1. Regulatory Context and Objectives

Pharmaflex operates in the field of medical devices geared toward orthopedic support, with a particular focus on vertebral decompression, a clinically validated biomechanical principle for the management of spinal disorders. The tests performed, the subject of this extended report, meet national and international standards in the field of ergonomic certification (ErgoCert ST02.01) and are supported by academically recognized scientific literature.

2. ErgoCert Test on Topper and Mattress

2.1 Protocol and Methodology

• Sample of 10 subjects (BMI between 16 and 28.4).
• Detections by high-sensitivity barometric mats.
• Comparison of:
• Pharmaflex mattress
• Pharmaflex topper
• reference firm mattress

2.2 Parameters Analyzed

• Mean pressure in supine and lateral position
• Pressure peaks
• % surface area at risk (pressures > 0.4256 N/cm²)
• Comfort Index (CI) calculation.

2.3 Results

Product | IC | Mean Pressure (sup.) | Peak Pressure (sup.) | % Area Risk Sup.

Pharmaflex mattress
8.67 | 0.27 N/cm² | 0.70 N/cm² | 8.37%

Pharmaflex Topper
8.71 | 0.27 N/cm² | 0.85 N/cm² | 10.6%

Rigid Mattress
7.38 | 0.31 N/cm² | 0.99 N/cm² | 19.8%

2.4 Interpretation

The obtained values show that the topper, despite its reduced thickness, is able to replicate the biomechanical effects of the mattress due to the same orthopedic wave design. Both exceed the IC > 7 threshold required by ErgoCert for biomedical certification.

3. ErgoCert test onCervical" and "Reflux" Pillows.

3.1 Protocol

• 6 subjects, with morphological variation (height, BMI, shoulder and neck length).
• Detection by 17-sensor MVN Biomech Awinda (Xsens) system.
• Evaluation of angular deviations between C7 and head vertex.
• Positions analyzed: supine and lateral.

3.2 Results and Compliance

• Pillow deflections Cervical between 2° and 19° in almost all subjects.
• Conformity classification according to ErgoCert:
• ≤ 14°: compliant
• 15-19°: partially compliant
• ≥ 20°: non-compliant

3.3 Conclusion

TheCervical" pillow has been shown to be effective in maintaining proper alignment of the cervical spine, with optimal results in lateral position. The effect is further improved in combination with the orthopedic mattress from the same line.

4. IGR Germany Study: Measuring Vertebral Decompression.

4.1 Experimental Setup

• Headquarters: IGR Institut für Gesundheit und Ergonomie
• Technology: Video-Raster-Stereographie (VRS BackMapper)
• Duration: 25 minutes per system tested
• Comparison of:
• Conventional system (standard polyurethane mat.)
• Pharmaflex Performance system (mattress + Cervical pillow)

4.2 Monitored Parameters

• Kyphosenwinkel (kyphotic angle)
• Lordosewinkel (lordotic angle)
• Beckentorsion (twisting pelvis)
• Max. Seitenabweichung (lateral deviations)
• Lumbaler Biegungswinkel (lumbar angle)

4.3 Significant Results

• Kyphose and lordosis approaching normative values with Pharmaflex (98-104% norm)
• Lateral deviations and pelvic torsion statistically significantly reduced
• Better postural recovery after only 25 min of use

4.4 Clinical Impact

The study shows that the Pharmaflex system promotes active postural correction during rest, consistent with the mechanisms of vertebral decompression, by acting passively on thoracolumbar and pelvic segments.

5. Functional Equivalence of Products

Biomechanical tests have shown that there is substantial functional equivalence between the mattresses and the Pharmaflex topper. This result stems from the fact that they both share the same orthopedic wave design, which allows:

• optimized distribution of loads
• attenuation of pressure peaks
• maintaining neutral posture
• passive support for vertebral decompression

In particular:

• The topper, despite having a lower thickness than the mattress, showed almost identical Comfort Index (CI) values and mean pressures, ensuring the same ergonomic and biomechanical effectiveness.
• The mattresses exhibit stable performance, regardless of the variant tested, as they are based on the same wave architecture.

Regarding cervical pillows, biomechanical testing certified by ErgoCert showed that theCervical" pillow:

• Maintains the physiological alignment of the cervical spine
• Reduces abnormal head angulation in supine and lateral positions

In addition, the cushion was tested in combination with the mattress during the IGR study, contributing to the positive results in vertebral decompression measured by VRS. This consolidates its role as a synergistic component of the Pharmaflex orthopedic system, validating its effectiveness in the treatment of musculoskeletal dysfunctions related to the spine.

6. Vertebral Decompression: Therapeutic Principle Applied

The principle of vertebral decompression is a noninvasive therapeutic approach aimed at reducing intradiscal pressure and promoting retraction of protrusions and herniated discs. It has been shown in the clinical literature that proper postural support can simulate, in a static or semi-passive position, the decompressive effect.

Relevant Studies:

• Gose EE, Naguszewski WK. "Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome." Neurological Research, 1998.
• Ramos G, Martin W. "Effects of vertebral axial decompression on intradiscal pressure." Journal of Neurosurgery, 1994.
• Apfel CC et al. "Efficacy and Safety of Non-Surgical Spinal Decompression: A Systematic Review." Pain Practice, 2010.

