Real-world data from the largest U.S. Lyme disease registry, MyLymeData, shows current clinical trials for persistent Lyme disease (PLD) systematically exclude most patients who are clinically diagnosed with the condition. A groundbreaking analysis of over 4,000 patients reveals that 9 out of 10 people with PLD are barred from participating in clinical trials, primarily due to outdated eligibility criteria. The impact is severe. Nearly two million Americans live with PLD, with 72% reporting poor or fair health—compared to just 13% of the general population. These patients also face elevated suicide risk. Key findings: Most exclusions stem from co-existing tick-borne infections or previous misdiagnoses of chronic fatigue syndrome or fibromyalgia Relaxing unnecessary restrictions could increase patient enrollment from 10% to 64% This is the first real-world data analysis of PLD trial criteria, despite FDA’s 2018 recommendation to broaden eligibility across all… 

Concept Medical Inc., a global leader in innovative drug-delivery technology, proudly reports positive outcomes from the SIRONA (Head-to-Head Comparison of SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery) RCT, which show that its sirolimus-coated balloons (SCB) (MagicTouch -PTA) provide patency and functional benefits on par with paclitaxel-coated balloons for patients suffering from peripheral artery disease (PAD). The 1-year data was presented by Principal Investigator Prof. Ulf Teichgräber at the TCT USA 2024 conference in a Late–Breaking Clinical Trials Session (LBCT). Coverage by TCTMD has highlighted these findings, underscoring sirolimus-based therapy as a viable new option in femoropopliteal interventions. The prospective, multi-center, head-to-head, core lab adjudicated RCT enrolled a total of 482 patients across 25 sites in Germany and Austria and compared the MagicTouch PTA sirolimus-coated-balloon against 7 commercially available paclitaxel-coated-balloons.

GORTEC, known as Head and Neck Radiation Oncology Group, today announced that the randomized Phase 3 NIVOPOSTOP GORTEC 2018-01 trial evaluating nivolumab, Bristol Myers Squibb’s anti-PD-1 therapy, as a post-operative treatment component for resected patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN), with high risk of relapse met its primary endpoint of Disease-Free survival (DFS) across all comers.  The study evaluated after surgery the addition of nivolumab to standard-of care (SOC) radiotherapy and cisplatin, compared to SOC radiotherapy and cisplatin alone. At a pre-determined number of DFS events, there was a statistically significant and clinically meaningful improvement in DFS for patients receiving nivolumab. The safety profile of nivolumab was consistent with that reported in previous studies, and the compliance to SOC treatments was similar between the 2 arms of the study.

Funding will continue supporting VAPOR 2 pivotal clinical study and U.S. commercialization of Vanquish Water Vapor Ablation proprietary prostate cancer treatment MINNEAPOLIS, Jan. 7, 2025 /PRNewswire/ — Francis Medical, Inc., a privately-held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney and bladder cancer, today announced the completion of the company’s oversubscribed $80 million Series C equity financing, the largest fundraising round to date for the company. Arboretum Ventures and Solas BioVentures co-led the Series C round. New investors Orlando Health Ventures and two additional strategic partners joined this round, along with previous investors Coloplast A/S and Tonkawa. The Series C proceeds will continue to fund the VAPOR 2 pivotal clinical study for the management of prostate cancer and the development and U.S. commercialization of its Vanquish Water Vapor Ablation proprietary…