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LEWISVILLE, Texas: Orthofix Medical Inc (NASDAQ:OFIX), a medical device company with a spine and orthopedics focus, today announced a strategic partnership agreement with CGBio, a developer of innovative, synthetic bone grafts currently used clinically in Asia for spine, orthopedic, trauma and dental applications. The two companies will work together for clinical development and commercialization of Novosis™ recombinant human bone morphogenetic protein-2 (rhBMP-2) bone growth materials and other future tissue regenerative solutions for the US and Canadian markets.
Under the terms of the license and distribution agreement, Orthofix will conduct clinical studies, obtain regulatory approvals, and commercialize the Novosis’ rhBMP-2 technology in the US and Canada. As a consideration of the agreement, CGBio will receive an upfront payment and potential development milestone payments upon achievement of regulatory milestones.
“This announcement represents the start of an exciting partnership to bring the next evolution of recombinant bone growth factor technology to the market,” said Orthofix President and CEO Jon Serbousek. “Pending successful US clinical trials and subsequent approvals, this surgeon-driven biologic solution will provide a moldable, flowable, bioactive rhBMP-2 bone graft material in the US and fits well within our comprehensive portfolio of allografts with viable cells, demineralized fiber allografts, DBMs, synthetic scaffolds, and spinal constructs. Expanding our regenerative technology portfolio will further provide important procedural options for surgeons to enhance the clinical outcomes for their patients.”
“We are pleased to collaborate with Orthofix who has a long history of success in the US biologics market,” said CGBio CEO Hyun Seun Yu. “The potential to bring our solutions to the US and Canadian markets is exciting and aligns well with our strategic goal of broadening the availability of our regenerative biopharmaceuticals.” (AP)
SOUTH SAN FRANCISCO, Calif:
Twist Bioscience Corporation (NASDAQ:
TWST), a company enabling customers to succeed through its offering of highquality synthetic DNA using its silicon platform, and Biotia, Inc, a company that uses proprietary analytical software for infectious disease diagnostics, today received expanded Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay for the qualitative detection, identification and differentiation of SARS-CoV-2 lineages and identification of specific genomic mutations. The Assay was developed in 2020, and this expanded authorization builds on the initial EUA that was received in March 2021 for the qualitative detection of the SARS-CoV-2 virus.
The hybridization capture-based SARSCoV-2 NGS Assay has the ability to analyze the entire RNA viral sequence, and to determine the presence or absence of the virus. With the expanded authorization, the reporting of the identified and differentiated SARS-CoV-2 genetic mutations and viral lineages (e.g. Delta, Omicron) to clinicians is now authorized, potentially aiding them to direct appropriate clinical management based upon the specific lineage of virus, when clinically indicated. (AP)
SAN DIEGO: Vektor Medical, developer of the first technology to rapidly map arrhythmias anywhere in the heart using only 12-lead ECG data, announced the appointment of three key executives. The appointments, which come as Vektor prepares to expand the commercial availability of its vMap technology in the US, are Joe Braidwood as Chief Strategy Officer, Christian David Márton, Ph.D., as Vice President of Technology and Averee Chang as Vice President of Product.
“Through its early commercial success, we’ve seen that vMap has the potential to transform arrhythmia care,” said Rob Krummen, CEO. “Joe, Averee and Christian are leaders in their respective fields, with distinct perspectives that will help drive our vision forward. I’m thrilled to welcome them to the team and look forward to working closely together through this exciting phase of our journey.” (AP)