URO-1

What URO-1 does

URO-1, Inc. is an early-stage medical device company that develops biopsy instruments and tissue transfer systems for urology, with primary focus on prostate cancer diagnostics. Founded by serial entrepreneur Ted Belleza following his personal prostate biopsy experience, the company is headquartered in Greensboro, North Carolina, and operates with a small team of 1-10 employees. The company targets hospital systems, urology practices, interventional radiology departments, and GU pathology labs that face challenges with inadequate tissue yield, fragmentation, tortuosity, and downstream diagnostic delay in soft tissue biopsies.

The company's product platform consists of two FDA-cleared technology lines. The SUREcore® family of biopsy needles is built on a patented coaxially centered needle design that virtually eliminates needle deflection; the family includes the single-use disposable SUREcore® Needle (18-gauge, 22/25cm), the reusable SUREcore® Prime handpiece, and the fully integrated single-use SUREcore® Plus instrument. The coreCARE® tissue transfer system uses a 'Touch and Go' cradle to minimize tissue handling, preserve specimen integrity, and prevent fragmentation during transfer and grossing. The combined SUREcore/coreCARE platform has been clinically validated in over 3,000 prostate biopsy cores, demonstrating approximately 11% greater tissue volume in transrectal ultrasound-guided procedures and 21% greater volume in transperineal biopsies versus standard of care, 72% intact samples vs. 40% for standard of care, and 60% straight (low tortuosity) samples vs. 41%. Clinical data has been presented at AUA 2022, 2023, and 2025, USCAP 2025, and the Society of Interventional Oncology 2025.

URO-1 generates revenue through direct hardware sales of its FDA-cleared biopsy instruments and tissue transfer systems to healthcare providers and hospital systems. Its go-to-market is enterprise field sales, currently anchored on Novant Health hospitals across North Carolina and South Carolina, with stated expansion plans targeting additional U.S. hospital systems, military hospitals, VA medical centers, and international markets. The company is a portfolio company of the North Carolina Biotechnology Center, is led by an experienced team with multiple prior medical device exits, and has raised approximately $12.1M in disclosed equity financing to date across rounds in 2017, 2020, and 2024.

Name

URO-1

Legal name

URO-1, Inc.

Website

https://uro1medical.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

URO-1, Inc. is an early-stage medical device company developing FDA-cleared SUREcore® biopsy needles and coreCARE® tissue transfer systems for prostate cancer diagnostics, serving hospital systems, urology practices, interventional radiology, and GU pathology departments.

Ownership category

akta.pro rank

Product category

Urology Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Endoscopic Therapeutic & Access Devices (Trocars, dilators, biopsy/ablation tools) (HLAHADAN)

akta.pro secondary industry

General Urology (HLAKAOAA)

Keywords

• Prostate biopsy devices
• Biopsy needle systems
• Tissue transfer devices
• Urology medical instruments
• Soft tissue biopsy

Headquarters

HQ city

Winston Salem

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Sales: Sale of FDA-cleared biopsy instruments and tissue transfer systems (SUREcore® needles and coreCARE®) to healthcare providers and hospital systems. Revenue generated through product sales for soft tissue biopsies, primarily prostate cancer diagnostics.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

URO-1 develops and sells FDA-cleared SUREcore® biopsy needles and coreCARE® tissue transfer systems for prostate and soft tissue biopsy procedures. The SUREcore product family includes a single-use disposable 18-gauge needle, a reusable biopsy handpiece, and a fully integrated single-use instrument. The coreCARE system is a Touch and Go tissue transfer cradle that minimizes tissue handling. The devices are sold to hospital systems and urology practices, primarily for prostate cancer diagnostics.

Product overview

URO-1 offers a two-product platform consisting of the SUREcore® biopsy needle family and coreCARE® tissue transfer system. The SUREcore® product line includes the SUREcore® Needle (single-use disposable 18ga needle for existing handpieces), SUREcore® Prime (reusable handpiece), and SUREcore® Plus (fully integrated single-use instrument). These FDA-cleared devices are designed to work together with the coreCARE® tissue transfer cradle to improve tissue sampling accuracy, increase tissue volume by 12-21%, reduce fragmentation and tortuosity, and preserve specimen integrity throughout the biopsy and pathology workflow.

