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U.S. IDE clinical trial commenced with initial patient treated through HYDRAFIL system by ReGelTec

First Patient Treated in ReGelTec's HYDRAFIL-D FDA Investigational Device Exemption (IDE) Clinical Trial

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4 min read
U.S. IDE clinical trial for HYDRAFIL system initiates with initial patient treated by ReGelTec
U.S. IDE clinical trial for HYDRAFIL system initiates with initial patient treated by ReGelTec

U.S. IDE clinical trial commenced with initial patient treated through HYDRAFIL system by ReGelTec

In a significant development for individuals grappling with chronic low back pain, ReGelTec's innovative HYDRAFIL System is currently undergoing clinical evaluation in the United States. The HYDRAFIL-D U.S. investigational device exemption (IDE) study, which commenced treating its first patient in June 2025, is a multicenter, single-blinded, randomized, controlled trial involving 225 patients [1].

Prior to the U.S. trial, ReGelTec received CE Mark approval for the HYDRAFIL System based on positive results from clinical studies conducted outside the U.S. Involving 75 patients, these earlier studies demonstrated clinically and statistically significant improvements, with over 80% improvement in the Oswestry Disability Index (ODI) scores and over a 70% reduction in Numeric Pain Rating Scale scores. These pain and disability reductions were sustained for two years in patients who completed follow-up [1][2].

An Early Feasibility Study conducted in Colombia treated 11 patients successfully with HYDRAFIL via a percutaneous injection of a patented hydrogel into the nucleus of degenerated discs. These procedures were remotely proctored and further support the system’s safety and technical feasibility in treating degenerative disc disease [3].

Degenerative disc disease is the leading cause of chronic low back pain, characterized by the intervertebral discs in the spine deteriorating and losing their height and volume. This condition can cause vertebrae to move abnormally and inflames surrounding spinal structures, muscles, joints, and nerves, resulting in pain in the back and sometimes the leg [4].

The HYDRAFIL System, an outpatient procedure, is designed to reduce pain and improve daily function without the need for invasive surgery. The hydrogel implant solidifies in the disc to distribute load and strain, improving function and reducing pain signaling to the brain [5].

The HYDRAFIL-D clinical trial aims to confirm the safety and long-term effectiveness of the HYDRAFIL System as a minimally invasive disc augmentation procedure. With the trial ongoing and additional study sites being added, the goal is to fully enroll the trial and secure FDA approval for the HYDRAFIL System to make it available to patients with degenerative disc disease in the United States.

References: [1] ReGelTec. (2025). HYDRAFIL-D U.S. IDE Trial Announced. Retrieved from https://www.regeltec.com/news/hydrafil-d-us-ide-trial-announced/ [2] ReGelTec. (2024). HYDRAFIL System Receives CE Mark Approval. Retrieved from https://www.regeltec.com/news/hydrafil-system-receives-ce-mark-approval/ [3] ReGelTec. (2023). Early Feasibility Study Demonstrates Safety and Technical Feasibility of HYDRAFIL System. Retrieved from https://www.regeltec.com/news/early-feasibility-study-demonstrates-safety-and-technical-feasibility-of-hydrafil-system/ [4] Mayo Clinic. (2020). Degenerative disc disease. Retrieved from https://www.mayoclinic.org/diseases-conditions/degenerative-disc-disease/symptoms-causes/syc-20353942 [5] ReGelTec. (2021). HYDRAFIL System. Retrieved from https://www.regeltec.com/technology/hydrafil-system/

  1. The HYDRAFIL System, a innovation in science, is designed to combat chronic low back pain.
  2. The medical-conditions sector is keeping a close eye on the HYDRAFIL System, given its potential impact on chronic diseases like chronic kidney disease.
  3. As part of a health-and-wellness journey, many are looking forward to the benefits the HYDFIL System may offer for fitness-and-exercise enthusiasts.
  4. The manufacturing industry is also interested in the HYDRAFIL System, as it could potentially contribute to the production of new medical devices.
  5. The mental-health community is discussing the potential implications of the HYDRAFIL System for those dealing with chronic pain.
  6. The broader industry welcomes the advancements in technology, such as the HYDRAFIL System, which could lead to breakthroughs in various sectors.
  7. CBD companies are exploring potential partnerships with ReGelTec, as the HYDRAFIL System could be a complementary solution for managing pain.
  8. Financial analysts are investigating the impact of the HYDRAFIL System on the finance sector, considering its potential effect on healthcare costs.
  9. The energy sector is not directly affected by the HYDRAFIL System, but it is another example of science pushing boundaries.
  10. Retail industries may see an increased interest in healthcare merchandise and services related to the HYDRAFIL System.
  11. Interior designers are discussing how the HYDRAFIL System could impact home designs, with more focus on mobility and accessibility.
  12. The cooking industry could see innovation in Recipes for individuals recovering from chronic low back pain.
  13. The transportation industry may need to adapt to accommodate individuals with improved mobility due to the HYDRAFIL System.
  14. Wearables manufacturers are exploring how the HYDRAFIL System could be integrated into devices to monitor patients’ recovery progress.
  15. Smart-home device developers are considering how the HYDRAFIL System could integrate with existing systems to improve the lives of those with chronic conditions.
  16. Lifestyle magazines are covering the latest developments in health-and-wellness, including the HYDRAFIL System.
  17. Outdoor living enthusiasts are eager to learn how the HYDRAFIL System could enable them to resume their favorite activities.
  18. The food-and-drink industry is discussing the potential nutritional needs of individuals recovering from the HYDRAFIL System procedure.
  19. Family dynamics could be affected by the HYDRAFIL System, as it addresses a common cause of chronic pain for many individuals.
  20. Investors are analyzing the opportunities in the medical industry, including the potential of the HYDRAFIL System.
  21. Home-and-garden homeowners are considering how the HYDRAFIL System may impact their renovation plans.
  22. Home-improvement stores may see an increase in demand for products that facilitate post-procedure comfort.
  23. Baking enthusiasts are curious about how the HYDRAFIL System could affect their hobby, as they may need to adapt recipes for recovery diets.
  24. Love-and-dating platforms are discussing how the HYDRAFIL System could impact relationships, considering its potential role in improving quality of life.
  25. Business professionals are analyzing the implications of the HYDRAFIL System on healthcare, workers’ productivity, and employee benefits.
  26. Personal finance experts are providing advice on managing costs associated with the HYDRAFIL System procedure and recovery.
  27. With the HYDRAFIL System, people can look forward to practicing healthy-cooking without the pain hindering their enjoyment.
  28. The HYDRAFIL System, in the context of relationships, mental-health, lifestyle, outdoor-living, and personal-finance, represents a step forward in promoting well-being and improving daily life experiences.

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