Insulet had recently presented findings that highlighted the significant benefits of Omnipod 5 in improving health outcomes and easing life for people with type 2 diabetes. The SECURE-T2D clinical study indicated that, when compared to previous insulin therapies, Omnipod 5 use resulted in considerable reductions in HbA1c levels—0.8% overall and 2.1% in those with prior HbA1c of 9.0% or higher. The study further showed a reduction in hyperglycemia and total daily insulin dose, along with a 20% improvement in time in range, increasing by 4.8 hours daily, without an increase in hypoglycemia. Moreover, there was a noted improvement in diabetes distress, underscoring the system’s positive impact.
The Omnipod 5 System simplified diabetes management and improved outcomes by eliminating the need for multiple daily injections (MDI) and automatically adjusting insulin delivery every 5 minutes with its advanced SmartAdjust™ technology. The system had also been easy to prescribe through the pharmacy and was widely covered by many insurance plans, including Medicare Part D.
As per DelveInsight’s “Insulin Delivery Devices Market Report,” the global insulin delivery devices market was valued at USD 15.51 billion in 2023, growing at a CAGR of 9.28% during the forecast period from 2024 to 2030, to reach USD 26.35 billion by 2030. The rise in demand for insulin delivery devices is predominantly driven by the increasing prevalence of diabetes due to lifestyle changes, aging populations, and genetic factors. Secondly, awareness campaigns and educational initiatives have significantly increased public knowledge about diabetes management. Patients and healthcare providers are now more informed about the benefits of using advanced insulin delivery devices, which offer precise dosing, convenience, and improved blood glucose control compared to traditional methods. Additionally, technological advancements have further fueled market growth by introducing innovative features such as smart insulin pumps, continuous glucose monitor (CGM) integration, and mobile app connectivity. Collectively, these factors create a robust market environment that drives the demand for insulin delivery devices, ensuring better health outcomes for diabetes patients, during the forecast period from 2024 to 2030.
Vericel Announced the FDA Approval and Commercial Availability of MACI Arthro
On August 26, 2024, Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) to expand the MACI® (autologous cultured chondrocytes on porcine collagen membrane) label. This expansion included the arthroscopic delivery of MACI for repairing symptomatic single or multiple full-thickness cartilage defects of the knee up to 4 cm² in size. The newly introduced MACI Arthro™ provided a less invasive technique, allowing surgeons to evaluate and prepare the defect site and deliver the MACI implant through small incisions using custom-designed MACI Arthro instruments.
“The approval of MACI Arthro represents another significant milestone in our strategy to provide innovative solutions for patients suffering from pain and dysfunction caused by cartilage defects in the knee,” said Nick Colangelo, President and CEO of Vericel. “MACI Arthro provides orthopedic surgeons and their patients with a less invasive option for MACI administration, which we believe has the potential to significantly increase penetration into the largest segment of the MACI addressable market and will support sustained top-tier revenue growth for the Company in the years ahead.”
“Arthroscopic delivery of MACI represents a significant advancement in cartilage repair,” said Grant H. Garcia, MD, Orthopedic Specialists of Seattle. “The technique and specially-designed MACI Arthro instrumentation provides surgeons with a less invasive option to administer a clinically-proven treatment to patients, and may be preferable for patients given the many post-operative benefits of arthroscopic versus open surgery.”
MACI was recognized as the first FDA-approved cellularized scaffold product that utilized tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee. It stood out as the only restorative biologic cartilage repair product approved for arthroscopic administration. The MACI Arthro system combined the benefits of an arthroscopic approach with the long-term durability and proven clinical results of MACI. The custom-designed MACI Arthro instruments were tailored to address the most common defects in the MACI market, specifically targeting 2-4 cm² defects on the femoral condyles, which accounted for approximately 20,000 patients annually, representing one-third of the $3 billion addressable market for MACI. Additionally, with the launch of MACI Arthro, Vericel expanded its target surgeon base from 5,000 to 7,000, aiming to include surgeons who performed high volumes of cartilage repair surgeries, mainly through arthroscopic procedures.
