Shippert Tech, LLC Intraosseous Safety Sheath Receives FDA 510(k) Cleared Medical Device

BELLEFONTE, PA, February 17, 2023 – The FDA has issued a 510(k) Clearance for the Shippert Tech Intraosseous Safety Sheath. As a Critical Care physician, Dr. Brian Shippert has seen colleagues accidentally stick themselves while removing interosseous (IO) needles from patients. While using a winged cork screw, he realized a design solution to this serious needle stick problem. Shippert patented the Intraosseous Safety Sheath (IOSS). In 2019, he contracted with Actuated Medical to develop the IOSS medical device. The Actuated Medical Team refined the device, performed FDA required testing, wrote and submitted the FDA 510(k) premarket application. The IOSS received clearance (K220890) in October 2022.

Intraosseous needles are inserted into bone to infuse fluids quickly when vascular access is difficult. These needles carry high risk of accidental needle sticks as they are often troublesome to remove from the bone matrix. The IOSS device encloses around the IO needle prior to removal then acts as a protective cover as the IO needle is pulled out of the bone. The IOSS is indicated for use with 25mm or 45mm EZ-IO vascular access needles. Shippert Tech is contracting with Actuated Medical on the next phase of making the IOSS available to hospital systems.

“We teamed with Dr. Shippert to realize his dream of making the IO needle easier to remove and safer than currently available methods for clinicians. We are excited to see this medical device available to clinicians,” said Maureen L. Mulvihill, President and CEO of Actuated Medical.

“I took my patent to Actuated Medical and they have been very thorough. They completed the development, wrote and submitted the FDA 510(k). Because of the Actuated Medical team and their expertise, my patent is an FDA cleared medical device,” Brian Shippert, DO, Critical Care Physician, Shippert Tech, LLC.

Actuated Medical Awarded NIH Phase I and Phase II Exploratory/Developmental Grants for Wearable Deep Vein Thrombosis (DVT) Sensors

BELLEFONTE, PA – Actuated Medical, Inc. has been awarded a Phase I and Phase II Exploratory/Developmental Phased grant from the National Institutes of Health (NIH) under the National Heart, Lung, and Blood Institute (NHLBI) Catalyze Program. The project focuses on completing the development and commercializing of wearable, graphene-based flexible sensors for chronic monitoring of venous thromboembolism for high-risk patients. Actuated Medical is partnering on this project with Associate Professor Huanyu (Larry) Cheng from The Pennsylvania State University.

Deep vein thrombosis (DVT), a subset of venous thromboembolism, is a condition in which blood clots form deep within peripheral veins, typically in the lower extremities. This disease can cause swelling, vascular damage, and pain. More critically, when clots dislodge and travel through the blood stream they may lodge in lung, heart, or brain vessels and lead to death. Though medications are available to mitigate risk, there are few options for chronic or continuous monitoring. This project develops a wearable approach for monitoring at-risk patients for DVT formation.

“Having a lightweight, low cost DVT sensor that can be easily worn is important for the quality of care for surgical patients that are at a higher risk for DVTs. There are many other applications where a flexible sensor would improve patient outcomes which makes the market potential for this technology very large” said Maureen L. Mulvihill, Actuated Medical President, CEO, and Co-Founder.

“We are pleased to build the healthy and productive academia-enterprise partnership for technology translation and commercialization, which creates clear pathways for our device innovation to reach the marketplace and benefit public health” said Dr. Huanyu “Larry” Cheng, Associate Professor of Engineering Science and Mechanics, at The Pennsylvania State University.

