BioSig Technologies Inc plans to kick off a national commercial launch campaign for its PURE EP System on July 1, 2022 following multiple initiatives to accelerate its transition from limited market release to nationwide availability.
BioSig has more than 30 qualified leads ahead of the launch and to-date, more than 73 physicians have completed over 2,200 patient cases with the PURE EP System, the company said.
“As a company, we have worked tirelessly to reach this point to commercially roll out our PURE System nationwide. We have put the right people in place and have executed on a strategy to see this come to fruition,” BioSig CEO Kenneth Londoner said in a statement.
“We believe July 2022 will be a major milestone for our company and we look forward to collaborating with our new medical centers that recognize the invaluable benefits of Pure EP for their patients," he added.
The company also streamlined product evaluations from 180-360 days to 60 days with a succinct clinical and economic value proposition that it says showcases the technology's advantages and accelerates adoption.
In terms of commercial strategy, BioSig said it reached an agreement with Summit Blue Capital in March to implement a leasing and finance program, which is designed to expedite the pathway to purchase and increase the scope of PURE EP adopters across the US.
Personnel-wise, BioSig has restructured its clinical support and installation teams in preparation for increased commercial activity. The company’s new commercial structure includes national account directors covering five regions in the US to support product evaluations and the rapid transformation of qualified leads into sales.
BioSig's PURE EP system is a US Food and Drug Administration 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology.
Clinical data acquired by the PURE EP System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology, and is available electronically with open access via the Wiley Online Library.
Study results showed 93% consensus across the blinded reviewers, with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP signals over conventional sources.
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