Article Date: 9/1/2008

Scanning the Whole Eye with One Instrument

Scanning the Whole Eye with One Instrument

How Optovue is revolutionizing the diagnosis and management of posterior and anterior eye disease.

Jay Wei

Optical Engineer Jay Wei pioneered commercial development of optical coherence tomography (OCT) at the former Humphrey Instruments in 1993, earning 30 patents in ophthalmic devices as he helped guide the technology forward. But it wasn't until he launched his own company that he fulfilled his vision for a unique form of ophthalmic imaging.

Under his direction, Optovue, Inc., like the groundbreaking instrument it produces, has raced forward, securing FDA approval for the RTVue scanner, the first FDA-approved Fourier domain OCT system in history.

The RTVue can help you diagnose and manage virtually any eye disease.

Following this 2006 breakthrough, Optovue announced that the FDA had cleared a cornea/anterior segment module (CAM) for the RTVue. The Optovue CAM, approved in September 2007, is an optional attachment, enabling 5-micron-resolution, high-magnification imaging of the cornea, angle and anterior crystalline lens, as well as pachymetry mapping and keratoconus analysis.

Combined with the retina and glaucoma scanning and analysis functions provided by the RTVue, the CAM has helped create the first all-in-one solution for posterior and anterior, high-speed, high-resolution OCT imaging. "I was never planning to start my own company, but the technology provided me with the motivation to undertake such a mission," says Wei. "With your own company, you gain certain advantages and you can turn your idea into reality much faster."

High-speed performance

The RTVue's Fourier (or spectral) domain OCT technology uses low-coherence interferometry to detect light echoes, relying on a spectrometer and high-speed CCD camera. Because it has the effect of measuring all echoes of light simultaneously — as compared to sequentially in the case of time domain OCT — Fourier domain OCT significantly improves sensitivity and imaging speed.

RTVue produces images at a 5-micron resolution, allowing unprecedented views of the angle.

The system features a parallel acquisition design that enables you to obtain a whole axial scan by simultaneously capturing 2,048 pixels. It provides a high-definition image in 0.04 seconds, without creating significant motion errors. The system performs 26,000 A-scans per second, a speed that is 65 times faster than the scanning capability of time domain OCT.

Components of a cornea transplant are precisely presented in this RTVue OCT scan.

This advance in technology is analogous to the advantage that jet propulsion achieved over propeller-powered aviation in the 1960s. Fourier domain OCT provides 3-D views of all layers of retinal tissue and clearly images landmark features such as the macula, blood vessels and the optic disc. Besides eliminating significant motion distortion, the RTVue also reduces sampling errors, links fundus photograph findings to cross-sections of disease and detects focal pathology that can be missed with time domain OCT images.

"We view the RTVue as a unique technology platform, not just a new instrument," says Wei. "Like the changes that magnetic resonance imaging (MRI) and ultrasonography produced in medicine, our technology is revolutionizing how eye disease is understood, diagnosed and treated. This instrument addresses more specific diseases and offers more specific solutions than any general imaging device."

Rapid growth

In 2007, the first year that Optovue sold the RTVue, the company installed 425 of the units in clinical settings, turning a profit during the first 6 months and becoming one of the fastest growing firms in eyecare history.

"The profits financed our production and marketing costs, and enabled us to make advances in long-term technology development for future products," says Wei. "Because we have not yet tapped into our investors' funds, we are well-positioned for the coming years."

The company far surpassed sales goals and has performed so well that it hasn't touched the $10.5 million in Series B funding that it secured through venture capital lead by Trevi Health Ventures, a venture capital firm that specializes in helping healthcare companies grow.

Wei has a particular focus on customer service. "We plan to invest heavily in our already-strong customer service infrastructure," he says. "We want to provide physicians with the tools and support they need to improve the diagnosis and management of their patients."

Who is buying RTVue?

Twenty-five of the RTVue units have been installed at clinical sites involved in studies and data collection efforts, such as development of the Phase 1 Normative Database for Glaucoma and Retina, released in December of 2007. This release made the RTVue the first spectral OCT machine to have such a database.

