Gravitas Medical Launches Multicenter NICU Study of Next-Generation Smart Feeding Tube System

BERKELEY, Calif., April 21, 2026 - Gravitas Medical, Inc., a developer of advanced enteral feeding technologies, today announced the initiation of a prospective, multicenter clinical study evaluating its next-generation (Gen 2) smart feeding tube system in neonatal and infant patients. The Gravitas Entarik™ Feeding Tube System is FDA-cleared and has received Breakthrough Device Designation from the U.S. Food and Drug Administration. The study is being conducted at three leading institutions, including HCA Memorial Health Savannah.

The prospective study will enroll up to 100 patients and evaluate the safety and effectiveness of the Gravitas Entarik system, which provides real-time guidance during tube placement and continuous monitoring of tube position and gastric activity. Study endpoints include placement accuracy, time to feeding initiation, number of confirmatory X-rays, detection of tube dislodgement, and measures of feeding tolerance.

Feeding tubes are currently placed blindly at the bedside, with reported misplacement rates ranging from 4% to 59%, contributing to serious complications including inadvertent airway placement, aspiration, and delays in nutrition delivery. The Gravitas system is designed to address these risks by providing clinicians with real-time feedback on tube location during placement and continuous monitoring throughout feeding.

"This study represents an important step toward improving both the safety and effectiveness of enteral feeding in neonates and infants," said Saheel Sutaria, CEO of Gravitas Medical. "Our goal is to provide clinicians with real-time, actionable data that reduces risk and enables more personalized nutrition."

Beyond placement, the Gravitas system continuously captures impedance and temperature data to provide insights into gastric activity, reflux, and feeding readiness-capabilities that may support earlier detection of feeding intolerance and more optimized nutrition delivery.

"We already saw improvements in safety and nutrition with the Gen 1 system, and are looking forward to using the Gen 2 system," said Dr. Brad Buckler, Physician-in-Chief for the Memorial Health Dwaine and Cynthia Willett Children's Hospital of Savannah.

The Gravitas Entarik system builds on prior clinical experience and is designed to integrate seamlessly into existing hospital workflows while enhancing standard-of-care methods.

About Gravitas Medical

Gravitas Medical, Inc. is a Berkeley, California-based medical device company developing smart enteral feeding technologies that provide real-time guidance, continuous monitoring, and data-driven insights to improve patient safety and nutrition. The company's platform is designed to reduce complications associated with feeding tube placement and enable more personalized care in critical settings such as the NICU and ICU.