WINSTON-SALEM — H3Pelvic Therapy Systems says it received a $2.2 million federal grant to support early commercialization and user-protocol work for its investigational pelvic-pain devices.
Founder and CEO Zack Lyon announced the National Institutes of Health Notice of Award on Sept. 18. The company identified it as a second-round Small Business Innovation Research Phase II grant under Award No. R44HD112219.
The company said the funding will support early commercialization and development of user protocols evaluating the devices for postpartum pain and related pelvic conditions. It said the Phase II work is being conducted in collaboration with Duke University and Wake Forest University.
Triad Business Journal independently reported the $2.2 million grant and said it will fund commercialization work for the Triad startup’s thermal-therapy system.
The new award follows a Phase I grant, R43HD112219, that the company said was performed at Duke University’s Pratt School of Engineering under Paolo Maccarini. The Phase II designation moves the federally backed work from the earlier feasibility stage toward product and protocol development, but it does not constitute regulatory clearance or a commercial launch.
H3Pelvic describes its technology as thermal neuromodulation for pelvic pain. Its website presents home-use and in-hospital devices, including an ergonomic seat and control unit. The same site says the system has not been cleared or approved by the U.S. Food and Drug Administration, is not available for commercial sale and is limited to investigational use in the United States.
The business consequence is the non-dilutive capital available to the Winston-Salem medical-device startup: the grant gives H3Pelvic $2.2 million for commercialization and protocol work without requiring an equity financing. No job target, revenue forecast, FDA submission timetable or product-launch date was disclosed in the reviewed sources.
The company separately said it has applied for a $7 million NIH Blueprint MedTech award with the University of Alabama at Birmingham and Virginia Commonwealth University. That application is not an award and is not included in the $2.2 million announced Sept. 18.
Image: Contextual electronic device-testing equipment photographed by Alex Cioaba via Unsplash under the Unsplash License. The equipment shown is not an H3Pelvic product or company facility. The photograph was cropped, labeled and given the standard NC Business Desk footer; no generative content.