Class I

Low-risk Devices with minimal safety considerations

29 Members with Class I capabilities

Humanetics Corporation
Humanetics Corporation

Humanetics Corporation is a clinical-stage pharmaceutical company based in Minneapolis, Minnesota, focused on developing and commercializing products to enhance human health and wellbeing. Founded in 1988, the company specializes in radiation modulators, adjunctive oncology therapies, and pulmonary protective therapies, particularly for COVID-19. Humanetics is known for its lead drug candidate, BIO 300, which is being developed as a radioprotectant for military and civilian use, as well as a treatment to improve outcomes in cancer patients receiving radiotherapy. The company is actively engaged in research programs for non-small cell lung cancer, prostate cancer, and head and neck cancers.

Altra Inc.
Altra Inc.

Altra Inc. is at the forefront of revolutionizing infusion therapy with its innovative Altra Infusion System. The company is dedicated to addressing the critical challenges in the infusion industry, such as mechanical failures, flow issues, and false alarms, which contribute to a significant portion of medication errors and adverse drug events. Altra's mission is to ensure patient safety and improve healthcare delivery through advanced technology solutions.

Action Medical Technologies
Action Medical Technologies

Action Medical Technologies is a pharmaceutical and medical device company focused on developing innovative solutions that integrate medications with advanced devices and injector systems to improve patient outcomes, particularly in austere prehospital environments.

Bessel
Bessel

Bessel's mission is to deliver breakthroughs that scale by empowering medtech startups and teams. Bessel provides comprehensive strategy, execution, and fundraising support from initial concept to commercial release. The company is committed to fostering innovation and high-performance teams through its various programs, including the Powered by Bessel accelerator, Bessel Origin learning laboratory, and Bessel Rapid Innovation consulting services.

Purgo Scientific
Purgo Scientific

Purgo Scientific is a medical device company dedicated to developing effective solutions for the biofilm infections crisis in orthopedic surgery. Their mission is to provide a locally targeted sustained delivery device that ensures the right therapy is delivered to the right place for the right duration, ultimately improving patient outcomes and reducing the impact of surgical site infections.

PPD
PPD

PPD, a clinical research business of Thermo Fisher Scientific, is a leading provider of global contract research organization (CRO) solutions. The company is dedicated to helping clients accelerate the development of life-changing therapies through comprehensive drug development, laboratory, and lifecycle services. With a commitment to operational excellence and innovative technology, PPD empowers its customers to bring therapies to market faster and improve patient health. PPD has been recognized as an industry leader in clinical development digital transformation services and patient engagement digital transformation. With over 30 years of clinical leadership and a workforce of more than 30,000 employees globally, PPD has conducted over 2,100 trials in the past five years.

Solventum
Solventum

Solventum is a healthcare company dedicated to enabling better, smarter, and safer healthcare solutions. With a legacy of innovation, Solventum focuses on improving patient outcomes through advanced medical technologies, oral care solutions, health information technology, and purification and filtration systems.

Smith+Nephew
Smith+Nephew

Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company aims to restore people's bodies and their self-belief by using technology to take the limits off living. With a commitment to medical education and improving patient outcomes, Smith+Nephew operates in over 100 countries and is dedicated to sustainability and community health. Their purpose is to promote health and wellbeing, not just through their products but also by ensuring a positive impact on society and the environment. Smith+Nephew is also committed to increasing diversity within the medical device industry through initiatives like the Orthopaedics for All global advisory board.

Alira Health
Alira Health

Alira Health is a global consulting and clinical services company that aims to humanize healthcare and life sciences through innovative technologies and expert guidance. They focus on improving patient outcomes by integrating patient voices into the development of treatments and enhancing care quality across the healthcare ecosystem.

Aerstone
Aerstone

Aerstone is a cybersecurity firm dedicated to elevating businesses beyond the security status quo. With a focus on personalized cybersecurity solutions, Aerstone prioritizes understanding the unique needs and challenges of each client. The company is NSA-certified and boasts over 20 years of experience in the field, offering a boutique approach to cybersecurity that emphasizes quality over quantity. Aerstone's mission is to secure the digital world, one client at a time, by providing tailored strategies that deliver maximum impact. Aerstone's security architecture services are designed to fortify digital landscapes, safeguard assets, and keep organizations ahead of evolving threats, ensuring compliance and business continuity.

