Mainstay Medical offers ReActiv8®, the first FDA-approved restorative neurostimulation therapy specifically designed to treat mechanical chronic low back pain by stimulating the muscles that stabilize the lumbar spine. This non-invasive solution interrupts the cycle of pain and dysfunction, leading to significant long-term improvements in pain reduction and quality of life for patients.
Funding
$125M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
GHVGFounders
Product
Problem
Chronic low back pain (CLBP) often stems from the muscles that stabilize the lumbar spine not functioning correctly. Existing treatments like pain medication and physical therapy may fail to provide lasting relief for mechanical CLBP caused by multifidus muscle dysfunction. Many patients are not candidates for invasive spine surgery.
Solution
Mainstay Medical offers ReActiv8, a restorative neurostimulation therapy designed to address mechanical chronic low back pain by stimulating the nerves of the muscles directly responsible for stabilizing the lumbar spine. The ReActiv8 system interrupts the cycle of pain, degeneration, and loss of function by delivering bilateral stimulation to the L2 medial branch of the dorsal ramus. This minimally-invasive procedure helps restore muscle control, leading to long-term improvements in pain reduction and quality of life. The ReActiv8 system is full body MRI conditional.
Target Audience
The primary audience includes adults with intractable chronic low back pain associated with multifidus muscle dysfunction who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.
Features
- Restorative neurostimulation therapy targeting the source of mechanical chronic low back pain
- Bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the transverse process at L3
- Designed to restore muscle control of the lumbar spine
- Minimally-invasive outpatient procedure
- Full body MRI conditional
- Demonstrated reduction in pain (VAS) and improved function (ODI) in clinical trials
- Potential to reduce or eliminate opioid use