“I want to thank our employees for their hard work and dedication in bringing this product to the market and our shareholders for their ongoing support of the Company. We will continue to deliver on our mission of enabling ‘diabetes care for the rest of us’ and delivering on the needs of all patients and clinicians,” added Paul DiPerna, Chairman and President of Modular Medical.
As per DelveInsight’s “Insulin Infusion Pumps – Market Insights, CompetitiveLandscape, and Market Forecast – 2030” the global insulin infusion pumps market was valued at USD 6.48 billion in 2023, growing at a CAGR of 8.69% during the forecast period from 2024 to 2030 to reach USD 10.68 billion by 2030. The insulin infusion pumps market is slated to witness prosperity owing to factors such as growing prevalence of diabetes, increasing sedentary lifestyle, growing aging population base which is susceptible to the development of diabetes, and the growing focus on improving the safety and usability of insulin infusion pumps are further expected to result in the appreciable revenue growth in the insulin infusion pumps market during the forecast period (2024-2030).
iRhythm Technologies Announced Japanese Regulatory Approval Of The Zio® ECG Monitoring System, Marking it as the First Product to Deliver Arrhythmia Monitoring Service Utilizing Artificial Intelligence
On September 11, 2024, iRhythm Technologies, Inc., a leading digital healthcare company focused on developing trusted solutions for detecting, predicting, and preventing disease, announced that it received regulatory approval from the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the Zio® fourteen-day, long-term continuous ECG monitoring system. Following this approval, iRhythm aimed to pursue a reimbursement decision for the Zio ECG monitoring system with the Japanese Ministry of Health, Labour, and Welfare (MHLW).
The Zio long-term continuous monitoring (LTCM) service consisted of a prescription-only patch ECG monitoring device (Zio monitor) that was worn for up to 14 days, along with the ZEUS (Zio ECG Utilization Software) System, which utilized iRhythm’s advanced AI algorithm. This system generated a comprehensive end-of-wear report that was reviewed and curated by certified cardiographic technicians. The Zio system represented a significant advancement in cardiac arrhythmia diagnostics compared to traditional Holter monitoring, and it was designed to deliver high clinical accuracy to assist doctors in making the correct diagnosis the first time. iRhythm’s deep learning approach classified a broad range of distinct arrhythmias with diagnostic performance comparable to that of cardiologists, and in clinical settings, this service was shown to reduce the rate of misdiagnosed computerized ECG interpretations and improve clinical efficiency.
“With the strong support from our partners at the Japanese Heart Rhythm Society, we are thrilled to receive this approval from the Japanese PMDA as a testament to iRhythm’s commitment to innovation and the highest standards of quality and performance,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We are very grateful for their diligent review of our Shonin application as we seek to drive better health outcomes and more equitable access for patients around the globe. We look forward to continuing working closely with the MHLW during their market access and reimbursement review of the Zio service.”
As per DelveInsight’s “ECG Monitoring Equipment – Market Insights, Competitive Landscape, and Market Forecast – 2030” the Electrocardiogram (ECG) monitoring equipment market was valued at USD 4.44 billion in 2023, growing at a CAGR of 5.74% during the forecast period from 2024 to 2030 to reach USD 6.20 billion by 2030. The global increase in the incidence of cardiovascular diseases (CVDs) due to lifestyle changes, smoking, and lack of physical activities, excessive alcohol consumption, obesity, and other factors are escalating the global market of Electrocardiogram (ECG) monitoring equipment. Additionally, public health campaigns and initiatives to raise awareness about cardiovascular health encourage individuals to undergo regular check-ups and screenings. Increased public knowledge about the importance of early detection and management of heart diseases leads to higher utilization of cardiovascular imaging services. Furthermore, key market players continuously investing in research and development to introduce innovative Electrocardiogram (ECG) monitoring equipment, increased partnerships and collaborations, product launches, and approvals ensure that the market remains dynamic and innovative, during the forecast period from 2024 to 2030.
SpectraWAVE Announced $50M Series B Financing to Support the Commercial Expansion and Addition of New Products to the HyperVue™ Imaging System
On September 11, 2024, SpectraWAVE, Inc., a medical imaging company dedicated to enhancing treatment and outcomes for patients with coronary artery disease (CAD), announced that it raised $50 million in a Series B funding round. The round was led by Johnson & Johnson Innovation – JJDC, Inc., with participation from S3 Ventures, Lumira Ventures, SV Health Investors, Deerfield Management, NovaVenture, Heartwork Capital, and undisclosed parties. The funding was aimed at supporting the commercial expansion and product enhancements of the Company’s 510(k)-cleared HyperVue™ Imaging System.
Intravascular imaging is an essential tool for optimizing coronary stenting procedures, providing key insights into plaque morphology, plaque modification decisions, stent and balloon sizing, landing zone selection, confirmation of treatment optimization, and future adverse event risk. Previous intravascular imaging technologies had compromises in image resolution, image depth, and ease of use. HyperVue became the first intravascular imaging technology to combine two important imaging methods, DeepOCT and NIRS, while enhancing image quality and procedural efficiency in the cath lab. Its features included no-flush catheter preparation, fast and long pullbacks designed to minimize and eliminate the use of contrast, and the most comprehensive AI-driven workflow and image analysis available.
Namati said, “In addition to our commercial intravascular imaging system, we are developing a wire-free physiology software add-on to allow physicians rapid assessment of pressure drops in the coronaries using the same HyperVue hardware. This is an important step in our journey to enhance the clinical decision-making for these patients and establish an anchor point for future innovation in the cath lab.”
According to DelveInsight’s “Diagnostic Imaging Equipment – Market Insights, Competitive Landscape, and Market Forecast-2030,” the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2023, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion by 2030. The demand for Diagnostic Imaging Equipment is primarily attributed to the rising technological advancement, growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, growing demand for effective & efficient imaging technologies for diagnosis, and increasing geriatric population.
Rockwell Medical Announced a Product Purchase Agreement With a Leading Provider of at- Home and Acute Care Dialysis Services
On September 9, 2024, Rockwell Medical, Inc., a healthcare company specializing in the development, manufacturing, commercialization, and distribution of hemodialysis products to dialysis providers globally, announced that it entered into a product purchase agreement with the leading at-home and acute care dialysis provider in the United States. Under the agreement, Rockwell Medical supplied the Customer with its liquid acid RenalPure® and liquid bicarbonate SteriLyte®, packaged in either the Company’s four-per-case format for larger dialysis settings or two-per-case format for smaller acute care and at-home care settings.
Rockwell Medical’s convenience pack included two 1-gallon pre-mixed containers of one of the Company’s hemodialysis concentrate products, RenalPure or SteriLyte. It offered several advantages for home patients, caregivers, healthcare providers, and acute facilities, such as easier handling and a streamlined workflow.
“This customer has a leading patient-centric care model that addresses the increasing demand for technological advancements in the dialysis space,” said Tim Chole, Chief Commercial Officer at Rockwell Medical. “The underserved at-home hemodialysis segment presents an exciting evolution, offering patients an alternative to traveling, in many instances, several hours, multiple times a week to receive their life-sustaining hemodialysis treatments. We are pleased to be this Customer’s preferred provider domestically and internationally for liquid acid and liquid bicarbonate hemodialysis concentrates products. Additionally, we are proud to support this Customer’s vision to transform the dialysis experience for patients and make dialysis available anytime, anywhere.”
According to DelveInsight’s “Dialysis Devices – Global Market Insights, Competitive Landscape, and Market Forecast – 2030”, the global dialysis devices market was valued at USD 74.44 billion in 2023, growing at a CAGR of 4.84% during the forecast period from 2024 to 2030 to reach USD 98.84 billion by 2030. The demand for dialysis devices is witnessing a surge majorly due to the rising prevalence of kidney failure due to various reasons such as the rising geriatric population wherein age acts as a major risk factor for loss of kidney function, rising prevalence of diabetes in which hyperglycemia is linked with blood vessel damage in kidneys. Furthermore, hypertension is another key factor that is extensively linked with kidney failure. Additionally, technological advancements such as the development of continuous renal replacement therapy (CRRT) have also been a major influential factor in boosting the growth of the dialysis devices market during the forecast period from 2024-2030.
Autonomix Announced 83% Reduction in Pain at the 4-6 Week Follow-up From Lead-in Patients in its Ongoing Human Clinical Trial Involving Pancreatic Cancer Pain Patients
On September 9, 2024, Autonomix Medical, Inc., a medical device company specializing in precision nerve-targeted treatments, announced that preliminary results from the first five “lead-in” patients in their ongoing proof-of-concept human clinical trial showed positive outcomes after 4-6 weeks. The trial was designed to evaluate the safety and effectiveness of delivering transvascular energy to ablate problematic nerves and alleviate pain in patients with pancreatic cancer.
The goal of the trial was to assess pain reduction via radiofrequency (RF) ablation. The company’s catheter-based microchip sensing array, which was designed to detect and differentiate neural signaling, was not used in this trial and was scheduled for evaluation in future studies.
The first five patients were enrolled and treated according to protocol at the beginning of the trial to familiarize the Principal Investigator (PI) with the procedure and were not included in the analysis of the trial objectives. These initial “lead-in” patients completed the procedure per protocol without immediate procedural-related complications or significant adverse events.
