Notizia - Recent Pharma, Healthcare and Biotech Happenings
May 08, 2025
Table of Contents
On April 30, 2025, Teleflex Incorporated, a global leader in medical technologies, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded Indications for Use of its QuikClot Control+™ Hemostatic Device. The clearance extended the device’s application to include all grades of internal and external bleeding. Previously, the QuikClot Control+™ Device was cleared for the temporary control of class III and IV internal organ space bleeding, severely bleeding surgical wounds, mild to moderate bleeding in cardiac procedures, and bleeding from bone surfaces following sternotomy.
“Bleeding remains a major contributor to mortality and morbidity in the United States,” said Kevin Robinson, President and General Manager, Anesthesia and Emergency Medicine, Teleflex. “Uncontrolled, disruptive bleeding can significantly impact the clinical and economic outcomes of surgery. The expanded indication for the QuikClot Control+™ Device portfolio allows us to target more procedures where fast, effective control of bleeding could benefit patients, clinicians, and health systems. Our primary focus remains on trauma, but this expanded indication will also support procedures in general surgery, gynecologic surgery, orthopedic surgery, and other areas. We estimate that these additional clinical spaces add more than $150 million to our serviceable addressable market in the United States.”
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“Real-world evidence was leveraged by Teleflex to obtain FDA clearance for this clinically important, expanded indication,” said Michelle Fox, Corporate Vice President and Chief Medical Officer, Teleflex. “This means we are able to bring the technology of the QuikClot Control+™ Device portfolio to more clinicians who will benefit from its ability to provide improved bleeding control for all grades of bleeding, from surgery to resuscitation.”
To support the labeling change, Teleflex relied on real-world evidence (RWE) derived from a retrospective, statistically powered observational study involving 603 emergency, trauma, and surgical patients. The study evaluated the safety and effectiveness of the QuikClot Control+™ Device in managing all grades of bleeding across various anatomical sites during surgical procedures and injury-related bleeding. This RWE, which included a diverse patient population from multiple locations across the U.S., contributed to the FDA’s decision to grant clearance for expanded indications. Following this approval, the QuikClot Control+™ Hemostatic Device became indicated in the U.S. for the temporary control of external and identifiable internal bleeding, ranging from mild to life-threatening levels.
In the European Union, the QuikClot Control+™ Hemostatic Device was indicated for the temporary control of internal and external bleeding, including mild, moderate, severe, and traumatic bleeding resulting from injuries or surgical wounds. It was commercially launched in the EU in 2024.
As per DelveInsight’s “Hemostats Market Report”, the global Hemostats market was valued at USD 3.64 billion in 2023, growing at a CAGR of 5.72% during the forecast period from 2024 to 2030 to reach USD 5.07 billion by 2030. The Hemostats market is slated to witness prosperity owing to factors such as the increasing number of surgical procedures, the growing focus on blood loss management during surgeries, emphasis on improving the safety and usability of hemostats for end users along with technological advancements are expected to result in appreciable revenue growth in the hemostats market during the forecast period from 2024 to 2030.
On May 01, 2025, Edwards Lifesciences announced that the U.S. Food and Drug Administration (FDA) approved its transcatheter aortic valve replacement (TAVR) therapy, specifically the SAPIEN 3 platform, for the treatment of severe aortic stenosis (AS) in patients without symptoms. This marked the first FDA approval of a TAVR therapy for use in asymptomatic individuals.
The approval of the SAPIEN 3 platform, which includes the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves, was supported by pivotal findings from the EARLY TAVR trial. The trial showed that asymptomatic severe AS patients who were treated with Edwards’ TAVR experienced significantly better outcomes than those who received the standard guideline-recommended approach of clinical surveillance or watchful waiting.
“There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop,” said Philippe Genereux, M.D., director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey. “As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system.”
