MiRus has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its CYGNUS Molybdenum-Rhenium (MoRe) Anterior Cervical Plate (ACP) and MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated MoRe plate fixation.

MiRus, a Georgia, US-based life sciences company, claimed that both the systems are the narrowest and thinnest plating systems among all existing plates in the global spine industry.

MoRe is the company’s proprietary molybdenum rhenium superalloy for medical implants. It is said to offer a superior blend of strength, ductility, durability, and biological safety.

The superalloy allows the development of a new generation of biocompatible, smaller, stronger, and longer-lasting implants that cause less disruption to soft tissue and promote faster patient recovery, said the company.

MiRus chief commercial officer Mahesh Krishnan said: “The CYGNUS MoRe Anterior Cervical Plate is a world class product in the ACDF marketplace that furthers our commitment to minimally invasive, stronger biofriendly implants.

“With its thin 1.0mm profile, the CYGNUS MoRe ACP will lead to less retraction and anterior vertebral body preparation resulting in shorter operative times and minimising risk of complications such as dysphagia and dysphonia in patients undergoing anterior cervical fusion.”

The Integrated MoRe lateral plate’s molybdenum-rhenium alloy allows a much-reduced footprint of around 2mm thickness without compromising performance.

As there is minimal space around the vital nerve and psoas structures in a lateral spinal fusion technique, a plate that is 40–60% thinner than the ones that are currently available would have a major positive therapeutic impact, the life sciences company said.

MiRus founder and CEO Jay Yadav said: “Both the CYGNUS MoRe ACP and the MiRus 3DR Lateral Lumbar Interbody Fusion system with Integrated MoRe plate fixation are major accomplishments in the global spine market, as we strive to develop products that are best in class with a resolve to provide meaningful innovations to surgeons that improve patient outcomes.”

In 2021, MiRus closed a $65m funding round to develop structural heart disease solutions and advance its spine and extremity portfolios.