FDA Clearance for New Indication
The FDA cleared the Catamaran SI Joint Fusion System for an extended indication for use in augmenting thoracolumbar fusion. This expands the platform's versatility and opens a previously untapped market, potentially increasing adoption.
Strong Intellectual Property Portfolio
Received two European patents in the first quarter related to the Catamaran SI joint fixation device. The portfolio now includes 12 issued US and foreign patents, along with 31 pending applications.
Positive Clinical Outcomes
Interim analysis from the MAINSAIL study showed statistically significant reduction in SI joint pain and disability at six months, with a robust safety profile and high patient satisfaction.
Significant Cash Infusion
Received $7.1 million in gross proceeds from equity financing, contributing to a cash balance of $10.3 million, providing a strong runway for future growth initiatives.