ORTHOPAEDICS · FLAGSHIP PRODUCT

Intraarticular Implant Gels

Sterile, single-use intra-articular hyaluronic acid gels for viscosupplementation in osteoarthritis and joint disorders. Four grades, developed and manufactured by SKY Biotechnology.

Overview

Intraarticular implant gels are injectable viscoelastic devices used to supplement the synovial fluid of joints affected by osteoarthritis and degenerative disorders. By supporting lubrication and shock absorption, they are intended to improve joint mobility and comfort. SkyVisc covers four grades on a common concentration range of 10–30 mg/mL: SkyVisc Pure (sodium hyaluronate alone), SkyVisc + (with L-proline), SkyVisc GGP (with L-proline, glycine and N-acetyl glucosamine) and SkyVisc Cross (the cross-linked grade) — three linear gels and one cross-linked, from a single source. As the flagship line of SKY Biotechnology, these products are developed and produced in-house.

Product Line

Four grades of intra-articular hyaluronic acid gel — three linear, one cross-linked.

SkyVisc PureHA only

Highly purified sodium hyaluronate with no additives. Linear gel. Pre-filled syringe from 1 to 5 mL, in concentrations from 10 to 30 mg/mL.

SkyVisc +HA + Proline

Hyaluronic acid with L-proline, an amino acid that is a structural component of collagen. Linear gel. Pre-filled syringe (1–5 mL) or flacon (5 or 10 mL), in concentrations from 10 to 30 mg/mL.

SkyVisc GGPHA + Proline + Glycine + NAGA

Hyaluronic acid with L-proline, glycine and N-acetyl glucosamine — the constituents behind the GGP name (Glucosamine, Glycine, Proline). Linear gel. Pre-filled syringe (1–5 mL) or flacon (5 or 10 mL), in concentrations from 10 to 30 mg/mL.

SkyVisc CrossCross-linked HA

Highly purified cross-linked hyaluronic acid of bacterial origin. Cross-linking bonds the polymer chains into a network that maintains its shape longer and slows disintegration. One injection per treatment. Pre-filled syringe (1–5 mL), 10 to 30 mg/mL.

SkyVisc Pure SkyVisc + SkyVisc GGP SkyVisc Cross
Hyaluronic acid 10 – 30 mg/mL 10 – 30 mg/mL 10 – 30 mg/mL 10 – 30 mg/mL
Concentrations 10 / 14 / 15 / 20 / 24 / 25 / 30 mg/mL 10 / 14 / 15 / 20 / 24 / 25 / 30 mg/mL 10 / 14 / 15 / 20 / 24 / 25 / 30 mg/mL 10 / 14 / 15 / 20 / 24 / 25 / 30 mg/mL
Additional components L-proline L-proline, glycine, N-acetyl glucosamine
Bonding Linear Linear Linear Cross-linked
Syringe 1 / 2 / 2.5 / 3 / 4 / 5 mL 1 / 2 / 2.5 / 3 / 4 / 5 mL 1 / 2 / 2.5 / 3 / 4 / 5 mL 1 / 2 / 2.5 / 3 / 4 / 5 mL
Flacon 5 / 10 mL 5 / 10 mL
Formulation Sodium hyaluronate in buffer (sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride) — with L-proline in SkyVisc +; with L-proline, glycine and N-acetyl glucosamine in SkyVisc GGP.

All SkyVisc grades: sterile viscoelastic solution, single use. Shelf life: 2 years. Storage: 2–25 °C — no cold chain required. CE marked.

Technical Highlights

Linear and cross-linked in one rangeThree linear grades and one cross-linked grade, so a single supplier covers both formulation types. Grade selection and injection regimen follow the Instructions for Use and clinical judgement.
No cold chain requiredAll SkyVisc grades are stored between 2 °C and 25 °C with a shelf life of 2 years — no refrigerated transport or storage, which simplifies distribution in warm-climate markets.
Syringe and flacon presentationsEvery grade is offered as a pre-filled syringe from 1 to 5 mL, in seven concentrations from 10 to 30 mg/mL. SkyVisc + and GGP are additionally available as 5 and 10 mL flacons.
In-house manufacturingDeveloped and produced by SKY Biotechnology at our own facility under an ISO 13485 certified quality management system.
CE markedSkyVisc is CE marked. Refer to the Instructions for Use for the full intended purpose, contraindications and warnings.

Indications & Use Areas

Per the Instructions for Use. Intended for use by qualified healthcare professionals.

Osteoarthritis of the kneeHip and shoulder joint disordersDegenerative joint diseaseDegenerative meniscopathyCartilage problems associated with synovial fluid deficiency

What Is SkyVisc Pure?

