“We are very fortunate to have such an experienced medical device investor group supporting iVEAcare, and I look forward to partnering with them to develop this novel neuromodulation technology. This Series A financing enables iVEAcare to deliver innovative neuromodulation therapy to patients and clinicians,” Kerkow said in prepared remarks.
“We are very excited to see the third spin-off from NuXcel attract support from a syndicate comprised of such seasoned investors. We look forward to working with our co-investors and the iVEAcare team to develop this impactful therapy,” added Treo Ventures General Partner, Tracy Pappas, and iVEAcare co-founder & Chairman, Mudit Jain.
“Neuromodulation is one of the most exciting frontiers in medicine,” said Vensana Capital Partner Amrinder Singh and Managing Partner Kirk Nielsen. “We are enthusiastic to partner with iVEAcare’s experienced team to advance a best-in-class therapy that will impact the lives of countless patients.”
As per DelveInsight’s “Neuromodulation Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030” the global neuromodulation devices market was valued at USD 5.71 billion in 2023, growing at a CAGR of 8.95% during the forecast period from 2024 to 2030, to reach USD 9.56 billion by 2030. The demand for neuromodulation devices is primarily motivated by the increasing prevalence of neurological disorders coupled with the rising aging population, expansion of the devices to other chronic indications and target applications, technological advancement in the product portfolio, rising government initiatives to raise awareness among patient regarding neurological disorders, among others.
AI Medical Service Inc. Signed Joint Research Agreement with Mahidol University in Thailand
On April 22, 2024, AI Medical Service Inc. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, signed a joint research agreement with Mahidol University in Thailand and began research its activities. AIM is the first Japanese company to sign a joint research agreement with Mahidol in the field of endoscopic AI, and Mahidol is the first Thai institute that AIM has collaborated with thus far.
On December 23, AI Medical Service Inc. received manufacturing and marketing approval from Japan’s Minister of Health for an AI-equipped endoscopic imaging diagnosis support system. The endoscopic AI detects lesion candidates for biopsy or other additional exams based on gross features during the endoscopic examination and starts sales in March 2024. Furthermore, AI Medical Service Inc. has also completed regulatory review and device registration for the same product in Singapore in February 2024.
AI Medical Service Inc. is aiming to expand its product reach beyond Japan to clinical sites worldwide. Collaboration with Mahidol will facilitate joint research designed to test the applicability of Japanese endoscopic AI in Thailand.
“I am very pleased to start a joint research project on endoscopic AI for gastric cancer with Mahidol University, one of the leading universities in Thailand. In the Asian region, the large number of gastric cancer cases and deaths, as well as difficulties associated with the detection of cancer at an early stage are serious issues that need to be addressed. AIM is committed to advancing our collaboration to promptly bring the culmination of Japan’s leading expertise and achievements in endoscopic medicine, embodied in endoscopic AI, to clinical settings in Thailand.” commented CEO of AIM, Tomohiro Tada, M.D., Ph.D.
“We are excited to begin collaborating with AIM, the world leader in research and development of endoscopic AI. As you know, esophageal cancer and gastric cancer cases are on the rise. The early detection and early treatment to the upper GI malignant would lead to better survival and quality of life. In our country, the diagnosis of these GI cancers at an early stage is difficult for both training and clinical practice. We hope that AIM’s technology will be impact on clinical challenges and improve Thailand health care standards in the near future.” commented Jirawat Swangsri, M.D., Ph.D.
According to DelveInsight’s “Disposable Endoscopes – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global disposable endoscopes market was valued at USD 1.69 billion in 2023, growing at a CAGR of 12.44% during the forecast period from 2024 to 2030 to reach USD 3.41 billion by 2030. The demand for disposable endoscopes is primarily being boosted by the increasing prevalence of various disorders related to gastrointestinal tract, respiratory tract, and others amongst the population that has raised the market for disposable endoscopes contributing to the overall growth of the disposable endoscopes market during the forecast period from 2024-2030.
CERENOVUS Launched Catheter to Treat Acute Ischemic Stroke
On April 23, 2024, CERENOVUS, part of Johnson & Johnson MedTech, launched CEREGLIDE 71 Aspiration Catheter in Europe, an aspiration catheter equipped with TruCourse technology, indicated for the revascularisation of patients suffering from acute ischemic stroke.
CEREGLIDE 71 Aspiration Catheter is the latest innovation in a planned CEREGLIDE Family of catheters to join the CERENOVUS Stroke Solutions portfolio. CEREGLIDE 71 is optimized for effective, direct aspiration of blood clots and the delivery of compatible stent retrievers, including the EMBOTRAP III Revascularisation Device and CERENOVUS NIMBUS geometric clot extractor, into the neuro vasculature.
The CEREGLIDE 71 Aspiration Catheter represents the newest addition to the CERENOVUS Stroke Solutions lineup, forming part of the planned CEREGLIDE Family of catheters. Specifically designed for efficient removal of blood clots through direct aspiration, it also facilitates the deployment of compatible stent retrievers like the EMBOTRAP III Revascularisation Device and the CERENOVUS NIMBUS clot extractor within the neurovascular system.
