The NB3 laser probe received FDA 510(k) clearance in December 2023 and has been in limited market release since February 2024 in leading institutions across the United States. Surgeons participating in the initial launch phase used the probe across a comprehensive set of workflows, lesion types, sizes, locations, target depths, and patient profiles. Lesion types include primary tumors, progressive metastatic lesions, radiation necrosis, and epileptogenic foci in both adult and pediatric patients. Lesion sizes ablated during limited market release have ranged from less than 10mm in diameter to nearly 30mm in diameter and have included deep-seated targets and multiple trajectory procedures.
“We are thrilled to bring the highly anticipated NB3 laser probe to our neurosurgeons and hospital system customers for use across a broad spectrum of patient needs, including the pediatric LITT population,” said Martin J. Emerson, president and chief executive officer of Monteris. “NB3, used in combination with Monteris’ best-in-class NeuroBlate software and robotics, provides our neurosurgeon users the precision and flexibility they demand for their patients. We expect the forward-thinking engineering incorporated into NB3 will become the platform for our future probe designs. In addition, our near-term cadence of new software releases will put even greater options in the hands of our neurosurgeon customers.”
As per DelveInsight’s “Neuromodulation Devices Market Report,” 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.
Vesica Health Announced The Launch of AssureMDx Test to Improve Bladder Cancer Detection
On May 03, 2024, Vesica Health, Inc. launched its laboratory-developed AssureMDx™ test.
AssureMDx is a multi-omic noninvasive urine-based DNA test designed to transform the triage of hematuria patients. By providing physicians with a precise method for identifying patients at increased risk for bladder cancer, AssureMDx facilitates immediate urological referral and clinical evaluation when needed. Importantly, the test also helps physicians effectively distinguish patients at very low risk, who may bypass invasive procedures and avoid unnecessary CT scans, thereby reducing potential radiation exposure risks. Backed by extensive research, the AssureMDx epigenetic and somatic biomarkers have been reported in 22 peer-reviewed studies involving over 6,000 patients, including multiple prospective clinical validation studies.
These studies consistently demonstrate the test’s robust clinical performance, notably 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), and 96% Sensitivity for the detection of bladder cancer in hematuria patients. Moreover, AssureMDx will provide urologists with a noninvasive means to monitor bladder cancer patients at heightened risk of recurrence following treatment, thereby enhancing patient management and improving outcomes.
AssureMDx represents a significant leap forward in bladder cancer diagnostics, offering unparalleled accuracy and reliability backed by rigorous scientific validation. This transformative test embodies Vesica Health’s unwavering dedication to advancing the standard of care for hematuria patients worldwide.
Christopher Thibodeau, Chief Executive Officer of Vesica Health, expressed his enthusiasm, stating, “We are delighted to officially introduce AssureMDx for patient testing. With an extensive evidence dossier of over 22 peer-reviewed publications, including three clinical validation studies, coupled with the recent successful completion of our analytical validation, we stand prepared to empower hematuria patients and their physicians with this vital tool for enhancing patient care.”
Laura Caba, MPH, President of Vesica Health, underscored the significance of this innovation, declaring, “We are reshaping the landscape of early bladder cancer detection and fulfilling our commitment to elevating patient care and clinical outcomes.”
According to DelveInsight’s “Blood Cancer Diagnostics Market Report”, the global blood cancer diagnostics market is estimated to grow at a CAGR of 6.34% during the forecast period from 2024 to 2030. The blood cancer diagnostics market is slated to witness prosperity owing to factors such as the growing prevalence of blood cancer worldwide, the increasing geriatric population, the rising number of risk factors associated with blood cancer, and the growing focus on improving the safety, and usability of blood cancer diagnostics for end users are further expected to result in the appreciable revenue growth in the blood cancer diagnostics market during the forecast period (2024-2030).
Anaut Announced Japanese Regulatory Approval of AI-Powered Surgical Visualization Tool, Eureka α
On May 02, 2024, Anaut Inc., announced regulatory approval of its medical device, “Eureka α”. This first-of-its-kind software device in Japan received approval from the Ministry of Health, Labour and Welfare (approval number: 30600BZX00061000) and is set to transform surgical practices with its advanced artificial intelligence capabilities.
