BioSig Technologies Inc. said it has entered into a manufacturing and professional services agreement with Plexus Corp.
Headquartered in Neenah, Wisconsin, Plexus counts healthcare and life sciences as one of its largest market sectors representing nearly 40% of annual revenue.
Under the terms of the newly reached agreement, BioSig said Plexus will bring to market its PURE EP System, the company’s signal processing technology for arrhythmia care.
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Plexus also will develop a new product pipeline for BioSig’s subsidiary NeuroClear Technologies Inc.
“We are fundamentally proud to partner with Plexus on our mission to advance therapies through technological innovation,” said BioSig CEO Kenneth Londoner in a statement.
“Their engineering and manufacturing capabilities and outstanding expertise in building complex medical devices make Plexus a foundational cornerstone to support BioSig’s growth objectives now and well into the future. The recent release of our clinical data has increased physician interest in our technology. "
Londoner added: "We believe that the post-pandemic recovery in elective procedures will further drive our installation footprint, and we are confident that Plexus’ first-class operational infrastructure will ensure a quality supply of the PURE EP systems to meet growing market needs.”
The PURE EP is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, more than 60 physicians have completed over 1,300 patient cases with the PURE EP System across 12 clinical sites.
The company recently completed its first multi-centered, prospective clinical trial and presented preliminary clinical data during the annual Heart Rhythm 2021 convention in July in Boston.
BioSig is in a focused commercial launch of the PURE EP System in the Northeast, Texas, and Florida and is in regular use in some of the country’s leading centers of excellence, including the Mayo Clinic in Rochester, Minnesota, and St. David’s Medical Center in Austin, Texas.
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