As per DelveInsight’s “Collagen Meniscus Implants Market Report, the global collagen meniscus implants market was valued at USD 389.5 million in 2023, growing at a CAGR of 4.7% during the forecast period from 2024 to 2030. The collagen meniscus implant market is primarily driven by the rising incidence of knee injuries and meniscal tears, especially among athletes and active individuals. As demand grows for effective, long-lasting treatments, these implants have gained traction due to their ability to support tissue regeneration and restore knee function. Furthermore, the advancements in biomaterials and tissue engineering have further enhanced these implants, making them more effective and appealing, thus boosting market growth market during the forecast period from 2024 to 2030.
Research Demonstrated the Success of Systematic Ultrasound Imaging in the Management of Non-melanoma Skin Cancer Through Image-guided Superficial Radiation Therapy
On August 26, 2024, SkinCure Oncology, a leader in Image-Guided Superficial Radiation Therapy (Image-Guided SRT), announced the publication of a new study highlighting the importance of performing full dermal visualization (FDV) with high-resolution dermal ultrasound (HRDUS) before each treatment fraction for nonmelanoma skin cancer (NMSC). The study, titled “Understanding the Importance of Daily Imaging in the Treatment of Non-Melanoma Skin Cancer with Image-Guided Superficial Radiation Therapy,” was featured in the peer-reviewed international skin science journal Dermato.
The study was authored by Jeffrey Stricker, DO, MBA, CPE, FCAP from Dermatology Specialists of Alabama in Huntsville; Janine Hopkins, MD, FAAD from Hopkins Dermatology in Monroe, Louisiana, and Southlake, Texas; Aaron Farberg, MD from Bare Dermatology in Dallas, Texas; and Peyton Harris from the College of Medicine at Texas A&M University in College Station.
The authors report, “Increasing and decreasing tumor depth measurements during Image-Guided SRT inform[s] dermatologists when adaptive changes in energy (kV), TDF, and dose will result in more efficacy and less toxicity, respectively.”
Lead author Dr. Jeffrey Stricker said, “We found that 92 percent of NMSC tumors undergoing Image-Guided SRT exhibited measurable changes in the depth of invasion compared to that of the previous image. Because these measurements were collected immediately prior to treatment, they allowed the opportunity for adaptive changes in treatment parameters, such as kV, TDF, dose and boost. These adaptive changes were necessary in nearly 40 percent of reviewed cases, directly benefiting patients by maximizing efficacy and minimizing toxicity.”
The authors emphasized that “any measured increase in NMSC depth is clinically significant during Image-Guided SRT because it lowers the percent of the prescription dose received by the tumor cells as a function of their depth (PDD). A lower PDD means significantly less radiation is delivered to the deepest tumor cells, diminishing therapeutic efficacy, potentially allowing the deepest cells to receive significantly less than required for cure. Thus, by performing HRDUS depth measurements prior to every fraction, dermatologists and RTTs know exactly when to make adaptive increases in kV, TDF and dose/boost. This ensures that every NMSC tumor is adequately and uniformly radiated to achieve 99% cure rates.”
The study involved a retrospective review of medical records for 883 patients with 1,507 NMSC cases treated with Image-Guided SRT at seven dermatology clinics from 2017 to 2018. The principle of radiation safety, ALARA (“as low as reasonably achievable”), guided the study to minimize unnecessary radiation exposure. Routine HRDUS depth measurements before each fraction enabled dermatologists and RTTs to make precise adjustments, reducing radiation toxicity. The authors also highlighted that HRDUS imaging before treatments allowed clinicians to track tumor repopulation, assess the biological effectiveness of Image-Guided SRT, and monitor for potential radioresistance.
