Tim Schmid, Executive Vice President and Worldwide Chairman of Johnson & Johnson MedTech, said, “We’re excited to officially welcome V-Wave to Johnson & Johnson MedTech. V-Wave’s novel implantable device, the Ventura® Interatrial Shunt, offers tremendous promise for patients experiencing heart failure with reduced ejection fraction. This technology has the potential to be the first device of its kind to market. We look forward to working with the talented V-Wave team to bring this transformative innovation to patients.”
In compliance with U.S. GAAP, the transaction will be treated as an asset acquisition, leading to an in-process research and development charge of around $600 million in the fourth quarter of 2024. As previously announced, Johnson & Johnson anticipates the transaction will reduce adjusted earnings per share (EPS) by approximately $0.24 in 2024 and by about $0.06 in 2025. The company will update its full-year 2024 financial outlook when it reports its third-quarter results on October 15, 2024.
As per DelveInsight’s “Coronary Stents Market Report,” the global coronary stents market was valued at USD 9.27 billion in 2023, growing at a CAGR of 7.51% during the forecast period from 2024 to 2030, to reach USD 14.28 billion by 2030. The rise in demand for coronary stents is primarily attributed to the rising prevalence of cardiovascular disorders such as stroke, atherosclerosis, and heart attack due to the increasing geriatric population; a growing number of PCI (Percutaneous Coronary Intervention) procedures; increase in demand for minimally invasive surgeries, and technological advancement in the product line, among others.
CalmiGo Launched Next Generation Healthcare Platform, CalmiGo Plus, for Users to manage Anxiety and Track Data Insights
On October 09, 2024, CalmiGo, the developer of the first and only mental health platform offering immediate relief and long-term care for individuals dealing with anxiety, PTSD, and panic attacks, announced the launch of its next-generation platform, CalmiGo Plus. This new platform is designed to manage anxiety within minutes and provide valuable data insights. It includes the award-winning CalmiGo device along with a new app that uses gaming technology to enhance outcomes and help users manage their anxiety more effectively each day. With CalmiGo Plus, both users and clinicians can monitor anxiety levels and track progress through the app.
The habit-forming game within the app is based on psychological principles designed to support users in their healing process. The app also creates personalized treatment plans and offers rewards to motivate users as they work to manage their anxiety. Its user-friendly and intuitive design ensures that people of all ages and backgrounds can easily benefit from it. CalmiGo developed the app as an optional add-on, catering to various preferences—some users may prefer the gaming features, while others might focus on progress tracking, use the timer with calming music, or simply sync the device every two weeks. This flexibility ensures that every user can benefit from the app and accelerate their healing journey. Additionally, the CalmiGo app offers an accessibility mode for screen readers, making it available to everyone.
“Oftentimes anxiety and panic attacks can cast a heavy burden on individuals and as a consequence they avoid situations and places and live in fear of the next attack,” says Adi Wallach, CEO of CalmiGo. “CalmiGo is designed to empower users with a device so that they can go anywhere knowing that they have relief in their pocket at all times and now the new app creates the habit of regular use effortlessly.”
The CalmiGo device is a scientifically proven, drug-free solution that lowers stress hormone levels and offers immediate relief, helping users break the cycle of anxiety and regain control of their lives, no matter where they are. This innovative portable exhaler, developed with patented technology, uses sensors and machine learning to regulate breathing patterns. It adapts to each user’s unique breathing in real time, providing guidance and feedback to help extend exhalation during each breath cycle. By gradually lengthening exhalation, the device activates the parasympathetic nervous system, which counteracts the “fight or flight” response triggered by the sympathetic nervous system during stressful situations.
