San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time.

The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions. Align plans to roll out the Itero Element 5D scanner in the U.S. during the second quarter of 2020. However, officials acknowledged the market’s uncertainty as the country continues to grapple with COVID-19.

Diagnosing interproximal lesions can be difficult, due to factors such as the shape and alignment of teeth. Traditional X-ray exams often fail to provide a clear picture due to variability in exposure level, bad angulations in the X-ray image or overlapping contacts in the image. Using Itero Element 5D’s integrated technology, doctors can scan patients on a regular basis and discuss treatment options, based on the changes they see over time.

Better patient engagement

Itero Element 5D is designed to improve patient engagement and compliance with recommended dental treatments, the company said. The NIRI technology helps to detect and monitor interproximal caries lesions, cavities that occur between two adjacent teeth, above the gingiva without the use of radiation. The integrated dental imaging system records 3D, intraoral color and NIRI with a single scan, allowing for comparisons over time utilizing the company’s Itero Timelapse technology.

Other features include analysis instruments and the Invisalign Outcome Simulator and Progress Assessment. One full arch scan takes about a minute to complete.

The company noted that doctors will still need X-rays to see through bone and surrounding structures. The Itero Element 5D system is intended to complement traditional X-rays as part of comprehensive dental care.

Three scanning technologies in one

“The Itero Element 5D Imaging System seamlessly combines three key scanning technologies – 3D data, intraoral color photos and NIRI images – into one, integrated scan, and we are excited to bring this advancement in intraoral scanner technology to the U.S. market to help doctors provide better oral care for their patients,” said Yuval Shaked, Align’s senior vice president and managing director for Itero scanners and services. “At the same time, we are mindful of the current environment and the impact that the COVID-19 pandemic is having across the word and are focused solely on customer education regarding this new technology while so many dental practices in the U.S. are operating on a limited schedule.”

An Align spokesperson told BioWorld that the company has taken a number of proactive steps to limit the exposure of its teams around the world, including travel restrictions and screening procedures.

Align launched the Itero Element 5D system outside the U.S. in the spring of 2019. It is currently available in Europe, the U.K., Canada, Latin America, Australia, New Zealand, Hong Kong, Thailand, Japan, South Korea, Singapore and Taiwan.

A survey of OUS doctors who had used the system for at least six months reported upticks in interproximal caries detection, patient acceptance of treatment recommendations and practice revenue, the company said.

Pandemic’s impact

Align reported $2.4 billion in revenue for fiscal year 2019, up 22.4% from the previous year. Revenue from Itero scanners grew 38.5% year over year to $381 million. During a fourth-quarter earnings call in January, CEO Joseph Hogan reported that more than 20.5 million orthodontic scans and 4.7 million restorative scans have been performed with Itero scanners.

In a March 18 Form 8-K filing with the Securities and Exchange Commission, Align said that global disruptions to its business – from dental practice closures and travel restrictions – as a result of COVID-19 is taking a toll on the company. “We now expect these disruptions will have a material impact on our financial results in the first quarter of fiscal year 2020 and is expected to continue into the second quarter of 2020,” the filing notes. “At this date, we cannot predict the specific extent or duration of the impact of the COVID-19 outbreak and the actions to slow its spread on our financial results.”

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