Magle Group today announces that its review of available clinical evidence for the use of EmboCept® S in Genicular Artery Embolisation (GAE) for symptomatic knee osteoarthritis demonstrates excellent efficacy and safety, including patient data originating from clinics in Germany and Italy. Based on these findings, Magle Group has commenced compiling the regulatory documentation to seek an extension of indication in Europe for EmboCept® S® for the treatment of GAE.
GAE is a minimally invasive, image-guided treatment that reduces synovial hypervascularity associated with knee osteoarthritis pain. Recent peer-reviewed studies and multicentre protocols report sustained pain reduction and functional improvement with favourable safety profiles, supporting GAE's role as a promising non-surgical option for patients who have not responded to conservative care.
Helena Ossmer Thedius, Chief Marketing & Innovation Officer at Magle Group, commented:
"Today's announcement is an important step in broadening access to a degradable embolic option for patients living with knee osteoarthritis pain. EmboCept® S leverages our proprietary degradable starch microsphere technology, designed to deliver effective, temporary embolisation with an established safety profile. We are now advancing a European regulatory submission for the use of EmboCept® S in GAE and look forward to working closely with clinicians as adoption grows."
Growing clinical need and market potential
Knee osteoarthritis is one of the leading causes of disability worldwide, with hundreds of millions affected, and prevalence rising with ageing populations and obesity. In parallel, healthcare systems are seeing increasing demand for minimally invasive pain-relief interventions. The broader interventional radiology market is projected to grow at ~7% CAGR this decade, and adjacent knee-OA therapeutic segments (e.g., injectables and drugs) are each forecast to expand at ~7-8% CAGR through 2034, highlighting a substantial, fast-growing opportunity into which GAE is emerging. With EmboCept® S already established in embolisation and built on Magle's degradable starch microsphere (DSM)platform, the company believes the product is well positioned to serve the expanding GAE segment as clinical adoption increases across Europe.
Next steps
Magle Group is compiling its European regulatory dossier for the use for EmboCept® S in GAE and will provide updates as the submission progresses.
Contacts
Justin Pierce, CEO, phone +46 (0)70 593 58 21, justin.pierce@maglechemoswed.com
About Us
The Magle Group aims to establish itself as a leader in high-quality life-changing healthcare innovations to meet medical needs through scientific excellence. The Magle Group is founded on strategic acquisitions aimed at driving growth and diversifying risk. Today, the Group includes three operational areas. Magle Chemoswed - a contract development and manufacturing organization (CDMO) with a strong reputation for its high-quality development and manufacturing expertise and Magle PharmaCept - an established sales and marketing company for development and direct sales of the Groups medical technology products. Magle Biopolymers A/S- a specialized manufacturing organization of Dextran technology. Learn more on www.maglechemoswed.com and www.maglegroup.com and www.maglepharmacept.com and www.maglebiopolymers.com
Vator Securities is the Company's certified adviser on Nasdaq First North Growth Market and can be reached at ca@vatorsec.se or +46 (0)8-580 065 99.