“This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” said Larry Wood, Edwards’ corporate vice president and group president, Transcatheter Aortic Valve Replacement and Surgical. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
As per DelveInsight’s “Transcatheter Aortic Valve Replacement/Implantation Market Report,” the global transcatheter aortic valve devices market was valued at USD 3.23 billion in 2023, growing at a CAGR of 15.41% during the forecast period from 2024 to 2030 to reach USD 7.64 billion by 2030. The demand for transcatheter aortic valve replacement devices is primarily being boosted by the increasing prevalence of aortic stenosis disorder, rise in cardiovascular disorders, increasing demand for TAVR procedures, increasing prevalence of aortic regurgitation and the technological advancements pertaining to the transcatheter aortic valve replacement arena which are expected to increase in the product demand thereby contributing in the growth of the transcatheter aortic valve replacement devices market during the forecast period from 2024 to 2030.
On May 07, 2025, LivaNova PLC, a leading medical technology company, announced 12-month top-line data from its OSPREY randomized controlled trial (RCT), which evaluated the aura6000™ System for treating moderate to severe obstructive sleep apnea (OSA). At the 12-month mark, 65% of patients in the treatment arm were responders, those achieving at least a 50% reduction in baseline apnea-hypopnea index (AHI) and reaching an AHI below 20. The trial employed proximal hypoglossal nerve stimulation (p-HGNS), which used six electrodes on the proximal hypoglossal nerve trunk, enabling broader airway control and personalized titration.
Previously, the company announced that OSPREY met its primary and secondary endpoints at six months. Results continued to improve at 12 months, with a 68% median reduction in both AHI (from 34.3 to 11.0) and oxygen desaturation index (ODI) (from 34.9 to 11.1). Additionally, treated patients showed clinically meaningful improvements in sleep-related quality of life scores, namely the Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ).
“OSPREY is the first major multi-center randomized, controlled pivotal trial of hypoglossal nerve stimulation. Patients in the device stimulation group experienced a rapid onset of therapy with continued improvement over time,” said Dr. Atul Malhotra, lead investigator for the study, who is also a professor of medicine at the University of California, San Diego School of Medicine anda sleep medicine specialist at UC San Diego Health. “Responder rates in the treatment group were strong throughout the first year, with one in four patients responding on day one, 50% responding by month three, and 65% responding by the 12-month mark. In addition, patient-reported outcomes for daytime sleepiness and functional outcomes of sleep quality demonstrated meaningful improvement over the course of 12 months.”
“The OSPREY trial demonstrated rapid and sustained improvement for patients who received active proximal hypoglossal nerve stimulation, including those with severe obstructive sleep apnea, elevated body mass index, and high risk of complete concentric collapse,” said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. “The OSPREY 12-month results further validate the potential of this therapy as a treatment alternative for the large and growing OSA population. With the strength of our clinical data, expertise of our neuromodulation team, and strategic growth opportunity ahead, we are eager to bring this innovation to patients.”
The baseline values for OSA severity and body mass index (BMI) in the OSPREY study reflected those typically seen in the general obstructive sleep apnea (OSA) population. Compared to other large-scale hypoglossal nerve stimulation (HGNS) trials that supported FDA approval, OSPREY enrolled patients with more severe OSA and higher BMI. Additionally, the study was intentionally designed to include patients with complete concentric collapse (CCC). According to a recently presented predictive algorithm, the OSPREY trial successfully enrolled a patient cohort with a CCC risk ratio representative of what is commonly observed in clinical practice.
At the 12-month mark, response rates and reductions in the apnea-hypopnea index (AHI) among patients with predicted CCC risk were consistent with those observed across the overall study population, underscoring the robustness of the therapy’s effectiveness. LivaNova completed its premarket approval submission to the U.S. FDA for the aura6000™ System based on meeting OSPREY’s primary safety and efficacy endpoints after six months of treatment. The company also provided interim 12-month data from the study to the FDA and indicated plans to submit the full dataset during the regulatory review process.
The aura6000™ System, an investigational implantable device for proximal hypoglossal neurostimulation, was undergoing clinical evaluation for treating adults with moderate to severe OSA. Notably, no serious device-related or procedure-related adverse events were reported throughout the OSPREY study.
