Regulatory statements

EU

Biocomposites^®
©2021, Biocomposites, STIMULAN, genex, Biosteon, Bringing Calcium to Life, Power to Transform Outcomes, DRy26 and Power to Restore 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: EP 1390086 B1, US 8632796, CN ZL02809194.9, US 8496955, GB2367552, EP 1204599 B1, US 6780391, EP 1436019 B1, US 8563024, CN ZL02825134.2, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1, US 10390954, US 10,588,748, CN ZL201610089710.5
Patents pending: GB1502655.2, GB1704688.9, EP 18275044.8, US 15/933936, CN 108619579A

STIMULAN^®
For indications, contraindications, warnings and precautions see Instructions for Use. Concurrent use of locally administered antibiotics may affect setting time, absorption characteristics 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 brochure 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.

©2021, 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 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1, US 10390954, US 10,588,748, CN ZL201610089710.5
Patents pending: GB1502655.2, GB1704688.9, EP 18275044.8, US 15/933936, CN 108619579A

genex^®
For indications, contraindications, warnings and precautions see Instructions for Use.

©2021, Biocomposites, genex and Power to Restore are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorised copying, reproduction, distributing or re-publication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

Patents granted: EP 1390086 B1, US 8632796, CN ZL02809194.9, US 8496955

USA

Biocomposites^®
©2021, Biocomposites, STIMULAN, Bilok, genex, Allogran, Biosteon, Bringing Calcium to Life, Power to Transform, DRy26 and Power to Restore are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorized copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.
Patents granted: EP 1390086 B1, US 8632796, CN ZL02809194.9, US 8496955, GB2367552, EP 1204599 B1, US 6780391, EP 1436019 B1, US 8563024, CN ZL02825134.2, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1, US 10390954, US 10,588,748, CN ZL201610089710.5
Patents Pending: GB1502655.2, GB1704688.9, EP 18275044.8, US 15/933936, CN 108619579A

STIMULAN^®
For indications, contraindications, warnings and precautions see Instructions for Use. Concurrent use of locally administered antibiotics may affect setting time.

©2021, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorized copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.

genex^®
For indications, contraindications, warnings and precautions see Instructions for Use.
©2021, Biocomposites, genex and Power to Restore are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorized copying, reproduction, distributing or re-publication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.
Patents granted: EP 1390086 B1, US 8632796, CN ZL02809194.9, US 8496955

Canada/International

Biocomposites^®
©2021, Biocomposites, STIMULAN, Bilok, genex, Allogran, Biosteon, Bringing Calcium to Life, Power to Transform Outcomes, DRy26 and Power to Restore are trademarks/registered trademarks of Biocomposites Ltd. All Rights reserved. No unauthorized copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.
Patents granted: EP 1390086 B1, US 8632796, CN ZL02809194.9, US 8496955, GB2367552, EP 1204599 B1, US 6780391, EP 1436019 B1, US 8563024, CN ZL02825134.2, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1, US 10390954, US 10,588,748, CN ZL201610089710.5
Patents pending: GB1502655.2, GB1704688.9, EP 18275044.8, US 15/933936, CN 108619579A

STIMULAN^®
For indications, contraindications, warnings and precautions see Instructions for Use. The treating physician is responsible for deciding the type and quantity of antibiotic used. Concurrent use of locally administered antibiotics may affect setting time.
The mixing of antibiotics with the STIMULAN Kit/STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon/healthcare professional.
This brochure 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.
©2021, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes and DRy26 are trademarks/registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorized copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.