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 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. FiteBac K21 uniquely targets the underlying disease state, given that most diseases involve microbial-associated inflammation and mitochondrial dysfunction.

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. 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.

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.

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 a leading distributor and commercialization partner for clinically validated diagnostic tools, monitoring devices, and health and wellness technologies. The company is dedicated to enabling proactive healthcare decisions and equipping providers, organizations, and individuals with advanced solutions for early detection, timely intervention, and improved patient outcomes. With a mission to make advanced science and technology accessible to all, Ease Healthcare focuses on expanding access to effective solutions for major health challenges, including cancer, cardiovascular disease, and infectious conditions. Their vision centers on breaking barriers in healthcare by making innovative medical solutions affordable, accessible, and easy to use for individuals, providers, and communities, regardless of economic or geographic barriers. Ease Healthcare also offers turnkey services for medical device manufacturing and distribution, supporting partners from product development through regulatory compliance and market entry.

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.

Limax Biosciences is dedicated to revolutionizing tissue healing through innovative biomaterials inspired by the natural slime of slugs. Their hydrogels provide superior adhesion and healing capabilities, addressing unmet medical needs both inside and outside the body.

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.

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 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.