Sequana Medical Launches Belgian IPO
Sequana Medical has launched an IPO on Euronext Brussels a few days after the US FDA granted a breakthrough device designation to Sequana’s alfapump for liver ascites.
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One year on from its IPO on Euronext Brussels, abdominal implant maker Sequana Medical has secured €19m ($21m) in an equity placement. The company said it had been backed by new and existing investors.
US FDA issued a final guidance that sets out requirements for its new Breakthrough Devices Program mandated by Congress. Under the new program, which replaces the Expedited Access Pathway, sponsors have more certainty about how quickly they will get responses from the agency and fewer requirements when setting up early interactions.
Following a fresh injection of funding, Sequana Medical is gearing up to grow its European business and begin a pivotal US study for alfapump, its implantable, automated pump for the continual removal of ascites. The Belgian company is positioning itself as a key player in the growing liver disease treatment market.