First patient enrolled in BrainQ’s Pivotal Trial, EMAGINE™, for frequency-tuned electromagnetic field therapy to reduce disability following Ischemic Stroke  

On December 09, 2021, BrainQ announced the enrollment of the first patient at MedStar National Rehabilitation Hospital in its pivotal, randomized, double-blind, multicenter trial, EMAGINE (the BQ5 Study). The trial is piloted on moderate to severe ischemic stroke patients to recover and evaluate its frequency-tuned electromagnetic field treatment.

Dr. Jeffrey Saver, director of the UCLA Comprehensive Stroke and Vascular Neurology Program and a co-lead Principal Investigator for BrainQ’s pivotal trial, said that they had made tremendous advances in acute stroke treatment over the past two decades. But still, 90% of stroke patients suffer long-term disability. Progress in recovery is the next frontier for the stroke community. The success of this study would be a game-changer for stroke recovery and aid in making it easier for a new standard of care for stroke.

Yotam Drechsler, CEO, and Co-founder of BrainQ, added that with one in four adults anticipated to have a stroke in their lifetime, and few options on the market for decreasing disability, this trial has the potential to make a tremendous impact on the ever-growing population of stroke survivors affected from the long term disability. Recruiting the first patient is just the first step to revealing new opportunities for survivors and helping to meet this tremendous unmet need. They hope to continue strong recruitment for their trial over the next year.

Moreover, Pamela Duncan, Ph.D., PT, Professor of Neurology at Wake Forest School of Medicine and a co-lead Principal Investigator of BrainQ’s pivotal trial, states that for many years, stroke rehabilitation has lacked novel technologies, which modify the treatment paradigm for patients. There is a potential that BrainQ’s therapy coupled with exercise training starting within a few days of the stroke and continuing for nine weeks will optimize recovery and decrease stroke disability.

As per DelveInsight’s analyst, the product’s approval will help provide better treatment for the patients. The reports from the Centers for Disease Control and Prevention add that more than 795,000 people in the United States have a stroke every year, and about 610,000 of these are first or new strokes. Also, around 87% of all strokes are ischemic strokes, in which blood flow to the brain is blocked.

FDA approves Optilume® Urethral Drug-Coated Balloon, a breakthrough treatment for urethral strictures

On December 13, 2021, Urotronic, Inc., a Minnesota-based medical device company, received approval from the US Food and Drug Administration (FDA) for the use of Optilume® Urethral Drug-Coated Balloon for male urethral strictures. Optilume received CE mark approval for use in urethral strictures in 2020.

The Optilume paclitaxel-coated balloon technology was created in response to patient and physician disappointment with existing endoscopic solutions for urethral strictures. Optilume inhibits new scar tissue growth, which usually recurs after endoscopic dilations. This innovative, proprietary technology represents a major paradigm change from the methods presently utilised by urologists for treatment of these conditions and offers a durable, low-cost, minimally invasive treatment option for millions of patients affected from these conditions worldwide. 

Dr. Sean Elliott, the principal investigator for the Re-establishing Flow Via Drug-Coated Balloon for the Treatment of Urethral Stricture Disease (ROBUST) trials, added that as the ROBUST 1 and ROBUST 3 clinical trials shown, Optilume tremendously decreases the stricture recurrence incidence. At three years, durability persisted with a 77% freedom from reintervention rate, a 176% increase in Qmax, and a 65% decrease in IPSS. Optilume may serve as a vital alternative for men with recurrent strictures who want to avoid or delay urethroplasty.

David Perry, President, and CEO of Urotronic, Inc., stated they are excited to introduce Optilume to the US urology community and their patients who suffer from this debilitating disease. The technology can decrease burdens across the US healthcare landscape as a treatment, which is easy to comprehend and can be performed as an outpatient procedure. Optilume treatment can break the cycle of recurrent urethral strictures.

As per DelveInsight’s Ureteroscope Market & Competitive Landscape, the global ureteroscope market was worth at USD 0.86 billion in 2020, increasing at a CAGR of 5.47% during the forecast period from 2021 to 2026, to touch USD 1.18 billion by 2026. The increase in need for ureteroscopes is due to the increasing urolithiasis or nephrolithiasis prevalence along with the increasing burden of obesity. Moreover, sedentary lifestyle, innovation in product design, and new product launches, among others, are the factors leading to the global ureteroscopes market growth.

AtaCor Medical completes enrollment in its initial Acute Extravascular Implantable Cardioverter Defibrillator (EV-ICD) study

On December 13, 2021, AtaCor Medical, Inc. announced the completion of enrollment in its initial acute Extravascular Implantable Cardioverter Defibrillator (EV-ICD) study. The PASS-PULL EV-ICD Study is designed for acute evaluation of AtaCor’s EV-ICD lead in connection with commercially-available ICDs. When patients require ICD therapy, wires or other hardware are inserted into the veins and attached to the inside of the heart. Once implanted, this hardware can lead to severe complications and challenging removal procedures.

