PENDERIA TECHNOLOGIES, INC. — Department of Health and Human Services SBIR Phase I: NIAMS

Description

Abstract The emerging interdisciplinary research field of Regenerative Rehabilitation is based on recent evidence that post-operative rehabilitation is as important as surgical technique to achieve optimal functional restoration following orthopedic injuries. Despite this recognition, current rehabilitation protocols remain primarily based on qualitative prior experience or preferences and lack patient-specific, real-time quantitative feedback. The goal of this project is to develop a sensing system that can monitor the local mechanical environment at orthopedic repair sites, specifically rotator cuff surgeries, thus providing quantitative feedback for surgeons and physical therapists (PTs) to improve patient outcomes and reduce cost by optimizing rehabilitation time and reducing rates of failure and revision surgeries. The sensor would have other applications in large tendon reconstruction and rehabilitation such as Achilles tendon repair as well. The sensing system is based on battery-free sensors embedded in suture anchors used for rotator cuff repairs. The suture anchor is wirelessly monitored with a wearable device, allowing real-time, continuous biofeedback for surgeons and PTs to make informed decisions and accurately apply evidence-based care. To our knowledge, there is no comparable technology that can perform similar tasks efficiently, and successful implementation of our system could lead to significant cost savings in the orthopedic industry. We have performed preliminary experiments showing the technical feasibility, and conducted over 100 customer interviews confirming the need and market opportunity of this technology. We have also set up a funding strategy and collaborators for continuing study the effectiveness and commercialization of this technology. The goal of this Phase I project is to develop and evaluate the sensor system, as well as conduct an ex vivo experiment to demonstrate the functionality and practicality of the device- integrated sensor.Narrative Current standards in post-surgical rehabilitation rely on extremely conservative estimates of patient progress to prevent repair failure despite overwhelming evidence that early loading of the injury is critical in regaining range of motion and strength. Conversely, treatment programs can result in reinjury of the repaired tissue, leading to increased healthcare costs, prolonging the healing process, and resulting in poor outcomes. The proposed wireless force-sensing system for rotator cuff repairs will allow patient-specific and evidence-based orthopedic care, which will result in a significant cost savings by reducing repair failures, reducing healing times, and providing improved patient outcomes.