The primary objective of the trial was to assess the success rate of ablating relevant nerves to alleviate pain in patients with pancreatic cancer pain using RF ablation in a transvascular approach to the nerves in the region. Secondary objectives included assessing the incidence of device- and procedure-related adverse events up to 4-6 weeks post-procedure; estimating the change in pain levels from pre- to post-procedure; and estimating the change in quality of life from pre- to post-procedure. All patients who underwent a successful procedure were evaluated at 7 days, 4-6 weeks, and 3 months post-procedure. All patients entered the study with severe abdominal pain from unresectable pancreatic cancer and a life expectancy of 3 months or less. Following the successful completion of the procedure, two patients had since succumbed to their disease. Both events were expected outcomes and not related to the trial procedure.
“We are encouraged by the significant, sustained pain reduction demonstrated from the lead-in patients in our ongoing first-in-human trial. These are very sick individuals, who up until this point primarily relied on opioids to help mitigate their pain, which our baseline data shows were not effective. Following our treatment, all the responders had a clinically meaningful mean reduction in pain from 8 to 1.33 on the VAS pain scale at 4-6 weeks post-procedure,” commented Brad Hauser, Chief Executive Officer of Autonomix. “While these data are preliminary, we are excited about our precision nerve-targeted technology and the potential it has to revolutionize electrophysiology therapies.”
According to DelveInsight’s “Radiofrequency Ablation Devices – Market Insights, Competitive Landscape and Market Forecast-2030”, the global radiofrequency ablation devices market was valued at USD 3.64 billion in 2023, growing at a CAGR of 9.37% during the forecast period from 2024 to 2030 to reach USD 6.19 billion by 2030. The demand for radiofrequency ablation devices is witnessing growth due to the growing prevalence of chronic diseases such as cardiovascular diseases, cancers, rising geriatric population, and technological advancements in product development and design improvement.
The Once-Weekly Dose of Insulin Efsitora Alfa Delivered an A1C Reduction Consistent With That of the Most Advanced Daily Insulin in People With Type 2 Diabetes
On September 10, 2024, Eli Lilly and Company announced detailed results from the QWINT-2 phase 3 trial that evaluated once-weekly insulin efsitora alfa (efsitora) compared to once-daily insulin degludec in adults with type 2 diabetes who were insulin naïve. The data were published in The New England Journal of Medicine (NEJM) and presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024.
In the trial, efsitora met the primary endpoint of non-inferior A1C reduction. For the efficacy estimand, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec, resulting in A1C levels of 6.87% and 6.95% respectively at 52 weeks.
Additionally, participants taking efsitora achieved 45 minutes more time in range per day, a key secondary endpoint, without experiencing additional time in hypoglycemia (glucose <54 mg/dL) compared to insulin degludec for the efficacy estimand.
In the trial, efsitora demonstrated a safety profile comparable to daily insulins. No severe hypoglycemic events were reported during treatment with efsitora, whereas six such events were reported with insulin degludec. Overall hypoglycemia rates in the study were low, with estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL) hypoglycemic events per patient-year of exposure being 0.58 with efsitora compared to 0.45 with insulin degludec. Estimated combined rates of severe or clinically significant nocturnal hypoglycemic events per patient-year of exposure were 0.08 for both efsitora and insulin degludec. Additionally, rates of hypoglycemia were similar among individuals currently using GLP-1s and those not using GLP-1s. Adverse events were comparable between treatment groups in the trial.
“For the past century, we’ve been searching for the next scientific breakthrough that would alleviate the complexity that comes with starting insulin treatment,” said Jeff Emmick, M.D., Ph.D., senior vice president, product development, Lilly. “With these results, we believe we’re headed towards a future where people with type 2 diabetes who use basal insulin can achieve their desired results with a simple treatment option like efsitora.”
“Traditionally, basal insulins are dosed once a day — a treatment schedule that can make compliance difficult for a significant portion of people living with type 2 diabetes,” said Carol Wysham, M.D., clinical professor of medicine at the University of Washington School of Medicine. “Efsitora has the potential to address treatment burden and improve adherence — all while lowering A1C. These results can make a significant impact for people living with type 2 diabetes looking for a once-weekly option that provides similar outcomes as daily insulins.”
According to DelveInsight’s “Short-Acting Insulin – Market Insights, Competitive Landscape, and Market Forecast – 2030”, the short-acting insulin market was valued at USD 7.01 billion in 2023, growing at a CAGR of 3.55% during the forecast period from 2024 to 2030 to reach USD 8.92 billion by 2030. The rising prevalence of diabetes, fueled by sedentary lifestyles and unhealthy diets, has led to an increasing demand for insulin therapy to manage blood glucose levels effectively. Simultaneously, rising awareness and diagnosis of diabetes globally have encouraged more individuals to seek treatment, further driving the market expansion, and thereby boosting the market for short-acting insulin products during the forecast period from 2024 to 2030.