According to DelveInsight’s “Sleep Apnea Devices Market Report”, the global sleep apnea devices market was valued at USD 7.53 billion in 2023, growing at a CAGR of 6.26% during the forecast period from 2024 to 2030 to reach USD 10.82 billion by 2030. The demand for sleep apnea devices is primarily being boosted due to the increasing cases of sleep apnea and the rising population with obesity. Further, the rising adoption of advanced and innovative technologies, the rising awareness about sleep apnea devices, the increasing geriatric population, and the increasing product launches and approvals among others, thereby contribute to the overall growth of the sleep apnea devices market during the forecast period from 2022-2030.
On May 07, 2025, Lipogems announced the successful completion of the ARISE I U.S. FDA IDE Study, with the last patient’s final visit now completed. This milestone marked the conclusion of a crucial phase in the development of Lipogems as a treatment for knee osteoarthritis (OA) in patients who were not yet ready for or did not qualify for knee replacement surgery. The double-blinded, randomized controlled trial involved 173 subjects across 18 respected U.S. sites. The primary endpoints of the study assessed improvements in pain and function 12 months after injection. The efficacy and safety results from the ARISE studies were expected to be announced in late 2025.
While the Lipogems device has been FDA-cleared for use in orthopaedics and arthroscopic surgery for 10 years, these studies represented the largest clinical trials conducted by the company. The ARISE I and II studies were designed to support Lipogems in obtaining a separate indication specifically for knee OA. The data collected would be analyzed in the following months to evaluate the safety and efficacy of Lipogems, focusing on how it improved pain and function in patients with mild to moderate knee OA.
“We are thrilled to reach this significant milestone,” said Carl Llewellyn, Chief Executive Officer of Lipogems USA. “This accomplishment brings us one step closer to making Lipogems a mainstream treatment option for patients with knee osteoarthritis who historically have had limited options. The successful conclusion of this trial represents the hard work and dedication of our team, clinical sites, and the patients who have placed their trust in us.”
As per DelveInsight’s “Orthopedic Device Market Report”, the global orthopedic devices market was valued at USD 44.09 billion in 2023, growing at a CAGR of 4.78% during the forecast period from 2024 to 2030 to reach USD 57.79 billion by 2030. The orthopedic devices market is slated to witness increasing revenue owing to factors such as a growing population of people above the age of 65, a rise in the cases of bone disorders such as osteoarthritis and osteoporosis among others, increasing cases of occupational injuries and non-occupational injuries along with latest technological developments in healthcare technology are further expected to result in the appreciable revenue growth in the orthopedic devices market during the forecast period from 2024 to 2030.
On May 06, 2025, Roche announced the launch of its Elecsys® PRO-C3 test, a new diagnostic solution aimed at assessing the severity of liver fibrosis in patients showing signs of metabolic dysfunction–associated steatotic liver disease (MASLD). Developed in collaboration with Nordic Bioscience, the test provided clinicians with a simple and efficient method for identifying patients with varying levels of liver fibrosis, enabling timely intervention and proper disease management.
MASLD affected approximately 30% of the population and was one of the most prevalent causes of chronic liver disease in the developed world. Primarily caused by diabetes, obesity, and other cardiometabolic risk factors, the number of individuals living with MASLD is growing rapidly, posing a significant burden on patients and healthcare systems globally. Despite being responsible for around one in every 25 deaths worldwide, liver fibrosis linked to MASLD often remains asymptomatic until reaching advanced stages, often going undetected for years. If left unmanaged, it could lead to severe outcomes such as cirrhosis, liver cancer, and liver failure.
“The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging, and management of liver fibrosis,” said Matt Sause, CEO of Roche Diagnostics. “With MASLD affecting a growing number of people worldwide and new treatments emerging, it is critical to detect fibrosis accurately and early. Our innovative solution simplifies the diagnostic process and eases the burden on healthcare services, providing a clear and rapid assessment while reducing the requirement for invasive biopsies.”
The Elecsys PRO-C3 test requires only a single assay, which delivers results in only 18 minutes on Roche’s cobas® analysers. This streamlines the process compared to currently available tests and reduces costs. Used in combination with the ADAPT formula, which includes PRO-C3 levels, platelet count, age and diabetes status, it provides a clear assessment of the severity of fibrosis, including distinguishing between different severities such as significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4). This is crucial for determining the appropriate treatment pathway for patients and identifying those who are eligible for new and emerging therapies.
