Biocomposites announces new CE Mark for STIMULAN®

First calcium matrix to receive European approval as an antibiotic carrier for use in bone and soft tissue

Biocomposites announces U.S. launch of new STIMULAN® Rapid Cure 3cc product

Targeting smaller voids in foot and ankle, orthopaedic reconstruction and trauma

STIMULAN®

Uniquely engineered for the precision and control you demand every time

Bullet Mat and Introducer

Streamlined, flexible design that simplifies delivery of STIMULAN into hard-to-reach defects.

Perfect partner for your infection management strategy

STIMULAN is a truly absorbable calcium sulfate antibiotic carrier – specifically designed to support the proactive management of dead space and surgical site infection with unrivaled flexibility and the broadest surgical application.¹

  • The only calcium matrix approved for use in bone and soft tissue
  • Approved for mixing with vancomycin, gentamicin and tobramycin
  • Can be placed directly into infected and non-infected sites

Bring the challenge of infection under your control

With the ability to mix substances according to the specific antimicrobial needs of each infection, STIMULAN combines flexibility with the predictability and consistency necessary to ensure sustained antibiotic cover.

Properties that drive performance

The unique crystal configuration and construction of STIMULAN brings its own set of qualities to fully support your infected cases.2

  • Physological pH
  • Controlled purity
  • No hydroxyapatite, insoluble impurities or PMMA debris
  • Easily mixed with liquid and powder antibiotics

See the STIMULAN difference in your cases

  • Predictable, supra-therapeutic elution profile3
  • Flexibility to tailor antibiotic to clinical need4
  • Proven action against biofilms5
  • Completely absorbs at an optimal rate1,6-11
  • Low levels of drainage12-18
  • Does not cause third body damage19,20
  • Does not prevent use in articulating surfaces19-20
  • Does not act as a nidus for infection6-11
Predictable, supra-therapeutic elution profile3

Antibiotic levels sustained above MIC for over 40 days

Flexibility to tailor antibiotic to clinical need4

Effective against a broad spectrum of pathogens

Proven action against biofilms5

No viable organisms were recovered from pre-formed biofilms

Low levels of drainage12-18
Truly absorbable and totally synthetic calcium sulfate – absorbs at an optimal rate1,6-11

Leaves no nidus for infection.

Post-operative
1 month
11 weeks
6 months

Unrivaled evidence and expertise bring confidence

With our industry-leading knowledge, dedication and experience, you can be sure that the high level of consistency you demand in your cases will be met.

Consistency is hard earned and uniquely achieved

STIMULAN is uniquely engineered through our DRy26™ recrystallization method.2 Each and every synthesis undergoes a 26 step process that starts with pharmaceutical grade precursors and takes over 6 weeks to reach maturity.

Case-by-case flexibility

Every part of STIMULAN has been designed to provide simplicity, intra-operative flexibility and optimum results. A variety of formats are available, all convenient and fast to set.

No challenge too large or small

Introducing the new STIMULAN Rapid Cure 3cc pack size with combination bead and bullet mat for smaller void volumes.

  • Versatile application
  • Full range of bead and bullet sizes
  • Reduce waste

*Only available in the USA

STIMULAN® products
STIMULAN® Bullet Mat and Introducer

Innovative design that simplifies delivery into hard-to-reach defects.

  • Bullets have a groove down one side to reduce the risk of pressurizing the defect site
  • Bullets can be prepared in two diameters – 7mm and 9mm
STIMULAN® Rapid Cure

Rapid setting paste with individual bead kit.

  • Beads can be prepared in three sizes; 3, 4.8 and 6mm
  • Available in 3cc, 5cc, 10cc and 20cc packs (bead volume 7cc, 12cc, 25cc and 50cc)
  • Rapid setting in approx. 4 minutes
STIMULAN® Kit

Standard setting, fully injectable paste with individual bead kit.

  • Beads can be prepared in three sizes; 3, 4.8 and 6mm
  • Available in 5cc and 10cc packs (bead volume 10cc and 20cc)
  • Standard setting in approx. 8 minutes
STIMULAN - power to transform outcomes
01:16
STIMULAN Bullet Mat and Introducer technique guide
04:19
How to prepare STIMULAN Rapid Cure with liquid and powder antibiotics
06:13
Hear what surgeons have to say about STIMULAN
01:09
Dr Hohman case study - tibial osteomyelitis
04:04
Dr Wassef case study - infected hip revision
03:18
Dr Webb case study - bilateral high energy femoral fractures
03:24
Hear what surgeons have to say about STIMULAN
03:52
Library

Listed below are 4 of the most relevant articles for this product but there is much more unrivalled evidence to explore on our Library page.

