A serial medtech entrepreneur who came out of retirement to redesign a procedure he calls antiquated - and built a company around a better biopsy.
Ted Belleza had already built a career most people in medical devices would envy. Over more than three decades he moved through commercialization and business development roles, co-founded companies, and watched two of them get acquired by larger players. By his own account he was retired. Then a prostate cancer experience put him on the other side of the procedure, and what he found there sent him back to work.
The problem, as he saw it, was not the science of diagnosis but the tools. Standard prostate biopsy relied on needles that had barely changed in decades. "This is antiquated," he said of the technology. To a founder who had spent a career in device design, an outdated instrument was not a fact of life. It was a gap in the market and a reason to build.
In 2017 he founded URO-1, Inc., launching the company in Winston-Salem, North Carolina before settling operations in Greensboro. The premise was direct: give physicians bigger, cleaner and more consistent tissue samples, then protect the quality of those samples all the way to pathology. Two products carry that idea. SUREcore is the biopsy needle. coreCARE is the specimen-retrieval kit that moves the tissue without degrading it.
If there ever was a procedure begging for innovation, it is prostate biopsy.
- Ted Belleza, on the case for URO-1Belleza is precise about why URO-1 needed both pieces at once. "We designed and developed a superior biopsy needle that obtains bigger, better, and longer tissue samples and a method to retrieve that tissue and preserve its quality during transport to pathology," he explained. "Without these two elements, we couldn't develop the ultimate concept we envisioned, which is automation and reduced instrument passes." The needle and the kit are steps toward a larger goal: fewer passes, more automation, and a more reliable read for the pathologist at the end of the line.
The clinical numbers gave the pitch teeth. In comparative studies, the SUREcore needle delivered 12 to 21 percent greater tissue volume by weight than standard needles, with less sample-to-sample variability. The coreCARE kit preserved tissue integrity, reduced artifact, and cut specimen preparation time. For a diagnosis that depends on how much usable tissue reaches the lab, those are not cosmetic gains.
Building the company meant building a team. Belleza assembled technical leaders with long track records in device development, contract manufacturing and R&D, and positioned URO-1 as a portfolio company of the North Carolina Biotechnology Center. The company's stated mission is blunt about ambition: make SUREcore and coreCARE the standard of care for prostate and soft tissue biopsies.
Money followed the milestones. URO-1 set out to raise a $5.0 million Series A, led by Acorn Campus of Taiwan, with angel investors from Tennessee and Kentucky and an early $250,000 loan from the North Carolina Biotechnology Center back in 2018. Reported figures put total funding at $10.6 million. Then came the regulatory and legal validation any device company chases: FDA clearance for both SUREcore and coreCARE, and in 2024, U.S. Patent #11,903,569 for the SUREcore soft tissue biopsy needle.
What makes Belleza's story more than a resume is the loop it closes. He is a patient who became a builder, applying decades of commercial and product experience to a problem he had personally run into. That combination - lived motivation plus operator's discipline - is rare, and it shows in how he frames the work. He is not selling a gadget. He is arguing that a routine, high-stakes diagnostic step deserved better engineering, and he built the company to prove it.
URO-1's reach already extends past the prostate. The company's Repris bladder injection system targets overactive bladder treatment in women, a sign that Belleza is thinking about a platform rather than a single product. The through-line is office-based urology and urogynecology - procedures done routinely, at scale, where small improvements compound across thousands of patients.
For a founder who once considered himself done, the second act has been substantial: a company, a patent, two cleared products, and a clear target. The needle he called antiquated is being replaced by one he designed.
Greater tissue volume by weight vs. standard needles, per URO-1 comparative studies.
SUREcore - FDA-cleared soft tissue biopsy needle, protected by U.S. Patent #11,903,569, engineered for larger and more consistent cores.
coreCARE - FDA-cleared specimen-retrieval kit that preserves tissue integrity and reduces artifact on the way to pathology.
Repris - bladder injection system for overactive bladder treatment, extending URO-1 into urogynecology.
Vice President of Clinical Marketing at Gynesonics, Inc., later acquired by Hologic.
Chief Commercial Officer at LiveLeaf Bioscience.
Co-Founder and VP Business Development at Endosee Corp., later acquired by CooperSurgical.
Founded URO-1, Inc. and became President & CEO, launching in Winston-Salem, North Carolina.
URO-1 reached its $5.0M Series A goal and announced FDA clearance of SUREcore and coreCARE.
URO-1 awarded U.S. Patent #11,903,569 for the SUREcore soft tissue biopsy needle.
This is antiquated.
If there ever was a procedure begging for innovation, it is prostate biopsy.
We designed and developed a superior biopsy needle that obtains bigger, better, and longer tissue samples - and a method to retrieve that tissue and preserve its quality during transport to pathology.
The ultimate concept we envisioned is automation and reduced instrument passes.
Leads URO-1, Inc. as President and Chief Executive Officer.
Based in the San Francisco Bay Area; URO-1 headquartered in Greensboro, North Carolina.
Prior ventures reached acquisitions by Hologic and CooperSurgical.
Prostate biopsy (SUREcore/coreCARE) and overactive bladder treatment (Repris).
Series A led by Acorn Campus of Taiwan, plus US angel investors.
Make SUREcore and coreCARE the standard of care for soft tissue biopsy.
He is the founder, President and CEO of URO-1, Inc., a medical device company developing the SUREcore biopsy needle and coreCARE specimen-retrieval kit.
URO-1 is a Greensboro, North Carolina medical device company focused on office-based urology and urogynecology, with products for prostate biopsy and overactive bladder treatment.
He held leadership roles at Gynesonics (acquired by Hologic), co-founded Endosee (acquired by CooperSurgical), and was Chief Commercial Officer at LiveLeaf Bioscience.
SUREcore is URO-1's FDA-cleared soft tissue biopsy needle, protected by U.S. Patent #11,903,569, that clinical studies showed delivers 12-21% greater tissue volume by weight than standard needles.
After his own experience with prostate cancer, Belleza came out of retirement to redesign what he called an antiquated biopsy procedure, aiming to improve tissue quality and diagnostic accuracy.