Single Pass

Executive Summary

Single Pass, Inc. is a Cambridge-based medical device company developing the first disposable biopsy cauterization device designed to prevent bleeding during deep tissue biopsies. Their product integrates a cauterization mechanism within a guide needle, enabling safe, swift, and easy biopsy procedures by controlling bleeding at the site of tissue extraction. This innovation addresses a critical unmet need in interventional radiology and oncology, where post-biopsy bleeding can lead to complications and additional procedures. By offering a single-use, disposable solution, Single Pass aims to improve patient safety, reduce procedure time, and lower healthcare costs. The company is privately held and currently in early development stages, with limited public financial or regulatory information available. Given the clear clinical need and novelty of the approach, Single Pass has the potential to disrupt the biopsy device market, but execution risks remain as the device is likely still in preclinical or early clinical validation.

Upcoming Catalysts (preview)

• Q2 2027FDA 510(k) Clearance60% success
• Q1 2027First-in-Human Clinical Trial Initiation70% success
• Q3 2026Series A Funding Round50% success