Company Profile
MiRus is a US-based manufacturer of orthopedic and cardiovascular implants, headquartered in Marietta, Georgia, USA. Founded in 2015, the company operates as an independent, privately-held entity backed by Boston Scientific (34% equity stake acquired May 2026), serving spine, orthopedic, and structural heart markets globally.
Core Products ＆ Technologies
Spine Fixation ＆ Fusion Systems
• EUROPA™ Posterior Cervical Fusion System: 2.9 mm MoRe rod with low-profile pedicle screw tulips for cervical and upper thoracic fixation; FDA Breakthrough Device Designation and CMS NTAP awarded
• CYGNUS™ MoRe Anterior Cervical Plate: 1.0 mm thin-profile plate for ACDF, FDA 510(k) cleared; reportedly the narrowest and thinnest anterior cervical plate on the global spine market
• MiRus 3DR™ Lateral Lumbar Interbody Fusion System: Integrated MoRe lateral plate fixation with tapered 2 mm thickness; 2023 Spine Technology Award recipient
• IO™ Expandable TLIF/PLIF Spacer: Expandable interbody device for posterior lumbar fusion
• RIGEL 3DR™ Stand-Alone ACDF Spacer: Zero-profile 3D-printed titanium anterior cervical spacer
• EUROPA™ Thoracolumbar Open and MIS Pedicle Screw System: Posterior fixation for thoracolumbar deformity and fusion
Extremity ＆ Osteotomy Systems
• IO™ Expandable Wedge Osteotomy System: FDA 510(k) cleared (February 2026) intraoperatively adjustable nitinol wedge powered by the MoRe Expansion Engine for Evans osteotomy and lateral column lengthening
Structural Heart Systems
• Siegel™ 8-F Transcatheter Heart Valve (THV): Nickel-free rhenium-alloy balloon-expandable TAVR system with dry porcine tissue leaflets, nitric oxide-coated rhenium frame, and minimal recoil; all sizes (23 mm, 26 mm, 29 mm) delivered via an 8-French expandable sheath approximately 50% smaller than current commercial TAVR sheaths; FDA IDE approved for the STAR pivotal trial (April 2026); investigational device not approved for sale in any country
Market Position ＆ Certifications
MiRus holds a disruptive position in the global orthopedic implant and structural heart markets, competing with Stryker and Medtronic in spine fixation and Edwards Lifesciences in transcatheter aortic valve replacement. Key strengths include:
• 10+ years of biomaterial R＆D heritage in molybdenum-rhenium superalloys
• MoRe® Superalloy: Proprietary high-yield-strength, fatigue-resistant, biofriendly alloy enabling smaller, more durable implants than conventional titanium or cobalt-chrome
• Regulatory compliance: FDA 510(k) cleared (CYGNUS, 3DR, IO Wedge, EUROPA navigated instruments); FDA Breakthrough Device Designation (EUROPA PCF); CMS NTAP (EUROPA PCF); FDA IDE (Siegel TAVR)
• Strategic backing: $1.5 billion strategic investment from Boston Scientific in May 2026, with exclusive option to acquire the TAVR business for an additional $3 billion upon milestones, plus an option to acquire mitral and tricuspid replacement valve assets
Corporate Timeline
2015 — Founded in Marietta, GA to develop proprietary rhenium-based medical alloys and implants
2021 — Closed $65M oversubscribed funding round led by Mammoth Scientific
2023 — FDA 510(k) clearance granted for CYGNUS ACP and 3DR lateral lumbar system; 3DR lateral plate awarded 2023 Spine Technology Award
2024 — FDA Breakthrough Device Designation granted for EUROPA Posterior Cervical System
2025 — CMS New Technology Add-on Payment (NTAP) awarded for EUROPA PCF System
2026 — FDA 510(k) clearance for EUROPA navigated instruments (March); FDA 510(k) clearance for IO Expandable Wedge Osteotomy System (February); STAR pivotal trial initiated for Siegel TAVR with first patients enrolled at Piedmont Heart Institute (April); Boston Scientific $1.5B strategic investment for 34% equity stake with pathway to full TAVR business acquisition (May)
Target Markets ＆ Applications
• Spine deformity and fusion: Cervical, thoracolumbar, and lateral lumbar fixation and interbody systems for degenerative and deformity conditions
• Foot and ankle reconstruction: Expandable wedge osteotomy for adult-acquired flatfoot and multiplanar deformity correction
• Aortic stenosis: Transcatheter aortic valve replacement for severe symptomatic patients across low, intermediate, and high surgical risk profiles
Contact Information
Global Headquarters
Address: Marietta, Georgia, USA
Phone: 770-317-5564
Parent Company
MiRus, LLC operates as an independent, privately-held entity with no publicly traded stock.
Boston Scientific holds a 34% equity stake as of May 2026.
Website: mirusmed.com
Investor Relations: Private company; contact mkrishnan@mirusmed.com
