Surgeons could move freely and efficiently during the examination with advanced features such as an intuitive wireless user interface and multilingual voice control, giving them more options to streamline the examination process.
“The most precious commodity for ophthalmologists today is time,” said Oliver Hvidt, CEO and co-founder of Norlase. “That’s why, since the invention of the pattern-based laser more than 15 years ago, LIO ophthalmoscopes with pattern tracking have been in demand. With the advent of the LYNX, LIO with pattern tracking is finally becoming a reality. Faster examinations with this device mean less ergonomic strain, more quality time with patients, and more workdays that end on time. I am extremely proud of our team and grateful to the physicians who helped drive the development. LYNX is our fourth product launch in just five years and is a testament to our ongoing mission to simplify ophthalmology practice while maximizing efficiency and comfort.”
As per DelveInsight’s “Ophthalmoscopes Market Report”, the ophthalmoscopes market is estimated to grow at a CAGR of 4.73% during the forecast period from 2024 to 2030. The increase in the demand for ophthalmoscopes is primarily attributed to the increased prevalence of ophthalmic disease and the increased prevalence of age-related macular degeneration. Further, rising awareness among patients about the need for eye care and the treatment of its disorders will augment the overall market growth of ophthalmoscopes. Moreover, technological advancements in laser ophthalmoscopes that offer advantages like direct digital imaging, improved contrast, and lower levels of light exposure among others are anticipated to bolster the market, thereby contributing to the overall growth of the ophthalmoscopes market during the forecast period from 2024 to 2030.
Imperative Care Secured FDA 510(k) Clearance for the Zoom System, Including the First Large-Bore .088” Catheter for Aspiration When Used With the Zoom Catheters, for Stroke Treatment
On January 27, 2025, Imperative Care, Inc. announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Zoom System, making it the first comprehensive stroke thrombectomy system to include large-bore .088” catheters indicated for both access and aspiration when used with a Zoom Catheter. This clearance expanded Imperative Care’s existing portfolio of .035” – .071” aspiration catheters to include the Zoom .088” catheters – Zoom 88, Zoom 88 Support, and TracStar – for aspiration as part of the Zoom System.
Clinical evidence submitted to the FDA to support the clearance included final data from the Imperative Trial. This prospective, multi-center clinical trial evaluated the clinical benefits of the Zoom System in patients treated across 26 U.S. institutions. The analyzed cohort included 211 patients who had been treated with concomitant aspiration thrombectomy using two catheters.
“At Imperative Care, we are focused on developing a patient-centric and well-studied comprehensive stroke system for physicians to best care for their patients based on their specific needs and anatomy,” said Ariel Sutton, Executive Vice President and General Manager of Imperative Care’s Stroke business. “We know that with stroke, time is the most critical factor in driving positive patient outcomes. The Zoom System is the first purpose-built technology from access to aspiration that maximizes versatility for rapid and effective procedures as validated by the Imperative Trial and previous clinical studies of the Zoom Stroke Solution. Thank you to all the physicians, patients, and their families who participated in this landmark trial and placed their trust in our technology.”
As per DelveInsight’s “Thrombectomy Devices Market Report”, the thrombectomy devices market is poised for significant growth, projected to achieve a remarkable CAGR of 5.24% during the forecast period. The demand for thrombectomy devices is being boosted by the increasing prevalence of lifestyle disorders such as low blood pressure, diabetes, obesity, age, and others. Further, the increasing prevalence of venous thromboembolism, cardiovascular diseases, cancer, and neurological diseases such as ischemic stroke, hemorrhagic stroke, and peripheral diseases, among others will lead to the formation of blood clots, thereby leading to the increased demand for thrombectomy devices.
In addition, the increasing demand for minimally invasive approaches for treatment, lack of physical activity, rising adoption of smoking, rising device launches and approvals, surging innovations in product development, and shifting key players’ focus towards the development of technologically advanced product and initiatives to increase awareness regarding neurovascular diseases and their prevention among others are thereby contributing to the overall growth of the thrombectomy devices market during the forecast period from 2024 to 2030.
Lunit AI Enhanced Precision in Predicting Outcomes for HER2-Targeted Therapy in Metastatic Colorectal Cancer
On January 23, 2025, Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, announced the publication of a new study in the Journal of Clinical Oncology Precision Oncology. Conducted in collaboration with Japan’s National Cancer Center Hospital East (NCCHE), the study revealed how Lunit’s AI-powered pathology solutions, Lunit SCOPE® HER2 and Lunit SCOPE IO, significantly improved HER2 biomarker evaluation and the prediction of clinical outcomes in metastatic colorectal cancer (mCRC) patients undergoing HER2-targeted therapy.
The study presented findings from the TRIUMPH phase II clinical trial, which evaluated 30 patients with HER2-positive metastatic colorectal cancer treated with dual HER2-targeted therapy using Trastuzumab and Pertuzumab. Lunit’s AI solutions were applied to assess HER2 status and tumor microenvironment (TME) variables, yielding significant findings:
Enhanced HER2 Assessment Accuracy: Lunit SCOPE HER2 demonstrated 86.7% accuracy compared to pathologist assessments for HER2 immunohistochemistry (IHC), achieving 100% accuracy in identifying HER2 IHC 3+ cases.
