Core Insights - The publication of a study confirms the clinical value of Cxbladder, emphasizing its importance for payers, providers, and patients who may avoid unnecessary invasive procedures [1][4] - The study's findings will be considered by the Contractor Advisory Committee (CAC) for Medicare reimbursement decisions regarding Cxbladder tests, with a meeting scheduled for February 19, 2026 [1][4] Study Findings - The study demonstrated that Cxbladder Triage significantly reduced cystoscopy and imaging procedures for low and intermediate-risk patients while increasing appropriate procedures for higher-risk patients [2][3] - A total of 3,353 risk-matched patients were evaluated, showing a cystoscopy rate of 3.8% for low probability patients compared to 46.5% in the risk-matched group, and a rate of 73.4% for high probability patients versus 45.7% in the standard care group [6] - Cancer detection rates were similar between Cxbladder Triage patients and standard care patients (0.6% vs 0.7%), indicating that unnecessary procedures were reduced without compromising cancer detection [6] Company Overview - Pacific Edge Limited is a global cancer diagnostics company focused on bladder cancer diagnostic and prognostic tests, headquartered in Dunedin, New Zealand [5] - Cxbladder tests are available in the US, Australasia, Israel, and various markets in Asia and South America, with over 5,000 urologists in the US having ordered more than 130,000 tests [10] - The company has a strong evidence portfolio with over 25 peer-reviewed publications supporting Cxbladder, which is included in the American Urological Association's Microhematuria Guideline [9]

Financial Performance & Capital Raising - Pacific Edge reported a net loss after tax of $29.9 million, a 1.4% increase compared to FY24[22] - Operating revenue decreased by 8.6% to $21.8 million compared to FY24[22] - Commercial tests decreased by 9.9% to 24,642 compared to FY24[22] - Global tests decreased by 11.5% to 28,894 compared to FY24[22] - The company raised $20.735 million in new equity through a Placement of $16.073 million and a Share Purchase Plan (SPP) of $4.662 million[28] Medicare & Reimbursement - Medicare non-coverage in April 2025 impacted US volumes and revenue, with Medicare previously accounting for approximately 61% of revenue in FY25[21, 46] - A draft price for Triage Plus of US$1,018 per test was published by CMS, which could improve unit economics if Medicare coverage is re-established[26, 75, 77] - The company is seeking re-coverage via LCD reconsideration and Medicare appeals, with positive engagement with Novitas to restore coverage for Triage and Monitor[47] Clinical & Commercial Strategy - Cxbladder Triage was included in the American Urological Association (AUA) Microhematuria guideline, providing clinical validation and driving commercial payer opportunities[26, 35] - US commercial volumes in 2H 25 increased 2.7% against 1H 25, supported by contracted payer volumes[61] - Non-Medicare volumes represented 47% of US commercial volumes (~9,366) in FY 25, compared to 40% (~5,358) in 1H 24[61] - The company is investing in innovation and product development for IVD kits to support entry into international markets[29]