A SOLUTION FOR TODAY’S BLEEDING CHALLENGES

THAT’SREALSTOPPINGPOW ER.

HIGH-PERFORMANCE HEMOSTASIS MADE SIMPLE.

This material is intended for Health Care Professionals in Europe.

Meeting today’s surgical bleeding challenges.

CHONDROITIN SULFATE

COLLAGEN THROMBIN PHYSIOLOGIC HEMOSTASISHEMOBLAST™ Bellows contains (human-derived) thrombin.2 Thrombin converts fibrinogen to fibrin, a basic element in a blood clot.3

The clot formed by HEMOBLAST™ Bellows offers visibility of the wound site after application. The hemostatic powder resorbs within 4 weeks.2HEMOBLAST™ Bellows clot

in a porcine liver model

CONTAINS CHONDROITIN SULFATEHEMOBLAST™ Bellows is the only hemostat that contains (bovine-derived) chondroitin sulfate.2

MECHANICAL HEMOSTASISThe (porcine-derived) collagen in HEMOBLAST™ Bellows supports a controlled swell.2 Additionally, in the coagulation cascade, collagen is known to induce platelet aggregation and coagulation.3

FOR A COHESIVE AND STABLE CLOT

PROVENThe only hemostatic agent proven clinically effective on a quantitative, validated bleeding scale for minimal, mild, and moderate bleeding.1

READY TO USENo reconstitution, mixing, or thawing.2

CONTAINS HUMAN-DERIVED THROMBIN2

In the physiologic coagulation cascade, thrombin converts fibrinogen into fibrin.3

VERSATILE• Effective for focal (pooling/flowing) bleeding1

• Allows broad coverage to treat large area bleeding without the need for a power source or spray kit2

• Effective on bony and soft tissue2

SYNERGISTICCOMPONENTS

SIMPLE BELLOWSAPPLICATOR

HIGH-PERFORMANCEHEMOSTASIS+ =3 1

HIGH-PERFORMANCE HEMOSTASIS IS SIMPLER THAN EVER:

HEMOBLAST™ Bellows is indicated in open surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical in the following specialties: Cardiac, Vascular, Abdominal, Urology, Gynecology, Orthopedic, Spine, Ear Nose and Throat (ENT) and Head and Neck surgeries. HEMOBLAST™ Bellows is also indicated in laparoscopic surgical procedures in the following specialties: Vascular, Abdominal, Urology, Gynecology and Head and Neck surgeries.

THE POW ER TO BE VERSATILE

THE FORMULA FOR SUCCESS:

CARDIOVASCULAR SURGERY• Coronary artery bypass• Heart transplant• Reoperative procedures• Valve replacements and repairs

SPINE SURGERY• Laminectomy• Corporectomy• Discectomy

Hepatic Surgery• Hepatectomy• Tumorectomy • Liver transplant

THE ONLY PRODUCT PROVEN EFFECTIVE IN A QUANTITATIVE, VALIDATED BLEEDING SCALE1

Biom’up developed the SPOT GRADE™ scale also known as the Surface Bleeding Severity Scale (SBSS) to quantitatively determine the amount of bleeding from a surgical wound and standardize bleeding definitions across surgical specialties and procedures. HEMOBLAST™ Bellows performed impressively, receiving US FDA indications for the control of SPOT GRADE™ bleeding levels 1 through 3, covering oozing to flowing bleeding.1

†American College of Surgeons – Advanced Trauma Life Support.

THE POW ER TO PERFORM

POSTOPERATIVE BLEEDING DATA

APPLICATION THAT’S EASY2

Apply HEMOBLAST™ Bellows PowderApply HEMOBLAST™ Bellows powder to the bleeding site by

squeezing the bellows. Enough powder (multiple layers, if needed) should be applied to cover the entire source of bleeding.

2

Once Hemostasis is Achieved, Irrigate Excess Once bleeding has ceased, remove the excess hemostatic

powder by gentle irrigation

4

Blot Excess BloodBlot excess blood from the target bleeding site with gauze/pad

or suction. The wound surface should be as dry as possible before application.

1

Hold Wet Gauze/PadImmediately apply pressure using a gauze/pad completely

soaked with saline. Hold for at least 2 minutes.* Gently lift the pad and inspect the area.

3

EFFICACY THAT’S PROVEN1

The US pivotal study evaluating the safety and efficacy of HEMOBLAST™ Bellows against absorbable gelatin sponge and thrombin involved 242 patients randomized across 16 sites and found HEMOBLAST™ Bellows statistically superior at achieving hemostasis:

• 71.1% vs. 45.8% at 3 minutes (p<0.0001)• 93.1% vs. 73.5% at 6 minutes (p=0.0001)• No clinical signs or symptoms of postoperative

bleeding with HEMOBLAST™ Bellows within 24 hoursIf hemostasis has not been achieved, repeat steps 1-3 or use an alternate method of hemostasis treatment. Please refer to the Instructions for Use for full prescribing information.2

Do not disrupt the hemostatic powder clot complex by physical manipulation. This may cause clot disruption and subsequent bleeding*Clinical data suggest hemostasis is best achieved after applying a wet lap pad for approximately 3 minutes, then gently lifting the lap pad or gauze using gentle irrigation with saline.1

SIGNS OR SYMPTOMS OF POSTOPERATIVE BLEEDING10%

REOPERATIONS DUE TO BLEEDING10%

Hemostasis that meets a higher standard.

