Neurent Medical obtains FDA Clearance for NEUROMARK™, a novel multi-point Nerve Disruption Treatment for Chronic Rhinitis  

On November 18, 2021, Neurent Medical, a company working in developing treatments for chronic inflammatory sino-nasal diseases, received clearance from the Food and Drug Administration (FDA) for its proprietary NEUROMARK™ Rhinitis Neurolysis Therapy™ (RNT). This will provide clinicians access to an in-office treatment intended to develop lesions to disrupt the posterior nasal nerves for chronic rhinitis patients.

Marc Dubin, MD, Scientific Advisor for Neurent Medical, said that the FDA clearance of NEUROMARK™ RNT means otolaryngologists can now proffer precise care to patients with chronic rhinitis while avoiding the trial and error. 

As per Neurent Medical CEO Brian Shields, “NEUROMARK™ addresses the limitations of other treatments and utilises advanced technology to do so safely, gently, and with ease. The market requirement is immense and underserved, and they are excited to bring their initial product delivery to the market, offering symptom relief to as many patients as possible. They are equally excited to continue their product pipeline development to address other sino-nasal inflammatory conditions and realise the full potential of the NEUROMARK™ platform.

According to DelveInsight’s analyst in the report Rhinitis Market“, around one in four Americans have chronic rhinitis. This illness results in persistent congestion, rhinorrhea (runny nose), sneezing, and nasal itching triggered by inflammation and swelling of the mucosal membrane in the nose. This approval from FDA for NEUROMARK™ Rhinitis Neurolysis Therapy™ (RNT) will provide comfort to the patients as the system’s unique design, biofeedback monitoring features, and advanced algorithmic controls enable the physician to disrupt multiple nerve branches with a high degree of anatomical precision and safety at the same time.

This system is the first in-office treatment to disrupt symptom-causing nerve tissue for Chronic Rhinitis patients.

Theradaptive receives Breakthrough Medical Device Designation

On November 19, 2021, the US Food and Drug Administration (FDA) granted Breakthrough Medical Device designation to Theradaptive, a privately-held biopharmaceutical company pioneering a new class of regenerative implants, for its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar interbody spinal fusion for treating degenerative disc disease, spondylolisthesis, or retrolisthesis.

Dr George Muschler of the Cleveland Clinic said that Theradaptive had developed a technology that may offer various significant advantages over the current state-of-the-art in spinal fusion and musculoskeletal repair, comprising greater safety and more consistent outcomes. This is an exciting development in the field and receiving a Breakthrough Designation from the FDA is a strong validation of the approach. The potential for patients is enormous.

John Greenbaum, Senior Vice President of Clinical & Regulatory Operations at Theradaptive, added that this designation is a significant milestone for Theradaptive as we aspire to change the practice of medicine by allowing precise tissue regeneration and opens the door to entirely new treatments for conditions that currently have very few options.

According to DelveInsight’s Spinal Fusion Devices Market & Competitive Landscape, there are no precision regenerative implants available in the market to treat spinal fusion, orthopaedic repair, or craniomaxillofacial repair as of 2021. The rising prevalence of patients affected with spine deformities and chronic lower back pain, and neuronopathic pain due to injuries and trauma is anticipated to strengthen the market for Spinal Fusion Devices during the forecasted period (2021-2026). According to the National Spinal Cord Injury Database 2019, the annual incidence of spinal cord injury (SCI) is around 54 cases per one million people in the United States and the prevalence is approximately 291,000 persons. Thus, the high cases of spinal cord injuries are propelling the market for global spinal fusion devices.

Fujifilm launches ColoAssist PRO, a real-time endoscope visualisation system for endoscopists 

On November 24, 2021, Fujifilm introduced ColoAssist PRO, a real-time endoscope visualisation system intended to help endoscopists perform colonoscopies.

This is the newest system of Fujifilm’s ELUXEO Ultra family of technologies, which provides real-time visualisation, allowing clinicians to visualise the endoscope’s configuration throughout the procedure. ColoAssist PRO is intended to help healthcare professionals efficiently and accurately manoeuvre the colonoscope inside the patient.

The system works together with the existing ELUXEO platform and a colon polyp detection and characterisation function utilising AI technology, CAD EYE, offering improved support to the operator and delivering Fujifilm’s most powerful and comprehensive package for endoscopists.

