News

Optovue Announces Eye tracking upgrade option now available for RTVue FD-OCT

New real-time tracking option for the RTVue FD-OCT provides 30-frames/second tracking of the patients’ retina during scanning posterior structures of the eye.

FREMONT, CA, Feb 1st, 2012 – Optovue Inc., has announced the release of a real-time tracking upgrade for the RTVue Fourier-domain OCT system. Demonstrated at the recent Academy of Ophthalmology meeting, the innovative option is as simple as a software upgrade* to the company’s flagship RTVue FD-OCT (also called SD-OCT) system used world-wide by eye care clinicians to aid in the diagnosis and management of ocular diseases.
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Optovue and Carl Zeiss Meditec have reached settlement in their current patent infringement disputes.

FREMONT, CA, / DUBLIN, CA, January 10, 2012 – Optovue Inc. and Carl Zeiss Meditec Inc. announced today that they have signed a settlement agreement resolving two pending Federal District Court patent infringement cases. Under the terms of the agreement, the companies dismissed all currently pending litigation and entered into a cross-license agreement of certain issued and to be issued patents owned or controlled by each party. The specific terms of the settlement are confidential.
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Optovue Announces FDA Approval for Corneal Power Measurements

Using RTVue® to find a precise measurement of Total Corneal Power (TCP™)

FREMONT, CA; October 17, 2011 – Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), announces that the RTVue has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Optical Coherence Tomography (OCT) measurements of central corneal power, curvature, and thickness in human corneas, pre- and post-cataract surgery.

The RTVue can be used to calculate the Total Corneal Power (TCP) of the cornea in eyes that have undergone corneal refractive surgery. Furthermore, the RTVue directly measures posterior corneal power and does not rely on good preoperative vision or previous clinical record(s). The success of IOL selection in cataract surgery is largely determined by corneal power. However, corneal refractive power has previously been very difficult to measure in post-refractive patients.
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Optovue Announces FDA 510(k) Clearance for iStand™

New stand adds versatility to the iVue® SD-OCT Device

FREMONT, CA, June 14, 2011 – Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), announces that the new iStand, a multi-directional stand for universal positioning of the iVue SD-OCT system, received FDA 510(k) clearance in June.

The iStand expands the clinical utility of the iVue SD-OCT device delivering enhanced clinical decisions, procedure planning and documentation. The system enables eye-care professionals to follow patients from diagnosis through post-operative care. By mounting the iVue onto iStand, clinicians can now take further advantage of iVue’s compact size and portability to easily move their OCT between the exam lane, hospital facilities, and satellite offices. The simple, easy-to-use articulating arm facilitates scanning supine patients as well as patients in other positions.
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Optovue Announces iWellnessExam™ with iVue® SD-OCT

A new program revolutionizes the way clinicians can implement SD-OCT technology

FREMONT, CA, June 22, 2011 – Optovue, an innovator in spectral-domain optical coherence tomography (SD-OCT), announces the launch of a new wellness program implemented as a “pay per visit” arrangement with eye care clinicians. The iWellness Program formerly iHealthCheck, was revealed to great acclaim at the “Heart of America Contact Lens Society” meeting in Kansas City MO.

The iWellnessExam has been added to the portable new spectral OCT from Optovue – the iVue – launched in 2010, and already setting industry records. The incorporation of the new iWellness exam, which scans for both retinal and glaucomatous pathology, will complement the everyday comprehensive eye exam. This pay per visit model will allow an office to provide better medical care and a wellness testing option with no capital outlay. The diagnostic capabilities of the practice will be greatly enhanced with the implementation of the iWellness program.
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Optovue Announces Success At 20th Anniversary Vision Source Annual Meeting

Vision Source members embrace Optovue’s new iWellnessExam™ Program

FREMONT, CA, May 23, 2011 – Optovue, a pioneer in spectral-domain optical coherence tomography (SD-OCT), announces its success at the 20th anniversary meeting of Vision Source, a leading group of
independent private practice optometrists, held April 14-17, 2011 in Houston, Texas. The annual
meeting provides member optometrists the opportunity to attend practice management sessions, vendor
presentations and visit the exhibit hall.

