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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

Medtronic Announces Clinical Studies Are Underway for 2 Additional Indications for Hugo™ RAS System in the U.S.

The Hugo™ RAS system is not cleared or approved in all markets. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the U.S., the Hugo™ RAS system is an investigational device not for sale.

Neuros Medical Reports: | Landmark Study of a Revolutionary Device for the Treatment of Post Amputation Pain Accepted for Publication in the Journal of...

Neuros Medical advises the study, which enrolled 180 patients with a unilateral lower limb amputation across 35 sites in the U.S., is the largest prospective, double-blinded, randomized study ever conducted for treatment of chronic post-amputation pain.

Inflammatory Acne, Acinonyx Bio, & Benzoyl Peroxide

“Lindys Health’s involvement in this study underpins our commitment to helping our partners bring safe and effective dermatological therapies to market. Inflammatory acne can significantly diminish quality of life,” states Michael Young, co-founder of Lindus Health. “We are enthusiastic about the opportunity to leverage our unique technical and service-based capabilities in another dermatology study, building on our vast experience in this space.”

Gameto Reports: New Data Demonstrating Clinical-Grade Manufacturing of In Vitro Maturation Solution for Fertility Care

"This study highlights the core underlying mechanism of action of our ovarian support cells in maturing eggs outside of the body and provides a deeper look into the role that Fertilo plays in promoting high quality egg maturation for IVF treatment," said Dr. Christian Kramme, Chief Scientific Officer of Gameto.

Avenda Health Reports: New Study Demonstrates Avenda Health’s Unfold AI to Better Predict Focal Therapy Success by 77% Percent as Compared to Standard Methods

"These results demonstrate a marked change in how physicians will be able to diagnose and recommend treatment for prostate cancer patients," said Avenda Health CEO Shyam Natarajan, PhD. "By increasing the confidence in which we can predict a tumor's margins, patients and their doctors will have increased certainty that their entire tumor is treated and with the appropriate intervention in correlation to the severity of their case."

Coya Therapeutics Presents Updated ALS Biomarker Data at the 2nd Annual Johnson Center Symposium

The data presented highlights the strong predictive value of oxidative stress biomarker (4-HNE) levels with the rate of disease progression and survival in ALS patients from a longitudinal patient registry cohort.

Sedana Medical Completes Patient Recruitment for INSPiRE-ICU 1 Clinical Trial in the US

Peter Sackey further elaborated: "Once the 30-day follow-up of all patients is complete, we will enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months will be collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results in the autumn of this year and a swift regulatory submission in Q1, 2025".

Unlocking New Hope: Alzheimer’s Patients Join Amyloid-Targeting Therapy Study

The study is designed to assess the clinical utility and workflow benefits of Swoop® system images acquired at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy at the times specified in the labeling (before the fifth, seventh, and fourteenth infusions).

Indaptus Therapeutics Presents Positive Mechanism of Action Data at the American Association for Cancer Research Annual Meeting

Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”

Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preliminary safety profile consistent with its highly selective design. Not only did all evaluable patients have improved or stable BCR::ABL1 transcript levels, but, importantly, 89% of all patients enrolled remain on study. We believe the initial data demonstrate the potential clinical utility of ELVN-001 for all types of patients, including those that are earlier in the treatment paradigm.”
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Recent News

Shoulder Innovations Further Strengthens IP Portfolio in Key Areas with Recent Patent Grants

"These recent grants further strengthen key patent families that are foundational to our technology, and we are pleased the USPTO continues to recognize our meaningful innovation in the shoulder arthroplasty segment," said Rob Ball, CEO of Shoulder Innovations. "This noteworthy expansion of our IP position represents the culmination of over 10 years of research and development, and we are proud of our team for their continued dedication to creating practical solutions for shoulder surgeons and advancing patient outcomes."

Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting

This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors, which will be used to scale the company and expand the Radical platform notes Radical Catheter Technologies.

Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution

“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking for technologies that increase the clinical possibilities and safety for the patient, we want Rapid to be the first place they look.”