STA363 a disease modifying single treatment

The STA363 treatment is a worldunique, patented innovation capable of alleviating the pain of patient’s suffering from herniated discs (LDH).

Instead of costly and time-consuming procedures, such as spinal fusions or long-term physiotherapy, STA363 is administered as a one-time injection.

Removing the root cause of the pain

Both indications are single injection treatments tackling the root cause of the problem, and is expected to remain effective over a lifetime, requiring minimal rehabilitation. As such, it is anticipated to decrease the number of people on sick leave, reduce the usage of painkillers, and substantially increase the patients’ quality of life.

Making disc herniation treatment available – for everyone

Stayble´s treatment is intended for patients suffering from pain thought to be caused by disc herniation. Our main aim is to help people who do not respond adequately to conservative treatment. Our treatment is much less time-consuming than conservative therapies and an experienced radiologist or spine surgeon can perform it in less than an hour

Lumbar disc herniation (LDH)

STA363 aims to significantly reduce nerve root pain caused by chronic herniated discs and drastically increase the patient’s quality of life. Following the preclinical and clinical results (phase 1b and 2b) from previous studies in degenerative disc disease, which show a volume reduction of the discs, the Company is currently conducting a phase 1b study for the treatment of herniated discs.

The study focuses on safety and tolerability as well as determining a reduction in disc volume to demonstrate that the treatment concept has been shown to work. Additional endpoints are pain and disc transformation to connective tissue. Final data is expected during H2 2024.

Phase 1B

A typical patient suffering from LDH

  • 30-50 years old
  • Moderate disc degeneration
  • No improvement after 12 weeks of acute leg pain
  • Surgery is the only option

Intradiscal injection of a well documented molecule

STA363 is based on an endogenous and well documented small molecule together with a contrast agent assuring safe and accurate injection. Administration will be a single intradiscal injection. The effect of one single injection of STA363 is presumed to last the patient’s entire life and require minimal if any rehabilitation. STA363 transforms the disc into connective tissue and has therefore the potential to permanently achieve a significant reduction of the patient’s pain.

The treatment is aimed at patients suffering from herniated discs. It is designed to reduce pressure in the disc by shrinking the herniated disc, leading to pain relief. The volume and pressure in the disc is reduced and the disc is converted into connective tissue. This reduction in both volume and pressure causes the disc herniation to shrink, reducing nerve pressure and relieving pain. Furthermore, the conversion to connective tissue will stabilize the disc, which in turn reduces the risk of renewed herniation.

Healthy disc

A disc consists of two main parts: Nucleus pulposus (disc centre) and anulus fibrosus (disc wall). Nucleus pulposus consists largely of a highly hydrated gel together with nucleus pulposus cells and fibroblasts.

Herniated disc

As the disc degenerates throughout ageing, tears in the anulus fibrosus appear and nucleus pulposus loses its gel-like structure resulting in a mechanically unstable disc. Inflammatory changes occur and the tears allow leakage of pro-inflammatory substances from the nucleus pulposus irritating and sensitising nerves both within and outside the disc.

Disc injected with STA363

One single injection of STA363 transforms the disc into dense connective tissue. The transformation restricts synthesis and leakage of pro-inflammatory agents and re-stabilises the intervertebral segment. By achieving these two effects, Stayble believes that STA363 has the potential to significantly reduce discogenic low back pain.


STA363 has previously been evaluated in a clinical phase 2b within degenerative disc diseases in a total of 110 patients. The results from the phase 2b study strengthen our belief in treatment for herniated discs. This primarily due to the following:

  • STA363 demonstrated a good safety profile for up to 12 months
  • In the high dose of STA363, a statistically significant difference in disc intensity was established, indicating that STA363 affects the disc in the intended way
  • In both high and low doses of STA363, a dose-dependent statistically significant difference was established in disc height, a clear sign of a reduced disc volume.

Clinical research

Learn more about our pre-clinical and early clinical work in our scientific publication in the prestigious journal SPINE.

Read more

Invest in the future treatment of pain

Stayble is listed on Nasdaq First North under the ticker STABL. You will find all relevant information on the Stayble share in our Investors section.