ReCor Medical and Otsuka Medical Devices Announce Primary Endpoint Met in the RADIANCE II US Pivotal Trial of the Paradise™ System for the Treatment of Hypertension

On July 26, 2022, ReCor Medical, Inc., a completely owned subsidiary of Otsuka Medical Devices Co., Ltd., with its headquarters in Palo Alto, California, a firm dedicated to revolutionizing the treatment of hypertension and Otsuka Medical Devices Co., Ltd., a fully owned subsidiary of Otsuka Holdings Co., Ltd. announced that the RADIANCE II US FDA IDE pivotal trial evaluating the Paradise™ Ultrasound Renal Denervation (uRDN) System as a treatment for hypertension met its primary efficacy endpoint, showing a statistically significant decrease in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.

The RADIANCE II US FDA IDE pivotal trial is a randomized, sham-controlled clinical trial of the ReCor Paradise uRDN System for treating patients with uncontrolled hypertension. At more than 60 trial locations in 8 countries, 224 patients with mild-to-moderate uncontrolled hypertension who had previously been treated with up to two drugs were randomly assigned.

The third and largest part of ReCor’s RADIANCE Global Program, RADIANCE II consists of randomized, sham-controlled trials assessing the Paradise uRDN System in hypertensive patients. The previously announced RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO investigations are the first two in the series (conducted in those who remained hypertensive despite being on antihypertensive therapy). The primary effectiveness endpoints of both studies were met. ReCor currently has a third successful study with RADIANCE II, and the RADIANCE Global Program has randomized more than 500 participants. The Global Paradise System (“GPS”) Registry, a real-world trial including up to 3,000 patients with uncontrolled hypertension, has also been started by ReCor.

“Despite the truly formidable challenges of conducting a complex clinical trial in the throes of the COVID-19 pandemic, we are thrilled to observe these positive results of RADIANCE II, especially in light of those we have previously reported from RADIANCE-HTN SOLO and TRIO,” said Study Principal Investigators Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYork-Presbyterian Hospital and Michel Azizi, Professor of Medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France. “We cannot adequately convey our thanks to the patients, coordinators, and study physicians for their collective efforts, and we very much look forward to being able to present and publish the complete study details shortly.”

According to DelveInsight’s “Blood Pressure Monitoring Devices Market” Report, the global blood pressure monitoring devices market was valued at USD 1.04 billion in 2021, growing at a CAGR of 10.68% during the forecast period from 2022 to 2027 to reach USD 2.10 billion by 2027. The blood pressure monitoring devices market is witnessing positive growth owing to various factors such as the increasing prevalence of hypertension, the surge in the geriatric population, the increasing prevalence of cardiovascular disease, and technological advancements in product offerings. Therefore, the market for blood pressure monitoring devices is estimated to grow during the forecast period from 2022 to 2027.

Seegene to Pave Way for PCR Testing at Local Clinics with EU-approved Multiplex Test and Fully Automated PCR Solution

On June 29, 2022, Seegene Inc., South Korea’s leading molecular diagnostics (MDx) firm, received EU approval for its Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay, which is compatible with the company’s fully automated ‘AIOS’ (All-in-One System). This is expected to help small hospitals, local clinics, and public health centers effectively recognize COVID-19, influenza A and B, and respiratory syncytial virus (RSV).

The Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay can find six targets associated with the four respiratory viruses. Three separate COVID-19 genes (S, RdRp, and N) are the targets to detect positive instances even when new variations appear consistently. Two internal controls are also used during the test to ensure adequate sampling and testing validity. Using no extraction, the product can produce results in just two hours, saving time and money.

According to DelveInsight’s “Molecular Diagnostics Market” Report, the global molecular diagnostic market was valued at USD 16.94 billion in 2021, growing at a CAGR of 9.16% during the forecast period from 2022 to 2027, to reach USD 28.44 billion by 2027. The increase in demand for molecular diagnostics 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, increasing demand for point-of-care diagnostics, and 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.

