The iReach Omnia, introduced by Genesis Medtech, set a new benchmark in surgical stapling with its 90° articulation capability. This advancement provides surgeons with enhanced maneuverability and precision, enabling effective stapling even in the tightest spaces. The innovation reduces the need for multiple stapler firings, minimized weak points in the staple line, and lowered the risk of anastomotic leakage. By addressing these challenges, the iReach Omnia allows surgeons to achieve better patient outcomes in complex colorectal and thoracic procedures.
Colorectal cancer, one of the top three cancers globally, affects millions annually. Surgical resection remained the primary treatment for low rectal cancer, but surgeons faced difficulties in achieving clear margins in confined spaces, preserving sphincter function, and avoiding complications such as anastomotic leakage. The iReach Omnia’s 90° articulation capability resolves these issues by enabling precise vertical cutting and stapling in low rectal resections, reducing leakage risks and enhancing long-term patient outcomes.
As per DelveInsight’s “Surgical Stapling Devices Market Report”, the surgical stapling devices market was valued at USD 3.80 billion in 2023, growing at a CAGR of 8.36% during the forecast period from 2024 to 2030, to reach USD 6.15 billion by 2030. The surgical stapling devices market is experiencing significant growth due to the rising number of trauma cases resulting from road traffic accidents, the rising number of sports-related injuries, and the growing number of obese people who need bariatric surgery, which are acting as major factors contributing to the overall growth of the surgical stapling devices market during the forecast period from 2024 to 2030.
Inogen Received FDA 510(k) Clearance for SIMEOX 200 Airway Clearance Device
On December 30, 2024, Inogen, Inc., a medical technology company specializing in innovative respiratory products for homecare settings, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SIMEOX 200 Airway Clearance Device. This milestone expanded the company’s capability to market and address the diverse needs of patients with chronic respiratory diseases in the U.S.
The SIMEOX 200 represented the next generation of the original Simeox, which is previously available in select international markets. It is designed to promote and enhance bronchial drainage by facilitating the mobilization of bronchial secretions through high-frequency oscillatory vibrations and intermittent negative pressure applied to the airway during exhalation. The device is intended to be prescribed for patients capable of independently generating a cough. SIMEOX 200 is primarily targeted at assisting patients with chronic lung diseases associated with mucus hypersecretion and retention, including Bronchiectasis, COPD (Chronic Obstructive Pulmonary Diseases), Cystic Fibrosis, and Primary Ciliary Dyskinesia.
“We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,” said Kevin Smith, President and Chief Executive Officer. “By tapping into our well-established network of healthcare providers, B2B partners, and our Direct-to-Patient team, we aim to bring this next-generation airway clearance device to patients within the next year and significantly expand our reach over time.”
Traditional airway clearance therapies can be time consuming and constraining with mixed results. SIMEOX 200 provides an innovative alternative, delivering efficient bronchial drainage, specifically in low lung volumes, that can be administered in healthcare centers and institutions, as well as at home.
As per DelveInsight’s “Airway Management Devices Market Report”, the airway management devices market was valued at USD 1.60 billion in 2023, growing at a CAGR of 6.21% during the forecast period from 2024 to 2030, to reach USD 2.29 billion by 2030. The market for airway management devices is poised for substantial growth due to several interrelated factors. The rising burden of chronic respiratory diseases, such as asthma & COPD, and laryngeal and pharyngeal disorders drive up the demand for effective airway management solutions to manage these conditions. Concurrently, the increase in surgical procedures, both elective and emergency, necessitates advanced airway devices to ensure patient safety and effective ventilation. Additionally, the worsening air pollution further exacerbates respiratory problems, leading to more frequent and severe cases that require airway management. Furthermore, increasing awareness and screening programs promote early detection and better management of respiratory issues, thus amplifying the need for these devices. Moreover, the surge in product launches and approvals by key market players introduces innovative solutions and expands the available options, fueling market growth. Collectively, these factors create a robust demand for airway management devices, supporting market expansion and innovation during the forecast period from 2024 to 2030.
Microtech Announced First Human Case of Implantable Microsensor for Heart Failure
On December 26, 2024, Microtech, a wholly owned subsidiary of Medinol Inc., a global leader in medical technology research and development, announced that it initiated human clinical trials of its microsensor platform aimed at measuring atrial pressures critical for heart failure treatment.
