The WRAPSODY® Cell-Impermeable Endoprosthesis is designed to extend long-term vessel patency in dialysis patients. Many dialysis patients rely on vascular access sites, such as arteriovenous (AV) fistulas—surgically joining an artery and vein—or AV grafts, which are soft tubes placed in the arm. Maintaining adequate blood flow through these access sites is critical for patient survival. However, over time, life-threatening complications can occur, including stenosis (narrowing of the vasculature) and thrombosis (blood clot formation), which can significantly compromise the effectiveness of the access site. WRAPSODY addresses these challenges by improving long-term vascular health and ensuring sustained blood flow, enhancing patient outcomes in dialysis treatment.
“Historically, interventions for patients who experience a stenosis in their AV fistula or AV graft have not provided sustained clinical benefits and often require multiple re-interventions,” said Mahmood K. Razavi, MD, FSIR, FSVM, Interventional Radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, Calif., and Co-Principal Investigator of the WAVE trial. “Results from the WAVE trial have demonstrated that the WRAPSODY device is associated with high patency rates and is likely to become the new standard of care.”
As per DelveInsight’s “Vascular Graft Market Report,” the global vascular graft market was valued at USD 2.73 billion in 2023, growing at a CAGR of 6.38% during the forecast period from 2024 to 2030 to reach USD 3.96 billion by 2030. Factors such as the rising prevalence of lifestyle disorders such as hypertension and diabetes which present themselves as major risk factors for the development of cardiovascular diseases such as aortic aneurysms and peripheral artery disease, growing geriatric population base where age itself plays a major role in disease etiology, and technical innovation in product development such as manufacture of coated vascular graft with improved features among other factors are expected to drive the vascular graft market.
AVITA Medical Announced FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market
On December 19, 2024, AVITA Medical, Inc., a commercial-stage regenerative medicine company specializing in innovative wound care management and skin restoration devices, announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Cohealyx™, a new collagen-based dermal matrix. Developed in collaboration with Regenity Biosciences, Cohealyx™ is designed to promote tissue integration and revascularization, supporting faster wound healing, reducing treatment timelines, and enhancing patient outcomes in the treatment of full-thickness wounds. This clearance marks a significant advancement in AVITA Medical’s portfolio of cutting-edge solutions for wound care and skin restoration.
“Cohealyx is a strategic addition to our RECELL-centric portfolio, unlocking the powerful synergies of RECELL and Cohealyx to address full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “This expansion to our product portfolio strengthens our ability to deliver superior patient outcomes and significantly expands our commercial potential in burns. By equipping clinicians with more comprehensive treatment options, we strengthen our competitive position, drive new growth opportunities, and further our commitment to advancing regenerative medicine.”
Cohealyx™ addresses the critical need in the treatment of full-thickness wounds with an advanced bovine collagen-based design engineered to promote cellular migration and blood vessel formation. Preclinical studies conducted in porcine models demonstrated that Cohealyx generated robust tissue capable of consistently supporting a split-thickness skin graft in a two-stage procedure faster than leading dermal matrices. Although animal model results may not directly translate to clinical outcomes, this accelerated timeline is expected to result in quicker wound closure, streamlined clinician workflows, and shorter hospital stays. These improvements may also contribute to reduced treatment costs and better patient outcomes, with further evaluation to be conducted in an upcoming clinical study.
As per DelveInsight’s “Advanced Wound Care Market Report”, the global advanced wound care market was valued at USD 9.45 billion in 2023, growing at a CAGR of 10.51% during the forecast period from 2024 to 2030, to reach USD 16.97 billion by 2030. The advanced wound care market is expanding rapidly due to the collective impact of rising chronic and acute wound prevalence such as diabetic ulcers and pressure sores, increasing surgical procedures, and the growing product launches and approvals by key market players is expected to significantly drive the demand for advanced wound care from 2024 to 2030.
SeaStar Medical Activated 14th Site its Adult AKI Pivotal Trial
On December 23, 2024, SeaStar Medical Holding Corporation, a commercial-stage medical device company focused on developing proprietary solutions to mitigate the impact of hyperinflammation on vital organs, announced the activation of its 14th site for enrollment in the NEUTRALIZE-AKI pivotal trial. This trial is assessing the safety and efficacy of the company’s proprietary therapeutic device, the Selective Cytopheretic Device (SCD), in patients with acute kidney injury (AKI) in the intensive care unit (ICU) who are receiving continuous renal replacement therapy (CRRT). The activation of this additional site marks a key milestone in advancing the trial, which aims to provide innovative solutions for critically ill patients with AKI.
