ReActiv8

What ReActiv8 does

ReActiv8 is a restorative neurostimulation medical device developed and commercialized by Mainstay Medical Holdings plc (Dublin, Ireland), with regional operations in Australia via Mainstay Medical (Australia) Pty Ltd (Artarmon, NSW). The system targets mechanical chronic low back pain caused by multifidus muscle dysfunction, an impairment of neuromuscular control of the largest lumbar stabilizing muscle. The device consists of an Implantable Pulse Generator (IPG), two proprietary self-anchoring leads placed adjacent to the medial branch of the dorsal ramus nerve, and an external Activator controller. Patients self-administer therapy twice daily in 30-minute sessions, with the goal of restoring neuromuscular control rather than masking pain signals as palliative treatments (e.g., spinal cord stimulation, opioids) do.

The company has regulatory approvals across the European Union, United Kingdom, Australia, and the United States, and has secured full-body MR Conditional labeling in EU/UK/Australia (July 2024) and MRI labeling in the US. Clinical evidence includes the ReActiv8-B pivotal trial (204 randomized patients, 5-year follow-up demonstrating ~80% reporting substantial pain or function improvement and ~70% reducing or eliminating opioids) and the ReActiv8-A trial supporting CE Mark (97% satisfaction at 4 years).

ReActiv8 generates revenue through hardware sales of the implantable system on a per-procedure basis, distributed exclusively through certified specialist physicians (interventional pain specialists, neurosurgeons, orthopedic surgeons, anesthesiologists) in hospital and ambulatory surgery center settings. In Australia, reimbursement flows through the Prescribed List under the 'Pain Management with device' category, with assigned item numbers for private health insurers. GTM is enterprise field sales targeting physician certification, supported by patient-facing educational content and clinical resource libraries.

Name

ReActiv8

Legal name

Mainstay Medical (Australia) Pty Ltd

Website

https://fixmylowerback.com.au

Company type

Public

Founded year

2008

Operating status

Operating

Headcount range

101–250 employees

Short description

ReActiv8, developed by Mainstay Medical Holdings plc, is an implantable restorative neurostimulation system that treats mechanical chronic low back pain by restoring neuromuscular control of the multifidus muscle, sold through certified specialist physicians in the EU, UK, Australia, and the US.

Ownership category

akta.pro rank

Product category

Implantable Neurostimulation Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK)

akta.pro secondary industries

Rehabilitation Therapy Equipment (PT/OT Modalities, Exercise & Balance Devices) (HLAHAMAG), Chronic Pain Rehabilitation & Functional Restoration (HSADAIAJ)

Keywords

• Restorative neurostimulation systems
• Implantable medical devices
• Chronic back pain therapy
• Spinal neuromodulation implants
• Pain management devices

Headquarters

HQ city

Artarmon

HQ country

Australia

HQ region

Oceania

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: ReActiv8 generates revenue through the sale of its implantable neurostimulation system. The device includes the Implantable Pulse Generator (IPG) and electrical leads. Revenue is realized upon implant procedures performed by certified physicians in hospital or ASC settings. The company also supplies replacement components and accessories.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

ReActiv8 manufactures and sells the ReActiv8 Restorative Neurostimulation System, an implantable medical device that delivers bilateral electrical stimulation to the medial branch of the dorsal ramus to activate the multifidus muscle and treat mechanical chronic low back pain caused by multifidus dysfunction. The system comprises an Implantable Pulse Generator (IPG), proprietary self-anchoring leads, and an external patient-controlled Activator used for twice-daily 30-minute home therapy sessions.

Product overview

ReActiv8 is a medical device company offering the ReActiv8 Restorative Neurostimulation System — a single core product consisting of an Implantable Pulse Generator (IPG), proprietary self-anchoring leads, and an external Activator controller. The system provides restorative treatment for mechanical chronic low back pain by targeting multifidus muscle dysfunction through bilateral electrical stimulation of the L2 medial branch of the dorsal ramus. The company also conducts clinical research programs including the ReActiv8-A Trial (for CE Mark) and ReActiv8-B Pivotal Trial (for FDA approval). Patients self-administer therapy twice daily for 30 minutes per session using the Activator device.

Differentiator

Problem solved

Functional benefit

Brands

• ReActiv8 System: Restorative Neurostimulation System for treatment of chronic low back pain associated with multifidus muscle dysfunction

Products and services

• ReActiv8 Restorative Neurostimulation System Implantable neurostimulation system providing bilateral stimulation of the L2 medial branch of the dorsal ramus to treat intractable chronic low back pain associated with multifidus muscle dysfunction. Sold to certified physicians and hospitals for outpatient implant procedures in patients who have failed conservative care.
• ReActiv8 Implantable Pulse Generator (IPG) Internal implanted generator component of the ReActiv8 system that delivers electrical stimulation pulses through leads to the medial branch of the dorsal ramus, targeting the multifidus muscle for restorative neurostimulation therapy.
• ReActiv8 Self-Anchoring Leads Proprietary electrical leads placed adjacent to the medial branch of the dorsal ramus that deliver stimulation pulses. Available in 45 cm length for full-body MRI compatibility. Self-anchoring design prevents lead migration.
• ReActiv8 Activator External wireless controller device used by patients to self-administer twice-daily 30-minute therapy sessions at home. Patient-controlled therapy sessions designed to feel like a deep tissue massage.

Quantifiable outcome

• Approximately 8 out of 10 (80%) patients reported substantial improvements in pain and/or function at 5 years
• +6 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators7 records

Recent moves5 records

Expansion highlights4 records

Market position

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about ReActiv8