Palm Beach, FL – September 16, 2020 – In the world of cardiovascular devices the electrophysiology segment is poised to have substantial growth according to various industry reports. It has recently become of great interest in the medical devices field as advancements in technology have allowed doctors to more easily and effectively identify and ablate troublesome material. This has resulted in a huge spike in growth of electrophysiology treatments at the expense of pharmacological treatments. Competition within this sphere will still remain intense, however, as competing technologies evolve to out-perform one another. According to a report from MarketsAndMarkets the global electrophysiology market is projected to reach USD 10.6 billion by 2025 from USD 6.8 billion in 2020, growing at a CAGR of 9.1% from 2020 to 2025. Another report agrees with Markets that there will be an increase but Grand View Research projects a higher amount a year later… confirming continued growth. Grand View projected that The global electrophysiology market size is expected to reach USD 12.2 billion by 2026, expanding at a CAGR of 11.70% over the forecast period. So they agree that the electrophysiology market is expected to remain a highly competitive and dynamic market for years to come. Active healthcare stocks in news today include: BioSig Technologies, Inc. (NASDAQ: BSGM), iRhythm Technologies (NASDAQ: IRTC), Acutus Medical, Inc. (NASDAQ: AFIB), Johnson & Johnson (NYSE: JNJ), Boston Scientific Corporation (NYSE: BSX).
The reports show that electrophysiology is uniquely positioned amongst cardiovascular devices to enjoy both explosive and sustained growth across the international markets due to a combination of as-yet unsaturated markets and a constantly growing patient population due to the overall ageing of the world’s population. Grand View said that: “The demand for electrophysiology devices is expected to increase owing to growing old age population and frequent cardiac arrhythmias incidents. Adoption of ablation and diagnostics techniques among physicians has resulted in increased usage of the product in the past few years and is likely to drive market growth. Development of new devices… is also anticipated to fuel demand in the market.”
BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS – BioSig Releases PURE EP Study Abstract with Data Presented at European Society of Cardiology’s ‘ESC Congress 2020’ – BioSig Technologies, a medical technology company developing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, announced a scientific abstract and poster entitled, “A novel cardiac signal processing system for electrophysiology procedures: early insights from the PURE EP 2.0 study” is available electronically from August 30th at the ESC Congress 2020 – The Digital Experience.
The abstract is co-authored by Carola Gianni, M.D., Amin Al-Ahmad, M.D., Shane M. Bailey, M.D., G. Joseph Gallinghouse, M.D., Rodney P. Horton, M.D. and Andrea Natale, M.D. of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Austin, TX. The independent, blinded reviewers were Bradley P. Knight, M.D. (Northwestern University), Wendy Tzou, M.D. (University of Colorado), and Pasquale Santangeli, M.D. (University of Pennsylvania).
Identical electrocardiographic and intracardiac signal data were recorded during 15 atrial fibrillation ablation procedures from the PURE EP™ System, the signal recording system, and the 3D mapping system. The collected signals underwent blinded, controlled evaluation by three independent electrophysiologists to determine whether the PURE EP™ signals are a viable alternative to conventional sources and if it provides additional or clearer diagnostic information. Reviewers were asked to record the quality of each signal sample on a scale of 1-10 and select a rationale for their rating in a dropdown menu.
Based on the ratings for each pair of signals, a cumulative total of 29 PURE EP™ signals out of 34 (85.3%) were rated as statistically equivalent or better for this dataset. In 35.5% of samples, the reviewers selected PURE EP™ data because “more signal components were visible.” The abstract concludes that the PURE EP™ System is able to produce reliable and high-quality signals when compared to the available standard of care systems.
