BELLEFONTE, Pa. - Sept. 23, 2020 - Actuated Medical, Inc. has been awarded a Small Business Innovative Research (SBIR) Phase II grant for $2.1M from the National Institutes of Health (NIH) / National Institute of Child Health and Human Development for its "Vibration-integrated Lancing System to Reduce Stress, Pain Response, Heel Damage and Developmental Harm from Recurring Heel Sticks in Neonates."
Blood collection in neonates is routinely necessary, with heel sticks being the most common technique for small samples. Heel sticks are one of the most frequent painful procedures performed in the NICU, resulting in a repeated pain response, believed to negatively impact development. The BabyGentleStick heel stick aid is a medical device designed for reducing pain and stress during heel sticks in neonates through vibration-induced anesthesia. The project includes clinical testing at Nationwide Children's Hospital (NCH; Columbus, OH) and Hershey Medical Center (HMC; Hershey, PA).
"BabyGentleStick's innovation is its simplicity while solving a clinical problem," said Maureen L. Mulvihill, PhD, president and CEO of Actuated Medical. "With our early clinical data, we're confident we'll be reducing heel stick pain for these fragile kids."
In the project's Phase I, initial safety and effectiveness was demonstrated through three pilot clinical trials. In this Phase II SBIR, Actuated Medical will finalize development and seek regulatory approval to bring this innovative technology to neonatal patients.
# # #
About Actuated Medical, Inc.
Actuated Medical develops medical devices that integrate electronically controlled motion technologies that improve patient outcomes and reduce healthcare costs. Their development process focuses on intellectual property, regulatory, and reimbursement strategies to decrease commercialization risk and attract medical device technology licensing partnerships. Their devices solve unmet clinical needs in target markets (e.g., GI, oncology, critical care and pediatrics). Actuated Medical a certified women-owned business located in Bellefonte, PA and is ISO 13485:2016 certified.
For more information, please visit http://www.actuatedmedical.com
Contact
Maureen L. Mulvihill, PhD.
Actuated Medical, Inc.
