PARIS – Intrasense SA, of Montpellier, France, has gained CE marking for its CT scanner reading protocol designed for COVID-19. “This major step forward, coming at the same time as U.S. FDA clearance, will allow a true mass rollout of our Myrian XP-Lung system designed for COVID-19,” Nicolas Reymond, CEO of Intrasense, told BioWorld.

In light of recommendations issued by academic associations, including the American College of Radiology and the French Society of Radiology, the chest scanner is indicated as a reference examination as part of patient follow-up for those with suspected or confirmed, or signs of deteriorating, COVID-19. Until now, no medical imaging software suite has made it possible to quantify lung damage objectively, and thus to classify COVID-19 patients into one of five stages to determine the therapeutic response.

Electronic, computer and image processing engineers from Intrasense developed this scanner protocol in just three weeks. It will be available free of charge to health care professionals in hospitals. “We have already received more than 450 license applications,” said Reymond.

15 years of research, $11M invested in R&D

Nicolas Reymond, CEO of Intrasense SA

This latest software suite from Intrasense is based on Myrian, a platform for medical imaging and advanced postprocessing. The platform is the result of 15 years of development, millions of lines of code and $11 million invested in R&D.

“Our COVID-19 protocol, based on Myrian XP-Lung, automatically measures the patient’s expiratory reserve volume,” said Reymond. This protocol provides a separate figure for the left and right lungs. It automatically calculates total lung capacity and functional reserve capacity, while also visualizing healthy areas. The protocol also makes it possible to differentiate and quantify the different types of COVID-related lesions: “frosted glass,” “condensation,” “crazy-paving” nodules and areas with emphysema. “Lastly, it automatically generates a full report in keeping with academic association recommendations,” said Reymond.

A single U.S.-based competitor

The company has just one direct competitor among the suppliers of advanced imaging systems: Durham, N.C.-based Terarecon Inc. That company announced May 7 the launch of two new lung density analysis systems for assessment and vital follow-up care of COVID-19 patients. These systems provide two deployment options for rapid access to lung segmentation and quantification tools that can be applied to a range of lung conditions.

With that said, Intrasense remains the player that reacted first – and with a validated and more intuitive clinical application. Terarecon’s system is not FDA cleared or CE marked. Further, the company noted that the volumetric histogram and lung segmentation functionality is not FDA cleared specifically for COVID-19. “It should only be used as an aid, and that final interpretation should be performed by a licensed health care practitioner with the appropriate training,” it said in a release. In terms of functionality, Terarecon uses a range of threshold windows that each give a percentage; it is then up to the user to define the lesions coming under “frosted glass," “condensation," “crazy paving” and areas with emphysema.

A potential market worth more than $800M

Intrasense is developing a business model based on three pillars: direct sales of its multimodal systems to hospitals in France and China, partnerships with artificial intelligence startups that want to integrate their innovation into the Intrasense platform, and agreements with other suppliers of hyper-specialized image processing systems.

Last year, Intrasense posted sales growth of 10.6%. Reymond said “the continents of Europe and Asia constitute our commercial priority.” China, where it has a subsidiary in Shanghai, accounts for 29% of its revenues. Intrasense is targeting a potential market of over more than $800 million of the $3 billion or so achieved by advanced imaging software. “We intend basing our growth on R&D and targeted investment, with key partnerships in those two continents,” said Reymond.

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