Differentiator

Problem solved

Functional benefit

Brands

• SUREcore: Biopsy needle technology platform that produces greater tissue volume and higher quality samples. Includes SUREcore Needle (single use disposable 18ga), SUREcore Prime (reusable handpiece), and SUREcore Plus (single use biopsy instrument)
• coreCARE
• SUREcore Prime
• SUREcore Plus

Products and services

• SUREcore® Needle Single-use, disposable 18-gauge biopsy needle (22cm and 25cm lengths) designed for existing reusable biopsy handpieces. Features a patented coaxially centered design that virtually eliminates needle deflection and produces approximately 11-21% more tissue volume compared to standard of care. Intended for hospital systems and urology practices performing prostate biopsies.
• SUREcore® Prime Reusable biopsy handpiece compatible with SUREcore needles, designed for targeted prostate biopsy procedures. Used by urology departments and interventional radiology for repeated biopsy workflows with disposable needle components.
• SUREcore® Plus Single-use 18-gauge (22cm and 25cm) fully integrated biopsy instrument combining needle and handpiece in one disposable device. Designed for urology practices and hospital systems needing a complete single-use biopsy instrument without reusable handpiece investment.
• coreCARE® Tissue Transfer System Touch and Go tissue transfer cradle system that minimizes tissue handling to preserve specimen integrity. Prevents fragmentation and deformation during transfer, preparation, and grossing for pathology analysis. Used by GU pathology departments and urology practices processing prostate biopsy specimens.

Quantifiable outcome

• 11% greater tissue volume in transrectal ultrasound-guided (TRUS) procedures
• +4 more outcomes

Named customers1 record

Segments5 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• AngioDynamics: Mid-cap interventional medical device company with biopsy and soft tissue sampling products used across hospital systems. Comparable commercial motion to URO-1 with broader product breadth.
• Argon Medical Devices: Specialist in biopsy, drainage, and interventional devices, including prostate biopsy needles (e.g., Tru-Cut, BioPince). Closely comparable to URO-1 in scale, channel, and target customer.

Broad incumbents

• BD (Becton, Dickinson and Company): Global medical device incumbent with a portfolio including core biopsy instruments (e.g., MaxCore, Mission) used in prostate and soft tissue biopsies. Direct overlap with URO-1 in urology biopsy needles, but BD serves many other specialties and modalities.
• Cook Medical: Privately held medical device manufacturer with a leading prostate biopsy needle portfolio (e.g., Quick-Core, Tru-Core) and broad urology franchise. Directly comparable to URO-1's SUREcore needle family across hospital customers.
• Boston Scientific: Large medtech incumbent with a urology franchise and biopsy-related products. Overlaps with URO-1 at the hospital procurement level and competes for capital allocation in urology programs.
• Hologic: Women's health and diagnostics company with biopsy and tissue-based diagnostic capabilities. Less direct overlap in prostate specifically, but comparable in tissue handling, pathology workflow, and hospital channel presence.

Emerging players

• Veracyte: Genomic diagnostics company with prostate cancer tests (Decipher Prostate) that depend on high-quality biopsy tissue. Indirectly comparable — same clinical workflow and customer — and validates the demand for better biopsy specimens.
• Exact Sciences: Oncologic diagnostics company with the Oncotype DX Prostate test and broader cancer screening franchise. Like Veracyte, depends on quality biopsy samples and serves the same urology decision-making workflow.
• Leica Biosystems: Pathology workflow and tissue processing company (part of Danaher). Comparable in targeting the downstream specimen handling and grossing workflow that coreCARE addresses, but operates in adjacent step of the biopsy-to-diagnosis chain.

Regional players

• Galen Medical / Mermaid Medical: Smaller specialty biopsy device distributors with prostate and soft tissue biopsy products. Comparable scale and product focus to URO-1, but with different geographic footprints.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/uro-1-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds3 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about URO-1