Premia Spine, Ltd

What Premia Spine, Ltd does

Premia Spine, Ltd is a privately held medical device company that designs, manufactures, and commercializes spinal surgery implants, with a core focus on motion-preserving alternatives to lumbar spinal fusion. Its flagship product, the TOPS (Total Posterior Segment) System, is a mechanical posterior arthroplasty implant comprising two titanium plates connected by polycarbonate urethane components and anchored with four polyaxial pedicle screws. The device allows full range of motion in flexion, extension, lateral bending, and axial rotation while blocking shear forces, positioning it as an alternative to traditional spinal fusion for patients with degenerative spondylolisthesis and moderate to severe lumbar spinal stenosis. In June 2023, the TOPS System received FDA approval (P220002) with an unprecedented superiority-to-fusion claim, the first such designation granted to any lumbar spine implant, supported by a 37-center IDE trial on 300+ patients and an 11-year clinical follow-up dataset.

The company also markets the ProMIS System, a complementary pedicle screw platform with direct skin-to-screw technology, and offers the VersaLink Fusion System as a combination product for multi-level disease. Premia Spine operates a direct B2B medical device sales model targeting spine surgeons at hospitals and medical centers, with a network of over 100 surgeons across 37+ US investigational centers and commercial presence in Spain, Germany, France, Israel, Mexico, and the UK. Revenue is generated through one-time hardware sales of implants, surgical instruments, and accessories per procedure, with pricing conducted through hospital procurement channels. Medicare/CMS Category B pre-approval has been granted, establishing a coverage pathway for Medicare beneficiaries. Leadership includes Ron Sacher as CEO and co-founder, Ilan Ofir as CFO, and Rafi Haziza as R&D and Engineering Manager, operating from US headquarters in Norwalk, CT, with corporate roots in Herzliya, Israel. The company acquired Impliant in May 2011 to consolidate complementary spine assets.

Name

Premia Spine, Ltd

Legal name

Premia Spine, Ltd

Website

https://premiaspine.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Short description

Premia Spine is a privately held medical device company commercializing the FDA-approved TOPS System, a mechanical lumbar motion-preservation implant that offers an alternative to spinal fusion for patients with degenerative spondylolisthesis and lumbar spinal stenosis.

Ownership category

akta.pro rank

Product category

Spinal Surgery Implants

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), 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 industry

Orthopedic Trauma & Extremities Fixation (Plates/Screws/Nails/External Fixation) (HLAHAEAB)

Keywords

• Spine surgery implants
• Motion preservation devices
• Lumbar spinal stenosis treatment
• Posterior arthroplasty system
• Pedicle screw systems

Headquarters

HQ city

Herzliya

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Technology or R&D, Marketing or Sales, Operations, Personnel

Revenue model

1. Medical Device Sales: Sale of FDA-approved TOPS System implants to hospitals and surgeons for treatment of lumbar spinal stenosis and degenerative spondylolisthesis. One-time hardware sale per procedure, with associated surgical instruments and accessories.
2. ProMIS System Products: Sale of ProMIS pedicle screw system and related spinal surgery products. Complementary product line for spinal fixation procedures.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Premia Spine develops, manufactures, and commercializes motion-preserving spinal implant systems used by spine surgeons at hospitals. Its flagship FDA-approved TOPS System is a posterior arthroplasty device that replaces tissues removed during lumbar decompression and preserves motion in all directions, serving as a non-fusion alternative for patients with lumbar spinal stenosis and degenerative spondylolisthesis. The company also sells the ProMIS pedicle screw system and offers the VersaLink Fusion System as a complementary fixation solution for multi-level disease.

Product overview

Premia Spine, Ltd is a medical device company offering two primary product systems for spine surgery: the TOPS (Total Posterior Segment) System and the ProMIS System. The TOPS System is a motion-preserving lumbar implant that serves as an FDA-approved alternative to spinal fusion for treating lumbar spinal stenosis and degenerative spondylolisthesis. The ProMIS System is another spinal surgery platform. The Versalink Fusion System can be combined with TOPS for multi-level disease cases. The company operates as a single unified product portfolio focused on spine surgery implants and motion preservation technology.