“We are pleased to welcome the 14th hospital to our trial, especially as this site has been among the top CRRT programs in the country,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “As of today, 70 of the planned 200 subjects have been enrolled, including 24 so far in the fourth quarter. We plan to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrollment, we anticipate a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025.”
“We estimate the annual U.S. total addressable market for the SCD in adult AKI at $4.7 billion to $6.3 billion. This significant market opportunity represents a highly attractive return on a clinical trial estimated to cost SeaStar Medical approximately $15 million, with some of those costs already incurred,” said Eric Schlorff, SeaStar Medical CEO. “AKI is one of several high-value indications for our SCD that we plan to pursue. As we work to increase accessibility of our therapeutic device among those afflicted with potentially life-threatening hyperinflammation, we believe that our clinical data showing reduced mortality and probable savings for the healthcare system will encourage adoption by the medical community.”
The Selective Cytopheretic Device (SCD) previously received FDA Breakthrough Device Designation for the treatment of acute kidney injury (AKI) in adults. This designation is awarded to therapies that address serious or life-threatening conditions and show preliminary clinical evidence suggesting they may offer substantial improvements over existing treatments on clinically significant endpoints.
According to DelveInsight’s “Continuous Renal Replacement Therapy (CRRT) Market Report”, the global CRRT machines market was valued at USD 1.17 billion in 2023, growing at a CAGR of 7.38% during the forecast period from 2024 to 2030 to reach USD 1.78 billion by 2030. The CRRT machines market is experiencing significant growth due to the increasing instances of acute kidney injury and sepsis, coupled with advancements in technology and product launches which are acting as major factors contributing to the overall growth of the CRRT machines market during the forecast period from 2024 to 2030.
Contego Medical Announced First Patients Treated with Neuroguard IEP System
On December 19, 2024, Contego Medical announced the successful completion of the first commercial cases using the newly FDA-approved Neuroguard IEP® System, an innovative 3-in-1 device that combines a high-performance carotid stent, integrated dilation balloon, and integrated filter. The Neuroguard IEP System has been clinically proven to significantly reduce the risk of procedural and long-term stroke in patients with carotid artery disease, marking a major advancement in the treatment of this condition.
“The Neuroguard System is very easy to use and streamlines the steps for treating our patients with carotid artery disease. I believe this innovation will reduce the risk of stroke during and after carotid artery stenting procedures,” said Dr. John Gaughen. Dr. Srinivas Attanti added, “The pores on the integrated filter are much smaller than those on traditional technology, improving stroke protection for our patients.”
“When we started Contego, we always had our sights set on this day. The introduction of the Neuroguard IEP System ushers in a new era for treating patients with carotid artery disease, providing a level of safety and confidence that was previously unmatched,” said Dr. Ravish Sachar, Contego Medical’s CEO and Founder.
Clinical studies of the Neuroguard IEP® System, including the PERFORMANCE I Trial and PERFORMANCE II IDE Trial, have consistently reported unprecedentedly low event rates, including zero major strokes, zero neurologic deaths, and zero stent thromboses at up to 2 years of follow-up.
According to DelveInsight’s “Neurovascular Thrombectomy Devices Market Report”, the global neurovascular thrombectomy devices/neurothrombectomy devices market was valued at USD 722.78 million in 2023, growing at a CAGR of 6.15% during the forecast period from 2024 to 2030 to reach USD 1033.33 million by 2030. The rise in demand for neurovascular thrombectomy devices/neurothrombectomy devices is predominantly imputed to the rising prevalence of neurovascular disorders across the globe which require neurovascular thrombectomy devices/neurothrombectomy devices for their treatment such as ischemic stroke and hemorrhagic stroke, the growing burden of old age population. In addition, shifting key player’s focus toward the development of technologically advanced products and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors among others that are likely to upsurge the market for neurovascular thrombectomy devices/neurothrombectomy devices during the forecast period.
SMT Launched Hydra™ TAVI System in Russia, Offering Advanced Care for Aortic Stenosis Patients
On December 20, 2024, Sahajanand Medical Technologies (SMT), a global leader in innovative cardiovascular solutions, announced the launch of its Hydra™ Transcatheter Aortic Valve Implantation (TAVI) system in Russia. The Hydra™ TAVI system offers a highly refined approach to managing severe aortic stenosis, providing physicians with a reliable and advanced option for high-risk patients who are not candidates for open-heart surgery.
“Russia’s medical community has shown significant interest in adopting TAVI technologies, and Hydra™ is a meaningful addition to the solutions available for treating complex cases,” said Mr. Sergey Antonov, Head of Commercial Operations for Russia. “Our entry into the market reinforces SMT’s dedication to supporting physicians with devices that combine precision, flexibility, and reliability.”
