Cancer changes people, it changes families, and it changes lives. Getting well is hard enough. Getting diagnosed shouldn’t be. For prostate cancer survivor and founder of URO-1, Ted Belleza, cancer not only changed him but also inspired him to come out of retirement and improve the technology used to collect the biopsies essential for diagnosis.
As Belleza tells it, “One of my oldest and closest friends is a urologist whose clinical focus is prostate cancer. Twenty years ago he told me that if ever there was a procedure begging for innovation it is prostate biopsy. I had my epiphany 11 years later when I had my prostate biopsied at the University of California, San Francisco Center of Excellence in Prostate Cancer.”
“When they did my biopsy, it was 16 individual piercing shots. I sat up afterward and told my doctor, ‘This is from the Stone Age,’” Belleza shares with a laugh. “The biopsy ‘gun’? Ridiculous.” Not only is the device archaic, but it isn’t overly efficient either and often fails to provide sufficient tissue for accurate diagnosis.
Up to 40% of biopsies using current technologies either overestimate or underestimate the severity of the disease. Overestimation can lead to costly, unnecessary treatments, while underestimation may compromise outcomes. Inaccurate prostate biopsy is due in large part to insufficient tissue quantity and inferior quality resulting from existing biopsy needle designs and suboptimal specimen handling techniques.
Additionally, samples that test positive for cancer are often sent for further molecular analysis to help assess the aggressiveness of the disease. These analyses require adequate cancer in the submitted tissue for gene extraction, but unfortunately, up to 15% of these samples go unanalyzed due to insufficient tissue.
Belleza imagined a modern device for prostate biopsies that could do what current breast biopsy technology does: take samples with less hassle and pain while improving accuracy.
Getting Belleza’s idea off the ground wasn’t easy. His first design didn’t work as expected. “We went back to square one,” he explains. “COVID hit, and we had to focus on keeping things moving, but we never stopped working.”
Belleza and his team of biomedical and MedTech experts redesigned the biopsy needle, which not only addresses prostate biopsies but also has the potential to revolutionize and dominate the market in other soft tissue cancer indications. URO-1’s innovative products include the SUREcore needle, which increases biopsy tissue volume with high tissue quality, and the coreCARE specimen retrieval cradle, which allows for efficient and effective tissue transfer by preserving tissue integrity and minimizing artifacts. Both have been cleared to market by the US FDA and are patent-protected. Initial results from a multicenter clinical study indicate that the use of SUREcore and coreCARE significantly increases both the quantity and quality of biopsy samples to allow for more accurate prostate cancer diagnoses and reduce the need for repeat procedures.
The URO-1 Founders and Team
Belleza and his URO-1 colleagues didn’t build the company to make another medical device. “I have always wanted to work in healthcare and improve patient care.” Belleza tried out medical school early on in his life but realized quickly that it wasn’t for him. “I dropped out. I didn’t want to be a doctor, but I got a job as a research assistant at the University of California, San Francisco, developing a neurosurgical monitor.” It was fortuitous for Belleza. “I thought, ‘This is fun.’ I can make a career out of this.”
Since then, he has been making waves. “I have developed several instruments that have become industry standards including the first non-bladed laparoscopic trocars,” notes Belleza. He and his colleagues at URO-1 have also successfully led multiple ventures to profitable exits. “I don’t love the term, ‘serial entrepreneur,’” Belleza jokes as it may be confused with the phrase “serial killer.”
He continues, “But, yes, we have been fortunate enough to develop groundbreaking products that make a difference.”
URO-1’s co-founder is Philip Allred. As Vice President of Research & Development, he contributes over two decades of experience in medical device innovation. Allred’s extensive knowledge of material science, product design, and manufacturing has manifested into a portfolio of successful products, including endoscopes, catheters for brain aneurysms and deep vein thrombosis, instruments for spinal fusion, urodynamic devices, and biometrics. Allred enjoys pushing the limits of technology, which is evident from URO-1’s solutions and his portfolio of 16 patents. Jack Snoke rounds out the trio of founders. He is VP of Applications Development and has successfully developed a number of medical and consumer products.
Chloe Chan is URO-1’s Chief Financial Officer. Chan’s expertise in financial management and mergers and acquisitions has been instrumental in scaling businesses and navigating complex deals. She is recognized for her acumen in guiding startups through IPOs and strategic acquisitions, including leading Adaptec, Auspex Systems, and Alteon WebSystems in their successful evolution from private to public.
Leading the technical side at URO-1 is Chief Technology Officer Kevin Rackers. His engineering experience spans 35 years, including designing nuclear reactor systems for the US Navy and robotic technology for the International Space Station. “Rackers has a unique ability to translate advanced technologies into practical, high-impact solutions,” asserts Belleza. His portfolio also includes 25 patents, several of which are medical devices.
Belleza adds, “A venture capitalist once asked me why I’d invest in a commodity product like a prostate biopsy tool to which I replied, ‘I don’t deal in commodities. I take undervalued products and make them premium by innovating and improving clinical outcomes.’ In 1996, we did it with laparoscopic trocars. We invented a bladeless version that reduced injuries from laparoscopic entry and became the standard of care. We changed the status quo. We are doing the same thing with prostate biopsy tools. Our goal is to improve outcomes and raise the value of the product.”
URO-1’s patented, FDA-cleared technology is ready for rapid market expansion and making notable progress. The company has secured $250,000 in funding from the North Carolina Biotechnology Center and established a Clinical Trial Agreement with Duke University to ensure rigorous validation of its products and make them available for the masses. Collaborations with prominent urology groups, including Georgia Urology and New River Urology, further validate URO-1’s technology and its potential impact on improving biopsy accuracy and patient outcomes.
The team at URO-1 is certainly ambitious and innovative, but they aren’t just innovating for the sake of innovation—they are focused on transforming an outdated standard, an archaic, inefficient process, into a premium solution that sets new benchmarks in biopsy technology, a technology that could save lives. Belleza closes with, “We are all deeply and personally motivated and have unparalleled expertise. We remain focused on delivering precision, improving patient outcomes, and ultimately changing the standard of care for prostate cancer diagnosis.”
