Product Introduction
Reviscon® Mono 2.0% is a single-dose, linear sodium hyaluronate (NaHA) formulation engineered for intra-articular viscosupplementation in osteoarthritic synovial joints. Controlled bacterial fermentation delivers a non-animal derived, preservative-free hyaluronate with consistent purity and sterility.
With an average molecular weight near 3 MDa, the formulation maintains high zero-shear viscosity and elasticity under load—critical metrics that replicate healthy synovial fluid mechanics. Reviscon® Mono 2.0% is optimized for sustained effect through a single clinical visit.
Fast Facts
- Format: Single-use 2.4 ml prefilled syringe
- Origin: Bacterial fermentation, non-animal derived
- Preservatives: None
- Manufacturer: VSY Biotechnology GmbH
Reviscon® Mono 2.0% at a glance
Keep these fast facts handy when colleagues need the highlights on formulation, handling, and dosing logistics.
| API | Linear sodium hyaluronate |
|---|---|
| Concentration | 48 mg / 2.0% (2.4 ml prefilled syringe) |
| Molecular weight | ~3 MDa |
| Viscosity | ~900,000 mPa·s (zero-shear) |
| pH | 6.8–7.6 |
| Osmolality | 300–350 mOsm/kg (physiologic) |
| Origin | Bacterial fermentation; non-animal |
| Excipients | Sodium chloride, phosphate buffer, water for injection |
| Injection interval | Single intra-articular dose (~6 months) |
| Shelf life | 36 months ≤ 25°C |
| Reference number | 700 000 54 |
Indications & Patient Selection
- Indicated for osteoarthritis of synovial joints classified as Kellgren–Lawrence grades II–III.
- Appropriate following arthroscopic lavage or debridement when synovial fluid integrity is diminished.
- Consider when oral NSAIDs or intra-articular corticosteroids are contraindicated, not tolerated, or inadequate.
- Not indicated for prophylactic use or performance enhancement in healthy joints.
Patient dialogue cues
Align with conservative care pathways: position Reviscon® Mono 2.0% after structured physiotherapy, weight management, and oral analgesics but before surgical escalation.
Mechanism of Action
- Restores viscoelasticity of synovial fluid, reducing mechanical friction and peak contact stresses.
- Enhances lubrication and shock absorption across flexion-extension and rotational movements.
- Supports intra-articular hydration and may dampen mechanically induced inflammatory signaling.
- Sustained symptom relief typically extends up to six months following a single 2.4 ml injection.
Mechanical + biochemical
Reviscon® Mono 2.0%’s molecular architecture yields cohesive yet elastic behavior. Under low shear, hyaluronate chains align to maintain lubrication; under high shear, they entangle to absorb shocks while conserving film integrity.
Clinical Evidence
Diracoglu D. et al., 2024
Reviscon portfolio (1.0%, 1.6%, 2.0%) achieved 42% WOMAC total reduction and ~35% VAS pain decrease at six months with single-injection Mono.
Schneider S. et al., 2014
Post-arthroscopy HA injections significantly improved function and pain, supporting viscosupplementation once lavage reduces native synovial cushioning.
VSY Biotechnology Data
Post-market surveillance reports no product-related adverse events and confirms symptom control for approximately six months per injection.
Single-injection hyaluronic acid programs deliver adherence comparable or superior to multi-visit regimens, reducing logistical burden for both patients and clinics.
Supporting Research
Eric Ferkel, Ajay Manjoo, Damion Martins, Mohit Bhandari, Paul Sethi, Mathew Nicholls. Cartilage. 2023;14(4):424-432. doi:10.1177/19476035231154530 View on PubMed
“Products with higher molecular weight, linear (non–cross-linked) structure, and nonavian source were more likely to be associated with improved patient outcomes and fewer inflammatory reactions.”
— Ferkel et al., Cartilage, 2023
This systematic review examined the physicochemical properties of commercially available intra-articular hyaluronic-acid products and how those characteristics relate to clinical outcomes across WOMAC, VAS, and inflammatory-safety measures. The authors identified a recurring profile associated with more favourable patient outcomes: higher molecular weight, linear (non–cross-linked) structure, and non-avian origin.
Reviscon® Mono 2.0% reflects this profile, offering a high–molecular-weight (~3 MDa), linear, non-avian formulation aligned with the characteristics associated with improved outcomes in the review. The comparison table below summarizes this alignment in a side-by-side format.
This table shows 1) ideal HA properties highlighted by Cartilage Journal, 2) the corresponding Reviscon® Mono 2.0% specification, and 3) the clinical implication.