SkyVisc Pure is a sterile, single-use intra-articular implant gel whose active component is highly purified sodium hyaluronate of bacterial fermentation origin, supplied as a linear, non-cross-linked solution with no additives. It addresses the loss of synovial fluid viscoelasticity seen in osteoarthritis and degenerative joint disease: by restoring lubrication and shock absorption between the articular surfaces it is intended to reduce friction, relieve pain and support range of motion. SkyVisc Pure is offered in seven concentrations from 10 to 30 mg/mL in pre-filled syringes of 1 to 5 mL, is CE marked, and is developed and manufactured in-house under an ISO 13485 certified quality management system, with a two-year shelf life at 2–25 °C and no cold chain requirement.

Composition and Clinical Rationale

Component-level view of the SkyVisc range. Refer to the Instructions for Use for the full intended purpose, contraindications and warnings.

Component Concentration Clinical advantage Certification
Sodium hyaluronate, bacterial fermentation origin 10 – 30 mg/mL in seven steps: 10 / 14 / 15 / 20 / 24 / 25 / 30 mg/mL Supplements depleted synovial fluid, restoring lubrication and shock absorption between articular surfaces CE marked · ISO 13485 certified QMS
Phosphate buffer: sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride Isotonic carrier, common to all grades Matches the physiological environment of the joint space and carries the hyaluronate at injectable viscosity CE marked · ISO 13485 certified QMS
L-proline, in SkyVisc + Added to the buffer of the 10 – 30 mg/mL formulation An amino acid that is a structural constituent of collagen, added alongside the hyaluronate CE marked · ISO 13485 certified QMS
L-proline, glycine and N-acetyl glucosamine, in SkyVisc GGP Added to the buffer of the 10 – 30 mg/mL formulation The three constituents behind the GGP name: Glucosamine, Glycine, Proline, delivered with the hyaluronate in one injection CE marked · ISO 13485 certified QMS
Cross-linked sodium hyaluronate, in SkyVisc Cross 10 – 30 mg/mL, cross-linked network Cross-linking bonds the polymer chains into a network that holds its shape longer and slows disintegration, allowing one injection per treatment CE marked · ISO 13485 certified QMS
Presentation and storage, all grades Syringe 1 / 2 / 2.5 / 3 / 4 / 5 mL; flacon 5 or 10 mL for SkyVisc + and GGP Two-year shelf life at 2 – 25 °C with no cold chain, which simplifies distribution in warm-climate markets CE marked · ISO 13485 certified QMS

Frequently Asked Questions

Common questions from distributors and clinicians about the SkyVisc range.

What is the difference between linear and cross-linked intra-articular hyaluronic acid?

In a linear gel the hyaluronate chains are not chemically bonded to one another, so the gel behaves as a viscous solution and is cleared from the joint relatively quickly. Cross-linking bonds the chains into a three-dimensional network, which holds its shape longer and slows disintegration. SkyVisc Pure, SkyVisc + and SkyVisc GGP are linear grades; SkyVisc Cross is the cross-linked grade and is given as one injection per treatment. All four share the same 10 to 30 mg/mL concentration range, so the choice is a question of bond structure and intended duration rather than of dose.

Which SkyVisc grade should be selected?

Grade selection follows the condition of the joint, the intended duration of effect and the viscosity required, and remains a matter of clinical judgement under the Instructions for Use. SkyVisc Pure contains hyaluronate alone and is the reference grade. SkyVisc + adds L-proline. SkyVisc GGP adds L-proline, glycine and N-acetyl glucosamine. SkyVisc Cross changes the bond structure itself rather than the additive package.

Does SkyVisc require cold chain storage?

No. Every SkyVisc grade is stored between 2 and 25 degrees Celsius with a two-year shelf life, so no refrigerated transport or storage is needed. For distributors this removes cold chain cost and risk, which matters in warm-climate and long-lead-time markets.

What does GGP stand for?

GGP refers to the three constituents added to the hyaluronic acid in that grade: Glucosamine, Glycine and Proline. Precisely, SkyVisc GGP contains sodium hyaluronate with L-proline, glycine and N-acetyl glucosamine.

Who manufactures SkyVisc?

SkyVisc is developed and produced in-house by SKY Biotechnology at its own facility in Pendik, Istanbul, Turkiye, under an ISO 13485 certified quality management system. It is the flagship line of the company, which exports to more than fifty countries.

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Product information is provided for healthcare professionals, distributors and business partners and does not constitute medical advice. Availability, specifications and regulatory status may vary by country.

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