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.

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.

Arsenal Medical is dedicated to transforming medical devices with innovative biomaterials. Founded by Carmichael Roberts, Robert Langer, and George Whitesides, the company aims to address unmet medical needs through thoughtfully designed products. Their vision is to provide local therapy for important medical conditions across various therapeutic areas, leveraging expertise in materials science and chemistry.

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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.

AmacaThera is a clinical-stage biotechnology company focused on transforming therapeutics to improve patient health. Utilizing a unique injectable hydrogel platform, the company aims to provide localized, sustained drug delivery across various therapeutic areas, including post-surgical pain management and cancer treatment.

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.

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.

Exponent is a multidisciplinary science and engineering consulting firm serving sectors including healthcare, energy, manufacturing, and consumer products. The firm offers technical, regulatory, and risk management expertise supporting clients across the product lifecycle, with capabilities in advanced analytical modeling, laboratory and field testing, product safety, failure analysis, and regulatory compliance. Exponent's professionals contribute peer-reviewed research and leadership to major scientific and engineering forums.

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, 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.