As president and CEO of closely-held ELENZA, Rudy Mazzocchi knows a thing or two about taking startups across the finish line. Among other things, he was the founder of eV3, which is now part of Covidien, and co-founder and CEO of image-guided NEUROLOGICS, which was acquired by Medtronic in 2005. In all, he was a founder or co-founder of 11 different companies, mainly in the medical device and biotech sectors. Mr. Mazzocchi first saw ELENZA’s ocular implant technology in the late 2000s while he was managing director of Accuitive Medical Ventures and the Innovation Factory of Atlanta, which was considering funding the startup company. After a stint as interim-CEO of NovaVision, a vision restoration therapy company, he moved into the executive suite at ELENZA in April 2010. In this interview with BioTuesdays.com, Mr. Mazzocchi discusses the development and potential of the company’s electro-active, accommodating intraocular lens (IOL), called the Sapphire AutoFocal IOL, for the treatment of cataracts and presbyopia, a condition of blurred near vision.
Let’s begin with a short history of ELENZA.
Our initial technology was developed by PixelOptics of Roanoke, the developer of the world’s first electronic focusing spectacles. ELENZA secured exclusive licensing rights to this implantable lens technology from PixelOptics and now holds a significant and growing patent portfolio. In 2008, we received an initial $6.5-million Series A financing from the Carlyle Group, Delphi Ventures and other private investors. And in 2011, we completed a $12-million Series B-1 round of financing with our original investors, as well as Itochu Corp. of Tokyo and a strategic corporate investor from the ophthalmic industry.
What’s the essence of the device?
What we’ve done is taken our own high quality monofocal lens and encapsulated an electronic package inside it. The electronic package includes a liquid crystal (which is electrically activated to change optical power based on the distance that a patient is viewing), power cell batteries, microchips and sensor technology, which are wirelessly programmable from an external source.
How does it work?
The device combines nanotechnology, artificial intelligence, smart optics and advanced electronics to seamlessly autofocus an image from far to near vision without movement following cataract surgery. The lens doesn’t have to rely on precise contact with ciliary muscles in the eye to move and accommodate properly. The technology includes algorithms and an electro-active, switchable element that automatically adjusts focusing power, in milliseconds, to maintain constant in-focus vision regardless of the level of light. This is the most sophisticated computer chip and algorithm ever used in an implantable medical device. Within the first 300 seconds after surgery, the IOL learns the specific pupil dynamics of a patient and customizes its own internal algorithm. As the patient’s needs change with time, the physician can alter the programming remotely and noninvasively. Therefore, the IOL is patient-specific, adaptive and programmable.
What’s the clinical status of the device?
In 2012, we completed a 350-patient study to collect data on how the pupil of the eye is affected by light and distance viewing. The data were used to complete the design and validation of the device’s algorithm, and we are now developing our manufacturing processes. Our plan is to have the electronics and smart optics fabricated in Holland and Switzerland and then to have the finished electronic wafer shipped to a contracted facility in India to be encapsulated into an acrylic lens.
Currently, we’re engaged in a significant round of fundraising to support manufacturing and build several thousand units for a clinical study in Europe for CE Mark approval. We are planning to do 60 implants and then follow those patients for six months in order to file for marketing approval. We’re hoping to have the financing concluded by the end of this year and perform our first-in-man implant before the end of 2014. If the study is successful, we hope to be commercially available in Europe by the end of 2015.
What are your plans for regulatory approval in the U.S.?
Before we go to the FDA, we want to have good clinical outcomes in Europe and hope to convince the FDA to accept a portion of that data. Recent discussions with the FDA have indicated that our device would be considered a multi-staged monofocal lens, which may accelerate the regulatory process since monofocal lenses have been around for over 50 years. So we’re hoping to start down the regulatory path with the FDA during 2015, but we know the process will take time and a lot more money.
What’s your company’s market opportunity?
The cataract market today consists of some 23 million annual procedures and represents about $3.9-billion in revenue. The U.S., Western Europe and Japan account for about three-quarters of global revenue. More than 98% of the IOLs sold globally are implanted in cataract patients. The IOL market leaders are Alcon, Abbott Medical Optics and Bausch & Lomb. We believe the ELENZA Sapphire can serve about two-thirds of the total cataract market. In addition, there’s a new and emerging market for presbyopia patients called clear lens exchange or refractive lens exchange, which is essentially cataract surgery, but exclusively for refractive purposes, in order to reduce the need for reading glasses. Unlike cataract surgery, which is reimbursed by insurers, there is no current reimbursement for refractive lens exchange.
Can you summarize how the ELENZA Sapphire IOL differentiates itself from the competition?
As we’ve previously described, this autofocal lens is designed to feel and look like a conventional monofocal lens. It will be inserted using the same surgical techniques as those used today for current cataract procedures. However, the encapsulated electronics and smart optics will provide for corrected vision at various distances without either moving the lens, such as other proposed shape-changing accommodating IOLs, or by creating multiple images on the retina, such as current multifocal IOLs. Multifocal lenses are known to cause halos, glare and blur due to the multiple images projected on the retina. We believe our multi-staged monofocal approach, which projects only one image on the retina at any given time, will prove to be more adaptable to patients seeking far, intermediate and near corrected vision. This device also includes an RF microcoil link that enables physicians to send, receive and store data on the lens. This will eventually allow us to expand the future capabilities of this active implantable device. And finally, in the event the electronics fail for any reason, or the patient forgets to recharge the power cells, then this lens defaults to a high-quality monofocal distance lens.
What are the next-generation applications of the device?
Our device has the potential to do, inside the eye, what the Google Glass project is doing as a wearable computer with an optical head-mounted display. We are exploring the ability to pixelate our lens and create a holographic heads-up display for the patient. What we would like to do eventually is use the RF link on the lens, not only to recharge the power cell, but also to eventually communicate with other implantable devices, such as a chip that goes under the skin to measure blood glucose levels for diabetics. So by programming our lens to a specific blink sequence, patients could see a digital image of their blood glucose level—any physiological data for that matter—as a holographic display one meter in front of them. There have been more than 50 generations of pacemakers, so you can imagine what this device could possibly do multiple generations from now.