“In Russia, medical devices are regulated by Roszdravnadzor (The Federal Service for Surveillance in Healthcare). This agency oversees the registration, monitoring, and quality control of medical devices to ensure their safety and efficacy for use within the Russian Federation. We are very proud that Hydra is now approved in Russia which has its own strict regulatory requirements”, added Mr. Ammad Shorbaji, Head of regulatory Affairs at SMT.
The Hydra™ Transcatheter Aortic Valve Implantation (TAVI) system features several advanced design elements to enhance aortic valve replacement procedures. Its adaptable design is re-sheathable, re-positionable, and retrievable, offering greater precision and flexibility during valve placement. The supra-annular valve configuration optimizes blood flow, improving post-procedure outcomes. Integrated frame markers guide accurate valve placement, while patient-centric safety features, such as a sealing skirt and stent frame design, minimize paravalvular leaks and reduce interference with the conduction system. Additionally, the open-cell frame design facilitates future coronary access, supporting long-term patient care and interventions.
According to DelveInsight’s “Transcatheter Aortic Valve Replacement Devices 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 2024-2030.
SandboxAQ Announced More Than $300 Million of Funding to Drive Next Era of AI
On December 18, 2024, SandboxAQ announced a successful funding round of over $300 million, led by Fred Alger Management, LLC, T. Rowe Price Associates, Inc., Mumtalakat, Parkway Venture Capital, Breyer Capital, Rizvi Traverse, S32, US Innovative Technology Fund, Ava Investors, and notable investors such as Eric Schmidt, Marc Benioff, David Siegel, Yann LeCun, and IQT.
SandboxAQ raised new funding to accelerate the development of its Large Quantitative Models (LQMs) and expand its AI applications across various sectors, including drug discovery, materials science, chemistry, cybersecurity, navigation, and medical devices. SandboxAQ’s AQBioSim division made significant progress in advancing therapeutic approaches for neurodegenerative diseases, securing partnerships with two leading academic research institutions to leverage its AI capabilities.
FloPatch revolutionizes IV fluid management in critical care by offering a straightforward, rapid, and reliable method to monitor blood flow and heart function changes tied to IV fluid levels. This innovation enhances precision in patient care, particularly for those with conditions like septic shock, a leading cause of hospital mortality in the U.S.
Positioned on the neck, FloPatch provides continuous, hands-free assessment of carotid artery blood flow, offering insights into left ventricle function. Its wireless transmission to a secure iOS app delivers actionable, real-time data to clinicians at the bedside, empowering swift and informed decision-making.
“Leading global enterprises are realizing that they must look beyond the capabilities and limitations of LLMs and embrace LQMs in order to maximize the ROI from their AI investments,” said Eric Schmidt, Chairman of SandboxAQ. “Jack Hidary and his team at SandboxAQ have shown the ability to create significant customer value across key industries such as biopharma, chemicals, and financial services. Jack is a world-class, high-integrity CEO leading a deeply technical team. With this round, SandboxAQ can move even faster to its goals and impact.”
“We see significant growth potential and opportunity for LQMs across a broad range of industries, which is why investing in SandboxAQ is an investment in AI’s future,” said Jim Breyer, Breyer Capital. “Through SandboxAQ, Breyer Capital has a front-row seat to a generation-defining company with some of the most inspiring uses of AI technology. Jack is both a visionary and a high-performance CEO, uniting science and AI in bold and meaningful ways to address the world’s most pressing challenges.”
The company also strengthened its collaboration with major biopharma companies, using LQMs to identify new biomarkers and optimize clinical development for investigational medicines. Furthermore, SandboxAQ introduced a new generative AI application, IDOLPro, which enables the rapid design of drug molecules with specific properties, accelerating drug discovery and R&D efforts. Several prominent organizations have joined SandboxAQ’s innovation network, further enhancing AQBioSim’s AI-driven drug discovery capabilities.
According to DelveInsight’s “Artificial Intelligence (AI) In Drug Discovery Market Report”, the global artificial intelligence (AI) in drug discovery market is estimated to advance at a CAGR of 37.67% during the forecast period from 2024 to 2030. The AI in drug discovery market is witnessing positive growth owing to factors such as the rising prevalence of various diseases across the globe, advantages of AI in the pharmaceutical sector, and investments in drug research and development, among others. In addition, extensive partnerships and collaborations between public and private entities at the both national and international levels are further expected to boost the AI in drug discovery market during the forecast period from 2024 to 2030.