Wei says that most of Optovue's customers are general ophthalmologists. Most practices purchase the corneal/anterior segment module in addition to the RTVue to provide full diagnostic capability.

"This instrument is effective for them from an economic standpoint because they only need to buy one instrument with a 1010-mm-by-520-mm footprint to cover both the posterior and anterior segments of the eye," notes Wei. "The RTVue provides a comprehensive solution."

Customer support

Optovue has built customer loyalty with free monthly online training and real-time remote support. Optovue's Web-based Lecture series (OWLs) provides online instruction on:

■ Comparing time domain OCT to Fourier domain OCT

■ Comprehensive ocular assessment with the RTVue

■ The retina, including clinical cases of age-related macular degeneration, diabetic macular edema, central serous chorioretinopathy, macular holes and other conditions

■ Glaucoma, including early diagnosis of pathology, tracking changes, normative databases and analyses

■ Anterior segment, exploring evaluation of the cornea, angle, conjunctiva, iris and lens

■ Updated information on new RTVue software that features live image-quality feedback during scanning acquisition to improve image quality, functionality and analysis in 3-D scans

■ Advanced techniques for using the RTVue, focusing on image quality, retinal pigment epithelium tips, contour line drawing and other features.

Other courses include sessions with distinguished faculty, orientation sessions for new users and advanced imaging techniques.

Imaging experts

Besides technology and reliable customer support, the cornerstone of Optovue's success has been the talented group of scientists, clinicians and business development specialists that Wei has assembled. The company's scientific and medical advisory board includes the inventors of OCT technology and leaders in its clinical use, including:

■ James Fujimoto, Ph.D., Professor of Electrical Engineering & Computer Science, Massachusetts Institute of Technology (MIT)

■ David Huang, M.D., Ph.D., Director of the Doheny Laser Vision Center and Associate Professor of Ophthalmology, University of Southern California

■ Yasuo Tano, M.D., Professor and Chairman of the Department of Ophthalmology, Osaka University Medical School

Optovue's management includes individuals who have led the development and commercialization of OCT and other ophthalmic imaging products:

■ Tom Zhao, Ph.D., Co-Founder and Chief Technology Officer, is a former senior staff scientist at Carl Zeiss Meditec, where he was responsible for OCT product development. He has more than 8 years of direct OCT research and development experience. A co-inventor of phase-resolved Doppler OCT, he contributed significantly to the success of the Stratus OCT and Visante OCT. Dr. Zhao's role as Optovue's chief technology officer is to develop the company's OCT technology and IT infrastructure.

■ Paul Kealey, Vice President of Marketing, has 30 years of medical sales, marketing, strategy and product development experience. Most recently the VP of Marketing for Clarity Medical, Paul joined Optovue in 2006 to set up the sales distribution channels, and develop the marketing and pricing strategy for the RTVue. With an in-depth understanding of the clinical requirements of diagnostic devices, he also has experience marketing OCT and imaging devices while at Carl Zeiss Meditec.

■ Bill Shields, Vice President of International Sales, is the former Director of International Sales for Laser Diagnostic Technologies and Director of Sales, Diagnostics, Europe, Middle East, Africa for Carl Zeiss Meditec. He has 18 years of sales and international sales management experience in the ophthalmic industry, having worked for Humphrey Instruments (a Carl Zeiss company) and Allergan Medical Optics. In both positions, he was responsible for developing and implementing global and regionalized strategic initiatives, and managing direct distribution networks worldwide.

■ John Hawley, Vice President of Business Development, comes to Optovue directly from Heidelberg Engineering, where he was responsible for building the U.S. business over a 15-year period. He has more than 25 years experience in ophthalmic diagnostic instrumentation. He has also held management and executive positions at Cilco, BioRad and Interzeag, bringing experience in service, sales, marketing and strategic planning to Optovue.

■ Jeff Keeling, Vice President of North America Sales, was most recently Vice President of Sales for the Western U.S. region at Optos, Inc. He has more than 15 years of experience in the eye industry, having started his career with Bausch and Lomb Surgical. He built the U.S. Sales Force for Laser Diagnostic Technologies and promoted the GDx technology for more than 5 years. Keeling will lead the U.S. sales team and continue the company's growth in the U.S. market.

