Prostate cancer is the most common solid tumor in men and ranks second only to lung cancer as a leading cause of cancer-related deaths among men. The most definitive test for diagnosing prostate cancer is a biopsy. However, up to 40% of prostate biopsies either overestimate or underestimate the severity of the disease. The needles used to collect the samples are archaic and inadequate. They may miss cancerous tissue, leading to false-negative results, and the potential for poor tissue quality is great, as the needles can damage the extracted samples, making them difficult for pathologists to analyze. Inconsistent techniques, such as varying needle angles or depths, can also lead to uneven sampling, further compromising accuracy.
Additionally, these methods have limited detection capabilities, especially in early-stage cancer or multifocal cases, where small lesions are scattered throughout the prostate. The procedure’s discomfort (Including 16 pokes with a needle) and risks, such as infection and pain, may also discourage repeat biopsies, leading to delayed diagnoses. This lack of diagnostic precision can lead to significant risks, including unnecessary treatments or delayed diagnoses, all of which can greatly compromise patient outcomes.
Fortunately, URO-1, Inc. has a game-changing solution to address these challenges and significantly improve the accuracy of not only prostate biopsies but other traditional biopsy methods across various medical conditions.
Given the lack of innovation in biopsy instrumentation, the company recognized a pressing unmet need: improving the tools used in prostate cancer diagnosis. Under the leadership of Ted Belleza, himself a prostate cancer survivor, and a skilled technical team, URO-1 tackled the complexities of prostate biopsy, leading to the creation of two cornerstone patent-protected products: the SUREcore biopsy needle and the coreCARE tissue retrieval platform.
These products are innovative and set URO-1 apart in the medical device landscape. The SUREcore needle is revolutionary and engineered to significantly increase the quantity and quality of biopsy samples. By enhancing tissue volume and quality, it reduces the ambiguity in sample interpretation, leading to more accurate diagnoses. Initial clinical studies have shown that the SUREcore and coreCARE platform offers a significant improvement over current biopsy methods in both the quantity and quality of tissues obtained for pathologic analysis. These products not only mitigate the risk of misdiagnosis but also position URO-1 as a leader in urological innovations.
The URO-1 leadership team is world-class. Belleza, President and CEO, is a serial MedTech entrepreneur who returned from retirement to improve prostate biopsy technology after his own experience with prostate cancer. With a history of developing market-leading instruments, Ted’s previous ventures have resulted in exits with solid investor returns.
CTO Kevin Rackers’ diverse background in mechanical engineering, including developing systems for US Navy Nuclear submarines and robotic control software for the International Space Station have been critical. He has over 25 patents and leads his own R&D and manufacturing company.
Philip Allred, Co-founder and VP of R&D, has over 20 years of experience in medical device development with 16 patents and a portfolio that includes endoscopes, catheters, and spinal instruments, while Co-founder and VP of Applications Development, Jack Snoke, has a 20-year history of developing medical and consumer products. Rounding out the team is CFO Chloe Chan, renowned for guiding high-tech startups through successful IPOs and acquisitions for major companies like Adaptec, Auspex Systems, Alteon WebSystems, and Otosense.
The team’s journey to developing this groundbreaking technology wasn’t straightforward. The original concept envisioned a less invasive approach, similar to the automated breast biopsy guns developed in the late 1990s, which would allow multiple tissue samples to be collected with a single insertion. However, the concept proved technically unfeasible, leading Belleza and his team back to the drawing board. Through persistence and rigorous research, they identified the key shortcomings of existing prostate biopsy instrumentation — insufficient tissue volume and poor tissue quality — and developed solutions that directly addressed these issues.
Belleza explains, “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. Without these two elements, we couldn’t develop the ultimate concept we envisioned, which is automation and reduced instrument passes,” explains Belleza. These innovations are crucial as they enhance diagnostic accuracy, and with improved accuracy comes a reduction in the need for repeat procedures, minimizing patient discomfort and risk.
URO-1 has a scalable business model and high growth potential. The company’s proprietary technology offers a unique value proposition that addresses a significant market need. With the SUREcore and coreCARE platform cleared by the FDA for all soft tissue biopsies (prostate, breast, lung, liver, kidney, lymph node, etc.), URO-1 is unlocking new revenue streams and positioning itself for rapid market expansion. The company’s strong competitive advantage lies in its ability to deliver significantly improved diagnostic tools that meet the stringent demands of both clinicians and patients.
The company’s focus on enhancing diagnostic accuracy while reducing risks is not just a technical achievement but a strategic move that capitalizes on emerging trends in personalized medicine. With a clear vision and proven track record, URO-1 is on track to make a significant impact on healthcare and become a highly profitable company.
