Q&A with Brad J. Buscher of Triopsy Medical, Inc.

Triopsy™ is addressing prostate cancer, which represents an enormous patient population that does not currently have strong options. The current standard of care for diagnosing prostate cancer results in inaccurate diagnosis 40-50% of the time, which leads to missed identified of disease or overtreatment. Triopsy™ addresses this by taking increased core length biopsies, resulting in 3-6 times more tissue biopsied with no increase in number of punctures, which will increase diagnosis of cancer. Triopsy™ is further able to achieve strong results because the Needle is designed to reduce deflection and tissue fragmentation. Triopsy’s™ pathology device reduces mishandling and keeps tissue intact for processing and subsequent molecular/genomic analysis. The Triopsy™ System with Software is expected to improve diagnostic accuracy to >90% vs. 50-60% using current biopsy devices. The information provided by the Triopsy™ System may ultimately help properly characterize patients for active surveillance, targeted focal therapy, and definitive therapy. The Triopsy™ System is not just intended to improve patient outcomes, but also reduces overall health care costs as better diagnosis will reduce the overtreatment of indolent prostate cancer.

Existing biopsy tools rely on 30-year-old technology, and have not kept up with other technological advancements in the field. Serum and Tissue Markers have been shown to improve the specificity of diagnostics over that of PSA alone, and improved specificity decreases the number of prostate biopsies performed. As these new genomic techniques become more sensitive and specific, the need for a highly accurate biopsy system will grow substantially, greatly improving the likelihood of increased adoption of the Company's technology.

Due to the inaccurate diagnostic capability of existing tools, screening (PSA) has decreased in the past decade as patients and clinicians are hesitant to get screened as they fear the potential for overtreatment. Recent data has shown, however, that this reduction in screening is resulting in the increased diagnosis of later stage lethal cancers. With better diagnostics (i.e., the Triopsy™ System), the Company believes screening will rebound. Currently, physicians often order an MRI instead or before a biopsy is taken. However, data indicates that, due to its lack of sensitivity, an MRI can result in a false negative in 30% of the time, missing smaller, but no less dangerous, lesions. Triopsy™ intends to address these shortcomings in the market, by being a safe, effective, and readily available diagnostic tool.

The Company’s devices and software have been significantly de-risked from a design and development standpoint over the past number of years, and the regulatory pathway to achieve market clearance has been identified. The Company’s devices and software are intended to be cleared via FDA’s 510(k) regulatory pathway; the Company believes that it will meet the substantial equivalence requirement. The European approval pathway is centered on CE Mark via a notified body. The Company intends on submitting its 510(k) to the FDA in 2022 for the Needle and Biopsy Device for TRUS approach and 2023 for the entire Triopsy™ System. CE Mark submission will be 3-6 months behind FDA submission.

With regards to reimbursement, codes already exist for biopsy procedures that will utilize the Company’s devices and software, and the Company will rely on its experienced management team to target the market with accessible channels of distribution. While development has been ongoing, the Company has worked to build significant market awareness through publications, trade shows, and pre-marketing surveys and has worked to identify early adopters to prime the market upon clearance.