Post its exit, SmileDirectClub left behind $450 million-dollar business on the table, adjusted for full year basis. More than 80 percent of this business value was open to be captured in North America alone, and insightsZ predicted that homebrewed DTC brand Byte™ was particularly expected to benefit from this windfall. And despite a challenging macro environment LTM, Byte™ did succeed in capturing an outsized share of growth – growing at +18% and +16% in Q1’24 and Q2’24 respectively (on YoY basis) and making it to the list of insightsZ Superbrands.
Fast forward to OCT 25, XRAY announced voluntarily suspending the sales & marketing activities of its Byte aligners. This move comes as XRAY reviews its regulatory requirements in consultation with the U.S. FDA.
insightsZ analyzed all MDRs related to Byte™ within the FDA’s MAUDE database and performed quant analysis of the event descriptions for the observation period (Jan 1 – Sep 30, 2024) – focussed on product code of ‘NXC’ (sequential aligners) for brand name ‘Byte’. As we earlier expected, our analysis revealed that there is much more to it than meets the eye.
Like SDC, Byte too suffered from ongoing Quality issues – as became evident by the sheer volume as well as seriousness of the patient injuries (Reportable Per 21 CFR Part 803), and adverse events reported in the FDA MAUDE database.
The company's recent announcement underscores that the launch of Byte+ represents ‘insufficient’ and ‘delayed’ damage control efforts.
Find out more about our deep-dive into Byte's adverse event reports in the FDA MAUDE database here. Please note that our Research Report is available for paid members only.
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