In their update sent to the shareholders, they wrote:
Gray Fleming and John Sieckhaus redefined our product development and commercial strategies one year ago. The company has established new sales and clinical teams, introduced new corporate and product branding, launched potentially game-changing software, secured numerous evaluations, developed new research protocols, signed purchase agreements, and built a promising revenue pipeline during this time. In the near future, BioSig will reach many more exciting milestones.
While BioSig has made significant commercial progress over the past twelve months, 2022 has been a challenging year for the economy and for Life Sciences companies. This was reflected in our valuation. From history, we know that innovative companies and technologies can survive economic downturns. Following sharp declines in 2000-2002 and 2008-2009, new leaders emerged during economic recovery. BioSig will be among those emerging leaders based on the exciting commercial, technological, and corporate activities underway in 2023.
We at BioSig believe that every clinical decision counts, and that personalized patient care is crucial. There has never been a greater need to maintain intracardiac signals precisely and clearly without driving up costs. For healthcare organizations in the coming year, innovation will be increasingly important, and BioSig's technology can help.
Highlights of the year
Despite the challenging operating environment, the Company, our customers, and our shareholders achieved several positive outcomes. At relatively attractive terms, we raised approximately $3.8 million through private placements of common stock and warrants. Our goal is to grow revenue and expand our value proposition by developing our technology, while continuing to find shareholder-friendly ways to fund the Company. In addition, Nasdaq informed us that the Company was granted another 180 days to regain compliance with the Stockholders' Equity Requirement, or until May 22, 2023. Management believes that this is sufficient time for compliance to be regained.
Here are a few examples that demonstrate BioSig's unique position within the Medtech industry and the growing interest in our disruptive technology.
Bellin Health announced on January 10, 2023 that it had entered into an agreement to acquire a PURE EPTM System. According to Bellin, clear cardiac signals positively impacted procedural efficiency, resulting in cost savings.
In the United States, more than 80 physicians have used the PURE EPTM System to perform more than 3,000 procedures.
In Singapore, the PURE EPTM System was presented in an abstract at the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session. The PURE EPTM System appears to promote shorter procedural times and higher cost savings during catheter ablation procedures, according to the results of the randomized study.
Journal of Atrial Fibrillation & Electrophysiology (JAFIB-EP) highlighted BioSig's PURE EPTM System in a peer-reviewed case report. PURE EPTM and its groundbreaking High Frequency Algorithm (HFA) were detailed in this clinical abstract.
In order to explore expanded applications for its digital signal processing technology, a Master Research Agreement was signed with the Cleveland Clinic.
San Antonio Methodist Hospital signed a purchase agreement.
The new version of PURE EPTM software with ACCUVIZTM Module features a proprietary High Frequency Algorithm (HFA) that identifies the key frequency components of cardiac data that are difficult to identify in traditional waveforms.
One of the world's leading medical centers, Cleveland Clinic, agreed to evaluate the PURE EP System, and a short time later requested to evaluate a second system.
Overland Park Regional Medical Center signed a purchase agreement with Kansas City Heart Rhythm Institute.
In addition to the Kansas City Heart Rhythm Symposium 2022, the 17th Edition Venice Arrhythmias 2022 Congress and EPLive 2022, the PURE EPTM System was featured at numerous conferences.
In Conclusion
In spite of a challenging year, we are energized for what the new year holds and have the courage to build on what has been accomplished. We will continue to add hospitals and centers of excellence to our portfolio of PURE EPTM adopters as part of our commercialization strategy. The EP market is growing rapidly. As the number of catheter ablation procedures increases, it is estimated that the global EP market will reach $16 billion by 2028, growing at a compound annual growth rate of 11.2%. With the increasing number of catheter ablation procedures, PURE EPTM will set a new standard for intracardiac visualization.
Developing innovative treatment solutions for arrhythmias that require greater clarity is our goal as physician advocates. It takes both respect and humility to advance electrophysiology, advance science and technology, and solve healthcare's greatest challenges.
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