Medical device company Bioptigen is developing its medical imaging technology into a new device for eye surgeries and the North Carolina firm has found two partners to join the effort.
Bioptigen will combine its imaging technology with research from Irvine, California-based Adventus Technology and The Brien Holden Vision Institute, an Australian nonprofit group that works in eye care research.
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Bioptigen CEO Eric Buckland did not return phone calls seeking comment. But information on Bioptigen’s website says that the new device will be developed by the Research Triangle Park, North Carolina-based company. Bioptigen has already commercialized a device that allows a doctor to see images of the inner areas of the eye. The system employs technology called optical coherence tomography, or OCT. The technology is analogous to ultrasound but uses low power light instead of sound waves. Bioptigen says that OCT provides resolution 100 times finer than ultrasound. This device can be used to image the retina or other parts of the eye to study the eye and diagnose eye conditions. The non-invasive device scans the eye without touching it. But it is not currently used in eye surgeries.
The new device would combine Bioptigen’s technology and expertise in the posterior of the eye with the anterior eye knowledge of Adventus. The new device will employ software “that enhances surgical precision.”
Adventus is currently working on its own initiative called the Dynamic Vision project, an effort to develop a product that replaces the natural ocular lens of the eye with a polymer gel. This gel would be a replacement for patients who have presbyopia or cataracts. Sylvie Franz, deputy CEO of Adventus Technology, said in a statement that the new surgical device that will be developed has potential for broader applications, including use in the 18 million cataract surgeries conducted worldwide each year.
Bioptigen has some new money to finance its new initiative. Securities filings show that the company has raised $1.5 million, the company’s first new funding in four years. Only Buckland and CFO Thomas Livingston are listed on the filing.
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Bioptigen was founded in 2004 based on spectral domain technology developed in the biomedical engineering department of Duke University’s Pratt School of Engineering. The company’s eye imaging devices are currently used by doctors for non-invasive imaging of the eye. But the company recently raised concerns from the U.S. Food and Drug Administration. The agency in February sent a warning letter to Bioptigen regarding how the company was marketing its product. The FDA expressed concern that information on Bioptigen’s website and brochures claims that the hand-held system may be used for specific diagnostic purposes such as retinopathy of prematurity, pediatric retinoblastoma and shaken baby syndrome. These uses are outside of the company’s 510(k) clearance, the letter said.
In a response to the warning letter, Buckland acknowledged that Bioptigen’s marketing materials “might be interpreted as suggesting diagnostic capabilities exceeding cleared indications for use.” He noted that while those suggestions were not intended, the company has completely revised the marketing material. He emphasized that technology provides images and it’s up to doctors to decide how to view them.
“While our system provides distinctly beautiful and high quality images, the responsibility for interpreting those images and providing a diagnosis rests with you, the clinician, as it always has,” he said.