Actuated Medical Awarded NIH SBIR for the Miniature Ultrasound Beamforming Array (MUBA)

BELLEFONTE, PA – Actuated Medical, Inc. has been awarded a Phase I Small Business Innovative Research (SBIR) grant from the National Institutes of Health – National Institute of Neurological Disorders and Stroke (NIH-NINDS) entitled “Development of a miniaturized wearable ultrasonic beam-forming device for localized targeting of brain regions in freely moving experimental subjects.” This project intends to commercialize an innovative ultrasound beamforming technology that was first developed under a BRAIN initiative-funded exploratory research grant (R21EY029424) led by Dr. Mehdi Kiani, Associate Professor in the Department of Electrical Engineering at The Pennsylvania State University. The system will be the first commercially available transcranial focused ultrasound system. Long term project goals, include feasibility studies for therapeutic treatment of conditions like Parkinson’s disease.

“In collaboration with Actuated Medical, I am confident that a novel technology will be developed that will benefit neuroscience researchers to study brain functions with low-intensity focused ultrasound pulses.” Dr. Mehdi Kiani, Associate Professor, The Pennsylvania State University.

“Actuated Medical’s goal is to be a leader in developing and commercializing innovative neuroscience technologies that will help to treat patients with neurological conditions. We are excited to be a partner with Dr. Kiani to bring this technology to researchers that are focused on understanding the brain.” Maureen L. Mulvihill, Actuated Medical President, CEO, and Co-Founder.

Actuated Medical Awarded NIH Continuation SBIR to Clinically Test the GripTract-GI Endoscopic Tissue Manipulator

BELLEFONTE, PA, November 22, 2022 – Actuated Medical, Inc. has been awarded a continuation Small Business Innovative Research (SBIR) grant from the National Institutes of Health – National Institutes of Diabetes and Digestive and Kidney Diseases (NIH-NIDDK) entitled “An active disposable cap for endoscope tip stabilization and complete visualization, and dissection of serrated sessile polyps.”

Nearly 15% of the 7 million endoscopic polyp removal (polypectomy) procedures performed annually in the U.S., as a part of the regimen for colorectal cancer prevention, are considered complex. Many are large polyps (≥2cm). There is a lack of practical accessories that aid resection of these complex polyps, while also not interfering with the electrosurgical tools used in the working channel of the endoscope. The GripTract device is a disposable endoscopic accessory that enables physician-controlled tissue manipulation to facilitate complex polypectomy procedures like endoscopic submucosal dissection (ESD) – a technique that reduces the risks of reseeding potentially malignant lesions or producing incomplete resections.

“The GripTract device is an endoscopic accessory that gives doctors ‘a third hand’ so that they can manipulate tissue to improve visualization during complex colonoscopies. The clinical goal is to minimize the need to switch to open procedures to remove the tissue. Open procedures have increased surgical complication risks, recovery time and cost.” said Maureen L. Mulvihill, Actuated Medical President, CEO, and Co-Founder.

Actuated Medical Awarded NIH Fast-track SBIR for Acoustic Implant Protection System

BELLEFONTE, PA – Actuated Medical Inc. has been awarded a Fast-track Small Business Innovative Research (SBIR) grant from the National Institutes of Health-National Institute of Mental Health (NIH-NIMH) entitled “Development of an Acoustic Implant Protection (AIP) system to improve performance and longevity of neural interfaces”. The project partners with Associate Professor (TK) Kozai from the Department of Bioengineering, The University of Pittsburgh.

Electrodes inserted into the nervous system may revolutionize treatment for a range of medical conditions (e.g., prosthetic control for amputees, restoring mobility for stroke patients). Unfortunately, the body looks at the inserted electrodes as foreign objects and attacks them which causes the device to fail over time. This project develops and tests a device that minimizes the body’s negative response resulting in longer electrode life.

“We are very excited to develop our acoustic system to extend the life of neural electrodes as these electrodes have significant promise of treating patients with neurological conditions. We are partnering with a recognized leader in the field Dr. Kozai who will test our system.” said Maureen L. Mulvihill, Actuated Medical President, CEO, and Co-Founder.

“This is a very rewarding collaboration and we’re already starting to see some very exciting and promising results, which would open up many more possibilities” said Takashi D.Y. Kozai, Ph.D., Associate Professor, University of Pittsburgh.

More information about Actuated neural device innovations. See