Tenon Medical (NASDAQ: TNON) shares skyrocketed over 283% in regular trading on Tuesday following a major regulatory win. The company announced that the U.S. Food and Drug Administration (FDA) has granted an expanded indication for its Catamaran® SI Joint Fusion System. The device, which was initially approved for Sacroiliac Joint (SIJ) disorders, is now approved for augmenting thoracolumbar fusion, potentially unlocking a new market segment.
The approval marks a significant milestone for Tenon Medical, as it could drive broader adoption of the Catamaran system, particularly among physicians incorporating spinal fusion procedures into their practices.
Richard Ginn, Co-Founder and Chief Technology Officer of Tenon Medical (NASDAQ: TNON), emphasized that the expanded approval allows the company to enter a previously untapped market. He highlighted the Catamaran system’s unique design, which enhances surgical flexibility and provides physicians with a more effective tool for treating spinal conditions.
Chief Executive Officer Steve Foster called the FDA clearance a major milestone in line with the company’s long-term growth strategy. He pointed to encouraging clinical data from the MAINSAIL trial, demonstrating the system’s safety and effectiveness in SI Joint fusion. Foster expressed confidence that this approval validates the Catamaran’s effectiveness and strengthens Tenon Medical’s market position in complex spinal surgeries.
Investor enthusiasm was evident in the stock movement, reflecting optimism about Tenon Medical’s ability to capitalize on this new opportunity. With FDA approval and continued advancements in medical technology, the company is strengthening its foothold in the medical device industry, particularly in complex spine surgeries.
