Benefits for you
and your patients1,2

Fills gap in the chronic low-back pain treatment continuum

Minimally invasive

Short learning curve

Single-injection & fast treatment with sustained relief of pain

Restores the disc to close-to-normal function

Limited associated risks

Benefits for you
and your patients1,2

Fills gap in the chronic low-back pain treatment continuum

Minimally invasive

Short learning curve

Single-injection & fast treatment with sustained relief of pain

Restores the disc to close-to-normal function

Limited associated risks

Current pain relieving therapies for early-mid stage disc degeneration are not satisfactory4 

Gelmetix’s novel solution focuses on rehydrating the disc1

DXM addresses the shortcomings of the following existing treatment options4, none of which affect the mechano-biological root cause of pain4:

  • Painkillers may be the best option for many patients with light back pain. However, these often do not appropriately relieve chronic low-back pain; NSAIDs and steroids are associated with potentially severe side effects and dependency. None of these will ever tackle the mechano-biological root cause of the pain.

  • These therapies are effective at relaxing muscles, thus providing some pain relief or at least modifying the perception of the pain. Studies show that they do not improve the disability associated with low-back pain.

  • The application of targeted electrical stimulation to the area of the painful lower back helps the patient not to feel pain. While it works for many pain sufferers, it only provides short-term pain relief with limited efficacy for chronic low-back pain. Sometimes, even implantation of wires close to the targeted nerves or muscles is needed.

Disc rehydration is critical for treating early-mid stage degenerative disc disease5

The nucleus pulposus is located at the center of the disc, which is located between two vertebrae. It acts a shock absorber and a fulcrum for motion thanks to its water content6.

Recent advances in the study of the nucleus pulposus help us to understand its functioning and what happens when it doesn’t work well7.

The nucleus is a complex tissue with many active mediators, communicating with its environment and other nucleus cells7.

See infographic

Collagen

Collagen fibrils in the NP consist primarily of Type II and some Type I, representing 10-20% of the NP dry weight. Collagen fibrils are a few hundred nanometers in diameter and tens of microns in length. The fibrils are structured, but randomly oriented.

Proteoglycans

The most significant biochemical change that occurs in disc degeneration is the loss of proteoglycans in the nucleus pulposus. These large molecules are degraded to smaller fragments that are lost from disc tissue. The consequence is fall in osmotic pressure in the disc matrix and loss of water molecules.

Bio-mechano Sensors

In cells, mechanotransduction is the means by which physical forces, such as stretching, compression and shear stress are translated into biochemical impulses and signals. These result in changes to both cellular and extracellular structures. Even when mechanotransduction-related processes within cells are functioning normally, disturbances in the physical inputs that cells receive from their extracellular environs can then cascade to produce pathological results, such as degeneration of the entire nucleus pulposus tissue.

DXM is composed of a unique hydrogel formulation1

High in water content1

  • Brings water to the extracellular matrix
  • Restores water content of the nucleus pulposus
  • Restores hydrostatic pressure needed by the NP cells to function normally
  • Stable under load pressure
Good distribution1
Good distribution within the NP’s extracellular matrix – fills proteoglycan and collagen depleted zones
Well-contained1
Is well-contained by the annulus fibrosus, which is mechanically effective at the early stage of the degenerative process

DXM is composed of a unique hydrogel formulation1

High in water content1

  • Brings water to the extracellular matrix
  • Restores water content of the nucleus pulposus
  • Restores hydrostatic pressure needed by the NP cells to function normally
  • Stable under load pressure

Good distribution1
Good distribution within the NP’s extracellular matrix – fills proteoglycan and collagen depleted zones

Well-contained1
Is well-contained by the annulus fibrosus, which is mechanically effective at the early stage of the degenerative process

An introduction to Gelmetix’s
polymer gel technology


DXM is a pH-responsive, double cross-linked hydrogel, which is designed to supplement the existing nucleus pulposus1.

DXM seeks to act as a substitute to compensate for the progressive degradation of the proteoglycan matrix of the nucleus1.


DXM has the mechanical properties to restore and maintain disc height and is suitable for restoring close to a normal dynamic pressure environment within the disc. It restores the mechanical conditions with favourable effect on nucleus cell biology that contributes to the relief of pain as it restores the normal function of the nucleus cells1.


DXM fills an unmet gap in the treatment continuum between conservative and surgical methods that has the potential to provide significant pain relief for patients, slow the progression of the disease and reduce the need for more invasive surgical intervention1. 

Stages of degenerative disc disease

At Gelmetix, we have identified that by intervening in the early stages of degenerative disc disease, we can take a “mechano-biological” approach to addressing the underlying cause of pain and slow progression of the disease8.