According to DelveInsight’s “Digital Health Market Report”, the digital health market was valued at USD 178.37 billion in 2023 and is estimated to grow at a CAGR of 18.25% during the forecast period from 2024 to 2030 to reach USD 486.55 billion by 2030. The increase in AI-powered algorithms which help in analyzing large datasets to identify patterns and insights that aid in early disease detection and intervention is boosting the market of digital health. Additionally, the increasing medical conditions necessitating regular check-ups probably escalate the market of digital health as regular therapy sessions, psychiatric consultations, children requiring frequent health check-ups for vaccinations, growth monitoring, and skin conditions often need ongoing evaluation and treatment adjustments which increases the demand for digital health. Furthermore, the increase in mobile health applications promoting proactive healthcare management, reducing emergency room visits, and lowering healthcare costs associated with chronic disease management further propels the market. Additionally, government initiatives including the launch of national telehealth programs, subsidizing digital health solutions for underserved populations, and promoting interoperability standards for health information exchange collectively boost the digital health market, during the forecast period from 2024 to 2030.
Vy Spine Announced FDA Clearance of 3D Printed LumiVy OsteoVy PEKK Lumbar IBF
On September 03, 2024, Vy Spine, a leader in spine innovation with a focus on unique materials and designs, announced that it received clearance from the U.S. Food and Drug Administration (FDA) for its LumiVy OsteoVy PEKK Lumbar IBF.
The device is intended for intervertebral body fusion at one or two adjacent levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. The LumiVy OsteoVy PEKK Lumbar IBF integrates the osseointegration capabilities of the 3D-printed OXPEKK material with Vy Spine’s innovative OsteoVy lattice structure.
The LumiVy OsteoVy PEKK Lumbar IBF is available in a variety of footprints and heights, from 6mm to 21mm, accommodating a wide range of lumbar interbody approaches, including anterior, oblique anterior, lateral, oblique posterior, posterior, and transforaminal. Additionally, the implants come in different degrees of lordosis and hyperlordosis. The LumiVy Lumbar IBF System also includes IBF-S implants, equipped with self-drilling screws to help securely anchor the device to the bone.
OXPEKK has demonstrated advantages such as promoting bone ingrowth, avoiding radiographic interference, preventing fibrotic tissue membrane formation, and showing a significant increase in bone attachment over time, along with substantially higher push-out strength compared to standard PEEK. Beyond these benefits, OXPEKK is bacteriostatic and a suitable choice for patients with metal sensitivities. Vy Spine’s proprietary OsteoVy lattice structure further enhances bone integration and wicking, with PEKK’s hydrophilic properties offering additional benefits as an interbody implant.
“The LumiVy OsteoVy PEKK Lumbar IBF clearance is another product in a long line of Vy Spine implants which will utilize the unique qualities of our proprietary OsteoVy PEKK designs,” said Bret Berry, President of Product Development for Vy Spine. “As we researched OXPEKK and its unique characteristics, we found that this composition accomplishes what PEEK cannot. We are excited about the OXPEKK material and our continued partnership with Oxford Performance Materials.”
“We are thrilled that Vy Spine has reached this important milestone with its second OsteoFab product approval,” said Scott DeFelice, CEO of Oxford Performance Materials. “We are confident that the combination of OPM’s novel 3D printed PEKK technology and Vy Spine’s unique designs & experience within the spine marketplace will drive substantial adoption of this best-in-class solution.”
As per DelveInsight’s “Spinal Fusion Devices Market Report,” the global spinal fusion devices market was valued at USD 6.49 billion in 2023, growing at a CAGR of 4.55% during the forecast period from 2024 to 2030 to reach USD 8.47 billion by 2030. The rise in demand for Spinal Fusion Devices is primarily attributed to the rising prevalence of spinal disorders such as degenerative disc disorders, spondylolisthesis, disc herniation, and spinal stenosis among the growing old-age population worldwide; the increase in demand for minimally invasive surgeries. In addition, technological advancement in the product line, and new product launches among others are also expected to drive the global spinal fusion market.
InspireMD Announced Approval of Investigational Device Exception (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid Stent System
On October 07, 2024, InspireMD, Inc., the developer of the CGuard™ Embolic Prevention Stent System (EPS) aimed at stroke prevention, announced that the U.S. Food and Drug Administration (FDA) approved the company’s Investigational Device Exemption (IDE) Application to launch the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures.
