Vivonics, Inc. Awarded $999,962 Contract from US Marine Corps for Continued Development of Traumatic Brain Injury Treatment System

 

Boston, MA — [9-12-24] — Vivonics, Inc. is pleased to announce the award of contract M67854-24-C-6544 from the U.S. Marine Corps (USMC) for $999,962 to advance the development of the Intranasal Cooling for Encephalopathy Prevention in Combat Casualties (ICEPICC) system. The ICEPICC system is a breakthrough technology aimed at mitigating the effects of traumatic brain injury (TBI) in combat trauma care.

Headed by Ms. Michaelina Dupnik, this contract represents a major milestone for Vivonics, as it continues the development of ICEPICC under the Small Business Innovative Research (SBIR) program. This current award marks the base period of a second Phase II SBIR contract, with an additional $500,000 proposed for an option period, contingent on successful outcomes from the ongoing research. ICEPICC is poised to become a critical tool in addressing brain injuries sustained by soldiers in combat, offering potentially life-saving interventions during the crucial moments following head trauma.

Vivonics is collaborating closely with NeuroIntact, Inc., a partner that has licensed the technology from Vivonics for commercialization. NeuroIntact CEO Bryan Nicholson emphasized the significance of this partnership, stating, “Through our partnership with Vivonics, we’ve gained a deep understanding of the brain injuries faced by our soldiers. The funding raised by NeuroIntact, along with the grant from the Marine Corps, will advance the development of our intranasal Targeted Temperature Management (TTM) therapy. This therapy has the potential to bring about a paradigm shift in the treatment of brain injuries for both military and civilian patients.”

The innovative ICEPICC system builds on earlier research that was developed during Phase I and the initial Phase II of the SBIR program. Its intranasal delivery method for cooling provides an effective, portable solution for managing brain injuries in austere environments, particularly in the high-stress, high-risk scenarios faced by military personnel.

This collaboration between Vivonics and NeuroIntact exemplifies the power of public-private partnerships in developing cutting-edge medical solutions. With continued support from the USMC and other stakeholders, the ICEPICC system could have a far-reaching impact, not only for military trauma care but also in civilian healthcare settings to treat TBI and other conditions where targeted temperature management of the brain can improve patient outcomes.

About Vivonics, Inc.  Vivonics, Inc. is a small medical device technology development company located in Bedford, MA, near Boston. Founded in 2012 by CEO Gordon B. Hirschman, Vivonics has created innovative medical technologies, some of which are already licensed to other companies for commercialization. Looking forward, Vivonics' mission is to improve human health, wellness, and performance in diverse and challenging environments by developing innovative mobile physiological monitoring, advanced diagnostics, non-invasive intervention and clinical decision support technologies.

For more information about Vivonics, Inc. and their innovative technologies, visit www.vivonics.com

About NeuroIntact, Inc. NeuroIntact, Inc. is a dynamic start-up company headquartered in Baltimore, MD. Founded by visionary CEO Bryan Nicholson, NeuroIntact Inc. is a medical device development company focused on preserving the brain by maintaining neurological intactness. The licensing of Vivonics' intra-nasal brain cooling technology is a significant milestone in NeuroIntact's mission to preserve brain function of our patient population. 

For more information about NeuroIntact, Inc. and their mission of preserving the brain by maintaining neurological intactment, visit www.neurointact.com.

 

Vivonics receives NIH-NIDCD award for development of Galvanic Vestibular Stimulation technology

Vivonics is excited to announce that we have been awarded a $319,000 grant from the National Institute on Deafness and Other Communication Disorders (NIDCD) for Phase I development of our Galvanic Vestibular Stimulation (GVS) technology to treat the symptoms of Ménière's disease, led jointly by our CEO Gordon Hirschman and Devin McCaslin, Ph.D. of the University of Michigan, with key support from Mindy Bishop, Ph.D. at Vivonics. Ménière's disease is a debilitating illness characterized by episodic attacks of vertigo, which can make many activities of daily living dangerous or impossible. GVS is an innovative technology that allows for treatment of vertigo and balance issues by applying electricity via the skin to the vestibular system, a key component of balance in humans. Vivonics has been developing GVS technology over the past decade for many different applications to explore new ways of treating these conditions without pharmaceuticals or invasive implants, and this project is the latest extension of that work. An important part of this program will include a human study in collaboration with Dr. McCaslin to demonstrate the effectiveness of the system. With this technology, sufferers of Ménière's disease will have a new way of treating their symptoms without the side effects of drugs or other conventional methods, allowing them to resume their normal lives in safety and comfort.

