“We are thrilled to partner with Centurion Therapeutics,“ said Jason Bandy, CEO of Pensar Medical. “Their strong presence and rapid growth in the inpatient market, combined with our novel NPWT technology, will enable us to reach more patients and improve outcomes.”
Robert Goodwin, President and CEO of Centurion Therapeutics, affirmed, “Adding the Microdoc® sNPWT system to our product portfolio aligns perfectly with our commitment to providing comprehensive wound and surgical management solutions nationwide. We are excited about the opportunity to offer this innovative product to our distribution partners and their customers.”
As per DelveInsight’s “Advanced Wound Care Market Report”, the advanced wound care market was valued at USD 9.45 billion in 2023, growing at a CAGR of 10.51% during the forecast period from 2024 to 2030, to reach USD 16.97 billion by 2030. The advanced wound care market is expanding rapidly due to the collective impact of rising chronic and acute wound prevalence such as diabetic ulcers and pressure sores, increasing surgical procedures, and the growing product launches and approvals by key market players is expected to significantly drive the demand for advanced wound care from 2024 to 2030.
BD Completed Acquisition of Critical Care from Edwards Lifesciences
On September 03, 2024, BD (Becton, Dickinson, and Company), a global leader in medical technology, announced that it completed the acquisition of Edwards Lifesciences’ Critical Care product group, which will now be rebranded as BD Advanced Patient Monitoring.
BD Advanced Patient Monitoring is a global leader in advanced monitoring solutions, enhancing BD’s portfolio of smart connected care technologies with its expanding range of leading monitoring systems, advanced AI-driven clinical decision tools, and a strong innovation pipeline. BD Advanced Patient Monitoring’s technologies are frequently used alongside the BD Alaris™ Infusion System in operating rooms and intensive care units. The integration of BD’s new advanced monitoring and existing infusion platforms opens up future innovation opportunities for closed-loop hemodynamic monitoring and IV fluid and medication administration, by leveraging combined company data and interoperability features.
BD Advanced Patient Monitoring’s portfolio features the gold-standard Swan Ganz pulmonary artery catheter, minimally invasive sensors, non-invasive cuffs, tissue oximetry sensors, and monitors. These smart technologies are powered by advanced data analytics, incorporating machine learning and AI-based predictive and prescriptive algorithms to help clinicians gain deeper insights into current and future patient conditions and provide robust clinical decision-support tools.
BD Advanced Patient Monitoring will function as a distinct business unit within BD’s Medical segment to support its smart connected care strategy, and it will continue to operate from its location in Irvine, California.
According to DelveInsight’s “Patient Monitoring Devices Market Report”, the global patient monitoring devices market was valued at USD 35.21 billion in 2023, growing at a CAGR of 8.20% during the forecast period from 2024 to 2030, to reach USD 56.46 billion by 2030. The escalating demand for patient monitoring devices is primarily attributed to the increase in the prevalence of various chronic and lifestyle-associated disorders. Additionally, the growing preferences for remote patient monitoring systems among patients and healthcare providers, the increase in technological advancement in the product arena, and the rise in the approval of various patient monitoring devices in the current year, among others are also some of the factors responsible for potentially increasing the global patient monitoring devices market during the forecast period (2024-2030).
Haleon Announced the Launch of Eroxon®, the First and Only FDA Cleared OTC Gel for Erectile Dysfunction, Available for U.S. Preorder Without a Prescription
On September 03, 2024, Eroxon®, the first and only FDA-cleared gel for the treatment of erectile dysfunction (ED) available without a prescription, is now available for pre-order in the United States through Amazon and will be available at most major retailers starting in October 2024.
Eroxon® is clinically proven to help men achieve an erection within 10 minutes to enhance physical intimacy (individual results may vary). The treatment works by stimulating nerve endings in the penis, aiding men with ED in attaining and maintaining an erection during sex. Unlike some prescription solutions that may take up to an hour to be effective, Eroxon® addresses a significant unmet need for men dealing with erectile dysfunction.
Clinical study results demonstrate that Eroxon® is both safe and effective for men with erectile dysfunction (ED). Although ED can stem from underlying physical conditions, psychological factors such as stress, anxiety, depression, and other mental health issues can also play a role, particularly in younger men. Eroxon® is designed to help men with ED improve intimacy and connection in their relationships, promoting closer and more fulfilling partnerships.
Lisa Paley, President, North America at Haleon, said, “At Haleon, we have a clear purpose to deliver better everyday health with humanity. Introducing Eroxon to U.S. consumers reflects our belief that sexual health is a critical part of wellness. We understand how important making meaningful and intimate connections are to one’s wellbeing, and Eroxon helps achieve just that. We are proud to take this bold step to make this first-of-its-kind over-the-counter (OTC) gel treatment accessible to the millions of men in the U.S. who are affected by ED.”
Gerald Brock, MD, FRCSC, Haleon Partner, said,“The body of scientific evidence for Eroxon supports it as an effective, fast-acting, and accessible OTC ED treatment with an excellent safety profile.”
