PALM BEACH, Florida, June 19, 2018 /PRNewswire/ --
MarketNewsUpdates.com News Commentary
The healthcare solutions sector of the overarching biotech industry is an active market as of late, with leaders in the space unveiling new breakthroughs, therapies and products designed to meet a variety of healthcare patient needs and conditions. For example, one of these is that of cardiac health, as advancements have allowed innovative and new devices to pinpoint and address cardiac issues earlier on. Heart disease is one of the most common and threatening life conditions, with over 92 million people in America alone living with some sort of heart condition. According to the World Heart Federation, CV diseases are the biggest killers in the world accounting for 17.5 million deaths every year with the number expected to cross 23 million by 2030. Some of the factors contributing to these numbers include uncontrolled hypertension, high cholesterol levels, obesity, smoking, diabetes and a sedentary lifestyle. Leaders in the biotech industry are leveraging billions in research to help develop and execute innovative treatments to help combat these startling, rising numbers. Active companies in the markets this week include Zenosense, Inc. (OTC: ZENO), BioTelemetry Inc. (NASDAQ: BEAT), Fortress Biotech (NASDAQ: FBIO), Irhythm Technologies Inc. (NASDAQ: IRTC), Johnson & Johnson (NYSE: JNJ).
Zenosense, Inc. (OTCPK:ZENO) BREAKING NEWS: Zenosense, a healthcare technology company focused on the development and commercialization of the MIDS Cardiac™ hand-held technology for the early detection of heart attack at the Point of Care, is pleased to announce that its MIDS Medical Ltd. joint venture ("MML") has successfully completed a second testing round of its revised detection system.
In 2017 the first next generation troponin assay for the early diagnosis of heart attack was approved for use in the U.S. by the FDA. High sensitivity ("HS") troponin assays have been in use in other parts of the world for over 7 years. These assays are performed on state of the art central laboratory analyzers, which are expensive and typically take about an hour to turnaround results, when minutes are vital. The key to the MIDS technology is its ground breaking ability to magnetically detect and measure diagnostic assay beads in low enough numbers to support a HS troponin assay. MML aims to embody this highly compact technology into an easy to use, hand-held MIDS Cardiac device for rapid diagnosis in emergency rooms, or by paramedics responding to chest pain patients at the scene.
- Extensive revision and improvements to core Hall effect sensor electronics during H1 2018
- Testing on new electronics which confirms and materially improves upon the testing results announced in late 2017, with a near doubling of sensitivity
- Results achieved using two leading brands of commercially available assay beads
- Assay bead numbers detected are well within the Limit of Detection ("LoD") required for a HS troponin assay
2018 Quantitative Testing Results - Quantitative testing was conducted to (a) determine the minimum number of assay beads that can be detected; and (b) to prove linearity of detection signal to quantified bead numbers. MML has been advised by Future Diagnostics Solutions B.V. (a leading assay developer engaged to MML) that a capability to detect below 200,000 assay beads and preferably less than 110,000 is required to support a HS troponin test.
Two brands of beads were tested: GE Sera-Mag™ (3μm) and Thermo Fisher Scientific M-270 Dynabeads® (2.8 μm), both of which are regarded as suitable for a HS troponin assay and have similar paramagnetic characteristics. The MIDS LoD of both these brands was seen on a reliable, repeatable basis at around 50,000 beads, with good signal linearity (required for accurate assay quantitation) at higher numbers. This number of beads detected at the LoD is approximately four times lower than the maximum threshold and therefore well within the range advised by Future Diagnostics as suitable for a HS troponin assay.
MML Managing Director and Chief Scientific Officer Dr. Nasser Djennati commented: "MIDS is a hugely challenging development. The results of this second round of testing are quite extraordinary, as magnetic detection at this level for this application is unheard of. We can now move forward and apply the MIDS detection to established assay techniques used in conventional analyzers as we seek to deliver state-of-the-art laboratory standard, high sensitivity cardiac troponin testing at the Point of Care." Read this and more news for Zenosense at http://www.marketnewsupdates.com/news/zeno.html
Other recent and current developments in the healthcare industry include:
BioTelemetry Inc. (NASDAQ: BEAT) recently announced the release of its next-generation wireless blood glucose monitor for diabetes management. As an industry pioneer, BioTel Care developed the first FDA-cleared, cellular-enabled glucometer which supports real-time transmission and consolidation of patient data in an FDA-cleared cloud. Building on the success of this technology, BioTel Care is launching its next-generation blood glucose monitor, which includes an innovative touch-screen user interface, enabling patients to easily test blood glucose levels while capturing additional personal health data. The monitor's remote capabilities allow patients to quickly communicate a wide range of relevant health information to their care providers. Clinicians can access and track their patients' data through the BioTel Care cloud and can provide immediate feedback, as needed, directly to their patients via the new monitor's messaging feature.
Fortress Biotech's (NASDAQ: FBIO) and Caelum Biosciences, Inc. ("Caelum") recently announced that Columbia University ("Columbia") will present a complete analysis of cardiac data from the Phase 1b trial of CAEL-101 (mAb 11-1F4) for the treatment of relapsed or refractory amyloid light chain ("AL") amyloidosis in a poster session at the American Society of Echocardiography (ASE) 29th Annual Scientific Sessions, to be held June 22-26, 2018, in Nashville, Tenn. Investigators concluded that the Phase 1b trial of CAEL-101 in AL amyloidosis is the first trial to show a significant improvement in global longitudinal strain ("GLS") after exposure to an anti-fibril specific mAb in subjects with AL amyloidosis experiencing cardiac involvement. GLS is a sensitive measure of cardiac functional impairment in patients with cardiac involvement, and may detect early cardiac functional improvement and be an important predictor of cardiac survival.
Irhythm Technologies Inc. (NASDAQ: IRTC) closed Monday up slightly closing at $84.41 by the final bell. iRhythm Technologies is a leading digital health care solutions company focused on the advancement of cardiac care that in mid May had announced results of a study which utilized Zio by iRhythm, an extended continuous cardiac monitoring system, to provide a comprehensive picture of the burden of atrial fibrillation (AF) in patients. Utilizing this data in combination with electronic health record data, the researchers concluded that an increase in the burden of atrial fibrillation (AF) is independently associated with a higher risk of ischemic stroke and arterial thromboembolism in patients who are not taking anticoagulant medication.
Johnson & Johnson (NYSE: JNJ) recently announced the U.S. Food and Drug Administration (FDA) approval of the iDESIGN Refractive Studio, making it the only system to use topography-integrated, wavefront-guided technology.2 This allows doctors to take a precise measurement of the eye inside and out to deliver a LASIK procedure personalized to the individual patient. It is approved for myopia, hyperopia, and mixed astigmatism. Additionally, it is the only available LASIK platform indicated for monovision LASIK in presbyopic myopic patients. Monovision is a procedure designed for patients over 40 years old who are experiencing blurry near vision due to aging of their eyes. In the U.S., an estimated 130 million people3 could potentially benefit from a monovision procedure, which includes improved distance and near vision.
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