“The CEREGLIDE 71 Aspiration Catheter using TruCourse technology represents a great advancement in acute ischemic stroke treatment,” said Mark Dickinson, worldwide president, CERENOVUS. “It provides physicians with a greater level of flexibility while offering reliable trackability, durable delivery, and versatility for both direct aspiration and stent-retriever use.”
Acute ischemic strokes account for 85% of all strokes in Europe. By utilizing aspiration catheters during thrombectomy procedures, physicians can restore blood flow in the brain by directly withdrawing a blood clot or using the catheter in combination with a stent retriever. However, in up to nearly 50% of cases, challenging anatomical features are present that can impact access to the clot, procedure time, recanalization success, and clinical outcomes.
The TruCourse technology used in the CEREGLIDE 71 Aspiration Catheter increases the flexibility of the device, which is designed to deliver smoother navigation and access to clots, even in challenging anatomical conditions. This provides physicians with optimal compatibility, durable delivery, and reliable trackability during thrombectomy procedures.
“The introduction of the CEREGLIDE 71 Aspiration Catheter in Europe is an important step in endovascular thrombectomy, as it allows swift targeted clot access and removal during stroke treatment,” said Professor Kyriakos Lobotesis, Imperial College London. “With CEREGLIDE 71 Aspiration Catheter, we can now access occlusion sites and aspirate clots more rapidly and efficiently, maintaining a smooth interaction with stent retrievers when used in co-aspiration. This leads to the prompt restoration of blood flow in the patient’s brain, which has the potential to save more lives and improve long-term clinical outcomes.”
According to DelveInsight’s “Transcatheter Heart Valve Replacement Devices – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global transcatheter heart valve replacement market is estimated to grow at a CAGR of 13.75% during the forecast period from 2024 to 2030. The transcatheter heart valve replacement market is observing significant market growth primarily owing to the growing number of valvular heart diseases and aortic stenosis disorders across the globe. Further, the rising focus on minimally invasive surgeries, increasing technological advancements in device & surgical procedures, the increasing burden of the geriatric population prone to aortic stenosis, mitral regurgitation, and other cardiovascular disorders, increasing burden of risk factors leading to valvular diseases, presence of a large number of devices in the pipeline, increasing product launches and approvals, surging investments by key players, among others will ultimately affect the demand for transcatheter heart valve during the forecast period from 2024-2030 growing at a substantial CAGR.
Cochlear Received FDA Clearance To Lower The Age For The Osia System To 5-Years-Old (Regulatory Update)
On April 19, 2024, Cochlear Limited obtained U.S. Food and Drug Administration (FDA) clearance to lower the age of the Cochlear™ Osia System from 12 years old to 5 years old for children with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness (SSD).
The Osia System is a new category of bone conduction hearing solutions that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea). It is the first and only active bone conduction system that allows patients to undergo MRI scans at both 1.5 T and 3.0 T without the need for surgery.
Now children as young as 5 will be able to have full access to the Osia System’s unique technology that is optimized to deliver high power and clarity, especially in high-frequency sounds, which are important for hearing what others are saying.
“The Osia System is a transformative technology, and we’re pleased that it’s now accessible for children as young as 5. This aligns with our commitment to empower people across all stages of life to stay connected and thrive,” Lisa Aubert, President, of Cochlear North America said.
According to DelveInsight’s “Cochlear Implants – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global cochlear implants market was valued at USD 1.52 billion in 2023, growing at a CAGR of 9.92% during the forecast period from 2024 to 2030, to reach USD 2.68 billion by 2030. The rise in demand for cochlear implants is primarily owing to the growing prevalence of hearing loss of different types such as conductive hearing loss, mixed hearing loss, one-sided sensorineural hearing loss, and others among the population worldwide. Moreover, the growing burden old-age population, technological advancement in cochlear implants, and increase in product approvals by the authorities are some other factors responsible for cochlear implants market growth.
Immunovia Announced Positive Results From The Model-Development Study For Its Next-Generation Pancreatic Cancer Detection Test
On April 22, 2024, Immunovia, the diagnostics company with the mission to increase pancreatic cancer survival through early detection, announced its next-generation pancreatic cancer test achieving both the primary and secondary endpoints in a model-development study.
In the study, Immunovia’s next-generation test demonstrated a specificity of 98 percent and sensitivity of 75 percent in detecting early-stage (1 and 2) pancreatic ductal adenocarcinoma (PDAC), a very aggressive and the most common form of pancreatic cancer. The Immunovia test was also significantly more accurate than CA19-9, the biomarker commonly used to detect pancreatic cancer.
Importantly, these results confirm the technical advancement of the next-generation test over Immunovia’s first-generation test, IMMray PanCan-d. The next-generation test includes high-performing protein biomarkers, making the test less reliant on CA19-9. This is a major achievement as around 10 percent of patients, including many patients of African ancestry, do not produce CA19-9, so the IMMray PanCan-d test could not be used in those patients. The results with the new test were achieved including PDAC patients with low CA19-9 values.