Eureka α utilizes state-of-the-art AI to analyze real-time video from laparoscopic and robotic surgery, enhancing surgeons’ accuracy by highlighting the dissection planes characterized by connective tissue. Connective tissue, critical in surgical navigation, acts as a key landmark during surgeries. Known variably as the “dissection plane” or “holy plane”, its proper identification is crucial for safe and effective surgical outcomes. Visualization of connective tissue is critical in almost any surgical procedure in the abdomen, including those that involve the stomach, large intestine, and abdominal hernias.
Eureka α offers a secondary monitor view that differs from the primary surgical display to optimize the surgeon’s visual field. Supported by expert-guided training data, the technology harnesses deep learning and computer vision technologies to improve surgical precision and safety.
The development of Eureka α was made possible by a robust partnership with over 20 of Japan’s largest and most prominent academic research institutions and medical university hospitals. This initiative has also received backing from significant public organizations such as the Tokyo Metropolitan Government, the New Energy and Industrial Technology Development Organization (NEDO), the Japan External Trade Organization (JETRO), Kawasaki City, and others.
According to DelveInsight’s “Image Guided Surgery Devices Market Report”, the global image-guided surgery devices market was valued at USD 5,540.87 million in 2023, growing at a CAGR of 5.81% during the forecast period from 2024 to 2030 to reach USD 7,765.22 million by 2030. The image-guided surgery devices market is observing remarkable market growth due to factors such as the escalating burden of the geriatric population prone to chronic diseases and the rising prevalence of chronic diseases such as cardiovascular, cancers, neurological, and others across the globe. Further, a gradual increase in approval of image-guided surgery devices, rapid technological advancement in the products, increasing demand for minimally invasive surgeries, and others will create a necessity for Image Guided Surgery Devices in the market. Therefore, the market for image-guided surgery devices is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
Geneoscopy Won FDA Approval for Labcorp-Partnered Colon Cancer Test
On May 06, 2024, Geneoscopy, Inc., announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC.
Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.
“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”
Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment. This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.
Colorectal cancer is the second deadliest cancer in the United States. However, millions of eligible Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. CRC incidence rates are also rising among younger populations under 50 years old, prompting a recent shift in the United States Preventive Services Task Force’s guidelines to recommend initiation of CRC screening at age 45.3 Underscoring the critical nature of this issue, the American Cancer Society recently reported that colorectal cancer is now the leading cause of cancer death for males and the second leading cause of death for females under 50.4 Further compounding this challenge, approximately 40% of unscreened and eligible Americans are ages 45-49
“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It’s essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients,” said Anjee Davis, president of Fight CRC. “We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”
FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. Geneoscopy will launch ColoSense in collaboration with Labcorp.
According to DelveInsight’s “Cancer Diagnostics Market Report”, the global cancer diagnostics market was valued at USD 125.13 billion in 2023, growing at a CAGR of 9.43% during the forecast period from 2024 to 2030, to reach USD 214.88 billion by 2030. The increase in demand for cancer diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, growing manufacturers’ focus on developing 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 patients, and others are anticipated to drive the global cancer diagnostics market during the forthcoming years.
Novel Omeza® OCM™ Wound Healing Platform Combined With Offloading In Patients With Diabetic Foot Ulcers Demonstrated Dramatic Healing Rates Within 12 Weeks Or Less
On May 03, 2024, Omeza®, presented final data from a diabetic foot ulcer (DFU) clinical trial showing that Omeza® OCM™ plus offloading of weight on the affected foot achieved a 94 percent area reduction (PAR) rate in DFUs within twelve weeks, and a 62 percent PAR within four weeks. PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a strong predictor of subsequent complete healing.
“Diabetic foot ulcers are one of the leading causes of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continuously strives to identify novel therapies to prevent or reduce these complications and their significant burden to patients, families, and the healthcare system at large,” said Dr. Richard Simman, Professor of Plastic Surgery at the University of Toledo College of Medicine, Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio. ProMedica conducted the DFU clinical trial.
“We’re extremely encouraged by the final results of our clinical trial evaluating Omeza®’s OCM™ platform, which showed significant healing—and in over half the cases, complete closure—of patients’ diabetic wounds in twelve weeks or less. This is a notable achievement, given the resistance to standard treatments that DFUs often display,” said Simman, principal investigator at the ProMedica clinical trial site.
In the study, 19 patients suffering from diabetic foot ulcers (DFUs) were administered OCM™, a drug/device combination composed of cold water fish peptides and other pharmaceutical-grade components. This formulation generates an absorbable matrix that conforms to the wound bed, fostering the formation of new tissue. To facilitate healing, patients also practiced offloading, which involves reducing or eliminating weight bearing on the affected foot. A control group received current standards of wound care, including offloading, debridement, collagen, hypochlorite solution, and/or wound dressings containing silver alginate.
