Imricor jumped 19pc after ethics approval to commence cardiac arrest study. Picture Getty
Health & Biotech
Medical devices company Imricor Medical Systems (ASX:IMR) jumped 19% this morning after being granted an ethics approval to begin the VISABL-VT trial at Haga Hospital in The Hague, Netherlands.
The VISABL-VT trial will study the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia (VT) when performed with IMR’s Vision-MR Ablation Catheter 2.0 device in a real time iMCR cardiac environment.
The study calls for treating 64 patients and includes a six-month follow-up for each patient.
Imricor’s chair and CEO, Steve Wedan, said this is a major milestone for Imricor that brings the company one step closer to treating ventricular tachycardia with ablation procedures guided by real-time iCMR.
“Since this is our first clinical trial submission under the new Medical Device Regulations in Europe, we do not have a clear estimate of how long the approval process will take, but we are hopeful that we can begin enrolment before the end of the year,” he said.
Opthea (ASX:OPT) rose 8% today after releasing a presentation on the safety of its drug sozinibercept (OPT-302), an anti-VEGF-C/-D ‘trap’ in patients with retinal vascular diseases.
Opthea says that when combined with any VEGF-A inhibitor, OPT-302 completely blocks VEGFR-2 and VEGFR-3 signaling, inhibiting the most important pathways driving angiogenesis and vascular leakage.
The company also said that analysis of OPT-302 serum pharmacokinetics (PK) of completed studies is important for interpreting safety and efficacy results, and informing dosing for Phase 3 trials.
Opthea currently has two ongoing global pivotal Phase 3 studies in wet AMD (Age-Related Macular Degeneration).
The company holds fast track designation from the US Food and Drug Administration (FDA) for this indication, and sozinibercept is Opthea’s proprietary drug with issued patents running to at least 2034.
Health & Biotech
Health & Biotech
Health & Biotech
