“Based on our experience with NEXUS in Europe since 2019, we continue to see a significant global opportunity for the NEXUS technology and expect that it will further solidify our position as a global leader in aortic repair,” said Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion. “We view our revised credit facility and option purchase agreements with Endospan as an investment in the next frontier of aortic arch surgery. Should we exercise our option to acquire Endospan, we believe we will be able to meaningfully expand our total addressable market at that time on terms more favorable than existed prior to these amendments.”
Under the revised term of the Endospan credit facility, Artivion will extend up to an additional USD 25 million in debt financing to Endospan, distributed over three tranches. The first USD 7 million will be drawn at closing, with the subsequent tranches contingent upon the progress and achievement of the NEXUS PMA. The loan terms are nearly identical to those of the original USD 15 million loan, with the exception that both the original and new loans will now benefit from a first-priority lien on Endospan’s assets, on equal footing with other first-lien Endospan liabilities.
The amendments to the credit facility and Securities Purchase Option Agreement had been approved by the boards of directors of both companies and Endospan’s security holders. There were no changes to the existing Exclusive Distribution Agreement between the parties.
As per DelveInsight’s “Abdominal Stent Graft Market Report”, the global abdominal stent graft market is estimated to grow at a CAGR of 4.31% during the forecast period from 2024 to 2030. The demand for abdominal stent grafts is primarily being boosted by the growing prevalence of abdominal aortic aneurysms and other related issues such as atherosclerosis. Furthermore, the rising prevalence of cardiac disease due to smoking, obesity, and high blood pressure as these complications are significant risk factors for the development and progression of abdominal aortic aneurysms (AAAs) are also propelling the growth of the market. Additionally, the large number of product approvals and product launches are some of the other key drivers that are responsible for contributing to the positive growth of the abdominal stent graft market during the forecast period from 2024 to 2030.
Masimo and Cleveland Clinic Entered Into Collaboration to Improve Hospital Remote Care
On June 27, 2024, Masimo, a leading global provider of medical technology and hospital automation solutions, and Cleveland Clinic, a nonprofit academic medical center, announced the launch of a new partnership focused on hospital-based remote patient monitoring (RPM), including TeleCritical Care. This collaboration will integrate Cleveland Clinic’s critical care (eHospital) and non-critical care (eCMU) central patient monitoring platforms with the Masimo Hospital Automation™ platform. The objective is to equip clinicians with tools that enhance situational awareness and provide clinical decision support for hospitalized patients, including those who are critically ill. The collaboration will involve joint development efforts on predictive analytics and AI-based algorithms to enhance cardiac care.
Cleveland Clinic’s central monitoring platform for both critical and non-critical care provides continuous monitoring of various vital signs, including ECG, for ICU and non-ICU patients across more than 2,000 beds. Its hospital-based RPM programs serve 11 hospitals, offering intensivist monitoring, 24/7 critical care nursing, and patient management. These programs have reduced patient mortality, decreased ICU length of stay, and increased caregiver satisfaction. Through this partnership, Masimo and Cleveland Clinic aim to extend these innovations and benefits to other healthcare systems. The goal of the enhanced program is to increase awareness and facilitate triage with proactive responses to changes in a patient’s condition. This improves patient care and saves lives by ensuring high-risk patients receive timely treatment while maintaining the quality of care for all patients.
The Masimo Hospital Automation platform features technologies aimed at assisting clinicians in enhancing patient care from the bedside to the care continuum. It encompasses monitoring and wearable technologies, seamless integration of high-fidelity medical devices, system-wide applications for surveillance and data visualization, and advanced AI capabilities. These capabilities enable intelligent patient prioritization and aid clinicians in promptly detecting changes in patient conditions.
“We see great opportunities to enhance remote care, particularly for critically ill individuals,” said Chiedozie Udeh, M.D., Medical Director of ICU Operations at Cleveland Clinic. “By combining our technical and clinical expertise, we aim to improve situational awareness for clinicians and continue to improve outcomes for patients.”
Thomas Callahan, M.D., Staff Cardiologist at Cleveland Clinic’s Heart, Vascular & Thoracic Institute, and principal investigator for the AI study, added, “We look forward to exploring the effects of next-gen inpatient wearables, and as the capabilities of AI continue to advance, studying the potential impact on the care of cardiac patients, including those undergoing cardiac surgery.”
Joe Kiani, Founder and CEO of Masimo, said, “We are truly honored to have the opportunity to partner with Cleveland Clinic to advance patient care. By harnessing Masimo’s AI-powered decision support tools, automation solutions, and monitoring devices, alongside Cleveland Clinic’s vast clinical expertise and dedication to providing the highest quality, most innovative care, our partnership has the potential to significantly ease staff shortages, better standardize care, and promote intensivist- and specialist-led care. Ultimately, we will make significant strides in shifting from reactive to predictive and proactive care – improving patient outcomes, safety, and quality of care across the board.”
