Critical Innovations LLC
About Critical Innovations LLC
Winner of the MTEC 2020 Prototype of the Year Award, Critical Innovations LLC is an ISO 13485:2016 certified, 21 CFR§820 QSR (cGMP) and DCAA compliant, medical research and development company focused on creating cutting-edge solutions to health threats that span the pre-hospital, hospital, and military environments. The FDA-registered small business employs an iterative development methodology focused on human factors engineering to rapidly advance products.
Company focus areas include:
- Combat Casualty Care
- Critical Care
- Emergency Medical Services
- Emergency Medicine
- Prolonged Field Care
- Trauma Care
- Traumatic Brain Injury
- Wound Care
Critical Innovations is currently developing multiple medical devices toward regulatory clearance. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. To date, the company has worked under more than 20 different Department of Defense awards from all three military branches charged with medical technology development (i.e. U.S. Army, Air Force, and Navy), including such agencies as the Air Force Medical Support Agency; Army Medical Research and Development Command; Defense Health Agency; and, Office of Naval Research. Contract types have included Small Business Innovation Research (SBIR), Joint Warfighter, and Other Transactional Authority. As a prime contractor, Critical Innovations currently has a 100% transition rate from Phase I to Phase II, as well as Phase II to Phase III, for all eligible SBIR programs.
Core company technologies:
- BurRapid™ Intracranial Access Platform
- Donaldson Decompression Needle™
- Fast Onset Abdominal Management™ (F.O.A.M.™)
- PleuraPath™ Thoracostomy System
- Succor™ Combat Foam
Ross I. Donaldson, MD, MPH, CTropMed, FACEP – President & CEO
Timothy Fisher, M.B. Ch.B. – Vice President of Research
Jonathan Armstrong, PhD, CSci, CChem FRSC – Director of Quality Assurance & Regulatory Affairs
Oliver Buchanan, BSc (Hons) – Director of Development & Engineering
John Cambridge, PhD – Director of Special Projects
Perry Lew, MS, MBA – Director of Operations
About Indiana University
Founded in 1820, Indiana University (IU) is one of the world’s foremost public institutions. With more than 112,000 students and 19,000 employees statewide, IU continues to pursue its core missions of education and research while building a foundation for the university’s enduring strengths in teaching and learning, world-class scholarship, innovation, creative activity, community engagement and academic freedom. Bloomington is the flagship campus of the university, and each one of IU’s seven campuses is an accredited, four-year degree-granting institution.
IU’s world-class researchers have driven innovation and creative initiatives that matter for nearly 200 years. From curing testicular cancer to collaborating with NASA to search for life on Mars, IU has earned its reputation as a world-class research institution. Supported by $680 million in 2019, IU researchers are building collaborations and uncovering new solutions that improve lives in Indiana and around the globe. Indiana University’s School of Medicine is recognized as a national leader in the research, diagnosis, treatment and rehabilitation of traumatic injuries including mild to severe traumatic brain injuries.
The researchers at Indiana University are involved in pioneering trauma-care research like:
Precision Trauma Care
Physician researchers at the IU School of Medicine and partnering institutions are working to better understand why some patients recover and are more likely to die after traumatic injury, even when those injuries are very similar. Elucidating what factors contribute to trauma-related morbidities such as multi-organ dysfunction and sepsis can help predict which patients are at greater risk of suffering these secondary effects of trauma. The goal is to be able to deliver more targeted trauma care and ultimately, save more lives.
Traumatic Brain Injury (TBI)
Faculty investigators at IU School of Medicine and partnering organizations utilize innovative approaches to better understand the causes of concussions, in addition to interventions, to improve the overall treatment and recovery of individuals with TBI.
Trauma Regeneration and Rehabilitation/Military Medicine Program
Focusing on developing patient-specific interventions, the investigators are working to treat acute interventions and regenerative interventions for both bone and muscle. The primary goal is to enable military personnel to lead normal, productive lives and perform daily activities comparable to their non-injured cohorts, but an important secondary goal is the potential to return to active duty status and continue their military service.
