Record Quarterly Revenue and Rapid Growth
Q1 2026 revenue of $563,000 was the company's highest quarterly revenue to date, representing ~136% quarter-over-quarter growth vs Q4 2025 ($238,000) and ~186% year-over-year growth vs Q1 2025 ($197,000). Q1 2026 revenue accounts for approximately 51% of total 2025 revenue ($1.1M).
Very High Gross Margin
Gross profit for Q1 2026 was $479,000, corresponding to a gross margin of 85.1%, indicating attractive unit economics for the RenovoCath device.
Commercial Footprint Expansion
Active commercial cancer centers increased to 16 as of May 2026 (up from 5 at the start of 2025 and 8 at year-end 2025). There are 32 additional centers in evaluation/approval/activation for a total pipeline of 48 centers — described as a quadrupling vs Q1 2025. Management targets 36 active centers by year-end 2026.
Repeat Orders and Physician Adoption
Management reports strong repeat order behavior and physician-to-physician advocacy as adoption drivers; RenovoCath has been used in >750 procedures since initial 510(k) clearance in 2014, supporting durability of commercial traction.
Phase III TIGeR-PaC Trial Nearing Enrollment Completion
As of May 14, 2026, TIGeR-PaC had randomized 106 of 114 required patients (~93%) with 74 of 86 required events observed (~86%). Management expects enrollment closure by end of June 2026 and final data in mid-to-late 2027, which supports site conversions to commercial use.
Successful Financing and Cash Runway
Closed an oversubscribed private placement in March 2026 generating approximately $10.0M in gross proceeds. Cash and cash equivalents were ~$12.4M as of March 31, 2026, providing runway into the second half of 2027 per management.
Reiterated 2026 Revenue Guidance and Q2 Outlook
Management reiterated full-year 2026 revenue guidance of $3.0M–$4.0M and expects Q2 2026 revenue to exceed Q1 2026, driven by expanding active centers and anticipated conversions of Phase III sites.
Scientific Validation and New Investigator-Initiated Trials
A TIGeR-PaC pharmacokinetic sub-study was presented at ASCO-GI showing reduced systemic gemcitabine levels with TAMP/IAG vs IV gemcitabine; the full paper is submitted. Two new IITs (metastatic and borderline resectable pancreatic cancer) have been greenlighted, expanding clinical interest and potential indications.