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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 www.neuralglider.com

Actuated Medical Presenting at the Society for Neuroscience (SfN) ‘Neuroscience 2022’ Conference in San Diego, California

BELLEFONTE, PA – Actuated Medical will attend Neuroscience 2022, the annual meeting of SfN. Roger Bagwell, Ph.D. (Director R&D & Co-Founder) and Kyle Gheres, Ph.D. (Neural Device Leader & Senior Scientist) will be representing Actuated Medical and the NeuralGlider inserter at the NeuroNexus Booth (#: 2717). In addition, both Drs. Bagwell and Gheres will be presenting posters.

“Actuated Medical is focused on developing innovative solutions to help researchers understand the brain with our goal to help clinicians treat neurological conditions. We are proud to be presenting some of our neural device innovations like the NeuralGlider inserter that is already on the market supporting neuroscientists,” said Maureen L. Mulvihill, Actuated Medical President, CEO, and Co-Founder.

Poster Details:

Title: Delivery of Low-Intensity Pulsed Ultrasound in the Cortex to Improve Longevity and Performance of Neural Interfaces
Poster #: 460.10
Presenter: Roger Bagwell, Ph.D.
Session: # 460: Title: Traumatic Brain Injury: Developing Therapeutic Strategies
Session Time: Tuesday November 15, 8:00 AM -12:00 PM

Title: Insertion of planar and 3D matrix-style electrode arrays using ultrasonic vibration decreases electrode shank damage while maintaining electrode recording integrity
Poster #: 666.06
Presenter: Kyle Gheres, Ph.D.
Session: # 666 Title: Probing Technologies II
Session Time: Wednesday November 16, 8:00 AM -12:00 PM

Actuated Medical Awarded Phase I SBIR for Alcohol Addiction Treatment

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 on Alcohol Abuse and Alcoholism (NIH-NIAAA) entitled “Oscillated Insertion Tool for Minimally Invasive, Low-Damage, Accurate Placement of Delivery Cannula to Improve Efficacy for DREADDS Therapy in Alcohol Addiction Treatment”.

Alcohol addiction is both a major public health burden and a complex neuroscience problem. Recently, the powerful research tools used to better understand neurological disorders like addiction have also gained interest as therapies. However, a crucial issue is that the medication used must be reliably and safely delivered to specific areas within the brain. The project will demonstrate feasibility of a vibrated tool to assist in the accurate placement of a very small delivery device that may ultimately improve alcohol addiction treatment.

“Actuated is focused on developing innovative medical devices to treat neurological diseases. The goal for this technology is to use our knowledge of vibrating needles to develop a medical device that reliably enables safer and more precise injections within the brain than is currently possible, paving the way for more effective treatments for conditions like alcohol addiction,” said Maureen L. Mulvihill, Actuated Medical President, CEO, and Co-Founder.

Actuated Medical Hires a Nurse Educator to build TubeClear clinical evidence

BELLEFONTE, PA – Actuated Medical is pleased to welcome Paula M. Mulhall, RPN, RGN, RN, to the Actuated Medical team as their Nurse Educator. Using her clinical nursing background in medicine/surgery, head trauma, spinal cord injury rehab, and long-term care, she will focus on the development of TubeClear clinical evidence through communications and collaboration with various medical facilities and personnel. The TubeClear system is an FDA cleared medical device that clears feeding tubes while the tube stays in the patient and operates at bedside.

“Paula’s experience dealing with clogged feeding tubes during her career gives her the passion and understanding of the nursing issue that TubeClear solves. She is an excellent addition to the TubeClear team,” said Maureen L. Mulvihill, Actuated Medical President, CEO, and co-Founder.

About Paula M. Mulhall, RPN, RGN, RN Paula is a Registered Psychiatric Nurse and General Nurse with a diploma in Behavioral Science from the Royal College of Surgeons in Dublin, Ireland. She boasts a clinical nursing background in Medicine/Surgery, Acute Psychiatry, Head Trauma, Spinal Cord Injury Rehab, and Long Term Care. In 1995, she began her research nursing career at the Pennsylvania State University (PSU), as a Clinical Research Nurse at the General Clinical Research Center (GCRC), where she assisted with all medical aspects of invasive clinical studies and trials with participants ranging in age from 3 to 90 year-olds. During this time, she coordinated the inaugural 5 year Nationwide Diabetes Prevention Trial (DPT-1) and assumed the role of Nurse Manager of the GCRC for 4 years before transitioning to PSU’s College of Nursing in 2010 as the Project Director of an National Institutes of Health 5- year Clinical Trial on Delirium Superimposed on Dementia. She completed her PSU career working in Social Science research for 6 years in the field of Child Maltreatment. During her time at PSU, she also volunteered as an alternative member of the Internal Review Board for 7 years.