A rocky month for dental technology

The dental technology sector has had a difficult month as companies deal with a challenging business market, forcing some executives to make tough decisions to ensure stability and future success. 

Here are four dental techn company updates to know from the last month:

1. Intraoral scanner provider 3Shape and dental 3D scanner provider Medit recently settled U.S. patent infringement litigation. The settlement comes from a complaint filed against Medit in 2022, alleging that Medit's intraoral scanner systems infringed on 3Shape's patents for wireless scanning, scanning software and tooth color shade measurement.

2. Dental laser company Biolase has found a buyer after filing for Chapter 11 bankruptcy in October. The company had originally entered a $14 million purchase agreement to sell nearly all of its assets to dental technology company Sonendo, but the winning bid ended up coming from MegaGen Implant Co., a South Korean-based dental implant company. MegaGen was approved by a judge to acquire Biolase's assets for more than $20 million Nov. 15. 

MegaGen Implant plans to form a U.S. subsidiary to complete the transaction.

3. Dentsply Sirona is facing multiple probes stemming from a 2022 internal investigation into possible securities fraud and the company's decision to suspend the sale of its Byte clear aligners and impression kits.

Dentsply Sirona's internal investigation into possible securities fraud in March 2022. The investigation was completed in November 2022, with the company stating it identified "weaknesses in the company's internal control over financial reporting" and determined its financial statements and related disclosures for the months leading up to Sept. 30, 2021, and for the 2021 fiscal year are unreliable because of "certain misstatements contained in those financial statements." The investigation also determined that certain members of senior management violated provisions of the company’s code of ethics and business conduct. 

Several law firms launched investigations in 2022 and 2023 to look into possible breaches of fiduciary duties and federal securities law violations as a result of the investigation, with the most recent investigation beginning this month by Kaskela Law.

Three law firms are also investigating the company for the Byte suspension. Dentsply Sirona voluntarily suspended the sale and marketing of its Byte clear aligners and impression kits Oct. 24 while reviewing regulatory requirements. The company also paused shipment and processing of new and recently placed orders for the products. Byte disclosed in an Oct. 25 notice on its website that its patient onboarding workflow "may not provide adequate assurance that certain contraindicated patients do not enter treatment with Byte aligners." This conclusion followed a review of medical device reports related to its aligners and discussions with the FDA.

4. Invisalign manufacturer Align Technology announced its plans to lay off 700 employees worldwide in its third quarter financial documents filed Oct. 23. The company said it would also be eliminating the role of executive vice president and managing director of the Americas region and chief marketing officer, currently held by Raj Pudipeddi. 

John Morici, Align Technology's CFO and executive vice president of global finance, said the layoffs are meant to align the company's operations with the current business environment. 

Align anticipates restructuring charges during the fourth quarter, including approximately $30 million in severance. 

The decision comes after the company restructured its business during the fourth quarter of 2023, which led to approximately $14 million in restructuring expenses.

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