Rick Sanghera, AtaCor Medical’s CEO, said that while AtaCor persists in creating novel solutions for extravascular pacing, they are excited to finish their first defibrillation study. Their goal is to revolutionize the entire cardiac rhythm management industry, and this study showcases that effort.

Martin Burke, AtaCor’s Chief Medical Officer, added that extravascular lead developments are a vital step forward for patient care, and AtaCor’s EV-ICD lead is designed to simplify EV-ICD lead insertion while offering defibrillation shock and pacing therapies using ICDs already available on the market.

According to DelveInsight’s Implantable Cardioverter Defibrillators Pipeline Insight and Competitive Landscape,” the defibrillator market is witnessing various technological advancements and product innovations. The report estimates that the global Defibrillators Market was worth USD 9.89 billion in 2020, increasing at a CAGR of 3.10% during the forecast period from 2021 to 2026, to touch USD 11.31 billion by 2026. The need for Defibrillators is because of the growing cardiac disorders incidence, integration of advanced technology, rising investments by government and private manufacturers, and increasing awareness programs on cardiovascular diseases and usage of defibrillators, among others.

Baxter completes acquisition of Hillrom, creating around USD 15 Billion global Medtech leader

On December 13, 2021, Baxter International Inc., a global MedTech leader, completed the acquisition of Hillrom. Baxter paid USD 156 in cash for each outstanding share of Hillrom common stock for a purchase price of USD 10.5 billion. Including the assumption of Hillrom’s outstanding debt obligations, the enterprise value of the transaction is approximately USD 12.5 billion

José (Joe) E. Almeida, Baxter’s chairman, president, and chief executive officer, said that the Baxter-Hillrom combination reveals the next phase of their transformation, showcasing a new wave of potential to drive more significant impact for patients, clinicians, employees, shareholders, and other communities they serve worldwide. Integrating their complementary capabilities introduces more opportunities for growth across their broad geographic footprint. It creates remarkable new possibilities for connectivity with leading-edge digital health innovation focused on enhancing care, decreasing costs, and increasing workflow efficiency.

Furthermore, Mr. Almeida, U.S. Chief Executive Officer, Helio Health, said that they are energized by the potential to make value for patients and customers in new ways as a combined company.

It is estimated that the merger of two leading MedTech organizations will transform healthcare and advance patient care worldwide. Baxter will be able to capture a significant market share and offer support for millions of patients each day across homes, physician offices, ambulatory care centers, and nearly every hospital department. 

The company seeks to build on its robust worldwide footprint, comprising commercial and service infrastructure, to extend legacy Hillrom and Welch Allyn products into novel international markets, bringing the complete portfolio of products and services to even more patients and providers globally.

Medtronic INVOS™ 7100 Cerebral/Somatic Oximetry System receives 510(k) clearance for pediatric indications

On December 14, 2021, Medtronic plc, a global leader in healthcare technology, received 510(k) clearance from the US Food and Drug Administration (FDA) for its INVOS™ 7100 cerebral/somatic oximetry system for children from birth through age 18. 

The INVOS system picks up vital signals to apprise time-critical decisions by pediatric clinicians pertinent to hemodynamic management, ventilation, and resuscitation for premature infants, neonates, children, and other patients treated by pediatric clinicians.

Frank Chan, president of the Patient Monitoring business, part of the Medical-Surgical Portfolio at Medtronic, said that timing is critical for vulnerable pediatric patients, and the INVOS™ 7100 system can alert clinicians to modifications in patient condition before traditional monitored parameters even react. The INVOS™ 7100 system can benefit clinicians to decide if intervention is necessary, a core component in successful outcomes. And their technology consistently allows users to determine if they are required to intervene sooner.

According to DelveInsight’s “Pulse Oximeters Market & Competitive Landscape,” the global Pulse Oximeters Market was worth USD 1.9 billion in 2020, increasing at a CAGR of 10.13% during the forecast period from 2021 to 2026, to touch USD 3.3 billion by 2026. Some of the key players operating in the Pulse Oximeters market comprise Medtronic, Non in Medical Inc., Lepu Medical Technology, TytoCare Ltd., VYAIRE., OMRON Corporation, Meditech Equipment Co ., Ltd, among others.

Sam Ajizian, MD, FAAP, FCCM, CPPS, and chief medical officer of the Patient Monitoring business at Medtronic, added that clinicians face so many time-critical conditions when treating some of their youngest patients in intensive care units, from RSV to complex heart conditions and beyond. They see this as an opportunity to equip providers with technology, improving results among the most vulnerable populations. They are thrilled that the INVOS™ 7100 system has been cleared for pediatric indications.

The INVOS™ is based on technology that proffers continuous, non-invasive readings of organ-specific regional blood oxygen levels in up to four site-specific areas picked up by the care team and oxygen saturation from vascular beds to evaluate organs individually or in combination to track brain/body perfusion shifts. The INVOS™ 7100 system with pediatric indications will be available globally for commercial use in spring 2022.