Microtech’s implantable microsensor platform represented the culmination of decades of development into a new class of sensor technology designed for use not only as a standalone device but also for integration into existing devices. With its sub-millimeter size, completely passive function, and external communication via ultrasound, this technology enabled the transformation of existing implants into smart devices capable of collecting data and performing multiple functions simultaneously.
Microtech’s sensor platform, Professor Sharoni, Director of Cardiothoracic Surgery, explained, “This incredible technology has the potential to change the standard of care for patients suffering from heart failure and in particular, in this current study, those receiving LVAD devices or heart transplants.”
“Incorporating sensors into existing medical devices gives physicians the ability to treat patients based on quantifiable physiological parameters rather than symptoms and is a critical step in increasing access to equitable healthcare across the global community. Using a compact home unit, a patient with a Microtech-enabled implant can provide immediate and highly accurate pressure readings directly to their physician, making geographic distance or mobility issues no longer an issue,” said Dr. Yoram Richter, CEO of Medinol.
“This unique capability is transformative for a wide range of clinical scenarios, including patients suffering from heart failure, glaucoma, hydrocephalus, portal hypertension, AAA endoleaks and many more, providing broader access to healthcare and fewer office or hospital visits. Most importantly, from the perspective of treating physicians and device manufacturers, sensor-enabled smart devices will go beyond acute anatomical corrections, extending treatment to lifelong patient care.”
According to DelveInsight’s “Cardiac Implantable Electronic Devices (CIEDs) Market Report”, the global Cardiac Implantable Electronic Devices (CIEDs) market was valued at USD 28.1 billion in 2023, growing at a CAGR of 7.8% during the forecast period from 2024 to 2030. The market for Cardiac Implantable Electronic Devices (CIEDs) is driven by the rising prevalence of cardiovascular diseases, including atrial fibrillation and heart failure, globally. Advancements in technology, such as wireless connectivity and extended battery life, have improved device functionality and patient convenience. Increased awareness about early diagnosis and treatment options, coupled with a growing aging population prone to heart-related conditions, further propel market growth. Additionally, supportive government initiatives, expanding healthcare infrastructure, and increasing adoption of minimally invasive procedures are contributing to the heightened demand for CIEDs worldwide.
NAVIGANTIS VASCO™ Robotic Platform Used with First Patients Enrolled in Neurovascular Study
On December 27, 2024, Navigantis Inc. announced the first successful neurovascular clinical cases performed with its VASCO interventional robotic platform for patients suffering from neurovascular disorders.
“This achievement marks an important milestone in our mission to introduce the advantages of robotic procedures to the interventional neurovascular field,” said Mor Dayan, CEO of Navigantis. “The VASCO robotic platform has the potential to redefine how we approach the most complex and time-sensitive neurovascular procedures, ultimately improving both patient outcomes and procedural efficiencies. This is one of the first steps towards enabling robotic telesurgery for stroke patients, which could dramatically reduce response times and enhance access to timely critical care.”
The neurovascular interventional robotic clinical trial included patients undergoing diagnostic cerebral angiogram, brain tumor embolization, and mechanical thrombectomy for Ischemic Stroke. This study was led by Prof. Dong Joon Kim, a pioneer in the robotic neuro interventional space and the Chairman of Radiology at Severance Hospital in Seoul, South Korea. “These first successful robotic cases are a major stepping stone towards treating more complex neurovascular diseases,” said Prof. Kim.
According to DelveInsight’s “Neurovascular Devices/Interventional Neurology Report”, the global neurovascular devices market was valued at USD 2.84 billion in 2023, growing at a CAGR of 8.12% during the forecast period from 2024 to 2030, to reach USD 4.53 billion by 2030. The demand for neurovascular devices is gaining importance owing to the rising prevalence of the target patient population, increasing demand for minimally invasive neurosurgical procedures, ongoing development of technologically advanced products, and rising R&D investments, among others.
Innovent Entered into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate
On January 01, 2025, Innovent Biologics, Inc., a leading biopharmaceutical company specializing in the development, manufacturing, and commercialization of high-quality medicines for oncology, cardiovascular and metabolic, autoimmune, ophthalmology, and other major diseases, announced a collaboration and exclusive license agreement with Roche. This partnership was established to advance the development of IBI3009, a novel DLL3-targeted antibody-drug conjugate (ADC) candidate. IBI3009 had already received IND approvals in Australia, China, and the U.S., with the first patient for the Phase 1 study dosed in December 2024. The collaboration aimed to provide innovative treatment options for patients with advanced small-cell lung cancer.
