FDA Approves First Medical Implant with New Superalloy
MiRus™ Receives FDA 510(k) Clearance for the First MoRe® Implant
ATLANTA — March 27, 2019— MiRus has received FDA 510(k) approval for the MoRe® based Europa™ Pedicle Screw System making it the first FDA approved medical device with this new class of implant material. The Europa™ System received the 2018 Spine Technology Award at the NASS meeting for excellence and innovation in spine surgery.
MiRus has developed MoRe®, a proprietary molybdenum rhenium superalloy for medical implants, to provide an unprecedented combination of strength, ductility, durability, and biological safety that is unmatched by current materials. MoRe® was designed to meet these criteria and is patent protected for use in all medical devices.
The clinical needs of many patients remain unmet due to the limitations of current titanium, cobalt and iron based alloys originally developed more than 40 years ago. The MoRe® superalloy allows for the design of a new generation of smaller, stronger, more durable, and bio-friendly implants that will result in less soft tissue disruption, quicker recovery and better outcomes for patients.
“Spine deformity surgery in adults remains plagued by the poor performance of current implants with rod failure occurring in 18%-20% of patients,” noted Munish Gupta MD, Mildred B. Simon Distinguished Professor of Orthopaedic Surgery, Director of Adult/Pediatric Spinal Deformity service and Professor of Neurological Surgery at Washington University, “The MoRe alloy shows great promise in improving the durability of adult spine deformity constructs. This advance will help prevent early revision surgery and improve outcomes in adult deformity surgery in particular.”
Peter Newton, MD, Chief of Orthopaedic Surgery at Rady Children’s Medical Practice Foundation and Clinical Professor, UCSD observed “I am excited by the excellent material properties of this new alloy and the potential to improve orthopaedic implants.”
James Nunley, MD, Goldner Jones Professor of Orthopaedic Surgery at Duke, remarked “This new material with its greater strength, fatigue resistance and superior biological properties will allow us to make lower profile foot and ankle implants leading to smaller surgical exposures and reduced revision rates. “
Jay S. Yadav MD, Founder and CEO of MiRus, stated: “FDA approval of the Europa™ Pedicle Screw System with our patented MoRe® superalloy is the culmination of over ten years of research and development. Our scientists and engineers working with world class metallurgists have created the greatest advance in medical implant material technology in at least four decades. The MoRe® superalloy will revolutionize many aspects of the medical device industry as the first alloy approved by the FDA for use in an implant which is not based on titanium, cobalt or iron with their inherent limitations.
The FDA requires a rigorous level of scientific investigation to establish the safety and effectiveness of a spine implant that utilizes a new medical alloy. In response to FDA guidance, our scientific team led by Jordan Bauman, VP of Regulatory, developed a comprehensive body of evidence which served as the basis for approval of this major advance in patient care.
We are fortunate to be collaborating with an outstanding worldwide group of orthopaedic and neurosurgeons in developing transformative spine solutions. Additionally, MiRus is rapidly expanding into other orthopaedic applications such as foot and ankle and has made significant progress in cardiovascular applications of the MoRe® superalloy.”
About MiRus, LLC.
MiRus is a medical device company that has developed and is commercializing proprietary novel biomaterials, implants and software solutions for spine, orthopaedics and cardiovascular disease. We are addressing the demands of today’s healthcare environment with an integrated platform of pre-operative planning and risk assessment tools, a breakthrough navigation and robotics system and post-operative monitoring and risk mitigation. Find more information about MiRus at www.mirusmed.com.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.
* MoRe® is a registered trademark of MiRus, LLC. Europa™ and MiRus™ are trademarks of MiRus, LLC.