SANUWAVE retained MCRA in January of 2015 to lead interactions and correspondence with the FDA for the dermaPACE. SANUWAVE withdrew a PMA submitted previously using data from the first DFU clinical study and recognized the need to enlist MCRA's expertise. SANUWAVE's Chairman of the Board and CEO, Kevin A. Richardson II said, "We chose MCRA for their extensive regulatory experience and interaction with FDA over the past decade. They took clinical data from, essentially, a Not-Approvable PMA, and worked wonders in obtaining a de novo decision with basically the same clinical data. Their depth of knowledge and experience in regulatory and clinical science made them an excellent partner for working hand-in-hand with our team and the FDA."
This significant achievement marks the third clearance of a de novo application for a wound care technology since 2010. Samuel Pollard, a Senior Regulatory Associate at MCRA, added "MCRA was excited to assist SANUWAVE on the strategy and execution of a viable US market solution to a unique regulatory challenge. MCRA's US Regulatory and Clinical Research Organization (CRO) experience helped drive this device to a successful FDA decision. These successes demonstrate MCRA's commitment to a surgeon-centric approach, which provides medical solutions that enable patients to regain a healthy lifestyle."
About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA's value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA's integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves nearly 450 clients globally. MCRA has a demonstrated history of driving successful de novo and other regulatory submissions in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.
David W. Lown
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