About Bioptigen

As a pioneer in the development and manufacture of leading edge Spectral Domain Optical Coherence Tomography (SDOCT) equipment and software, Bioptigen is helping researchers open windows into the wonders of ocular development and the mysteries of ocular disease.

Bioptigen Envisu™ SDOIS systems and software are used at leading institutions worldwide for in vivo optical imaging to advance translational research objectives. Envisu systems enable real-time, non-invasive imaging of internal tissue microstructures, and is supported by a growing array of tools for visualization and data analysis. We believe that we are only just beginning to explore the richness of information embedded within high resolution OCT images.

Our Vision

Images Matter. Spectral domain optical coherence tomography is a critical tool for understanding the nature of the physiology of the eye, the processes of disease, and the efficacy of therapy. As rapid and broad as the adoption of OCT has been in clinical ophthalmology, tremendous opportunity remains to exploit the richness of high resolution OCT images for new markers of diseases of the eye. The benefits of OCT must be extended to the pediatric population that is not well served by tabletop imaging systems, and through truly portable OCT to underserved populations throughout the world. Extracting the greatest value from OCT begins with the image.

Our Mission

At Bioptigen, we have lead the industry with high resolution image quality and system versatility. We were the first company to introduce OCT systems convertible from posterior to anterior imaging, the first company to introduce OCT imaging for neonates and premature infants, and the first to introduce handheld OCT perioperative applications. Our mission today is to bring our fundamental capabilities to the broader pediatric and perioperative markets, improve our ease of use, and introduce new tools for research and clinical diagnostics. We will constantly strive to be your preferred partner in research and opening new avenues of diagnostic ocular healthcare.

Our Quality Policy

Bioptigen strives to be the leader in OCT medical and research imaging by providing demonstrably better quality images earlier in the disease process and contributing to better outcomes in therapeutic planning, execution and follow-up. We are committed to maintaining compliance with applicable regulatory requirements while pushing the frontier of healthcare research through the provision of unique, advanced tools to both pre-clinical and clinical users. We will consistently meet these commitments by maintaining an effective and efficient quality management system and establishing and reviewing quality objectives tailored specifically to meet the needs of our customers.

Indications

Please note that Bioptigen Inc. in no way endorses use of its Envisu Spectral Domain Ophthalmic Imaging Systems (SDOIS) for human use outside of the following indications:

The Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). Envisu SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaging patients under anesthesia.

Awards and Recognition

Bioptigen has been awarded multiple Phase II Small Business Innovation Research grants administered through the National Eye Institute of the National Institutes of Health.

In 2007, Frost & Sullivan awarded Bioptigen with its prestigious North American Excellence in Research Award, which honors disruptive research and development that has great potential to change its industry.

Bioptigen is located in Research Triangle Park, NC, within the geographic nexus of three world-renowned research universities – Duke University, North Carolina State University and the University of North Carolina at Chapel Hill.

 

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