Michael A. McRobbie – President
Fred H. Cate – Vice President for Research
Jay Hess – Executive Vice President for University Clinical Affairs and Dean, Indiana University School of Medicine
Phil and Penny Knight Campus for Accelerating Scientific Impact at the University of Oregon
About the Phil and Penny Knight Campus for Accelerating Scientific Impact at the University of Oregon
The Phil and Penny Knight Campus for Accelerating Scientific Impact is an ambitious initiative to fast-track scientific discoveries into innovations that improve the quality of life for people in Oregon, the nation, and the world. The campus creates the intellectual infrastructure to establish Oregon as a center for both research and development, making Oregon a place where companies can start-up, grow, and stay.
Mission: Science advancing society
Vision: Dramatically shorten the timeline between discovery and societal impact through world-class research, training and entrepreneurship in a nimble scientific enterprise.
- Redefine the modern research university by fostering world-changing research unfettered by traditional academic boundaries
- Serve as the educational engine driving the new economy of Oregon
- Transform student education through discovery-driven learning
- Engage the public in the excitement and creativity of scientific research
- Foster diverse perspectives and participation in scientific research
- Improve the health and wellbeing of the citizens of Oregon, the nation, and the world
Robert Guldberg – Vice President and Robert and Leona DeArmond Executive Director
Jim Hutchison – Senior Associate Vice President and Lokey-Harrington Chair in the Department of Chemistry and Biochemistry
Moira Kiltie – Associate Vice President and Chief of Staff
Andrew Nelson – Associate Vice President of Entrepreneurship and Innovation, Randall C. Papé Chair in Entrepreneurship and Innovation, and Associate Professor of Management
Prytime Medical Inc.
About Prytime Medical, Inc.
Prytime is a privately held medical device company that designs, develops and commercializes minimally invasive solutions for hemorrhage control. The company’s flagship product is the ER-REBOA™ Catheter, a 7 Fr compatible balloon catheter designed specifically for rapid, temporary occlusion of large vessels in the emergency and critical care environment during the REBOA (Resuscitative Endovascular Occlusion of the Aorta) procedure. The underlying intellectual property for the ER-REBOA™ Catheter was invented by experienced military vascular and trauma surgeons, COL. Todd Rasmussen and Dr. Jonathan Eliason, based on lessons learned on the battlefront during combat.
Prytime has continued to partner with the military to bring life-saving innovations to clinical practice. The company has recently received FDA approval for its next generation catheter, the pREBOA-PRO. This device addresses the most important limitation of REBOA and will bring this treatment to military and civilian patients with life-threatening hemorrhage. It builds on the success of the ER-REBOA catheter by adding an advanced occlusion balloon designed to enable controlled partial occlusion to prevent ischemic injury during severe hemorrhage.
At Prytime, we are proud to be a part of bringing military medical innovation to the civilian marketplace. We believe that no one should bleed to death; and the sooner you stop bleeding, the better.
Wake Forest Institute for Regenerative Medicine (WFIRM)
About the Wake Forest Institute for Regenerative Medicine (WFIRM)
The Wake Forest Institute for Regenerative Medicine is recognized as an international leader in translating scientific discovery into clinical therapies, with many world firsts, including the development and implantation of the first engineered organ in a patient. Over 400 people at the institute, the largest in the world, work on more than 40 different tissues and organs. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the institute. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories – flat structures, tubular tissues, hollow organs and solid organs – and 15 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney, and vaginal organs, have been successfully used in human patients. The institute, which is part of Wake Forest School of Medicine, is located in the Innovation Quarter in downtown Winston-Salem, NC, and is driven by the urgent needs of patients. The institute is making a global difference in regenerative medicine through collaborations with over 400 entities and institutions worldwide, through its government, academic and industry partnerships, its start-up entities, and through major initiatives in breakthrough technologies, such as tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.
Anthony Atala, MD – G. Link Professor and Director
James Yoo, MD, PhD – Chief Operations Program Officer
Shay Soker, PhD – Chief Scientific Program Officer