Demetra Acquires OrthoFundamentals and Launches Global Spine Division

Analysis reveals significant industry trends and economic implications

Release Date

2025-08-04

Category

Merger / Acquisition Event

Reference

Source

Breakthrough Clinical Results

Demetra, a medical company specializing in bone cements and biomaterials, announced the acquisition of OrthoFundamentals, a provider of single-use solutions for sacroiliac (SI) joint fusion procedures. This acquisition led to the launch of Demetra Spine, a new global business unit focused on transforming spinal surgery with innovative, value-based solutions. Demetra Spine will offer minimally invasive, infection-risk reducing, and environmentally sustainable products. The acquisition builds on Demetra's recent acquisitions of GetSet Surgical and assets from Bespoke Technologies, strengthening its position in spine surgery. The new division aims to establish a leadership position in the outpatient spine surgery market.

Key Highlights

  • Acquisition of OrthoFundamentals, LLC, a leading provider of single-use solutions for SI joint fusion.
  • Launch of Demetra Spine, a new global business unit focused on spinal surgery.
  • Focus on minimally invasive, infection-risk reducing, and environmentally sustainable solutions.
  • Strengthened position in spine surgery through previous acquisitions of GetSet Surgical and Bespoke Technologies assets.

Risk Factors and Comorbidities

Top 3 Risk Factors and Comorbidities for Sacroiliac (SI) Joint Fusion

Primary Risk Factors

  1. Prior SI joint injection represents the most significant risk factor for requiring subsequent SI joint fusion, with the highest odds ratio of 8.70 (95% CI: 8.25-9.16; P < 0.001). This indicates that patients who have previously received SI joint injections are substantially more likely to progress to surgical fusion.

  2. Increased construct length in spinal fusion significantly elevates the risk for future SI joint fusion:

  3. 7+ vertebral segment fusion more than doubles the risk (OR: 2.17; 95% CI: 2.03-2.33; P < 0.001)

  4. 3-6 vertebral segment fusion increases risk by nearly 50% (OR: 1.49; 95% CI: 1.42-1.57; P < 0.001)

Biomechanical studies support this finding, providing evidence of adjacent segment stress in the SIJ in fusion constructs extending to S1. Clinical studies further suggest that SIJ degeneration occurs in the setting of lumbosacral fusions.

  1. Female gender is consistently associated with higher risk of SI joint fusion. This is particularly notable in women with postpartum posterior pelvic girdle pain (PPGP), which affects nearly 20% of women with back pain in the peripartum period. The sacroiliac joint is a source of pain in 75% of women with persistent PPGP. Interestingly, women with PPGP requiring SI joint fusion were significantly younger (43.3 years) compared to females without PPGP (52.8 years) and men (50.5 years).

Significant Comorbidities

Several comorbid conditions are associated with increased risk for SI joint fusion:

  • Obesity is strongly associated with future SI joint fusion, likely due to increased mechanical stress on the joint
  • Fibromyalgia increases risk for SI joint fusion, possibly related to central sensitization and pain amplification
  • Diabetes is a comorbidity linked to SI joint fusion
  • Tobacco use is associated with increased risk, potentially through vascular and inflammatory mechanisms

Clinical Implications

The sacroiliac joint has been implicated as a source of chronic low back pain in 15% to 30% of patients. SI joint pain can present with lower extremity radicular-type pain and closely mimic a herniated vertebral disc, making accurate diagnosis challenging. Diagnosis can be supported with local anesthetic SI joint blocks, and imaging often demonstrates sacroiliac joint degeneration (joint space narrowing, vacuum phenomenon, osteophyte formation, sclerosis).

When nonsurgical approaches fail, sacroiliac joint fusion may be recommended, particularly for patients with degenerative sacroiliitis and/or sacroiliac joint disruptions. In a study of patients treated with minimally invasive SI joint fusion, 47% had prior lumbar spinal fusion, further highlighting the relationship between spinal fusion and subsequent SI joint problems.

Incidence and Prevalence

Latest Estimates of Sacroiliac Joint Fusion Incidence and Prevalence

According to the most recent data from 2024, a comprehensive retrospective cohort study identified 549,625 patients who underwent posterior spinal fusions. Among these patients, 6,068 individuals (1.1%) subsequently required sacroiliac joint fusion procedures.

Several risk factors have been identified that increase the likelihood of requiring future SI joint fusion following spinal fusion procedures. These include:

  • Female gender
  • Obesity
  • Fibromyalgia
  • Diabetes
  • Tobacco use
  • Increased construct length
  • Prior SI joint injection

Of these risk factors, prior SI joint injection demonstrated the strongest association with subsequent SI joint fusion, with an odds ratio of 8.70 (95% CI: 8.25-9.16; P < 0.001). Patients who underwent fusion of 7 or more vertebral segments had an odds ratio of 2.17 (95% CI: 2.03-2.33; P < 0.001), while those with 3-6 vertebral segment fusion had an odds ratio of 1.49 (95% CI: 1.42-1.57; P < 0.001).

The sacroiliac joint has been identified as a significant source of pain in various populations. Research from 2015 found that the SI joint is responsible for pain in 75% of women with persistent postpartum posterior pelvic girdle pain. Additionally, studies have found that up to one-third of patients with low back pain (LBP) have sacroiliac joint dysfunction as a contributing cause, and a 2014 publication indicated that the sacroiliac joint has been implicated as a source of chronic low back pain in 15% to 30% of patients.

Clinical evidence suggests that SIJ degeneration commonly occurs following lumbosacral fusions, as noted in a 2024 biomechanical investigation. This may partially explain the need for subsequent SI joint procedures in some patients who have undergone spinal fusion.

In terms of treatment efficacy, a 2019 randomized controlled trial involving 103 subjects with chronic sacroiliac joint pain demonstrated that minimally invasive sacroiliac joint arthrodesis with triangular titanium implants was safe and more effective than conservative management throughout a 2-year follow-up period, showing improvements in pain, disability, and quality of life.

Long-term outcomes following sacroiliac joint arthrodesis are generally positive, with a 2020 study finding that most patients reported no pain and minimum pain-related disability post-procedure, with physical activity profiles comparable to healthy controls. However, these patients did show impaired walking performance compared to healthy controls, suggesting that some functional limitations may persist despite excellent clinical results.

Company drugs in pipeline

Demetra S.p.A. Pipeline Indications

I don't have specific information about Demetra S.p.A.'s drug pipeline indications in the provided context. The context does not contain details about which therapeutic areas, disease states, or medical conditions are targeted by Demetra S.p.A.'s investigational drugs, nor does it specify any disease indications or treatment targets represented in their preclinical and clinical-stage drug candidates.