Acquisition of Spin-out Company Bioptigen to Bring Duke Imaging Technology to New Markets

Joe Izatt and student

Professor Joe Izatt, right, works with a student on OCT research.

In June 2015, microscopy and imaging systems company Leica Microsystems acquired Bioptigen Inc., a company born from Duke's Pratt School of Engineering. Formed in 2004, Bioptigen has become a leader in optical coherence tomography (OCT), an imaging technique that uses light to capture extremely high-resolution, three-dimensional pictures of the eye.

Bioptigen was the brainchild of Duke’s Michael J. Fitzpatrick Professor of Engineering Joseph Izatt and CEO Eric Buckland. Since its launch, the company secured more than 60 issued patents in OCT technology, many of which were licensed from intellectual property developed by Izatt, his students, and collaborators at Duke and Case Western Reserve University.

Below is an excerpt from an interview with Izatt. The full interview is on The Duke Innovation & Entrepreneurship Initiative website.

Q: How does OCT diagnose eye disease?

IZATT: OCT produces 2-D and 3-D images of tissue with a resolution scale many times finer than other medical imaging modalities such as ultrasound, computed tomography or magnetic resonance imaging. It provides in-depth, cross-sectional images of tissue with a resolution of about 10 micrometers – smaller than the width of a human hair. By 2003, using the new fast imaging technology, we were able to obtain these cross-sectional images live at video rate – essentially movies taken inside of living tissue. That was a big advance over the prior technology, which took several seconds per image. By taking these movies while also scanning the light in the third dimension across the tissue, we could acquire three dimensional blocks of data which doctors could explore in detail later using special software. 

Most optical images people are familiar with are images of the surface of things — with conventional ophthalmoscopes, for example, doctors look at the surface of the retina through a special microscope. OCT allows you to go from surface imaging to cross-sectional or volumetric imaging and with much greater resolution. That’s important because many diseases that cause blindness are quite subtle to diagnose accurately with conventional instruments, requiring many years of training. The retina is a layer of neuronal tissue spread out over the back of the eyeball which is only a half-millimeter thick, and telling the difference between various kinds of injuries, detachments and the effects of blinding diseases such as macular degeneration or diabetic retinopathy can be challenging. OCT is a major advance in the speed and ease of diagnosing these problems, and just as importantly in monitoring their successful treatment.

 

Q: How did Bioptigen progress as a company and move its technology forward?

IZATT: One of Bioptigen’s first products to go to market was a table-top instrument for retinal imaging--one of the first instruments using the new fast imaging technology to receive clearance from the Food & Drug Administration. Previous OCT instruments were not optimized for speed, and in many cases if a doctor ordered a test, the imaging would be done by a technician and the doctor wouldn’t see the resulting images until much later. Bioptigen’s key strategy was to develop technologies to obtain the highest quality images and to do it in real time, so that doctors themselves could operate the instrument while interacting with patients and see the images right away.

Bioptigen’s first product, which made successful use of its real-time imaging capability, was the industry’s first commercial handheld OCT device. A doctor can hold this device over the patient’s eye and the images appear simultaneously on a screen so the doctor can tell right away whether he or she is collecting the right images correctly. It’s particularly helpful with patients who aren’t easy to accommodate with previous table-top technologies, such as children, babies or bed-ridden patients.

 

Q: How is Bioptigen technology being used?

IZATT: There were two principal applications Bioptigen developed for its handheld OCT technology. The first was pioneered by Dr. Cynthia Toth, the Joseph A.C. Wadsworth Professor of Ophthalmology here at Duke with whom I have collaborated for over 15 years. She recognized the potential for handheld imaging of babies and children. Babies squirm and cry, so imaging them takes quite a bit of skill. Dr. Toth introduced the concept of using the handheld OCT device in the pediatric arena, and used it in a landmark study in premature babies to discover fundamental new knowledge about how the retina develops before and even after birth. Dr. Toth now runs a course for pediatric ophthalmologists who come to Duke from around the world for them to learn from her team how to do these examinations.

The second major market for Bioptigen handheld OCT was in pre-clinical imaging – animal imaging. No other OCT company had taken that market seriously, but with the development of Bioptigen’s handheld device, research labs could use state-of-the-art ophthalmic imaging technology on mice, rats and other important research animals for the first time. This was quite successful for Bioptigen and remains important to advance our fundamental understanding of disease and to test treatment protocols.

 

Q: What role or roles did Duke play in getting Bioptigen to this point and supporting your efforts?

IZATT: Over its history, Bioptigen licensed more than two dozen patents from Duke. These arose from research in my laboratory done by myself and many students, post-docs and collaborators. Bioptigen also developed a very substantial patent portfolio on its own, the extent of which was a key component of its attractiveness for acquisition.

Throughout this start-up experience, Duke’s policies on faculty outside activities, conflicts of interest, and inventions, patents, and technology transfer were instrumental in enabling my constructive involvement in Bioptigen while maintaining my professional responsibilities as a faculty member.

The Duke Office of Licensing and Ventures (OLV) deserves credit for managing my laboratory’s substantial patent portfolio and putting considerable effort into negotiating and administrating licensing deals appropriate for a start-up company. Duke had to take a chance on each of our patents, and to be flexible in dealing with a small entity.