Ethicon Announced European Approval and Introduction of ETHIZIA™ Hemostatic Sealing Patch Used to Stop Disruptive Bleeding

On November 15, 2023, Ethicon, a Johnson & Johnson MedTech company, received approval for ETHIZIA™, an adjunctive hemostat solution that has been clinically proven to achieve sustained hemostasis in difficult-to-control bleeding situations.

ETHIZIA Hemostatic Sealing Patch is the first and only hemostatic matrix made of a special synthetic polymer technology that is equally active and effective on both sides. Its ultimate adaptability is derived from its capacity to be trimmed, adjusted, pulled apart, rolled up, and otherwise handled with ease during both open and minimally invasive procedures. ETHIZIA Hemostatic Sealing Patch stopped bleeding in 30 seconds on average in 80% of clinical trial participants, which is an average of six times faster than the industry-leading Fibrin Sealant Patch. 

ETHIZIA™ Hemostatic Sealing Patch has received CE Mark approval as an adjunctive hemostat for disruptive bleeding on internal organs, except cardiovascular and neurological, and is expected to launch in EMEA in Q1 2024, and other key markets in North America, APAC, and LATAM following regulatory approvals.

GATT Technologies B.V., a Netherlands-based business that uses unique synthetic polymers to make hemostatic and sealant products to handle difficult surgical bleeding and leak issues, was acquired by Ethicon in May 2022. The synthetic technology from GATT enhanced Ethicon’s existing capabilities and allowed for the creation of novel solutions to meet important unmet needs. One such product is the ETHIZIATM Hemostatic Sealing Patch, which can provide sustained hemostasis in situations where bleeding is difficult to control.

“As a global leader in surgery, we are committed to empowering healthcare providers to safeguard patients from surgical complications by continuously delivering breakthrough solutions,” said Vladimir Makatsaria, Company Group Chairman, Ethicon. Vladimir Makatsaria also added, “Disruptive bleeding can contribute to serious complications, and with the addition of ETHIZIA to our portfolio, we are well positioned to deliver critical hemostasis solutions for patients.”

As per DelveInsight’s “Hemostats Market” report, the global Hemostats market was valued at USD 3.64 billion in 2022, growing at a CAGR of 5.72% during the forecast period from 2023 to 2028 to reach USD 5.07 billion by 2028. 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 in the upcoming years. 

Medtronic Received FDA Approval of Minimally Invasive Device to Treat Hypertension

On November 17, 2023, Medtronic plc, a global leader in healthcare technology, announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization. 

A novel, minimally invasive blood pressure therapy called the Medtronic Symplicity administers radiofrequency energy to the kidney-neighbor nerves, which can become hyperactive and lead to high blood pressure. Following anesthesia, the physician threads a single, thin tube, called a catheter, into the kidney’s artery. After inserting the tube, the physician pulses energy into the system to reduce the hyperactivity of the kidney-related nerves. The tube is removed, leaving no implant behind.

According to results from a Medtronic-led patient preference study, when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one-third of patients were likely to choose the interventional treatment.

“Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. Jason Weidman also added, “It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure. The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension.”

“The Symplicity blood pressure procedure is safe and effective, providing significant ‘always on’ blood pressure reductions for patients,” said David Kandzari, M.D., chief, of Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. David also added, “This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study.”

“This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes,” said Raymond Townsend, M.D., from the Hypertension Section, Department of Internal Medicine / Renal, University of Pennsylvania School of Medicine and co-principal investigator of the SPYRAL clinical program. Raymond Townsend further said, “The Symplicity blood pressure procedure is a promising treatment option for clinicians and patients alike and offers the opportunity to fulfill a significant unmet need in hypertension care, especially for those patients who are desperately seeking additional approaches to get their blood pressure down.”

According to DelveInsight’s Blood Pressure Monitoring Devices Market, the global blood pressure monitoring devices market was valued at USD 1.04 billion in 2022, growing at a CAGR of 10.68% during the forecast period from 2023 to 2028 to reach USD 2.10 billion by 2028. The blood pressure monitoring devices market is witnessing positive growth owing to various factors such as the increasing prevalence of hypertension, the surge in the geriatric population, the increasing prevalence of cardiovascular disease, and technological advancements in product offerings. Therefore, the market for blood pressure monitoring devices is estimated to grow during the forecast period from 2023 to 2028. 

Boston Scientific Closed the Acquisition of Relievant Medsystems, Inc.

