About DanaMed, Inc.
DanaMed, Inc. is a medical device venture formed in 2014 to develop and bring to market a superior surgical approach to reconstructing Anterior Cruciate Ligaments (ACLs). The approach was conceived in 2013 by Dr. Dana Piasecki, a leading Sports Medicine orthopedic surgeon, and evolved through over 20 iterations to become the Hybrid Transtibial Technique (HTT). The HTT combines the advantages of the two widely-used conventional approaches to ACL reconstruction, but avoids the significant surgical and clinical disadvantages of each.
The HTT is enabled by the Pathfinder™ ACL System – a surgical instrument (Pathfinder™ ACL Guide) and a flexible, steerable guide wire (Pathfinder™ Guide Pin with Sheath). Typically, the HTT procedure places the ACL graft in the anatomical path equivalent to the native ACL and with equivalent tibial and femoral positioning.
The Pathfinder System was patented in the U.S. and international countries in 2014. FDA registration as a Class I surgical devices occurred in 2015. The first commercial patient use was in 2015. Since then, over 1,000 HTT procedures with the Pathfinder System have been performed with excellent clinical results. The Pathfinder is routinely used by multiple sports medicine surgeons in the U.S. and is being adopted rapidly in additional practices.
DanaMed’s corporate headquarters address is in Chadds Ford, PA – a Philadelphia suburb. Distribution, regulatory and quality assurance functions are located in Streetsboro, OH – a Cleveland suburb. Manufacturing is outsourced to parts manufacturers in five states.
Dana P. Piasecki, MD
Chairman, Founder, Medical Director
Dr. Piasecki is the innovator, the driving force behind the Hybrid Transtibial Technique concept, and the developer of the Pathfinder ACL System. He is a partner in OrthoCarolina LLC, the largest orthopedic medical partnership in the US and is a recognized expert in repair and reconstruction of sports injuries to the knee and shoulder.
Dr. Dana Piasecki’s medical career has taken him all over the nation. His education began with an undergraduate degree in Biology at Harvard University. He then moved south to obtain his doctorate in medicine from Vanderbilt and back north to New York to complete an orthopedic surgery residency at the esteemed Hospital for Special Surgery. Dr. Piasecki completed his Sports Medicine Fellowship at Rush University Medical Center, where he also served as Assistant Team Physician for the Chicago White Sox and Chicago Bulls, and Head Team Physician for the Chicago Steel Hockey Squad. During his fellowship year, he instructed orthopedic surgery residents and authored more than twenty peer-reviewed publications. He is currently active in cutting-edge orthopedic research and serves as a surgeon educator, helping to train orthopedic residents at Carolinas Medical Center.
In addition to his professional pursuits, Dr. Piasecki has a long personal history of athletics. He is a former rower, water polo player, Division I NCAA swimmer, and was a member of the United States National Flatwater Sprint Kayaking Team (1996-2000). He was a U.S. Olympic Training Center resident athlete for two years, narrowly missing a 2000 Olympic kayaking berth and winning medals at the U.S. Olympic Team Trials, U.S. National Championships, World Sprint Team Trials and Canadian National Championships. He now serves as a volunteer physician for the U.S. Olympic Committee.
Beyond his love of sports, Dr. Piasecki greatly enjoys traveling with his wife, who is a neonatologist, son, and two daughters.
Jim Duncan spent 41 years in the medical device industry before retiring in 2012. During that career he rose from sales, business development and marketing positions to executive level with two major market-leading multinational corporations and three successful market-defining start-up companies. From 2006-2012 he was CEO and Chairman of Monteris Medical Inc., a startup venture with a unique MRI-guided, laser ablation technology for destroying otherwise inoperable brain tumors and other lesions. Under his leadership tenure Monteris rose from an early-stage development company to be a presence in the US market today.
Jim graduated in 1963 with a mechanical engineering degree from Cornell University. He began his career as a mechanical/optical engineer with the leading optical systems/photography corporation. He left to obtain an MBA at Cornell, then began with a major glass technology corporation in marketing and business development focused on advanced science and government opportunities. That led to his transition to medical devices and his first startup.
DanaMed is Jim’s fourth new venture. After “retirement” Jim reconnected with Dr. Dana Piasecki in 2014. They had a mutual interest in developing and bringing to market Dr. Piasecki's concept for the new game-changing concept of the hybrid transtibial technique. Together they formed DanaMed, Inc., finalized development and manufacturing, and introduced to the market and leading surgeons in 2015. As CEO Jim oversees all aspects of DanaMed business.
Manager, Regulatory, Quality Assurance and Operations
Nick Wilkins started his quality and regulatory career in 2011, after nearly a decade in retail and business banking management. He joined a small company specializing in permanent patient-specific cranial implants where he was able to successfully clear outstanding regulatory issues, expand regulatory clearance internationally, and obtain three 510(k) clearances for new products, including a novel sterilization method for their cranial implants. Nick is the owner/operator of Flux Solutions Group, LLC, which specializes in providing regulatory and quality consulting solutions to small companies that are exploring regulatory compliance and certification.
Nick has successful audit experience involving many regulatory standards, including 21 CFR 820, ISO 9001:2015, ISO 13485:2016, AS9100 RevD, and Nadcap. He has a financial resource management degree from The Ohio State University, and previously attended Oakland University where he played Division I soccer and studied computer science.