Professor Shekhar Kumta Joins Nexsen Board Ahead of FDA Submission
Nexsen Limited has appointed internationally acclaimed surgeon-scientist Professor Shekhar Kumta to its board, aiming to fast-track clinical validation and regulatory approval for its rapid diagnostic platforms ahead of a planned 2026 market entry.
- Appointment of Professor Shekhar Kumta as Non-Executive Director
- Enhances Nexsen’s clinical, regulatory, and commercial capabilities
- Strengthens access to major health systems in Hong Kong, UK, India, and Australia
- Supports FDA 510(k) submission and international market-entry strategy in 2H 2026
- Advances GBS Rapid Sensor and Kidney Function Diagnostics platforms
A Strategic Board Addition
Nexsen Limited (ASX – NXN) has bolstered its leadership team with the appointment of Professor Shekhar Kumta, a globally respected surgeon-scientist with over 45 years of experience across Australia, Hong Kong, India, and the UK. His addition as a Non-Executive Director comes at a critical juncture as Nexsen prepares to transition from development to commercialisation of its rapid point-of-care diagnostic technologies.
Professor Kumta’s extensive clinical leadership roles at prestigious institutions such as the Chinese University of Hong Kong and NHS-linked UK hospitals provide Nexsen with invaluable access to influential healthcare networks. This strategic move is designed to accelerate clinical adoption and regulatory engagement across multiple key markets.
Enhancing Clinical and Regulatory Pathways
With the GBS Rapid Sensor and Kidney Function Diagnostics platforms advancing through clinical validation, Professor Kumta’s expertise is expected to significantly strengthen Nexsen’s regulatory strategy. His experience will be pivotal in navigating complex approval processes, including the anticipated FDA 510(k) submission, positioning Nexsen for international market entry in the second half of 2026.
His appointment also signals a commitment to embedding clinical insights directly into product development and commercial execution. This alignment is crucial for ensuring that Nexsen’s diagnostics meet real-world clinical needs and gain acceptance among frontline healthcare providers.
Unlocking Global Market Access
Professor Kumta’s longstanding relationships with clinicians and hospital groups across Hong Kong, India, and the UK offer Nexsen immediate entry points for early evaluation and commercial discussions. These connections are particularly valuable in maternal health and renal medicine, where Nexsen’s rapid diagnostics aim to address significant unmet needs.
The company’s focus on delivering lab-grade, rapid diagnostic results at the point of care promises to transform patient management in conditions such as Group B Streptococcus infections and kidney diseases affecting hundreds of millions globally. By enabling faster, decentralised testing, Nexsen’s platform could reduce delays in diagnosis and improve clinical outcomes.
Looking Ahead
Nexsen’s leadership is confident that Professor Kumta’s appointment will accelerate the company’s momentum toward global commercial rollout. As the company prepares for scaled manufacturing and expanded clinical partnerships, this enhanced board expertise will be instrumental in navigating the challenges of international market entry and sustained growth.
Bottom Line?
With Professor Kumta on board, Nexsen is poised to turn clinical promise into global market reality by 2026.
Questions in the middle?
- How will Professor Kumta’s networks influence Nexsen’s early clinical trial sites and partnerships?
- What are the key milestones and timelines for Nexsen’s FDA 510(k) submission and regulatory approvals?
- How will Nexsen’s rapid diagnostics compete with existing solutions in maternal and renal health markets?
