Joining the podcast today is Mark Muzzin, Managing Director, Nexsen, ASX:NXN. Mark will speak about the recent FDA feedback on StrepSure®, the company’s global rollout strategy, and the pathway toward regulatory submission and initial commercialisation.

Podcast Questions

Introduction to company 1. Nexsen is developing rapid point of care diagnostics, can you outline the core focus of the business and the unmet need you are targeting in healthcare?

Strategy 2. With the FDA pre submission feedback now received, how does this shape your regulatory and commercial strategy for StrepSure® moving forward?

Flagship Projects 3. StrepSure® is your lead diagnostic product, what differentiates it from current lab based testing methods and why is this clinically important?

Market Dynamics 4. Group B Streptococcus screening is integrated into standard prenatal care, how does this existing framework support adoption of StrepSure®?

Growth Opportunity 5. With an estimated 132 million births annually, how do you view the scale of the global opportunity for StrepSure®?

Community Engagement 6. You are working with hospitals, CROs and clinical partners across multiple regions, how important are these relationships in supporting validation and adoption?

Financial Position 7. With multiple workstreams progressing across clinical, regulatory and commercial activities, how are you managing execution to support consistent milestone delivery? I

ndustry Collaboration 8. How does engagement with regulators such as the FDA and partnerships across different jurisdictions strengthen your pathway to market?

Upcoming Milestones 9. Looking ahead, what are the key milestones investors should focus on over the coming months, particularly around clinical trials, QMS audits and regulatory submission timing?

Vision of Success 10. As StrepSure® progresses toward commercialisation, how does this product validate the broader diagnostic platform and future pipeline?