BioSig has made several milestone achievements of the past year and we look forward to even greater advancements in 2019.
2018 was a time of significant growth and development for the Company. During the past twelve months, we have established ourselves as a recognized name in the electrophysiology (EP) industry.
In September, we officially completed the listing of our shares to the Nasdaq stock exchange. This move allows us access to larger investor audience as well as expanded institutional exposure in 2019. The uplisting culminated with an invitation to ring the Nasdaq opening bell on November 13th, 2018.
Recently, BioSig forged key relationships with some of the most respected entities in the industry. This fall we signed an agreement with Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Austin, Texas to conduct First-in-Human studies using the PURE EP™ System. These First-in-Human studies are aimed at validating the key value proposition elements of the PURE EP™ System that have already been established in pre-clinical studies. Furthermore, we entered into a new advanced research agreement with Mayo Clinic. The new program will be run under the leadership of Samuel J. Asirvatham, M.D., Mayo Clinic’s Vice-Chair of Innovation and Medical Director, Electrophysiology Laboratory. This agreement will consist of several two-to three-year projects, which will focus on development of additional advanced features of PURE EP™ System within the field of electrophysiology and potential clinical applications of BioSig’s technology in a new, previously unexplored, field.
In August, the Company announced that it had received 510(k) clearance for the PURE EP™ System, from the U.S. Food and Drug Administration (FDA). Our vision is to harness advanced biomedical signal processing to diagnose and treat disease. We are excited about our first step in implementing that vision with the PURE EP™ system, as we have the potential to save lives and to disrupt the $4.6 billion electrophysiology (EP) marketplace.
BioSig has made several strategic additions to our team in 2018. Most recently we added Mrs. MaryAnn Edzards as our first Account Manager. Mrs. Edzards brings to the Company over 10 years of experience in electrophysiology (EP), including six years at Biosense Webster, a division of Johnson & Johnson. Earlier in the year, we announced the hiring of Mr. Charles Austin to scale up operational activities ahead of the commercial launch of the PURE EP™ System. Mr. Austin brings to the Company over 25 years of experience in medical devices, pharmaceuticals and consumer products. Most recently, he served as Corporate Vice President, Global Supply Chain at Johnson & Johnson, and was a member of the J&J Management Committee. In preparing our commercialization efforts, we announced that we had partnered with Mrs. Amy Ansfield Scott in order to assist with nationwide physician engagement ahead of the commercial launch of the PURE EP™ System in the U.S. Mrs. Scott brings to the Company over 30 years of experience in medical devices, including over 20 years in electrophysiology (EP). Most recently, she served as Director of Strategic Partnerships for Biosense Webster (Johnson & Johnson), a role which she was responsible for primarily U.S. engagement of physicians and management of the company’s Scientific Advisory Board.
We believe that these strategic initiatives coupled with the strengthening of key industry relationships have positioned us for significant growth in the upcoming year and beyond. I look forward to bringing forth new and exciting announcements in 2019 as we continue to move towards commercialization.
Thank you all for your continued support. On behalf of the entire BioSig team, I wish you and your family a very happy, healthy and prosperous new year.
Chairman and CEO
BioSig Technologies, Inc.