The FDA’s feedback is critical in EMvision’s growth narrative.
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The EMvision Medical Devices Ltd (ASX: EMV) share price has spent the morning in the red. It is currently changing hands for $2.91, down 5.21%.
EMvision’s shares are on the move today after it announced an important update regarding a device application in the United States.
Here’s what we know.
What did EMvision announce?
For context, EMvision is currently on the tools developing a portable medical imaging device that uses electromagnetic microwave imaging.
Its primary purpose is to diagnose the serious and complicated brain condition known as a stroke. However, it will diagnose other conditions as well.
EMvision advised it had received feedback from the US Food and Drug Administration (FDA) on its recent application for a Breakthrough Device Designation (BDD) in the US.
Under the Breakthrough Devices Program, applicants get priority review of their proposed therapy or intervention. This includes “interactive communication across the device development and validation path,” per the release.
The release notes that preliminary evidence supports the use of its technology to “differentiate and localise” both types of stroke in patients.
However, the company reports that the FDA requires more clinical study data to support the case. It will need this before EMvision’s device can get approval for the market.
As a result of the FDA feedback, EMvision advised it “has not been granted the BDD at this time.”
It’s not all over, though. The company still intends to go after the BDD once it has the clinical data on hand. EMvision will “generate [data] through further clinical development.”
Importantly, the company emphasises that its pursuit of the “FDA De Novo regulatory marketing authorisation pathway” for its 1st Gen portable brain scanner product remains unaffected.
EMvision itself didn’t appear to be fazed by the rejection. The medical tech company opting to take the feedback on board instead and get the ball rolling again.
Speaking on the announcement, EMvision CEO Dr Ron Weinberger said the company was “grateful for the quality feedback” provided by the FDA.
The decision has done little to deter the company’s growth vision. Weinberger confirmed the marketing authorisation “remains unchanged, as does (its) preparation for expanded future clinical studies.”
EMvision share price snapshot
The EMvision share price has had more than a choppy year so far, and has lagged the major benchmarks with a year-to-date loss of 5.81%.
Despite this, it’s rallied 4% this past month, and is still 14% in the green over the past year.
Nonetheless, the EMvision share price has lagged the S&P/ASX 200 Index (ASX: XJO) gain of around 21% in the 12 months.
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The author Zach Bristow has no positions in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. owns shares of and has recommended EMvision Medical Devices Limited. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.