November 5, 2020
Patient Alerting Logistics advises that GenAssist, an innovative medical device company associated with Saint Louis University (SLU), has signed an agreement with Patient Alerting Logistics (PAL) to track its implantable Musculus Wound Matrix that promotes muscle tissue regeneration in the human body.
Patient Alerting Logistics notes following successful animal testing, the innovative matrix is pursuing a Federal Food and Drug Administration (FDA) De Novo classification as a novel device, establishing a new 510k category. The groundbreaking technology was born out of the musculoskeletal tissue engineering laboratory at SLU. Dr. Koyal Garg and CEO Gabe Haas are co-inventors of device.
“Comprehensive and precise tracking of our Musculus Matrix are imperative, given the complex regulatory processes required to bring this first-of-its-kind product to market and to prove its efficacy and safety on an ongoing basis after commercialization,” says Joe Beggs, COO for GenAssist. “The product supports muscle regrowth and is reabsorbed by the body during a five-year period. Carefully identifying and monitoring each and every patient for positive results are essential as we progress.”
Beggs points out that the GenAssist investigated numerous methods of achieving this, from time- and labor-intensive in-house processes to utilizing several solutions from unrelated companies that would help address certain aspects of patient tracking. “PAL emerged as the only comprehensive and seamless solution that met all our needs today and that could carry us into the future,” says Beggs. “It also was by far the most cost-effective and efficient way of meeting our goals. The PAL system really is in a class by itself.”
PAL will help GenAssist aggregate and share relevant device information from traditionally fragmented sources—researchers, hospitals, physicians, regulators, distributors and patients. A sophisticated, computerized communications nexus, it will continuously ensure that all communication links are current, fast and secure. The PAL platform replaces traditionally disjointed manual processes, including reliance on the postal system, with advanced digital operations. It will seamlessly integrate with GenAssist systems and those of its clinical partners, including an EMR to automatically associate a patient with a specific GenAssist implant and track that patient over time.
PAL also seamlessly captures FDA-mandated device tracking information from healthcare providers and other final device distributors. Additionally, if the FDA requires GenAssist to submit post-market device surveillance information, PAL will automatically collect and submit that data.
“We are extremely excited to welcome GenAssist on board as a client,” notes Ryan Bass, PAL President and COO. “GenAssist has created a truly innovative product that requires compliance with significant regulatory complexities. PAL will support GenAssist in meeting their goals, while cutting costs through reliable comprehensive process automation. I am personally looking forward to our longstanding and productive relationship.”