Noninvasix Granted the US FDA Breakthrough Device Designation for Non-Invasive Monitoring Technology for Sepsis

On February 23, 2022, Noninvasix, Inc. received the US FDA breakthrough device designation for its LIVOx™ Central Venous Oxygenation Monitor. It is a non-invasive device and provides real-time, continuous, or spot monitoring of central venous oxygen saturation (ScvO2) in adults at risk of septic shock. 

At present there are no non-invasive approaches available that can efficiently provide ScvO2 information with high sensitivity and specificity, nevertheless, Noninvasix will be the first company to non-invasively monitor sepsis by detecting the key indicator of septic shock as early as possible. The patented optoacoustic platform of the company comprises a disposable patient interface, reusable probe, data display, and hardware. The patients can wear the probe on the chest to continuously monitor venous oxygen saturation levels in real-time. The monitor can be used to target specific blood vessels based on the desired metric.

David J. Giarracco, Noninvasix CEO, said, “The Breakthrough Device Designation validates the company’s focus to monitor patients with sepsis by measuring central venous oxygenation non-invasively, addressing a serious unmet need in healthcare. Measuring ScvO2 non-invasively will open new paths to more efficient and earlier diagnosis of septic shock, enabling better patient care and reducing healthcare costs. This milestone marks the beginning of future developments, enhancements, and evidence to expand the use and clinical impact of our technology into other indications and settings. We are dedicated to making a difference in a major issue in healthcare.”

“We are moving quickly to realize the potential of Noninvasix to facilitate the early diagnosis of sepsis progressing to septic shock. The Breakthrough Device Designation brings us a step closer to providing clinicians with a new technology that will rapidly and accurately diagnose their critically ill patients and tailor treatments to improve outcomes and even save lives” said Tom Luby, Ph.D., Director of Texas Medical Center Innovation Venture Fund.

According to Delveinsight’s analyst, the sepsis diagnostic market is expected to witness a steady growth owing to the rising burden of sepsis, the increasing number of hospital-acquired infections. In addition, the development of rapid diagnostic/POC techniques for early sepsis diagnosis could provide a potential opportunity for market growth.

LivaNova Declared First Patient Implanted in OSPREY Clinical trial for Patients Coping with Obstructive Sleep Apnea (OSA)

On February 24, 2022, LivaNova PLC, a leading medical devices company focused on developing solutions for head and heart declared the first patient implanted with aura6000 System in the investigational device exemption (IDE) clinical trial, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation” (OSPREY).” The study is a randomized clinical trial (RCT) to demonstrate the safety and effectiveness of the LivaNova aura6000™ System, an implantable hypoglossal neurostimulator intended to treat adult patients with moderate to severe obstructive sleep apnea (OSA). Dr. Mitchell Miller at BayCare’s Morton Plant Hospital from Clearwater, Florida implanted the system in the first OSPREY patient.

The OSPREY study will be conducted at approximately 20 sites across the United States and will ultimately enroll a maximum of 150 adult patients with moderate to severe OSA who do not achieve results from a traditional continuous positive airway pressure (CPAP) machine or have declined its use.

Damien McDonald, LivaNova Chief Executive Officer, said, “Approximately one billion people worldwide live with OSA, but most are undiagnosed and untreated, which can seriously impact their health, increasing the rates of death, stroke, hypertension, motor vehicle accidents, heart failure, diabetes, depression, and daytime sleepiness. There is a great need to offer patients diagnosed with OSA new and less restrictive treatment options. The OSPREY study will be the first RCT to confirm the efficacy of hypoglossal nerve stimulation and now, with the first OSPREY patient implanted, we are another step closer to successfully bringing the innovative aura6000 System to market.”

“With this first patient and the launch of this randomized clinical trial, we are taking a major step toward finding new, effective treatments for the global population of OSA patients and adding to the clinical literature surrounding these therapies. The clinical study will determine if the apnea-hypopnea index responder rate of subjects stimulated via the device is statistically significantly higher than the rate of subjects without stimulation. Throughout the study, independent statisticians will conduct interim data analyses to determine the predictive probability of success for OSPREY. With this being a randomized study rather than simply observational, we will get a clear sense that targeted hypoglossal neurostimulation therapy is the mechanism of improvement for the patients.” commented Dr. Atul Malhotra, Professor of Medicine at the University of California, San Diego, and Principal Investigator for OSPREY.