Furthermore, the new test does not provide indeterminate or “borderline” results; all patients are classified as positive or negative for pancreatic cancer. With the first-generation Immunovia test, IMMray PanCan-d, about 10 percent of patients received a test result of “borderline”, creating indecision for clinicians.
“Pancreatic cancer is a brutal and lethal cancer. People at risk for pancreatic cancer need a simple, fast, and easy blood test to detect cancer early. We are very excited about the potential of our test to meet this need and increase survival rates for these patients,” said Jeff Borcherding, CEO and President of Immunovia.
The model development study was designed to select the highest-performing biomarkers to include in the next-generation test, to define the algorithm to produce a diagnostic result, and to provide an initial assessment of the test’s clinical performance. The study included 481 blood samples from the U.S. and Europe. Of these, 133 were samples from patients with stage 1 or 2 PDAC. The 348 control samples represented a wide range of subjects, including people at high risk for hereditary and familial pancreatic cancer, diabetics, patients with benign pancreatic lesions worrisome for PDAC, and healthy individuals.
Immunovia will now move to a second phase of the model development study, expected to be completed in 6 – 8 weeks, in which it will conduct additional statistical analyses to refine and assess the robustness of the test model. In addition, test performance will be evaluated in a more selective cohort of patients at high risk for pancreatic cancer.
According to DelveInsight’s “X-Ray Detector Market – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global X-Ray Detectors market was valued at USD 2.97 billion in 2023, growing at a CAGR of 6.76% during the forecast period from 2024 to 2030 to reach USD 4.38 billion by 2030. The X-ray detectors market is witnessing positive growth owing to various factors such as the rising incidence of several types of cancers, the rising incidence of cardiovascular diseases, the increasing number of falls, and the increasing prevalence of dental problems. Therefore, the market for X-ray detectors is estimated to grow during the forecast period from 2024 to 2030.
Hyalex Orthopaedics Reported Treatment of First Patients with Novel HYALEX® Knee Cartilage System
On April 22, 2024, Hyalex Orthopaedics, announced that patients have successfully received HYALEX Knee Implants as part of the company’s first-in-human clinical trials of its novel HYALEX Knee Cartilage System. The company is currently running two prospective, multi-center, single-arm studies in the U.S. and Europe, with sites for both studies having already enrolled and treated patients.
HYALEX Cartilage is engineered to replicate the structure and function of hyaline cartilage, the strong and flexible tissue that enables the smooth and pain-free movement of your joints. By incorporating components that provide both strength and lubrication, HYALEX Cartilage is designed to replace painful cartilage lesions and provide immediate restoration of the knee surface by matching the strong and slippery properties of the body’s native cartilage. The HYALEX Knee Implant leverages this innovation to offer a potentially disruptive treatment approach for knee cartilage repair as compared to traditional orthopedic materials.
The ongoing clinical trials (NCT06368700 and NCT06344481) are evaluating the safety and technical performance of the HYALEX Knee Cartilage System in symptomatic patients who require surgical treatment due to loss of articular cartilage in the knee femoral condyle. The unique design of the HYALEX Knee System allows surgeons to treat patients with or without bony involvement. Following implantation, study investigators will regularly assess patients with imaging, physical exams, and patient-reported outcome measures. Active sites in the U.S. study include Oregon Health & Science University (OHSU) in Portland, Oregon, and the Hospital for Special Surgery (HSS) in New York. In Europe, investigational sites at the SPORTO Clinic in Lodz, Poland, and the Enel-Sport Center for Orthopedics and Rehabilitation in Warsaw, Poland, are screening and enrolling patients.
“Initial assessments of the Hyalex patients I have treated suggest that they are responding positively to the implant procedure and recovering very well. These are very promising results for cartilage patients at this stage of their treatment journey,” said Professor Marcin Domzalski, Head of SPORTO Clinic and Chief of Orthopaedics and Trauma at the University of Lodz.
“An off-the-shelf surgical solution for cartilage repair is the largest unmet need in orthopaedics today. Market studies indicate that there are approximately 750,000 cartilage injuries diagnosed annually in the US that could be addressed by Hyalex,” said Carl Vause, President and Chief Executive Officer of Hyalex. “Our preclinical evaluations and testing of the HYALEX Knee Cartilage System have demonstrated the impressive resilience and durability of this technology. The quality of this data and our rigorous test methods were validated with the full FDA IDE approval of the US study. The initiation of these studies is a critical step on the path to providing Hyalex technology to orthopaedic surgeons, allowing them to treat these currently untreated patients.”
According to DelveInsight’s “Orthopedic Devices – Market Insights, Competitive Landscape, and, Market Forecast – 2030”, the global orthopedic devices market was valued at USD 44.09 billion in 2023, growing at a CAGR of 4.78% during the forecast period from 2024 to 2030 to reach USD 57.79 billion by 2030. The orthopedic devices market is slated to witness increasing revenue owing to factors such as a growing population of people above the age of 65, a rise in the cases of bone disorders such as osteoarthritis and osteoporosis among others, increasing cases of occupational injuries and non-occupational injuries along with latest technological developments in healthcare technology are further expected to result in the appreciable revenue growth in the orthopedic devices market during the forecast period (2024-2030).
