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 therapy^1,2.
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.

Transforming the future of back pain treatment

SpinaFX is a medical treatment solution company providing rapid and sustained relief to patients with back pain due to contained lumbar herniated discs, using innovative, minimally invasive image-guided therapy.

Back Pain is the #1 cause of disability in the world ¹ and the most expensive health condition treated² .

Filling a Therapeutic Gap for Contained Herniated Disc-Related Back and Leg Pain

Lumbar disc herniation affects between 5 and 20 adults per 1,000 annually.³ For many of these patients, there is a gap in treatment options for contained lumbar disc herniation that would fall between conservative care and surgery. Some find conservative treatment options address their symptoms but fail to treat the root cause of pain. For others, surgery could be an undesired option.

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.Al Qaraghli MI, De Jesus O. Lumbar Disc Herniation. [Updated 2021 Aug 30]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560878/

SpinaFX

Pioneering minimally invasive, image-guided treatments

At SpinaFX Medical, we are committed to filling the therapeutic gap in treating radiculopathy by bringing innovative, minimally invasive, image-guided treatments to market. Using our patented technology backed by published clinical data, we aim to address and eliminate low back and leg pain for the benefit of patients, physicians, facilities, and payers.

A New Treatment Option for Radiculopathy

Clinically backed, patented technology from SpinaFX Medical

Our flagship treatment solution aims to relieve back and leg pain caused by a contained herniated disc through the intravertebral injection of a mixture of oxygen and ozone gas.¹ This technology is not currently available for promotion or sale.

Promising research shows there is a potential for oxygen-ozone injections to help treat radiculopathy caused by a contained herniated lumbar disc. In fact, a study of 283 patients showed intradiscal ozone injections are associated with a statistically significant volume reduction of the herniated lumbar disc². An average disc volume reduction was seen in 96.1% of treated disks six months after treatment²* Animal studies and mathematical modeling have shown a 6% nucleus pulposus volume reduction can lead to a 9.84% reduction in pressure, relieving nerve root compression and herniated disc-related pain.³

* Average disc volume reduction (mean 7.7+/-5.45%; range, 0.29%-22.31%). P < 0.0001.

Triojection™ is not currently available for promotion or sale in North America, the EU, or the U.K. 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.
Lehnert T et al 2012, Lumbar Disk Volume before and after Ozone–Oxygen Injection, pubmed.ncbi.nlm.nih.gov/22999458/
Murphy et al, 2016, Percutaneous Treatment of Herniated Lumbar. Discs with Ozone: Investigation of the Mechanisms of Action.pubmed.ncbi.nlm.nih.gov/27363296/

SpinaFX News

ASSR Las Vegas

02.14.24 We are excited to be a part of ASSR 2024 in Las Vegas organized by American Society of Spine Radiology. Looking forward to discussing innovative procedures that are transforming patient care.

RESI San Francisco

01.12.24 - SpinaFX was present at the annual JP Morgans Conference, gained additional exposure to conference attendees and pitched directly to a panel of judges, featuring active investors and industry experts.

MNVC Conference

11.16.23 - SpinaFX CEO Jeff Cambra presented at the Musculoskeletal New Ventures Conference (MNVC) in Memphis, Tennessee: an exciting opportunity to exchange ideas with investors, industry leaders and researchers.

NASS 2023

10.23.23 - Our team took on NASS 2023 In LA! Great participation and insightful conversations with industry leaders, surgeons and spine specialists.

Addition to SpinaFX Team

08.01.23 - We’re pleased to announce Kevin Leung has joined SpinaFX as Director of Program Management. Kevin brings over 15 years of experience in the field of medical technology to SpinaFX.

LSI Barcelona

09.24.23 - Proudly presenting SpinaFX at LSI Europe ‘23 - a must-attend event for innovators, investors, strategically building the future of medical technology.

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

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

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

Shorter Procedure

Shorter Stay

Lower Cost

Patients are Eligible

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.