Check-Cap Initiated the US Pivotal Trial for C-Scan®

On May 11, 2022, Check-Cap Ltd., a clinical-stage diagnostic company initiated the US pivotal trial for C-Scan® at Mayo Clinic in Rochester Minnesota. C-Scan is the first and only patient-friendly, preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC). The company has obtained the Institutional review board (IRB) approval for the study and is anticipating to promptly begin the patient enrolment. The principal investigator of the study will be Elizabeth Rajan, M.D., gastroenterologist, and professor of medicine at Mayo Clinic.

About the trial:

The US pivotal trial with NCT05271656 is designed to get FDA approval for C-Scan in the US. The trial is a two-part open-label trial and will study the accuracy of the device to identify subjects who are at an elevated risk of colon polyps. The study will enroll around 1,000 subjects aged 50-75 and will be conducted at up to 15 clinical sites in the US. The first part of the trial is designed to enable further calibration of the C-Scan for the average risk U.S. population and will enroll up to 200 subjects. The second part consists of a statistically powered, randomized study that will compare the performance of the C-Scan to traditional colonoscopy, using sensitivity and specificity measures, and will enroll approximately 800 subjects.

Alex Ovadia, chief executive officer of Check-Cap, said, “We are excited to announce the accomplishment of this important milestone in our path to demonstrate the potential of C-Scan to detect colorectal polyps before they may turn into cancer in the average-risk population. We are pleased to have engaged with expert gastroenterologists at Mayo Clinic and continue to advance the participation of additional experienced clinical trial centers in this study. We have established a supply and distribution infrastructure and process of the C-Scan and our plan is to complete the calibration portion of the trial and begin the second statistically powered portion of the study during Q4 2022.” He continued, “Detecting precancerous polyps is needed to effectively prevent colorectal cancer. However, the acceptance of the colonoscopy procedure is low, in part due to the invasiveness of the procedure and bowel cleansing. We believe Check-Cap has the potential to reach those who are deterred by colonoscopy and to help improve colon cancer screening through a patient-friendly solution without the need of bowel cleaning, sedation, and fasting.”

Additionally, According to DelveInsight’s “Cancer Diagnostic Market” report, the global cancer diagnostic market was valued at USD 125.13 billion in 2021, growing at a CAGR of 9.43% during the forecast period from 2022 to 2027, to reach USD 214.88 billion by 2027. The increase in demand for cancer diagnostic products and services is predominantly attributed to the spike in the cancer cases reported worldwide. In addition, growing manufacturers focus to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among the patients, and others are anticipated to drive the global cancer diagnostic market during the forthcoming years. As per the Delveinsight analysis, among all the regions, North America has occupied a major share of 42% in the overall Cancer Diagnostic market in 2020 and will continue to dominate during the forecasted period. This domination is due to significant factors such as the rise in cancer cases, the presence of key manufacturers, well-established healthcare infrastructure, and rising awareness regarding cancer and its proper management, among others.

Remedee Labs Obtained FDA Breakthrough Device Designation for its Endorphin Stimulation Solution

On May 12, 2022, Remedee Labs, a French startup, received FDA breakthrough device designation for its groundbreaking endorphin stimulator to treat patients with fibromyalgia patients. The designation recognizes both the highly innovative nature of Remedee’s device and its potential benefits for fibromyalgia patients adjunctively with the standard of care. Obtaining Breakthrough Device status is a strong first step toward US market authorization.

The endorphin stimulation technology by Remedee Labs is a novel non-pharmaceutical approach to pain treatment for fibromyalgia patients, offering relief from major symptoms including pain, sleep disorders, fatigue, and stiffness. 

David Crouzier, co-founder and CEO, Remedee Labs, said, “Achieving Breakthrough Device status for our endorphin stimulator is a major step, one that recognizes its potential for treating fibromyalgia patients’ pain. We look forward to working closely with the FDA to bring our solution to patients in the United States as fast as possible.”

According to DelveInsight’s “Neuromodulation Devices Market” report, the global neuromodulation devices Market was valued at USD 5.71 billion in 2021, growing at a CAGR of 8.95% during the forecast period from 2022 to 2027, to reach USD 9.56 billion. 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, the rising government initiative to raise awareness among patient regarding neurological disorders, among others. As per the Delveinsight analysis, in the neuromodulation devices product segment, spinal cord stimulators hold a significant market during the forecasted period. This is owing to the growing patient population suffering from chronic pain, failed back syndrome, and complex regional pain syndrome (CRPS). For instance, according to CDC 2020 data, in 2019, 20.4% of adults had chronic pain and 7.4% of adults had chronic pain that frequently limited life or work activities (referred to as high impact chronic pain), and both increased with age and were highest among adults aged 65 and over.

Brainlab Declared the Majority Acquisition of medPhoton

On May 12, 2022, Brainlab, a digital medical device company, declared the majority acquisition of medPhoton GmbH, an Austria-based company, primarily focused on developing and manufacturing robotic imaging solutions for image-guided radiation therapy and surgery. Together Brainlab and medPhoton will explore additional areas of application for the technology including radiotherapies, such as brachytherapy, particle therapy, and intraoperative radiation therapy. However, medPhoton will continue to operate as an independent research and development company within the Brainlab Group. In addition, both companies will also further expand the capabilities at the medPhoton site in Salzburg, Austria.