After the study, all subjects in the treatment group saw a PAR greater than 73%, with 3 subjects seeing a PAR of 100% at 4 weeks of treatment. Eight of fourteen subjects achieved 100% PAR at 12 weeks. Five patients had DFUs that were greater than 12 months old, and 3 of those patients had 100% PAR. No adverse events related to the treatment were reported during the study.
“It is gratifying to see the positive impact of OCM™ on patients who had been struggling without resolution from ulcers that are very difficult to treat, and to demonstrate these positive results in both a real-world setting as well as in a clinical trial truly reinforces the potential of Omeza® OCM™ to fulfill an unmet need for patients with nonhealing wounds,” said Desmond Bell, DPM, Chief Medical Officer at Omeza®.
“All of the components in OCM™ are natural, pharmaceutical-grade ingredients that are known to be safe and have been shown to harness an individual’s innate immune processes to activate healing at the site of the wound,” Bell said. “Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action that underlie the exciting results we’re accumulating in clinical trials and the real-world setting.”
Studies to further evaluate the performance of OCM™ in patients with venous leg ulcers (VLUs) and other wound types are underway, and ProMedica will begin recruiting patients for a VLU RCT trial starting Q4 2024.
According to DelveInsight’s “Diabetic Foot Ulcer Treatment Market Report”, the global diabetic foot ulcer treatment market is estimated to grow at a CAGR of 7.31% during the forecast period from 2024 to 2030. The demand for diabetic foot ulcer treatment is primarily being boosted owing to key factors such as the increasing prevalence of diabetic foot ulcers, increasing risk factors such as diabetes, and others associated with the development of diabetic foot ulcers, the growing technological advancements along with research and development activities, among other factors are expected to create a positive impact on the market growth during the forecast period from 2024-2030.
LEO Pharma Reported Positive Data From Phase III Plaque Psoriasis Trial
On May 07, 2024, LEO Pharma A/S, announced positive results from the Enstilar® phase 3 trial in China in adult patients living with stable plaque psoriasis.
Enstilar®, an aerosol spray foam, enstilar combines 50mcg/g calcipotriol monohydrate and 0.5mg/g betamethasone dipropionate.
The trial is a phase 3, randomized, investigator-blind, actively controlled, parallel-group, multicentre trial comparing the efficacy and safety of once-daily application with Enstilar (LEO 90100) and Daivobet® ointment for 4 weeks of treatment in adult Chinese subjects with stable plaque psoriasis. A total of 604 patients were recruited across 39 sites in China.
The primary objective of the study was to evaluate the efficacy of Enstilar (LEO 90100) compared with Daivobet® ointment on the severity and extent of stable plaque psoriasis. The secondary objective evaluated treatment safety. Exploratory objectives included evaluating health-related quality of life.
The topline results show that Enstilar demonstrated superiority to Daivobet ointment in the primary objective.
“With these inspiring clinical results, we are very happy to be able to proceed towards submission of Enstilar to the Chinese authorities, but I am equally pleased that we will now proceed towards hopefully providing Chinese patients with a new treatment option for their psoriasis in addition to the existing portfolio offering from LEO Pharma China,” says Byron Yin, General Manager for LEO Pharma in China.
Professor Zhang Jianzhong from Peking University People’s Hospital, the leading principal investigator of this study, stated, “In China, approximately 7 million patients are affected by this condition2. Topical medications are the basic treatment for psoriasis and are suitable for most patients. As a principal investigator in this study, I am delighted to see that Enstilar has achieved its primary and secondary endpoints in the Phase III clinical trial in Chinese patients, demonstrating superior efficacy to Daivobet with a good safety profile. I look forward to sharing detailed data from this high-quality study in the near future. I look forward to sharing detailed data from the study soon and hope it will help us provide another treatment option to psoriasis patients in China.”
According to DelveInsight’s “Plaque Modification Devices Market Report”, the global Plaque Modification Devices Market has experienced substantial growth in recent years. According to research analysis, the Plaque Modification Devices Market Size was valued at over USD 1.21 Billion in 2023, and it is expected to continue growing at a Compound Annual Growth Rate (CAGR) of around 8.09% from 2024 to 2030.
