Cordance Medical, a pioneering leader in medical technology, today announced its acceptance into the Food and Drug Administration’s (FDA) Total Product Life Cycle (TPLC) Advisory Program Pilot (TAP Pilot). This prestigious program will significantly bolster the development of NeuroAccess, our state-of-the-art device designed to non-invasively open the blood-brain barrier, facilitating groundbreaking liquid biopsy tests for patients with brain tumors.
The FDA’s TPLC Advisory Program represents a significant opportunity for Cordance Medical as the program provides valuable insight and resources not typically available to medical device companies. These insights and resources will greatly aid in the development of our device, with an unparalleled focus on patient safety, efficacy, and regulatory compliance. Cordance Medical’s NeuroAccess, which has received an FDA breakthrough device designation for facilitating liquid biopsies in brain tumors, will leverage the TAP framework to ensure broad product market fit by incorporating payer, physician, and medical guidelines stakeholder feedback to bolster the product and clinical development initiatives supporting NeuroAccess.
“We are thrilled to be accepted into the TPLC Advisory Program,” said Ryan Dittamore, CEO of Cordance Medical. “This collaboration isn’t just about gaining regulatory approval; it’s about shaping NeuroAccess into a groundbreaking tool that meets the highest standards of medical innovation, physician needs, and patient care.”
“Our collaboration with the FDA through the TPLC program represents a proactive approach to ensuring that NeuroAccess not only meets but exceeds industry standards, while also aligning with evolving medical practices and patient needs,” added Dittamore.
The TPLC Advisory Program does not alter statutory or regulatory requirements for participating devices or manufacturers. Cordance Medical remains committed to meeting these requirements, including obtaining investigational device exemption (IDE), premarket notification, premarket approval, and De Novo classification requirements.
Cordance Medical will have the opportunity to meet with the FDA to discuss the TAP Pilot process, expectations, and engagement opportunities. This participation underscores Cordance Medical’s dedication to innovation and compliance, fostering an environment of continuous improvement and patient-centric development.
For more information about Cordance Medical and NeuroAccess, please visit Cordance Medical’s website.
For more information about FDA TAP Advisory Program, visit the FDA website.
About Cordance Medical:
Cordance Medical is a seed-stage medical technology company focused on developing, validating, and distributing a patient-centric non-invasive, small-footprint, and portable clinical device—the NeuroAccess platform. The platform aims to improve drug delivery and enable liquid biopsy for patients with neurological diseases by safely, temporarily, and non-invasively opening the BBB.
LinkedIn: Company Profile