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3Spine

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uuid00028m7

Namestring
3Spine
Legal namestring
3Spine, Inc.
Websiteurl
3spine.com
Company typeenum
Private
Founded yearint
2014
Short descriptiontext

3Spine is a privately-held medical device company developing MOTUS, the first lumbar total joint replacement, as a motion-preserving alternative to spinal fusion for degenerative spine patients in the United States.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersChattanooga, United States
HQ citystring
Chattanooga
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
lumbar total joint replacement, spinal motion preservation, MOTUS spinal implant, spinal fusion alternative, lumbar degenerative surgery
Industry3 codes
1Spine Implants & Motion Preservation (Fusion/Disc/Interspinous)
CodeHLAHAEACPrimaryYes
2Orthopedic Joint Reconstruction Implants (Hip/Knee/Shoulder/Elbow/Ankle)
CodeHLAHAEAAPrimaryNo
3Prosthetic Components & Rehabilitation Accessories (Liners, Feet, Knees, Sockets)
CodeHLAHAMADPrimaryNo
NAICS code3 codes
  • Surgical and Medical Instrument Manufacturing339112
  • Surgical Appliance and Supplies Manufacturing339113
  • Medical Equipment and Supplies Manufacturing3391
SIC code2 codes
  • Orthopedic, Prosthetic & Surgical Appliances & Supplies3842
  • Surgical & Medical Instruments & Apparatus3841
Product category
Spinal Implants and Motion Preservation Medical Devices
No data
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1Medical Device Commercial Sales
TypeHardware Sales
Description

3Spine is currently pre-revenue as the MOTUS device is approved for investigational use only under FDA IDE. Upon FDA Pre-Market Approval (PMA), the company plans to commercially distribute the device through specialized Motion Surgery centers. Revenue will be generated through device sales and associated surgical procedures.

3spine.com
Marketing channels5 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels2 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 record
1MOTUS
Description

First total joint replacement device for the lumbar spine, replacing the function of the disc and facet joints.

3spine.com
Core offering1 text field

3Spine develops, manufactures, and plans to commercially distribute the MOTUS lumbar total joint replacement, a motion-preserving spinal implant that replaces the function of both the disc and facet joints as a single prosthesis. Delivered via the BALANCEDBACK posterior surgical procedure, the device reestablishes stability after discectomy and broad decompression while preserving the anterior longitudinal ligament and enabling dynamic adaptation between standing and sitting postures. The product is currently investigational under FDA IDE and will be sold to hospitals and specialized Motion Surgery centers upon FDA Pre-Market Approval.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 5 values shown
  • 2.4x improvement in Oswestry Disability Index (ODI) Substantial Clinical Benefit (SCB) compared to fusion at one year
+4 more records
Product overview1 text field

3Spine is a medical device company offering a single unified product: the MOTUS™ Spinal Implant, which is the first total joint replacement for the lumbar spine. The MOTUS device replaces the function of the disc and facet joints as a total joint replacement (TJR) for the lumbar spine, offering a motion-preserving alternative to spinal fusion. The company also provides the associated BALANCEDBACK® surgical procedure for implant placement. The technology is currently in FDA Investigational Device Exemption (IDE) clinical trials and is not yet commercially available in the United States.

Product and service2 records
1MOTUS Spinal Implant
CategorySpinal Implants / Motion Preservation Medical Devices
Description

The first total joint replacement for the lumbar spine, replacing the function of both the disc and facet joints as a single motion-preserving prosthesis for adult patients undergoing single-level lumbar reconstruction (L1/L2 to L5/S1) as an alternative to spinal fusion. Made of vitamin E stabilized polyethylene with cobalt chromium spherical counterfaces, intended for hospitals, surgeons, and patients with degenerative lumbar conditions.

