Rx Bandz TXA Study Shows Early Success

First Step in Creating Much-Needed Tranexamic Acid (TXA) Auto-Injector To Reduce Preventative Deaths from Hemorrhages

FAIRFIELD, NJ, UNITED STATES, August 21, 2024 /EINPresswire.com/ -- Rx Bandz, a medical device platform and formulation development company, recently announced the promising results of a pre-clinical study for bioavailability of its proprietary concentrated tranexamic acid (TXA) formula in a representative animal model.

TXA, which inhibits fibrinolysis in which the body breaks down blood clots, is a standard drug for reducing certain hemorrhages. It is conventionally delivered through intravenous (IV) administrations to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, and other FDA-defined indications.

Rx Bandz has developed a concentrated TXA formulation to be delivered at a small volume by Miniject^® auto-injector via intramuscular (IM) administration compared to a high volume required for a standard care using the conventional formulation on the market via intravenous (IV) administration.

Jessica Walsh, CEO of Rx Bandz, said, “We are excited by the results of this pharmacokinetic study. Our concentrated TXA lasted longer than IV within the therapeutic range and we did not see the drug spikes that occur with TXA given intravenously. We are optimistic that we will continue to see promising results in our next study to deliver the high strength TXA medication using our MiniJect auto-injector in a clinical study.”

Promising Results from Pre-Clinical Study
In this preclinical study, the levels of drug (TXA) in the bloodstream were measured and found that TXA given intramuscularly was available in the blood serum at a therapeutic level longer than that given intravenously. For instance, a 1 gram dose of TXA in a representative animal model reached a therapeutic level for inhibiting fibrinolysis after 10 minutes of IM administration and maintaining above that level at least for six hours.

Walsh explained, “This is an important step forward in developing a TXA auto-injector, as requested by the US military, emergency services companies, and healthcare providers in remote locations. Walsh continued, “More than 55,000 women die annually from postpartum hemorrhages and thousands of warfighters succumb to preventable non-compressible hemorrhages. Saving these lives is our mission.”

Compact auto-injector for TXA delivery
Rx Bandz has developed the world’s smallest auto-injectors and for use at point of injury, with the potential to save thousands of people from preventable deaths from hemorrhages, whether on the battlefield, accident sites or birthing rooms.

The Company's hydraulics-driven MiniJect auto-injector is particularly well suited to deliver high volume, viscous therapies in austere environments, like battlefields or medically scarce and remote situations. Other auto-injectors, which are operated by spring, battery and gas, have problems delivering this type of drug.

Advantages of IM over IV administration
TXA has been studied in multiple double blinded and is frequently used off-label to reduce uncontrolled hemorrhage due to trauma globally. Intramuscular administration of TXA requires less medical training and is faster to use than intravenous one.

This is a significant advantage at the point of injury, in mass casualty situations, in remote locations, and all critical emergencies when seconds can save lives. TXA has been proven to be most effective if administered within minutes of injury.

It takes about 6-8 minutes to set up an IV and longer than that if a patient is bleeding, moving around and a vein is hard to find due to blood loss. This assumes that a trained someone is onsite with an IV and the situation allows for IV access. The use of auto-injectors eliminated the need to have IV tubing, saline bags readily available. Delivering IV via auto-injector is cost effective in equipment and trained personnel resources. IV bags are more fragile, more expensive, and harder to set up than an IM syringe.

Walsh summed up the advantage of TXA delivered via its MiniJect auto-injector, “The combination of our novel auto-injector plus the new TXA formulation gives the military, EMS , Homeland Security and healthcare providers in remote locations, an important advantage when one or hundreds of people have non-compressible hemorrhages. Our auto-injectors are easy to stockpile, transport and then move to the point of injury.

“With our TXA auto-injectors nurses can quickly give the hemorrhaging mother TXA. They do not have to transport the women to a hospital. We can save lives by making a lifesaving medication easy to use and bringing it right to the patient.”

About Rx Bandz
Rx Bandz is a privately owned company with its laboratory in Fairfield, NJ. Rx Bandz is developing the next generation of patient-centric auto-injectors to deliver a wide range of injectable medications for patients around the world. Designed to treat numerous emergency medical conditions, its MiniJect auto-injector will initially focus on delivering epinephrine to treat anaphylactic shock. The device is the world’s smallest auto-injector that is faster and easier-to-use than traditional auto-injectors. Rx Bandz is reformulating drugs for IM delivery as well as creating auto-injectors to deliver 1mL to 5mL of medications with various viscosities and molecular size.

For more information, see the company’s website at www.rxbandz.com

Myrna Walsh
Rx Bandz
+1 617-347-3475
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