“This new study reaffirms what our partner dermatologists and Mohs surgeons have seen in their practices over the past several years, that image-informed treatments produce optimal clinical outcomes,” said Kerwin Brandt, Chief Executive Officer of SkinCure Oncology. “We are encouraged by the growing adoption of this technology, the future of imaging in diagnostics and treatment, and the continued impact that this model of care is having on patients and their families.”
According to DelveInsight’s “Ultrasound Devices Market Report”, the global ultrasound devices market was valued at USD 6.76 billion in 2023, growing at a CAGR of 6.82% during the forecast period from 2024 to 2030 to reach USD 10.05 billion by 2030. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early disease detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period from 2024 to 2030.
SDC Capture Revolutionized Clinical Trials With its New BYOD ePRO Solution
On August 28, 2024, Statistics & Data Corporation (SDC), a global leader in life sciences biometrics services and technology solutions, announced the launch of its groundbreaking Bring Your Own Device (BYOD) electronic Patient Reported Outcomes (ePRO) solution, which transformed the way clinical trials were conducted.
This cost-efficient, state-of-the-art platform was designed to completely eliminate paper from the clinical trial process. In an era where flexibility and efficiency were paramount, SDC Capture’s BYOD ePRO solution allowed participants to use their personal devices. This paved the way for greater efficiency, reduced patient burden, enhanced patient adherence, and improved data quality, resulting in optimized trials and successful endpoint realization.
“We are excited to introduce this innovative, cost-efficient solution that meets the evolving needs of clinical trials,” said Dr. Richard Abelson, CEO of SDC. “Our BYOD ePRO solution represents a significant advancement in eliminating paper, enhancing participant experience, and optimizing trial efficiency. We are confident it will deliver exceptional results more affordably and efficiently than any other competing technologies”.
Faith Kolb, COO of SDC further added, “SDC Capture BYOD is an integral part of our product growth strategy. We continue to focus our resources and invest effectively in technology development and optimization that will drive the next generation of clinical research solutions.”
According to DelveInsight’s “Clinical Laboratory Service Market Report”, the clinical laboratory service market was valued at USD 263.53 billion in 2023, growing at a CAGR of 6.18% during the forecast period from 2024 to 2030 to reach USD 399.78 billion by 2030. The demand for clinical laboratory services is primarily being boosted owing to the rising cases of chronic and infectious diseases, lifestyle disorders such as obesity, diabetes, and high blood pressure, and growing initiatives by global market players and collaborations to provide diagnostic services, among others, are the key factors driving the demand for clinical laboratory services during the forecast period from 2024 to 2030.
PaceMate® Acquired Medtronic Paceart Optima™ System
On August 27, 2024, PaceMate®, a pioneer in cardiac data management and remote monitoring, announced the acquisition of the Paceart Optima™ system from Medtronic PLC. This strategic acquisition expanded PaceMate’s global presence significantly, adding nearly 1,000 clinic locations worldwide. It further enhanced PaceMate’s ability to offer the leading and most comprehensive cardiac remote monitoring solution, solidifying its position as the preferred partner in advanced cardiac data management.
“After a comprehensive evaluation, we are confident PaceMate is the best organization to service Paceart customers and their future cardiac data workflow needs,” said Kweli P. Thompson, M.D., M.P.H., senior vice president and president, Medtronic Cardiac Rhythm Management. “PaceMate offers best-in-class cardiac data management solutions and will provide excellent ongoing support to Paceart customers.”
“Our shared values, dedication to customer experience, and commitment to exceptional patient-centric cardiac solutions make this agreement a perfect fit,” said Tripp Higgins, CEO of PaceMate. “Paceart customers will benefit from the continued support of Paceart employees transitioning to PaceMate, as well as enhanced service delivery and innovation. We are excited to set a new standard in the market by combining the strengths of both technologies for unparalleled support and advancement.”
PaceMate delivered the industry’s leading comprehensive end-to-end platform, supporting a full spectrum of cardiac device types, including implantables, ambulatory monitors, heart failure devices, and remote patient monitors. This was complemented by a complete suite of flexible solutions, including software, patient communications, and clinical service support.
