Vista, California and Heidelberg, Germany- September 11th, 2009 – Heidelberg

Engineering today announced two new additions to the SPECTRALIS® family of multi-modality ophthalmic imaging devices. The new models add BluePeak laser autofluorescence to the company’s more economical spectral-domain OCT (SD-OCT) devices.

“BluePeak autofluorescence adds a functional indicator of retinal health by measuring the metabolic activity of the RPE,” said Karl Csaky MD, PhD, Retina Foundation of the Southwest.  “Recent results from the Geographic Atrophy Progression (GAP) study clearly demonstrate the need to use autofluorescence to track the progression of geographic atrophy for dry AMD patients.  This has attracted the interest of the pharmaceutical companies; at least ten new therapies for dry AMD are now under clinical investigation. The combination of BluePeak and OCT will enable clinicians to potentially take advantage of these emerging therapeutics in the same way that ranibizumab and OCT changed the management of wet AMD.”   

BluePeak laser autofluorescence is now available on five of the SPECTRALIS models.     

“The SPECTRALIS imaging platform was designed to be modular,” said Carole McCallum, marketing manager for Heidelberg Engineering.  “These new models demonstrate our ability to incorporate new imaging technology into our existing platform and offer clinicians more utility and value with the multi-modality design.” 

There are now seven different SPECTRALIS models available. The main differences between the models are which of the available imaging modalities they include, whether the instrument is set up for Wide Field imaging, and hardware upgrade options.

Learn more about BluePeak™ Technology

About Heidelberg Engineering GmbH

Headquartered in Heidelberg, Germany, this privately-held company is a leader in light-based medical devices for ophthalmic applications. The company designs, manufactures and markets a variety of instruments that aid in the diagnosis and management of anterior and posterior disease of the eye.  The U.S. corporate office is located in Vista, California.

Vista, California and Heidelberg, Germany- May 8, 2009 - OCT measurement of retinal thickness showed reproducibility of 1 micron in a new study with a head-to-head comparison of six commercial OCT devices.  The SPECTRALIS^® spectral-domain OCT device from Heidelberg Engineering showed the lowest co-efficient of variation in the test-retest study.  The authors concluded that each instrument measures differently, and that the measurements cannot be used interchangeably.

The study by Ute Wolf-Schnurrbusch, MD, et al, University of Bern, was published online in February 2009 [Epub ahead of print] and is slated for publication in Investigative Ophthalmology and Visual Science (IOVS). The purpose of the study was to compare central retinal thickness (CRT) measurements in healthy eyes by different commercially available OCT instruments and to compare the intersession reproducibility of such measurements.  The method used was to measure central retinal thickness (CRT) in twenty subjects with healthy eyes using six different, commercially available OCT instruments and to assess the intersession reproducibility of these measurements. Instruments tested in the study were:  the Stratus^TM OCT, SOCT Copernicus, Spectral OCT/SLO, RTVue-100, SPECTRALIS^® HRA+OCT, and Cirrus^TM HD-OCT.

According to Dr. Wolf-Schnurrbusch the lead investigator of the study, “The high repeatability of the SPECTRALIS^® HRA+OCT measurements is most likely related to the unique feature of the system that allows eye tracking during the scanning process

(TruTrack^TM Active Eye Tracking) and automatic recognition of the exact same scan location for follow-up examination (AutoRescan^TM). By using this feature for all follow-up scans with the SPECTRALIS^® HRA+OCT we could minimize extrinsic factors, such as patient fixation and the operator’s ability to consistently place the macular grid over the same points during each scan.”

In the study data, central retinal thickness measurements differed significantly between the different OCT instruments, with the SPECTRALIS^® HRA+OCT and Cirrus^TM HD-OCT showing significantly higher values than all other instruments and the Stratus^TM OCT showing the lowest values.  This is due in part to different methods of segmentation of the retinal borders used by the various systems. In the study the only instrument with a Coefficient of Variation below 1.0 was the SPECTRALIS^® system. The SPECTRALIS^® was also the only system with a Smallest Measurable Change of less than 2 microns.  The data suggest that the different OCT systems should not be used interchangeably in follow-up examinations for the measurement of macular thickness.

“All of the newer spectral-domain OCT devices have higher resolution images than time-domain OCT, however, faster scanning speeds and higher resolution do not automatically translate to consistent reproducibility as was shown in this study,” noted Carole McCallum, marketing manager at Heidelberg Engineering.  “The ability to minimize motion artifact and reliably re-scan in the same location, however, can lead to improved reproducibility”.

