U.S. Pivotal Trial CSR Finalised and PMA Submission Update

• The Clinical Study Report for PolyNovo’s U.S. pivotal randomised controlled trial has been finalised.

• Following updated FDA guidance effective from February 2026, the Company has proactively refined its PMA submission plan, including the sequencing of key manufacturing and validation activities.

• Certain activities originally planned post‑submission will be included to strengthen the submission package, and align with updated regulatory expectations and PolyNovo’s quality standards.

• The PMA submission is now expected before the end of calendar 2026.

• The revised timing does not impact current sales or clinical use of NovoSorb® products.

Frequently Asked Questions

1. What is the PMA submission and why is it important?

A Premarket Approval (PMA) submission is the regulatory pathway required by the U.S. Food and Drug Administration (FDA) to assess the safety and effectiveness of Class III medical devices.

For PolyNovo, a PMA supports an on-label indication for NovoSorb® BTM in full-thickness burns in the United States. Although NovoSorb® BTM is used routinely in the management of difficult burns, a PMA would enable PolyNovo to actively promote use of NovoSorb technology in full-thickness burns to HCPs, hospitals, and payors. A PMA may also support future reimbursement opportunities.

2. What is the status of the PMA submission?

• The Clinical Study Report (CSR) for the pivotal RCT is complete. The Clinical Study Report (CSR) has been finalised based on 12‑month patient follow‑up data, which supports proceeding with the PMA submission.

• Following updated FDA guidance effective from February 2026, the Company has proactively refined its PMA submission plan, including the sequencing of key manufacturing and validation activities.

• The PMA submission is now expected before the end of calendar 2026.

3. When is the PMA submission expected?

The submission timeline has been adjusted to before the end of calendar year 2026 to ensure all elements meet FDA expectations and PolyNovo’s internal quality standards.

4. Why was the timeline adjusted?

Key reasons for the modest extension to the submission timeline include:

• Regulatory expectations

  Quality Management System Regulation (QMSR) requirements came into effect in February 2026. These requirements provide more detailed expectations for submission content, particularly around quality systems.

• Internal review

  PolyNovo undertook a disciplined review of manufacturing and supplier processes to ensure alignment with FDA expectations.

5. Does the timeline change affect the likelihood of approval?

The adjustment is expected to strengthen the overall quality and completeness of the PMA submission.

6. What clinical data will be included in the PMA?

The PMA submission will include data from the U.S. pivotal randomised controlled trial (RCT), which:

• Enrolled 120 patients, with recruitment completed in September 2024

• Was designed with an 18-month follow-up period for all patients, with the PMA submission now expected to include both 12‑month and 18‑month data as a result of the updated submission timeline.

7. Does the timeline change impact PolyNovo’s commercial performance?

No material impact is expected:

• Current revenue and sales of NovoSorb® products are not impacted.

• NovoSorb® products continue to be used by clinicians in accordance with existing approvals, and demand remains strong.

8. What work remains before the PMA submission?

Remaining activities are focused on finalising a complete and review-ready submission package, including:

• Completion, validation and documentation of key manufacturing and supplier processes; and

• Incorporation of the eighteen‑month follow‑up data as it becomes available, consistent with regulatory expectations.

9. What happens after the PMA is submitted?

The FDA review of a Premarket Approval application (PMA) is a four-step review process consisting of:

• administrative and limited scientific review by FDA staff to determine completeness (acceptance and filing reviews);

• in-depth scientific, regulatory, and Quality System review by appropriate FDA personnel (substantive review);

• review and recommendation by the appropriate advisory committee (panel review); and

• final deliberations, documentation, and notification of the FDA decision.

Further information is available on the FDA website here: https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process