Cystosure

Executive Summary

Cystosure, operating under Emmy Medical LLC, is a San Francisco-based medical device company that aims to simplify diagnostic cystoscopy for female patients. The company's flagship product, CystoSure® Plus, is a patented urinary catheter system that integrates a scope port, enabling clinicians to visualize the bladder without removing the catheter. This innovation addresses inefficiencies in current cystoscopy procedures by reducing patient discomfort, procedure time, and the need for multiple device insertions. Designed for use in both hospital operating rooms and outpatient office settings, CystoSure® Plus targets a significant unmet need in urological diagnostics, where traditional cystoscopy often requires sequential catheterization and scope insertion. By combining these steps, Cystosure's technology has the potential to improve clinical workflow, patient experience, and overall healthcare utilization. Founded in 2019, Cystosure is still in the early commercial stages, with no disclosed funding rounds or valuation. The company's success hinges on widespread clinical adoption and regulatory milestones. Given the competitive landscape of urological devices, Cystosure must differentiate itself through clinical evidence, ease of use, and cost-effectiveness. If the product gains traction, it could capture a meaningful share of the diagnostic cystoscopy market, particularly in outpatient settings where efficiency is paramount. However, limited public information on commercial traction and financial backing tempers the conviction. The company's ability to secure partnerships or distribution agreements will be critical for scaling.

Upcoming Catalysts (preview)

• Q3 2026FDA 510(k) Clearance or Additional Regulatory Approvals70% success
• Q4 2026First Commercial Sales or Distribution Partnership Announcement50% success
• Q1 2027Clinical Study Results Demonstrating Improved Outcomes40% success