Startup SetPoint Medical has raised $15.7 million of a total $20.5 million it is seeking in a new funding round, according to a regulatory filing.
The Valencia, Calif.-based company will use the money to help it prepare for a pivotal clinical trial of its implantable bioelectronic device intended to treat rheumatoid arthritis (RA), according to CEO Murthy Simhambhatla.
In June, the company announced that a first-in-human study demonstrated “significant, sustained improvement” over two years in using bioelectronic therapy in RA patients. SetPoint is still working with the FDA on setting up the pivotal trial, so details such as the number of patients the company would like to enroll, principal investigators, sites and duration of the trial have not been determined, Simhambhatla told MassDevice.
The round began September 4, 2019, and has attracted additional funding from seven previous investors and one new one, Simhambhatla said. Excluding the unidentified new investor, they are Morgenthaler Ventures, New Enterprise Associates, Topspin Partners, Medtronic, GlaxoSmithKline’s Action Potential Venture Capital Limited and Boston Scientific. The round is still open and could attract more, he added.
SetPoint intends to begin the pivotal trial later this year. The company is seeking PMA approval, as the device is a Class III active implantable.
“We’re pleased with the results from our pilot study and now it’s time to test this therapy in a larger randomized clinical trial,” Simhambhatla said in an interview. “We look forward to working with the FDA to advance this therapy.”
Original Article: (https://www.massdevice.com/setpoint-medical-looks-to-raise-20-5-million-for-pivotal-trial/)
