Soft Tissue Regeneration Articles & Analysis
17 news found
End of study brings Robocath closer to commercializing R-One in China in 2023 149 patients enrolled over six months in four Chinese centers Results of first vascular robotics study on this scale in China will be published in March 2023 Robocath, a company that designs, develops and commercializes innovative robotic platforms for the treatment of vascular diseases, announces today that ...
ByRobocath
Robocath, a company that designs, develops and commercializes innovative robotic platforms for the treatment of vascular diseases, today announces the successful completion of the first coronary angioplasty in China assisted by its R-One™ robotic platform. The procedure took place at the 301 Hospital in Beijing on November 24; performed by Dr. Yundai Chen, a renowned interventional ...
ByRobocath
The four new patents relate to Biorez’s proprietary BioBrace Implant, which is a biocomposite soft tissue scaffold intended to reinforce soft tissue repair, and act as a biologic scaffold to promote healing. ...
Biorez Inc., a New Haven start-up advancing tendon and ligament healing, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for two sizes of its BioBrace Implant. This new biocomposite soft tissue scaffold is intended to be used in a broad range of surgical procedures to reinforce soft tissue where weakness exists, and can be used with ...
” “Implants that are bioinductive while providing structure for healing tissues during the repair or reconstruction continuum is the natural progression with this type of technology and I am looking forward to working with our surgeons to deliver the best-in-class implant for their practice and their patients,” commented Mr. ...
The University of Chicago Medicine has announced today that it is now enrolling patients into LymphBridge, a randomized clinical study to evaluate a novel investigational surgical device for the treatment of breast cancer-related lymphedema. This study is sponsored by Fibralign Corporation with funding provided by the National Cancer Institute (NCI) and being led by world-renowned microsurgeon ...
“I have spent most of my career evaluating new technologies in orthopedics and have long awaited an implant that can meaningfully improve soft tissue healing,” said Dr. Pachuda. “Biorez has developed a regenerative scaffold that can reinforce soft tissue repair, improve healing, and naturally resorb over time. ...
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced enrollment of the first patient in a multi-site, randomized clinical trial in Europe evaluating its BioBridge® Collagen Matrix as a novel preventative treatment for secondary lymphedema. The study plans to enroll 40 patients that have been diagnosed with advanced stage breast cancer and ...
Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced that it has received CE mark for its first product, the BioBridge Collagen Matrix. BioBridge is classified as a Class III device with an indication for use to support lymphatic tissue repair and can be used after or in conjunction with surgical procedures addressing lymphedema. CE mark is a ...
Fibralign Corp., a Stanford spin-out developer of therapeutic biomedical devices, has announced today that it has executed a long term distributor agreement with Terumo Corporation to market and distribute the BioBridge® Collagen Matrix in Japan for treating and preventing secondary lymphedema. BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh made of highly ...
CoNextions Inc. (www.conextionsmed.com) announced today that it received a 510(k) clearance (K200028) from the U.S. Food and Drug Administration (FDA) for CoronetTM System, a tenodesis product intended for the fixation of tissue to bone and tissue to tissue. The Coronet’s novel design improves the soft tissue fixation strength of these repairs compared to conventional suture repairs. A ...
CoNextions Medical, a developer of novel soft tissue repair devices, announced today that it has completed enrollment in a key clinical trial for its pioneering tendon-to-tendon repair device, CoNextions TR. Pending successful results of the trial, the company plans to submit a 510(k) application to the FDA for US marketing approval in the first quarter of ...
Fibralign received Certification Notification on February 18, 2018 from notifying body DEKRA Certification B. V. that it’s management system meets the requirements of EN ISO 13486:2016:2012 + AC:2012. The scope of the certification is for the design, development, manufacture and distribution of porcine collagen scaffold implants used for soft tissue repair and support, ...
Dan Gruppo, the Vice President of Sales and Marketing for Stryker Upper Trauma and Extremities at Stryker Orthopaedics, Joins CoNextions Medical as Executive Vice President of Sales and Marketing as CoNextions Prepares for its anticipated FDA Clearance and the Launch of its Revolutionary CoNextions TR Device in the United States CoNextions Medical (www.conextionsmed.com) has announced that Dan ...
Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. In conjunction with its formation, Colibri has granted Colorado Therapeutics a license to develop and market innovative and disruptive xenogenic (sourced from different mammalian species) biologic tissue ...
Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. In conjunction with its formation, Colibri has granted Colorado Therapeutics a license to develop and market innovative and disruptive xenogenic (sourced from different mammalian species) biologic tissue ...
CoNextions Medical, Inc. (conextionsmed.com) announced that it will premiere their next generation tendon repair technology, CoNextions TR, at the 70th annual scientific meeting of the American Society for Surgery of the Hand (ASSH) in Seattle. CoNextions TR has been designed to provide several advantages over the current suture-based repair which is the standard of care, including: stronger ...