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Mainstay Medical

Full company profile

uuid00044v4

Namestring
Mainstay Medical
Legal namestring
Mainstay Medical Holdings plc
Websiteurl
http://www.mainstay-medical.com
Company typeenum
Private
Founded yearint
2008
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
101–250
akta.pro rankint
HeadquartersDublin, Ireland
HQ citystring
Dublin
HQ countrystring
Ireland
HQ regionstring
Europe
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
implantable neurostimulation devices, restorative neurostimulation therapy, chronic low back pain treatment, spinal neuromodulation systems, medical device manufacturing
Industry2 codes
1Rehabilitation Therapy Equipment (PT/OT Modalities, Exercise & Balance Devices)
CodeHLAHAMAGPrimaryYes
2Chronic Pain Rehabilitation & Functional Restoration
CodeHSADAIAJPrimaryNo
NAICS code1 code
  • Electromedical and Electrotherapeutic Apparatus Manufacturing334510
SIC code1 code
  • Electromedical & Electrotherapeutic Apparatus3845
Product category
Implantable Neurostimulation Devices
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1ReActiv8 Neurostimulation System Sales
TypeHardware Sales
Description

Mainstay Medical generates revenue through the sale of its ReActiv8 implantable neurostimulation system. The device is implanted by certified physicians in outpatient settings. Revenue is derived from the device itself, with potential for follow-up services, programming, and replacement components.

mainstaymedical.com
Marketing channels6 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
Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain
Pricing details1 tier
1ReActiv8 Neurostimulation System - no public pricing listed
ModelOtherBilling cadenceMulti-year contract
Notes

As an implantable prescription medical device, ReActiv8 pricing is not publicly disclosed. Coverage varies by insurance provider. Blue Cross Blue Shield of North Dakota has established exclusive coverage for the device.

mainstaymedical.com
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 record
1ReActiv8
Description

Restorative Neurostimulation system for treating mechanical chronic low back pain

mainstaymedical.com
Core offering1 text field

Mainstay Medical develops and commercializes the ReActiv8 Restorative Neurostimulation System, an implantable medical device that delivers restorative neurostimulation therapy to treat mechanical chronic low back pain. The system stimulates the L2 medial branch of the dorsal ramus to activate the multifidus muscle and restore control of the lumbar spine, and is implanted by certified physicians in outpatient settings. The company sells the device and supporting components directly to healthcare providers across the United States, Europe, and Australia.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 4 values shown
  • VAS Reduction ≥50% after 3 years (ReActiv8-B clinical trial)
+3 more records
Product overview1 text field

Mainstay Medical offers a single unified product—the ReActiv8 Restorative Neurostimulation System—which includes the implantable pulse generator (IPG), leads, and external components. The system is supported by the ReActiv8-B clinical trial data demonstrating long-term efficacy. The portfolio centers exclusively on ReActiv8 for treating chronic low back pain through restorative neurostimulation that targets multifidus muscle dysfunction.

Product and service1 record
1ReActiv8 Restorative Neurostimulation System
CategoryImplantable Neurostimulation Devices
Description

The ReActiv8 Restorative Neurostimulation System is an implantable medical device, comprising an implantable pulse generator (IPG) and leads, that delivers bilateral stimulation to the L2 medial branch of the dorsal ramus to activate the multifidus muscle and restore lumbar spine stabilization. It is indicated for adult patients with mechanical chronic low back pain who have failed conservative therapy (pain medications, physical therapy) and are not candidates for spine surgery, and is implanted by certified physicians in outpatient settings. The system holds full-body 1.5T MRI conditional labeling in the EU, UK, and Australia.

Scale indicator4 records

Each record includes

Type, Value, Description, Source

Partnership1 partner
1Blue Cross Blue Shield of North Dakota
Strategic tierCoreTypeChannel Partner/ Reseller/ DistributorAnnounced on2026-02-04
Description

Blue Cross Blue Shield of North Dakota established exclusive coverage for ReActiv8, providing insurance coverage that improves market access for the device and influences patient treatment options in North Dakota.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
1Medtronic
TypeBroad incumbent
Description

Global leader in spinal cord stimulation (Intellis, Vanta) and broader neuromodulation. Direct overlap in the implantable neurostim market for chronic pain, with vastly greater scale, sales force, and payer relationships.

2Boston Scientific
TypeBroad incumbent
Description

Major player in spinal cord stimulation (Precision Spectra, WaveWriter) and chronic pain therapies. Competes with Mainstay in the same physician call points and payer landscape for implantable neurostimulation.

3Abbott
TypeBroad incumbent
Description

Sells the Proclaim XR and Eterna neurostimulation systems for chronic pain. Overlaps with Mainstay's physician targets (pain specialists, spine surgeons) and reimbursement pathways.

