Why Endoscopy Matters
We are dedicated to transforming lives through innovative medical device designs that facilitate clinicians and improve the health of patients. AdaptivEndo's approach to single-use endoscopy maximizes efficacy while minimizing the the risk of cross-contamination and infection.
AdaptivEndo™ endoscope designs are for a single-use, flexible, ready-to-go solution that improves safety and productivity. Without the workload, costs. and staff hazards associated with re-processing conventional endoscopes, AdaptivEndo’s approach to single-use endoscopy provides the clinician immediate access to endoscopes when and where needed.
From the beginning, AdaptivEndo™ understood the importance of clinician guided product design. Highly regarded clinicians, who were experts in their respective fields, were recruited early during the design process to ensure that real needs were being addressed. Understanding that the clinician would be just one of many professionals that interact with our endoscopes, we also listened closely to endoscopy technicians, clinical support staff, and medical device sales professionals. With each prototype iteration, we would ask our clinical advisors for input to determine where we hit the mark and where we needed to improve.
Endoscopic therapeutic procedures are rapidly advancing as an alternative approach to open surgery or laparoscopic procedures such as sleeve gastroplasty, deep mucosal resection, and fundoplication.
The growth rate for the US endoscopy market 7.5% CAGR (US).
The growth rate for the US single-use flexible endoscopy market segment is 26.9% (US) with a total market opportunity of $2 billion.
Reimbursement strategies are moving toward direct reimbursement for higher infection risk scopes.
With an increased focus on the complex cleaning procedures needed for reusable endoscopes, the capital and operating costs for endoscopy has risen dramatically. More endoscopes are needed by each endoscopy facility or they are not available as needed. Recent tests performed by manufacturers at the demand of the FDA found that 17 out of 22 gastroscopes sampled retained disease-causing microbes after proper cleaning.
The FDA has been diligent in investigating the cause for endoscope-related infections and encouraging the development of solutions to mitigate their risk. It now recommends that healthcare facilities begin transitioning to endoscopes with single-use scopes.
"The FDA believes the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary."
The technology required to develop an efficacious and economically viable single-use endoscope has only recently become available.
Single-use endoscopes have the potential to fundamentally change the field of endoscopy.
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication