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Nexsen Limited ( (AU:NXN) ) has provided an update.
Nexsen has cleared a major regulatory milestone for its StrepSure® rapid GBS test in the U.S., with the FDA confirming a 510(k) pathway, agreed intended use and validation plan, significantly de-risking its route to market approval. The company is advancing clinical data collection in Australia, preparing to onboard U.S. clinical sites, and progressing toward ISO 13485 certification of its quality management system, a key requirement for medical device manufacturers.
Alongside U.S. progress, Nexsen has launched a global rollout strategy for StrepSure®, prioritising early entry into Hong Kong, Malaysia, India and selected emerging markets while U.S. approval is pursued. Backed by two non-dilutive government grants totalling about A$1.7 million this quarter and over A$13 million to date, the company plans to establish Hong Kong as its Asia-Pacific manufacturing and distribution hub and to expand StrepSure® into neonatal diagnostics, broadening its clinical footprint and strengthening its competitive position in rapid diagnostics.
More about Nexsen Limited
Nexsen Limited is an ASX-listed medical technology company focused on diagnostic solutions for infectious diseases, with its lead product StrepSure®, a rapid point-of-care lateral flow test for Group B Streptococcus in pregnant women and newborns. The company is targeting global healthcare markets, with a particular focus on the U.S., Asia-Pacific, and other emerging regions where faster bedside diagnostics can address critical gaps in neonatal and maternal care.
Average Trading Volume: 386,508
Technical Sentiment Signal: Strong Buy
See more data about NXN stock on TipRanks’ Stock Analysis page.