NextBiomedical’s artery-blocking device, Nexsphere-F, has significantly improved outcomes in patients with knee osteoarthritis in a European clinical study – a move the company says takes it closer to establishing the solution as a standard of care (SoC) in genicular artery embolisation (GAE).
During a prospective observational study conducted by researchers at the Charité – Universitätsmedizin Berlin hospital, results of which were published in the journal Radiology, 194 non-responders to corticosteroids or hyaluronic acid injections who received treatment with NextBiomedical’s gelatin-based, fast-resorbable microspheres experienced a mean 57% reduction in knee osteoarthritis pain.
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Over 239 procedures, patients also experienced statistically significant improvements in key measures of knee injury and osteoarthritis outcomes, while around 80% of patients passed the bar of minimum clinically important difference following treatment with Nexsphere-F.
The device also triggered no moderate-to-severe treatment-related adverse events (TREAs).
NextBiomedical will likely welcome these results, as the South Korea-based company looks to Nexsphere-F’s role in clinical care across geographies like Europe, where the device currently holds a CE Medical Device Directive mark.
In a bid to secure a potential place on the US knee osteoarthritis market, NextBiomedical is also testing Nexsphere-F through the RESORB clinical trial (NCT06872567), which is currently ongoing and will enrol around 126 patients, according to ClinicalTrials.gov.
The potential of microspheres in osteoarthritis
In recent years, osteoarthritis has become an increasing burden on both patients and healthcare systems alike, with the condition now impacting approximately 7.6% of the global population – with total cases up 132.2% since 1990, according to a paper published in The Lancet Rheumatology.
Parallel to development efforts in the pharmaceutical space, the medtech sector has also been looking for novel ways to improve outcomes and patient quality of life. NextBiomedical hopes to achieve this through GAE, which is designed to reduce pain by blocking abnormal, excess blood vessels growing in the inflamed lining of the knee joint through the injection of resorbable microspheres.
Unlike most microsphere-based approaches such as Siemens Healthineers-owned Varian’s Embozene, which tend to harness permanent particles that have previously been linked to high rates of skin discolouration in up to 65% of cases, Nexsphere-F has only been linked to transient skin discolouration present in 6.3% of procedures – with this side effect resolving within 24 hours.
Outside of microsphere-based approaches, Contura’s non-degradable hydrogel, Arthrosamid, has demonstrated its potential as a minimally invasive, long-term solution that can help reduce pain and stiffness in patients with knee osteoarthritis.