Thanks to everyone at Vivonics for making this happen!

Vivonics Presents at MHSRS 2024

Michaelina Dupnik (left) and Joshua Colls (right) at MHSRS 2024.

Michaelina Dupnik and Joshua Colls recently presented on behalf of Vivonics at the 2024 Military Health System Research Symposium (MHSRS) in Kissimmee, FL. MHSRS is an annual scientific conference and educational symposium run by the Department of Defense for presenting scientific knowledge on military-related research and development into technologies designed to meet the unique medical needs of warfighters. Topics covered at the conference include combat casualty care, clinical and rehabilitative medicine, military operational medicine, and others.

Ms. Dupnik and Mr. Colls presented posters on three of our ongoing projects, showcasing the variety of innovative work being developed at Vivonics: Vestibular Intervention via Portable Electrical Stimulator (VIPES), E‐Textile Enabled Active Monitoring System (E-TEAMS), and Next-Generation Virtual Health (NGVH). The posters can be viewed below.

 
 
 

Vivonics receives DoD award for development of Continuous Thermal Strain Monitoring and Prevention system

Vivonics is pleased to announce that we have been awarded a $197,000 contract from the Department of Defense Chemical and Biological Defense Program for Phase I development of our Continuous Thermal Strain Monitoring and Prevention (CTS-MAP) system, spearheaded by Dr. Michele Pierro. Military servicemembers often need to wear heavy protective gear in hazardous environments, which puts them at risk for heat stress and heatstroke. To prevent this, the military utilizes personal cooling systems; however, for the cooling systems to be used optimally and power consumption to be minimized, a method is needed to detect the onset of heat stress so cooling can be activated only when needed. CTS-MAP uses a novel optical approach to identify key markers of early heat stress in servicemembers, ensuring that they can be provided with optimal personal cooling to preserve their health, safety, and effectiveness.

Thanks to the entire Vivonics team for making this happen!

Vivonics receives USAMRAA award for development of VIPES

Vivonics is excited to announce that we have been awarded a $1.3 million sequential (second) Phase II SBIR contract from the United States Army Medical Research Acquisition Activity (USAMRAA) for continued development of our Vestibular Intervention via Portable Electrical Stimulator (VIPES) system. An impaired vestibular system is a hallmark of acute traumatic brain injury (TBI) and causes considerable long-term deficits in quality of life, including dizziness and loss of balance. Headed by Ms. Michaelina Dupnik, the VIPES project aims to create a wearable system that uses electrical stimulation of the vestibular system to correct balance disorders, allowing patients to resume normal activities of daily living. This award will allow us to test VIPES in a pilot clinical trial, advancing the device further toward commercialization, where it can improve the quality of life in military and civilian populations alike.

Thanks to the Vivonics team for making this happen!

Vivonics receives NIH-NIDDK award for development of Diabetic Foot Ulcer Monitor

Vivonics is delighted to announce that we have been awarded a $325,000 grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) for Phase I development of our Near InfraRed Layered Imaging of Tissue Hemodynamics (NIR-LITH). Developed by Dr. Michele Pierro, NIR-LITH is a novel non-invasive method of monitoring the extent and severity of diabetic foot ulcers, which can lead to serious health complications and even result in amputation. By providing clinicians with an easy to use, objective method of measuring these ulcers, NIR-LITH will give them the tools they need to manage the health of diabetic patients, improving long-term outcomes and preventing unnecessary surgeries. As a key part of the project, NIR-LITH will be tested in a clinical human study conducted in collaboration with Dr. Lawrence Lavery of the UT Southwestern Medical Center.

Thanks to all of the Vivonics team for making this happen!

