First Patient Enrolled in I-STEP Clinical Study of EndoBarrier in India

On February 13, 2023, GI Dynamics Inc., a medical device company, announced the enrollment of the first candidate in the I-STEP clinical trial in India. The trial aimed to assess the safety and effectiveness of the EndoBarrier® System for glycaemic improvement in patients with type 2 diabetes and obesity that is not effectively controlled. 

I-STEP is a multi-centered, randomized, controlled, pivotal trial of the EndoBarrier® System in India. Around 100 candidates are expected to enroll in the trial and throughout the 24-month research period, patients treated with EndoBarrier will receive medication, monitoring, and counseling. 

All participants will have hemoglobin A1c levels that fall within a predetermined range, maintain a moderately active lifestyle, and get nutritional counseling in addition to routine medication maintenance.

Dr. Usha Ayyagari, Senior Consultant in Diabetes and Endocrinology, and Dr. Bharath Kumar Mookiah, Consultant Gastroenterologist, were the study’s principal investigators at Apollo Speciality Hospital, OMR, Chennai, one of the four clinical study sites.

“I am honored and delighted to be the first site to enroll participants in the I-STEP clinical trial,” said Dr. Ayyagari, Senior Consultant in Diabetes and Endocrinology at Apollo Specialty Hospitals, Chennai, India. She added, “The twin epidemics of diabetes and obesity, with the consequent co-morbidity, affect a significant proportion of Indians, usually at a younger age. We believe that EndoBarrier is a novel and powerful clinical tool for us to treat individuals with type 2 diabetes and obesity.” 

Joe Virgilio, President and Chief Executive Officer of GI Dynamics, commented, “We are very excited to be able to offer EndoBarrier treatment to patients in India via the I-STEP Clinical Trial. Apollo has proven to be a very collaborative partner, and their innovative approach to treating patients should serve to accelerate access to new technologies like EndoBarrier. Given the widespread incidence of type 2 diabetes and obesity throughout the country, there appears to be a significant need for alternative treatments for patients who, in particular, struggle to control their HbA1c.”

As per DelveInsight’s “Insulin Delivery Devices Market” report, the global insulin delivery devices market was valued at USD 15.51 billion in 2021 and is likely to register a CAGR of 9.28% during the forecast period from 2022 to 2027 to reach USD 26.35 billion by 2027. The insulin delivery devices market is observing remarkable market growth due to the factors such as the rising prevalence of diabetes among the geriatric population, favorable reimbursement scenarios, rising awareness about proper diabetes management with insulin delivery devices, and technological advancements in the product line, among others. 

Premium Women’s Health Ultrasound Introduced by Samsung 

On February 8, 2023, Boston Imaging, the United States headquarters of Samsung’s digital radiography and ultrasound business, introduced HERA W10 Elite, the premier model of the HERA platform for Obstetrics and Gynecology. 

HERA W10 Elite enhances the diagnostic experience of clinicians by assisting them with greater insight into diagnosis through its intuitive visualizations, precise analytic features, and quick operation. This is done with the help of powerful artificial intelligence (AI) tools. 

The revolutionary system has also improved upon its forerunner in several ways, including:

  • Advanced MV-FlowTM: It offers 2D and 3D visualization of microcirculatory and sluggish blood to show the intensity of blood flow.
  • Larger OLED Display: The display area has grown by 57%2, and the OLED3 screen’s ability to accurately depict the hues of black makes it ideal for a variety of ultrasound picture characteristics.
  • New Transducer: Starting at eight weeks endovaginally, the EV2-124 enables imaging of the fetal heart and brain. 

The system is also equipped with enhanced AI features, such as:

  • HeartAssist™: This software offers measurement data and automatically divides an ultrasound image into measurement views needed to diagnose embryonic heart defects. 
  • ViewAssist™: It classifies ultrasound images automatically and marks up the structures for simple measurements. 
  • BiometryAssist™: It enables quick measurement of fetal growth parameters while maintaining exam consistency. 

“Women’s health is a fast-growing field that requires state-of-the-art equipment for patient care. The HERA W10 Elite will bring visionary change to Obstetrics and Gynecology with sophisticated image processing and an ergonomic-friendly design,” commented Tracy Bury, Women’s Health Ultrasound Business Leader, Boston Imaging. 

According to DelveInsight’s “Women’s Health Market” report, the global women’s health market was valued at USD 31.94 billion in 2021, growing at a CAGR of 5.40% during the forecast period from 2022 to 2027, to reach USD 43.76 billion by 2027. The women’s health market is estimated to register positive revenue growth primarily due to the rising prevalence of chronic diseases such as breast cancer, cervical cancer, and others, increasing awareness of birth control methods among women, rise in menstrual disorders and infertility issues in women, increase in age-related health problems such as osteoporosis, among others, and the growing focus on improving the safety, affordability, and usability of women’s health products are further expected to result in the appreciable revenue growth in the women’s health market during the forecast period (2022-2027).

