Following the US Food and Drug Administration’s (FDA) decision to award a De Novo authorisation to Tissium’s sutureless nerve repair system exactly one year ago, the fledgling medtech company is gearing up for its market debut after banking €60m in financing.
The funding comes from a €30m Series D2 financing round and a further €30m funding agreement with the European Investment Bank (EIB) available to Tissium in three clinical, commercial and financial milestone-tied instalments. It will allow Tissium tol take the COAPTIUM CONNECT system to market – making it the first atraumatic system of its kind to reach US patients.
The Coaptium Connect system is based on Tissium’s platform, which harnesses a light-activated surgical polymer to join severed nerve ends together within a bioresorbable, 3D printed biopolymer chamber. When performing a procedure with Coaptium Connect, surgeons use silicone applicators to ensure a controlled connection between the nerve endings. After this, they use a light to activate the viscous pre-polymer, creating a flexible bond that facilitates nerve healing.
This marks a new approach in peripheral nerve surgery to traditional suture-based methods, which can often be associated with scar formation, variable outcomes in terms of the quality of repair, and potentially more nerve damage caused by the procedure itself.
According to Christophe Bancel, CEO and co-founder of Tissium and brother of Moderna’s CEO, this financing round will be pivotal in the medtech company’s transition to a commercial-stage company, while further funds will allow it to “continue advancing a differentiated pipeline” built on its biopolymer platform.
The French medtech company also plans to allocate some capital from this raise to expand its platform, which prominent biomedical scientists, Maria Pereira, Jeffrey Karp and Robert Langer originally invented at the Massachusetts Institute of Technology (MIT) and Brigham & Women’s Hospital.
Expanding use cases
In a previous single-arm clinical study (NCT04327154), the Coaptium Connect system touted a 100% procedural success rate in 12 patients with nerve injuries present in their fingers or thumbs, with all patients being able to fully flex and extend the injured digit with no pain one year after the procedure.
However, Bancel has further plans for Tissium's technology beyond peripheral nerve repair, with the company's pipeline including a high-pressure vascular sealant for cardiovascular care and an atraumatic hernia repair solution, which researchers are currently evaluating in the clinic.
Tissium debuts its entirely atraumatic solution with a potential competitive advantage against other players in the nerve repair space, such as BioCircuit’s Nerve Tape, which brings nerves together via miniature hooks.
Coaptium Connect could also demonstrate benefits over approved implants like Axogen’s nerve allograft, Avance, which require surgical implantation.
