The regulatory shift follows a period of uncertainty triggered in May, when CMS lowered rates after the FDA reclassified these devices from Class III to Class II. At the time, the company warned investors that the change would erase positive cash flow for the year and force a 10% reduction in average reimbursements. By withdrawing the guidance without issuing an immediate replacement, the agency has effectively nullified that financial headwind.
Investors responded sharply to the news, pushing shares of Orthofix up 10% to $10.96 in after-hours trading. Despite this recovery, the stock remains down 34% for the year, reflecting the volatility caused by the initial reclassification. The company confirmed the policy restoration in a Thursday filing with the Securities and Exchange Commission.
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