4Nevro Corp
TypeDirect peer
Description

Direct competitor in implantable neurostimulation for chronic pain, with HFX/Senza 10 kHz therapy. Closely comparable device category, indication, and physician customer base.

5Saluda Medical
TypeDirect peer
Description

Develops the Evoke closed-loop spinal cord stimulation system targeting chronic pain. Competes head-to-head with ReActiv8 in the implantable restorative/closed-loop neurostim category.

6Nalu Medical
TypeEmerging player
Description

Emerging player in peripheral nerve stimulation (PNS) for chronic pain. Overlaps in target indication (chronic pain) and physician channel, though delivery mechanism (external wearable vs. fully implantable IPG) differs.

7Biotronik
TypeEmerging player
Description

Sells the Prospera spinal cord stimulation system for chronic pain. Smaller incumbent-style neuromodulation player overlapping with Mainstay's implanters and payer contracts.

8SPR Therapeutics
TypeEmerging player
Description

Developer of the SPRINT PNS system for chronic and acute pain. Targets overlapping patient populations (failed back surgery, low back pain) using a different (peripheral, temporary) delivery modality.

9Cirtec Medical
TypeOthers
Description

Contract manufacturer specializing in implantable neurostimulation devices and components. Adjacent ecosystem participant that supports the supply chain for companies like Mainstay.

10Integer Holdings
TypeOthers
Description

Contract manufacturer of medical device components including implantable pulse generators and leads for neuromodulation. Adjacent enabling supplier to the neurostim industry in which Mainstay competes.

Market position
Strengths1 record

Each record includes

Headline, Details, Source

Weaknesses1 record

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers1 record

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

Feature3 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles4 records

Each record includes

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

No data
Compliance2 records

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds8 records

Each record includes

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

Investors15 records

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 →

Mainstay Medical

Implantable Neurostimulation Devicesmainstay-medical.com

Mainstay Medical firmographics

Firmographics
Name
Mainstay Medical
Legal name
Mainstay Medical Holdings plc
Website
http://www.mainstay-medical.com
Company type
Private
Founded year
2008
Operating status
Operating
Headcount range
101–250 employees
Ownership category
akta.pro rank

Mainstay Medical industry classification

Industry
Product category
Implantable Neurostimulation Devices
NAICS
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
SIC
Electromedical & Electrotherapeutic Apparatus (3845)
akta.pro primary industry
Rehabilitation Therapy Equipment (PT/OT Modalities, Exercise & Balance Devices) (HLAHAMAG)
akta.pro secondary industry
Chronic Pain Rehabilitation & Functional Restoration (HSADAIAJ)

Keywords

  • Implantable neurostimulation devices
  • Restorative neurostimulation therapy
  • Chronic low back pain treatment
  • Spinal neuromodulation systems
  • Medical device manufacturing

Where Mainstay Medical is headquartered

Location

Headquarters

HQ city
Dublin
HQ country
Ireland
HQ region
Europe

Offices1 record

Markets served

Mainstay Medical business model

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

Revenue model

  1. ReActiv8 Neurostimulation System Sales: Mainstay Medical generates revenue through the sale of its ReActiv8 implantable neurostimulation system. The device is implanted by certified physicians in outpatient settings. Revenue is derived from the device itself, with potential for follow-up services, programming, and replacement components.

Pricing tiers

ModelBillingPrice
OtherMulti-year contractReActiv8 Neurostimulation System - no public pricing listed

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Mainstay Medical product offering

Product offering

Core offering

Mainstay Medical develops and commercializes the ReActiv8 Restorative Neurostimulation System, an implantable medical device that delivers restorative neurostimulation therapy to treat mechanical chronic low back pain. The system stimulates the L2 medial branch of the dorsal ramus to activate the multifidus muscle and restore control of the lumbar spine, and is implanted by certified physicians in outpatient settings. The company sells the device and supporting components directly to healthcare providers across the United States, Europe, and Australia.

Product overview

Mainstay Medical offers a single unified product—the ReActiv8 Restorative Neurostimulation System—which includes the implantable pulse generator (IPG), leads, and external components. The system is supported by the ReActiv8-B clinical trial data demonstrating long-term efficacy. The portfolio centers exclusively on ReActiv8 for treating chronic low back pain through restorative neurostimulation that targets multifidus muscle dysfunction.

