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Clinical Data

HEMOBLAST™ Bellows is the only powdered surgical hemostat that contains thrombin, collagen, chondroitin sulfate and is indicated as an adjunct to hemostasis for minimal, mild, and moderate bleeding.1-13

Biom’Up developed the SPOT GRADE™ scale also known as the Surface Bleeding Severity Scale (SBSS) to quantitatively and qualitatively determine the amount of bleeding from a surgical wound and standardize bleeding definitions across surgical specialties and procedures. HEMOBLAST™ Bellows met its endpoints and received indications for the control of SPOT GRADE™ bleed levels 1 through 3, covering oozing to flowing bleeding.1

SPOT GRADE™ SCALE HEMOBLAST™ Bellows1 Effective hemostasis on SPOT GRADE™ levels 1 through 3: minimal, mild, and moderate bleeding.1
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 Moderate Severe; 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, adjuvant hemostat(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 Site16
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;+∞]

Efficacy That’s Proven1,15

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:

3 minutes (p=0.001)1,15

HEMOBLAST™ Bellows

71.1%

Absorbable Gelatin Sponge and Thrombin

45.8%

6 minutes (p=0.001)1,15

HEMOBLAST™ Bellows

93.1%

Absorbable Gelatin Sponge and Thrombin

73.5%

Uncontrolled Surgical Bleeding May Impact Patient Health. 16

Patient care and safety is at the forefront of everything we do. Without an efficient and effective means of addressing surgical bleeding, surgeons run the risk of longer hospital stays, increased complications and increased costs that ultimately impact the well-being of their patients.

Large blood loss is frequent and associated with18:
Higher Mortality
  • 1.2%−7.3% for uncontrolled bleeding
  • 0%−1.2% for controlled bleeding
Longer Hospitalization18:
  •  7.1–17 days for uncontrolled bleeding
  •  4.1–10 days for controlled bleeding
Increased Reoperations Rate
46% 19
42% 21
50% 23

0% Signs or Symptoms of Postoperative Bleeding1
0% Reoperations Due to Bleeding1