AZD8601 is an investigational, locally administered mRNA therapy that encodes for VEGF-A. EPICCURE is a randomised, placebo-controlled, double-blind, multicenter, 6-month, Phase 2a clinical trial of the safety, tolerability, and exploratory efficacy of epicardial injections of AZD8601 in patients with stable coronary artery disease and moderately decreased LVEF who are undergoing CABG surgery. Exploratory efficacy endpoints comprised left ventricular ejection fraction, NT-proBNP (a biomarker that measures the level of a hormone that is elevated in patients with heart failure), and functional patient-reported outcomes.
Wision AI receives CE Mark approval for AI-powered endoscopy software EndoScreener
Wision AI has secured CE Mark approval to utilise its artificial intelligence (AI)-assisted polyp detection software during colonoscopy, EndoScreener.
EndoScreener is the first solution to secure a CE Mark class II certificate under the new Medical Devices Regulation, MDR 2017/745.
As per the company, the device offers superior benefits in terms of clinical trial evidence compared to previous self-declared class I devices for automatic polyp detection during colonoscopy.
EndoScreener is a real-time diagnosis software, which is beneficial for endoscopists to deliver a visual notification and sound alarm for polyp detection during colonoscopy. It is a software-only medical device (SaMD) with proper off-the-shelf computer hardware and relatively economical total cost of ownership (TCO), as informed by the company. The device is compatible with most mainstream endoscope systems and can be deployed in several clinical environments for colonoscopy.
EndoScreener has shown efficacy in improving adenoma detection on more than 5,000 patients in six randomised controlled trials (RCTs). In a recently published multi-centre tandem colonoscopy trial in the US, the device has decreased 41% precancerous lesion miss rate and improved 33% adenoma per colonoscopy (APC). No ceiling effect was observed, even with a high average adenoma detection rate (ADR) of 43.64% in the screening of the population under the standard of care.
Getinge acquires medical device company Verrix
Getinge, a provider of products and solutions to hospitals life science institutions, has taken over US-based medical device company Verrix for an undisclosed sum. Based in San Clemente, California, Verrix has developed a rapid biological indicator system for initial application in the operating room’s steam sterilisation workflow. Verrix will utilise advanced technologies to protect patients from healthcare-associated infections.
Getinge surgical workflows president Stéphane Le Roy said that there is an increasing need for biological indicators from healthcare institutions worldwide, and what Verrix has developed in this field is truly amazing, setting new standards of speed and accuracy.
Using scientific expertise and establishing partnerships with healthcare professionals, Verrix zeroes in on developing advanced solutions for sterility assurance, environmental monitoring, and infection control. Originally discovered at NASA’s Jet Propulsion Laboratory, the foundational sterility assurance technology incorporates advanced optical physics, chemistry spectroscopy, and molecular biology.
Verrix CEO Sami El-Saden said they are excited to be part of the Getinge team. This transaction strategically gets their global market entry into the hospital sterility monitoring segment.
They believe that Verrix’s EVA platform will also allow the development of future biological indicators to augment Getinge’s expertise and commercial offerings across the healthcare and life science segments.
LumiThera buys modern visual electrophysiology solutions provider Diopsys
Commercial stage medical device firm LumiThera has agreed to purchase current visual electrophysiology medical devices provider Diopsys for an undisclosed sum.
As part of the agreement, Diopsys stockholders will receive stock in LumiThera, and Diopsys will operate as a wholly-owned subsidiary of LumiThera.
Diopsys’s modern visual electrophysiology medical devices will allow eye care professionals to evaluate the complete visual pathway for visual and neuro-visual disorders.
The firm offers visual evoked potential (VEP) and ERG vision testing technology. Its product portfolio comprises Diopsys NOVA, Diopsys ARGOS, Diopsys RETINA PLUS ERG and VEP Vision Testing System series, and the Enfant Paediatric VEP Vision Testing System.
Diopsys CEO Joe Fontanetta said that Diopsys ERG testing is a robust and quantitative diagnostic, coupled with LumiThera’s PBM treatments to characterise early patient benefits on visual function. The acquisition will allow LumiThera to add a complementary diagnosis and monitoring platform to its treatment platform using Photobiomodulation (PBM) for ocular disease and damage.
Electroretinography (ERG) is a diagnostic test developed to gauge the electrical activity of the retina in response to a light stimulus. Diopsys, in combination with Diopsys, is anticipated to have a tremendous ophthalmology/optometry customer base.
LumiThera has recruited 100 subjects in the US LIGHTSITE III dry Age-related Macular Degeneration (AMD) trial during the first quarter of this year.
The company is continuing the trial to reach the 13-month efficacy time point for all patients, which is anticipated in the first quarter of next year.
At the start of this year, LumiThera and Diospys disclosed final positive topline data from the ELECTROLIGHT pilot study in intermediate Dry Age-related Macular Degeneration (AMD) patients.
In the trial, a total of 23 eyes from 15 patients with AMD were treated with PBM using the Valeda Light Delivery System. It assessed the Diopsys NOVA ERG system.