Coincidently, 2011 marks the 20th anniversary of both the founding of Vision Source and the introduction
of optical coherence tomography technology. Optovue’s founders have been at the forefront of the
evolution of OCT since its inception and continue to push the technology forward. Earlier this year,
Optovue launched a new “pay per visit” acquisition model based on a wellness platform. The
iWellnessExam Program was introduced to Vision Source members during Optovue’s vendor
presentation during the annual meeting.
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New! Medicare Reimbursement for SCODI of the Posterior and Anterior Segment

Click on the following links: Medicare Reimbursement for SCODI of the Anterior Segment;
Medicare Reimbursement for SCODI of the Posterior Segment

Optovue’s Dr. Larry Alexander named President of the Optometric Retina Society and joins Macular Degeneration Association’s Medical Advisory Board

Optovue’s Dr. Larry Alexander was recently named the president of the Optometric Retina Society. Dr. Alexander has also joined Macular Degeneration Association’s Medical Advisory Board.
Click on the following link to read more: http://www.prbuzz.com/non-profit/49458-macular-degeneration.html

OPTOVUE ANNOUNCES THE SHIPMENT OF THE 600TH IVUE™ COMPACT SD-OCT SYSTEM

600 Compact SD-OCT shipped for growing international demand

FREMONT, CA, October 4th, 2010 – Optovue Inc., the company that launched the first FDA cleared fourier/spectral domain OCT in the US, announced it has shipped the 600th iVue™ compact SD-OCT system in early September from its Fremont California manufacturing facility.

“We continue to see accelerating growth in the demand for the iVue system, both domestically and internationally,” stated Paul Kealey, Vice President of Marketing for Optovue. “Despite the US launch occurring just recently in June, we are on track to exceed our first year projections on the new compact system. The streamlined GUI, ease-of-use and short “chair time” are helping with patient flow in clinical practices. This functional simplicity, along with the exceptional clinical value of retina, glaucoma and anterior segment imaging as standard features, is proving to be the right combination for the broader eye care market.”
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OPTOVUE Q2 AND FIRST SIX MONTH REVENUE 2010 UP 57% OVER 2009

Continued strong revenue growth for fourier-domain OCT pioneer

FREMONT, CA, September 17, 2010 – Optovue, the company that launched the first FDA cleared fourier/spectral domain OCT in the US, announced its second quarter revenue results for 2010 grew 57% over the same period in fiscal 2009. This also puts the first six months of 2010 at a 57% revenue increase over the same period in 2009.

“Following our 57% revenue growth in Q1 over prior year, our six month year-to-date revenue growth for 2010 is holding very strong.” stated Gordon Wong, Vice President of Finance for Optovue. “With the recent FDA clearance of the Normative Database for the RTVue FD-OCT system and the strong growth in the sales of iVue compact OCT systems, the remainder of 2010 is on track to significantly exceed forecast.”
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OPTOVUE Announces FDA 510(K) Clearance ON Normative Database

The largest FDA cleared Normative Database for OCT is now available for the RTVue FD-OCT from Optovue, Inc.

FREMONT, CA, September 16, 2010 – Optovue, the company that launched the first FDA cleared fourier/spectral domain OCT in the US, announced that it has received 510(k) clearance on its Normative Database (“NDB”) for the RTVue OCT device.

“This affirms that our protocols and management of this large international, multi-site normative population are at the level that FDA regulatory guidelines require,” stated Mike Sinai, PhD, Sr. Director of Clinical Research for Optovue. “Most importantly, this demonstrates the safety and efficacy of our NDB based on FDA current standard for its intended uses. This is the only normative database taking into account patient age, signal strength of scan, and even optic disc size in certain scan type. These factors along with the large normal sampling offer clinicians a high degree of confidence in our NDB as a reference tool in assessing retina nerve fiber thickness.”
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OPTOVUE Announces FDA 510(K) Clearance for iVue SD-OCT

New compact SD-OCT changes the landscape for imaging once again

FREMONT, CA – May 4/PRNewswire – Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced that the new iVue compact SD-OCT has received FDA 510(k) clearance on April 29, 2010.

“The iVue compact SD-OCT was officially launched outside the United States in January of this year, and we have seen very high demand – as expected – in the first quarter,” stated Paul Kealey, Vice President of Marketing for Optovue. “This regulatory clearance for the US market allows us to offer the benefits of advanced OCT imaging to more segments within eye care, where the economic feasibility of the larger systems simply did not work. The iVue begins the next phase of the OCT revolution in the US that started with the RTVue launch in 2006.”
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Optovue Announces 19% Revenue Increase Over FY 2008

Clinical Value and Clinical Utility prove to be the right combination in down economy

FREMONT, CA – April 30, 2010 – Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced fiscal year-end results for 2009 compared to fiscal year 2008. Despite the down economy, eye care clinicians proved that the right combination of clinical utility and clinical value is still the best package.
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Optovue Announces Formation of Eye-Give Foundation for World-Wide Eye Care Philanthropy

US based manufacturer of first FDA cleared FD/SD-OCT to share its success through charity foundation.

