Press Releases

MiRus Receives FDA 510(K) Clearance For
The Lowest Profile and Best-in-class Expandable Lumbar Interbody

ATLANTA- August 31, 2021 – MiRus LLC, the leading innovator in rhenium-based superalloy medical implants announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its IO™ Expandable Lumbar Interbody. The IO™ Expandable Lumbar Interbody can be utilized in both PLIF and TLIF procedures.  It features the lowest insertion profile …

MiRus Receives FDA 510(K) Clearance For
The Lowest Profile and Best-in-class Expandable Lumbar Interbody
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MiRus™ Raises $65 Million For Expansion of Rhenium-based Medical Devices

ATLANTA- July 27, 2021 – MiRus LLC, a commercial stage life sciences company, has completed a highly oversubscribed funding round for growth of its spine and extremity portfolios and development of structural heart disease solutions using its proprietary Rhenium-based alloys (MoRe®).  The round was led by Mammoth Scientific and multi-generational family offices who have supported …

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MiRus™ announced today that Mark Faucett has joined the company’s Leadership Team as Vice President of Business Development effective June 1, 2021.

Mr. Faucett has most recently served as founder and CEO of Capital Surgical Solutions, a medical device distributorship. He brings over 30 years of experience successfully growing sales teams by pairing proven leadership achievements in the medical device space with the ability to form key partnerships, developing high-performing teams, and creating compelling sales strategies in solution-oriented environments.
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MiRus™ Launches MoRe® Promise- a Lifetime Limited Warranty for its Molybdenum-Rhenium Superalloy Rod.

MiRus announced today that they will offer a LIFETIME LIMITED WARRANTY on its Molybdenum-Rhenium ( MoRe®) superalloy rod technology. The warranty will cover full replacement of the MoRe® Rod and corresponding MiRus hardware used in spinal fusion cases should the MoRe® Rod fracture. The warranty will cover all thoracolumbar MoRe® rods implanted as part of the EUROPA™ Pedicle Screw System supplied by MiRus in the United States effective March 1, 2021.
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MiRus™ Announces First Clinical Use of the MiRus™ 3DR™ Printed Lumbar Interbody Fusion System.

MiRus is pleased to announce that it received FDA 510(k) clearance for its 3DR™ (Randomized) Printed Lumbar Interbody Fusion System which consists of the CALLISTO 3DR™ PLIF, HYPERION 3DR™ TLIF, CALYPSO 3DR™ LLIF and the ANTARES 3DR™ ALIF.
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First Spine Surgeries using the MoRe® Superalloy.

MiRus announces successful spine surgeries at several centers across the country using the MoRe® superalloy. MiRus had received FDA 510(k) clearance for the MoRe® based Europa™ Pedicle Screw System earlier this year.
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MiRus Receives FDA Clearance for Lowest Profile Anterior Cervical Plate System.

MiRus is pleased to announce recent FDA 510(k) clearance of the CYGNUS™ Anterior Cervical Plate System, the narrowest and thinnest cervical plate on the market.
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First System for Dynamic Intra-operative Measurement of Segmental and Global Spine Alignment Receives FDA Clearance.

MiRus is pleased to announce FDA 510(k) clearance of the GALILEO™ Spine Alignment Monitoring System, a non-optical, wireless, real-time measurement system for segmental and global sagittal spine alignment.
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MiRus Aquires 50,000 SQFT Manufacturing Facility.

Following the 510(k) clearance by FDA in March 2019 of MoRe®, a proprietary molybdenum rhenium superalloy for medical implants, MiRus is excited to announce a major expansion of its manufacturing capacity with the addition of a fully operational 50,000 sqft orthopaedic and spine manufacturing plant in Marietta, GA.
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MiRus Receives FDA 510(k) Approval for First Medical Implant with New Superalloy.

MiRus has received FDA 510(k) approval for the MoRe® based Europa™ Pedicle Screw System making it the first FDA approved medical device with this new class of implant material.
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