Explore Library
Frequently asked questions
What is STIMULAN Rapid Cure indicated for?

Indications for use for STIMULAN Rapid Cure can be found in the Instructions for Use (IFU). Indications vary by Regulatory Authority.

In the EU, is it suitable as a carrier material for substances such as antibiotics and can be used at infected and non-infected sites in bone and soft tissue. It is indicated for use in musculoskeletal defects created by surgery, a cyst, a tumor, osteomyelitis or traumatic injury.

In the USA, it can be used in the presence of infection and is indicated for use to fill a bone void or defect of the skeletal system created by surgery, a cyst, a tumor, osteomyelitis or traumatic injury.
For other jurisdictions please contact your local representative.

What is STIMULAN Rapid Cure contraindicated for?

Contraindications for STIMULAN can be found in the Instructions for Use (IFU). These include contraindications for filling defects which are intrinsic to the stability of the bony structure, renal compromised patients, hypercalcaemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, severe degenerative bone disease and uncooperative patients who can’t or won’t follow post-operative instructions including individuals who abuse alcohol or drugs.

How long does STIMULAN take to absorb?

STIMULAN is absorbed in approximately 30-60 days when used in accordance with the device labelling. Contributing factors include the vascularity of the surgical site, quantity used and patient health.

Can I mix antibiotics with STIMULAN Rapid Cure?

This varies by Regulatory Authority.

In the EU, STIMULAN is approved for mixing with vancomycin, gentamicin and tobramycin and can be placed directly into infected and non-infected sites. Please refer to the Instructions for Use (IFU).

In the USA, STIMULAN is not currently FDA cleared/approved to be mixed with antibiotics. Please refer to the Instructions for Use (IFU).

What supporting data do you have for STIMULAN?

STIMULAN is used in over 50,000 cases every year and there are over 400 peer reviewed papers, presentations and posters covering a variety of data ranging from pre-clinical laboratory testing, in-vivo, clinical, in-vitro microbiology and antibiotic elution. Contact your local representative for more information.

Does STIMULAN damage articulating surfaces on joint prosthesis?

Biomechanical testing (Pin on Plate) indicates that STIMULAN does not significantly scratch implant grade cobalt chrome and does not lead to increased wear of high-density polyethylene components, when compared to a control with no STIMULAN present.

Why is there so little drainage associated with STIMULAN?

STIMULAN is a pharmaceutical-grade, synthetic calcium sulfate. The physical and chemical properties are tightly controlled through Biocomposites’ patented recrystallisation process to ensure optimum purity. Evidence has shown that STIMULAN is associated with reduced drainage rates when compared to non-synthetic calcium sulfates. Naturally occurring mineral sources of calcium sulfate can contain non absorbing earth impurities, may be of an acidic pH and hydrophobic in nature, and are often linked to significant problems with wound healing and drainage.

How does STIMULAN differ from an antibiotic loaded spacer?

STIMULAN is a void filler and the characteristics of STIMULAN make it suitable as a carrier material for substances such as antibiotics. STIMULAN is absorbed over 30-60 days and is therefore not suitable for load bearing. An antibiotic loaded spacer is a device placed into the joint to maintain normal joint space and alignment. Spacers are made with bone cement and loaded with antibiotics. The cement does not get absorbed by the body and therefore needs to be removed during revision surgery.