On November 17, 2023, Boston Scientific Corporation, closed the acquisition of Relievant Medsystems Inc., a company that offers the only US Food and Drug Administration-cleared Intracept® Intraosseous Nerve Ablation System, a therapy to treat vertebrogenic pain that is a form of chronic low back pain

The Intracept system, a basivertebral nerve ablation therapy, will be an addition to the Boston Scientific chronic pain portfolio that includes spinal cord stimulation, radiofrequency ablation, and an interspinous spacer procedure.

The acquisition includes an upfront cash payment of $850 million and undisclosed additional contingent payments based on sales performance over the next three years. On an adjusted basis, the transaction is expected to be immaterial to adjusted earnings per share in 2024, slightly accretive in 2025, and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be more dilutive due to amortization expense and acquisition-related charges.

“The revolutionary therapy from Relievant has tremendous potential to help even more people living with chronic pain,” said Jim Cassidy, president, of Neuromodulation, Boston Scientific. Jim Cassidy further added, “The completion of this acquisition further differentiates our position in advanced interventional chronic pain, offering physicians the broadest selection of evidence-based treatment options that address multiple pain targets and change patients’ lives.”

According to DelveInsight’s “Ablation Devices Market” report, the global ablation devices market is estimated to grow at a CAGR of 11.65% during the forecast period from 2023 to 2028. Factors such as the increasing incidence of cancers such as liver cancer, the rising prevalence of chronic pains such as musculoskeletal pains, the rising prevalence of cardiac arrhythmias such as atrial fibrillation, and the rising regulatory approvals for technologically advanced ablation devices. Therefore, the market for ablation devices is estimated to grow at a significant CAGR during the forecast period from 2023 to 2028.

AstraZeneca Launched Evinova, a Health-Tech Business to Accelerate Innovation across the Life Sciences Sector, the Delivery of Clinical Trials, and Better Health Outcomes 

On November 20, 2023, AstraZeneca launched Evinova, a leading provider of digital health solutions to better meet the needs of healthcare professionals, regulators, and patients. 

Evinova provides the life sciences and healthcare industry with globally-scaled digital goods and services, backed by AstraZeneca for an extended period and through strategic partnerships with Parexel and Fortrea. 

To enhance the clinical trial design and delivery, Evinova will give priority to bringing to market proven and scaled digital technology solutions that AstraZeneca is already using globally. This will lessen the time and expense associated with creating new medications, enable patients to receive care closer to home, and ease the strain on healthcare systems. With a pipeline of digital breakthroughs in these fields, Evinova will also look for potential in digital therapies and digital remote patient monitoring.

With the help of AstraZeneca’s extensive experience in creating innovative treatments as well as insights from thousands of patients and clinical researchers, Evinova will offer pharma, biotech, and CROs proven technological solutions to assist clinical research around the world. 

Leading CROs in the world, Parexel, and Fortrea, have agreements in place to provide Evinova digital health solutions to their extensive clientele. Evinova is working with Accenture and Amazon Web Services to quicken the industry’s adoption of its digital goods and to maintain and broaden its global reach.

Evinova aims to integrate its extensive knowledge in digital technology, which includes strategy and development, digital product development, data science and artificial intelligence, user experience design, and behavioral science, with its clinical and regulatory experience from AstraZeneca. 

Evinova will provide specific scientific solutions, such as novel endpoint solutions and remote patient monitoring, in addition to digital solutions. Consulting services and trial design will also be provided.

Pascal Soriot, Chief Executive Officer, of AstraZeneca, said, “The future of medicine development can be accelerated with digital solutions. We believe Evinova’s combination of scientific expertise and track record in developing AI-enabled digital technologies at scale, provides a real opportunity to fundamentally improve patient care, drive healthcare transformation, and reduce carbon emissions.”

Cristina Duran, President of Evinova, said, “We are excited to bring the portfolio of globally-scaled digital solutions developed to serve AstraZeneca’s drug development pipeline to the wider life sciences community. We believe this will help propel the sector forward in digital health, as we know healthcare professionals and regulators need digital solutions that work across pharma and support patients broadly. Coming from within the sector and with proven experience, Evinova will be uniquely placed to deliver science-based, evidence-led, and human experience-driven solutions to improve patient experience and outcomes.”

