Medical University of South Carolina
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Private
- Established
- 1955-01-01
- Employees
- 10K
- Market Cap
- -
- Website
- https://www.muschealth.com
Home Administration of Long-Acting HIV Injectable Therapy Proves Safe and Effective as Clinic Treatment
• A study by the Medical University of South Carolina demonstrates that home administration of long-acting injectable antiretroviral therapy (ART) for HIV patients is as safe and effective as clinic-based administration.
• Researchers found no differences in safety, efficacy, or patient satisfaction between home and clinic settings, with all patients achieving viral suppression after 12 months of treatment.
• The home administration option could potentially address transportation barriers that prevent approximately 3.6 million Americans from receiving needed medical care, though insurance reimbursement challenges remain.
Lupus Research Alliance Awards $4.5 Million to Pioneer Next-Generation Cell Therapies for Lupus
• The Lupus Research Alliance has launched its Targeted Research Program on Engineered Cell Therapies for Lupus (TRP-ECT), awarding grants to 11 researchers developing innovative cellular treatments.
• Funded projects include faster CAR T cell production methods, selective targeting of harmful B cells while sparing protective ones, and novel approaches using regulatory T cells and natural killer cells.
• The initiative builds on promising clinical results where CD19 CAR T cell therapy induced complete remission in lupus patients who had failed previous treatments, potentially offering a path to drug-free disease management.
Enspire DBS Therapy Expands Pivotal Stroke Recovery Trial with Second Site Implementation
• Brown University Health successfully implanted the first patient in their center for the RESTORE trial, expanding Enspire's Phase 2/3 study of deep brain stimulation therapy for post-stroke arm weakness.
• The RESTORE trial aims to enroll approximately 40 patients across nine clinical centers, building on promising results from the EDEN proof-of-concept study showing significant motor improvements.
• The study combines deep brain stimulation with rehabilitation therapy, offering new hope for stroke survivors who have plateaued with conventional treatments.
Enhanced Navigation Program Significantly Improves Timing of Post-Surgery Radiation in Head and Neck Cancer
• A novel patient navigation intervention (NDURE) doubled the rate of timely post-operative radiation therapy initiation in head and neck cancer patients, showing a 35% improvement over usual care.
• The intervention successfully reduced racial disparities in treatment delays between Black and white patients, demonstrating potential for improving healthcare equity.
• The scalable program, being validated in a multi-center trial across four major institutions, focuses on patient education, social risk screening, and improved care coordination.
Dental Flossing Associated with 22% Lower Stroke Risk and Reduced AFib in 25-Year Study
• A landmark 25-year study reveals regular dental flossing is linked to a 22% lower risk of ischemic stroke and 44% reduction in cardioembolic stroke risk, independent of other oral hygiene practices.
• Research involving over 6,000 participants demonstrates that flossing is associated with a 12% lower risk of atrial fibrillation, suggesting broader cardiovascular benefits beyond oral health.
• The findings, to be presented at the 2025 International Stroke Conference, highlight flossing as an accessible and affordable preventive measure against serious cardiovascular conditions.
MUSC Launches Clinical Trial for Revolutionary Wire-Free Cochlear Implant System
• The Medical University of South Carolina (MUSC) has been selected as one of seven national sites to test an innovative fully implantable cochlear implant system without external components.
• The novel device features an implantable battery pack in the chest connected to a behind-the-ear cochlear implant, representing the first major innovation in cochlear implant technology in decades.
• Envoy Medical is recruiting 56 patients with profound hearing loss across all study sites to evaluate this groundbreaking technology's safety and effectiveness.
Helius Medical's PoNS Device Exceeds Enrollment Target in Stroke Pivotal Study, Eyes 2025 FDA Submission
• Helius Medical Technologies has surpassed its initial enrollment target for its stroke registrational program, reaching 128 participants by December 31, 2024, and projecting 150 by January's end.
• The study evaluates the Portable Neuromodulation Stimulator (PoNS) for improving balance and gait deficits in stroke survivors, with FDA submission planned for Q2 2025.
