FDA Regulated Medical Devices

Volatylix, a Cambridge, MA based startup, is dedicated to early diagnosis enabling timely and appropriate treatment benefiting the patient, physician, provider and payor. Our patent pending platform – DECIPHER – and unique detection sensor technology – OFIS - combine to identify various disease states and conditions via proprietary breath biomarkers, volatile organic compounds (VOC’s). DECIPHER is disease agnostic and will speed diagnosis, while improving accuracy over currently available diagnostic methods. The tests use a noninvasive 4-minute breath sample with analysis taking ~15 minutes on our portable, battery powered platform. Initial products include fungal pneumonias, lung cancer (staging, monitoring, differential diagnosis and screening) and C. difficile.

FiteBac Technology/FiteBac Pharma's K21 uniquely targets the underlying disease state, given that most diseases involve microbial-associated inflammation and mitochondrial dysfunction. FiteBac Technology innovations stem from the work of numerous international academic research scientists. FiteBac Pharma K21 is the blockbuster antimicrobial small molecule designed to modulate biological, immunological, and metabolic systems for treating a wide range of infectious and inflammatory diseases. This patented drug substance has demonstrated the ability to safely eliminate bacterial, fungal, and viral infections, enhance innate immunity, induce mitophagy while improving mitochondrial and cellular metabolism, accelerate wound healing, and even promote the development of zebrafish and chickens, leading to increased adult mass. Rigorous research from Dr. Bhupesh Prusty's laboratory and Dr Christopher Rongo's laboratory is focused on various aspects of mitochondrial remodeling and reprograming, as well as mitochondrial-to-nuclear signaling with K21.

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.

Qidni Labs is a NATO DIANA company recognized by Fast Company as a 2025 World Changing Idea. The company has developed a portable, nearly waterless hemodialysis system that will make treatment accessible for over 10 million patients every year.

STAT Therapeutics is focused on developing a drug- device combination for easy, rapid administration of intramuscular, life-saving medications by users in any setting, aiming to improve access and usability for acute emergency treatments such as pain, anaphylaxis, and seizures.

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 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.

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Harmac is a global contract design and manufacturing organization specializing in single-use medical devices. With over four decades of experience, Harmac provides comprehensive services including product design and development, advanced manufacturing, automation, value engineering, quality assurance, and packaging and sterilization. The company is known for its operational excellence, regulatory compliance, and commitment to sustainability and community engagement. Harmac operates facilities across the United States, Ireland, and Mexico, supporting customers worldwide and across a range of clinical applications. ISO 13485 Certified and FDA Registered.

PinMed, Inc., is a National Innovation Award-winning bioinformatics/medical-device company that develops high-fidelity cardiovascular monitoring systems, personalized (adaptive) software, and integrated systems and custom solutions for tracking cardiovascular data in the most challenging environments (e.g., intensive activity, extreme electromagnetic interference, and interventional cardiovascular procedures) and identifying subtle but clinically important indicators of cardiovascular events. PinMed’s award-winning solutions include versatile, multisensor, high-fidelity monitoring systems for various hospital and ambulatory settings. The company has extensive experience in electronic and mechanical engineering, development of software and firmware for various processors, computational modeling, and cardiovascular physiology. PinMed’s flagship mobile platform, PELEX, provides unparalleled versatility in physiological monitoring and has been cleared by the FDA for diagnostic 12-lead ECG testing and various types of ambulatory monitoring.

Military Operational Medicine funded for PTSD, Adjustment Disorder and Pain and Sleep (over $5m). 3 trials in progress. Sana Health is an FDA Breakthrough Designated Device, currently in front of the FDA for Neuropathic Pain as a de novo - expecting to be on market Q4 2025. Sana is a wearable audiovisual neuromodulation device, that provides anxiety and pain relief, and sleep on demand. $25m raised to date, and in the middle of a Series A extension SAFE note round.

Evimero is an interdisciplinary company focused on understanding the interactions between microorganisms and human health, agriculture, and the environment, utilizing Systems Biology and AI/ML. Evimero applies molecular principles to infectious disease and microbiome science to improve health outcomes and environmental sustainability through targeted interventions in dysbiotic microbiomes and in people with infectious disorders. Evimero has an infectious disease product pipeline including both prophylactic and diagnostic assets against common causes of Travelers' Diarrhea, including a unique approach to preventing infection with human Norovirus, enterotoxigenic E. coli (ETEC) and others. Evimero's pipeline of drugs targeting human and animal microbiomes includes early-stage assets aimed at generalized microbiome-driven inflammation and gut leak, and specific disease-targeted disorders including Parkinson Disease and Inflammatory Bowel Diseases. Evimero's platform also makes possible a suite of point-of-care diagnostics that can be used for patient cohorting (infectious diseases), risk stratification, and ultimately informing therapeutic decision-making. The nature of Evimero's platform assures a steady stream of novel assets targeting both infectious diseases and chronic disorders with roots in microbiome dysfunction.

ExcelCoat Technologies, Inc., based in Frederick, Maryland, is an emerging biotechnology company. It is developing novel medical devices to improve wound healing with proprietary atmospheric non-thermal plasma technology. The reactive plasma species generated in the non-thermal plasma can be optimized to effectively disinfect bacteria to prevent delayed healing, and at the same time stimulate epithelial cell migration and proliferation. This novel device will be used by care providers in clinic settings to treat wounds without causing pain to the patient. The company also holds a US patent on biocompatible nanocoating, which can be applied onto cardiovascular stents to prevent both in-stent restenosis and thrombosis.

RBT Resources is a service-disabled veteran-owned medical device company focused on rapidly improving damage-control resuscitation and blood delivery in austere, prehospital, and mass-casualty environments. The company is developing a next-generation rapid blood transfusion platform that leverages a compact, reusable pump and mission-configurable disposables to enable faster, more controlled administration of whole blood and blood products at the point of injury. Founded by former U.S. Special Operations Forces operators, RBT Resources is dedicated to closing critical medical capability gaps observed in combat through user-driven design and close collaboration with military medical teams. ​

Ease Healthcare (a registered DBA of MPS Medical, Inc.) is committed to advancing next-generation military medicine by accelerating access to clinically validated diagnostic tools, monitoring devices, and health and wellness technologies. As a trusted commercialization partner and distributor, the company empowers providers, organizations, and individuals with advanced solutions that support early detection, timely intervention, and improved health outcomes in both civilian and military settings. With a mission to make cutting-edge science and technology accessible to all, Ease Healthcare focuses on addressing critical health challenges such as 02 delivery, cancer, and cardiovascular disease —areas that directly impact force readiness and resilience. The company’s vision is to break barriers in healthcare by delivering innovative medical solutions that are affordable, accessible, and simple to use, regardless of economic or geographic limitations. In addition to bringing transformative technologies to market, Ease Healthcare provides turnkey services for medical device manufacturing and distribution, guiding partners from product development through regulatory compliance and successful deployment. By combining technical expertise with a dedication to accessibility, Ease Healthcare supports the Department of Defense’s priorities in preparing and protecting service members with next-generation healthcare solutions.