According to DelveInsight’s “Telehealth Market Report”, the global telehealth market is estimated to grow at a CAGR of 31.57% during the forecast period from 2024 to 2030. The increase in demand for telehealth is primarily attributed to the rise in shifting focus among the population for lowering healthcare costs and the rise in the government initiatives to launch telemedicine to provide increased access among the patient population. Moreover, the sudden outbreak of the COVID-19 pandemic and the increasing prevalence of chronic disorders will propel the demand for telehealth in the market. Further, the increasing number of diagnostic telehealth platforms, shortage of physicians, and technological advancements telehealth market across the world is anticipated to bolster the market, thereby contributing to the growth of the telehealth market during the forecast period from 2024 to 2030.
Academic Medical Center Became the First to Offer Sedation-Free TNE With the EvoEndo Endoscopy System
On July 2, 2024, EvoEndo®, Inc. (EvoEndo) announced that Duke Health is the inaugural provider in the region to offer Sedation-Free Transnasal Endoscopy (TNE) of the Upper Gastrointestinal (GI) Tract using the EvoEndo® Single-Use Endoscopy System to patients aged five and older in North Carolina.
“We take pride in being the first to provide our patients with new procedures and clinical advances,” said John Lyles, assistant professor in the Department of Pediatrics at Duke University School of Medicine. “This technology – sedation-free transnasal endoscopy – has demonstrated benefits for older school-age children and adolescents, enabling us to increase access to endoscopy overall and provide more options for these patients and their families.”
Duke Health is committed to enhancing patient lives through elevated standards of care.
“Transnasal endoscopy is a safe and sedation-free procedure that allows doctors to examine the esophagus and stomach of children. We are pleased to announce that Duke Children’s Hospital is the first in North Carolina to provide this innovative option for families,” said Bruno Chumpitazi, chief of the Division of Pediatric Gastroenterology, Hepatology & Nutrition at Duke University School of Medicine.
Jonathan Hartmann, Chief Executive Officer at EvoEndo, stated, “We are delighted that Duke Health, a leader in pediatric gastroenterology, is providing patients with the option of having sedation-free TNE with the EvoEndo System. Their commitment to improving care for children in North Carolina has a broad impact on patients and families by offering them an alternative to sedated endoscopy. By making this safe, patient-friendly option available, Dr. Lyles and his team at Duke are enabling families to spend less time in the hospital and more time engaged in school, sports, and family activities.”
As per DelveInsight’s “Endoscopes Market Report”, the global endoscopes market was valued at USD 12.95 billion in 2023, growing at a CAGR of 6.05% during the forecast period from 2024 to 2030 to reach USD 18.32 billion by 2030. The increase in demand for endoscopes is primarily attributed to the increasing prevalence of chronic diseases that require the use of endoscopes for diagnoses, such as some gastrointestinal diseases like irritable bowel syndrome (IBD), gastroesophageal reflux disease (GERD), peptic ulcer disease, and Crohn’s disease, increase in the geriatric population who are more prone to chronic ailments, increasing awareness and demand of minimally invasive surgeries and no blood loss surgery, and rise in technological advancements in endoscopes like image magnification, high-definition optical systems and digital imaging are anticipated to bolster the market, thereby contributing to the growth of the endoscopes market during the forecast period from 2024 to 2030.
US FDA Granted Regulatory Clearance to IceCure for Next-Gen XSenseTM Cryoablation System With CryoProbes
On July 01, 2024, IceCure Medical Ltd., a developer of minimally-invasive cryoablation technology for tumor destruction through freezing rather than surgical removal, announced that it had obtained marketing authorization from the United States Food and Drug Administration (FDA) for its latest-generation single probe cryoablation system, the XSense™ Cryoablation System with CryoProbes.
“This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology,” commented Eyal Shamir, IceCure’s Chief Executive Officer. “The next-generation XSense™ system is cleared for the same indications as our flagship ProSense® system and we believe it has future potential to address other indications in the U.S. for significant indications with unmet needs. Through our innovation, IceCure is a global leader in liquid nitrogen-based cryoablation systems that offer a new minimally invasive treatment with benefits for patients, doctors and payors alike.”
XSense™ and its cryoprobes are approved for all the indications previously cleared by the FDA for ProSense®, covering various fields such as general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is engineered to eliminate tissue through the application of extremely cold temperatures, targeting conditions like fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions, and warts.