FREMONT, CA – April 11, 2010- Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has founded “Eye-Give”, a non-profit foundation for the purposes of donating technology and funding to sight saving charities and organizations around the world.
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Optovue Announces Shipment of the 2000th RTVue Advanced OCT System and 100th iVue Compact SD-OCT Systems

First FDA Cleared SD-OCT System hits world-wide installed mark and smaller companion SD-OCT in high international demand.

FREMONT, CA – April 1, 2010 – Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced a milestone of shipping serial number 2000 of the RTVue fourier/spectral-domain OCT system at the end of February, 2010. Optovue also announced that it has shipped the first 100 iVue compact SD-OCT systems against initial international orders of more than 200 in the first 60 days since the January launch. The iVue compact advanced OCT is currently only available outside the United States in specific countries.
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Optovue announces the hiring of John Hawley as VP of Business Development

Fremont, CA – January 22, 2008 — Optovue, Inc., the first company to introduce a Fourier-domain optical coherence tomography (FD-OCT) system to the US market, today announced that John Hawley has signed on as Vice President of Business Development.

“John has a tremendous amount of experience in a fast growing company environment and an excellent understanding of the eye care market”, stated founder and CEO Jay Wei. “John is well known and respected in this industry, and is a great addition to our management team.”
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Optovue Receives FDA Clearance for Cornea/Anterior Module for RTVue

Fremont, CA — October 25, 2007 — Optovue, Inc., the first company to introduce a Fourier-domain optical coherence tomography (FD-OCT) system to the US market, today announced that on September 28, FDA 510(k) clearance was received for its Cornea/Anterior Module (CAM).

The CAM is an optional attachment for the RTVue, Optovue’s high-speed and high-resolution FD-OCT device for retinal imaging. The CAM add-on enhances the RTVue by enabling five-micron resolution, high-magnification imaging of the cornea, angle and anterior crystalline lens, as well as pachymetry mapping and keratoconus analysis. Together with the retina and glaucoma scanning and analysis functions already provided by the RTVue, the CAM allows the first all-in-one solution for posterior and anterior high-speed, high-resolution OCT imaging.
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Speed and Resolution Improve in Newest OCT

High-speed, spectral/Fourier domain OCT brings better imaging and the potential for more sensitive diagnosis.
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RTVue on Good Morning America

BC News Good Morning America interview: “New Tool Could Prevent Blindness – Spectral OCT Helps Doctors Identify Eye Diseases Early.” May 9th, 2007
http://abcnews.go.com/GMA/OnCall/story?id=3155121&page=1

Optovue, Incorporated Secures $10.5 Million in Series B Funding Led by Trevi Health Ventures

Fremont, CA – March 21, 2007 – Optovue, the first company to introduce a fourier-domain, optical coherence tomography system to the US market, announced today that the Company has secured $10.5 million in Series B funding. The investment was led by Trevi Health Ventures, the venture capital firm focused on medical devices, biopharmaceuticals and healthcare services with office in New York and London.

Acorn Campus, iD Soft Capital, H&Q Asia Pacific, Harbinger Ventures, and the lead investors in Optovue’s Series A round, also participated in the Series B financing. Since Optovue’s Series A funding in 2004, the founders and development team have successfully launched their first product and completed a long-term strategic product development plan that will enable Optovue to become the industry leader for the development of new innovated technology for the eye care market. Read more ……

For further information, please contact:

Jay Wei
President/CEO
Paul Kealey
VP Sales & Marketing

Optovue Receives 2007 Medical Design Excellence Award

Optovue Receives Bottom Line Design Award

Optovue Receives Bottom Line Design Award. The feature story “World’s 11 Coolest Products,” has posted this morning on CNNMoney.com, and was one of “Top Stories” on CNN.com as of noon EST which will lead to great coverage of the story! It is the headlining article on the Business 2.0 site. February, 2007 http://money.cnn.com/ http://www.bottomlinedesignawards.com/2007/winners/optovue-rtvue.html