What was the inspiration behind the founding of Prytime Medical?
Our company’s inspiration is deeply rooted in the challenges the U.S. military faced during conflicts in Iraq and Afghanistan. The unique injury patterns caused by IED blasts, particularly hemorrhage and bleeding from extremities or internal organs, remain significant challenges in battle. While some injuries are potentially survivable with immediate medical intervention, internal bleeding from organs such as the spleen or liver presents an intractable problem. This dilemma spurred military investment into finding solutions, ultimately leading to Prytime Medical's genesis.
Our motivation extends beyond military applications as we continue to develop and grow. We recognized a parallel in civilian trauma, particularly in car accidents, which result in similar types of internal bleeding. There are more than 43,000 deaths annually in the U.S. due to car crashes, which underlines the urgent need for effective hemorrhage control solutions in both military and civilian settings. The company's mission is to leverage medical advancements made during wartime to improve trauma care and save lives in everyday situations.
How did you personally become involved with Prytime Medical?
My involvement with Prytime Medical began while I was engaged in economic development work for the state of Texas. I discovered that $45 million worth of federal funding for medical research was leaving Texas due to a lack of infrastructure, so I began work to address this issue. This led me to Fort Sam Houston in San Antonio, where I discovered a hub of military medical research focused on combat casualty care. There, I saw an opportunity to contribute to developing medical devices that address the needs of combat-wounded soldiers civilian trauma care. With these two patient populations in mind, we launched Prytime Medical.
Can you explain the principal product of Prytime Medical, REBOA, and how it addresses internal bleeding?
REBOA stands as Prytime Medical’s principal product, designed to offer a solution for internal bleeding, a critical issue in trauma care. The challenge with internal bleeding, especially in the case of severe trauma, is that traditional, more invasive exploratory surgeries to locate and address the source of bleeding have high mortality rates. The REBOA technique involves inserting a balloon catheter into the aorta through a small incision in the leg, effectively blocking blood flow to control hemorrhage and maintain vital blood supply to the heart, lungs, and brain. This approach significantly reduces the procedure's invasiveness and increases the chances of survival by preventing further blood loss.
The development of REBOA was inspired by the dire need for effective hemorrhage control in both military and civilian trauma cases. The concept, initially conceived by military doctors, aims to mitigate the risks associated with traditional methods of controlling severe internal bleeding so that military surgeons in the field can control the bleeding and transport soldiers to safer locations. By introducing a minimally invasive technique that can be quickly deployed, REBOA represents a significant advancement in trauma care, offering a lifeline in situations where traditional surgical interventions would be too time-consuming or risky.
Does Prytime Medical offer products other than REBOA?
While our focus remains on balloon occlusion and hemorrhage control, Prytime Medical has evolved our REBOA technology to address a critical limitation—the risk of ischemic and reperfusion injury following the balloon's removal.
Our latest innovation, which we call Prolonged REBOA, incorporates a design that allows for controlled, continuous blood flow past the occlusion site to maintain perfusion of the kidneys, liver, and other organs.
This innovation extends the window of time for medical intervention from 30 minutes to 2-4 hours, significantly improving patient outcomes by reducing the risks associated with blood flow obstruction.
How widespread is the use of your product?
Our device is currently being used in over 250 hospitals across the United States and in 28 different countries. For our newest product, we initiated a very limited market release involving 13 centers. Additionally, our technology has found application in the Ukrainian conflict, highlighting its significance in war scenarios, similar to its utility in civilian emergencies such as car accidents. An incident in Springfield, Massachusetts, where our device played a critical role in attempting to save the lives of car crash victims, underscores the potential lifesaving impact of our technology. Despite tragic circumstances, this crash case illustrates the dire need for effective hemorrhage control in both everyday situations and mass casualty events.
How easy do you find it to change the standard of care of hospitals?
Changing the standard of care is challenging due to the inherent difficulties associated with altering established medical practices. Our strategy centers on building a robust device, demonstrating its efficacy, and raising awareness about its potential to revolutionize trauma care. The situation in Ukraine presents a unique case study. The inability of the Ukrainian military to evacuate casualties quickly due to drone threats has made our technology crucial for providing soldiers with a chance to survive by "turning down the faucet" on hemorrhage, thus buying time for medical intervention. This parallels the need in civilian trauma care for technologies that provide time-critical solutions to prevent death from hemorrhage.
How does the current conflict in Ukraine highlight the importance of your technology?
The war in Ukraine has brought to light significant challenges in combat casualty care, particularly the difficulty of evacuating wounded soldiers due to the threat of drone strikes. Both Ukrainian and Russian forces are unable to utilize air evacuation, which drastically limits the ability to transport injured personnel to medical facilities. Our technology is being deployed on the front lines to control bleeding, offering a temporary solution that allows for the safe transport of casualties. This situation not only underscores the value of our device in war zones but also hints at its potential applications in future conflicts where traditional evacuation methods may not be feasible.
Looking ahead, what can we expect from Prytime Medical in the coming years?
In the future, we aim to revolutionize trauma surgery by providing surgeons with the means to achieve proximal control of bleeding, a capability currently lacking in trauma care. Unlike other surgical specialties where bleeding can be anticipated and controlled preemptively, trauma surgery often involves rushing into procedures without a way to stop bleeding beforehand. Our device intends to change this by allowing trauma surgeons to "turn down the faucet," thereby giving them time to plan and execute life-saving interventions more effectively. This shift toward proactive hemorrhage control has the potential to significantly improve outcomes for patients suffering from traumatic injuries, whether from accidents, falls, or violent incidents.