Class II

Intermediate-risk device that is subject to "special controls" to assure safety.

20 Members with Class II capabilities

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.

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.

Pneuma Systems Corporation
Pneuma Systems Corporation

Pneuma Systems Corporation specializes in designing and licensing closed-loop fluid control systems that precisely manage small fluid volumes without the complexity of traditional pumping mechanisms. The company leverages over 30 inventions and three novel subsystems to revolutionize fluid flow, workflow, information flow, and cash flow, aiming to transform the standard of care in infusion therapy. Pneuma is a small team of experienced medical device professionals working on a new technology platform for precise fluid delivery, with an emphasis on infusion therapy. Armed with a strong IP portfolio, Pneuma’s infusion controller is designed to support all venues of infusion therapy including acute care, standalone infusion centers, and home care. The design offers significant advances in fluid flow, information flow, and work flow. The design has been accepted into an accelerated review program by the U.S. Food and Drug Administration (FDA), known as STeP.

CorNeat Vision
CorNeat Vision

CorNeat Vision is dedicated to developing innovative biomimetic medical solutions aimed at addressing unmet medical needs across various therapeutic fields. Their mission is to harness biomimicry to improve health and equality worldwide, focusing on creating permanent, synthetic implants that integrate seamlessly with human tissue.

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.

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.

Modulim
Modulim

Modulim is dedicated to preventing the complications of chronic wounds due to diabetes, peripheral arterial disease, and burns. Mapping tissue health at the point-of-care is key to preventing non-healing chronic wounds. This is made possible only by Modulim's handheld microvascular imaging solution, powered by Spatial Frequency Domain Imaging (SFDI), that empowers healthcare teams with proprietary data and proactive, personalized AI insights.

SilverStream Medical
SilverStream Medical

SilverStream Medical is actively seeking investment to significantly reduce Surgical Site Infection (SSI) rates and prevent infections during operations using our innovative SilverStream Solution. SilverStream Medical is a life sciences company dedicated to revolutionizing healthcare through advanced wound care management and SSI prevention. Our mission is to set new industry standards by minimizing SSI rates, shortening hospital stays, and reducing incision healing time, ultimately enhancing patient outcomes and alleviating the burden on healthcare systems. Our flagship product, a groundbreaking wound care solution, is already commercialized and globally recognized. It features a patented formulation combining antimicrobial silver ions with menthol, glycerol, and surfactants in a hypertonic solution. This comprehensive approach provides cleaning, biofilm destruction, pain relief, moisturizing, and granulation promotion, available in both liquid and gel forms to address diverse wound care needs from chronic conditions to post-surgical wounds and burns. This solution has achieved FDA 510(k) clearance, regulatory approval in 25 countries, and has been successfully used in over 500,000 treatments globally with no reported adverse effects.

PyrAmes Inc.
PyrAmes Inc.

PyrAmes is a digital health company focused on transforming healthcare delivery through advanced sensor measurement. The company is developing a proprietary platform for continuous, accurate, wireless, and non-invasive blood pressure monitoring for patients of all ages, from newborns to seniors. PyrAmes aims to make blood pressure monitoring easy, low-cost, unobtrusive, and painless, ultimately improving patient outcomes.

Cohesys
Cohesys

Cohesys is a clinical-stage company focused on innovating fracture repair solutions. Its product, BoneTape, is the first bone fixation device that does not require drilling into healthy bone. The company aims to disrupt the traditional surgical-repair industry that relies on invasive plates and screws.

Radiatric Inc.
Radiatric Inc.

Radiatric Inc. is dedicated to developing and commercializing innovative technologies to improve outcomes for patients with blood stream infections that can lead to sepsis, and septic shock. Antimicrobial resistance is a serious global health threat. Our flagship medical device, our RAD-01 system, is an extracorporeal non-antibiotic device designed to treat blood stream infections by targeting and killing pathogens even multi drug-resistant organisms. The company's focus is on non-pharmacological methods of killing pathogens, aiming to reduce the mortality and long-term effects associated with sepsis.

MRIGlobal
MRIGlobal

MRIGlobal is a renowned Midwest research institute based in Kansas City, dedicated to improving the overall health, safety, and well-being of people everywhere. With over 80 years of experience, MRIGlobal specializes in diagnostics, pharmaceutical sciences, vaccines and therapeutics, global health surveillance, infectious disease, public health, warfighter protection, agriculture, and management and operations. The organization is committed to using science and technology to create solutions for a safer, healthier, and more sustainable world.

NeuEsse Inc.
NeuEsse Inc.

NeuEsse Inc. is dedicated to advancing skin health through innovative plant-based technologies. Their mission is to provide effective solutions for skin repair, addressing challenges such as severe burns, wounds, and trauma. Their flagship product, OmegaSkin™, is a human skin substitute made from soy protein, designed to enhance healing outcomes with minimal scarring. NeuEsse aims to meet the unmet needs in wound treatment, offering products that are sustainable, vegan-friendly, and require no special handling.

Altrazeal Life Sciences Inc.
Altrazeal Life Sciences Inc.

Altrazeal Life Sciences Inc. is a specialty medical technology company dedicated to developing and commercializing innovative drug delivery systems. Their mission is to improve patient outcomes by providing comprehensive solutions for patients, providers, and payers. The company is known for its patented Altrazeal® Transforming Powder Dressing, which optimizes the wound healing environment and supports tissue repair.

Genomind
Genomind

Genomind is a leader in precision medicine for mental health, dedicated to helping healthcare providers and patients make better prescribing decisions by leveraging genetic, lifestyle, and environmental data. Their mission is to personalize mental health treatment and improve outcomes for individuals, providers, and healthcare systems. Genomind supports a wide range of stakeholders, including individuals, providers, long-term care facilities, ACOs, employers, health plans, and international partners. Through innovative pharmacogenetic testing, precision medicine software, consultative services, and educational resources, Genomind aims to advance mental health care and empower both patients and professionals.

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Projects

Technology Showcase

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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.