Mechanisms Involved:

• Reduction of lumbar intradiscal pressure
• Increased foraminal space (greater distance between vertebrae)
• Paravertebral relaxation
• Potential stimulation of disc rehydration

Application to Pharmaflex Products:

Pharmaflex mattresses and toppers, with their wave design and optimized pressure distribution, allow:

• A passive reduction of compression on the column
• A maintenance of neutral posture during sleep
• A synergistic effect with the cervical pillow, which contributes to the overall alignment of the spinal axis

These aspects make the products suitable for individuals with:

• Disc herniations/protrusions
• Lumbosciatica
• Cervicalgia with postural component
• Piriformis syndrome and other radicular compressions

7. Extended Scientific Bibliography

1. Gose, E.E., Naguszewski, W.K., & Naguszewski, R.K. (1998). Vertebral axial decompression therapy for pain associated with herniated or degenerated discs or facet syndrome: an outcome study. Neurological Research, 20(3), 186-190. https://doi.org/10.1080/01616412.1998.11740505
2. Ramos, G., & Martin, W. (1994). Effects of vertebral axial decompression on intradiscal pressure. Journal of Neurosurgery, 81(3), 350-353. https://doi.org/10.3171/jns.1994.81.3.0350
3. Apfel, C.C., et al. (2010). Efficacy and safety of non-surgical spinal decompression: a systematic review. Pain Practice, 10(2), 118-129. https://doi.org/10.1111/j.1533-2500.2009.00330.x
4. Defloor, T., et al. (2005). The effect of various combinations of support surfaces and turning schedules on pressure ulcer incidence. Journal of Advanced Nursing, 52(1), 61-68.
5. Reenalda, J., et al. (2009). Clinical use of interface pressure to predict pressure ulcer development: a systematic review. Assistive Technology, 21(2), 76-85.
6. Gyi, A., & Porter, J.M. (1999). Interface pressure and the prediction of pressure sore risk. Journal of Clinical Nursing, 8(2), 131-136.
7. Levy, M., et al. (1996). Relationship between pressure sores and interface pressure measurements. Journal of the American Geriatrics Society, 44(4), 471-476.
8. Cagnie, B., et al. (2010). The use of a neck support pillow and the cervical spine in side sleeping position. Manual Therapy, 15(6), 593-598.
9. Gordon, S.J., et al. (2009). Effect of mattress design on back pain and sleep quality in chronic low back pain sufferers. The Spine Journal, 9(1), 47-54.
10. ErgoCert (2024). Pharmaflex certified mattress + topper + pillows evaluation report. Code ST02.01-BIO.
11. IGR Institut für Gesundheit und Ergonomie (2024). Studienbericht: Vergleichende ergonomische Bewertung Pharmaflex Performance vs Matratze Standard. Nuremberg, Germany.

8. Post-Market Surveillance.

In compliance with regulations under the Medical Device Regulation (EU) 2017/745, Pharmaflex has implemented a structured Post-Market Surveillance (PMS) system. This system aims to continuously monitor the clinical performance, perceived effectiveness, and safety of devices even after they are placed on the market.

8.1 Sources of data collection.

PMS data are acquired from:

• Certified reviews on public platforms
  
  
• After-sales satisfaction questionnaires
  
  
• Spontaneous reports from customers
  
  
• Feedback collected from physical therapists and contracted centers
  
  

8.2 Evaluation of perceived effectiveness

Aggregate analysis of the more than 3,000 reviews collected over the past 36 months indicates an average rating of 4.7 out of 5, with the following aspects having a particularly positive impact:

• Reduction in lower back and neck pain reported as early as the first days of use
  
  
• Improvement in subjectively perceived sleep quality
  
  
• Increased comfort in lateral and supine positions
  
  
• Product confidence through transparent reporting of clinical data
  
  

8.3 Use of data

Evidence gathered through post-market surveillance is being:

• integrated into the internal quality management system (QMS)
  
  
• Used for continuous product improvement
  
  
• submitted during the renewal of compliance certifications
  
  

Conclusion: The data collected confirm that Pharmaflex products not only meet the clinical standards expected in testing, but also maintain high performance in daily practice, benefiting users with musculoskeletal disorders.

9. Clinical Discussion and Final Conclusions

Joint analysis of biomechanical testing and clinical evidence shows that Pharmaflex orthopedic devices possess characteristics suitable not only for improving comfort but also for managing pathological conditions of the spine. The proven effectiveness in reducing local pressures, the ability to maintain a neutral postural stance, and the instrumentally measurable decompressive effect make these systems suitable for:

• Prevention of pressure sores in at-risk individuals
• Support in conservative treatment of hernias, protrusions and lumbosciatica
• Postural support during physiotherapy recovery
• Home use in patients with chronic musculoskeletal conditions

Pharmaflex is thus configured as a medical brand geared toward functional prevention and noninvasive treatment of spinal dysfunction through scientifically and clinically validated solutions.

Full version updated to 2025 - Edited by the scientific and technical department.