Stefan Vilsmeier, President and CEO of Brainlab, said, “Through the completion of this majority acquisition, we want to build on the previous success of Loop-X and decisively shape the future of intraoperative imaging. In this way, we can combine and align the entrepreneurial pursuits and innovative potential of both companies. Our united goal is to expand the market position of Loop-X as a 3D imaging device for surgery so that doctors can gain access to cutting-edge equipment for patient treatment.”

Heinz Deutschmann, CEO of medPhoton added, “From the very beginning, Brainlab believed in the strength of our innovation, creativity, and drive in the field of radiotherapy. Through our partnership, Brainlab provided us with significant support as we established our presence in the surgical device market and developed our production capabilities. Moving forward, we will continue to advance the production of Loop-X as well as coordinate research and development efforts to build next-generation systems to explore new medical applications to improve surgical procedures and therapies. The majority acquisition by Brainlab is therefore the next logical step for us to achieve our most important goal: to advance research and development work at the highest level and expand the production of best-in-class medical technology to provide efficient therapies with optimal safety for patients.”

According to DelveInsight’s “Image-Guided Surgery Devices Market” report, the global image-guided surgery devices market was valued at USD 3.38 billion in 2021, growing at a CAGR of 7.53% during the forecast period from 2022 to 2027, to reach USD 5.22 billion by 2027. The escalating demand for image-guided surgery devices is primarily attributed to the rising burden of the geriatric population who are susceptible to developing various disorders, increasing prevalence of chronic disorders such as cancer, neurological indications, and others, across the globe. In addition, the growing number of product approvals, and technological advancement in the product arena, among others are also some of the factors contributing to the global image-guided surgery devices market growth. Moreover, as per the Delveinsight research analyst, among all the regions, North America is expected to hold a major share in the overall image-guided surgery devices market during the forecasted period. This domination is owing to the rising burden of the population in the region suffering from chronic disorders. Moreover, the rapidly growing old age population in the country in comparison to previous years is also a factor contributing to the rising market for image-guided surgery devices.

GE Healthcare Steps into the Homecare Segment with Strategic Investment in Pulsenmore

On May 12, 2022, GE Healthcare, a global medical device, pharmaceutical diagnostics, and digital solutions manufacturer, agreed to invest up to USD 50 million in Israeli start-up Pulsenmore, a developer of portable ultrasound devices for home use. With this agreement, the company marks another strategic step forward in enabling precision health.  Moreover,  the company is aiming to accelerate the global adoption of Pulsenmore’s homecare ultrasound solutions. It will also support their goal to pursue the US FDA approval and commercial expansion. Furthermore, in addition to the equity investment, GE Healthcare will also distribute Pulsenmore products in Europe and other markets as soon as the product becomes available for commercial distribution.

Pulsenmore CEO and founder Dr. Elazar Sonnenschein, said, “Our agreement with GE Healthcare is a resounding vote of confidence in our ultrasound technology and our company. With GE Healthcare’s market leadership position and reach, we are one step closer to achieving our vision of making home ultrasound universally accessible for remote and reliable care, ultimately improving maternal health across the globe. Through this exciting partnership, we will accelerate the empowerment of women to proactively manage their pregnancy, in collaboration with their health care providers, and will lead the next wave of ultrasound innovation that will benefit patients and providers alike.”

“Healthcare providers are predicting a significant shift of care services from traditional facilities to the home, which will require an increase in the level of quality or access. Homecare opens the door to a tremendous value for payers, healthcare facilities, physician groups, and care-at-home providers, with the opportunity to improve patients’ quality of care and experience. We also recognize the desire of patients—in this case, pregnant women—to be more empowered and involved in their healthcare. This is precisely why we are investing in Pulsenmore’s innovative homecare ultrasound technology. We are excited about adding this highly complementary offering to our market-leading Women’s Health and Primary Care standard of care ultrasound diagnostics solutions, marking a strong step forward in enabling precision health,” said GE Healthcare Ultrasound President and CEO Roland Rott.

According to DelveInsight’s “Ultrasound Devices Market” report, the global ultrasound devices market was valued at USD 6.76 billion in 2021, growing at a CAGR of 6.82% during the forecast period from 2022 to 2027 to reach USD 10.05 billion by 2027. The Ultrasound Devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early detection, increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the Ultrasound Devices market during the forecast period. Additionally, as per the Delveinsight analysis, North America is expected to account for the largest share of the Global Ultrasound Devices market. Factors such as the rising incidence of severe chronic diseases such as cardiovascular, oncology, and others, further rapid technological developmental activities, growing awareness for early detection, increasing incidences of the aging population, and increased product launches are expected to aid in the growth of North America Ultrasound Devices Market.

