Lima Corporate and TechMah Medical Receive Regulatory Approvals for Smart SPACE Digital Platform
Knoxville, Tennessee, USA – February 12, 2021 – LimaCorporate and TechMah Medical LLC announced today important strides in the development of their digital platform designed to assist surgeons in delivering improved outcomes with an accessible and sustainable economic model, following LimaCorporate’s milestone-based acquisition of TechMah Medical. TechMah Medical was founded by Dr. Mohamed Mahfouz, Professor of Biomedical Engineering at the University of Tennessee, Dr. Michael Johnson, and Dr. Emam ElHak Abdel Fatah in 2014.
On December 28, 2020, TechMah Medical LLC received 510-K clearance from the FDA for its proprietary Smart SPACE Humeral 3D Positioner for use in Total Shoulder Arthroplasty, and on February 3, 2021, it received 510-K clearance for its Smart SPACE Cubit Guidance also for Total Shoulder Arthroplasty. In addition, on January 19, 2021, the CE Mark for the Apple Macintosh OS version of the Smart SPACE 3D Virtual Planner was obtained by LimaCorporate.
Smart SPACE is LimaCorporate’s digital platform and features novel orthopedic technology and a rich pipeline of landscape-changing applications. Smart SPACE is a new environment designed to further enable the surgeon and enhance the predictability of surgical outcomes providing peace-of-mind to the physician. The Humeral 3D Positioner and Shoulder Cubit Guidance are important and innovative cornerstones of the Smart SPACE ecosystem.
This pioneering digital platform is intended to allow surgeons to develop a complete pre-operative plan, utilizing the Smart SPACE 3D Virtual Planner and execute the plan precisely using a combination of patient-customized 3D Positioners and the Cubit Guidance System with its proprietary sensor technology. Surgeons using the system receive real-time feedback regarding instrument and implant positioning, all while maintaining their desired OR and patient set up.
Smart SPACE Shoulder Planner is currently in a controlled release within the United States and Europe. LimaCorporate is planning to commence the commercial release of the Shoulder Planner later in Q1 2021 and will initiate surgeries with the Humeral 3D Positioner and Shoulder Cubit Guidance in Q2 2021. Smart SPACE was developed in collaboration with TechMah Medical LLC.
Luigi Ferrari, LimaCorporate CEO, stated: “Following with our tradition of innovation, we are planning a significant number of new product releases for 2021. We are thrilled that many of our new product releases in 2021 involve Smart SPACE, our contribution to transforming orthopedics in 2021. I am very excited to see tangible progress on the release of Smart SPACE.”
LimaCorporate is a global medical device company providing reconstructive orthopedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select the ideal solution for every individual patient. LimaCorporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.
About TechMah Medical
TechMah Medical is a technology company focused on delivering orthopedic solutions. We build innovative applications designed to improve patient and clinician experience throughout the joint replacement process. Based in Knoxville, Tennessee, our team of scientists and engineers are driven to improve quality and efficiency through customization.
About the Founders
Professor Mohamed R. Mahfouz
Dr. Mahfouz is a professor of biomedical engineering at the University of Tennessee, Knoxville, Tennessee. His research interest is in medical imaging and wireless sensors in the biomedical field. He has more than 150 journal articles published in upper-tier distinguished international journals, more than 400 abstracts and short papers accepted for publication at international conferences, and has given more than 50 guest lectureships worldwide. Dr. Mahfouz has also authored 14 book chapters. In addition, he has more than 90 issued patents in medical sensors, medical imaging, and surgical navigation systems.
Dr. Mahfouz is the Principal Founder and President/CEO of TechMah Medical LLC. His primary focus is on moving research concepts into medical applications in the fields of medical imaging, orthopedic surgery, real-time positioning, electronic hardware, and many others. Dr. Mahfouz has over 30 years of experience in industry and academia.
Dr. Michael Johnson
Dr. Johnson is a co-founder and Senior Vice President at TechMah Medical. After receiving his Biomedical Engineering degree from Johns Hopkins University, Dr. Johnson pursued his Ph.D. at the University of Tennessee, Knoxville. He is focused on building the right teams, strategy, and infrastructure to take complex medical technology from concept to product. His previous experience includes positions of increasing responsibility in research, technical development, and management.
Dr. Emam ElHak Abdel Fatah
Dr. Emam ElHak Abdel Fatah is the Vice President of Research and Development of TechMah Medical LLC and one of its co-founders. In addition, he serves as a research assistant professor at the University of Tennessee. During his two decades of experience in medical imaging, machine learning and orthopedics he has bridged the gap between academia and industry. With a deep passion for innovation, Dr. Abdel Fatah aids in building the strategic vision for technologies, evolving ideas into products and guiding multiple development teams as they bring products through regulatory approvals.
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