Inspire Medical reveals DOJ civil investigation

CEO Tim Herbert told investors the company received a civil investigative demand from the Department of Justice in January for information on marketing and reimbursement practices.

Inspire makes mask-free implants to treat obstructive sleep apnea. The implants deliver pulses to help keep patients’ airways open and improve breathing during sleep. The company plans a full launch of its Inspire V device in 2025 after receiving Food and Drug Administration approval last year.

Inspire reported strong quarterly and annual revenue growth ahead of its earnings call. However, the announcement of the DOJ investigation overshadowed the financial performance and brought several questions from analysts.

The CID, which came from the DOJ’s U.S. Attorney’s Office for the District of Minnesota, is related to the government’s investigation into allegations of false claims submitted to government payers in connection with Inspire’s implants, including false claims arising from violations of the Anti-Kickback Statute, according to a securities filing.

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