TORONTO – Femtherapeutics Inc. is combining artificial intelligence-driven machine learning and 3D design to manufacture a device for relieving urinary incontinence and discomfort in women suffering pelvic organ prolapse. The custom-made pessary is intended to support vaginal tissues displaced because of the condition, replacing conventional pessaries that company officials said can result in irritation and penetrate soft tissues causing bleeding.
TORONTO – Titan Medical Inc. has received a $10 million license payment from Medtronic plc for a total of $30 million that the Irish med-tech firm has invested in robotic-assisted surgical technologies developed by Titan. Titan is pursuing gynecologic surgical applications for its Enos robotic single access surgical system, licensing it and related intellectual property to Medtronic while retaining worldwide rights to commercialize technologies for use with the Enos system.
Health Canada is proposing amendments to the Food and Drugs Act that would provide greater oversight of the manufacture of drugs for export. Currently, facilities that manufacture or prepare drugs in Canada for use outside the country are not required to obtain a drug establishment license or to follow Canadian requirements for good manufacturing practices, and they are exempt from fees.
Neovasc Inc. has hit pause on its Tiara transfemoral mitral valve replacement (TF) program and is cutting its workforce by more than 40%, citing the additional time and substantial investment required to develop the program and the associated costs. The changes are expected to extend its cash runway from about 18 months to more than three years. The changes were implemented with about 18 months to remain solvent as part of a series of actions to focus on enhancing current shareholder value and focusing investments on near-term value drivers, namely the Reducer stent and the Tiara transapical mitral valve replacement (TA) system.
The U.S. isn’t the only country tossing COVID-19 vaccines due to potential cross-contamination of the drug substances manufactured at an Emergent Biosolutions Inc. plant.
TORONTO – Nanology Labs Inc. has raised C$3 million (US$2.49 million) in seed funding to advance development of a polymer-lipid platform that transports nanoparticles into human cells where they “reprogram” hypoxic or oxygen-deprived cancer tumors.
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
A lawsuit filed last year challenging a federal rule and certification allowing certain drugs to be imported from Canada should be dismissed because no drug companies have been harmed yet, nor are they likely to be any time soon, the Biden administration said in a motion seeking dismissal of the suit.
TORONTO – Arthrolense Inc. has just seen its bank balance swell after Lynx Equity Ltd. invested $2 million to further develop the startup’s augmented, mixed reality surgical guidance systems for hip and knee replacement. According to orthopedic surgeon and company CEO David Backstein the Arthrolense system uses vastly improved hologram-based technologies to solve problems that persist in computer navigation and robotic systems.
TORONTO – Startup company Stoko Inc. has raised C$6 million (US$4.74 million) in seed funding to accelerate market expansion of a device it said will give rigid knee braces a run for their money.
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