Vivonics receives USAMRAA award for development of Remote Frostbite Detector

Vivonics is pleased to announce that we have been awarded a $3.5 million grant from the U.S. Army Medical Research Acquisition Activity (USAMRAA) for development of our Remote Frostbite Detector (RFD). This novel method of monitoring the early onset of frostbite was invented by Vivonics’ Director of Technology Development Michele Pierro, PhD, who will lead the development effort. The wearable system will allow users to detect and protect themselves from cold-induced injury before any serious damage occurs, giving our military servicemembers the tools they need to safely operate in Arctic and other cold-weather environments. RFD will alert individual users, medical teams, and leadership of frostbite onset in real time to ensure that servicemembers get the care they need to prevent permanent injury.

Thanks to everyone at Vivonics for making this happen!

Vivonics receives U.S. Army award for development of E-TEAMS

Vivonics is excited to announce that we have been awarded a $1.9 million grant from the U.S. Army for Phase II development of our E-Textile Enabled Active Monitoring System (E-TEAMS). Led by Dr. Michele Pierro and based off a novel conductive e-textile developed by our collaborators at UMass Lowell, E-TEAMS is a wearable monitoring system designed to track physiological indicators of physical and mental fatigue in soldiers, aimed at improving the safety and effectiveness of military personnel during training and operations. E-TEAMS will improve on existing commercial solutions by operating under heavy movement and physical activity and withstanding challenging training and battlefield environments, including intense cold, heat, and humidity.

Thanks to our team for making this happen!

Vivonics receives NIH-NIAAA award for development of Blood Alcohol Content Monitor

Vivonics is proud to announce that we have been awarded a $2 million contract from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for Phase II development of our wearable blood alcohol content monitor. Led by Dr. Michele Pierro, this effort aims to provide a non-invasive and discreet method of accurately measuring blood alcohol concentration without the disadvantages and social stigma of other commonly used methods. This program will provide an unobtrusive way for those undergoing treatment for alcohol abuse, as well as their healthcare providers, to monitor and track alcohol use to better inform treatment options and measure progress. It will also give researchers a new tool to better understand the effects of alcohol use and abuse and the progression of alcohol abuse disorders.

Thanks to the Vivonics team for making this happen!

Vivonics, Inc. Licenses Groundbreaking Intra-Nasal Brain Cooling Technology to NeuroIntact, Inc.

 

FOR IMMEDIATE RELEASE

Bedford, MA / Baltimore, MD - [8-9-23] - Vivonics, Inc., a pioneering medical device technology development company based in Bedford, MA, and NeuroIntact, Inc., an early-stage start-up company developing products to improve management of brain health, are pleased to jointly announce the licensing of Vivonics’ patented intra-nasal brain cooling technology to NeuroIntact.   

Under this intellectual property agreement, Vivonics has granted NeuroIntact exclusive rights to develop, manufacture, and market products based on the revolutionary intra-nasal brain cooling technology. The cutting-edge device utilizing this technology, known as ICEPICC (Intra-nasal Cooling for Encephalopathy Prevention in Critical Care), has shown significant potential in reducing brain swelling and mitigating the effects of traumatic brain injury, stroke, and other brain illnesses or injuries.

Vivonics, founded in 2012, has worked since 2017 to create the innovative brain cooling technology that now holds the potential to revolutionize critical care. The company's efforts were bolstered by Phase I and II Small Business Innovation Research (SBIR) funding from the US Marine Corps, with the specific aim of improving treatment outcomes for combat casualties.

"We are thrilled to enter this relationship with NeuroIntact to bring our groundbreaking intra-nasal brain cooling technology one step closer to making a positive impact on patients' lives," said Gordon B. Hirschman, President and CEO of Vivonics, Inc. "The licensing agreement reflects our commitment to advancing medical technologies and ensuring that the benefits of our innovation reach the patients who need it the most."

NeuroIntact, founded by its President Bryan Nicholson, is a visionary start-up that aims to revolutionize the field of critical care with its focus on advancing the application of cutting-edge technologies. With the acquisition of Vivonics' intra-nasal brain cooling technology, NeuroIntact plans to undertake full product development, seek FDA clearance, and ultimately bring the ICEPICC device to market.