In February 2024, InspireMD announced that Dr. Patrick Geraghty, a professor of surgery and radiology in the vascular surgery section at Washington University School of Medicine in St. Louis, MO, and Dr. Patrick Muck, program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, have agreed to serve as lead investigators for the trial.
Marvin Slosman, Chief Executive Officer of InspireMD, stated, “The approval of our CGUARDIANS II IDE is an important milestone and a significant step forward in our mission to serve the broadest range of physician and patient needs with a comprehensive set of tools that can deliver our best-in-class carotid stent system, CGuard Prime, for both CAS and TCAR procedures. The CGUARDIANS II study is intended to facilitate approval of the use of CGuard Prime in an optimized TCAR version and indication.”
“In parallel, we continue to advance development of our comprehensive next generation TCAR Neuroprotection System, SwitchGuard NPS. Each of these initiatives helps pave the way, once approved, for us to initiate commercial sales and strive for market leadership in the United States. Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company toward U.S. expansion and global success. Additionally, as we previously announced, we are thrilled to have Dr. Patrick Geraghty and Dr. Patrick Muck as co-principal investigators for the study, as well as a world class group of investigators committed to the trial’s success,” Mr. Slosman concluded.
As per DelveInsight’s “Carotid Artery Stent Market Report,” the global carotid artery stents market was valued at USD 575.76 million in 2023, growing at a CAGR of 3.21% during the forecast period from 2024 to 2030 to reach USD 718.25 million by 2030. The demand for carotid artery stents is primarily being boosted by the increasing prevalence of cardiovascular disorders such as stroke, ischemic stroke, and Transient Ischemic Attack (TIA), among others. Additionally, the increasing demand for minimally invasive surgical procedures is another key factor influencing the positive growth of the market. Further, rising technological developments in the domain of stents are also contributing to the overall growth of the Carotid Artery Stents market during the forecast period from 2024 to 2030.
GE Healthcare Announced Phase I Results for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent
On October 07, 2024, GE HealthCare announced the successful completion of its Phase I clinical development program for a pioneering manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent. The findings, presented in an abstract at the 2024 bi-annual Contrast Media Research symposium in Oslo, Norway, indicated that this manganese-based contrast agent was well tolerated in a first-in-human study, with no serious adverse events, dose-limiting toxicities, or clinically significant findings reported. These results will support the ongoing clinical development of the agent.
MRI contrast agents, which are usually gadolinium-based, enhance the visualization of abnormal structures or lesions and help distinguish between healthy and pathological tissue. This macrocyclic, extracellular, general-purpose manganese-based contrast agent offers comparable relaxivity (the ability to improve signal intensity) to gadolinium-based agents and is anticipated to have similar diagnostic performance to existing gadolinium products. Unlike gadolinium, manganese is a naturally occurring element that is efficiently eliminated from the body. In addition to its effective image-enhancing properties, this manganese-based agent could serve as a viable alternative to gadolinium, especially considering concerns about gadolinium retention and its potential environmental impact following patient excretion.
Dr Paul Evans, Head of Global R&D at GE HealthCare’s Pharmaceutical Diagnostics business segment, said, “These are encouraging Phase I results for this manganese-based contrast agent and we look forward to completing the next steps in the clinical development process. This is part of our pipeline of products aiming to improve patient outcomes across care pathways.”
Dr Robert J. McDonald, Radiologist at Mayo Clinic and Contrast Media Safety Committee Board member for the American College of Radiology, whose group has collaborated with GE HealthCare during the research phase, commented, “GE HealthCare’s manganese-based contrast agent could offer benefits such as reduced risk of tissue deposition and improved safety for certain vulnerable patient populations compared to gadolinium-based agents, while also providing comparable imaging capabilities and potentially lower environmental impact.”
The Phase I trial was conducted at the clinical research unit at Oslo University Hospital, Rikshospitalet, Norway, with partial funding from the Norwegian Research Council. GE HealthCare operates two contrast media facilities in Norway. One site in Oslo, where this manganese-based contrast agent was developed, is marking its 150th anniversary this year. Additionally, GE HealthCare’s active pharmaceutical ingredients (API) manufacturing facility in Lindesnes, southern Norway, is celebrating 50 years of production.