For more information, call Heidelberg Engineering at (800) 931-2230.

* Smallest Measurable Change is Central Retinal Thickness multiplied by Coefficient of Variation.  Results rounded to nearest micron.

About Heidelberg Engineering GmbH

Headquartered in Heidelberg, Germany, this privately-held company is a leader in light-based medical devices for ophthalmic applications. The company designs, manufactures and markets a variety of instruments that aid in the diagnosis and management of anterior and posterior disease of the eye. U.S. corporate office is located in Vista, California.

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“The upgrade adds four new features which build on our TruTrack™ eye tracking technology,” said Adam Doherty, Product Manager at Heidelberg Engineering.  “These include dynamic selection of reference images for progression analysis, manual adjustment of the layer segmentation lines, improved display options, and expanded printing options.” 

The set reference feature allows the user to select any image in an existing progression series as a reference in order to analyze changes from different time points. This is possible because TruTrack™ eye tracking technology places follow-up scans at precisely the same location thus enabling detection of subtle changes. The segmentation adjustment feature enables doctors to manually mark any layer of the retina for analysis.

In addition, since doctors often want to see fine detail in both the fundus and OCT images the new version is designed so the user can customize the display on the instrument or networked viewing stations. The new printing options provide similar capabilities for hardcopy printouts. 

Heidelberg Engineering has begun shipping the software upgrade to customers at no charge.  For more information visit the company’s new website at http://www.heidelbergengineering.com/. 

About Heidelberg Engineering GmbH

Headquartered in Heidelberg, Germany, this privately-held company is a leader in light-based medical devices for ophthalmic applications. The company designs, manufactures and markets a variety of diagnostic instruments for application in retina, glaucoma and cornea diseases. U.S. corporate office is located in Vista, California.

Vista, California and Heidelberg, Germany-June 25, 2008 - Heidelberg Engineering, Inc. today announced the launch of their newly updated website, http://www.heidelbergengineering.com/.  The company implemented several new and enhanced features to improve the ease of information retrieval, and to provide enhanced clinician and operator education for all Heidelberg Engineering products.

The site is easy to navigate and includes:

• An in-depth look at the proprietary technologies behind each instrument
  • HRT Glaucoma, Retina and Cornea modules
  • Spectralis^® HRA, Spectralis^® OCT, and Spectralis^® HRA + OCT
• Stunning image and movie libraries that demonstrate disease progression and pathologies over time, using different modes and functions
• Precise, detailed images that reveal structures never seen before
• Animations and videos that explain how each device delivers results that enable better clinical decisions
• Expanded education, support, reimbursement and clinical application pages

“We are a high-tech imaging company,” says Travis Lindsay, Chief Operating Officer at Heidelberg Engineering.  “Our new website is a powerful tool for clinical personnel in ophthalmology and optometry anywhere in the world.  Image libraries and videos illustrate and explain our instruments.  These online resources help doctors choose the right instrument for their practice and allow our customers to maximize their device’s utility by understanding its functions.”

About Heidelberg Engineering GmbH

Headquartered in Heidelberg, Germany, this privately-held company is a leader in light-based medical devices for ophthalmic applications. The company designs, manufactures and markets a variety of diagnostic instruments for application in retina, glaucoma and cornea diseases. U.S. corporate office is located in Vista, California.

VISTA, CALIFORNIA and HEIDELBERG, GERMANY– July 13, 2007 – Heidelberg Engineering GmbH will introduce a new perimeter technology at the World Glaucoma Congress being held this week in Singapore. The Heidelberg Edge Perimeter (HEP) uses a unique new stimulus called Flicker Defined Form, which targets M-cells, and has been shown to be highly sensitive to functional loss due to early glaucoma.

Using flickering black and white patterns, the stimulus creates an illusory edge where the patient perceives a circular stimulus. Not only does this methodology target early glaucoma, it is more comfortable for patients, resulting in higher test-retest reliability than conventional methods.

“The Heidelberg Edge Perimeter is specifically designed to investigate the earliest possible functional damage in patients with glaucoma, whilst also improving on traditional test-retest characteristics in order to better follow disease progression,” noted Professor John Flanagan, University of Toronto, developer of the unique technology.

The Ocular Hypertension Treatment Study highlighted the problems of repeatability frequently associated with standard visual field testing, indicating that 66% of patients returned to ‘normal’ after two consecutive abnormal visual field tests.

