Prytime Medical Devices, Inc. Company Profile

Background

Prytime Medical Devices, Inc., established in 2014 and headquartered in Boerne, Texas, is an innovative medical device company specializing in minimally invasive solutions for hemorrhage control. The company's mission is to revolutionize the care of severely injured patients by enabling trauma teams to gain control of life-threatening bleeding as a bridge to definitive repair. Their flagship product, the ER-REBOA™ Catheter, is a 7 Fr compatible balloon catheter designed specifically for rapid, temporary occlusion of large vessels in emergency and critical care environments during the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure. This device was developed based on lessons learned from military vascular and trauma surgeons, COL. Todd Rasmussen and Dr. Jonathan Eliason, during combat situations.

Key Strategic Focus

Prytime Medical's strategic focus centers on the development and commercialization of advanced hemorrhage control technologies, particularly in the field of REBOA. The company aims to enhance patient survival rates by providing tools that allow for controlled resuscitation and bleeding management in critical care settings. Their product line includes the ER-REBOA™ Catheter and the pREBOA-PRO™ Catheter, the latter being the first FDA-cleared REBOA catheter designed specifically for true partial REBOA. These products are primarily targeted at trauma centers, emergency departments, and military medical units, focusing on improving outcomes in severe hemorrhagic situations.

Financials and Funding

Prytime Medical has demonstrated strong financial growth, with annual revenue reported at $4.2 million and total funding raised amounting to $6 million. In June 2021, the company closed an oversubscribed $6 million inside financing round to support the commercialization of their innovative products. This funding is intended to accelerate the adoption of their advanced REBOA technologies and to enhance customer support and clinical outcomes.

Pipeline Development

The company's pipeline includes the ER-REBOA™ Catheter and the pREBOA-PRO™ Catheter. The ER-REBOA™ Catheter received FDA 510(k) clearance in October 2015 and has been adopted in over 365 hospitals worldwide. The pREBOA-PRO™ Catheter, which offers extended safe occlusion times up to 2 hours in Zone 1, received FDA 510(k) clearance in October 2025. This advancement allows for more controlled resuscitation and bleeding management in critical care settings.

Technological Platform and Innovation

Prytime Medical's proprietary technologies include the ER-REBOA™ Catheter and the pREBOA-PRO™ Catheter. The pREBOA-PRO™ Catheter is designed with flow channels that enable precise, smooth manual control of patient blood flow, allowing surgeons to stabilize blood pressure and reduce blood loss while minimizing the risk of distal ischemia and reperfusion injuries. This innovation represents a significant advancement in REBOA technology, providing surgeons with enhanced control during critical procedures.

Leadership Team

Prytime Medical's leadership team includes:

David Spencer: Chief Executive Officer (CEO). Spencer has been instrumental in driving the company's growth and commercialization efforts, overseeing the development and market introduction of key products.

Dr. Chance Spalding: Chief Medical Officer (CMO). Dr. Spalding, a Trauma and Critical Care Surgeon, provides clinical expertise and guidance, ensuring that the company's products meet the needs of healthcare professionals in trauma care.

Andrew Holman: Chief Commercialization Officer. Holman is responsible for leading sales, marketing, and clinical support to drive market growth and revenue in the emerging field of endovascular hemorrhage control in trauma.

Competitor Profile

Market Insights and Dynamics

The market for hemorrhage control devices, particularly in the field of REBOA, is expanding as trauma centers and emergency departments seek advanced solutions to manage severe bleeding. The adoption of minimally invasive techniques is increasing, driven by the need for effective and rapid interventions in critical care settings.

Competitor Analysis

Prytime Medical's primary competitors include companies like Alydia Health, Jibon Health, and Compression Works. Alydia Health focuses on medical devices for maternal health, while Jibon Health and Compression Works are involved in healthcare equipment manufacturing. Prytime Medical differentiates itself through its specialized focus on REBOA technology and its commitment to innovation in hemorrhage control.

Strategic Collaborations and Partnerships

In June 2021, Prytime Medical entered into an exclusive partnership with Red One Medical, a Service Disabled Veteran Owned Small Business, to supply life-saving medical devices to the U.S. military. This collaboration aims to enhance the availability and effectiveness of hemorrhage control technologies in military medical settings.

Operational Insights

Prytime Medical's strategic considerations include expanding its market presence by leveraging partnerships with military and civilian healthcare providers. The company's focus on innovation and customer support positions it to effectively compete in the hemorrhage control device market.

Strategic Opportunities and Future Directions

Prytime Medical plans to continue developing next-generation REBOA catheters and other minimally invasive solutions. The recent FDA clearance of the pREBOA-PRO™ Catheter with extended occlusion times opens new avenues for the company to address a broader range of clinical scenarios, potentially improving patient outcomes in trauma care.