HAIC with FOLFOX Plus Camrelizumab and Sorafenib Shows Limited Efficacy in Advanced HCC
• A phase II trial investigating hepatic artery infusion of FOLFOX chemotherapy plus camrelizumab combined with sorafenib in BCLC stage C hepatocellular carcinoma failed to meet its primary endpoint, showing a modest 44% objective response rate.
• The treatment demonstrated a manageable safety profile with grade ≥3 treatment-related adverse events in 76% of patients, primarily including decreased lymphocyte count (52%) and elevated liver enzymes (44%).
• In contrast, a separate trial combining HAIC with camrelizumab and apatinib as conversion therapy for unresectable HCC showed promising results with a 73.7% conversion rate and 47.4% R0 resection rate.
FDA Approves Terumo Neuro's First-in-Class Dual-Layer Micromesh Carotid Stent System
• Terumo Neuro has received FDA Premarket Approval for its innovative Carotid Stent System, marking the first dual-layer micromesh carotid stent approved for use in the United States.
• The device is indicated for treating carotid artery stenosis in high-risk patients, specifically those with ≥50% stenosis if symptomatic or ≥80% stenosis if asymptomatic, offering a new alternative to carotid endarterectomy.
• The stent system accommodates vessel diameters between 3.5mm and 9.0mm at the target lesion, providing physicians with a clinically proven option to improve outcomes in carotid artery disease treatment.
IceCure Medical Sees Sales Surge and Awaits FDA Decision on ProSense for Breast Cancer
• IceCure Medical reported a 42% increase in North American sales of its ProSense cryoablation system in 2024, signaling growing adoption for breast tumor treatment.
• The company anticipates an FDA decision on ProSense for early-stage breast cancer in Q1 2025, following positive advisory panel feedback based on the ICE3 study.
• ICE3 study results showed a 96.3% recurrence-free rate and 100% patient/physician satisfaction, aligning with lumpectomy outcomes for early-stage breast cancer.
• Interim results from the ICESECRET kidney cancer study demonstrated an 88.7% recurrence-free rate, highlighting ProSense's potential in treating kidney cancer.
Orchestra BioMed's BACKBEAT Trial Launch Drives 40% Stock Surge Amid Promising Cardiovascular Pipeline
Orchestra BioMed Holdings has initiated patient enrollment for its pivotal BACKBEAT study evaluating AVIM therapy for hypertension in pacemaker patients, driving a 40% increase in stock value. The company's strong clinical progress, backed by strategic partnerships with Medtronic and Terumo Corporation, positions it well in the expanding cardiovascular therapeutics market projected to reach $540 billion by 2029.
R3 Vascular Secures $87 Million in Series B Financing and Appoints New CEO
R3 Vascular Inc., a medical device company focused on developing bioresorbable scaffolds for peripheral arterial disease (PAD), has announced the completion of an $87 million Series B financing round. The funding, led by Deerfield Management, will support the ELITE FDA IDE pivotal trial of its MAGNITUDE® bioresorbable scaffold for below-the-knee PAD, alongside R&D, regulatory submissions, and manufacturing scale-up. Christopher M. Owens has been appointed as the new President and CEO, bringing over three decades of medical device industry experience to the role.
IceCure Medical CEO Highlights 2021 Achievements and 2022 Objectives
IceCure Medical Ltd. CEO Eyal Shamir outlines the company's 2021 achievements, including progress in the ICE3 clinical trial and expansion of the ProSense® system's global distribution network, and sets key business objectives for 2022, focusing on regulatory clearances and the development of next-generation cryoablation systems.
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