Cubresa Files First FDA 510(k) Application

Cubresa Inc. is pleased to announce the company has submitted the Cubresa BrainPET™ 510(k) Premarket Notification to the Food and Drug Administration (FDA)

This submission marks a pivotal step in our company’s mission to bring world-class brain imaging technology into clinical settings,” remarked James Schellenberg, Cubresa’s Founder and CEO, “by seeking FDA clearance for our BrainPET technology, we are moving one step closer to providing clinicians with high performing, cost-effective, simultaneous PET/MRI imaging to assist in the diagnosis and monitoring of a broad spectrum of brain diseases.”

A huge thank you to our incredible team, partners, and investors who help Cubresa reach this milestone.

Forward Looking Statements
This release contains certain forward-looking statements regarding Cubresa’s 510(k) premarket notification to the FDA for the BrainPET™ System. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, and there can be no assurance that Cubresa will obtain 510(k) clearance from the FDA for the BrainPET™ System or as to the timing of any such clearance. Many of these risks and uncertainties are beyond the company’s control, including without limitation, risks relating to regulatory clearance and market acceptance of the System.