Articulate Labs
Articulate Labs

Articulate Labs aims to expand physical therapy standards and improve patient outcomes through wearable medical devices. The company uses innovative, agile technology to develop devices that make physical rehabilitation more mobile, convenient, and effective. By integrating technology with everyday activity, Articulate Labs believes patients can conquer functional limitations and better restore physical mobility.

Southwest Research Institute (SwRI)
Southwest Research Institute (SwRI)

Southwest Research Institute (SwRI) is a nonprofit research and development organization that provides independent, premier services to government and industry clients. Founded in 1947, SwRI is committed to advancing science and technology to benefit humanity, focusing on innovative solutions that improve human health and safety. With a diverse range of technical divisions, SwRI addresses complex challenges in various fields including mechanical engineering, materials, aerospace, automotive, biomedical, and more.

Critical Innovations LLC
Critical Innovations LLC

Critical Innovations LLC is a medical research and development company focused on creating cutting-edge solutions to health threats across pre-hospital, hospital, and military environments. 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. The company is dedicated to developing innovative medical devices and technologies that enhance emergency care and trauma management, particularly in military settings.

ARMR Systems, Inc.
ARMR Systems, Inc.

ARMR Systems, Inc. is dedicated to revolutionizing trauma care by engineering simple solutions to complex challenges. The company focuses on creating hemorrhage control systems that enhance the survivability of traumatic pre-hospital injuries, especially in situations where advanced medical help is not immediately available. Their mission is to democratize access to care and empower first responders, ensuring that anyone, regardless of their location or background, can confidently respond to emergencies. ARMR Systems champions a new approach to trauma care and preparedness, aiming to replace barriers to access with systems of equity.

ANT5 Co., Ltd.
ANT5 Co., Ltd.

ANT5 Co., Ltd. is a startup originating from Yamaguchi University dedicated to the research and development of medical devices for patients suffering from severe brain diseases. The company aims to save lives and alleviate suffering through advanced technology, with a vision to become the global standard in sensor and cooling technology for brain disease treatment by 2030.

AI Optics
AI Optics

AI Optics is dedicated to transforming point-of-care diagnostics through innovative AI-powered retinal screening technology. The company aims to increase access to eye screening and empower healthcare professionals to make informed decisions quickly, ultimately improving patient outcomes and revolutionizing medical diagnostics. By developing portable hardware and AI-based software, AI Optics brings eye screening out of specialist offices and into primary care and retail health settings, making early diagnosis reliable, efficient, and user-friendly.

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Projects

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Manufacture of a Settable Polymer Composite Bone Graft to Stabilize Fractures

Open fracture injuries are one of the largest sources of morbidity on both the battlefield and in the civilian population. The design of biomaterials that mechanically stabilize fractures while remodeling to form new bone is an unmet challenge in bone tissue engineering. Vanderbilt has designed a new bone void filler that induces bone growth, provides bone-like mechanical properties, and undergoes resorption at a rate aligned with patient biology.

Critical Innovations LLC

BurRapid Epidural Drainage Attachment for Traumatic Brain Injury

Epidural bleeding from traumatic brain injury (TBI) is immediately life-threatening and can quickly lead to brain herniation and death unless there is immediate neurosurgical intervention. BurRapid™, developed by Critical Innovations, is a medical device that provides hematoma drainage and intracranial pressure monitoring to sustain TBI patients on the battlefield. This allows for provision of these life-saving interventions earlier in the roles of care, including at the point-of-injury.

University of Colorado, Denver Center for Combat Medicine and Battlefield (COMBAT) Research

Community-Engaged Research Shows Promise for Adapting Safety Interventions in Military Populations

Researchers at the University of Colorado Anschutz, supported by MOMRP and MTEC, adapted the Project Safe Guard (PSG) intervention for military populations, emphasizing peer discussions and addressing implementation challenges.

Potential for Early Covid-19 detection using Fitbit devices

Early detection of COVID-19 is a critical force readiness issue for the U.S. Armed Forces. Thus, there is an urgent need to develop wearable diagnostics to identify COVID-19 cases. Fitbit is currently working to further validate its COVID-19 algorithm through a prospective study with Northwell Health utilizing Fitbit Sense and Versa 3 smartwatches. The hope is to bring wearable illness detection capabilities to its users.