Transforming the future of back pain treatment

A simple, innovative, earlier treatment option for the world’s #1 source of disability - Back Pain!

Triojection™ From SpinaFX Medical

Minimally-Invasive Image-Guided Ozone Therapy1 .

The Triojection® System consists of a computer-controlled console and an ozone generation chamber inside a disposable single-use syringe and sterility case

Ozone generator and measurement console

Syringe with exterior case, filter and dual stopcocks.
  • Indicated for patients with “Contained Herniated Discs” causing back pain which has not responded to conservative therapy1,2.
  • Combines a self-contained, Ozone (O2+2.4% O3) generator and spectroscopic measurement.
  • Patented, disposable exterior case and syringe adheres to key aseptic principles guaranteeing sterile ozone delivery.
  • Built with high quality O3 and UV-compatible disposable syringe polymers including filters & stopcocks.
  • Ensures consistent treatment with a sterile, metered, measured, accurate, precise and repeatable O2/O3 concentration at the point of care.
1.Triojection™ is not currently available for promotion or sale in North America, the EU of UK. Triojection was previously awarded CE Mark under MDD and is undertaking re-registration under MDR. Contact SpinaFX for further information regarding anticipated commercial availability in your region. 2. Eligible patients include 71% of those with contained herniated discs and other borderline non-surgical patients for whom there are no effective treatment options.

A Simple, Innovative, Earlier Solution filling a therapeutic gap for contained herniated Disc-Related Back and leg pain.

Back Pain – The #1 cause of disability in the world1 and most expensive health condition treated2.

  • Treats the underlying condition, not just the symptom.
  • Rapid time to recovery, shorter procedure, fewer opioids, 90% lower cost.
  • Equivalent pain reduction without long-term disc or vertebral damage.
  • Reduced long-term consequences of degenerative changes.
  • High clinical success rate.
  • No barriers to later surgery if needed.
  • Swift and sustained relief.

1.NIH Low Back Pain Fact Sheet https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Low-Back-Pain-Fact-Sheet

2.Dieleman JL, Cao J, Chapin A, et al. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020;323(9):863–884. doi:10.1001/jama.2020.0734

3.Murphy K P et al. Intradiscal Oxygen-Ozone Chemo-nucleolysis versus Microdiscectomy for Lumbar Disc Herniation Radiculopathy: A Non-inferiority Randomized Control Trial.

How Ozone (O3) works

Naturally-occurring gas that  is precisely formulated.

Nucleus Pulposus Volume Reduction
  • Treatment effect is disc volume reduction.
  • Reduces the compression of nerve roots and vasculature.
  • Safe and effective with successful clinical outcomes.
A study of 283 patients showed intradiscal ozone injections are associated with statistically significant volume reduction of the herniated lumbar disc. Average disc volume reduction (mean 7.70+/- 5.45%; range, 0.29%–22.31%) was seen in 96.1% of treated disks at 6 months after treatment. (P < 0.0001).
Lehnert T et al 2012, Lumbar Disk Volume before and after Ozone–Oxygen Injection, pubmed.ncbi.nlm.nih.gov/22999458/
Animal studies and mathematical modelling showed a 6% nucleus pulposus volume reduction can lead to a 9.84% reduction in pressure, relieving nerve root compression and herniated disc-related pain.
Murphy et al,  2016, Percutaneous Treatment of Herniated Lumbar. Discs with Ozone: Investigation of the Mechanisms of Action.pubmed.ncbi.nlm.nih.gov/27363296/

How Ozone (O3) works

Ozone (O3) – a dehydrating, oxidizing, naturally occurring species of oxygen (O2) gas that can be injected into the gelatinous disc nucleus.
Nucleus Pulposus Breakdown
Ozone injected into the disc nucleus dehydrates and breaks down proteins* in the nucleus leading to reduction of the bulging disc herniation.

* Glycosaminoglycans (GAGs)-substituted proteoglycans

Murphy 2016, pubmed.ncbi.nlm.nih.gov/27363296/

Lehnert T 2012, pubmed.ncbi.nlm.nih.gov/22999458/

Reduces Inflammation
reduces inflimation
Ozone reduces the release of inflammatory proteins (cytokines) that lead to inflammation.
Niu 2018, pubmed.ncbi.nlm.nih.gov/29611536/ Murphy 2016, pubmed.ncbi.nlm.nih.gov/27363296/ Fuccio 2008, pubmed.ncbi.nlm.nih.gov/19100257/ Chang 2005 link.springer.com/article/10.1007/s00296-004-0526-1 Lu 2017, pubmed.ncbi.nlm.nih.gov/27744376/
Reduces Infection
reduces-infection
Ozone has proven antimicrobial properties. Reduced spine infection reduces potential degenerative (modic) changes in the disc, vertebral bones and reduces pain.
Albert 2013 pubmed.ncbi.nlm.nih.gov/23397187/
Holmes J. Clinical reversal of root caries using ozone, double-blind, randomised, controlled 18-month trial. Gerodontology. 2003 Dec;20(2):106-14. doi: 10.1111/j.1741-2358.2003.00106.x. PMID: 14697022.

Triojection vs discectomy

0%
Shorter Procedure
0%
Shorter Stay
0%
Lower Cost
0%
Patients are Eligible
0%
Avoiding Later Surgery
TRIOJECTION®
17/24 (71%) of Ozone patients avoided open surgery entirely3.
(Surgery can be done after triojection if needed in future)
DISCECTOMY
2/17 (12%) of surgical patients required repeat surgery for persistent symptoms.

1. Steppan, J,, Meaders, T, Muto, M, and Murphy, K: Metaanalysis of the Effectiveness and Safety of Ozone Treatments for Herniated Lumbar Discs. J Vasc Interv Radiol 2010; 21:534–548
2. Murphy K, Muto M, Steppan J, Meaders T, Boxley C. Treatment of Contained Herniated Lumbar Discs With Ozone and Corticosteroid: A Pilot Clinical Study. Can Assoc Radiol J. 2015 Nov;66(4):377-84. doi: 10.1016/j.carj.2015.01.003. Epub 2015 Jun 17. PMID: 26092159.
3. Murphy K P et al. Intradiscal Oxygen-Ozone Chemo-nucleolysis versus Microdiscectomy for Lumbar Disc Herniation Radiculopathy: A Non-inferiority Randomized Control Trial.

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