Press release
Dentsply Sirona Provides Update on Byte Aligner Products
Voluntarily Suspends Sales and Marketing of Byte Aligners and Impression Kits Provides Select Preliminary Third Quarter 2024 Results CHARLOTTE, N.C., Oct. 24,
About this update from Dentsply Sirona Inc.
[{"type":"text","content":"Voluntarily Suspends Sales and Marketing of Byte Aligners and Impression Kits Provides Select Preliminary Third Quarter 2024 Results CHARLOTTE, N.C., Oct. 24, 2024 (GLOBE NEWSWIRE) -- DENTSPLY SIRONA Inc. (“Dentsply Sirona” or the \"Company\") (Nasdaq: XRAY), today announced the voluntary suspension of sales and marketing of its Byte Aligners and Impression Kits while the Company conducts a review of certain regulatory requirements related to these products. The Company’s decision was made in consultation with the U.S. Food and Drug Administration (FDA). In connection with this review, and Dentsply Sirona’s proactive efforts to continuously improve its processes, the Company has suspended shipment and processing of new and recently placed orders for Byte Aligners and Impression Kits. The Company holds itself to the highest standards of quality and compliance with patient safety at the center of everything we do. To that end, we will continue to work closely with the FDA and other regulatory authorities, while communicating with treating dentists and their patients to support their continued care as appropriate. Independent of the above matter, the state regulatory environment has adversely impacted our Byte Aligner business model, resulting in declining conversion rates, and new documentation, records and additional requirements (such as evidence of visits to a dentist or patient x-rays). As a result, we had begun to assess our resources at Byte to leverage and/or redeploy infrastructure, talent, and capability elsewhere in our business. Examples include augmenting resources to improve other software platforms, accelerating DS Core functionality, and enhancing the patient experience. Additional details regarding today’s announcement can be found in the Company’s Form 8-K that was filed today with the Securities and Exchange Commission (SEC). Select Preliminary Third Quarter 2024 Results Dentsply Sirona is also announcing select preliminary financial results for the three months ended September 30, 2024 (“third quarter 2024”). The Company expects to report third quarter 2024 net sales of approximately $951 million and adjusted EPS is expected to be between $0.49 and $0.51. For the third quarter 2024, the Company expects to report year-over-year net sales growth in Essential Dental Solutions, partially offset by declines in Orthod...