References and regulatory statements

1.Biocomposites, STIMULAN Rapid Cure/Kit Instructions for Use. 2. Cooper, J.J., Method of producing surgical grade calcium sulphate; Patent. 1999. 3. Cooper, J.J., S.S. Aiken, and P.A. Laycock, Antibiotic stability in a synthetic calcium sulphate carrier for local delivery, in 32nd annual meeting of the European Bone and Joint Infection Society. 2013: Prague, Czech Republic. 4. Laycock, P., et al., In Vitro Efficacy of Antibiotics Released from Calcium Sulfate Bone Void Filler Beads. Materials, 2018. 11(11): p. 2265. 5. Delury, C., et al., Determining the Efficacy of Antibiotic-loaded Calcium Sulfate Beads against Pre-Formed Biofilms: An In Vitro Study, in ASM Microbe. 2019: San Francisco, USA. Somasundaram, K., et al., Proximal humeral fractures: the role of calcium sulphate augmentation and extended deltoid splitting approach in internal fixation using locking plates. Injury, 2013. 44(4): p. 481-7. 7. Lei, D., et al., Treatment of Distal Radius Bone Defects with Injectable Calcium Sulphate Cement., in Bone Grafting, A. Zorzi, Editor. 2012, InTech. p. 125-134. 8. Lei, D., L. Jing, and S. Yang-yong, Calcium sulfate versus calcium phosphate in treating traumatic fractures. JOURNAL OF CLINICAL REHABILITATIVE TISSUE ENGINEERING RESEARCH., 2008. 12. 9. Lei, D., Z. Ma, and X. Jing, Treatment of bone defect with injectable calcium sulfate powder in distal fractures of radius. Chinese Journal of Bone Tumor and Bone Disease, 2007. 10. Aiken, S.S., J.J. Cooper, and S. Zhou, Osseointegration of a calcium sulphate bone substitute in a large animal model, in The 5th International Congress of Chinese Orthopaedic Association. 2010: Chengdu, China. 11. Lazarou, S.A., G.B. Contodimos, and I.D. Gkegkes, Correction of alveolar cleft with calcium-based bone substitutes. J Craniofac Surg, 2011. 22(3): p. 854-7. 12. McPherson, E.J., M.V. Dipane, and S.M. Sherif, Dissolvable Antibiotic Beads in Treatment of Periprosthetic Joint Infection and Revision Arthroplasty. The Use of Synthetic Pure Calcium Sulfate (Stimulan®)Impregnated with Vancomycin & Tobramycin. Reconstructive Review, 2013. 3(1): p. 32-43. 13. McPherson, E.J., Dissolvable Antibiotic Beads in Treatment of Periprosthetic Joint Infection. The Use of Synthetic Pure Calcium Sulfate (Stimulan®) Impregnated with Vancomycin & Tobramycin, in 2nd Annual Oxford Bone Infection Conference (OBIC). 2012: Oxford, UK. 14. Gauland, C., The use of antibiotic impregnated, implanted synthetic calcium sulphate tablets in the treatment of soft tissue, vancomycin resistant, enterococcus infections, in The Symposium on Advanced Wound Care and Wound Healing Society Annual Meeting. 2011: Gaylord Texan Hotel & Convention Center, Dallas, Texas. 15. Borrelli, J., Jr., W.D. Prickett, and W.M. Ricci, Treatment of nonunions and osseous defects with bone graft and calcium sulfate. Clin Orthop Relat Res, 2003(411): p. 245-54. 16. Helgeson, M.D., et al., Antibiotic-impregnated calcium sulfate use in combat-related open fractures. Orthopedics, 2009. 32(5): p. 323. McKee, M.D., et al., The use of an antibiotic-impregnated, osteoconductive, bioabsorbable bone substitute in the treatment of infected long bone defects: early results of a prospective trial. J Orthop Trauma, 2002. 16(9): p. 622-7. 18. Noor, S., et al., The use of Osteoset-T in the treatment of chronic osteomyelitis of the tibia following exogenous trauma: A review of 22 patients at a regional trauma centre. Bone & Joint Journal Orthopaedic Proceedings Supplement, 2013. 95-B(SUPP 23): p. 4. 19. Analysis of the Wear Effect 3rd Body Particulate (Bone Cement) has on UHMWPE, Accutek Testing Laboratory, Fairfield OH, K13107732-1, 2014. 20. Cowie, R.M., et al., The influence of a calcium sulphate bone void filler on the third-body damage and polyethylene wear of total knee arthroplasty. Bone Joint Res, 2019. 8(2): p. 65-72.

For indications, contraindications, warnings and precautions see Instructions for Use. Concurrent use of locally administered antibiotics may affect setting time, absorption and/or bone formation. It is the surgeon/healthcare professional’s responsibility to give due consideration to the details in the medicinal product marketing authorization in deciding whether it is appropriate for the patient under his/her care. The relevant Summary of Product Characteristics (SmPC) must be consulted. The type and dose of medicinal substance should also be assessed according to the individual patient’s clinical circumstance.

This website may include the use of STIMULAN or techniques that go beyond the current clearance / approval granted by the relevant regulatory authority. Please contact your local representative for further information.

©2020, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorised copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 88883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1, US 10390954

Patents pending: GB1502655.2, US 15/040075, CN 201610089710.5, GB1704688.9, EP 18275044.8, US 15/933936, CN 108619579A

MA0033R2/MA0250R1/MA0148R1/MA0074R6