Differentiator

Problem solved

Functional benefit

Brands

  • ReActiv8: Restorative Neurostimulation system for treating mechanical chronic low back pain

Products and services

  • ReActiv8 Restorative Neurostimulation System The ReActiv8 Restorative Neurostimulation System is an implantable medical device, comprising an implantable pulse generator (IPG) and leads, that delivers bilateral stimulation to the L2 medial branch of the dorsal ramus to activate the multifidus muscle and restore lumbar spine stabilization. It is indicated for adult patients with mechanical chronic low back pain who have failed conservative therapy (pain medications, physical therapy) and are not candidates for spine surgery, and is implanted by certified physicians in outpatient settings. The system holds full-body 1.5T MRI conditional labeling in the EU, UK, and Australia.

Quantifiable outcome

  • VAS Reduction ≥50% after 3 years (ReActiv8-B clinical trial)
  • +3 more outcomes

Companies that use Mainstay Medical

Customer profile

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Mainstay Medical technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature3 records

Mainstay Medical partnerships and signals

Strategic signal

Partnerships

One partnership is on record.

  • Blue Cross Blue Shield of North DakotacoreChannel Partner/ Reseller/ Distributor · 4 February 2026Blue Cross Blue Shield of North Dakota established exclusive coverage for ReActiv8, providing insurance coverage that improves market access for the device and influences patient treatment options in North Dakota.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Mainstay Medical competitors and assessment

Company assessment

Broad incumbents

  • Medtronic: Global leader in spinal cord stimulation (Intellis, Vanta) and broader neuromodulation. Direct overlap in the implantable neurostim market for chronic pain, with vastly greater scale, sales force, and payer relationships.
  • Boston Scientific: Major player in spinal cord stimulation (Precision Spectra, WaveWriter) and chronic pain therapies. Competes with Mainstay in the same physician call points and payer landscape for implantable neurostimulation.
  • Abbott: Sells the Proclaim XR and Eterna neurostimulation systems for chronic pain. Overlaps with Mainstay's physician targets (pain specialists, spine surgeons) and reimbursement pathways.

Direct peers

  • Nevro Corp: Direct competitor in implantable neurostimulation for chronic pain, with HFX/Senza 10 kHz therapy. Closely comparable device category, indication, and physician customer base.
  • Saluda Medical: Develops the Evoke closed-loop spinal cord stimulation system targeting chronic pain. Competes head-to-head with ReActiv8 in the implantable restorative/closed-loop neurostim category.

Emerging players

  • Nalu Medical: Emerging player in peripheral nerve stimulation (PNS) for chronic pain. Overlaps in target indication (chronic pain) and physician channel, though delivery mechanism (external wearable vs. fully implantable IPG) differs.
  • Biotronik: Sells the Prospera spinal cord stimulation system for chronic pain. Smaller incumbent-style neuromodulation player overlapping with Mainstay's implanters and payer contracts.
  • SPR Therapeutics: Developer of the SPRINT PNS system for chronic and acute pain. Targets overlapping patient populations (failed back surgery, low back pain) using a different (peripheral, temporary) delivery modality.

Others

  • Cirtec Medical: Contract manufacturer specializing in implantable neurostimulation devices and components. Adjacent ecosystem participant that supports the supply chain for companies like Mainstay.
  • Integer Holdings: Contract manufacturer of medical device components including implantable pulse generators and leads for neuromodulation. Adjacent enabling supplier to the neurostim industry in which Mainstay competes.

Market position

Strengths1 record

Weaknesses1 record

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Mainstay Medical social profiles

Digital presence

Mainstay Medical compliance and trust

Trust signal

Compliance2 records

Mainstay Medical financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Mainstay Medical leadership team

Management profile

Number of profiles

Profiles4 records

Mainstay Medical funding detail

Funding detail

Funding overview

Funding rounds8 records

Investors15 records

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

Mainstay Medical 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 Mainstay Medical

What does Mainstay Medical do?

Mainstay Medical develops and commercializes the ReActiv8 Restorative Neurostimulation System, an implantable medical device that delivers restorative neurostimulation therapy to treat mechanical chronic low back pain. The system stimulates the L2 medial branch of the dorsal ramus to activate the multifidus muscle and restore control of the lumbar spine, and is implanted by certified physicians in outpatient settings. The company sells the device and supporting components directly to healthcare providers across the United States, Europe, and Australia.

Is Mainstay Medical a public or private company?

Mainstay Medical is a private company. It is classified as venture growth investor backed and is currently operating.

When was Mainstay Medical founded?

Mainstay Medical was founded in 2008. It employs 101 to 250 people.

Where is Mainstay Medical based?

Mainstay Medical is headquartered in Dublin, Ireland, in the Europe region.

How does Mainstay Medical make money?

One revenue line is on record: reActiv8 Neurostimulation System Sales.

Who are Mainstay Medical's main competitors?