Differentiator

Problem solved

Functional benefit

Brands

• TOPS™ System: FDA-approved lumbar motion device for treatment of spinal stenosis and spondylolisthesis without fusion surgery. A mechanical implant that replaces soft and bony tissues removed during decompression surgery.
• ProMIS™ System

Products and services

• TOPS (Total Posterior Segment) System FDA-approved mechanical motion-preserving posterior arthroplasty implant designed to replace soft and bony tissues removed during lumbar decompression surgery between L2 and L5, providing an alternative to spinal fusion for patients with lumbar spinal stenosis and degenerative spondylolisthesis.
• ProMIS System Spinal surgery implant system featuring direct skin-to-screw technology and proprietary pedicle screw designs intended for spinal stabilization and fixation procedures performed by spine surgeons.
• VersaLink Fusion System Fusion implant system that can be combined with the TOPS System to address multi-level lumbar disease between L1 and S1, providing rigid fixation at diseased levels while TOPS preserves motion at the transitional segment.

Named customers5 records

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Medicare/CMScoreOthers · 1 June 2023Centers for Medicare & Medicaid Services granted TOPS a Category B pre-approval for coverage of routine care and services, including the device, furnished to Medicare beneficiaries enrolled in the FDA clinical trial. This designation enables Medicare coverage pathways post-approval.

Scale indicators4 records

Recent moves2 records

Expansion highlights4 records

Direct peers

• SeaSpine: SeaSpine is a spine-focused medical device company offering fusion, orthobiologics, and minimally invasive surgical solutions. Comparable as a spine-only competitor of similar size targeting the same hospital and surgeon customer base.
• Alphatec Spine: Alphatec Spine develops and commercializes spine surgery solutions including novel lateral approaches and motion-preservation technologies. Comparable as a focused spine company of similar scale competing for surgeon adoption in lumbar procedures.
• Centinel Spine: Centinel Spine is a motion-preservation-focused spine company (prodisc cervical/lumbar disc replacements). Directly comparable to Premia Spine as a pure-play motion-preservation specialist pursuing alternatives to spinal fusion for degenerative lumbar conditions.

Broad incumbents

• B. Braun / Aesculap Spine: Aesculap (B. Braun division) offers activL artificial disc and spine fusion hardware across European and US markets. Comparable as an established motion-preservation competitor with international commercial reach similar to Premia's.
• NuVasive: NuVasive (now part of Globus Medical) pioneered XLIF and offers cervical disc replacement (Simplify Disc) alongside extensive fusion hardware. Comparable as a major spine incumbent with both motion-preservation and fusion products targeting the same lumbar stenosis and spondylolisthesis indications.
• Medtronic Spine: Medtronic's Spine division offers fusion hardware, cervical disc replacement (Prestige, Bryan), and biologics. Comparable as the dominant incumbent in lumbar surgery that TOPS would compete against for hospital formulary share and surgeon adoption.
• Orthofix Medical: Orthofix offers spine fusion hardware, biologics, and motion-preservation products (M6-C cervical disc). Comparable as a mid-sized spine competitor with both fusion and motion-preservation portfolios targeting similar surgeon customers.
• Stryker Spine: Stryker's spine business (post-K2M acquisition) provides a broad portfolio of cervical and lumbar fixation and motion-preservation technologies. Comparable as a large spine incumbent with established surgeon relationships and motion-preservation R&D capability.
• Globus Medical: Globus Medical (now merged with NuVasive) is a large spine device incumbent offering fusion, motion preservation, and enabling technology. Comparable as a competitor in the lumbar spine implant space with established hospital relationships and broad product portfolios.

Emerging players

• Spinal Kinetics (acquired by Orthofix): Spinal Kinetics developed the M6-C and M6-L artificial discs for cervical and lumbar motion preservation. Comparable as a focused motion-preservation technology player in the lumbar disc replacement space competing for similar clinical indications.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/premiaspine
• YouTubeyoutube.com/@premiaspine
• Facebookfacebook.com/Premia-Spine-106464717555758
• LinkedInlinkedin.com/company/6357917

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments

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

Frequently asked questions about Premia Spine, Ltd