2BALANCEDBACK Procedure
CategorySurgical Procedure / Operative Technique
Description

A posterior-approach surgical procedure associated with the MOTUS device, in which the surgeon removes both facet joints, performs decompression and discectomy, and inserts the MOTUS prosthesis to reconstruct the functional spinal unit. Designed for spinal surgeons and hospitals treating single-level lumbar degenerative disease at L1/L2 through L5/S1.

Scale indicator10 records

Each record includes

Type, Value, Description, Source

Partnership4 partners
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2020-01-01
Description

3Spine received Breakthrough Device Designation from FDA in 2020 and maintains close collaboration with both FDA and CMS. The company enjoys regulatory support for its IDE clinical trial and PMA pathway for the MOTUS lumbar total joint replacement.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2020-01-01
Description

3Spine maintains close collaboration with CMS in addition to FDA, indicating alignment on coverage and reimbursement pathways for the MOTUS lumbar total joint replacement upon commercial approval.

Strategic tierMinorTypeOthersAnnounced on2016-01-01
Description

International Surgical purchased the IP in 2016, rebranding the technology as BalancedBack and then MOTUS. International Surgical SEZC became 3Spine SEZC then 3Spine, Inc. The company is now fully capitalized and entirely independent.

Strategic tierMinorTypeOthersAnnounced on2014-01-01
Description

3Spine originated as a Medtronic spin-out. Medtronic purchased three-column IP in 2004 as the foundation for a posterior TJR IP portfolio, subsequently developing the KENAI device. In 2014, the portfolio was spun out to a private shell with Medtronic's support to complete additional refinements and the US IDE, leveraging private capital. The company is now fully independent.

Recent move8 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers8 records
TypeDirect peer
Description

Centinel Spine manufactures ProDisc L, one of two approved lumbar total disc replacement devices in the US. It is the most direct motion-preservation competitor to 3Spine's MOTUS, addressing a similar degenerative lumbar patient population with a different biomechanical approach.

TypeDirect peer
Description

Highridge Medical offers the activL lumbar artificial disc, the second FDA-approved lumbar TDR in the US. It competes with 3Spine in motion-preserving treatment of single-level lumbar degenerative disc disease.

TypeDirect peer
Description

Premia Spine's TOPS System is a posterior motion-preservation implant designed to replace the function of the facet joints. It overlaps with 3Spine in addressing lumbar motion preservation as an alternative to fusion.

TypeBroad incumbent
Description

Medtronic is a global spine incumbent and the originator of the three-column IP that became 3Spine's MOTUS. It sells a broad spine portfolio (including competitive fusion and interbody devices) and remains the dominant player in the US spinal implant market.

TypeBroad incumbent
Description

Globus Medical (which acquired NuVasive in 2023) is a broad spine incumbent with deep fusion, interbody, and emerging motion-preservation offerings. It competes in the same lumbar degenerative disease surgical setting as 3Spine.

TypeBroad incumbent
Description

Stryker's Spine division offers a comprehensive portfolio of cervical and lumbar fusion, interbody, and enabling technology products. It addresses the same lumbar degenerative patient population as 3Spine via the incumbent standard of care.

TypeEmerging player
Description

Orthofix is a smaller spine and orthopedics company with motion-preservation and biologics offerings. It is a more emerging competitor in the broader lumbar surgery market that 3Spine is targeting.

TypeEmerging player
Description

ATEC is a growth-stage spine company focused on degenerative and deformity surgery with a broad procedural portfolio. It is comparable in stage to 3Spine as a challenger to the major spine incumbents.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers4 records

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment3 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature5 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles3 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds6 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

3Spine

Spinal Implants and Motion Preservation Medical Devices3spine.com

3Spine is a privately-held medical device company developing MOTUS, the first lumbar total joint replacement, as a motion-preserving alternative to spinal fusion for degenerative spine patients in the United States.