• PoNS, already authorized in Canada for stroke, TBI, and MS-related gait deficits, has received FDA Breakthrough Designation, potentially benefiting over 7 million U.S. stroke patients.
• The registrational program includes three studies assessing PoNS's impact on gait, balance, fall risk reduction, and sustained therapeutic effects post-treatment.
Spectral Medical's Tigris Trial Nears Completion with Strong Enrollment
• Spectral Medical's Tigris trial, evaluating Polymyxin B Hemoperfusion (PMX) for endotoxemia and septic shock, has enrolled 146 patients, showing strong progress.
• Enrollment in December 2024 saw improvement as intravenous fluid supply issues eased, contributing to a robust overall enrollment for the year.
• The company projects full enrollment of 150 patients by the end of the first quarter of 2025, moving closer to potential FDA approval.
• PMX has received Breakthrough Device Designation from the FDA and is already approved for use in Japan and Europe, marking a significant step in sepsis treatment.
Study Calls for Optimization of High-Cost IVIG Therapy in BK Nephropathy Treatment
• Research from the Medical University of South Carolina indicates that single-dose IVIG therapy (2g/kg) may be sufficient for clearing BK viral load in nephropathy patients, potentially reducing overall treatment costs.
• Pharmacists play a crucial role in collaborating with healthcare providers to ensure appropriate patient selection and optimal use of high-cost IVIG therapy in BK nephropathy cases.
• Future large-scale studies are needed to identify ideal candidates for IVIG therapy and compare its effectiveness against standard care in BK nephropathy treatment.
Envoy Medical Enrolls First Participants in Pivotal Acclaim Cochlear Implant Study
• Envoy Medical has successfully enrolled the first two participants in its pivotal clinical study for the Acclaim cochlear implant.
• The study aims to evaluate the safety and efficacy of the fully implanted Acclaim device for treating severe to profound sensorineural hearing loss.
• The Acclaim CI, which received FDA Breakthrough Device designation in 2019, leverages the ear's natural anatomy for sound capture.
• Seven investigational sites are participating in the trial, with the goal of securing premarket approval for this innovative hearing solution.
Vagus Nerve Stimulation Shows Promise for Treatment-Resistant Depression
• A large-scale clinical trial reveals that vagus nerve stimulation (VNS) can significantly improve depressive symptoms, quality of life, and daily functioning in individuals with severe, treatment-resistant depression.
• The study, involving nearly 500 participants, showed that VNS therapy led to measurable improvements, even in patients who had previously failed multiple treatments.
• VNS delivers focused stimulation to mood-regulating brain regions and can be used alongside other treatments, offering sustained relief for those who do not fully respond to antidepressants or therapy.
• The RECOVER trial aims to provide data that could lead to health insurance coverage for VNS, making it more accessible for patients with treatment-resistant depression.
TRiCares Announces First U.S. Implantations of Topaz TTVR System in Early Feasibility Study
• TRiCares has successfully implanted its Topaz transcatheter tricuspid heart valve replacement (TTVR) system in the first patients in a U.S. Early Feasibility Study.
• The TRICURE EFS (NCT06506942) will evaluate the safety and performance of the Topaz TTVR system in adults with severe tricuspid regurgitation at increased operative risk.
• The initial implantations were performed at Piedmont Heart Institute and the Medical University of South Carolina, with both patients recovering well post-procedure.
• TRiCares is also progressing with its TRICURE EU Pivotal study in Europe, marking significant steps toward regulatory approvals for the Topaz valve.
Semaglutide Shows Promise in Reducing Alcohol Consumption and Cravings
• A new study reveals that semaglutide, known as Ozempic and Wegovy, significantly reduces alcohol cravings and consumption in individuals with alcohol use disorder.
• Participants on semaglutide experienced fewer heavy drinking days and decreased alcohol intake during lab tests compared to those on a placebo, indicating potential therapeutic benefits.
• The research suggests semaglutide's effects on alcohol cravings may surpass existing treatments, offering a promising avenue for addressing the unmet needs in alcohol use disorder.