In addition to bringing a new approach to visual field testing, the company designed the new device to work in combination with the well-established Heidelberg Retina Tomograph (HRT).

“With a common data platform and new analysis software, the two instruments provide a combined Structure-Function analysis,” according to Dr. Gerhard Zinser, Managing Director and head of Research and Development, Heidelberg Engineering GmbH. “By introducing the true integration of structure and function tests of the optic nerve, we will be providing new insights into the diagnosis and monitoring of the progression of glaucoma.”

“Integration of structural and functional tests of the optic nerve provide exciting potential for enhanced diagnosis and monitoring of progression of glaucoma,” according to Robert N. Weinreb, MD, Distinguished Professor of Ophthalmology and Director of the Hamilton Glaucoma Center at the University of California San Diego at the WGA Consensus on Glaucoma Diagnosis in November of 2003.

“The HEP system is the latest Heidelberg product introduction that incorporates our proprietary TruTrack™ technology,” noted Lisa Underwood, Senior Product Manager, Heidelberg Engineering, Inc. “Together, the HEP and OHTS-proven HRT ensure structure and function information are tracked simultaneously to give the best possible indicators of glaucomatous progression.”

About Heidelberg Engineering GmbH

Headquartered in Heidelberg, Germany, this privately-held company is a leader in light-based medical devices for ophthalmic applications. The company designs, manufactures and markets a variety of instruments for application in retina, glaucoma and cornea diseases. U.S. corporate office is located in Vista, California.

VISTA, CALIFORNIA and HEIDELBERG, GERMANY– April 26, 2007 – Heidelberg Engineering GmbH announces the expansion of the Spectralis™ family of retinal imaging products, adding a more economical 2-mode SD-OCT to the existing 6-mode SD-OCT and 5-mode HRA. The expanded family now consists of:

- Spectralis OCT (2 modes)
- Spectralis HRA, (5 modes) and
- Spectralis HRA+OCT (6 modes)
“These are exciting times for eye care professionals—these new imaging devices provide reliable data that our predecessors never imagined,” explains Scott Cousins, MD, retinal specialist and Director of the Duke Center of Macular Diseases at the Duke Eye Center. “Heidelberg has further improved upon spectral domain OCT by incorporating image alignment know-how from their experience with the HRA and HRT products. As a result, the Spectralis OCT can lock onto a specific location of interest on the retina, and accurately relocate this site on subsequent exams. This feature will improve our ability to monitor disease progression and treatment response over time.”

Spectralis OCT offers two imaging modes (Spectral Domain-OCT and Infrared), while the Spectralis HRA+OCT includes four additional imaging modes (autofluorescence, red free imaging, fluorescein angiography and ICG angiography). The new model shares three key features with the earlier version: 40,000 A-Scans per second, TruTrack™ eye-tracking technology and Heidelberg Noise Reduction for image clarity.

“We designed the new Spectralis OCT in response to requests from clinicians at smaller eye care practices who wanted an imaging system that could grow with their practice. Spectralis OCT offers the flexibility to upgrade later,” said Adam Doherty, product manager. “The expanded product family gives the clinician a range of choices to fit the economic and clinical needs of the practice.”

The Spectralis instrument captures the OCT cross-sectional scan under constant guidance of one of five fundus imaging modalities. This helps ensure image registration and enables the instruments to precisely track change over time, an advantage over the technical limitations of time domain OCT. In addition, the instrument incorporates Heidelberg Noise Reduction (HNR) technology, a proprietary method of image enhancement which significantly improves image quality by eliminating unwanted optical noise in both fundus and OCT images. In the way that Dolby®* noise reduction has the ability to improve sound quality, HNR has the ability to improve image quality. This feature will be available on all three Spectralis models.

“Studies done at Ohio State University and at the University of California, San Diego demonstrated that first generation OCT systems suffer from an inability to precisely identify the scan location, leading to hidden artifact and possible misinterpretation,” noted Doherty. “By imaging the fundus simultaneous with SD-OCT, we constantly track eye movement, enabling us to avoid much of the motion artifact while accurately locating the OCT scan on the fundus image.”

The Spectralis™ Family will be introduced at the upcoming American Society of Cataract and Refractive Surgery meeting in San Diego, beginning April 27, 2007. The company expects to begin shipping the product in summer.