3Spine firmographics

Firmographics
Name
3Spine
Legal name
3Spine, Inc.
Website
https://3spine.com
Company type
Private
Founded year
2014
Operating status
Operating
Headcount range
11–50 employees
Short description
3Spine is a privately-held medical device company developing MOTUS, the first lumbar total joint replacement, as a motion-preserving alternative to spinal fusion for degenerative spine patients in the United States.
Ownership category
akta.pro rank

3Spine industry classification

Industry
Product category
Spinal Implants and Motion Preservation Medical Devices
NAICS
Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)
SIC
Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841)
akta.pro primary industry
Spine Implants & Motion Preservation (Fusion/Disc/Interspinous) (HLAHAEAC)
akta.pro secondary industries
Orthopedic Joint Reconstruction Implants (Hip/Knee/Shoulder/Elbow/Ankle) (HLAHAEAA), Prosthetic Components & Rehabilitation Accessories (Liners, Feet, Knees, Sockets) (HLAHAMAD)

Keywords

  • Lumbar total joint replacement
  • Spinal motion preservation
  • MOTUS spinal implant
  • Spinal fusion alternative
  • Lumbar degenerative surgery

Where 3Spine is headquartered

Location

Headquarters

HQ city
Chattanooga
HQ country
United States
HQ region
North America

Offices1 record

Markets served

3Spine business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

  1. Medical Device Commercial Sales: 3Spine is currently pre-revenue as the MOTUS device is approved for investigational use only under FDA IDE. Upon FDA Pre-Market Approval (PMA), the company plans to commercially distribute the device through specialized Motion Surgery centers. Revenue will be generated through device sales and associated surgical procedures.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

3Spine product offering

Product offering

Core offering

3Spine develops, manufactures, and plans to commercially distribute the MOTUS lumbar total joint replacement, a motion-preserving spinal implant that replaces the function of both the disc and facet joints as a single prosthesis. Delivered via the BALANCEDBACK posterior surgical procedure, the device reestablishes stability after discectomy and broad decompression while preserving the anterior longitudinal ligament and enabling dynamic adaptation between standing and sitting postures. The product is currently investigational under FDA IDE and will be sold to hospitals and specialized Motion Surgery centers upon FDA Pre-Market Approval.

Product overview

3Spine is a medical device company offering a single unified product: the MOTUS™ Spinal Implant, which is the first total joint replacement for the lumbar spine. The MOTUS device replaces the function of the disc and facet joints as a total joint replacement (TJR) for the lumbar spine, offering a motion-preserving alternative to spinal fusion. The company also provides the associated BALANCEDBACK® surgical procedure for implant placement. The technology is currently in FDA Investigational Device Exemption (IDE) clinical trials and is not yet commercially available in the United States.

Differentiator

Problem solved

Functional benefit

Brands

  • MOTUS: First total joint replacement device for the lumbar spine, replacing the function of the disc and facet joints.

Products and services

  • MOTUS Spinal Implant The first total joint replacement for the lumbar spine, replacing the function of both the disc and facet joints as a single motion-preserving prosthesis for adult patients undergoing single-level lumbar reconstruction (L1/L2 to L5/S1) as an alternative to spinal fusion. Made of vitamin E stabilized polyethylene with cobalt chromium spherical counterfaces, intended for hospitals, surgeons, and patients with degenerative lumbar conditions.
  • BALANCEDBACK Procedure A posterior-approach surgical procedure associated with the MOTUS device, in which the surgeon removes both facet joints, performs decompression and discectomy, and inserts the MOTUS prosthesis to reconstruct the functional spinal unit. Designed for spinal surgeons and hospitals treating single-level lumbar degenerative disease at L1/L2 through L5/S1.

Quantifiable outcome

  • 2.4x improvement in Oswestry Disability Index (ODI) Substantial Clinical Benefit (SCB) compared to fusion at one year
  • +4 more outcomes

Companies that use 3Spine

Customer profile

Named customers4 records

Segments3 records

Ideal customer profiles2 records

3Spine technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature5 records

3Spine partnerships and signals

Strategic signal

Partnerships

Four partnerships are on record, tiered core and minor.