"NeuroIntact wants to thank the US Marine Corps and Vivonics for the opportunity to commercialize our first product. NeuroIntact, along with our partners, aims to ensure patients maintain brain function,” stated Bryan Nicholson, CEO of NeuroIntact, Inc. "Our team has experience in the Targeted Temperature Management (TTM) market, and we see a clear need for a deployable solution in minutes to cool the brain directly for neurological protection."

Focal brain cooling has emerged as a promising approach in the treatment of traumatic brain injuries, strokes, and other brain illnesses or injuries. By leveraging intra-nasal cooling, ICEPICC aims to provide an efficient and minimally invasive method to mitigate brain damage, leading to improved patient recovery and outcomes.

About Vivonics, Inc.

Vivonics, Inc. is a small medical device technology development company located in Bedford, MA, near Boston. Founded in 2012, Vivonics has created innovative medical technologies, some of which are already licensed to other companies for commercialization. Looking forward, Vivonics' mission is to improve human health, wellness, and performance in diverse and challenging environments by developing innovative, non-invasive physiological monitoring, diagnostic, and decision-support technologies.

About NeuroIntact, Inc.

NeuroIntact, Inc. is a dynamic start-up company headquartered in Baltimore, MD. Founded by visionary CEO Bryan Nicholson, NeuroIntact Inc. is a medical device development company focused on preserving the brain by maintaining neurological intactness. The licensing of Vivonics' intra-nasal brain cooling technology is a significant milestone in NeuroIntact's mission to preserve brain function of our patient population. 

For more information, please contact:

Vivonics, Inc. Address: 175 Great Road, Bedford, MA  01730.  Email:  info@vivonics.com   Phone:  781-373-1930

NeuroIntact, Inc. Address: 1100 Wicomico Street, Baltimore, MD 21230 Email: info@neurointact.com Phone: 717-576-8584

 

Vivonics / VU License to Influent Medical

Vivonics, in collaboration with physician researchers from Vanderbilt University Medical Center, developed a pulmonary artery flow restrictor system, covered by US Patent 10,568,634, for use in treating congenital heart disease. The device is designed to be deployed and adjusted minimally invasively via a percutaneous catheter by a cardiac surgeon, potentially avoiding an invasive surgical procedure. This technology has been licensed, through Vanderbilt University, to Influent Medical, LLC of Tennessee, which is further developing and commercializing the device.

Transcatheter Device And Minimally Invasive Method For Constricting And Adjusting Blood Flow Through A Blood Vessel: U.S Patent: 10,568,634

Vivonics to participate in “Precision in Medical Devices” Virtual Summit

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Vivonics has been invited to participate in a virtual summit titled “Precision in Medical Devices” being hosted by the Precision Evolution Global Precision on June 24, 2021. 

Vivonics will be represented by Lead Scientist & Director of Business Development Dr. Ryan Myers, who will be featured as a Keynote Speaker during the Medical Device Design & Development track and speak to non-dilutive government funding and how it provides small businesses a means and a reason to innovate! Dr. Myers has led and participated in a many research and commercial studies involving the development and testing of medical devices, biological equipment, biomaterials, flexible electronic fabrication, and wearable electronic systems, and has a proven track record of successfully soliciting non-dilutive government funding for these innovative biomedical approaches to complex problems.

Learn more at Info@Precision-Globe.com

Vivonics to participate in “Next Generation Sensor and Applications” at UMASS Lowell

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Vivonics has been invited to participate in a virtual seminar titled “Next Generation Sensor and Applications” being hosted by the UMass Lowell Innovation Hub on March 3, 2021.  The program will spotlight the work of UMASS and local industries on the growing role of sensors in the aviation, defense, environmental, health care and robotics. 

Vivonics will be represented by Biomedical Engineer Saukhyda Deshmukh, who received her Masters degree from UMASS Lowell and is involved in a collaborative research project between Vivonics and UMASS.

More information appears in this article in Lowell newspaper The Sun: https://www.lowellsun.com/2021/02/21/umass-lowell-to-showcase-the-future-of-sensor-technology/