Gel-One^® Cross-linked Hyaluronate

In a major study of 379 randomized patients¹ (248 receiving Gel-One Hyaluronate), the findings are clear:

• Gel-One Hyaluronate demonstrated superior pain relief from baseline at 13 weeks when compared with a PBS control.
• Patients receiving Gel-One Hyaluronate experienced, on average, a nearly 40% reduction in pain from baseline (28 mm reduction in WOMAC pain on a 100 mm VAS scale).
• Zero incidents of pseudosepsis or any other severe adverse events were reported with Gel-One Hyaluronate treatment.
• Side effects were as expected, and most commonly included joint swelling, joint effusion and joint pain.

¹Of the 379 enrolled patients, 377 patients received either Gel-One Hyaluronate or PBS injection, and 375 patients were analyzed for the Intent to Treat (ITT) population. Patients reported pain with symptomatic OA of the knee defined by WOMAC VAS Pain subscore of ≥40 mm in the study knee and ≤20 mm in the contralateral knee. Patients meeting the following criteria were excluded at randomization: Kellgren-Lawrence Grade 4, severe inflammation or joint effusion in either knee. The ITT population included all treated patients who had any post-injection evaluations.  Table 1 summarizes baseline and patient demographic characteristics for the ITT population.

Table 1: Patient Baseline Characteristics – ITT Population

Summary of Secondary Effectiveness^a Endpoints at Week 13 – ITT Population

^a Based on the quadratic spline model at week 13.

^b WOMAC Scale is 100mm.

^c P-value was not adjusted for multiplicity of secondary endpoints.

There were no serious AEs or pseudoseptic reactions related to Gel-One

Hyaluronate injection.

Conclusions

The study results demonstrated that a single injection of Gel-One Hyaluronate is safe and effective for treatment of pain in osteoarthritis of the knee in patients who have failed to respond to nonpharmacologic therapy, NSAIDs or simple analgesics.

Gel-One Hyaluronate is a sterile, transparent and viscoelastic hydrogel. It is a cross-linked hyaluronate, which is also referred to as hyaluronan, hyaluronic acid, or HA.

Gel-One Hyaluronate originates from an avian source (highly purified, from chicken combs). In processing, polysaccharide chains are part of the creation of the Gel-One Hyaluronate cross-linked polymer.The viscoelastic properties of this hydrogel provide cushioning and shock-absorption within the osteoarthritic joint.

Each 3mL disposable, latex-free glass syringe contains 3mL of a 1% (10mg/mL) hyaluronan solution. Detailed description of each 3mL dose of Gel-One Hyaluronate:

Gel-One Hyaluronate supplements the naturally occurring synovial fluid providing pain relief and improved knee function after just one injection.

Gel-One Hyaluronate Product Brochure

Technical Reference / Injection Technique

Indication: Gel-One Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen.

Important Safety Information

Before using Gel-One Hyaluronate, tell your doctor if you are allergic to hyaluronan products, cinnamon, or products from birds such as feathers, eggs, and poultry.Gel-One Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. You should not receive a Gel-One Hyaluronate injection if you have a skin disease or infection around the area where the injection will be given.Gel-One Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA.Gel-One Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21. You should tell your doctor if you think you are pregnant or if you are nursing a child. Talk to your doctor before resuming strenuous or pro-longed weight-bearing activities after treatment. The safety and effectiveness of repeat treatment cycles of Gel-One Hyaluronate have not been established. The side effects most commonly seen after injection of Gel-One Hyaluronate are knee pain, swelling, and/or fluid build-up around the knee. These reactions are generally mild and do not last long. Other conditions, including but not limited to skin redness and rash, knee stiffness, and bruising at the injection site, have also been reported rarely. If any of these symptoms or signs appears after you are given Gel-One Hyaluronate or if you have any other problems, you should call your doctor.

Gel-One Hyaluronate Prescribing Information

Gel-One Hyaluronate Patient Information

You can get additional information on Gel-One Hyaluronate at gel-one.zimmer.com.

Gel-One Hyaluronate is packaged in a single-injection, 3mL syringe (1% solution [10 mg/mL], 30mg total hyaluronan). It is injected into the intra-articular space of the knee.

Store in the original package below 77°F (25°C). DO NOT FREEZE.

DO NOT USE after expiration date indicated on package.Gel-One Hyaluronate has a 12-month shelf life from date of manufacture.

STERILE CONTENTS intended for single use:

• Use syringe immediately after blister package is opened.
• Discard any unused Gel-One Hyaluronate.

DO NOT USE if the package has been opened or damaged, or if the syringe is cracked or broken.

Questions regarding reimbursement may be addressed by contacting the Zimmer Reimbursement Hotline:

Phone: 1-866-946-0444

Email: reimbursement@zimmer.com

Zimmer Reimbursement Hotline Hours: Monday-Friday, 8am-5pm EST

Gel-One Reimbursement

Indication: Gel-One Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen.

Important Safety Information

Before using Gel-One Hyaluronate, tell your doctor if you are allergic to hyaluronan products, cinnamon, or products from birds such as feathers, eggs, and poultry.Gel-One Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. You should not receive a Gel-One Hyaluronate injection if you have a skin disease or infection around the area where the injection will be given.Gel-One Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA.Gel-One Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21. You should tell your doctor if you think you are pregnant or if you are nursing a child. Talk to your doctor before resuming strenuous or pro-longed weight-bearing activities after treatment. The safety and effectiveness of repeat treatment cycles of Gel-One Hyaluronate have not been established. The side effects most commonly seen after injection of Gel-One Hyaluronate are knee pain, swelling, and/or fluid build-up around the knee. These reactions are generally mild and do not last long. Other conditions, including but not limited to skin redness and rash, knee stiffness, and bruising at the injection site, have also been reported rarely. If any of these symptoms or signs appears after you are given Gel-One Hyaluronate or if you have any other problems, you should call your doctor.

Gel-One Hyaluronate Prescribing Information

Gel-One Hyaluronate Patient Information

You can get additional information on Gel-One Hyaluronate at gel-one.zimmer.com.