Ibex Obtained CE Mark for Galen™ Prostate

On February 9, 2023, Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, announced that Galen™ Prostate obtained a CE mark under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for supporting pathologists in the primary diagnosis of prostate biopsies, becoming the first standalone AI-based cancer diagnostics product of its kind to be certified under the IVDR. 

Galen Prostate uses artificial intelligence to analyze samples before they are reviewed by pathologists, giving them diagnostic insights to aid in their diagnosis. This helps to enhance the accuracy of cancer diagnosis, increase productivity, and optimize pathology workflows. The algorithms behind Galen Prostate were developed using sizable datasets from many pathology institutes across the globe that were enhanced with uncommon prostatic cancers. 

Galen offers decision support tools to help pathologists diagnose cancer more quickly and objectively. It also offers additional insights, such as a Gleason score, tumor size, and associated morphologies for each cancer slide.

Dr. Yael Liebes-Peer, Head of Regulatory Affairs and Quality Assurance at Ibex Medical Analytics commented, “Ibex continues to maintain the highest possible standards for its products, bringing cutting-edge computational solutions to improve outcomes of cancer care.” He added further, “Dedicated to our mission of providing every patient with an accurate, timely, and personalized cancer diagnosis, we are proud to provide the market’s first IVDR-certified product, elevating the quality of diagnosis for patients, pathologists, and laboratories.”

According to DelveInsight’s “In Vitro Diagnostics Market” report, the global In Vitro Diagnostics market was valued at USD 71.01 billion in 2021, growing at a CAGR of 4.71% during the forecast period from 2022 to 2027, to reach USD 93.60 billion by 2027. The increase in demand for in vitro diagnostics is predominantly attributed to the increasing prevalence of infectious diseases such as COVID-19, the growing prevalence of various cancers such as prostate cancer, breast cancer, and lung cancer, among others, increasing cases of hematological diseases, and increasing product development activities concerning in vitro diagnostics, among others. 

EndoStream Medical Announced Enrollment of First Patient in the US Clinical Trial for Nautilus™ Intrasaccular System 

On February 13, 2023, EndoStream Medical announced that the first patient in the TORNADO-US clinical study, which aims to assess the Nautilus™ Intrasaccular System, a groundbreaking medical innovations for the treatment of cerebral aneurysm, is being treated at one of the major hospitals in New York, Mount Sinai Hospital. 

The Nautilus™ is a self-conforming intrasaccular flow diverter that increases coil stability and neck coverage to maximize intrasaccular thrombosis and allows progressive aneurysm occlusion. 

The patient was also given treatment using Kaneka i-ED coils, which were employed in combination with the Nautilus™ Intrasaccular System. The Kaneka i-ED coils are a new generation of coils created for the treatment of cerebral aneurysms, and it has been demonstrated that they offer exceptional aneurysm occlusion rates. 

“The enrollment of the first patient in the TORNADO-US clinical study is a major milestone for the treatment of cerebral aneurysms,” commented Chris Kellner, MD, Assistant Professor of Neurosurgery at the Icahn School of Medicine at Mount Sinai and Principal Investigator of the TORNADO-US clinical study. He remarked, “We are excited to be at the forefront of this innovation.”

Tomoyoshi Shigematsu, MD, Assistant Professor of Neurosurgery, Neurology, and Radiology at Icahn Mount Sinai, and surgeon mentioned, “I was impressed by the ease of use and the versatility of the device. The procedure went smoothly, and the patient is recovering well.” 

According to DelveInsight’s “Intracranial Aneurysms Market” report, the global intracranial aneurysms market was valued at USD 1.13 billion in 2021 and is likely to register a CAGR of 9.10% during the forecast period from 2022 to 2027 to reach USD 1.90 billion by 2027. Some of the major factors driving the intracranial aneurysms market growth are the increasing patient population suffering from brain aneurysms and stroke and the increasing number of risk factors for brain aneurysms such as high blood pressure and others. Furthermore, the approval and launch of various intracranial aneurysm treatment devices and increasing research and development for the same are going to accelerate the growth of the intracranial aneurysms market during the forecast period (2022-2027). 

Sunrise Received FDA Clearance for At-home Sleep Apnea Test

On February 13, 2023, Sunrise, a Belgium-based company, announced the US Food and Drug Administration (FDA) clearance for the company’s at-home sleep apnea test. 

Based upon Artificial Intelligence (AI) technology, the at-home sleep apnea test is effective for the diagnosis of obstructive sleep apnea and sleep-related breathing disorders. Patients will be able to perform multi-night testing as one of the new features of this at-home sleep apnea test.