According to DelveInsight’s Digital Health Market” report, the global digital health market was valued at USD 178.37 billion in 2022 and is estimated to grow at a CAGR of 18.25% during the forecast period from 2023 to 2028 to reach USD 486.55 billion by 2028. The digital health market is observing remarkable market growth due to the growing awareness, adoption of digital healthcare, and the rising demand for IoT, AI, and others in the healthcare industry. Further, the increasing patient pool suffering from chronic disease and the rising burden of the geriatric population across the globe will increase the need for remote and virtual patient care, leading to the increased demand for digital health. Additionally, the growing demand for remote patient monitoring and mobile health applications, increasing penetration of smartphones in the healthcare industries along with the increasing product or service launches & approvals, and the presence of key players in the market, among others will create a requisite for the digital health in the market. Therefore, the market for digital health is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

Surmodics Announced 24-Month Data of the SWING Trial

On November 16, 2023, Surmodics, Inc., a leading provider of medical devices and in vitro diagnostic technologies to the healthcare industry, released 24-month data from the SWING Trial, a first-in-human study of the safety and performance of the Sundance™ Sirolimus Drug-Coated Balloon (DCB). 

The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries. The SWING Trial enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2 mm to 4 mm, and a total lesion length of ≤230 mm for treatment with the Sundance Sirolimus DCB at eight sites in Australia, New Zealand, and/or Europe. Study subjects will be followed for 36 months post-index procedure.

Results of the trial: 

  • Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects. 
  • The per protocol (PP) population reported an 8.3% rate of major adverse events (two clinically driven target limb revascularizations) at 6 months, with no additional adverse events reported for PP subjects in the 12 or 24-month data. 
  • Primary efficacy data show late lumen loss of 1.0 mm (±.79 mm) across 35 lesions at 6 months, indicating that the large luminal gain achieved immediately after the procedure was sustained post-procedure.
  • Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularization associated with deterioration of Rutherford Clinical Classification and/or increase in the size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >50%, was 71.4% at 24 months in the PP population. 
  • The Rutherford Clinical Classification describes 7 categories of peripheral artery disease, including both the patient’s clinical symptoms as well as objective findings, and is used to assess disease progression.

“The two-year safety and performance results of the SWING trial continue to show promise for the Sundance Sirolimus DCB in treating below-the-knee disease in a challenging CLTI patient population where options are currently limited,” said Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of Northern Region Interventional Radiology Service (Auckland City Hospital, Auckland, New Zealand), co-lead investigator. “We need to continue to strive for better treatments for treating infrapopliteal disease,” added Professor Varcoe. “These results are promising and will inform future trials, which we hope will continue to advance improved treatments 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 2022, growing at a CAGR of 8.09% during the forecast period from 2023 to 2028 to reach USD 4.08 billion by 2028. 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 (2023-2028).

GSK Announced Major Step towards Sustainability Ambitions with Advancement of LOW CARBON VENTOLIN PROGRAMME to Phase III Trials

On November 21, 2023, GSK plc, announced it will start Phase III trials of a low-carbon version of its metered dose inhaler (MDI), Ventolin (salbutamol), using a next-generation propellant, in 2024. If successful, it has the potential to reduce greenhouse gas emissions from the use of the inhaler by approximately 90%, significantly contributing to GSK’s ambitious net-zero climate targets.

GSK is funding a research and development effort to redesign the inhaler and switch to a propellant with less carbon. The next-generation propellant has undergone comprehensive testing to guarantee that it is suitable for usage with MDIs and patients. It has been under technological development for several years. The decision to move forward to phase III was supported by recent evidence from early clinical trials, and the first patient dose is scheduled for the first half of 2024. Submissions for regulations will start in 2025 if all goes well.

GSK Chief Executive Officer, Emma Walmsley, said, “As countries work to decarbonise their health systems, companies have an important role to play – and addressing the carbon emissions from inhalers is a key part of this. Harnessing our deep respiratory expertise, we have developed an innovative low-carbon inhaler and I am delighted that we are now progressing this programme into Phase III trials. If successful this could lead to regulatory submissions in 2025, supporting the health of asthma and COPD patients and making a significant positive impact on our transition to a more environmentally sustainable future.”

According to DelveInsight’s Metered Dose Inhaler Devices Market” report, the global metered dose inhaler devices market was valued at USD 16,613 million in 2022, growing at a CAGR of 3.99% during the forecast period from 2023 to 2028 to reach USD 21,423 million by 2028. The metered dose inhaler devices market is witnessing positive growth owing to various factors such as the increasing prevalence of COVID-19, the rising prevalence of diabetes, the increasing prevalence of asthma, the surge in cystic fibrosis cases, the surge in the prevalence of chronic obstructive pulmonary diseases (COPD), rise in geriatric population and increase in technological advancements concerning the product offerings. Therefore, the market for metered dose inhaler devices is estimated to grow during the forecast period from 2023 to 2028.