Merit Med Sys Inc Stock Price, News & Analysis

Merit Medical (NASDAQ: MMSI) said CMS has deferred consideration of its Transitional Pass-Through incremental payment application for the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) to the CY 2027 Outpatient Prospective Payment System, making Jan 1, 2027 the earliest possible effective date. Merit has withdrawn the TPT application and will begin full U.S. commercialization immediately. The company reiterated a 2025 U.S. revenue forecast of $2 million to $4 million for WRAPSODY CIE and cited 24-month efficacy results from its WRAPSODY WAVE Trial as a commercial differentiator. The device has FDA PMA (Dec 19, 2024), Health Canada approval (Apr 30, 2025), CE mark, and availability in Brazil.

Merit Medical (NASDAQ: MMSI) reported 24-month randomized AVF arm results from the WAVE trial showing the WRAPSODY Cell-Impermeable Endoprosthesis (CIE) had superior durability versus PTA.

Key results: target lesion primary patency (TLPP) 48.6% vs. 29.8% (p<0.0001) and access circuit primary patency (ACPP) 31.3% vs. 20.6% (p=0.003) at 24 months in 245 randomized hemodialysis patients across 43 centers. The device has US FDA premarket approval (Dec 19, 2024), Health Canada approval (Apr 30, 2025), CE mark, and availability in Brazil.

Merit Medical (NASDAQ: MMSI) reported 24-month efficacy from the non-randomized AVG cohort of the WAVE trial on Nov 3, 2025. The WRAPSODY CIE achieved a 6-month TLPP of 81.4% versus a 60% performance goal (p<0.0001). At 12 and 24 months TLPP was 60.2% and 41.7%, respectively; access circuit primary patency (ACPP) was 36.2% at 12 months and 25.7% at 24 months. The dataset includes 112 AVG patients across 43 centers; WRAPSODY holds FDA PMA (Dec 19, 2024) and Health Canada approval (Apr 30, 2025).

Merit Medical (NASDAQ: MMSI) reported Q3 2025 revenue $384.2M, up 13.0% year-over-year (constant currency +12.5%).

GAAP net income was $27.8M (GAAP EPS $0.46, down 3.0%), while non-GAAP net income was $54.9M (non-GAAP EPS $0.92, up 6.7%).

Gross margin improved to GAAP 48.5% and non-GAAP 53.6%. Free cash flow for the first nine months was $141.6M, up 17.6% YoY. Cash totaled $392.5M with total debt of $747.5M and ~$697M available borrowing capacity as of Sept 30, 2025.

Merit raised its 2025 guidance to $1.502–$1.515B revenue (11%–12% growth) and non-GAAP EPS $3.66–$3.79.

Merit Medical (NASDAQ: MMSI) signed a definitive asset purchase agreement to acquire the C2 CryoBalloon device and related technology from Pentax of America, a PENTAX Medical subsidiary, with closing expected in Q4 2025. Total consideration is $22 million ($19 million cash at closing plus up to $3 million contingent).

Merit expects the assets to contribute ~$1 million revenue from a projected Nov 1–Dec 31, 2025 closing, and to add approximately $6–8 million revenue for the twelve months ending Dec 31, 2026. The company said the deal will initially be dilutive to 2025 and 2026 earnings but is projected to be accretive thereafter.

PENTAX Medical announced on October 15, 2025 an asset purchase agreement selling the C2 CryoBalloon™ technology to Merit Medical Systems (NASDAQ: MMSI). The C2 CryoBalloon, part of PENTAX Medical's therapeutic portfolio since 2017, provides controlled cryotherapy for Barrett's Esophagus and related GI disorders.

Under the agreement, Merit will integrate C2 into its Endoscopy portfolio, transfer product manufacturing to its facility in South Jordan, Utah, and hire several PENTAX Medical employees to support continuity. PENTAX Medical said the sale lets it sharpen focus on its core business of flexible reusable endoscopy and deepen clinical partnerships.

Merit Medical Systems (NASDAQ: MMSI) will report third quarter 2025 results for the period ended September 30, 2025 after market close on Thursday, October 30, 2025.

The company will host an investor conference call the same day at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, 2:00 p.m. Pacific). Investors must pre-register for dial-in details; a live webcast and slide deck will be available on Merit’s investor website at www.merit.com. The press release lists media and investor contacts and notes Merit employs approximately 7,400 people and has a sales and clinical support team totaling more than 800 worldwide.

Merit Medical Systems (NASDAQ: MMSI) has announced a significant milestone for its SCOUT® Radar Localization technology, which has now been used to treat 750,000 patients worldwide. The wire-free, non-radioactive localization system helps physicians precisely target and remove abnormal breast tissue with accuracy of +/- 1mm.

The company recently introduced SCOUT MD™, a next-generation system featuring four distinct reflector shapes for improved tumor margin mapping. SCOUT technology has been implemented in over 1,100 facilities across 50 countries, with more than 500 cases performed daily and approximately 10,000 cases monthly. The system has been featured in over 100 clinical publications covering nearly 8,500 patients.

Merit Medical Systems (NASDAQ: MMSI) has received CE Mark approval for its Embosphere® Microspheres for use in genicular artery embolisation (GAE) to treat knee osteoarthritis in the European Union. This expanded indication targets a significant market, as osteoarthritis affects approximately 595 million people globally, with the knee being the most commonly affected joint.

Clinical data demonstrates that over 75% of patients treated with Embosphere for GAE achieved clinical success with significant pain reductions sustained through 24 months. The treatment showed superior results compared to corticosteroid injections, with greater improvements in pain and quality of life at 3 months. Embosphere has been used to treat more than 800,000 patients worldwide and has been studied in over 130 pivotal clinical articles over its 25-year history.