Distribution partnerships
Crespine Gel is a cross-linked hyaluronic acid viscosupplement for the conservative treatment of osteoarthritis, manufactured in Germany by BioPolymer GmbH & Co. KG and on the market since 2009. It is present in 65 territories.
We work with exclusive partners who have an established sales organisation, ideally in orthopaedics or pain management, and who can handle registration in their own market.
What makes the product different
One injection instead of a course of three to five, at a volume of 2 ml. Lower volume means less intra-articular pressure and makes the product usable in smaller joints, where larger preparations are excessive.
How the categories compare
| Product category | Injections per cycle | ml per injection | Cross-linked |
|---|---|---|---|
| Crespine® Gel | 1 | 2 | yes |
| Other cross-linked single-injection products | 1 | 3–6 | yes |
| Single-injection products without cross-linking | 1 | 2–4.9 | no |
| Multi-injection products | 3–5 | 2 | no |
Crespine Gel is, to our knowledge, the only viscosupplement that combines all three: a single injection, a volume of 2 ml, and cross-linked hyaluronic acid. Cross-linked single-injection products otherwise start at 3 ml; the products that match 2 ml are not cross-linked.
Category figures derived from Migliore A. Effectiveness and utility of hyaluronic acid in osteoarthritis. Clinical Cases in Mineral and Bone Metabolism. 2015;12(1):31–33. DOI 10.11138/ccmbm/2015.12.1.031, and from manufacturer documentation. A product-by-product comparison is available on request as part of the partner documentation.
Two variants from one manufacturer
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Crespine® Gel
Standard variant, without local anaesthetic.
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Crespine® Gel +
Additionally contains the local anaesthetic prilocaine, released slowly from the hyaluronic acid matrix.
Published clinical evidence
Three peer-reviewed studies. Each is listed with its design and its limitations — all three are cohort studies without a control group, which is what they can and cannot show.
Suppan VKL, Tew MM, Muthusamy H, et al. (2026)
BMC Musculoskeletal Disorders 27:209 · DOI 10.1186/s12891-026-09588-1 · PMID 41664047
Prospective single-arm cohort study, single-centre, open-label. 111 enrolled, 107 at 3 months, 92 at 12 months, 12 months.
KOOS4 rose from 62.2 to 71.0 at 12 months (+8.78; p < 0.001); pain VAS fell from 4.80 to 3.17 (−1.64; p < 0.001). The improvement appeared by month 3 and held to month 12.
Tolerability: 2 of 111 participants (1.8 %) reported transient knee pain within 24 hours, resolving within 48 hours without treatment. No septic arthritis, hypersensitivity reactions or systemic complications.
Limitations: No control or placebo arm; the authors state the design precludes causal inference. 19 of the 111 enrolled were missing at the 12-month assessment. Concomitant treatments were not recorded separately. The product studied was Crespine Gel+; any added benefit of the prilocaine was not assessed separately. Partially funded by Nexgen Medical Sdn. Bhd., Malaysia. The authors declare no competing interests.
Shahid H, Umer M, Zahid M. (2025)
Annals ASH & KMDC 29(1):17–24
Prospective cohort study, Aga Khan University Hospital Karachi, Kellgren-Lawrence I–II. 25 people, 39 knees, 12 months. Independent of manufacturer and distributor.
Knee Society Score rose from 72.28 ± 11.18 to 81.28 ± 9.76; Knee Society Function Score from 66.79 ± 15.23 to 76.54 ± 15.39 (both p = 0.001).
Limitations: Cohort study without a control group. The planned sample of 36 was not reached; 25 people were analysed. The 39 knees come from 25 people — two knees of the same person are not statistically independent observations. Limited to mild to moderate knee osteoarthritis (Kellgren-Lawrence I–II), with baseline and one-year measurements only. "Source of Funding: None", "Conflict Of Interest: None". The only one of the three studies with no funding from manufacturer or distributor.
Bashaireh K, et al. (2015)
Drug Design, Development and Therapy 9:2063–2072 · DOI 10.2147/DDDT.S81524
Post-marketing Phase IV study. 109 enrolled, 84 in the full analysis set, 9 months.
63 of 84 participants (75 %) met the OARSI criterion for 70 % responders.
Tolerability: 33 of the 84 analysed (39 %) had increased pain 72 hours after injection — 17 pain alone, 7 with redness, 5 with swelling, 4 with pain, swelling and redness. All 33 had limited knee mobility at that point. Most were treated with analgesics. All events were local and transient; no serious events occurred.
Limitations: No control group; nine-month observation period; funded by the manufacturer. The product studied was the standard variant, not Crespine Gel+. Funded by BioPolymer GmbH & Co. KG. Protocol, data handling, statistics and the initial study report were carried out by the contract research organisation Clinical Quest. The authors declare no conflicts of interest; the corresponding author additionally declares a business relationship with the funding organisation.
Quality and regulatory status
- Class III medical device under Directive 93/42/EEC, Annex II §4, notified body CE Certiso Kft. (NB 2409)
- Quality management certified to ISO 13485:2016, certificate 145211-23-12-15
- SRN DE-MF-000004926 · shelf life 3 years
- Every batch independently tested for endotoxin content by a third-party laboratory
- EU MDR transition: a formal application under Regulation (EU) 2017/745 is with the notified body and a written agreement under Regulation (EU) 2023/607 is in place. Transitional validity runs to 2027-12-31.
Full certificates and the declaration of conformity are provided on request as part of the partner documentation.
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