“BioSig Technologies is very pleased to see some of the early results from the PURE EP™ study shared during ESC 2020. We greatly appreciate the scientific collaboration with the team at TCAI and the independent EP reviewers. The PURE EP™ study is on-going, and we look forward to sharing multi-center data with the EP community in the coming months,” commented Julie Stephenson, VP of Clinical Affairs at BioSig Technologies, Inc. Read more news for BSGM by visiting: https://ir.biosig.com/press-releases
In other healthcare news of note:
iRhythm Technologies (NASDAQ: IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, has recently been named a winner of the Artifical Intelligence (AI) in Health and Care Award. The announcement was made by Secretary of State for Health, Matt Hancock at London Tech Week’s Founders Forum HealthTech Summit this morning.
A competitive process run by the Accelerated Access Collaborate (AAC) as part of the NHS AI LaB – in partnership with NHSX and the National Institute for Health Research (NIHR) – the award aims to benefit patients by combining the power of artificial intelligence with the expertise of the NHS to improve health and care outcomes. iRhythm will utilise the funding to trial its Zio service in selected sites – comprising trusts, CCG’s and networks – across the UK. Throughout the three-year program, clinical, pathway and economic outcomes will be monitored and evaluated in order to inform any future commissioning decisions around the adoption of Zio within the NHS.
Acutus Medical, Inc. (NASDAQ: AFIB) recently announced pre-clinical experimental results of a novel diagnostic and therapeutic workflow utilizing the AcQMap® System along with tissue-selective, non-thermal pulse field ablation (PFA) via a proprietary Acutus ablation catheter. While Acutus has been known for its rapid imaging and mapping platform along with access and diagnostic products, the company is now aggressively pursuing the therapeutic commercial market.
Pulsed field ablation (also known as electroporation) is an emerging ablation modality that distinguishes itself from traditional thermal ablation, such as radiofrequency energy ablation and cryoablation, by delivering therapeutic energy faster and more selectively with minimal collateral damage. While not fully clinically proven or approved by regulatory authorities for use in cardiac tissue in humans, recent pre-clinical and clinical studies suggest that PFA may enable rapid targeted ablation of cardiac muscle while leaving adjacent tissue, such as nerves, blood vessels and the esophagus, completely unaffected. In addition, PFA does not rely on heat or extreme cold to ablate tissue. The application time required to create a lesion takes less than a second compared to thermal ablation which may take many seconds to minutes at each location.
Johnson & Johnson (NYSE: JNJ) New: Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, recently announced results from the Phase 3b TRITON trial, the first randomised controlled study evaluating the efficacy and safety of initial triple oral combination therapy (UPTRAVI® [selexipag], OPSUMIT® [macitentan] and tadalafil) compared to initial double oral combination therapy (placebo, macitentan and tadalafil) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension (PAH). Study results were featured as an oral presentation as part of the digital European Society of Cardiology Congress held 29 August – 1 September 2020.
In the TRITON trial, both the initial triple oral therapy and initial double oral therapy arms demonstrated reductions in the primary endpoint, pulmonary vascular resistance, of 54 percent and 52 percent respectively, with no statistical difference observed between both groups. Improvements were observed in six-minute walk distance,1 N-terminal pro-brain natriuretic peptide (NT-proBNP) and clinical variables at week 26 in patients who were treated with either initial triple oral or initial double oral combination therapy, with no difference between treatment regimens.
Boston Scientific Corporation (NYSE: BSX) recently announced it has received CE Mark and initiated a limited market release of the fourth generation Vercise Genus™ Deep Brain Stimulation (DBS) System in Europe. Featuring full-body MRI conditional1and Bluetooth capabilities across the portfolio, the Vercise Genus System is indicated to treat the symptoms of Parkinson’s disease (PD), essential tremor, and dystonia by delivering precisely targeted electrical stimulation in the brain designed to provide optimal symptom relief.
“With neurodegenerative movement disorders, the ability to deliver the right dose of stimulation where it is needed can make a remarkable difference in controlling an individual patient’s symptoms,” says Veerle Visser-Vandewalle, M.D., Ph.D., Cologne University Hospital, Germany. Vercise Genus adds features for patients, including a low-profile two-in-one extension with the option of abdominal placement. New clinician software optimizes programming with integrated visualization using patient imaging via the company’s exclusive relationship with Brainlab.
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