IBI3009 targets DLL3, an antigen with low expression in normal tissues but significantly overexpressed in certain cancers, particularly small-cell lung cancer, and other neuroendocrine tumors. Developed leveraging Innovent’s proprietary novel topoisomerase 1 inhibitor (TOPO1i) platform, IBI3009 is one of the leading and potentially best-in-class DLL3-targeting ADCs. IBI3009 has shown encouraging anti-tumor activity in multiple tumor-bearing mouse models, particularly in chemo-resistant tumor types, and has demonstrated a favorable safety profile.
Dr. Samuel Zhang, Chief Business Officer of Innovent, stated, “We are delighted to once again enter a strategic collaboration with Roche, a global leader in oncology, to advance our potentially best-in-class DLL3 ADC candidate. By combining Roche’s scientific expertise and global development capabilities with our innovative approach, we are taking a significant step forward in our mission—to empower patients worldwide with affordable, high-quality biopharmaceuticals.”
“We are excited to enter this partnership with the Innovent team to further develop this promising investigational treatment for patients with small cell lung cancer. This partnership builds on Roche’s long history of innovation in the area of ADCs, to address the unmet needs of patients with solid tumors with transformational medicines,” said Boris L. Zaïtra, Head of Corporate Business Development at Roche.
According to DelveInsight’s “Antibody Drug Conjugate Market Report”, the global antibody drug conjugate market was valued at USD 10.13 billion in 2023, growing at a CAGR of 14.37% during the forecast period from 2024 to 2030 to reach USD 25.79 billion by 2030. The demand for antibody-drug conjugates is primarily being boosted by the growing prevalence of cancer globally, increasing research & development activities, and clinical trials for the development of antibody-drug conjugates, during the forecast period from 2024 to 2030.
Treace Expanded Reach into High-Volume Osteotomy Market with Second MIS Osteotomy Platform, Percuplasty™ Percutaneous 3D Bunion Correction® Procedure
On December 30, 2024, Treace Medical Concepts, Inc., a medical technology company, drove a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures. The company announced the limited market release and completion of its first surgical cases utilizing the Percuplasty™ Percutaneous 3D Bunion Correction® System and Procedure.
The Percuplasty™ System provided an instrumented, reproducible approach to 3D correction of the bunion deformity via cosmetically appealing, percutaneous incisions designed to minimize post-op pain and swelling, allowing patients to return to their active lifestyles quickly. This system marked the Company’s second entry into the metatarsal osteotomy segment, the largest portion of the bunion market, which is estimated to account for about 70% of the 450,000 bunion surgeries performed annually in the U.S.
“As the pioneers and leaders in 3D Bunion Correction®, we are excited to announce the limited market release of Percuplasty™ Percutaneous 3D Bunion Correction System, the second offering in our lineup of instrumented systems designed to democratize 3D minimally invasive osteotomy surgery,” stated John T. Treace, CEO and Founder of Treace. “The Percuplasty™ System follows the limited release of the Nanoplasty™ System, providing an additional, highly differentiated solution in the large metatarsal osteotomy segment of our $5B+ US bunion market opportunity. This represents another significant milestone in our strategy to provide a comprehensive portfolio of instrumented 3D bunion systems to meet the evolving needs of surgeons and patients.”
According to DelveInsight’s “Minimally Invasive Surgical (MIS) Devices Market Report”, the MIS devices market was valued at USD 28,873.25 million in 2023, growing at a CAGR of 7.38% during the forecast period from 2024 to 2030, to reach USD 42,499 million by 2030. The MIS devices market is witnessing positive market growth owing to factors such as the rising prevalence of various cancers such as lung cancer which accounted for the highest number of cancer-related deaths and highest cancer incidence, and other indications such as cardiovascular diseases, and neurodegenerative diseases among others. Furthermore, the presence of factors such as growth in the aging population wherein age plays a key role in the development of various indications is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development such as the development of surgical robots are further driving the MIS devices market as new products are gaining regulatory approvals and are entering the market.
