Urology in North Carolina

Urethrotech Inc. manufactures the Urethral Catheterization Device (UCD®), an FDA 510(k)-cleared, CE-marked medical device designed to address difficult or failed male urethral catheterization. The UCD® is a ready-to-use, non-traumatic catheterization solution featuring an integrated hydrophilic Nitinol guidewire integrated into a standard 16F silicone 3-way Foley catheter. The guidewire is inserted first to safely bypass anatomical obstructions (such as enlarged prostate lobes) before catheter placement, then removed after successful catheterization. The device is indicated as a second-line option in emergency departments and other high-risk clinical settings where standard catheterization has failed or is anticipated to be difficult. Clinical evidence demonstrates significant reductions in referrals (100% to 17%), major complications (54% to 17%), and per-patient costs (50% reduction). The company holds ISO 13485:2016 certification and provides comprehensive clinical education including on-demand training videos, live demonstration sessions, and free e-learning courses on advanced male urethral catheterization. Urethrotech serves hospitals, emergency departments, and clinical settings across the US, offering procurement support, sample evaluation programs, and structured in-service education to ensure safe and appropriate device use by qualified healthcare professionals.

Sonablate Corp. manufactures the Sonablate® HIFU (High-Intensity Focused Ultrasound) system, an FDA-cleared minimally invasive device for focal ablation of prostate tissue. The system provides customizable focal therapy with robotic accuracy and real-time ultrasound feedback, positioned as a precision alternative between active surveillance and surgery or radiation. The device incorporates multiple safety features including Tissue Change Monitoring, Total Acoustic Power tracking, and Reflexivity Index Monitoring to enable physician-controlled, safe ablation procedures. Sonablate HIFU received FDA clearance as the first focused ultrasound device approved for prostate tissue ablation in the United States and is available in more than 50 countries worldwide. The company supports clinical evidence demonstrating medium-term disease control in treated patients and provides educational resources and webinar series to assist healthcare institutions in developing focal therapy programs. The system is restricted to sale by or on the order of a physician per federal law.

Custom Medical Specialties manufactures FDA-registered (1063382), ISO 13485-certified disposable medical devices in a Class 8 cleanroom facility in Pine Level, North Carolina. The company specializes in sterile and non-sterile tubing sets (infiltration, aspiration, injection lines), universal drain bags, and custom pre-assembled procedure kits for IV therapy, urology, plastic surgery, and imaging applications. Products are assembled, packaged, and sterilized in-house with full 21 CFR Part 820 compliance. Beyond standard offerings, the company provides contract manufacturing, private labeling, and custom configurations tailored to healthcare provider specifications. With 30 years of operational experience and relationships with 43,000+ healthcare facilities, Custom Medical Specialties emphasizes supply chain reliability, same-day shipping capability, and direct customer support.

Hydromer, Inc. is a global B2B provider of surface modification and coating solutions, specializing in hydrophilic polymer research, development, and manufacturing. Founded in 1980 and based in Concord, North Carolina, the company is ISO 9001:2015 certified with over 40 years of expertise in creating innovative polymer-based products for medical devices, industrial plastics, and specialized applications. Hydromer offers a comprehensive portfolio of hydrophilic coatings—including UV-curable and thermal-curable systems—tailored for cardiovascular, gastroenterology, neurovascular, ophthalmology, peripheral vascular, and urological devices. The company provides end-to-end services including custom formulation development, contract coating, R&D services, FDA regulatory support, and technology transfer. With a 98% repeat customer rate and support for over 1,000 medical device customers worldwide, Hydromer delivers lubricious, anti-thrombogenic, and performance-enhanced coatings for catheters, guidewires, balloons, stents, endoscopes, and other interventional and diagnostic devices. Global production and service hubs ensure consistent quality and responsive support across Asia and the Americas.