According to DelveInsight’s “Neurostimulation Devices Marketreport, the global Neurostimulation Devices Market was valued at USD 5.21 billion in 2020, growing at a CAGR of 11.76% during the forecast period from 2021 to 2026, to reach USD 11.28 billion. The demand for Neurostimulation Devices Market is primarily motivated by the increasing incidence of chronic diseases, such as migraine and epilepsy, escalating product demand as add-on therapy, the prevalence of lifestyle diseases such as depression and chronic pain, adoption of technologically advanced products, and rising geriatric population. As per the DelveInsight analysis, the companies are increasing their research and development to develop products that have better efficacy and are easy to operate. High product efficacy demonstrated in treating neurological conditions along with the availability of limited treatment options for the disease is expected to impel market growth during the forecast period.

Oxford BioDynamics Launched Its Checkpoint Inhibitor Response Test (EpiSwitch® CiRT) for Oncology in the US

On February 25, 2022, Oxford BioDynamics Plc, a global biotechnology company focused on advancing personalized healthcare by developing and commercializing precision medicine tests for life-changing diseases, successfully launched its Checkpoint Inhibitor Response Test (EpiSwitch® CiRT) in the US. The US launch of CiRT follows the earlier launch of EpiSwitch CST (COVID Severity Test) and expands OBD’s immune health test offerings.

EpiSwitch CiRT was built using Oxford BioDynamics’s well-established EpiSwitch 3D genomics platform. It is used to discover the most important drivers that determine a patient’s response to Immune Checkpoint Inhibitors (ICIs). The robust EpiSwitch qPCR blood test has shown best-in-class performance, with high sensitivity (93%), specificity (82%), and accuracy (85%) across several ICIs from multiple pharmaceutical companies and more than 15 key oncological indications.

Dr. Jon Burrows, CEO of Oxford BioDynamics, said, “Oxford Biodynamics Checkpoint Inhibitor Response Test (EpiSwitch® CiRT) is a very important step forward for precision medicine. EpiSwitch® CiRT directly links clinical outcome to gene regulation and with high accuracy predicts patient response. Since one in two of us will be diagnosed with cancer in our lifetime, it is essential to develop smart testing that can rapidly predict treatment response and guide us to the most efficacious therapies and maximize benefits for patients. In terms of healthcare economics, ICIs alone cost the US healthcare system $17B annually. The ability to stratify patients based on their likelihood of response will enable the system to better manage these costs while allowing us to deliver smarter, better care to patients.”

Tom Reynolds, President of NEXT Molecular Analytics said, “We are excited to be working with Oxford BioDynamics to bring this novel and sensitive Checkpoint Inhibitor Response test to oncologists and their patients in the US market. The EpiSwitch CiRT will provide oncologists with a powerful new tool to help manage complex treatment decisions with their patients.”

According to DelveInsight’sMolecular Diagnostics Marketreport, the global molecular diagnostic market was valued at USD 9.56 billion in 2020, growing at a CAGR of 9.21% during the forecast period from 2021 to 2026, to reach USD 16.12 billion by 2026. The increase in demand for molecular diagnostic is primarily attributed to the growing incidence of infectious diseases such as the sudden outbreak of COVID-19 and the rising burden of cancers across the globe. Moreover, rapid technological advancement in the molecular diagnostic product arena and increasing demand for point-of-care diagnostics along with rising consumer awareness regarding quick diagnostics, among others are some of the key factors responsible for the molecular diagnostic market growth during the forecasted period.

Masimo Declared FDA Clearance for SedLine® Brain Function Monitoring and the SedLine Pediatric EEG Sensor in Paediatrics

On February 28, 2022, Masimo, a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, comprising innovative measurements, sensors, patient monitors, and automation and connectivity solutions, received FDA approval for its SedLine® brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor. The device is equipped with the company’s advanced signal processing technology and helps clinicians to monitor brain activity bilaterally by processing electroencephalogram (EEG) signals from Masimo’s four-lead SedLine EEG sensors. With the approval, the benefits of SedLine have been expanded to all patients one-year-old and above in the US. 

Joe Kiani, Founder, and CEO of Masimo said, “SedLine is achieving for brain function monitoring what Masimo SET® did for pulse oximetry. We believe SedLine is the best and most advanced way to monitor the depth of sedation, crucial to helping ensure patients with even the most challenging and the youngest brains are appropriately anesthetized. We are proud to be able to bring its benefits to children in the United States.

SedLine is an easy window into a child’s electroencephalogram. It helps us to personalize sedoanalgesia. Now, we can choose the appropriate dose according to its effects, not just according to weight or age. But in addition to monitoring anesthetic depth, it allows us to detect warning signs such as asymmetries or seizures; it tells us what is happening to the child’s brain.” said Dr. Cristina Verdú of Hospital Universitario La Paz, Madrid, Spain.