Medtronic’s Latest Generation Drug-Eluting Coronary Stent System Received FDA Approval

On May 13, 2022, Medtronic, a leading medical devices company obtained the US FDA approval for the Onyx Frontier™ drug-eluting stent (DES). The latest Onyx Frontier DES leverages the same best-in-class stent platform as Resolute Onyx™ DES, with an enhanced delivery system that is designed to enhance deliverability and increase acute performance in even the most challenging of cases. The Onyx stent system is indicated for the treatment of patients with coronary artery disease (CAD).

Some of the meaningful design changes in the stent system include increased catheter flexibility, an innovative dual-layer balloon technology, and a lower crossing profile led to a 16% improvement in deliverability with Onyx Frontier vs. the previous generation Resolute Onyx DES. Moreover, the former device provides a broad size matrix to treat more patients and is the only 2.0 mm DES available in the United States. It shares the same clinical indications as Resolute Onyx, including the most recent approval for patients that are at high risk of bleeding and may benefit from a dual antiplatelet therapy (DAPT) duration as short as one month.

Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic, said, “The Onyx Frontier DES FDA approval is a very important milestone for Medtronic’s Coronary business and demonstrates our commitment to interventional cardiologists by providing best-in-class products. The Onyx Frontier launch also correlates directly to Medtronic’s commitment to engineering. The team built upon the design and clinical successes of the Resolute Onyx DES and has continued to evolve proven DES technology to further address the needs of physicians. We look forward to continuing the pursuit of innovation each day.”

Azeem Latib, M.D., section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center in New York City said, “The new Onyx Frontier DES, with its enhanced deliverability, will continue to help interventional cardiologists treat complex coronary cases and larger ranges of vessel sizes more efficiently. Delivering safe and effective outcomes to our patients is our number one priority. It’s important that physicians have access to tools like the Onyx Frontier DES that can allow them to efficiently achieve those outcomes.”

According to DelveInsight’s “Coronary Stents Market” report, the global coronary stents market was valued at USD 9.27 billion in 2021, growing at a CAGR of 7.51% during the forecast period from 2022 to 2027, to reach USD 14.28 billion by 2027. 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; the growing number of PCI (Percutaneous Coronary Intervention) procedures; increase in demand for minimally invasive surgeries, technological advancement in the product line, among others. Furthermore, according to the Delveinsight analyst, in the Coronary Stents product segment, the drug-eluting stent is expected to hold the largest market share during the forecast period. This is due to the various advantages of drug-eluting stents over bare-metal stents and others. Drug-eluting stents are more effective in the prevention of restenosis than the use of bare-metal stents, the use of newer-generation drug-eluting stents also reduces the rate of stent thrombosis and myocardial infarction.

Curebase, Flow Neuroscience Launched a Joint Clinical Trial for the Use of an at-home tDCS Device for Treating Depression

On May 17, 2022, Curebase, a company focused on democratizing access to clinical studies and low Neuroscience, developing only medically approved transcranial direct current stimulation (tDCS) device and behavioral therapy app for depression, together launched a clinical trial in which participants will test the effectiveness of Flow’s at-home headset in reducing depressive symptoms.

The Flow headset is the first portable tDCS device to be medically approved for home use in the U.K. and European Union. 

The trial will include 270 participants in London and Houston across two research centers, UTHealth (University of Texas) and UEL (University of East London) to test the efficacy of using tDCS to treat depression through a portable device, the trial will see participants follow a treatment plan of ten weeks where they will have five stimulation sessions per week in the first three weeks and two stimulation sessions per week in the next seven weeks. 

Tom Lemberg, founder, and CEO of Curebase said, “Flow’s brain stimulation treatment has been shown in Europe to be an effective and safe alternative to medication for people battling depression. We are excited to be partnering with Flow Neuroscience on this important clinical trial.”

Flow co-founder and CTO, Erik Rehn, added, “This is a pinnacle moment as we embark on collecting large-scale data for the use of brain stimulation delivered via a portable device to treat depression. As we have the ability to carry out this clinical trial remotely, powered by Curebase’s platform and the Flow device, we will be able to reach more participants efficiently and bring results for new treatment options faster than would be possible with in-clinic trials using in-clinic devices. These results will pave the way for FDA approval of the Flow at-home brain stimulation treatment for major depressive disorder, enabling access to a non-pharmaceutical option for this debilitating condition.”According to DelveInsight’s “Neurostimulation Devices Market” report, Global Neurostimulation Devices Market was valued at USD 5.82 billion in 2021, growing at a CAGR of 11.77% during the forecast period from 2022 to 2027, to reach USD 11.34 billion by 2027. The demand for Neurostimulation Devices Market is primarily motivated by the increasing incidence of chronic diseases, such as migraine and epilepsy, escalating product demand as add-on therapy, and the prevalence of lifestyle diseases such as depression and chronic pain, adoption of technologically advanced products, and rising geriatric population. As per the Delveinsight analysis, in the application segment, the pain management segment is the highest contributor to the neurostimulation devices market, due to the increase in usage of neurostimulation devices for treating chronic and acute pain. Some of the diseases encompassed under this segment include chronic pain, disk surgery pain, and leg pain.