This announcement follows on from FDA Approval of Raplixa™ (Fibrin Sealant) and the RaplixaSpray™ device in April 2015. Raplixa™ is the first and only powdered fibrin sealant ready-to-use for mild to moderate surgical bleeding. It is used to provide adjunctive hemostasis when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.
The RaplixaSpray™ device originated with one of our clients, Leiden-based ProFibrix B.V., a start-up who came to us to further develop a concept to deliver powder via a handheld device into a solution suitable for use by surgeons in Phase II clinical trials.
Discussing the development of the device, Paul Greenhalgh, Director of Design at Team and a member of the project team since its beginning, said:
“Getting approval in both Europe and the US in 2015 was an incredible milestone for this device. We’re enormously proud of what we’ve achieved together on the development of what is now RaplixaSpray™ – it’s great to see all of the hard work come to fruition and become a new product on the market that will make a difference to many people.”