Improved Prediction of Treatment Response and Outcomes: Patients identified by the AI model as having a high proportion of HER2 IHC 3+ staining tumor cells (AI-H3-high, >50%) exhibited better clinical outcomes than those identified through traditional HER2 evaluation methods –
- Objective Response Rate (ORR): 42.1% (AI-H3-high) vs. 26.7% (overall TRIUMPH trial)
- Progression-Free Survival (PFS): 4.4 months (AI-H3-high) vs. 1.4 months (AI-H3-low)
- Overall Survival (OS): 16.5 months (AI-H3-high) vs. 4.1 months (AI-H3-low)
- Deeper Insights into the Tumor Microenvironment (TME)
Using Lunit SCOPE IO, the study performed detailed TME profiling, including lymphocyte, macrophage, and fibroblast densities. Among AI-H3-high patients, those with low stromal TME density (TME-low) achieved the most favorable outcomes –
- ORR: 57.1%
- PFS: 5.6 months
- OS: 26.0 months
The findings underscored the transformative potential of AI-powered pathology tools in precision oncology. By providing a more accurate and detailed evaluation of HER2 status and TME characteristics, Lunit’s solutions enabled better patient stratification and improved predictions of responses to HER2-targeted therapies. This capability contributed to more tailored treatment strategies, ultimately improving patient outcomes in mCRC and potentially other HER2-amplified cancers.
“This study underscores the potential of AI technology to redefine how we evaluate biomarkers and predict treatment responses,” said Dr. Takayuki Yoshino of the National Cancer Center Hospital East, principal investigator of the research. “The ability to more precisely stratify patients will lead to more personalized treatment options, improving outcomes for patients with HER2-positive metastatic colorectal cancer.”
“The findings from this study demonstrate how Lunit’s AI-powered solutions, Lunit SCOPE HER2 and Lunit SCOPE IO, can provide clinicians with actionable insights to refine treatment strategies,” said Brandon Suh, CEO of Lunit. “Our continued collaboration with NCCHE showcases the transformative potential of AI in precision oncology.”
According to DelveInsight’s “Cancer Biomarkers Market Report”, the cancer biomarkers market is estimated to grow at a CAGR of 13.73% during the forecast period from 2024 to 2030. The cancer biomarkers market is observing an optimistic market growth owing to an increase in the prevalence of various types of cancers globally, the growing population with risk factors for cancer development such as smoking, and high-fat diet, among others, and the increasing research & development activities in the cancer biomarkers arena leading to new product launches and increasing regulatory approvals are further expected to result in appreciable revenue growth of the cancer biomarkers market during the forecast period from 2024 to 2030.
ImmunoMet Therapeutics Presented Updated Clinical Data from Phase1b Study of Lixumistat in Pancreatic Cancer
On January 24, 2025, ImmunoMet Therapeutics, Inc., a clinical-stage biotechnology company committed to providing patients with a novel approach to fighting cancer, announced a data update from its single-arm Phase 1b trial of Lixumistat in combination with gemcitabine and nab-paclitaxel as frontline therapy for patients with advanced pancreatic cancer (NCT05497778). The study was led by Shubham Pant, MD, Professor of Gastrointestinal Medical Oncology and Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.
The clinical trial included a dose escalation phase followed by an expansion phase, evaluating the potential of Lixumistat, a metabolism-targeting inhibitor, in combination with gemcitabine and nab-paclitaxel to address resistance and improve patient outcomes. Of the fourteen patients treated, eight received Lixumistat at 400 mg QD, and six received the 800 mg QD dose. When combined with gemcitabine and nab-paclitaxel for the treatment of advanced pancreatic adenocarcinoma, the recommended Phase 2 dose (RP2D) of Lixumistat was determined to be 400 mg once daily.
Among the eight response-evaluable patients treated at the RP2D, five (62.5%) achieved an objective Partial Response (PR), three (37.5%) had Stable Disease (SD), and the Disease Control Rate was 100%. The estimated median Progression-Free Survival (PFS) was 9.7 months (5.75-NA), and the median Overall Survival (OS) was 18 months (8.5-NA). This group of patients had a mean age of 66.5 ± 8 years, and five (63%) were female.
Dr. Pant described the study’s results as follows: “Our study of Lixumistat at its RP2D in combination with gemcitabine/nab-paclitaxel shows quite encouraging clinical effects in this small signal-finding study. These findings suggest that the Lixumistat combination may provide a viable novel therapeutic option for advanced PDAC, warranting further investigation in larger studies.”
“Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive malignancy defined by high unmet need, morbidity, and mortality; currently the third-leading cause of cancer mortality in the US. There is substantial evidence that differential cancer cell metabolism, and oxidative phosphorylation (OxPhos) in particular, play a key role in the development of resistance to current therapies. Based on these early clinical data we are hopeful that this best-in-class OxPhos inhibitor can improve outcomes for these patients,” said Dean Welsch, CEO of ImmunoMet Therapeutics.” Additional information about the trial, which is recruiting patients, can be found at clinicaltrials.gov, the abstract presented at the ASCO-GI meeting at ASCO-GI Abstract, and poster at ASCO-GI Poster.
According to DelveInsight’s “Cancer Therapy Market Report”, the cancer therapy market was valued at USD 169.39 billion in 2023, growing at a CAGR of 9.12% during the forecast period from 2024 to 2030, in order to reach USD 285.96 billion by 2030. The cancer therapy market is witnessing positive market growth owing to factors such as the rising prevalence of various cancers which are contributing to the growing demand for cancer treatment, and the presence of factors like an increasing aging population wherein age plays a key role in cancer development in certain cancer types namely breast cancer. Moreover, the growing focus on developing targeted therapies due to advancements in precision medicine to provide a more pronounced therapeutic effect is further driving the cancer therapy market as new products are gaining regulatory approvals for cancer treatment.
Lumicell Announced the U.S. Launch and First Commercial Use of LumiSystem™, Pioneering Real-Time Detection of Residual Breast Cancer During Lumpectomy
On January 27, 2025, Lumicell, Inc., a leader in developing innovative fluorescence-guided imaging technologies for cancer detection, announced the U.S. commercial availability and first commercial use of LumiSystem™. This groundbreaking system combined two recently FDA-approved products: LUMISIGHT™, an optical imaging agent that fluoresced at sites of suspected cancerous tissue, and the Lumicell™ Direct Visualization System (DVS), an imaging device that provided real-time fluorescence guidance for scanning the breast cavity during lumpectomy surgery.
Unlike other detection systems that only evaluated tissue after it had been surgically removed, LumiSystem™ allowed for real-time visualization of cancer inside the breast. This enabled surgeons to identify and immediately resect any suspicious tissue during the surgery, improving the likelihood of achieving a more complete resection and reducing the need for follow-up procedures.
“We breast surgeons know all too well the limitations of lumpectomy and the difficult conversations we have with patients about the possibility of a second surgery due to positive margins,” said Irene Wapnir, MD, Professor of Surgery at Stanford University School of Medicine and Director of Breast Cancer Surgical Clinical Research at the Stanford Cancer Institute. “Stanford is excited to adopt LumiSystem because, with its real-time fluorescence guidance, we are now able to detect and remove more cancerous tissue during surgery while still sparing as much healthy breast tissue as possible.”
According to DelveInsight’s “Breast Cancer Diagnostics Market Report”, the breast cancer diagnostics market was valued at USD 4.20 billion in 2023, growing at a CAGR of 6.67% during the forecast period from 2024 to 2030 to reach USD 6.16 billion by 2030. The breast cancer diagnostics market is witnessing positive growth owing to factors such as the increasing prevalence of breast cancer, increasing age and sedentary lifestyle, technological advancements, and government initiatives to increase the rate of screening and diagnosis, thereby all factors contributing to the growth of Breast cancer diagnostics market during the forecast period from 2024-2030.
Inventia Life Science Launched RASTRUM™ Allegro to Revolutionize High-Throughput 3D Cell Culture for Drug Discovery and Disease Research
On January 27, 2025, Inventia Life Science, an innovator in 3D cell culture technologies, announced the launch of RASTRUM™ Allegro, a groundbreaking advancement in 3D cell culture technology designed to accelerate drug discovery and disease research with unprecedented scalability, reproducibility, and efficiency.
RASTRUM Allegro made it easier than ever to create high-throughput 3D cell culture assays that offered both speed and affordability. By significantly reducing per-sample costs, researchers were able to explore more variables and gain meaningful insights while ensuring data consistency across experiments.
“Scientists know the value of biologically relevant models for advancing their work,” said Julio Ribeiro, Founder and CEO of Inventia Life Science. “We developed RASTRUM Allegro to give researchers the ability to generate complex 3D cell models that better represent human biology. The system provides the precision and scalability needed to fuel discovery and reveal deeper biological insights.”
According to DelveInsight’s “Drug Discovery Market Report”, the drug discovery market will grow at a CAGR of 7.64% during the forecast period from 2024 to 2030 to reach USD 97,007.77 million by 2030. The drug discovery market is observing substantial market growth primarily owing to the increasing prevalence of chronic and rare diseases such as cancers, cardiovascular, diabetes, and sickle cell anemia, among others. Further, the growing interest in including AI in drug discovery and development owing to its advantages, increasing R&D expenditure and investments in the development of novel drug molecules, the presence of a robust number of pipeline products across the globe, surging number of biologics and generic drugs, increasing new drug launches and approvals, presence of key players and CRO’s in the market, and others will create a requisite for drug discovery services in the market. Therefore, the market for drug discovery is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
