It’s going, going, gone; Tenon (NASDAQ: TNON) stock up almost 400% in Pre-Market on Announcement of FDA Clearance

Tenon Medical, Inc. (NASDAQ: TNON) (“Tenon” or the “Company”), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of an expanded indication for the Catamaran® SI Joint Fusion System (the “Catamaran”) for use in augmenting thoracolumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion.

“The FDA has cleared the Catamaran SI Joint Fusion System for use in augmenting thoracolumbar fusion,” commented Richard Ginn, Co-Founder and Chief Technology Officer of Tenon Medical. “This is a significant milestone for Tenon Medical, as this new indication opens the door to a previously untapped market. The Catamaran stands out due to its unique design, providing physicians with greater flexibility in treating patients.”

“Recognition from the FDA of Catamaran’s use to augment spinal fusion has been a long-term goal of Tenon during the development of the Catamaran SI Joint Fusion System,” said Steve Foster, Chief Executive Officer of Tenon Medical. “As our clinical experience grows and the data from our MAINSAIL clinical trial emerges, it is clear that we achieve an authentic fusion of the SI Joint in a safe, reliable and efficient manner. We believe this can be an important tool in the complex spine surgeon arsenal to support the base of a multi-level fusion. This important achievement instills further confidence that the Catamaran delivers on its promises and unlocks access to a significant market opportunity for Tenon Medical.”