According to DelveInsight’s “Liver Disease Diagnostics Market Report”, the global liver disease diagnostics market was estimated to grow at a CAGR of 5.97% during the forecast period from 2024 to 2030. The demand for liver disease diagnostics is primarily being boosted by the increasing number of people with liver diseases, the rise in alcohol consumption, and bad eating habits, among others. Furthermore, the liver disease diagnostics market is anticipated to grow on account of a large number of ongoing research activities in this field, collaborations between healthcare providers, researchers, and industry players, and strategic partnerships among others are going to contribute to the overall growth of the liver disease diagnostics market during the forecast period from 2024 to 2030.
On May 01, 2025, iRhythm Technologies, Inc. announced the commercial launch of its Zio® long-term continuous ECG monitoring (LTCM) system in Japan, where it was introduced as the Zio® ECG Recording and Analysis System. The system provided up to 14 days of continuous, uninterrupted ECG monitoring and utilized a deep-learned artificial intelligence (AI) algorithm, which was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This launch represented a significant advancement over other ambulatory cardiac monitoring options available in Japan, such as commonly used wired Holter monitors that only captured 24 to 48 hours of data, and other patch-based services that monitored for up to 7 days.
“We are honored to introduce our AI-powered Zio ECG Recording and Analysis System that provides up to 14 days of continuous, uninterrupted cardiac monitoring to Japan, where we see a meaningful opportunity to help advance arrhythmia detection,” said Quentin Blackford, President and Chief Executive Officer of iRhythm. “Together with our trusted distribution partner, Senko Medical Instrument, we are committed to expanding access to advanced cardiac monitoring that supports clinical excellence and aligns with Japan’s dedication to high-quality, patient-centered care.”
“The Zio long-term continuous monitoring service offers a clinically validated approach to arrhythmia detection by combining advanced AI with expert clinical review to support accurate and timely diagnoses,” said Dr. Mintu Turakhia, iRhythm Chief Medical Officer, Chief Scientific Officer, and EVP of Product Innovation. “As the need for effective long-term monitoring grows, we believe the introduction of Zio LTCM in Japan presents an opportunity to enhance patient care and support evolving clinical needs in cardiac monitoring—an impact also recognized by the Japanese Heart Rhythm Society.”
The Zio® ECG Recording and Analysis System consisted of a prescription-only, patch-based ECG monitoring device (Zio monitor) and the ZEUS (Zio ECG Utilization Software) system. The Zio monitor, iRhythm’s latest-generation ECG patch, was designed for comfortable, discreet wear and enabled up to 14 days of continuous ECG monitoring. It demonstrated 99% patient compliance and 99% analyzable data, providing high-quality, actionable insights.
The system leveraged a PMDA-approved AI algorithm that detected 13 arrhythmia types, sinus rhythm, and artifacts, performing at the level of cardiologists. End-of-wear reports were reviewed by certified cardiographic technicians, achieving 99% physician agreement. The Zio system was associated with the highest diagnostic yield and lowest likelihood of retesting compared to other monitoring services, including 24- to 48-hour Holter monitoring. In clinical settings, the Zio LTCM service helped reduce misinterpretation of ECG data and improve clinical efficiency.
As per DelveInsight’s “Cardiac Monitoring System Market Report”, the global cardiac monitoring market size is estimated at USD 27.70 billion in 2025, and is expected to reach USD 35.53 billion by 2030, at a CAGR of 5.11% during the forecast period. The market for cardiac monitoring systems is primarily driven by the increasing prevalence of cardiovascular diseases, aging populations, and rising awareness of heart health. Advancements in technology, such as the integration of artificial intelligence and wearable devices, have enhanced the accuracy and convenience of monitoring. The demand for continuous, long-term monitoring solutions is growing due to the need for early detection of arrhythmias and other heart conditions. Additionally, the shift towards remote patient monitoring, along with the increasing adoption of telemedicine and digital health solutions, is propelling the market forward. Moreover, regulatory approvals and technological innovations are improving the effectiveness and accessibility of these systems, further boosting their market growth.
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