As per DelveInsight’s “Erectile Dysfunction Devices Market Report”, the global erectile dysfunction devices market was valued at USD 1.77 billion in 2023, growing at a CAGR of 9.46% during the forecast period from 2024 to 2030, to reach USD 1.77 billion by 2030. The erectile dysfunction devices market is expected to witness significant growth owing to the growing cases of erectile dysfunction, increase in the geriatric population of men, sedentary lifestyle that involves smoking, alcohol consumption, obesity, and technological advancements among erectile dysfunction devices product development from 2024-2030.
embecta Announced the FDA Clearance of its Disposable Patch Pump for Insulin Delivery Informed by Unique Needs of People with Type 2 Diabetes
On September 03, 2024, Embecta Corp., a global leader in diabetes care with a century-long history in insulin delivery, announced that it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary disposable insulin delivery system. Designed for adults with diabetes, including both type 1 (T1D) and type 2 (T2D), this system features a tubeless patch pump with a 300-unit insulin reservoir. The design was developed based on feedback from individuals with T2D and their healthcare providers.
“FDA clearance of our disposable insulin delivery system has been a top strategic priority for our team since launching embecta as an independent company, and achieving this milestone through strong execution exemplifies our commitment to making life better for the growing number of people living with diabetes,” said Dev Kurdikar, CEO. “As we continue to advance toward our vision of a life unlimited by diabetes, our team has focused on developing a patch pump that could address some of the most significant obstacles to adopting pump therapy for people who use insulin daily to manage their diabetes. This platform is also serving as the basis for an automated insulin delivery system in development.”
The system includes a wearable, fully disposable patch pump that delivers adjustable basal and bolus insulin for up to three days, based on the user’s needs. It features a 300-unit insulin reservoir, which is particularly suited for individuals with higher daily insulin requirements, commonly seen in people with type 2 diabetes (T2D). Traditional patch pumps may not have sufficient capacity for a three-day duration for these individuals. For instance, a recent study sponsored by embecta revealed that a 300-unit insulin reservoir could meet the needs of 64% of adults with T2D for a three-day period, compared to only 38% of those who would be adequately served by a 200-unit reservoir.
The system also includes a secure controller equipped with Bluetooth® wireless technology and a color touchscreen, designed to offer a streamlined interface and enhance the overall user experience.
“Our research and development, medical affairs and regulatory teams identified an unmet need within the diabetes community and shepherded this project from concept to clearance with dedication and diligence,” said Dr. Colleen Riley, Chief Technology Officer. “I want to thank the embecta team for their commitment to serving people with diabetes and thank the FDA for their timely review and clearance of a system that has the potential to reduce the burden of managing diabetes for more people and significantly move innovation in this area forward.”
As per DelveInsight’s “Transdermal Drug Delivery Devices Market Report”, the global transdermal drug delivery devices market is growing at a CAGR of 9.8% during the forecast period from 2024 to 2030. The demand for transdermal drug delivery devices is primarily witnessing growth on account of the increasing prevalence of chronic conditions, increase in adoption of third-generation transdermal drug delivery devices, technological advancements observed in the device, and the use of these devices from hormonal disorders to cardiovascular conditions and pain management.
INFINITY-SWEDEHEART Trial of Elixir Medical’s DynamX Bioadaptor Met Primary Endpoint and Clinical Results Confirmed Unique Mechanism of Action
On September 02, 2024, a developer of groundbreaking technologies for treating cardiovascular disease announced that the INFINITY-SWEDEHEART Randomized Controlled Trial (RCT) comparing the novel DynamX® Coronary Bioadaptor System with the contemporary Resolute Onyx™ zotarolimus drug-eluting stent (DES) achieved its primary endpoint of non-inferiority for target lesion failure (TLF) (2.35% versus 2.77%; p<0.001) at 12 months. The results were presented in a late-breaking Hot Line session at the European Society of Cardiology (ESC) Congress 2024 in London.
“The DynamX bio-adaptor represents a significant clinical advancement in the treatment of coronary artery disease with a unique mechanism of action six months following the percutaneous coronary intervention (PCI) procedure,” said principal investigator David Erlinge, M.D., Ph.D., and head of the Cardiology Department at Lund University, Lund, Sweden. “Each year millions of patients undergo PCI globally, and while a very safe procedure, the implantation of stents has been associated with an annual recurring adverse event rate. Sustained reduction and plateauing of these recurring adverse clinical events would create a major benefit over the lifetime of a patient.”
Clinical results from the 2,400-patient INFINITY-SWEDEHEART study demonstrated:
- TLF of 2.35% versus 2.77% met non-inferiority (p<0.001) at 12 months for DynamX bioadaptor and Resolute Onyx DES, respectively. The low TLF with DynamX was driven by numerically low adverse events across components of the composite endpoint with DynamX compared to Resolute Onyx DES, respectively:
- Target vessel myocardial infarction (TV-MI) (1.27% versus 1.52%)
- Ischemia-driven target lesion revascularization (ID-TLR) (1.27% versus 2.11%)
- Cardiovascular death (0.59% versus 0.50%)
- Target vessel failure (TVF) at 12 months was also lower at 3.03% versus 3.52%, for DynamX compared to DES, respectively.