Molecular Weight
High-molecular-weight (>2,000 kDa) HA correlates with stronger receptor binding, chondroprotection, and 3–6 month outcomes.
Reviscon® Mono 2.0%
~3,000 kDa (3 MDa) linear sodium hyaluronate.
Why it matters
Matches the ideal HMW criteria tied to durable symptom relief.
Cross-linking
Non-cross-linked HA is preferred because it produces fewer inflammatory reactions; cross-linking shows unclear benefit and sometimes higher flare rates.
Reviscon® Mono 2.0%
Linear, non-cross-linked architecture.
Why it matters
Preserves native HA behavior, supporting safety and bioactivity.
Source
Biologically derived, non-avian HA is associated with fewer adverse events than avian-derived sources.
Reviscon® Mono 2.0%
Non-animal, bacterial fermentation origin.
Why it matters
Minimizes immunogenic risk and avoids avian protein contaminants.
Rheology
HMW, non-cross-linked solutions best mirror healthy synovial elastoviscosity.
Reviscon® Mono 2.0%
Formulated to mimic synovial fluid with strong zero-shear viscosity and cohesion.
Why it matters
Supports joint lubrication, shock absorption, and mechanical protection.
Dosing Regimen
Effective HMW HA maintains durability for at least 3 to 6 months.
Reviscon® Mono 2.0%
Single 2.4 ml injection (48 mg HA, 2.0%).
Why it matters
Delivers guideline-aligned durability without multi-visit protocols.
Safety Profile
Biologic, non-cross-linked HA demonstrates lower flare rates.
Reviscon® Mono 2.0%
Non-avian, non-cross-linked HA with a simple excipient profile.
Why it matters
Aligns with the lowest observed flare rates in category.
Administration & Technique
- Administer intra-articularly using strict aseptic technique; ultrasound guidance at the physician’s discretion.
- Standard dose: one 2.4 ml prefilled syringe per affected knee joint.
- Recommended needle gauge: 21–22 G; anterolateral approach is common for the knee joint.
- Post-injection: avoid heavy or impact loading for 48 hours while encouraging controlled daily motion.
- Repeat administration at roughly six-month intervals contingent on persisting clinical benefit.
Procedure checklist
- ✔ Confirm absence of local infection or dermatologic compromise.
- ✔ Aspirate excess effusion prior to injection when indicated.
- ✔ Inject slowly to minimize post-procedural discomfort.
- ✔ Document joint, lot number, and follow-up plan.
Safety, Contraindications, Precautions
- Contraindicated when active infection or dermatologic lesions are present at the injection site.
- Use caution in severe joint deformity, systemic infection, or significant effusion.
- Transient injection-site pain or swelling may occur; events are typically mild and self-limiting.
- No product-related adverse events reported in clinical trials or post-market monitoring to date.
- Certified WADA Doping-Free, suitable for athletes under anti-doping oversight.
- Monitor patients receiving anticoagulation per standard intra-articular injection protocols.
Regulatory Status (Canada)
Health Canada Medical Device Licence ID 110891 (active) authorizes Reviscon® Mono 2.0% as Device ID 1050819, a Class III Medical Device manufactured by VSY Biotechnology GmbH, Germany. Licensed indication:
For intra-articular injection into synovial joints as a viscosupplement in the treatment of osteoarthritis to restore the viscoelastic properties of synovial fluid, relieve pain, and improve mobility.
Official Health Canada listing: MDALL Device Record .
Manufactured under ISO 13485-certified quality system, CE-marked, and compliant with Good Manufacturing Practice (GMP) standards.
Comparative Advantages
- Single-injection schedule supports patient adherence and clinic efficiency.
- High molecular weight delivers prolonged joint residence and mechanical stability.
- Preservative-free, non-animal origin reduces hypersensitivity risk.
- Clinical outcomes meet or exceed multi-injection hyaluronic acid regimens.
- Reduces recurring appointment load for physicians, allied staff, and patients.
- Aligns with evidence-based conservative management pathways.
Limitations
- Does not alter structural disease progression of osteoarthritis.
- Clinical response varies with OA severity, joint biomechanics, and adjunct therapies.
- Coverage and reimbursement differ by province and insurer; verify benefit programs in advance.
References & Further Reading
- Diracoglu D. et al., Istanbul Univ. Dept. Physical Medicine & Rehabilitation (2024).
- Schneider S. et al., Orthop Unfall Prävent. 2014; 7:333–339.
- VSY Biotechnology GmbH, Reviscon Brochure EN 2024 (Data on File).
- Health Canada MDALL Device ID 1050819 .
- VSY Biotechnology Press Release – Health Canada Approval .