|2018-12-05||Panther Orthopedics Announces Successful Clinical Use of the PUMA System™|
Panther Orthopedics Announces Successful Clinical Use of the PUMA System™
TAIPEI, Taiwan, Dec. 5, 2018 /PRNewswire/ — Panther Orthopedics, Inc., a medical device company headquartered in San Jose, California, is pleased to announce the successful clinical use of its innovative flexible fixation device, the PUMA System (TM).
The U.S. Food and Drug Administration 510(k) cleared PUMA System (TM) is a revolutionary advancement in the treatment of orthopedic injuries that provides the benefits of screws and flexible fixation devices but without their problems. “The PUMA System (TM) is a new way of thinking. The spring-like design of the PUMA Body does the work to provide initial and continuous compression without the need to overtighten,” said Kathy Stecco, M.D., co-founder and CEO of Panther Orthopedics, Inc.
“The PUMA System (TM) is a novel approach to syndesmotic fixation. It provides the best of both worlds. It gives stable dynamic fixation without postoperative creep/loss of fixation. It’s easy to use and its simplicity is also its elegance. It proves yet again how Nitinol will continue to penetrate orthopedics,” said J. Kent Ellington, M.D., Orthopedic Surgeon, OrthoCarolina Foot and Ankle Institute.
“PUMA is an easy to use, flexible Nitinol implant for syndesmosis fixation. It stabilizes the syndesmosis providing resistance to displacement without creep — all without overcompressing the syndesmosis joint, allowing rotational motion. This is a very promising platform technology,” said Kenneth Hunt, M.D., Associate Professor and Chief, Foot and Ankle Surgery, Department of Orthopedic Surgery, University of Colorado School of Medicine.
Panther Orthopedics, Inc. is developing next level dynamic fixation solutions for orthopedic trauma and sports medicine applications. The company successfully closed on a Series A investment led by Medeon Biodesign, Inc. in March 2017.
About Medeon Biodesign
Medeon Biodesign (TPEx: 6499) is a publicly traded company located in Taipei, Taiwan, and currently listed on Taipei Exchange. The company focuses on the development of medical devices for minimally invasive surgeries to treat diseases of sizable patient population, such as cardiovascular, peripheral vascular, orthopedic, neurosurgery, obesity, gastroenterology, hematology, nephrology, gynecology, urology, and plastic surgery. For more information, please visit www.medeonbio.com/en.
|2018-03-02||Medeon Entering Asset Purchase Agreement with Terumo for its Large Bore Vascular Closure System|
Medeon Entering Asset Purchase Agreement with Terumo for its Large Bore Vascular Closure System
TAIPEI, Taiwan, March 5, 2018 — Medeon Biodesign, Inc. (TPEx: 6499), a Taiwan publicly traded medical device company, is pleased to announce today that it entered into a definitive asset purchase agreement with Tokyo-based Terumo Corporation (TSE: 4543) for its large bore vascular closure system. The transaction consists of an up-front payment of US$20 million and milestone payments. Medeon will continue to provide its strong expertise in product innovation in collaboration with Terumo for future technical, clinical and regulatory developments of the closure system.
The large bore vascular closure system (XPro System™) is an automated suture-mediated closure device to simultaneously deliver two pairs of sutures, specifically targeting percutaneous large bore procedures, including Transcatheter Aortic Valve Replacement (TAVR), Endovascular Aneurysm Repair (EVAR), Thoracic Endovascular Aneurysm Repair (TEVAR), and percutaneous Balloon Aortic Valvuloplasty (BAV) procedures. The product’s safety and effectiveness have been successfully demonstrated through a CE Marking clinical study in New Zealand, Australia, and Taiwan, with patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheaths via the common femoral artery. The device achieved immediate or rapid hemostasis at the puncture sites with excellent clinical outcomes, including fast ambulation and discharge from hospitals.
“Access site complications in large bore procedures remain to be a significant concern among practicing clinicians. Leveraging the advantages of the security of suture-mediated closure and built-in safety mechanisms, the closure system provides a better solution for the large bore procedures with excellent outcomes and rapid hemostasis. We are pleased that the closure system’s unique and innovative technology complements Terumo’s vascular closure device portfolio, and we look forward, together with Terumo’s strong expertise in product development and commercialization, to accelerating the time to market of the closure system in the emerging large bore market and driving further innovation into the hands of healthcare providers,” said Dr. Yue-Teh Jang, Chairman and CEO of Medeon.
About Medeon Biodesign Medeon Biodesign (TPEx: 6499) is a publicly traded company located in Taipei, Taiwan, and currently listed on Taipei Exchange. The company focuses on the development of medical devices for minimally invasive surgeries to treat diseases of sizable patient population, such as cardiovascular, peripheral vascular, orthopedic, neurosurgery, obesity, gastroenterology, hematology, nephrology, gynecology, urology, and plastic surgery. For more information, please visit www.medeonbio.com/en.
Medeon Contacts Dr. Yi-Ju Chen +886.2.2881.6686 firstname.lastname@example.org