“The results of our trial strongly support the clinical impact of the Bio-adaptor in coronary artery disease treatment, with a potential to significantly reduce the recurring adverse event risk after percutaneous coronary intervention in a population representative of everyday clinical practice,” said study chair Stefan James, M.D., Ph.D., and Professor of Cardiology at Uppsala University, Sweden. “The Bioadaptor technology has proven to be able to do this through its unique design and mechanism of action of restoring hemodynamic modulation of a diseased artery.”
The DynamX bio-adaptor had recently received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation is for its use in enhancing coronary luminal diameter, restoring hemodynamic function, and slowing plaque progression in patients with symptomatic ischemic heart disease caused by discrete new native coronary artery lesions. The bio-adaptor employs an innovative mechanism of action, working through three distinct phases to improve vessel health and return vessel biology to a more normal state.
“Results from the INFINITY-SWEDEHEART trial validate in a broad, more clinically complex patient population what we’ve shown previously in BIOADAPTOR RCT and several mechanistic and investigator-initiated studies – consistency of low and plateauing adverse event rates after the unlocking of the bioadaptor at six months,” said Motasim Sirhan, CEO of Elixir Medical. “We are thrilled by the results from the landmark analysis data after six months showing statistically significant reduction in TLF and TVF versus DES. As an innovation-driven company, these data further validate the bioadaptor’s unique mechanism of action and its advantage in treating coronary artery disease to improve the standard of care for our patients”.
According to DelveInsight’s “Drug-Eluting Stents Market Report”, the global drug-eluting stents market was valued at USD 2.57 billion in 2023, growing at a CAGR of 8.09% during the forecast period from 2024 to 2030 to reach USD 4.08 billion by 2030. The drug-eluting stents market is slated to witness prosperity owing to factors such as the growing prevalence of cardiovascular diseases which can further be attributed to the increase in the geriatric population wherein aging is considered to have a deleterious effect on blood vessels, growing prevalence of lifestyle disorders such as hypertension, diabetes, and obesity that are linked to affect the health of blood vessels in long term and drastically increase the probability of atherosclerosis, and the growing focus on developing a newer generation of drug-eluting stents to minimize post-procedural complications are further expected to result in the appreciable revenue growth in the drug-eluting stents market during the forecast period (2024-2030).
Median Technologies Announced Pivotal REALITY Study of its eyonis™ LCS Lung Cancer Diagnostic Met All Primary and Secondary Endpoints
On August 29, 2024, Median Technologies announced that its proprietary Artificial Intelligence (AI)/machine learning (ML) powered software, eyonis™ LCS, designed for lung cancer screening (LCS), successfully achieved the primary and all secondary endpoints in REALITY. This is the first of two pivotal studies needed for marketing authorizations in the U.S. and Europe.
Median’s eyonis™ LCS SaMD is intended to enhance the detection and diagnostic accuracy of low-dose computed tomography (LDCT). LDCT imaging is the global standard of care and is currently the only approved method for lung cancer screening in the U.S. and Europe.
Fredrik Brag, CEO of Median Technologies said, “These data met our ambition for improving the performance of LDCT with eyonis™ LCS. Now, we are even more excited to report the upcoming RELIVE pivotal data and file for marketing authorizations in H1 2025. We believe that broad implementation of LDCT with eyonis™ LCS has the potential to vastly improve early detection and lead to far more cures, dramatically reducing lung cancer mortality.”
The average five-year survival rate for lung cancer patients is 18.6 percent, primarily because only 16 percent of lung cancers are identified at an early stage. In contrast, Stage 1 lung cancer, if detected early, has a high cure rate, with an 80% survival rate after 20 years, often due to deaths from other causes. For Stage 1A cancers that are 10 mm or smaller, the 20-year survival rate is as high as 92%.
Thomas Bonnefont, COO and CCO eyonis™ Business Unit said, “The high performances of our device can not only save lives but also prevent healthy patients undergoing unnecessary medical procedures. This will avoid unnecessary distress for patients and reduce healthcare costs.”
The definitive results from REALITY demonstrate that eyonis™ LCS can accurately detect and characterize cancerous nodules. The novel SaMD delivered outstanding performance, achieving an area under the curve (AUC) of 0.904 at the patient level, significantly exceeding the AUC of 0.80, which was the minimum primary endpoint for REALITY. Notably, 80% of the cancers in the REALITY cohort were challenging Stage 1 cases. Additionally, the REALITY cohort included a higher proportion of small non-spiculated cancers and large spiculated benign nodules—both of which present diagnostic challenges for radiologists.
The pivotal REALITY study, which began in July 2023, gathered retrospective imaging and clinical data from 1,147 patients across five major cancer centers and hospitals in the U.S. and Europe, as well as two clinical data providers. This study evaluated the capability of eyonis™ LCS to diagnose lung cancer. Its objectives were to assess the standalone performance of eyonis™ LCS in distinguishing between cancerous and non-cancerous patients (i.e., “performance at patient level”) and in detecting and characterizing suspicious versus malignant nodules. The primary endpoint, established in consultation with U.S. regulatory authorities, was set to demonstrate that eyonis™ LCS would achieve an AUC greater than 0.8.
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, the 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.