AbbVie and iSTAR Medical Announce Strategic Alliance for the Treatment of Glaucoma

On July 20, 2022, AbbVie, and iSTAR Medical SA announced a strategic transaction to develop further and commercialize iSTAR Medical’s MINIject® device, a minimally invasive glaucoma surgical (MIGS) device for patients with glaucoma. This beneficial partnership will aid iSTAR Medical’s research, development, and marketing efforts for MINIject® and give AbbVie the chance to grow its eye care division by enhancing its glaucoma products, which already includes drops, sustained release implants, and stents.

MINIject® is iSTAR Medical’s cutting-edge MIGS device for patients with primary open-angle glaucoma. MINIject® combines the distinctive porous structure of its proprietary STAR® material with the power offered by the supraciliary space. It is created to enhance the natural fluid outflow, reducing intraocular pressure (IOP) and the need for medication while bio-integrating with surrounding tissue, preventing inflammation, fibrosis, and related complications.

“As a leading company in eye care with a commitment to a broad and diverse portfolio from the front to the back of the eye, along with our global footprint and infrastructure in glaucoma, we are well-positioned to support bringing these MIGS offering to patients and glaucoma specialists through this strategic alliance,” said Michael Robinson, M.D, Vice President, Global Therapeutic Area Head of Eye Care, AbbVie. “This alliance with iSTAR Medical is an important step as we continue to be an innovator in glaucoma by maximizing the value of interventional approaches throughout the treatment paradigm.”

According to DelveInsight’s ‘‘Minimally Invasive Surgical (MIS) Devices Market” Report, the global MIS devices market was valued at USD 28,873 million in 2021, growing at a CAGR of 7.38% during the forecast period from 2022 to 2027, to reach USD 42,499 million by 2027. The MIS devices market is witnessing positive market growth owing to the factors such as the rising prevalence of various cancers such as lung cancer which accounted for the highest number of cancer-related deaths and highest cancer incidence in 2021, and other indications such as cardiovascular diseases, and neurodegenerative diseases among others. Furthermore, the presence of factors such as growth in the aging population, wherein age plays a key role in the development of various indications, is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development, such as the development of surgical robots, are further driving the MIS devices market as new products are gaining regulatory approvals and are entering the market.

Instylla Announces Positive Results from Preclinical Studies of Embrace™ Hydrogel Embolic System in Haemorrhage Models

On July 26, 2022, Instylla, Inc., a privately held company developing next-generation liquid embolic for peripheral vascular embolotherapy, announced two publications that evaluated the Embrace™ Hydrogel Embolic System (HES) in preclinical porcine hemorrhage models.

In a Journal of Vascular and Interventional Radiology (JVIR) publication, Dr. Gandras et al. evaluated the ability of Embrace HES to establish hemostasis in a porcine mesenteric artery hemorrhage model that mimics injury in humans. Results showed that 100% of the damaged arteries were completely, quickly, and durably embolized by Embrace HES with a mean delivery time of 5.3 minutes. Angiograms revealed no indication of non-target embolization.

“Embrace was effective in achieving hemostasis in an animal haemorrhage model without evidence of non-target embolization. This next-generation liquid embolic has tremendous potential to play an important therapeutic role in a wide variety of clinical applications including haemorrhage and interventional oncology,” commented Dr. Eric Gandras, Associate Chief, Vascular and Interventional Radiology at North Shore University Hospital, New York, and lead author of the study.

According to DelveInsight’s “Peripheral Vascular Devices Market” Report, the global peripheral vascular devices market was valued at USD 9.63 billion in 2021, growing at a CAGR of 7.88% during the forecast period from 2022 to 2027, to reach USD 15.13 billion by 2027. The demand for peripheral vascular devices is primarily being boosted by the rapid growth in the prevalence of cardiovascular diseases and peripheral vascular diseases, the approval of new and advanced products, and the rising incidence of lifestyle disorders such as diabetes and hypertension. Furthermore, the increase in the geriatric population is also likely to contribute to the peripheral vascular devices market growth.