  • FDAcoreStrategic or Co-development Partner · 1 January 20203Spine received Breakthrough Device Designation from FDA in 2020 and maintains close collaboration with both FDA and CMS. The company enjoys regulatory support for its IDE clinical trial and PMA pathway for the MOTUS lumbar total joint replacement.
  • CMS (Centers for Medicare & Medicaid Services)coreStrategic or Co-development Partner · 1 January 20203Spine maintains close collaboration with CMS in addition to FDA, indicating alignment on coverage and reimbursement pathways for the MOTUS lumbar total joint replacement upon commercial approval.
  • International Surgical (SEZC)minorOthers · 1 January 2016International Surgical purchased the IP in 2016, rebranding the technology as BalancedBack and then MOTUS. International Surgical SEZC became 3Spine SEZC then 3Spine, Inc. The company is now fully capitalized and entirely independent.
  • MedtronicminorOthers · 1 January 20143Spine originated as a Medtronic spin-out. Medtronic purchased three-column IP in 2004 as the foundation for a posterior TJR IP portfolio, subsequently developing the KENAI device. In 2014, the portfolio was spun out to a private shell with Medtronic's support to complete additional refinements and the US IDE, leveraging private capital. The company is now fully independent.

Scale indicators10 records

Recent moves8 records

Expansion highlights6 records

3Spine competitors and assessment

Company assessment

Direct peers

  • Centinel Spine: Centinel Spine manufactures ProDisc L, one of two approved lumbar total disc replacement devices in the US. It is the most direct motion-preservation competitor to 3Spine's MOTUS, addressing a similar degenerative lumbar patient population with a different biomechanical approach.
  • Highridge Medical: Highridge Medical offers the activL lumbar artificial disc, the second FDA-approved lumbar TDR in the US. It competes with 3Spine in motion-preserving treatment of single-level lumbar degenerative disc disease.
  • Premia Spine: Premia Spine's TOPS System is a posterior motion-preservation implant designed to replace the function of the facet joints. It overlaps with 3Spine in addressing lumbar motion preservation as an alternative to fusion.

Broad incumbents

  • Medtronic: Medtronic is a global spine incumbent and the originator of the three-column IP that became 3Spine's MOTUS. It sells a broad spine portfolio (including competitive fusion and interbody devices) and remains the dominant player in the US spinal implant market.
  • NuVasive (Globus Medical): Globus Medical (which acquired NuVasive in 2023) is a broad spine incumbent with deep fusion, interbody, and emerging motion-preservation offerings. It competes in the same lumbar degenerative disease surgical setting as 3Spine.
  • Stryker: Stryker's Spine division offers a comprehensive portfolio of cervical and lumbar fusion, interbody, and enabling technology products. It addresses the same lumbar degenerative patient population as 3Spine via the incumbent standard of care.

Emerging players

  • Orthofix Medical: Orthofix is a smaller spine and orthopedics company with motion-preservation and biologics offerings. It is a more emerging competitor in the broader lumbar surgery market that 3Spine is targeting.
  • ATEC (Alphatec Holdings): ATEC is a growth-stage spine company focused on degenerative and deformity surgery with a broad procedural portfolio. It is comparable in stage to 3Spine as a challenger to the major spine incumbents.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

3Spine financial estimates

Financial estimate

Revenue estimate

Valuation estimate

3Spine leadership team

Management profile

Number of profiles

Profiles3 records

3Spine funding detail

Funding detail

Funding overview

Funding rounds6 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

3Spine M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about 3Spine

What does 3Spine do?

3Spine develops, manufactures, and plans to commercially distribute the MOTUS lumbar total joint replacement, a motion-preserving spinal implant that replaces the function of both the disc and facet joints as a single prosthesis. Delivered via the BALANCEDBACK posterior surgical procedure, the device reestablishes stability after discectomy and broad decompression while preserving the anterior longitudinal ligament and enabling dynamic adaptation between standing and sitting postures. The product is currently investigational under FDA IDE and will be sold to hospitals and specialized Motion Surgery centers upon FDA Pre-Market Approval.

