HYDRAFIL: A Novel Thermosensitive Hydrogel for Chronic Low Back Pain Receives CE Mark

ReGelTecReGelTec, Inc. Announces Hydrogel Device for Disc Augmentation ---HYDRAFILReceived CE approval for marketing. With the CE marking,A New Treatment Option for Chronic Low Back Pain.HYDRAFILAllow patients to receive interventional treatment in an outpatient setting, and it can reduce pain, improve daily function, and avoid invasive surgery.

Expert Evaluation

"Chronic low back pain affects millions of people every year and is highly disabling. Degenerative disc disease, as its main cause, is particularly challenging to treat due to the lack of effective options between conservative treatments and invasive surgeries. Over the past three years, tracking 35 patients treated with HYDRAFIL, I have personally witnessed the remarkable effectiveness of this minimally invasive outpatient procedure in alleviating pain and dysfunction. It fills a significant treatment gap for patients eager to avoid major spinal surgery, and we look forward to initiating patient enrollment in the pivotal HYDRAFIL-D study in the United States."

---Olivier Clerk-Lamalice  chief executive officer of Beam Radiology

Executive Evaluation

"CE Approval for ReGelTec"Another milestone has been reached. We will use this momentum to accelerate the enrollment for the HYDRAFIL-D study required for FDA approval, and we look forward to securing more funding to support our global expansion."

---Bill Niland  ReGelTecCo-founder and CEO

More than one in ten adults in the U.S. suffer from chronic lower back pain, of which approximately 42% (over 10 million people) have degenerative disc disease. This condition leads to disc degeneration, loss of height and volume, causing abnormal vertebral movement and irritation to surrounding spinal structures.Muscles, joints, and nerves, causing lower back and even leg pain.

Chronic low back pain is an extremely costly condition, with estimated annual direct medical costs exceeding $50 billion and indirect economic losses due to productivity loss and work absenteeism surpassing $100 billion.

Currently forTreatment options for chronic low back pain include conservative treatments (physical therapy, pain medications, exercise rehabilitation, epidural steroid injections), although these methods can temporarily relieve symptoms, they do not address the root cause.

For patients who do not respond to conservative treatment, surgical options such as spinal fusion may be considered. However, literature indicates that such surgeries are not superior to conservative treatment in eliminating pain and improving dysfunction.

Fortunately, there are still many innovative companies that see the current situation.The Dilemma of Chronic Low Back Pain Treatment: A Decision to Change the Status QuoReGelTecThat is one of themA Member. Its groundbreaking hydrogel product---HYDRAFIL，Fills the existing treatment gap for patients, achieving long-term pain relief and functional improvement through minimally invasive surgery with a short recovery period.

HYDRAFIL

HYDRAFILIt is an implantable thermosensitive hydrogel, composed of hydrogel and a delivery system.

HYDRAFILHydrogel is a thermosensitive hydrogel, which can form a liquid-like state when heated in vitro. It can be guided by X-ray to...The viscous fluid is precisely injected into the nucleus pulposus of the degenerated intervertebral disc through an 18-gauge puncture needle.

Once injected into the body, the hydrogel can fuse with the patient's nucleus pulposus tissue and solidify in situ as an integrated solid implant upon cooling to body temperature.

HYDRAFILThe method of use and injection site are somewhat similar toPercutaneous Vertebroplasty (PVP), andHYDRAFILHydrogel can be used for the same purposes as bone cement.Nucleus Pulposus Augmentation. Unlike bone cement, HYDRAFILHydrogel is a kind of elastic material rich in water. Not onlyPerfectly fills fissures, recruits moisture to restore natural biomechanics, and alleviates pain.After solidification, the hydrogel can disperse the load strain of the intervertebral segment, improve function, and reduce pain signal transmission.

At the same time viaHYDRAFILHydrogel in situ cures within the annulus of the intervertebral discSingle Solid Cohesive Mass, effectively sealing the puncture path,Significantly reduce the risk of implant spillage。

HYDRAFIL Core Advantages

• Percutaneous minimally invasive operation is simple:Local anesthesia, can be completed in outpatient setting, short recovery period

• Biomimetic Biomechanics: The implant accurately simulates the biomechanical properties of natural intervertebral discs, effectively restoring the dynamic load-bearing capacity of the spine and improving spinal function.

• Ultra-Low Risk of Spillage：After curing, it integrates tightly with the surrounding tissue, demonstrating excellent long-term stability.

• Preservation of Motor Function: Avoiding rigid spinal fixation in traditional fusion surgery,Maximize the Retention of Natural Spinal Mobility。

• Long-lasting Stability Integration: Solid-state hydrogel forms mechanical continuity with surrounding tissues, reducing the risk of displacement and ensuring long-term efficacy.

HYDRAFIL Clinical Effects

HYDRAFILCE Registration Clinical Trial: AcceptedHYDRAFILPatients treated showed clinically and statistically significant improvements in both pain and functional disability. Data indicates that the Oswestry Disability Index (ODI) scores improved by over 80%, Numeric Pain Rating Scale (NPRS) scores decreased by more than 70%, and the effects remained stable for the 63 patients who completed the two-year follow-up.