During the test, mandibular jaw motions (MJM) are recorded using a lightweight sensor that is positioned on the chin and records the movements of the jaw. An app collects the data, an algorithm utilizing AI analyses it, and a secure internet gateway makes it available to healthcare practitioners.

Sunrise’s established technology opens the door for extending access and reach across health systems and clinics through its AI-based solution to improve health outcomes. 

“The new device utilizing the powerful Mandibular Jaw Movements signal alongside the traditional signals of airflow and oximetry brings a new level of clinical information and ease of use never seen before in-home sleep testing, said Laurent Martinot, CEO and co-founder of the Sunrise.” He added, “We have clinically validated our sensor against the gold standard of polysomnography on thousands of patients to measure sleep-disordered breathing.”

Atul Malhotra, MD, board-certified pulmonologist, intensivist, and research chief of Pulmonary, Critical Care, and Sleep Medicine at UC San Diego Health, remarked, “Home sleep tests have come a long way in recent years and are now well established in diagnosing sleep disorders in appropriate patients. Despite this success, there remain shortcomings and the Sunrise device appears to close some of these gaps in its ability to convey relevant information about the hypoxic burden and total sleep time spent with increased respiratory effort, a key component of obstructive sleep apnea that has been linked to cardiovascular and mortality outcomes”. He mentioned, “Night to night variability in sleep studies is well documented and incorporating a multi-night capability in an economical manner, allowing to capture longitudinal data over time, will improve diagnostic confidence.”

According to DelveInsight’s “Sleep Apnea Diagnostic Devices Market” report, the sleep apnea diagnostic devices market was valued at USD 4.89 billion in 2021, growing at a CAGR of 6.92% during the forecast period from 2022 to 2027 to reach USD 7.30 billion by 2027. The demand for sleep apnea diagnostic devices is primarily attributed to the increasing prevalence of sleep apnea worldwide due to unhealthy lifestyles and excess body weight. Moreover, the increasing geriatric population and the increasing prevalence of comorbidities such as hypertension, diabetes, obesity, and cardiovascular diseases are further going to propel the market growth of sleep apnea diagnostic devices during the forecast period (2022-2027). 

Globus Medical Announced Merger with NuVasive to form Global Musculoskeletal Company

On February 9, 2023, Globus Medical, a leading musculoskeletal solutions’ company, entered into the definitive agreement to combine in an all-stock transaction with NUVASIVE, the leader in spine technology innovation. 

With a common vision of innovation and a relentless pursuit of unmet clinical requirements to enhance patient care, the deal united two reputable technology firms in the musculoskeletal sector.

The agreement, which was unanimously approved by the boards of directors of both businesses, provides that for each share of NuVasive common stock held at the closure of the transaction, stockholders will receive 0.75 shares of Globus Medical Class A common stock. Based on the closing share price of Globus Medical on February 8 and the assumed exchange ratio, NuVasive’s implied share price would be $57.72, representing an equity value of $3.1 billion.

On a fully diluted basis, shareholders of NuVasive will hold about 28% and shareholders of Globus Medical will hold about 72% of the combined business when the acquisition closes.

The deal is anticipated to close in the middle of 2023, pending shareholder and regulatory clearance as well as other standard closing requirements.

“This transaction reflects our mission to become the leading musculoskeletal technology company in the world by developing products that promote healing in patients with musculoskeletal disorders,” commented Dan Scavilla, president and chief executive officer of Globus Medical. He said further, “With NuVasive, we can help support more patients through leading innovation and expanding our commercial reach to provide superior service to our surgeon and hospital partners. We look forward to combining the NuVasive and Globus Medical teams to capitalize on the many opportunities to improve patient care and create sustainable shareholder value.”

Chris Barry, chief executive officer of NuVasive said, “Our combination with Globus Medical is transformative, joining two companies with highly complementary capabilities, geographic footprints, and customer bases.” He added further,” Together, we will be able to offer an exceptional portfolio of clinically proven solutions, supported by strong commercial and surgeon education teams. The new company will be well-positioned to deliver value creation for shareholders, further support our surgeon partners—and most importantly, change the lives of more patients.”

According to DelveInsight’s “Orthopedic Devices Market” report, the global orthopedic devices market was valued at USD 44.09 billion in 2021 and will grow at a CAGR of 4.78% during the forecast period from 2021 to 2026 to reach USD 57.79 billion by 2027. Some of the key factors driving the growth of the global orthopedic devices market are the rising prevalence of orthopedic diseases such as arthritis, osteoporosis, and others, a growing burden of the geriatric population, the increasing cases of occupational and non-occupational injuries along with the latest technological advancements in healthcare technology are further expected to result in the appreciable revenue growth in the orthopedic devices market during the forecast period (2022-2027).