Tenon Medical, Inc. is a medical device company, which engages in the development of a minimally invasive approach to the sacroiliac joint (SI joint) using a single titanium implant for treatment of the most common types of SI Joint disorders. The company was founded by Richard Ferrari and Richard Ginn on June 19, 2012 and is headquartered in Los Gatos, CA.
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- Tenon Medical received FDA 510(k) clearance for its SImmetry+ sacroiliac joint fusion system, featuring 3D-printed titanium implants and minimally invasive lateral access technology. - The system utilizes proven orthopedic principles including joint decortication, bone graft delivery, and fixation to achieve true fusion for SI joint disruptions and degenerative sacroiliitis. - The clearance expands Tenon's portfolio to include both Catamaran and SImmetry+ systems, providing multiple surgical approaches backed by clinical evidence. - The company plans an alpha launch by the end of 2025 with select physicians to gather feedback before broader market introduction.
- Tenon Medical's MAINSAIL study demonstrates statistically significant pain reduction from 78.8mm to 23.0mm on VAS scale and disability improvement from 51.6% to 20.8% on ODI scale at 12 months (p<0.001). - The Catamaran SI Joint Fusion System achieved an 83% fusion rate with bridging bone across the SI joint, as confirmed by independent radiological review of CT scans. - The minimally invasive procedure showed robust safety profile with no serious adverse events, re-operations, or vascular injuries, while 83.3% of patients reported high treatment satisfaction. - Clinical outcomes exceeded literature benchmarks, with 57.8-point VAS improvement and 30.4% ODI improvement surpassing averages from prior SI joint fusion studies.
- Tenon Medical announced the full commercial launch of its Catamaran SE SI Joint Fusion System, featuring a reduced profile design compared to the original device. - The new implant provides surgeons greater flexibility for treating patients with smaller SI joint anatomy or performing revision surgeries where space is limited. - More than 1,000 Catamaran devices have been implanted to date, with early findings from the MAINSAIL Clinical Study indicating strong potential for successful fusion. - The launch includes expanded inventories and enhanced field support following the company's recent SiVantage acquisition.
- The FDA has granted Tenon Medical clearance for an expanded indication of its Catamaran SI Joint Fusion System to augment thoracolumbar fusion, beyond its original standalone treatment purpose. - The expanded indication represents a significant milestone for Tenon Medical, opening access to a previously untapped market segment and providing spine surgeons with additional treatment options for complex cases. - Clinical data from the ongoing MAINSAIL trial demonstrates the Catamaran system's ability to achieve authentic SI joint fusion in a safe, reliable, and efficient manner, particularly beneficial for supporting multi-level fusion procedures.
- Tenon Medical has secured $3.0 million in gross proceeds through a warrant inducement agreement with an existing healthcare-focused institutional investor at a reduced exercise price of $1.25 per share. - The transaction involves the immediate exercise of existing Series A and B Warrants, with the investor receiving new Series C-1 and C-2 Warrants that will be exercisable upon stockholder approval. - Proceeds will support Tenon's continued development and commercialization of The Catamaran SI Joint Fusion System, which offers a less invasive approach to treating sacroiliac joint disorders.
