The FDA has given thumbs up to two clinical studies for a transcatheter aortic valve replacement (TAVR) system developed by HLT Inc. to treat aortic stenosis among high-risk patients. Those studies will include aortic regurgitation which also occurs when an aortic valve doesn't open and close tightly enough but for which there are few suitable, noninvasive treatments.
Ossio Inc. has received FDA clearance for Ossiofiber suture anchors used to fix soft tissue to bone in the shoulder, foot and ankle. This is the most recent of clearances for the company’s intelligent bone regeneration technology which began in 2019 as a possible alternative to permanent fixation implants for the foot and ankle alone.
Biocircuit Technologies Inc. has joined forces with Smithfield Bioscience Inc. to scale up a medical alternative to sutures for repairing nerves on the peripheral side of the body damaged in an accident or during surgery. Nerve Tape is an implantable device composed of decellularized porcine tissue embedded with microhooks that attach to damaged nerves and may heal them more quickly and safely than conventional sutures.
3Spine Inc. has raised $33 million in an oversubscribed series C private offering for a phase II clinical study to assess what it calls “the first total joint replacement” for the lower back. This brings total private investment in the Balancedback total joint replacement to $50.3 million, largely due, said 3Spine CEO Marc Peterman, to “tremendous clinical outcomes and a mountain of benchtop research.”
Zeta Surgical Inc. has raised $5.2 million in seed funding to improve the accuracy and safety of image-guided surgical procedures through its Zeta neurosurgical navigation platform. Zeta CEO Jose Maria Amich told BioWorld the funding will also advance a non-invasive ultrasound system for imaging the brain and help complete initial clinical studies for its FDA approvals application.
Oculogica Inc. has signed an agreement with Minnetronix Inc. to launch a diagnostic device that tracks eye movements to detect possible brain concussion, this after receiving FDA clearance in December for its fourth iteration of the artificial intelligence-driven, battery-operated Eyebox.
Interrad Medical Inc. has formed a strategic partnership with Eloquest Healthcare Inc. to accelerate sales growth of what is described as the only subcutaneous catheter securement device in the world.
Developed by Infrascan Inc., the FDA-cleared Infrascanner device was touted as the first hand-held device to help detect bleeding in the skull and supported financially by the U.S. military anxious to treat moderate to severe traumatic brain injury in wounded service members. The FDA has now expanded the Infrascanner’s use to traumatic intracranial hematomas or brain bleeds in pediatric patients aged 2 years and older.
Vena Medical Inc. received Health Canada approval for a device that combines two neurovascular catheters that typically work separately to remove clots from the brains of people who have suffered stroke.
A needle-free injection system for patients with diabetes developed by Nugen Medical Devices Inc. has been approved for use in 40 countries but until now has yet to crack the North American market. Nugen said it is now gearing up for FDA and Mexican approval of the Nugen MD needle-free injector following Health Canada’s approval of the system less than a month after the Toronto med tech went public in late 2021.