See infographic

An overview of the medical procedure

  • DXM is indicated in skeletally mature patients with confirmed degenerative disc disease in the lumbar spine, 3-months pain history and relevant imaging
  • DXM is indicated for intradiscal injection in one or more degenerated intervertebral lumbar discs
  • Patients should have at least 3 months of non-operative treatment prior to the DXM injection

  • DXM is injected into the degenerated intervertebral disc using a double barrel syringe
  • Healthcare professionals who apply DXM need to be competent in discography and image-guided procedures (e.g. interventional radiologists, spine surgeons, neurologists or rheumatologists)

  • Patients may be discharged after resting for up to one hour following the procedure
  • Patients should be provided with an information sheet explaining how to return, step-by-step, to daily activities over the 1-2 weeks after the procedure

An overview of the medical procedure

  • DXM is indicated in skeletally mature patients with confirmed degenerative disc disease in the lumbar spine, 3-months pain history and relevant imaging
  • DXM is indicated for intradiscal injection in one or more degenerated intervertebral lumbar discs
  • Patients should have at least 3 months of non-operative treatment prior to the DXM injection

  • DXM is injected into the degenerated intervertebral disc using a double barrel syringe
  • Healthcare professionals who apply DXM need to be competent in discography and image-guided procedures (e.g. interventional radiologists, spine surgeons, neurologists or rheumatologists)

  • Patients may be discharged after resting for up to one hour following the procedure
  • Patients should be provided with an information sheet explaining how to return, step-by-step, to daily activities over the 1-2 weeks after the procedure

The Evidence

Based on decades of research. Scientific evidence for Gelmetix’s unique approach to disc rehydration.

Driven by deep understanding of degenerative joints and discs, the inventors saw the potential to link microgel particles together to form injectable, durable and load-bearing gels9.

Material-related publications

Doubly crosslinked hydrogels prepared from pH-responsive vinyl-functionalised hollow particle dispersions
Authors: Robert Bird, Somjit Tungchaiwattana, Tony Freemont and Brian R. Saunders
Journal: Soft Matter, 2012,8, 3062-3066

Dual pH-triggered physical gels prepared from mixed dispersions of oppositely charged pH-responsive microgels
Authors: James McParlane, Damien Dupin, Jennifer M. Saunders, Sarah Lally, Steven P. Armes and Brian R. Saunders
Journal: Soft Matter, 2012,8, 6239-6247

Doubly crosslinked microgel–polyelectrolyte complexes: three simple methods to tune and improve gel mechanical properties
Authors: Ruixue Liu, Jennifer M. Saunders, Tony J. Freemont and Brian R. Saunders
Journal: Soft Matter, 2012,8, 10932-10940

A study of hydrogel composites containing pH-responsive doubly crosslinked microgels
Authors: Chonlakan Supasuteekul, Amr H. Milani, Jennifer M. Saunders, Sarah Lally, Tony Freemont and Brian R. Saunders
Journal: Soft Matter, 2012,8, 7234-7242

Injectable Doubly Cross-Linked Microgels for Improving the Mechanical Properties of Degenerated Intervertebral Discs
Authors: Amir H. Milani, Anthony J. Freemont, Judith A. Hoyland, Daman J. Adlam, Brian R. Saunders
Journal: Biomacromolecules 2012, 13, 2793-2801

Doubly crosslinked pH-responsive microgels prepared by particle inter-penetration: swelling and mechanical properties
Authors: Ruixue Liu, Amir H. Milani, Tony J. Freemont and Brian R. Saunders
Journal: Soft Matter, 2011,7, 4696-4704

Tuning the swelling and mechanical properties of pH-responsive doubly crosslinked microgels using particle composition
Authors: Ruixue Liu, Amir H. Milani, Jennifer. M. Saunders, Tony J. Freemont and Brian R. Saunders
Journal: Soft Matter, 2011,7, 9297-9306

Using osmotic deswelling of microgel particles to control the mechanical properties of pH-responsive hydrogel composites
Authors: Sarah Lally, Ruixue Liu, Chonlakan Supasuteekul, Brian R. Saunders and Tony Freemont
Journal: Journal of Materials Chemistry, 2011,21, 17719-17728

Biology & clinic-related publications

New Treatments and Imaging Strategies in Degenerative Disease of the Intervertebral Disks
Authors: Lotz JC, Haughton V, Boden SD, An HS, Kang JD, Masuda K, Freemont A, Berven S, Sengupta DK, Tanenbaum L, Maurer P, Ranganathan A, Alavi A, Marinelli NL.
Journal: Radiology. 2012 Jul;264(1):6-19.