According to DelveInsight’s ‘Brain Monitoring Devices Marketreport, the global Brain Monitoring Devices Market was valued at USD 5.89 billion in 2020, growing at a CAGR of 7.27% during the forecast period from 2021 to 2026, to reach USD 9.13 billion by 2026. The demand for brain monitoring devices is primarily being boosted by the rising prevalence of neurological diseases, technological advancement in product development, raising awareness about neurodegenerative diseases, and increasing applications of brain monitoring in clinical trials. The growing demand for minimally invasive devices and the expanded therapeutic applications of brain monitoring devices are further expected to boost the brain monitoring devices market growth. According to the DelveInsight analysis, technological advancements such as the launch of wireless EEG systems wherein long-term EEG studies can be carried out have also contributed to the rising popularity of these devices among healthcare providers.

Medtronic Launched its NuVent™ Eustachian Tube Dilation Balloon

On February 28, 2022, Medtronic plc, a leading global healthcare technology company launched its FDA-cleared NuVent™ Eustachian tube dilation balloon for the treatment of chronic, obstructive Eustachian Tube Dysfunction. The device features a flexible balloon section that allows customized placement based on patient anatomy and enables surgeons to deliver treatment in an outpatient or office setting.

As office-based procedures for ENT conditions increase, we look forward to introducing more innovative technologies designed specifically for this setting. The NuVent™ balloon is another important product within this expanding portfolio.” said, Vince Racano, president of the Ear, Nose, and Throat business, which is part of the Neuroscience Portfolio at Medtronic.

Dr. Boris Karanfilov, a rhinologist and head of the Ohio Sinus Institute in Dublin, Ohio, said, Patients who suffer from Eustachian Tube Dysfunction often experience pain, pressure, and hearing difficulties, so it’s important to address their illness quickly. Balloon dilation restores proper Eustachian tube function and reduces these symptoms, plus the ability to perform the procedure in the office makes it both convenient and efficient.”

As per DelveInsight’s analysis, the market for Eustachian tube dilation balloons will grow due to the rising cases of the indication. Moreover, shifting preferences for the minimally invasive method for treating chronic obstructive Eustachian tube dysfunction, and rising regulatory approval of the devices could also boost the market in the upcoming years.

Conformis Reported Positive Data from its Bilateral Knee Implant Study

On February 28, 2022, Conformis, a medical device company primarily focused on developing personalized orthopedic solutions declared results of a published retrospective study of patients showing the superiority of Conformis’ implants in several key measures of clinical success and patient satisfaction. As per the study published in The Journal of Bone & Joint Surgery Reviews, the patients who had undergone bilateral total knee arthroplasty (TKA) preferred their Conformis fully personalized knee compared to their bilateral off-the-shelf knee at a rate of more than 10 to 1. Moreover, the study found that 72.3% of the patients studied preferred their fully personalized Conformis knee replacement over 6.4% of patients who preferred their traditional off-the-shelf (OTS) implant.

The study is believed to be the first-ever to examine patient-reported outcomes directly by comparing fully personalized and traditional off-the-shelf implants in the same patient as a control. Less pain, better-perceived mobility, and a more “normal” feeling in the fully personalized Conformis implant were reported by the patients.

Mark Augusti, Chief Executive Officer and President of Conformis commented, “This study confirms what the surgeons and engineers working at Conformis have known from the beginning: a fully personalized knee replacement that is designed specifically for each patient’s unique anatomy and original motion clearly contributes to better clinical outcomes and happier patients. Our fully personalized knee system has demonstrated its clinical benefits in dozens of peer-reviewed studies over the years, and this patient self-controlled research further validates that the patients who are living with two different knee implants can feel the difference. Simply put, our fully personalized implants fit better and feel more natural.”According to Delveinsight’s “Total Knee Arthroplasty Marketreport, the global market for total knee arthroplasty is likely to grow owing to the increasing prevalence of various knee diseases such as osteoarthritis, rheumatoid arthritis, and others. Moreover, technological advancement in the product arena and increasing efficiency of the newly developed products would increase the adoption of these devices thereby propelling the market. In addition, as per the DelveInsight’s analyst, B Braun Melsungen AG, ConforMIS Inc., Corin Group, Johnson & Johnson (Depuy Synthes), Zimmer Biomet, Exactech Inc., and others are some of the leading players in the total knee arthroplasty market.