The prostate biopsy hadn't changed in decades. A cancer survivor decided that was a design problem, not a law of nature.
Here is a fact that sounds like a complaint but is actually a business plan: the tool doctors use to biopsy a prostate has, by the account of the man now trying to replace it, been running on roughly Stone Age firmware.
Ted Belleza was retired. He had spent 35-plus years in medical technology, the kind of career where you help commercialize laparoscopic instruments and then, sensibly, stop. Then he needed a prostate biopsy of his own, and the experience was memorable for the wrong reasons. "This is from the Stone Age," he told his doctor. Sixteen individual piercing shots. A device he would later describe, with the specificity of a man who has designed better ones, as "ridiculous."
The thing about a complaint like that is you can either file it away or incorporate a company around it. Belleza incorporated. In 2017 he founded URO-1, Inc., a medical device company now based in Greensboro, North Carolina, on a premise that is almost annoyingly simple: a cancer diagnosis is only as good as the tissue you collect to make it. If the sample is small, fragmented, or curled into an uninterpretable knot, the pathologist reading it is working with worse raw material - and worse raw material produces worse answers.
And the answers, it turns out, are frequently worse. URO-1 likes to cite the numbers because the numbers are the whole argument: current tools over- or under-estimate the severity of disease in up to 40% of cases, and roughly 15% of samples don't contain enough tissue for molecular analysis. In an era where oncologists want to genomically profile a tumor, a needle that fails to bring back enough tissue isn't just an inconvenience. It's a data-collection failure dressed up as a routine procedure.
URO-1's answer comes in two parts, because the company decided the problem had two parts. The first is a better needle. The second is a better way to handle what the needle collects. Neither is glamorous. Both are the sort of thing that, if it works, quietly changes what a diagnosis is worth.
Two FDA-cleared products, designed to work as a pair. The premise: a great tissue core is worthless if it gets mangled on the way to pathology.
A single-use, 18-gauge biopsy needle for prostate and soft tissue. It's built to bring back a larger, higher-quality tissue core with minimal deflection - so the sample is big enough, and straight enough, to actually diagnose and profile.
A specimen retrieval system that preserves core integrity using a "touch and go" method. Less handling, less fragmentation, fewer artifacts introduced between the needle and the microscope. The unglamorous half that makes the first half count.
An expanding line of transrectal (TRUS) and transperineal (TPBP) instruments. The prostate is the wedge; URO-1 has said liver, lung, kidney and breast biopsies are where the same platform is meant to go next.
URO-1's reported figures from MRI-ultrasound fusion biopsy studies. In medtech, incremental is the norm. These gaps are not incremental - which means they're either wrong or interesting.
Figures as reported by URO-1 from its clinical validation studies and AUA presentations. Approximate; independent verification advised for clinical decisions.
URO-1 sells single-use devices. This is, if you are a business, a lovely place to be: every biopsy is a new needle and a new retrieval kit. The company's job is to convince urologists, radiologists, hospitals and clinics that the tissue quality is worth the switch - and then the razor-and-blades economics take care of themselves.
The money to get there arrived in 2024, when URO-1 closed an $8 million Series A led by Acorn Campus of Taiwan, rounded out by angel investors across Tennessee, California, Florida and Kentucky. Total reported funding sits around $10.6 million, including a $250,000 grant from the North Carolina Biotechnology Center, which counts URO-1 as a portfolio company. Manufacturing happens in-house, in a 300-square-foot ISO-certified cleanroom in Greensboro - which is to say, the entire supply chain for a cancer-diagnosis device fits in a room smaller than a two-car garage.
Clinical credibility came through a Clinical Trial Agreement with Duke University and a string of study results presented at American Urological Association meetings. Commercialization began in January 2025. The team is small - roughly ten people - but senior, stacked with serial entrepreneurs and engineers who collectively hold more than 76 patents. The competition is not small: BD (Bard), Argon Medical, Cook Medical and Merit Medical all sell the spring-loaded biopsy "guns" URO-1 is politely calling obsolete.
Ted Belleza comes out of retirement to modernize the prostate biopsy after his own diagnosis.
URO-1 presents prostate device study results at a national urology meeting.
Led by Acorn Campus of Taiwan, with angel investors across four U.S. states.
SUREcore and coreCARE cleared; a 300-sq-ft ISO cleanroom opens in Greensboro.
Sales begin in January; SUREcore results presented at AUA 2025.
A lean, veteran roster - several of them serial founders who have done the medical-device thing before.
URO-1 makes the SUREcore biopsy needle and the coreCARE tissue transfer system - a paired, FDA-cleared platform for prostate and soft tissue biopsies, designed to collect larger, more intact tissue cores.
It was founded in 2017 by Ted Belleza, a serial MedTech entrepreneur and prostate cancer survivor who serves as President and CEO.
URO-1 reports SUREcore achieved 92% targeting accuracy in MRI-ultrasound fusion biopsies versus 36% for conventional needles, with a higher rate of intact, straight tissue cores.
URO-1 completed an $8 million Series A in 2024 led by Acorn Campus of Taiwan, with total reported funding around $10.6 million, plus a $250,000 grant from the North Carolina Biotechnology Center.
Yes. URO-1 began commercialization of its prostate cancer biopsy platform in January 2025 following FDA clearance.
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