Clinical Trials
4
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
25.0%
Completed
1
25.0%
Not yet recruiting
1
25.0%
Recruiting
1
25.0%
No approval data available
- TISSIUM has secured a financing package worth up to €60 million ($68.2 million), including a €30 million Series D2 round and a €30 million facility from the European Investment Bank. - The funding will support the U.S. commercial rollout of Coaptium Connect, the company's first FDA-authorized sutureless platform for atraumatic peripheral nerve repair. - TISSIUM also appointed Marc Quartulli as Vice President of Clinical Affairs to strengthen clinical strategy and regulatory readiness across its three core indications. - The company's pipeline includes applications in atraumatic hernia repair and cardiovascular sealing, with an IDE clinical trial for ventral hernia repair approved in September 2025.
- TISSIUM's COAPTIUM® CONNECT with TISSIUM Light has received FDA De Novo marketing authorization, becoming the first and only FDA-authorized system designed for atraumatic sutureless nerve coaptation. - The system addresses limitations of traditional microsurgical sutures by offering a reproducible, atraumatic alternative that preserves nerve integrity and simplifies the coaptation process for peripheral nerve injuries. - In a clinical study of 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success with all patients regaining full digit function and reporting no pain at 12 months. - This regulatory milestone marks TISSIUM's entry into the U.S. market and validates the company's biopolymer platform for tissue reconstruction applications.
