Seal Hemostatic Wound Spray Gains Approval to be Utilized by Maryland EMS Clinicians

BC3 Technologies, a Baltimore-based, minority-owned company revolutionizing emergency medical response and trauma care, developed SEAL, the first and only FDA-cleared aerosolized hemostatic agent for rapid and efficient management of severe bleeding. 

The hemostatic wound spray can now be used by Maryland EMS clinicians to help stop blood loss fast with the recent protocol change by The Maryland Institute for Emergency Medical Services Systems (MIEMSS).

MIEMSS declared all FDA-approved/FDA-cleared chitosan or kaolin-based hemostatic agents will be permitted in Maryland for the purposes of hemorrhage control. 

MIEMSS Protocol Updates

MIEMSS updates its Maryland Medical Protocols for Emergency Medical Services annually, with the changes taking effect on July 1 of each year. However, this protocol change was made mid-term – a rare occasion for the process and was effective in December 2024. The protocols are updated based on the latest evidence-based recommendations from medical literature and multi-disciplined perspectives. 

Hemorrhage Control Advancements

“We recognize that hemorrhage control for injured patients is of paramount importance. Whether the bleeding is controlled with a gloved hand, gauze, or a tourniquet, every minute counts for the patients,” said Timothy Chizmar, MD, State EMS Medical Director, MIEMSS.

While some bleeding can be controlled by hand or gauze, many wounds prove to be more challenging to manage. MIEMSS and other groups of experts in trauma surgery and emergency medicine reviewed hemostatic agents in various forms including powder and spray that are currently available to the EMS community. 

Maryland EMS Systems Validate SEAL and Protocols are Altered

“We are fortunate that Maryland is a forward-leaning, highly data-driven EMS system with alterations and adjustments to protocol or EMS initiatives based on positive patient outcomes. MIEMSS examined our research, along with deployments internationally, and provided products to the University of Maryland Shock Trauma Center. They analyzed the data from our studies and FDA clearance documents, validated our products, and informed MIEMSS that SEAL was acceptable for trauma care in Maryland,” shared Wayne Grube, CEO and Co-Founder, BC3 Technologies.

“As a result of the assessment,  Maryland EMS clinicians may now utilize a chitosan- or kaolin-based hemostatic agent, which is FDA-approved or FDA-cleared, for hemorrhage control. The hemostatic agent may be embedded in gauze or packaged in another form (e.g. spray or gel). Individual hemostatic products should be reviewed with county or service medical directors prior to implementation,” included Chizmar. 

Now all Maryland EMS clinicians have consent to utilize SEAL as part of their protocols to stop blood loss fast. 

“This protocol change opens many doors for BC3 Technologies. Maryland is leading the way in improving patient outcomes by seeing SEAL as the innovative breakthrough that will save lives. With a Maryland EMS deployment, we are encouraging others to follow,” shared Grube.

SEAL’s Advantages to Stop Blood Loss Fast 

SEAL Hemostatic Would Spray is the first and only FDA-cleared aerosolized chitosan for rapid management of serious arterial bleeding. Marking a significant advancement in emergency medical response and trauma care, SEAL is an innovative product that acts as a strong physical barrier, effectively and quickly sealing wounds to stop blood flow within seconds. 

Unlike bandage or granule-based chitosan products that may be too slow or impractical, SEAL can be applied under windy and wet conditions and in low-light and allows for easy and effective debridement with a simple water, saline, or aqueous rinse and quick safe peel off.

The product is compact, easy to carry, and can be administered by first responders, professional medical staff, military, patients, or caregivers. SEAL Pro is available as a 2.5 oz single use spray and SEAL OTC a 1.5 oz single use spray. BC3 Technologies has developed several supporting accessories, including first aid kits and SEAL holders, that allow for quick deployment of the lifesaving product for first responders and the public. 

Enhances Survival Rate Globally 

By stopping severe bleeding within seconds, SEAL significantly enhances survival rates, especially in situations where immediate medical response is delayed. As both medical professionals and laypersons can provide the prompt, life-saving treatment, thus bridging the gap in emergency medical care on a global scale.

Local, national, and international collaborations are key to BC3 Technologies’ success to save lives, allowing the trauma tech innovator to validate SEAL in some of the most challenging real-world environments. 

Partnerships with esteemed local and national organizations such as University of Maryland Shock Trauma and MIEMSS, as well as Police departments, EMS systems, and school systems have allowed BC3 Technologies to refine their product and design supporting tools for quicker deployments and increased likelihood of survival for those affected during traumatic events.

SEAL has been used internationally on the battlefields of Ukraine with great success bringing it to the attention of other militaries globally. The battlefield testing, along with further collaborations with international EMS systems, such as in Africa, has further demonstrated the effectiveness of SEAL in diverse scenarios, including active conflict zones and regions with limited medical infrastructure. 

BC3 Technologies’ mission is to enhance the survivability and recovery of individuals experiencing severe bleeding, whether in a medical facility, on the battlefield, or in everyday emergencies. 

“We are constantly driven by a commitment to save lives and improve outcomes in critical care through groundbreaking products that combine advanced science with practical application,” shared Grube. “By addressing the shortcomings of existing interventions, SEAL has opened doors to new markets and solidified its role as a transformative solution in hemorrhage control. This global validation reinforces our commitment to developing innovative, practical, and effective medical technologies to save lives here in our hometown and worldwide.”