With eyes on FDA nod, Ivenix bags first of $50M for next-gen infusion pump

Ivenix reeled in the first tranche of $50 million in equity, which will support its bid for FDA clearance as well as a personnel expansion for the commercial launch of its infusion pump. The company will pick up the remaining funds when it meets regulatory milestones.

Infusion pumps are used to deliver fluids, including nutrients and drugs, to patients. With its next-generation system, Ivenix aims to tackle a number of issues that can affect these pumps.

Between 2005 and 2009, the FDA reported about 56,000 adverse events, including injuries and deaths, linked to these pumps. While some were caused by user error, the FDA noted that many stemmed from “deficiencies in device design and engineering.” These include software problems, alarm malfunctions and poor user interface design.

“A number of factors are fueling investor interest in Ivenix, including the lack of innovation in the market, and the incidence of errors in infusion administration,” Iveni CEO Stuart Randle said in a statement. “Our system represents a complete redesign of the infusion pump from the ground up, with fully integrated technology to support interoperability and improved safety and performance.”

The system comprises a new pump technology and a smartphone-like user interface, as well as an IT system that easily integrates data from the device into a patient’s electronic medical record.

Two new, undisclosed investors led the financing, while existing backers F-Prime Capital Partners and WuXi Healthcare Ventures also participated. Ivenix previously raised $42 million in 2015.