About Heidelberg Engineering GmbH

Headquartered in Heidelberg, Germany, this privately-held company is a leader in light-based medical devices for ophthalmic applications. The company designs, manufactures and markets a variety of instruments for application in retina, glaucoma and cornea diseases. U.S. corporate office is located in Vista, California.

*DOLBY is a registered trademark of Dolby Laboratories, Inc., which is not affiliated with Heidelberg Engineering

VISTA, CALIFORNIA and HEIDELBERG, GERMANY– November 3, 2006 – Heidelberg Engineering GmbH, the leading developer of laser diagnostics for ophthalmic applications, announced today the United States Food and Drug Administration (FDA) has granted clearance for the Spectralis™ HRA+OCT, the world’s first commercial spectral domain optical coherence tomograph (OCT) combined with laser angiography.

This ground breaking development provides clinicians with never before seen details of the structure of the retina. This new product detects previously unrecognized structures, combining high resolution cross-sectional images of the retina with any of four imaging modalities: autofluorescence, infrared, fluorescein angiography, or ICG angiography. The new device scans the retina 100 times faster than older existing technology known as time domain OCT. Spectralis™ HRA+OCT is a spectral domain system, sometimes called fourier domain, which scans the retina at 40,000 scans per second, creating highly detailed images of the structure of the retina.

Because the OCT and HRA images are captured simultaneously, the clinician can be assured of the exact location of the area of interest and can correlate the outer visible retina structure with the internal structure.

“This new technology represents a dramatic leap in our ability to image complex macular disease,” said Scott Cousins, MD, director, Duke Center for Macular Diseases, at Duke University. “The combination of these two cutting edge technologies will amplify our understanding of retinal structure and provide us with new insights into the biological processes of the retina.”

The new product is built on the company’s successful Heidelberg Retina Angiograph (HRA) platform, the first commercial angiography system to use lasers in combination with marker dyes such as sodium fluorescein and indocyanine green (ICG). Using the HRA instead of white light photography has allowed clinicians to capture detailed images of the blood vessel structure within the retina, a key diagnostic indicator for such common eye disease as age-related macular degeneration and diabetic maculopathy. Another advantage of using lasers is the fast frame rate which enables movies of the blood flow, adding a new diagnostic dimension over traditional photography.

Of recent interest is the HRA’s capability to cause certain retinal components to fluoresce in a process known as autofluorescence. Geographic atrophy of age-related macular degeneration is being followed using autofluorescence as a potential early indicator of disease progression in the recently announced AREDS 2 clinical trial.

The new product will be presented at the upcoming American Academy of Ophthalmology meeting in November. The company expects to begin shipping the product in mid-2007.

About Heidelberg Engineering, Inc.

Headquartered in Heidelberg, Germany, this privately-held company is the leader in light-based diagnostics for ophthalmic applications and has the world’s largest installed base of laser imaging equipment. The company designs, manufactures and markets a variety of diagnostic instruments for application in retina, glaucoma and cornea diseases. U.S. corporate offices are located in Vista, California.

VISTA, CALIFORNIA – November 1, 2006 – Heidelberg Engineering, the leading developer of laser diagnostics for ophthalmic applications, announced the release of its HRT Retina Module Premium Edition. This new software features advanced capabilities to precisely evaluate retina thickness and to help detect macular edema.

Technical advances seen in this highly sophisticated device allow clinicians to accurately measure structural changes to the retina which is critical to diagnosing and treating serious conditions including:

Age-related Macular Degeneration (AMD)
Diabetic Macular Edema (DME)
Cystoid Macular Edema (CME)
The HRT uses laser technology to produce a topographical image of a patient’s optic nerve, providing an objective analysis of the structure’s cup, rim and retinal nerve fiber layer. The HRT Retina Module tops the market in speed, volume and precision. These advantages allow for minimizing eye movement artifact, because images are taken up to ten times faster than those of other imaging devices. The HRT acquires 200 times more data and scans 32 times more images-per-exam, which help deliver the most accurate test results possible. Utilizing vessel patterns and other landmarks, the HRT precisely aligns scans for composite images that clearly document changes over time.

Among the appealing features of the HRT Retinal Module—Premium Edition PowerCheck™ are:

§ Color-coded 2-D and 3-D thickness maps of the retina.
§ Edema Index that can reveal early structural change
§ Automatic image alignment for follow-up investigations
§ Thickness map overlaid on vessel pattern for comparison with color fundus, FA and ICGA
§ Detect structural change from DME at a preclinical stage
§ Real-time quality checks with instant operator feedback
§ Quick patient review, non-invasive, with or without dilation
§ Free positioning of ETDRS grid

HRT users appreciate that this new module fits all existing HRT units, and no additional hardware is required at installation*.