SPOT GRADE™ SCALE4

SPOT GRADE™ 0 1 2 3 4 5

Maximum Expected ACS-ATLS† Shock Risk Class

1 1 1 2 3 4

Verbal Descriptor None Minimal Mild ModerateSevere; not

immediately Life-threatening

Extreme; immediately

Life-threatening

Visual Descriptor Dry Oozing Pooling Flowing Streaming Gushing

Expected Intervention(s) None

Manual pressure, cautery, adjuvant

hemostat(s)

Manual pressure, cautery, suture,

adjuvanthemostat(s)

Manual pressure, cautery, suture,

adjuvant hemostat(s)

Manual pressure, cautery, suture,

staples, tissue repair

Manual pressure, cautery, suture,

staples, tissue repair

Flow Rate (mL/min) Ranges for Target Bleeding Site

1 (cm2) 0 [0;4.8] [4.8; 12.0] [12.0; 25.3] [25.3; 102.0] [102.0; +]

10 (cm2) 0 [0;9.1] [9.1; 20.0] [20.0;71.3] [71.3; 147.4] [147.4; +]

50 (cm2) 0 [0;13.5] [13.5; 28.0] [28.0;117.3] [117.3; 192.7] [192.7; +]

THE ONLY POWDER WITH THROMBIN2,4

HEMOBLAST™ Bellows contains human-derived thrombin, for efficacy on minimal, mild, and moderate bleeding.1

Handles Oozing, Pooling, and Flowing Bleeding 1

Because it does not require advance preparation, HEMOBLAST™ Bellows optimizes hospital staff time and provides a possible solution to avoid waste from unused product.2

READY WHEN YOU NEED IT2

Stay Ready forUnexpected Bleeding

THE POW ER TO SIMPLIFY High-per formance hemostasis in a ready-to-use powder.

HEMOSTATS THAT REQUIRE

RECONSTITUTION

HEMOSTATS THAT REQUIRE THAWING

READY TO USE

GELATINCOLLAGEN

STARCH

MILD AND MODERATE (POOLING AND FLOWING BLEEDING)

MINIMAL BLEEDING (CAPILLARY, VENOUS, AND SMALL ARTERIAL/

ARTERIOLAR BLEEDING)

EFFICACY, EASE, & VERSATILITY – ALL IN ONE.1,5

In the US pivotal trial, one HEMOBLAST™ Bellows handled minimal, mild, and moderate bleeding in most cases, including application to focal and large area bleeding conditions.1

Effective for focal bleeding, including flowing bleeding.1

Potential Bleeding Sites

ATRIOTOMY SUTURE LINE(large area bleeding)

AORTIC CANNULA SITE(focal bleeding)

AORTOTOMY SUTURE LINE

(large area bleeding)

AORTA TO SAPHENOUS VEIN

SUTURE LINE(focal bleeding)

INTERNAL MAMMARY ARTERY HARVEST SITE

(focal bleeding)

STERNAL EDGE(large area bleeding)

EPICARDIAL SURFACE(large area bleeding)

ATRIAL CANNULA SITE(focal bleeding)

PERICARDIUM(large area bleeding)

Effective for large area bleeding.

One HEMOBLAST™ Bellows covers up to 50 cm2.6Do not inject in the circulatory system.

Avoid direct contact between the cannula and blood at the surgical site to minimize the potential for clogging the tip during HEMOBLAST™ Bellows application.

To learn more, visit www.hemoblast.com

1. Biom’up pivotal study. 2. HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Biom'up France SAS. 3. Spotnitz, W. Hemostats, Sealants, and Adhesives: A Practical Guide for the Surgeon. Am Surg. 2012;78:1305-1321. 4. Spotnitz WD, Zielske D, Centis V et al. The SPOT GRADE: a new method for reproducibly quantifying surgical wound bleeding. Spine (Phila Pa 1976). 2017 Oct 10. doi: 10.1097/BRS.0000000000002447. [Epub ahead of print]. 5. Biom’up, internal data. Data derived from clinical use of 186 cases in Germany and France (PME report). 6. Biom’up data on file (ET-2015-001-PC-019).

HEMOBLAST™ Bellows - Implantable Medical Device Class III for surgery reserved for use by qualified healthcare professionals in Europe. It is CE-Marked (CE0086: BSI) - Manufacturer: Biom'up France SAS. The trademark of HEMOBLAST™ Bellows, SPOT GRADE™ are the property of Biom’up, SA. The trademarks of the products listed herein are trademarks of their respective manufacturer. HEMOBLAST™ Bellows is not available in all countries or regions and reimbursement depends on each territory. Please contact your Biom’up representative for details regarding product availability and status. Prior to use, refer to the “Instructions for Use” accompanying each device for complete, specific and approved indications, contraindications, all warnings and precautions.

E-MKT-010-V1.0_EU

HIGH-PERFORMANCE HEMOSTASIS MADE SIMPLE.

QUANTITY PER BELLOWS PER PACKAGING CONTENT REFERENCE

1.65 grams 1 bellows and 1 short 10 cm cannula BQF02

Implantable Medical Device Class III