Is 3Spine a public or private company?

3Spine is a private company. It is classified as venture growth investor backed and is currently operating.

When was 3Spine founded?

3Spine was founded in 2014. It employs 11 to 50 people.

Where is 3Spine based?

3Spine is headquartered in Chattanooga, United States, in the North America region.

How does 3Spine make money?

One revenue line is on record: medical Device Commercial Sales.

Who are 3Spine's main competitors?

Direct peers on record are Centinel Spine, Highridge Medical and Premia Spine. Broad incumbents are Medtronic, NuVasive (Globus Medical) and Stryker. Emerging players are Orthofix Medical and ATEC (Alphatec Holdings).

Does 3Spine have an API?

No public API is recorded for 3Spine.

What industry is 3Spine in?

3Spine's product category is Spinal Implants and Motion Preservation Medical Devices. Its primary akta.pro industry code is HLAHAEAC, Spine Implants & Motion Preservation (Fusion/Disc/Interspinous), with a secondary code of HLAHAEAA, Orthopedic Joint Reconstruction Implants (Hip/Knee/Shoulder/Elbow/Ankle). Its NAICS code is 339112 and its SIC code is 3842.

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Live signals
SecSEC FORM D3Spine, Inc. filed a Form D with the U.S. Securities and Exchange Commission for an exempt offering of securities under Rule 506(b). The company is raising up to $10 million in debt securities, having already sold $8,217,000 from a total target amount.OrthotwBest New Spine Technologies for 2023Orthopedics This Week convened a panel of spine surgeons to recognize ten companies as having developed the best new spine technologies for 2023, covering areas including implants, surgical navigation, and rehabilitation platforms. The award-winning technologies include the 3Spine MOTUS Lumbar Total Joint Replacement (FDA Breakthrough Device Designation), HAPPE Spine's Integrate-C Interbody Fusion System, IncludeHealth's virtual physical therapy platform, MiRus's MoRe plating system, Proprio's PARADIGM surgical navigation system, Ruthless Spine's RJB disposable navigation tool, Spinal Stabilization Technologies' PerQdisc nucleus replacement implant, SurgiSTUD's SpineSTUD surgical simulator, VUZE Medical's navigation software, and Woven Orthopedic Technologies' Ogmend screw enhancement system. These innovations address clinical needs such as motion preservation, screw fixation in poor bone quality, radiation-free navigation, and improved patient rehabilitation outcomes.PR NewswireDr. Armen Khachatryan completes first lumbar total joint replacement surgeries in Park City, UT with 3Spine MOTUS technologyDr. Armen Khachatryan completed the first series of MOTUS lumbar total joint replacement surgeries at The Disc Replacement Center in Park City, Utah, as part of the BalancedBack pivotal clinical trial sponsored by 3Spine. The MOTUS device is a first-of-kind technology that replaces both the disc and facet joint functions through a posterior approach, offering an alternative to traditional spinal fusion for treating degenerative lumbar disease. 3Spine is pursuing FDA clearance for single-level indications from L1-S1 in patients with lumbar degeneration.PR Newswire3Spine Announces 200 of 300 Patients Enrolled in Ongoing Studies3Spine, Inc. announced completion of the 50th MOTUS lumbar total joint replacement procedure in the United States under FDA Investigational Device Exemption and full enrollment of the 150-patient Real-World Evidence fusion control study. The milestone allows eligible clinical sites to begin recruiting MOTUS patients for the broader IDE trial. The company expects U.S. regulatory approval for the device, which is a first-of-kind technology designed as an alternative to spinal fusion, in 2025.PR NewswireDr. Todd Lanman Begins Breakthrough Low Back Total Joint Replacement Clinical Trial in Beverly Hills with 3Spine, Inc.Dr. Todd Lanman, a spinal neurosurgeon in Beverly Hills, completed the first lumbar total joint replacement procedure in California as part of a pivotal clinical trial sponsored by 