For further information visit www.HeidelbergEngineering.com; or to arrange a demonstration call: 1-800-931-2230.

* Computer processors < 2.0 GHZ need to be upgraded

VISTA, CALIFORNIA – October 16, 2006 – Heidelberg Engineering announces new software features for its Heidelberg Retina Angiograph II (HRA 2), a powerful imaging device used by specialists to detect and monitor abnormalities in the retina.

New features of the HRA 2 include:

• Wide Field Imaging provides real-time panoramic views of the retina in either angiography modes or non-invasive imaging modes.

• 55 Degree Lens adds to the currently available 30 degree lens for greater versatility.

• ART (Automatic Real-Time) software—a new method of “on-line” image processing which meshes single frame images into a higher quality composite image and can also smooth pan-retinal images to create a seamless wide field view of the entire fundus.

• Enhanced Autofluorescence Imaging using ART software brings crisp images of such evolving areas as geographic atrophy of AMD.

These new features are available on new equipment, or as a software upgrade package for existing equipment.

Background: The HRA 2 provides unmatched detail and contrast in angiography images of both the retina and the choroid. Unique simultaneous digital Fluorescein Angiography (FA) and Indocyanine Green Angiography (ICGA) images with three-dimensional resolution improve the diagnosis of retinal and choroidal pathologies such as diabetic retinopathy and AMD.

The HRA 2 is the preferred imaging device of retinal specialists in major research centers and in private practice. Laser imaging with the HRA 2 provides detail and perspective unseen in still photography, whether digital or film. The secret lies in the unique properties of confocal scanning laser technology which enable wavelength-selective imaging and rabid scanning speeds enabling 16-frame-per-second motion images.

With the HRA 2, dynamic high speed angiography—Motion pictures that capture the full cycle of dye uptake and clearing—gives doctors clear images of pathology, useful in diagnosis, tracking progression, and in client education. This non-invasive procedure uses autofluorescence, “red-free” and infrared imaging modes, to aid in early disease detection. ICGA enables a clear view into the choriod, eliminates the “fog” seen on standard photographs, images created in higher contrast, greater detail, help clinicians point details that are often obscured by white light flash photography techniques.

For more information visit the Heidelberg Engineering website at http://www.heidelbergengineering.com/; or contact the sales department at 1-800-931-2230.

HEIDELBERG, Germany — Feb. 9, 2006 — Heidelberg Engineering GmbH has received U.S. Food and Drug Administration (FDA) clearance for the company’s pioneering SL-OCT™ product, the world’s first commercial optical coherence tomography (OCT) device used for cross-sectional anterior segment imaging. The SL-OCT was first introduced in Europe, receiving CE mark certification in 2003.

The device is innovative in two ways: Not only is it the first commercial application of OCT for anterior segment imaging, but its mounting on a slit lamp offers users both space savings and cost advantages. The SL-OCT provides easy-to-use, noncontact cross-sectional scans of the anterior segment. Chamber angle, pachymetry, flap thickness, corneal curvature and comprehensive biometric measurements are possible with the instrument, as well as pre- and post-surgical comparisons.

Heidelberg Engineering is marketing two additional products in Europe based on OCT technology: OCPglobal™, a stand-alone pachymeter, and OCPonline™, an online pachymeter for integration into refractive laser systems. The online pachymeter enables refractive lasers to obtain noncontact corneal thickness measurements immediately before, during and after surgery, providing complete surgical documentation, speeding patient throughput and increasing accuracy.

“We are now the only diagnostic device company with access to the two leading technologies for diagnostic imaging: confocal scanning laser ophthalmoscopy and optical coherence tomography,” said Gerhard Zinser, Ph.D., managing director and head of research and development at Heidelberg Engineering. “Having access to both technologies enables us to select the right technology for the right application. For example, OCT has not been as well suited to glaucoma analysis, especially for measuring progression, due to the difficulties with OCT image alignment. We are already working on new products that combine the strengths of each technology.”

About Heidelberg Engineering GmbH
Headquartered in Heidelberg, Germany, the privately-held company is the leader in light-based diagnostics for ophthalmic applications and has the world’s largest installed base of laser imaging equipment. The company designs, manufactures and markets a variety of diagnostic instruments for application in retina, glaucoma and cornea diseases.