The involvement of interleukin-1 and interleukin-4 in the response of human annulus fibrosus cells to cyclic tensile strain: an altered mechanotransduction pathway with degeneration
Authors: Gilbert HT, Hoyland JA, Freemont AJ, Millward-Sadler SJ.
Journal: Arthritis Research & Therapy 2011 Jan 28;13(1):R8.

Expression of semaphorin 3A and its receptors in the human intervertebral disc: potential role in regulating neural ingrowth in the degenerate intervertebral disc
Authors: Tolofari SK, Richardson SM, Freemont AJ, Hoyland JA.
Journal: Arthritis Research & Therapy 2010;12(1):R1.

Altered integrin mechanotransduction in human nucleus pulposus cells derived from degenerated discs
Authors: Le Maitre CL, Frain J, Millward-Sadler J, Fotheringham AP, Freemont AJ, Hoyland JA.
Journal: Arthritis Rheumatology. 2009 Feb;60(2):460-9.

The cellular pathobiology of the degenerate intervertebral disc and discogenic back pain
Author: Freemont AJ.
Journal: Rheumatology (Oxford). 2009 Jan;48(1):5-10.

Human cells derived from degenerate intervertebral discs respond differently to those derived from non-degenerate intervertebral discs following application of dynamic hydrostatic pressure
Authors: Le Maitre CL, Frain J, Fotheringham AP, Freemont AJ, Hoyland JA.
Journal: Biorheology. 2008;45(5):563-75.

Intervertebral disc biology, degeneration and novel tissue engineering and regenerative medicine therapies
Authors: Richardson SM, Mobasheri A, Freemont AJ, Hoyland JA.
Journal: Histol Histopathol. 2007 Sep;22(9):1033-41.

The role of interleukin-1 in the pathogenesis of human intervertebral disc degeneration
Authors: Le Maitre CL, Freemont AJ, Hoyland JA.
Journal: Arthritis Res Ther. 2005;7(4):R732-45.

Degeneration of intervertebral discs: current understanding of cellular and molecular events, and implications for novel therapies
Authors: Freemont TJ, LeMaitre C, Watkins A, Hoyland JA.
Journal: Expert Rev Mol Med. 2001 Mar 29;2001:1-10.

End-plate displacement during compression of lumbar vertebra-disc-vertebra segments and the mechanism of failure
Authors: Holmes AD, Hukins DW, Freemont AJ.
Journal: Spine (Phila Pa 1976). 1993 Jan;18(1):128-35.

1Gelmetix data on file (preclinical)

2An injectable nucleus replacement as an adjunct to microdiscectomy: 2 year follow-up in a pilot clinical study. Berlemann U, Schwarzenbach O. Eur Spine J. 2009;18:1706–1712.

3Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999;354(9178):581–585. doi:10.1016/S0140-6736(99)01312-4

4Chou R, Côté P, Randhawa K, Torres P, Yu H, Nordin M, et al. The Global Spine Care Initiative: applying evidence-based guidelines on the non-invasive management of back and neck pain to low- and middle-income communities. Eur Spine J. 2018;27(Suppl 6):851–60.

5Pennicooke B, Moriguchi Y, Hussain I, et al. (November 22, 2016) Biological Treatment Approaches for Degenerative Disc Disease: A Review of Clinical Trials and Future Directions. Cureus 8(11): e892. DOI 10.7759/cureus.892

6Walter BA, Korecki CL, Purmessur D, Roughley PJ, Michalek AJ, Iatridis JC. Complex loading affects intervertebral disc mechanics and biology. Osteoarthritis and Cartilage. 2011 Aug;19(8):1011–8

7Tolofari SK, Richardson SM, Freemont AJ, Hoyland JA. Expression of semaphorin 3A and ist receptors in the human intervertebral disc: potential role in regulating neural ingrowth in the degenerate intervertebral disc. Arthritis Res Ther. 2010;12(1):R1

8Richardson SM, Mobasheri A, Freemont AJ, Hoyland JA. Intervertebral disc biology, degeneration and novel tissue engineering and regenerative medicine therapies. Histol Histopathol. 2007 Sep;22(9):1033-41. doi: 10.14670/HH-22.1033. PMID: 17523081.

9Milani AH, Freemont AJ, Hoyland JA, Adlam DJ, Saunders BR. Injectable doubly cross-linked microgels for improving the mechanical properties of degenerated intervertebral discs. Biomacromolecules. 2012 Sep 10;13(9):2793-801. doi: 10.1021/bm3007727. Epub 2012 Aug 30. PMID: 22877136.