Baxter launches Welch Allyn RetinaVue 100 Imager PRO in South Korea

On July 25, 2022, Baxter, an American multinational health care company with headquarters in Deerfield, Illinois, launched its Welch Allyn RetinaVue 100 Imager PRO in South Korea.

The device has been created to make diabetic retinopathy screening simple and inexpensive in primary care settings. The company stated that RetinaVue can double the patient compliance each year for potentially vision-saving annual Diabetic Retinal Exams (DREs). It enables healthcare professionals in primary care practices to capture high-quality fundus pictures with minimal training. The portable device enables comfortable retinal screening without pharmacological dilatation and features nonmydriatic capture through a 3.0mm pupil. It uses integrated image-quality evaluation algorithms and patented touch less auto-focus/image capturing technology to assist in minimizing the need for re-imaging visits. The tool immediately rates the quality of the taken image.

Baxter Asia-Pacific vice-president Bruce Peatey said: “Diabetes is an epidemic. Diabetic retinopathy is the leading cause of vision loss among adults 20-to-74 years of age, affecting 7.7 million people worldwide”.

“It is simply tragic that a large percentage of patients with diabetes aren’t being screened for diabetic retinopathy when it’s one of the most preventable causes of blindness among adults.

“RetinaVue has the potential to change lives by helping to identify diabetic retinopathy in those individuals who had not previously been screened for the disease, enhancing the potential to save the sight of thousands, if not millions, of people with diabetes.”

According to DelveInsight’s ”Ophthalmic Imaging Equipment Market” Report, the global Ophthalmic Imaging Equipment Market was valued at USD 2.33 billion in 2021, growing at a CAGR of 5.97% during the forecast period from 2022 to 2027 to reach USD 3.29 billion by 2027. The demand for ophthalmic imaging equipment is primarily being boosted by the rising prevalence of diabetes and growing geriatric population base, which has resulted in the increased prevalence of ocular diseases of different etiologies, increasing number of image-guided surgeries, and technical innovation in product development which is expected to increase in the product demand thereby contributing in the growth of the ophthalmic imaging equipment market during the forecast period from 2022-2027.

Roche’s Elecsys Amyloid Plasma Panel Granted FDA Breakthrough Device Designation to Enable a Timely Diagnosis of Alzheimer’s disease

On July 19, 2022, Roche Diagnostics, a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys® Amyloid Plasma Panel.

 It is a cutting-edge novel method for enabling early Alzheimer’s disease detection. The Elecsys Amyloid Plasma Panel test examines and identifies biomarkers for Alzheimer’s disease in blood plasma to determine whether additional confirmatory testing for Alzheimer’s disease is necessary. For an Alzheimer’s blood-based biomarker test, Roche is the first in-vitro diagnostics firm to receive this designation.

The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau occur in the early stages of Alzheimer’s, while the presence of APOE E4 constitutes the most common genetic risk factor for Alzheimer’s disease. The outcome is meant to be taken into account together with other clinical data to recommend further confirmatory testing using amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients who test negative on the Elecsys Amyloid Plasma Panel are probably not positive for amyloid and should be checked for other possible reasons of cognitive deterioration.

“The key to transforming the lives of people with Alzheimer’s disease is to diagnose as early as possible and intervene with the right care plans,” said Thomas Schinecker, CEO of Roche Diagnostics. “Our new diagnostics test has the potential to streamline a patient’s journey, improving speed and access toward a confirmatory diagnosis, giving people with Alzheimer’s disease and their caregivers more time to plan and prepare for the future”.

According to DelveInsight’s “Brain Monitoring Devices Market” Report, the global Brain Monitoring Devices Market was valued at USD 6.31 billion in 2021, growing at a CAGR of 7.27% during the forecast period from 2022 to 2027, to reach USD 9.61 billion by 2027. The demand for brain monitoring devices is primarily being boosted by the rising prevalence of neurological diseases, technological advancement in product development, rising awareness about neurodegenerative diseases, and increasing brain monitoring applications 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.