we look at what this does for the cataract procedure, I think there is plenty of opportunity in the future to innovate around this foundation. What we have accomplished in the clinic is very disruptive to the traditional cataract procedure. We deliver the precision and accuracy with the capsulotomy. We’ve also seen a dramatic reduction in the use of ultrasound with Professor Burkhard in Germany.
That is a major finding clinically for us, and it creates a platform for the future to rethink the entire cataract procedure, from implants that me be synergistic with the precision that we provide with the capsulotomy to the various packs and solutions and these viscoelastics that are used in the procedure. I think all of those could potentially be areas for future innovation.
*Correction, July 17, 2012: This article mistakenly stated that the Catalys system won CE Mark approval in April 2011. The device won CE Mark in August 2011. Return to the corrected sentence.