Kevin O’Neill, President and CEO of GE HealthCare’s Pharmaceutical Diagnostics segment, added, “As we celebrate milestone anniversaries for these two facilities, the Phase I results are a reminder of Norway’s heritage of innovation that has shaped the field of diagnostic imaging, improving patient outcomes worldwide. We aim to offer more choice to radiologists, delivering a broad portfolio that can enable personalized care and address unmet patient needs.”
According to DelveInsight’s “Magnetic Resonance Imaging Devices Market Report”, the global magnetic resonance imaging devices market was valued at USD 7.79 billion in 2023, growing at a CAGR of 6.37% during the forecast period from 2024 to 2030 to reach USD 11.28 billion by 2030. The Magnetic Resonance Imaging Devices market is witnessing a positive growth owing to the factors such as the rising cases of severe chronic diseases like various cancers, cardiac abnormalities, and others, further rapid technological developmental activities, growing geriatric population, rising adoption owing to non-invasiveness, thereby contributing to the growth of the Magnetic Resonance Imaging Devices market during the forecast period.
Medinol Ltd. Announced the Successful First-in-Human Implantation of the ChampioNIR Drug-Eluting Peripheral Stent
On October 07, 2024, Medinol Ltd. announced the successful First-in-Human (FIH) implantation of the ChampioNIR Drug-Eluting Peripheral Stent by Drs. Gerard S. Goh and Thodur Vasudevan at the Alfred Hospital in Melbourne, Australia. This marks a groundbreaking advancement in the mechanics, durability, and drug delivery capabilities of peripheral drug-eluting stents.
The ChampioNIR Drug-Eluting Peripheral Stent System represents a transformative technology aimed at enhancing patient outcomes and procedural success. Featuring a pioneering hybrid mechanical design, the stent combines radial support from its metallic component with longitudinal structure from a bio-resorbable polymeric mesh, offering exceptional flexibility and long-term durability even in the most complex anatomies. Additionally, its unique drug-elution paradigm enables the release of medication from the entire cylindrical surface of the stent, significantly reducing diffusion distances and allowing for therapeutic dosing of a large peripheral vessel with a ‘limus’ drug over an extended period for the first time.
“We were impressed with ChampioNIR’s deliverability and its straightforward deployment”, said Prof. Gerard S Goh, Head of Interventional Radiology at The Alfred Hospital. “The Frictionless Deployment Mechanism made the precise positioning of the stent very straightforward”.
Dr. Yoram Richter, CEO of Medinol, added, “Medinol is excited to bring to clinical practice the culmination of years of research and development into novel stent designs, tailor-made for unmet clinical challenges in vascular interventions.”
The CHAMPIONSHIP First In Human study will enroll a total of 30 patients across 7 sites in Australia and the United States. Prof. Sahil Parikh, PI of the CHAMPIONSHIP study commented “The ChampioNIR stent represents a breakthrough in treatment for SFA lesions. I am excited to see this device come to life after years of development.”
According to DelveInsight’s “Drug-Eluting Stents Market Report”, the global drug-eluting stents market was valued at USD 2.57 billion in 2023, growing at a CAGR of 8.09% during the forecast period from 2024 to 2030 to reach USD 4.08 billion by 2030. The drug-eluting stents market is slated to witness prosperity owing to factors such as the growing prevalence of cardiovascular diseases which can further be attributed to the increase in the geriatric population wherein aging is considered to have a deleterious effect on blood vessels, growing prevalence of lifestyle disorders such as hypertension, diabetes, and obesity that are linked to affect the health of blood vessels in long term and drastically increase the probability of atherosclerosis, and the growing focus on developing a newer generation of drug-eluting stents to minimize post-procedural complications are further expected to result in the appreciable revenue growth in the drug-eluting stents market during the forecast period (2024 to 2030).