■ Michael J. Sinai, Ph.D., Senior Director of Clinical Affairs, is the former Director of Clinical Research for Laser Diagnostic Technologies and also former Director of Clinical Applications for Heidelberg Engineering. A vision scientist, he has been published in Nature, Ophthalmology, Journal of Glaucoma, Archives of Ophthalmology, Vision Research, and other journals. He holds several patents related to retinal imaging in ocular pathologies.

■ Peggy Fong, Chief Financial/Operations Officer, was previously Senior Vice President of Financial Operations for SYNNEX Corporation, as well as Senior Vice President of Business Development and General Manager for the Latin America region. SYNNEX is a $6 billion company. Peggy was also CEO and CFO of Hercules Computer Technology, a $50 million maker of high-end computer graphics cards. Her role will be to "make our operations as efficient as possible while helping us offer an instrument at a reasonable cost that will benefit practitioners and their patients," according to Wei.

■ John Moore, who has served as President for several leading companies in the vision care industry, including Zeiss Humphrey Systems (now Carl Zeiss Meditec), has signed on as a member of Optovue's board of directors. Moore was responsible for licensing OCT technology from MIT and for successfully developing the first commercial OCT product.

Why Venture Capitalists Are Bullish on Optovue
Trevi Health Ventures, a venture capital firm with offices in New York City and London, focuses on healthcare investments. In early 2007, the firm added Optovue, Inc., to its portfolio by leading a $10.5 million Series B financing for the upstart ophthalmic imaging company.
"We based our decision on a number of factors," says James Cha of Trevi Health Ventures. "The most important factor was the exceptional team at Optovue. They are the leading innovators in optical coherence tomography (OCT) technology and have vast expertise at development and commercialization of OCT instruments."
Optovue turned a profit within the first 6 months of selling its launch product, delighting its new financial partners by not even touching the capital funds provided for start-up expenses. Market acceptance of the RTVue, the first FDA-approved spectral/Fourier-domain OCT system, has shown no signs of slowing down.
"Optovue has far exceeded our lofty expectations," said Cha. "Their advanced analytical software has transformed the RTVue from an imaging device to a powerful tool for eye care physicians. They are financially strong and have an exciting pipeline – we are extremely excited about the company's prospects."

Earning Accolades
The RTVue earned the Bottom Line Design Award and was featured in a story on the "World's 11 Coolest Products" on in 2007.
According to "How does a startup compete with giants like Zeiss? Optovue created a radically new technology that uses an infrared beam to probe a patient's eyes for ailments like glaucoma. To make it more appealing to patients, Optovue encased the hardware in clean, welcoming lines."
The RTVue also was featured on "Good Morning America," where it was described as a technology that may be able to prevent blindness.

Anterior Advantages
The cornea/anterior segment module (CAM) attachment to the RTVue can assist with the following tasks:
  • Postoperative evaluation of LASIK flaps
  • Corneal power measurement
  • Treatment of corneal scars
  • Screening candidates for Intacs corneal insert implantation
  • Anterior chamber biometry related to phakic intraocular lens (IOL) implantation
  • Determining causes of secondary and narrow-angle glaucoma in cases of corneal opacity.
Because of the light source in the RTVue, the instrument provides higher resolution and significantly more detail than other instruments used in the market. Corneal detail such as the boundaries of Bowman's membrane, Descemet's membrane and Schlemm's canal are clearly visible and, in most cases, can be quantified. Tear film layer thickness also can be measured in many cases, as the tear film presents distinct reflections.

Bright future

With plenty of cash to invest in continuing development of its prized technology, Optovue is positioned for strong growth and an expanding presence in vision care. Wei notes that 27 published abstracts at ARVO this year were based on the use of the RTVue and many more papers are expected to reach publication as clinical experiences continue in the year ahead.

"I cannot say specifically what our next innovations will be," he says. "But what I can say, generally, is that we will continue to expand the scope of OCT and provide the physician with additional tools to improve patient care." ■

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Optometric Management, Issue: September 2008