• Further studies are warranted to explore semaglutide's long-term efficacy, optimal dosages, and safety, particularly for individuals without obesity or diabetes.
Helix Unveils Model Predicting Semaglutide Weight Loss Response
• Helix presented a precision effectiveness model at ASHG 2024 predicting 12-month weight loss from semaglutide in diverse populations.
• The model uses a polygenic risk score and co-morbid factors like type 2 diabetes and hypertension to predict individual responses.
• Patients in the top quintile of the score were approximately twice as likely to achieve 10% weight loss compared to the bottom quintile.
• The model aims to improve treatment decisions by estimating weight loss expectations and guiding dosage considerations for semaglutide.
New Heart Valve Device at MUSC Offers Safer Treatment for Tricuspid Regurgitation
A groundbreaking heart valve device, TriClip, has been introduced at the Medical University of South Carolina (MUSC), offering a safer and more effective treatment for patients suffering from tricuspid regurgitation. This minimally invasive procedure, approved by the FDA and CMS, marks a significant advancement in treating a condition that has been challenging to manage due to the high risks associated with traditional surgery.
Multi-Site Study to Evaluate Remote vs. In-Person Clinical Trial Methods
• A $2.1 million NCATS grant supports a multi-site study evaluating the effectiveness of remote versus in-person clinical trial methods.
• The study will assess recruitment efficiency, retention rates, and data quality across different conditions like smoking cessation, depression, and opioid addiction.
• Researchers aim to determine if remote methods enhance or hinder the inclusion of underrepresented populations in clinical trials.
• The findings will be disseminated through a web-based toolkit, webinars, and a national conference to inform future trial designs.
Multi-Site Study to Evaluate Remote vs. In-Person Clinical Trial Methods
• A multi-site study has been awarded a $2.1 million grant from NCATS to evaluate the impact of remote versus in-person approaches to clinical trials.
• The study will involve three clinical trials across four locations, focusing on smoking cessation, depression treatment, and opioid addiction.
• Researchers aim to determine if remote methods improve recruitment and representation of underrepresented populations in clinical trials.
• The findings will be disseminated through a web-based toolkit, webinars, and a national conference to inform future trial designs.
Cleveland Clinic to Host Head and Neck Cancer Clinical Trials Symposium
• Cleveland Clinic's Head & Neck Alumni Day on November 22, 2024, will focus on recent clinical trial advancements in head and neck cancer management.
• The symposium will cover contemporary surgical, radiation, and chemotherapy strategies, emphasizing a multidisciplinary approach to treatment.
• Discussions will include the latest clinical trials in curative mucosal squamous cell cancer and innovative trials in non-mucosal head and neck malignancies.
• Attendees will gain insights into diagnosing rare head and neck cancers and making appropriate referral decisions, tailored for various healthcare professionals.
Lack of Approved Therapies Highlights Challenges in Vaping Cessation
• E-cigarettes, initially seen as a smoking cessation tool, have led to a new wave of nicotine addiction, with many users finding it difficult to quit vaping.
• The FDA has not approved e-cigarettes for smoking cessation, and there is a lack of data on effective methods to stop vaping, creating a significant unmet need.
• Achieve Life Sciences is developing cytisinicline, a potential first-in-class medication for vaping cessation, which has received Breakthrough Therapy designation from the FDA.
• Alternative methods like nicotine pouches are being used to wean off vaping, but experts advise a short-term approach to avoid prolonged nicotine dependence.
Biodesix Presents Nodify Lung® Real-World Data and Launches CLARIFY Study
• Biodesix presented real-world data from over 35,000 patients tested with Nodify Lung® Nodule Risk Assessment at the CHEST 2024 Annual Meeting, showcasing its clinical use.
• The presentation highlighted the test's ability to reclassify patients into actionable risk categories, aligning with guideline-recommended diagnostic plans.
• Biodesix also announced the launch of the CLARIFY study to further validate the performance of Nodify CDT® and Nodify XL2® tests in diverse patient subgroups.
• The CLARIFY study aims to collect patient outcomes and clinical information from up to 4,000 patients through retrospective chart reviews.
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