The medical technology industry is an integral part of the healthcare sector, with life-saving devices being developed to address the prevention, diagnosis, and treatment of diseases and illnesses. Many investors look to major players in the space like Medtronic (NYSE: MDT), Johnson & Johnson (NYSE: JNJ), and Abbott Laboratories (NYSE: ABT) to innovate and make forward strides in the healthcare industry. But there are many smaller, lesser-known companies at the forefront of medical device innovation, too. One of those companies making waves in the industry is BioSig Technologies (Nasdaq: BSGM).

BioSig’s debut product, the PURE EP system, aims to dramatically improve cardiovascular health by delivering an advanced signal acquisition and processing platform that sets a new standard in electrophysiology (EP). This cardiology sector diagnoses and treats rapid heart rhythms, or arrhythmias. BioSig has developed a non-invasive technology that provides specific signal information to guide critical clinical decisions during catheter ablations, a procedure aimed at addressing arrhythmias.

Catheter ablation is a well-accepted minimally invasive surgical procedure that can provide a cure for people living with arrhythmias – a challenging disease that, if untreated, can lead to severe complications, including heart failure and stroke. According to the American Heart Association, arrhythmias account for over 40% of all cardiology encounters. However, the outcomes from ablation procedures have a lot of room for improvement. Precise cardiac signal information and the ability to interpret the data are the keys to locating the heart rhythm disturbance to ablate the harmful tissue causing it. If physicians can’t see it, they can’t treat it.

The PURE EP is a combination of advanced technologies, bringing together a range of proprietary hardware and software into a single platform. The product may be one of the most significant recent advancements in signal processing and creates an interesting new perspective in the industry that has been hungry for innovation for nearly two decades. Many of the early adopters of the technology confirmed that the PURE EP allows them to see what’s happening in the heart more clearly and work with greater confidence.

Addressing Known Challenges

The PURE EP was developed to address pressing clinical needs associated with the cardiac signal acquisition. Many signal acquisition technologies are currently outdated and fail to capture the wide range of diagnostic signals. The recording systems operate alongside other lab equipment, which can lead to further signal distortion and ‘lab noise.’ Thanks to its novel design, the PURE EP can capture some of the smallest signals that are virtually undetectable on other systems. These signals hold a lot of information and have already demonstrated high clinical value in all types of cardiac catheter ablations. Simply put, more information leads to better clinical decisions.

The PURE EP comes with a built-in set of features that allow physicians to customize it according to their preferences. The system integrates within existing EP workflows and is compatible with the majority of lab equipment. Through its robust software pipeline, research collaborations with leading institutions such as Mayo Clinic, and world-class AI and machine-learning partnerships, the PURE EP System is set to reinvigorate the industry and bring electrophysiology into the future.

How Has BioSig’s PURE EP System Fared With Clinicians?

More and more physicians are using the PURE EP to advance the treatment of cardiac arrhythmias – and sharing their insights via industry presentations and publications. It’s been recently referred to as a “breakthrough in signal acquisition and processing,” with some stating that the system’s tools and features, combined with the increase in acquired information, leads to better decisions, greater efficiency, and confidence.

In late 2019, BioSig Technologies deployed the first PURE EP System at the Texas Cardiac Arrhythmia Institute (TCAI), part of St. David’s Medical Center in Austin, TX (an HCA-owned hospital) where it quickly showed its potential.

Since the launch of the first clinical trial, the market acceptance of the PURE EP™ grew at a steady pace. More than 580 patient cases have been conducted with the PURE EP by 38 physicians across seven hospitals to date. These hospitals include Mayo Clinic, University of Pennsylvania, and Massachusetts General Hospital. BioSig has been consistently signing technology evaluation agreements and is due to install new systems at New York-Presbyterian/Weill Cornell Medical Center, Michigan Medicine–University Hospital, two of the most extensive electrophysiology programs nationwide, and Houston Methodist, bringing its total installation agreements to 10.

BioSig has also recently expanded its 10-year research and development collaboration with Mayo Clinic by announcing plans to develop a next-gen artificial intelligence-powered software to further enhance PURE EP. This project will allow the company to bring the unique clinical findings that may have otherwise been limited to the medical centers of excellence to a broader audience of physicians via a new set of machine learning-powered algorithms. These substantial partnerships solidify BioSig’s place in the medical field and allow the company to become an integral player in the EP industry.

Summary

While it can be hard to truly dive into emerging companies’ financials and compare them to others on traditional financial metrics, it is not difficult to see BioSig’s flagship product's unique value proposition and its vast potential to transform the way heart rhythm disorders are treated. The company has already demonstrated this is more than possible with the insights shared by their physician users and their technology partners' industry standing. However, the company’s ambitions don’t end there – BioSig recently announced its plans to develop a new product portfolio for the market of neurostimulation devices. This sector is estimated to reach USD $12.2 billion by 2024, making it one of the largest sectors in bioelectronic medicine. It will be interesting to see how far this technology can go to further advance the medical field.

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