Dispel knee pain and improve mobility with a single injection

HYAJOINT Plus® is a synovial fluid supplement, also known as a viscosupplement, that replaces the hyaluronic acid naturally present in the joint. The treatment requires a single injection into the synovial cavity of the joint knee 3.

HYAJOINT Plus® reduces knee pain and improves mobility for at least 6 months 1,2.

HYAJOINT Plus® is a safe and efficient viscosupplement that reduces pain and improves mobility in the osteoarthritic knee for at least 6 months with a single injection 1,2,3.

Active Ingredient

Sodium hyaluronate 60mg

HA Concentration

60mg/3mL (2%)

Injection Regimen

One single injection per treatment for adult into the OA knee joint

Package

3mL x 1 syringe

*This product is a class III medical device. CE marked (Notified body n°2797) in accordance with the rules and regulation in effect.

Single injection 3

Long-lasting relief of symptomatic knee OA pain for at least 6 months 1,2

Carefully controlled cross-linking 1,2

High molecular weight 1

Non-animal sourced 3

Prolonged degradation time 1,2

HYAJOINT Plus® is produced with a unique
CHAP™ technology*

HYAJOINT Plus® is a non-animal sourced hyaluronic acid produced by microbial fermentation, thus eliminating potential risks associated with allergies to avian proteins 1.

HYAJOINT Plus® is synthesised by a novel cross-linking process using 1,4-butanediol diglycidyl ether (BDDE) to create an antidegradation feature. The patented CHAPTM (Cross-linked Hyaluronic Acid Platform) process prolongs the degradation time by carefully transforming linear hyaluronic acid to crosslinked hyaluronic acid and thus increasing the molecular weight. This cross-linking technology enables the creation of a viscous gel with increased density (2% HA, 20mg/ml)1,2. The carefully controlled cross-linked hyaluronic acid increases the viscoelastic properties of the synovial fluid reducing pain and restoring knee joint mobility 1,2.

*For more information, please consult the available patent.

Cross-linking Technology

Linear hyaluronic acid before cross-linking.

Cross-Linking technology with less BDDE, minimising the amount of BDDE residue.

HYAJOINT Plus® Clinical Efficacy
Shown to be more efficient in pain relief than Synvisc-One® in a prospective, randomised double-blind, level I study 2.
Study Design

Prospective, randomised, controlled, double-blinded study with a 6 month follow-u 2.

132 patients (both genders, aged 40-85 years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3). Two groups: 1 intra-articular knee injection of 3mL of HYAJOINT Plus® (20mg/mL) (n=66) or 6 mL of Synvisc-One® (8mg/mL) (n=66)2.

Primary outcome was a significant change from baseline in the VAS pain score at 6 months 2.

11 patients did not return for follow-up visits, leaving 121 patients available for the intention to treat analysis at the 6-month follow-up evaluation 2.

The values of VAS score (mm) are given as the mean ± standard deviation. For statistical detail, please refer to the brochure.

Results

Better improvement of pain relief by 33.3 mm on VAS score in patients treated with HYAJOINT Plus® compared to 23.4 mm in the Synvisc-One® group at 6 months (mean difference between groups -6.6; p=0.045).2

Safety data

The frequencies and types of adverse events were comparable between Synvisc-One® and HYAJOINT Plus® groups. The majority of adverse events were mild or moderate, lasted 1 to 3 days, and resolved spontaneously or responded well to simple analgesics. The adverse events reported in each group were joint pain, joint swelling, joint stiffness, limb weakness, back pain. Twelve patients ( 9 treated with Synvisc-One® and 3 treated with HYAJOINT Plus®) developed joint effusion within 1 week after the injection, all infections revolved except for 2 patients treated with Synvisc-One® who required arthrocentesis for pain relief. No allergies, pseudosepsis or serious adverse events occurred during the study in either group.2

HYAJOINT Plus®, a long term treatment for symptomatic osteoarthritis; pain relief and restored mobility with a single injection 1.
Study Design

Prospective study with a 6 month follow-up 1.

3 patients did not return for follow-up visits 1.

49 patients (both genders, aged 40-85 years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3). 1 intra-articular knee injection of 3mL of HYAJOINT Plus® (20mg/mL) 1.

Results

6 months after injection of HYAJOINT Plus®, the WOMAC pain score (Western Ontario and McMaster Universities Osteoarthritis Index) was significantly reduced compared to the baseline (from 7.62 to 3.57; P<0.001)1.

The Single Leg Stance (SLS) duration was significantly improved at 6 months after HYAJOINT Plus® injection compared to the baseline (from 14.95 to 26.37 sec; p=0.008)1.

The mean VAS decreased by 28.45 mm from baseline at 6-month follow-up (from 60.12 to 31.67mm; p<0.001)1.

The values of WOMAC pain score (points) are given as the mean ± standard deviation (7.62±0.49 and 3.57 ±0.40 at baseline and 6 months respectively) in 46 patients assessed using a Bonferroni post-hoc test. Adapted from Tuan et al, 2018.

The values of SLS duration (sec) are given as the mean ± standard deviation (14.95±2.97 and 26.37±3.83 at baseline and 6 months respectively) in 46 patients assessed using a Bonferroni post-hoc test. Adapted from Tuan et al, 2018.

The values of VAS score (mm) are given as the mean ± standard deviation (60.12±2.31 and 31.67±25.02 at baseline and 6 months respectively) in 46 patients assessed using repeated measures one-way ANOVA and a Bonferroni post-hoc test. Adapted from Tuan et al, 2018.

Safety data

No infections, allergies or other serious adverse effects were reported. Five subjects developed joint pain without inflammatory signs and 1 patient developed mild and painful effusion which spontaneously subsided 9 days later.

Important safety information for HYAJOINT Plus®

HYAJOINT Plus®, should not be administered to patients who have experienced cases of past or present infections or skin diseases in the area of the injection site. Prior to injection, ask your patient if they have experienced hypersensitivity to any hyaluronic acid-based products. The injection of HYAJOINT Plus® must be administered by authorized personnel in accordance with local legislation.

References:

1. Tuan S., Liou I., Su H., Tsai Y., Chen G. and Sun S._Improvement of self-reported functional scores and thickening of quadriceps and femoral intercondylar cartilage under ultrasonography after single intra-articular injection of a novel crosslinked hyaluronic acid in the treatment of the knee osteoarthritis. JBMR._2018 ; 31 : 709-718

3. Instruction for use HYAJOINT Plus® (PIHPF-10(01) 20190801)

2. Sun, S.-F., Hsu, C.-W., Lin, H.-S., Liou I.-H., Chen, Y.-H. and Hung C.-L._Comparison of Single Intra-Articular Injection ofNovel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis. JBJS._2017 ; 99(6) : 462-471

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    SciViscion Biotech Inc.
    9, South 6th Rd. K.E.P.Z.,
    Kaohsiung 806
    TAIWAN, R.O.C

    Obelis s.a
    Bd. General Whahls 5,
    1030 Brussels – BELGIUM
    Tel : +32 2732 5954
    Fax: + 32 2732 6003

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    59420 Mouvaux – FRANCE
    Tel : +33(0) 3 20 11 84 30
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