Broad incumbents on record are Medtronic, Boston Scientific and Abbott. Direct peers are Nevro Corp and Saluda Medical. Emerging players are Nalu Medical, Biotronik and SPR Therapeutics. Others are Cirtec Medical and Integer Holdings.

Does Mainstay Medical have an API?

No public API is recorded for Mainstay Medical.

What industry is Mainstay Medical in?

Mainstay Medical's product category is Implantable Neurostimulation Devices. Its primary akta.pro industry code is HLAHAMAG, Rehabilitation Therapy Equipment (PT/OT Modalities, Exercise & Balance Devices), with a secondary code of HSADAIAJ, Chronic Pain Rehabilitation & Functional Restoration. Its NAICS code is 334510 and its SIC code is 3845.

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Live signals
BioSpaceMainstay Medical Announces Two-Year Outcomes from RESTORE Clinical Trial of ReActiv8®Mainstay Medical announced two-year outcomes from the RESTORE trial of ReActiv8 for intractable chronic low back pain. The treatment group showed sustained improvements in disability, pain, and quality of life, and 83% of control-group patients crossed over to ReActiv8 therapy. The company plans to engage payers to expand insurance access in the U.S.FinancialContent Business PageMainstay Medical Announces Positive Coverage Decision for ReActiv8® from Highmark Inc.Mainstay Medical announced that Highmark Inc. has established a favorable coverage policy for ReActiv8 Restorative Neurostimulation therapy, making it available as medically necessary for eligible members with chronic low back pain associated with multifidus muscle dysfunction, effective July 27, 2026. The decision expands ReActiv8's market access to more than 50 million Blues-affiliated members across the United States, representing a significant commercial milestone for the medical device company. Mainstay Medical indicated it will continue pursuing coverage decisions from other major health plans to further expand patient access.FinancialContent Business PageArticles from Mainstay Medical Holdings plcMainstay Medical Holdings plc announced multiple developments related to its ReActiv8 neurostimulation therapy, including coverage decisions by several health insurers, regulatory approvals, and clinical trial results. The company reported positive clinical outcomes, expanded regulatory clearances, and increased access across multiple regions.Ortho Spine NewsMainstay Medical Announces Receipt of European and Australian Approvals of MRI Labeling on ReActiv8® Restorative Neurostimulation System™ – Ortho Spine NewsMainstay Medical Holdings plc announced it received regulatory approvals from the European Union, United Kingdom, and Australia for full-body MR conditional labeling for its ReActiv8 Restorative Neurostimulation system, enabling patients implanted with the commercially available 45 cm leads to undergo 1.5T full-body MRI scans. The approvals were granted in connection with Mainstay receiving Medical Device Regulations certification from its Notified Body, making the company among the first in the neuromodulation field to achieve MDR certification for Europe and the UK. The company stated this will significantly broaden patient access to ReActiv8 in Europe and Australia for those who may require MRI imaging post-implantation.Pulse 2.0Mainstay Medical Raises $125 Million For Commercial Growth Of ReActiv8 Restorative NeurostimulationMainstay Medical Holdings raised $125 million in equity financing, co-led by Gilde Healthcare and Viking Global Investors. The company will use the funds to support commercial growth of ReActiv8 Restorative Neurostimulation in the U.S., Europe, and Australia, plus post-market clinical studies and research.FinSMEsMainstay Medical Announces US$125M Equity Financing TransactionMainstay Medical Holdings raised US$125M in equity financing led by Gilde Healthcare and Viking Global Investors. The company will use the funds to support commercial growth of its ReActiv8 Restorative Neurostimulation system and additional clinical studies. CEO Jason Hannon said the financing will accelerate efforts to revolutionize treatment of mechanical low back pain.MainstaymedicalMainstay Medical Announces US$125 Million Equity Financing TransactionMainstay Medical Holdings plc announced a US$125 million equity financing co-led by Gilde Healthcare and Viking Global Investors to support the commercial growth of its ReActiv8 neurostimulation device. The company intends to use the proceeds for expansion in the U.S., Europe, and Australia, as well as for additional clinical studies and general operations.OxfordfinanceOxford Finance Closes $50 Million Credit Facility with Mainstay MedicalOxford Finance LLC closed a $50 million senior secured term loan with Mainstay Medical Holdings plc. The funding supports Mainstay's preparation to launch its ReActiv8 implantable neurostimulation system for treating chronic low back pain in the US market.FinSMEsMainstay Medical Receives US$108M Equity FinancingMainstay Medical Holdings closed a US$108M equity financing round co-led by Ally Bridge Group and Sofinnova Partners. The funds will support the U.S. commercial launch of ReActiv8, expansion in Europe and Australia, and additional clinical studies. ReActiv8 is FDA approved and CE marked, with a planned U.S. launch in early 2021.