As per DelveInsight’s “Cryoablation Devices Market Report”, the global cryoablation devices market is estimated to advance at a CAGR of 8.8% during the forecast period from 2024 to 2030. The demand for cryoablation devices is primarily being boosted by the rising number of patients suffering from cardiovascular disorders, the increase in the number of patients suffering from chronic disorders such as cancer, the higher availability of customized probes for cryoablation, the increasing technological advancements associated with the cryoablation devices will help in contributing in the overall market growth of the cryoablation devices during the forecast period from 2024 to 2030.
KORU Medical Systems Received Regulatory Clearance for FreedomEdge® Infusion System in Japan
On July 02, 2024, KORU Medical Systems, Inc., a prominent medical technology company specializing in the development, manufacturing, and commercialization of advanced, patient-focused large-volume subcutaneous infusion solutions, announced that its cutting-edge FreedomEdge® System had received regulatory clearance in Japan. This clearance enabled the system to deliver multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg, and Sobi’s Aspaveli for paroxysmal nocturnal hemoglobinuria (PNH).
This regulatory achievement represented a major step forward in patient care in Japan, offering patients and healthcare providers access to advanced treatment options for Subcutaneous Immunoglobulin therapy (SCIg) and Paroxysmal Nocturnal Hemoglobinuria (PNH). The FreedomEdge® System recognized for its dependable performance, accuracy, and patient-centric design, facilitates the convenient and effective administration of large-volume subcutaneous therapies both in clinical settings and at home.
“We are very pleased to have received regulatory clearance for the FreedomEdge® System in Japan,” said Linda Tharby, President and CEO of KORU Medical. “This accomplishment underscores our commitment to advancing healthcare solutions that enhance patients’ lives worldwide and further strengthens KORU’s expansion into international markets. With the approval of the FreedomEdge System in Japan, we are proud to broaden access to critical therapies, empowering patients and healthcare providers with a reliable and user-friendly drug delivery platform.”
The FreedomEdge System is crafted to cater to the varied requirements of patients and healthcare providers, providing customizable features to tailor treatment experiences. With its compact and portable design, it offers flexibility in therapy administration, empowering patients to effectively manage their treatment in diverse settings.
According to DelveInsight’s “Drug Infusion System Market Report”, the global drug infusion systems market was valued at USD 11.73 billion in 2023, growing at a CAGR of 8.85% during the forecast period from 2024 to 2030 to reach USD 19.45 billion by 2030. The demand for drug infusion systems is primarily being boosted by the rising prevalence of chronic diseases such as cancer, diabetes, and others coupled with the increasing geriatric population and technological advancements in product development among others.
Reflow Medical Enrolled First Patient in Pilot Study of Coronary Sirolimus-Eluting Retrievable Scaffold System
On July 01, 2024, Reflow Medical, Inc., a developer of innovative cardiovascular devices, announced the enrollment of the first patients in the pilot study titled “A pilot study of the Drug-Eluting Coronary Spur™ Stent as a Primary Treatment for in-stent Restenosis (ISR) of the CORONARY arteries” (DEEPER CORONARY, NCT06117150). ISR presents a common clinical challenge associated with significant healthcare costs and heightened risks of death and rehospitalization. Referred to as the Coronary Sirolimus-Eluting Retrievable Scaffold System, or “Spur Elute,” this novel clinical approach aimed to address coronary ISR by delivering a proprietary sirolimus drug formulation to the affected lesion without leaving a permanent metallic implant. The study has received approval to enroll up to 10 patients across three centers in New Zealand.
Principal Investigator Prof. Scott Harding, M.D., is an interventional cardiologist specializing in the treatment of complex coronary disease at Wellington Hospital in Wellington, New Zealand. He shared his experience with the Spur Elute, saying, “It’s exciting to take part in the study of this novel platform, which has the potential to successfully treat patients suffering from in-stent restenosis.”
William Lombardi, M.D., and Kathleen E. Kearney, M.D., interventional cardiologists at the UW Medicine Heart Institute in Seattle, Washington, were in attendance at the first enrollment. “Being able to deliver anti-proliferative drugs while maintaining blood flow can be a crucial element for treating ISR patients,” said Dr. Lombardi, who is the Director of the Complex Coronary Program at the Institute
The Spur Elute is an innovative device that utilizes Retrievable Scaffold Therapy (RST) to create channels, enhancing the absorption of anti-proliferative drugs while expanding the arterial lumen to optimize procedural outcomes. Once the procedure is complete, the system is removed entirely, leaving no residual components behind.
“These enrollments take us one step closer to enabling physicians to utilize the Spur platform for treating patients with cardiovascular disease, and ISR in particular,” said Isa Rizk, CEO and Co-Founder of Reflow Medical, Inc. “We are so proud of the entire team and grateful to our external CRO, Mobius Medical, for reaching this milestone.” The pilot study of the Spur Elute for accessing and treating ISR follows last year’s successful introduction of the Reflow coraCatheters™ line for complex percutaneous coronary interventions (PCI).
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 to 2030).