PaceMate’s flagship product, PaceMateLIVE™, was recognized as the best-in-class remote cardiac monitoring software, utilizing powerful EHR integrations for seamless implementation, intuitive use, and intelligent patient prioritization. With its leading robust, research-grade data set, healthcare organizations have access to advanced tools for optimizing clinic operations and leveraging patient-centric data for groundbreaking research. This acquisition complemented PaceMate and advanced its position in global cardiac care, leading to improved patient outcomes and innovation worldwide.
According to DelveInsight’s “Cardiac Monitoring System Market Report”, the global cardiac monitoring market size is estimated at USD 26.35 billion in 2023 and is expected to reach USD 33.81 billion by 2030, growing at a CAGR of 5.11% during the forecast period from 2024 to 2030. The market for cardiac monitoring systems is primarily driven by several key factors. The increasing prevalence of cardiovascular diseases, including heart attacks, arrhythmias, and heart failure, necessitates continuous and accurate monitoring to manage these conditions effectively. Advances in technology, such as wearable devices and remote monitoring solutions, are enhancing the accessibility and convenience of cardiac monitoring, catering to a growing demand for real-time health data. Additionally, the rising health consciousness among the population and the emphasis on preventive healthcare contribute to higher adoption rates of cardiac monitoring systems. Technological innovations, including improved sensor accuracy, integration with electronic health records (EHRs), and advanced analytics capabilities, further propel the, during the forecast period from 2024 to 2030.
KARL STORZ Acquired a US-headquartered company to Establish a Surgical Robotics Hub and Advance Performance-Guided Surgery
On August 22, 2024, Asensus Surgical, Inc., a global leader in innovative digital solutions for the operating room, announced that it closed the merger with the KARL STORZ Group.
Under the terms of the merger agreement, KARL STORZ Endoscopy-America, Inc., a wholly-owned direct subsidiary of KARL STORZ, acquired all outstanding shares of Asensus Surgical for $0.35 per share in cash. As a result of the acquisition, Asensus Surgical became a subsidiary of KARL STORZ, and its common stock stopped trading on the NYSE American Exchange.
“We are thrilled to complete this merger with KARL STORZ, which marks an exciting new chapter for Asensus,” said Anthony Fernando, Asensus Surgical President and CEO. “By joining forces with a leading company in endoscopy that became a system provider for integrated MedTech, we are well-positioned to accelerate the development and delivery of our innovative robotic and digital surgical solutions. This union will benefit patients and surgeons worldwide by advancing precise, safer, and more predictable surgical outcomes.”
“Asensus’ cutting-edge technology and expertise in robotic surgery complements our comprehensive portfolio of surgical solutions,” said Karl-Christian Storz, CEO of KARL STORZ. “This enhances our portfolio and market presence, strengthening our position in the growing robotic and digital surgical market, particularly with the development of the next generation LUNA™ system. We are thrilled to welcome 200-plus talented Asensus team members into our company. Together, we will revolutionize healthcare by delivering better outcomes for patients and surgical teams worldwide.”
Asensus was chosen for acquisition by KARL STORZ for two main reasons: the organization’s talent and technology. As a potential partner, Asensus proved to be an ideal fit because of its similar philosophy and vision, as well as its experience in bringing its first-generation Senhance robot to market. Its second-generation LUNA™ System was also positioned to provide enhanced robotic precision, greater dexterity, and a superior range of motion manipulation, which complemented KARL STORZ’s advanced visualization capabilities.
According to DelveInsight’s “Surgical Robotic System Market Report”, the global surgical robotic systems market was valued at USD 5.02 billion in 2023, growing at a CAGR of 11.50% during the forecast period from 2024 to 2030 to reach USD 9.64 billion by 2030. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of the at-risk population for prostate cancer, valvular diseases, endometriosis among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the Surgical Robotic Systems market during the forecast period from 2024 to 2030.