3Spine, Inc., using the MOTUS implant. The procedure, performed on an outpatient basis at the Advanced Surgery Center of Beverly Hills, represents a first-of-kind technology that replaces both disc and facet joint function through a posterior approach, treating degenerative lumbar disease similar to hip or knee replacement. If the clinical trial succeeds, Dr. Lanman estimates the technology could enable treatment of up to 80% of degenerative lumbar patients with leg and back pain, including those with severe stenosis, worn-out facets, bad discs, and instability.PR Newswire3Spine, Inc. Opens Innovative Clinical Trial for Spine Procedure with Pinehurst Surgical Clinic in Pinehurst, North CarolinaPinehurst Surgical Clinic announced successful completion of the first series of cases in 3Spine's BalancedBack Total Joint Replacement pivotal clinical trial using the MOTUS device at FirstHealth Moore Regional Hospital in North Carolina. The MOTUS device is a first-of-its-kind lumbar total joint replacement that treats degenerative spinal disease through reconstruction of the functional spinal unit, offering an alternative to spinal fusion. 3Spine, Inc., the study sponsor headquartered in Chattanooga, Tennessee, is seeking single-level indications from L1-S1 for patients with lumbar degeneration.PR NewswireDr. Anton Jorgensen begins lumbar total Joint replacement clinical trial in San Antonio, TX with 3Spine, Inc.Dr. Anton Jorgensen at Ortho San Antonio completed the first cases in the BalancedBack Total Joint Replacement pivotal clinical trial using 3Spine's MOTUS device at Foundation Surgical Hospital of San Antonio. The procedure, a first-of-kind lumbar total joint replacement alternative to spinal fusion, targets degenerative lumbar disease through a posterior approach that addresses disc and facet joint function. 3Spine, Inc. is actively recruiting additional patients with single-level lumbar spine disease for the trial.PR Newswire3Spine, Inc. Opens Innovative Clinical Trial for Spine Procedure with Steamboat Orthopaedic & Spine Institute in ColoradoSteamboat Orthopaedic & Spine Institute in Colorado has completed its first series of surgeries in the BalancedBack Total Joint Replacement pivotal clinical trial using 3Spine Inc.'s MOTUS lumbar device, becoming the first clinical site in the western US for this trial. The MOTUS device is a motion-preserving lumbar joint replacement designed as an alternative to traditional spine fusion surgery, with 3Spine seeking FDA approval for single-level indications from L1-S1. The first procedures were performed on October 11, 2022, at the Steamboat Surgery Center, a facility jointly operated by UC Health and the institute.PR Newswire3Spine, Inc. Completes First US Surgeries3Spine, Inc. announced completion of the first series of US surgeries in its BalancedBack Total Joint Replacement Investigational Device Exemption (IDE) pivotal clinical trial, performed at the Center for Sports Medicine and Orthopaedics Surgery Center in Chattanooga, TN. The MOTUS device used in the procedure is described as a 'first of kind' technology that replaces the function of the disc and facet joints through a posterior approach, targeting patients with lumbar degeneration. All IDE patients will be propensity matched against participants in 3Spine's existing real-world evidence fusion study, which has been enrolling since May 2021.PR Newswire3Spine, Inc. Announces IDE Approval3Spine, Inc. announced FDA Investigational Device Exemption (IDE) approval for its US pivotal clinical trial of the MOTUS device, a first-of-kind total joint replacement for the lumbar spine developed through the BalancedBack procedure. The company plans to enroll approximately 150 real-world evidence patients and 150 IDE patients across 16 US centers using an adaptive statistical design. MCRA served as the contract research organization supporting 3Spine through the study design and IDE approval process, which involved FDA's review of over 10,000 pages of biomechanical data, clinical history, and non-clinical testing.