Dr Robert Berger, Director of Endoscopy at the Moncton Hospital in Canada, said that  Colonoscopy could be intricate for endoscopists, and can also be uncomfortable for patients. Fujifilm’s new function, ColoAssist PRO, enables clinicians to see the endoscope configuration in real-time during the intubation by reproducing a graphical model of the endoscope. This visualisation system can increase the confidence and efficiency of endoscopists by allowing the identification of loop formations, allowing better decision making by the endoscopist, and subsequently decreasing the patient burden during the procedures. ColoAssist PRO is just the new addition to the ELUXEO Ultra family of technologies that can generate a more efficient diagnosis and better outcomes for patients.

According to DelveInsight’s “Endoscopy Cameras Market & Competitive Landscape”, the demand for endoscopy procedures is primarily motivated due to the rise in chronic diseases, shift towards minimally invasive treatments, and growing technological advancements.

HAGAR GWave awarded FDA Breakthrough Device Designation 

On November 23, 2021, the US Food and Drug Administration (FDA) approved Breakthrough Device Designation for Hagar’s GWave, the world’s first non-invasive continuous glucose monitoring technology utilising radiofrequency (RF) waves for measuring glucose levels in the blood.

GWave First Generation is a third of the size of a smartphone and includes less RF exposure than a smartphone. It measures blood glucose levels without needing blood from pricking the skin. In people with diabetes and on insulin treatment, keeping check of blood glucose is essential. Furthermore, this easy, painless device can allow early detection of glucose elevations and boost good dietary and exercise practices. Earlier application of these lifestyle changes can help prevent the development of type 2 diabetes, the much more common form of diabetes.

Dr Gerry Waintraub, CTO and co-founder of HAGAR, said that receiving FDA Breakthrough Designation reflects their commitment to offering an innovative technology targeting one of the world’s most significant chronic diseases, which affects more than 422 million people, 8.5% of the world’s population. Their mission at HAGAR is to materially improve people’s health and quality of life impacted by diabetes.

Dr Irl Hirsch, Medical Advisor to HAGAR and Professor of Medicine and the Diabetes Treatment and Teaching Chair in the Division of Metabolism, Endocrinology, and Nutrition at the University of Washington, added that the study will comprise 250 patients with type 1 and type 2 diabetes and will test the GWave accuracy on a diverse group of individuals. They also have a second study due to commence this fall testing the device’s accuracy during conditions of rapidly changing glucose levels.

According to DelveInsight’s “Blood Glucose Monitoring Systems Market & Competitive Landscape”, the data provided by the International Diabetes Federation (IDF) Diabetes Atlas Ninth Edition 2019, there were approximately 463 million adults in the age group 20-79 years and is expected to reach to 700 million by 2045. Thus, there will be high demand for continuous glucose monitoring technology, further boosting the Blood Glucose Monitoring Systems market.

Brain Navi NaoTrac received European CE Mark approval in 2021 

On November 23, 2021, Brain Navi Biotechnology, a Taiwan-based startup specifying innovative navigation robots, received CE mark approval for brain surgery procedures in Q1 2021 for its NaoTrac, a robotic-assisted surgical robot. The company plans to submit documents for FDA clearance.

Jerry Chen, M.D., the CEO of Brain Navi Biotechnology, said that long surgery times, high concentration, and precision needs a lot of physical endurance for neurosurgeons in every procedure. This can, in turn, affect the surgery’s performance. Utilising NaoTrac to navigate in the cranial not only decreases anaesthesia time but also improves the patient’s well-being using less invasive interventions.

Shinn-Zong Lin, M.D. PhD., Superintendent of Hualien Tzu-Chi Medical Center. Dr Lin is also an honoured fellow of AAAS (American Association for the Advancement of Science), who added that Robotics and artificial intelligence are the future of healthcare, with remarkable potential to advance patient care and increase access to these benefits. It is vital to increase the degree of accuracy of the surgery. The technology used by Surgical Navigation Robot can be utilised in several medical fields, such as immunotherapy, cell transplant, microchip implantation, and others, where a high degree of accuracy is needed. Therefore, Surgical Navigation Robot can execute EVD or tumour resection and can collaborate within these fields.  

According to DelveInsight’s analyst, the approval of such products will drive the brain surgery market growth.