Inside Dental Hygiene
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Cube Click’s SMILE Dx Receives FDA Approval for Dental AI Diagnostic Platform
Cube Click, Inc. has received approval from the US Food and Drug Administration (FDA) for its SMILE Dx platform, an AI-based diagnostic tool designed for dental imaging. SMILE Dx analyzes radiographs to assist in the identification of dental issues, including cavities (caries), root canals (periapical radiolucencies), and periodontal disease.
“The Dental AI imaging market is growing at a compound annual growth rate (CAGR) of 22.3%. If SMILE Dx captures just 2% of this $3.1 BILLION market, that translates to $62 MILLION in annual revenue,” said Dr. Richard Ricci, CEO of Cube Click. “At a conservative 5x revenue multiple, SMILE Dx could command a $310 MILLION valuation. Under a more optimistic 10x multiple, that valuation rises to $620 MILLION, highlighting the significant upside potential for early investors.”
FDA data indicates that dentists may misdiagnose over 20% of cavities and root canal pathologies. According to Cube Click, SMILE Dx aims to improve diagnostic accuracy, with clinical studies showing an average 19% improvement in detection rates. The system is cloud-based and integrates with existing dental imaging setups, including both digital and phosphor plate sensors.
Additional technical and operational details include: FDA approval for use with both digital and phosphor plate sensors; FDA clearance for detection of primary, secondary, and gross caries; six awarded US patents and three pending applications; subscription-based cloud platform designed to support scalability and recurring revenue.
“SMILE Dx® represents a significant market disruptor,” said Dr. Andrea Cambria, CFO of Cube Click. “By dramatically improving diagnostic accuracy and treatment acceptance rates, we are unlocking substantial new revenue streams for dental practices—while creating a highly scalable, subscription-based business model for Cube Click.”
