Federal Grant Award Summary

The National Institute of Diabetes and Digestive and Kidney Diseases awarded $301,099 to Quintero & Kontopoulos PLLC (operating as The Fetal Institute) on July 1, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to support Phase I Small Business Innovation Research (SBIR) funding for the Q-Shunt device development project. The award funds design refinement and feasibility validation of a novel fetal shunting device intended to treat fetal lower urinary tract obstruction through vesicoamniotic shunting. This medical device incorporates a patented self-expanding nitinol anchor and bidirectional delivery system designed to overcome the high failure rates of existing shunting technologies, which experience dislodgement and mechanical malfunction in over 50% of clinical cases.

Under this one-year project period concluding June 30, 2027, the awardee will deliver engineered improvements to the Q-Shunt design through biocompatible materials selection and testing, bench-top performance validation across multiple parameters (flow rate, yield point, tensile strength, curl strength, and anchoring retention), development of regulatory-compliant engineering specifications and design documentation, and prototype assembly with final compliance testing against predefined safety and usability benchmarks. The deliverables are designed to establish technical feasibility and prepare the optimized device design for subsequent clinical trial stages based on preliminary proof-of-concept data demonstrating 93% proper placement, 100% device retention, and 88% live birth rate.