Anteris raises $320M, launches U.S. PARADIGM Trial, exits going-concern status

Filed May 12, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 13, 2025 · ~2 min read

Key Changes

• high

  January 2026 capital raise of $320M (public offering plus Medtronic private placement at $5.75/share) increased cash from $49M to $283M, eliminating going-concern disclosure and extending runway beyond 12 months.

  MD&A: Liquidity verify on EDGAR →
• high

  PARADIGM Trial secured FDA IDE approval (Nov 2025) and CMS Medicare reimbursement (Apr 2026), enabling first U.S. patient enrollments in May 2026 after European launch in Oct 2025.

  MD&A: Clinical Development verify on EDGAR →
• high

  Material weaknesses in financial controls remain unremediated as of Dec 2025, but remediation advanced to implementation and testing phase with enhanced segregation of duties, system automation, and formal documentation now complete.

  Controls and Procedures verify on EDGAR →