Evaluation of SEAL Hemostatic Spray: Marketing Claims vs. Published Data

The closest BC3 / SEAL hemostatic spray comes to unbiased studies were conducted by the USAISR in 2013 and 2014. The first involved three (3) pigs and a follow-up study the next year of only one (1) pig. They used a liver laceration model, rather than the more common USAISR hemostatic model first published in 2008⁵ and later standardized in 2011.⁶ They compared SEAL spray to gelfoam (a common surgical foam used to help control bleeding, frequently in operating rooms). The USAISR authors said the results were “limited and insufficient to make any conclusions” regarding the effectiveness of SEAL.

It appears the company did a study in Brazil using 16 pigs, split between their product and Celox. They heparinized half the pigs in each group to test the effectiveness of the hemostatic in a coagulopathic animal. 

Although they claim to have used the standard USAISR model⁶ in the Brazil study, they did not do so there either:

• They used a 4 mm femoral artery laceration, not the standard 6 mm.
• They used 30 seconds of free bleeding, not 45 seconds.
• It does not appear (in the manuscript or experimental video) that they applied their powder through a “pool of blood,” which occurred in the original USAISR⁵ model, but later was not specifically mentioned as a requirement. Spraying powder into a pool of blood will likely interfere with the agent reaching the source of bleeding, compared to gauze which can be manually placed in contact with the bleeding source.
• The company’s tests showed slightly better survival compared to Celox (100% vs 75%), but no statistically significant change in bleeding time or blood loss. There was a trend toward less bleeding with their product, but it wasn’t statistically significant.

The USAISR model is widely accepted in the medical community as a standard for testing the effectiveness of hemostatic products when applied consistently using standardized wounds, endpoints, and data collection.

They showed increased re-bleeding with Celox in heparinized pigs after removal of the agent at the end of the study. I would not consider this to be a pre-hospital task and question its significance.

  BC3 acknowledges the study was never published, and although they categorize it as “independent,” they can claim their results were whatever they want: As a manufacturer-sponsored study, the results are always questionable, as the manufacturer of a product clearly has a vested interest in the study outcome and success of their product. Drug companies don’t willingly publish “negative” studies, ie, data showing their product fails.

It’s also not clear to me whether they used Celox powder or gauze in that study, which could also affect the results.

A video included in their marketing materials showed a pig with a femoral artery laceration, as described, but it had a large open wound that exposed the artery, similar to the USAISR model. However, there wasn’t very aggressive bleeding from the wound, unlike what I’ve seen in similar videos of the actual USAISR model. Slower bleeding is usually easier to control.

Additionally, getting a powder, even one sprayed under pressure into a narrow-tracked bleeding wound, is very different than dumping hemostatic powder on a big open groin laceration with a slowly bleeding vessel at the bottom of it. Even Wayne Grube, the CEO of the company, said in interviews you have to get access to the artery, if the product is going to work.⁷

Hemostatic powders generally fell out of favor well over ten years ago because it is extremely difficult to get the powder to the point of bleeding. Essentially, it “washes away” secondary to the force of active bleeding. There were also issues with powders blowing into everyone’s eyes with overhead helicopter rotor wash.

The manufacturer has some data showing wound healing using their spray is similar to wounds treated with Celox. They also include a testimonial letter and photos from Ukraine talking about how well it works. That information is anecdotal, not data. Additionally, there doesn’t seem to be any significant bleeding in any of the human use videos or still photos included in their materials.

Ultimately, it might work as a wound “dressing” but they have failed to prove by the USAISR standardized model⁶ that their material works for life-threatening hemorrhage control.

Although they claim in a marketing video their product is “your frontline defense against life threatening bleeding emergencies,” they have acknowledged they have no published evidence to support this claim.

Ultimately, the answer as to whether SEAL hemostatic spray can control life-threatening or massive hemorrhage remains unproven until more appropriate scientific studies are conducted, published, and peer reviewed.