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CeloNova introduces ONCOZENE Microspheres

CeloNova introduces CeloNova introduces ONCOZENE Microspheres ONCOZENE Microspheres Precision Flexibility Control Precision Flexibility Control Indications Indications ONCOZENE Microspheres are FDA cleared with ONCOZENE Microspheres are FDA cleared with the indication for the embolization of: the indication for the embolization of: Hypervascular Tumors (HVT) Hypervascular Tumors (HVT). Arteriovenous Malformations (AVM) Arteriovenous Malformations (AVM). ONCOZENE Microspheres offer: ONCOZENE Microspheres offer: Deep penetration into the tumor vasculature due to very small sized 40, 75, and 100 m Deep penetration into the tumor vasculature due to very small sized 40, 75, and 100 m Microspheres . Microspheres . High confidence when performing super selective and targeted embolization procedures as High confidence when performing super selective and targeted embolization procedures as 95% of the Microspheres are within the stated size variance.

Size 2 ml Syringe 3 ml Syringe 40 ± 10 µm 10420-US1 10430-US1 75 ± 15 µm 10720-US1 10730-US1 100 ± 25 µm 11020-US1 11030-US1 INDICATIONS FOR USE: ONCOZENE Microspheres are FDA cleared with the indication for the embolization of hypervascu-

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Transcription of CeloNova introduces ONCOZENE Microspheres

1 CeloNova introduces CeloNova introduces ONCOZENE Microspheres ONCOZENE Microspheres Precision Flexibility Control Precision Flexibility Control Indications Indications ONCOZENE Microspheres are FDA cleared with ONCOZENE Microspheres are FDA cleared with the indication for the embolization of: the indication for the embolization of: Hypervascular Tumors (HVT) Hypervascular Tumors (HVT). Arteriovenous Malformations (AVM) Arteriovenous Malformations (AVM). ONCOZENE Microspheres offer: ONCOZENE Microspheres offer: Deep penetration into the tumor vasculature due to very small sized 40, 75, and 100 m Deep penetration into the tumor vasculature due to very small sized 40, 75, and 100 m Microspheres . Microspheres . High confidence when performing super selective and targeted embolization procedures as High confidence when performing super selective and targeted embolization procedures as 95% of the Microspheres are within the stated size variance.

2 95% of the Microspheres are within the stated size variance. Controlled embolization with precisely formulated and standardized Microspheres . Controlled embolization with precisely formulated and standardized Microspheres . Greater flexibility with single sale units in 2 ml and 3 ml sized syringes. Greater flexibility with single sale units in 2 ml and 3 ml sized syringes. Enhanced product stability with a shelf life of 3 years from the date of the manufacture* Enhanced product stability with a shelf life of 3 years from the date of the manufacture*. ONCOZENE Microspheres are available in prefilled 2 ml and 3 ml syringes ONCOZENE Microspheres are available in prefilled 2 ml and 3 ml syringes Size 2 ml Syringe 3 ml Syringe Size 2 ml Syringe 3 ml Syringe 40 10 m 10420-US1 10430-US1 40 10 m 10420-US1 10430-US1. 75 15 m 10720-US1 10730-US1 75 15 m 10720-US1 10730-US1. 100 25 m 11020-US1 11030-US1 100 25 m 11020-US1 11030-US1.

3 INDICATIONS FOR USE: ONCOZENE Microspheres are FDA cleared with the indication for the embolization of hypervascu- INDICATIONS FOR USE: ONCOZENE Microspheres are FDA cleared with the indication for the embolization of hypervascu- lar tumors and arteriovenous malformations. lar tumors and arteriovenous malformations. CONTRAINDICATIONS: The contraindications of ONCOZENE Microspheres include the presence of vasculature where CONTRAINDICATIONS: The contraindications of ONCOZENE Microspheres include the presence of vasculature where ONCOZENE Microspheres could pass directly into the central nervous system, central circulatory system, internal carotid ONCOZENE Microspheres could pass directly into the central nervous system, central circulatory system, internal carotid artery, or other non-target territories. Procedures should not be performed if vascular anatomy precludes correct catheter artery, or other non-target territories.

4 Procedures should not be performed if vascular anatomy precludes correct catheter placement or embolic injection. placement or embolic injection. WARNINGS AND PRECAUTIONS: Vascular embolization is a high-risk procedure. The procedure should be performed by WARNINGS AND PRECAUTIONS: Vascular embolization is a high-risk procedure. The procedure should be performed by specialized physicians trained in vascular embolization procedures. Complications can occur at any time during or after the specialized physicians trained in vascular embolization procedures. Complications can occur at any time during or after the procedure. procedure. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. A complete list of indications, contraindications, warnings and precautions are described in ONCOZENE Microspheres A complete list of indications, contraindications, warnings and precautions are described in ONCOZENE Microspheres Instructions for Use.

5 Please consult these before using the product. Instructions for Use. Please consult these before using the product. CeloNova BioSciences, Inc. CeloNova BioSciences, Inc. 18615 Tuscany Stone, Suite 100 San Antonio, TX 78258 18615 Tuscany Stone, Suite 100 San Antonio, TX 78258. tel + fax + tel + fax + The CeloNova BioSciences, and ONCOZENE names and logos are registered to CeloNova BioSciences. All product names in The CeloNova BioSciences, and ONCOZENE names and logos are registered to CeloNova BioSciences. All product names in any character format and/or with the trademark symbol are trademarks of CeloNova BioSciences, Inc. Distributed by CeloNova any character format and/or with the trademark symbol are trademarks of CeloNova BioSciences, Inc. Distributed by CeloNova BioSciences, Inc. San Antonio, TX 78258. 2013 CeloNova BioSciences. All rights reserved. BioSciences, Inc. San Antonio, TX 78258. 2013 CeloNova BioSciences.

6 All rights reserved. *When stored in accordance with the IFU APM0073, 130508, Rev. B *When stored in accordance with the IFU APM0073, 130508, Rev. B.


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