Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps

This SBIR CRP project conducts activities to increase hospital access, adoption, and sales of the ‘Active
Disposable Cap for Endoscope system (ACE).’ ACE is a cap pressed onto the distal end of the endoscope,
with integrated fingers connected to proximal controls. It allows a clinician to manipulate tissue during complex
polypectomies without occupying the endoscope’s working channel. Its design enables the physician to
maintain procedure ergonomics. The project goals are to: 1) optimize materials and industrial production
methods to reduce overall costs, 2) produce optimized models that integrate with the majority of endoscope
sizes used with differing human anatomies, and 3) conduct Verification and Validation and preclinical studies
designed to confirm device equivalence for 510(k) submission. Additionally, the project team will develop an
investor package, and a hospital engagement and Value Analysis Committee strategy, with business experts.
Public Health Problem: In the U.S., colorectal cancer is one of the most deadly and costly forms of cancer.
Current endoscopy tools are inadequate to consistently enable full resection of colon polyps. Large (rt2 cm),
complicated polyps (e.g., flat sessile lesions) are particularly prone to recurrence and malignancy, impacting
patient care and healthcare costs. Recurrence rates of standard piecemeal resection, which are significantly
associated with residual polyp and risk of reseeding of lesions if malignant, increase from 3% for lt2 cm polyps
to 85% for polyps rt2 cm. In one Japanese study, endoscopic submucosal dissection (ESD) enabled en bloc
removal of rt2 cm polyps in 84-95% of cases, and demonstrated a low 0-2% tumor recurrence rate. In the
U.S., the use of en bloc ESD in the colon is well below 50% frequency. ESD procedures can take over 100
minutes compared to 20-50 minutes for more commonly performed piecemeal resections, contributing to
limited use of the procedure. The few systems that are available to aid traction and countertraction in ESD are
expensive, complex, only fit a limited number of endoscopes, and are difficult to use one-handed. ACE will
enable safe and effective en bloc ESD with full lesion removal to be performed rapidly at a wider range of
facilities., the goal is to provide an ESD device to increase access and adoption of the technique in the U.S.,
improving efficacy, patient safety and outcomes while reducing cost.
Hypothesis: By accommodating the breadth of adult human anatomies, optimization of production and scale-up
and technical assistance, AMI produces a 4-model family of disposable endoscopic accessories for ESD that
enable greater market access, adoption, and sales.
Aim 1. ACE Models Expand Electrosurgical and Endoscope Equipment Compatibility (Mos. 1-7)
Aim 2. Reduce Bill of Materials and Assembly Costs (Mos. 6-9)
Aim 3. Verification and Validation (VandV) and Preclinical Study for Equivalence (Mos. 7-18)
Aim 4. Business Development and Value Proposition Validation (Mos. 1-18).