Preclinical data with BioSig's PURE EP™ continues to roll out of the research labs at Mayo Clinic. Last month, I wrote a brief article highlighting a paper published in the Journal of the American College of Cardiology: Clinical Electrophysiology by Ammar M. Killu, MBBS and fellow colleagues at Mayo Clinic. The paper discusses important research discoveries with PURE EP, BioSig's novel hardware and software platform electrophysiology recording system, demonstrating visualization of superior Purkinje potentials and other high-frequency signal visualization compared with standard recording systems.
Researchers at Mayo Clinic were back last week presenting even more important findings with PURE EP, this time at the 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC2016). Dr. Killu et al. presented a paper entitled, "Enhanced Electrophysiology Recording System" that demonstrates PURE EP provides enhanced visualization of cardiac signals with the objective of improving outcomes of electrophysiology procedures.
PURE EP stands for Precise Uninterrupted Real-time evaluation of Electrograms (PURE) EP Systems. BioSig's proprietary system is similar to traditional EP recording systems produced by GE Healthcare or St. Jude Medical, which have two computer screens and allow for independent, real-time review capabilities. However, where PURE EP is superior is in the systems very low noise (1 11V RMS), coupled with a minimum gain and maximum bandwidth (1 KHz). PURE EP delivers unique proprietary topology features, including high input impedance, high common mode rejection ratio (110dB@60Hz), and rejection of noise generated by an RF ablation generator.
This is all rather technical, but what investors need to understand is that as clinical decisions are made in real-time during ablation procedures, PURE EP's ability to display both small and large signals with similar resolution is a significant leap forward in the treatment of arrhythmias, including atrial fibrillation (AF) and ventricular tachycardia (VT).
In the Killu et al. paper published in JACC in August 2016, the researcher at Mayo Clinic were able to clearly visualize and analyze Purkinje potentials. Errant Purkinje potentials may indicate certain types of VT which can lead to ventricular fibrillation and death. According to researchers at Mayo Clinic, the restricted dynamic range and sampling rate in modern electrophysiology recording systems, such as GE Healthcare's CardioLab, make it challenging to identify high-frequency, low-amplitude signals, especially those temporally situated near low-frequency, high-amplitude signals. This is because such systems have a limited dynamic range and sampling rate, and therefore lack the adjustability and fidelity to observe Purkinje signals.
By use of PURE EP, researchers were able to visualize high-frequency signals which correlated with Purkinje potentials. Killu et al. believe that adjustability, along with enhanced filtering and processing provided by PURE EP improves the analysis of Purkinje potentials and other high-frequency signals such that it may help improve mapping / ablation outcomes in arrhythmia syndromes dependent on the Purkinje network.
New data presented at IEEE-EMBC2016 further builds upon the advantage of the high sampling rate (2000 samples/second) coupled with a high-resolution AID converter (24 bits) and an input voltage range of (±250mV) of PURE EP compared to existing EP recording systems. The figure below highlights the key findings presented by Killu et al last week at IEEE-EMBC.
Work at Mayo Clinic with PURE EP continues. In fact, they state that in the conclusion of the presentation at IEEE-EMBC! So I expect more data out of Mayo in the coming months.
As I noted in a previous article, this relationship is a major driving force of confidence and credibility for BioSig. The company has also worked with other prestigious institutions such as UCLA, Case Medical Center, and Mt. Sinai as they advance towards the filing of the U.S. 510(k) application to the FDA in the first half of 2017. Keep in mind, PURE EP is classified as a Class II medical device, which commonly does not require human clinical trials for FDA clearance to market. Approval should allow BioSig to start generating revenue from PURE EP in 2018; and, with the data that that Mayo Clinic has generated above, I expect the product to be a game-changer for electrophysiologists once commercialized.
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