This National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I Project Grant award of $275,000 to Surgic, LLC, located in Amarillo, TX, is for the development of a customizable surgical training platform supported by artificial intelligence. The project aims to improve the realism of recreated patient anatomy and enable scenario customization during surgical training using 3D printing, mechanical testing, and machine learning techniques. The platform will provide...
This Project Grant awarded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) under the Discovery and Applied Research for Technological Innovations to Improve Human Health program (CFDA 93.286) provides $1,418,716 to develop and validate an artificial intelligence (AI) surgical coaching system designed to enhance surgical performance and patient outcomes during urologic endoscopy procedures. The project aims to utilize machine learning algorithms to model real-life...
Resuture Inc. received a $273,462 Small Business Innovation Research Phase I Project Grant from the National Science Foundation to develop an Open Vascular Surgical Training System for Skill Acquisition and Evaluation. The NSF Engineering Program (CFDA 47.041) aims to improve quality of life and economic strength through engineering research and education. Under this award dated February 15, 2021 with a completion date of January 31, 2022, Resuture will create a virtual reality simulator to...
This $799,999 Project Grant award from the Center for Quality Improvement and Patient Safety, under the Research on Healthcare Costs, Quality and Outcomes (CFDA 93.226) program, aims to address barriers to large-scale adoption of the Operating Room Black Box (ORBB) technology. The ORBB is an innovative platform that captures and analyzes operating room team performance and patient outcomes to improve surgical quality and safety. The project has three specific aims: 1) Developing a...
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) awarded a $1,353,337 Project Grant under the Discovery and Applied Research for Technological Innovations to Improve Human Health program (CFDA 93.286) to The Johns Hopkins University. The goal of this 1-year project is to establish a new robotic system capable of performing autonomous soft tissue surgery, specifically for colonic anastomosis procedures. The funded work aims to develop novel 3D imaging, AI-based tissue...
This Project Grant award of $304,452 from the National Science Foundation's (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) program aims to develop a minimally invasive intrauterine labor augmentation system (ILAS) to directly increase labor forces and relieve uterine muscle demand during childbirth. The project objectives are to further develop the system's catheter-balloon component for safe prolonged intrauterine use, finalize the configuration and pleating pattern, and...
The Project Grant award R43HD115425 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) under the Child Health and Human Development Extramural Research program (CFDA 93.865) is supporting Theranova LLC, a veteran-owned medical device R&D company, to conduct a pilot clinical study evaluating the SOLESTIM neuromodulation system as a home-use treatment for dysmenorrhea (primary menstrual cramps). The $343,510 award will fund a 16-week,...
This Project Grant award from the National Science Foundation (NSF) under the Technology, Innovation, and Partnerships (CFDA 47.084) program provides $264,016 to Surgical Vision Systems, Inc. to design and develop a novel robotic surgery system for improving microvascular surgical procedures. The project aims to create a semi-autonomous image-guided robotic suturing system that leverages optical coherence tomography imaging, machine learning, and advanced robotics to enhance the accuracy and...
The National Institute of Child Health and Human Development (NICHD) awarded a $306,778 Project Grant (CFDA 93.865 - Child Health and Human Development Extramural Research) to Orygyn Medical Devices, LLC, a small disadvantaged business based in Portland, Oregon. The funding supports the development of a novel Tubal Selective Delivery System (TSDS) device designed to safely and selectively administer fluids, foams, or gels to the fallopian tubes through a nonsurgical transcervical approach....
This National Science Foundation (NSF) Technology, Innovation, and Partnerships (CFDA 47.084) Project Grant award of $275,000 to Opal Therapeutics Inc. aims to develop an advanced screening platform that utilizes patient-derived uterine organoids to identify new therapeutic Proteolysis-Targeting Chimeras (PROTACs) for treating uterine fibroids and endometriosis. The project goals include building a comprehensive gynecological biobank, training AI algorithms to detect disease-relevant phenotypes,...
DEVELOPMENT AND VALIDATION OF A HIGH-FIDELITY GYNECOLOGIC TRAINING PLATFORM FOR ROBOTIC-ASSISTED SURGERY USING 3D PRINTING TECHNOLOGY - ABSTRACT THIS PHASE I SMALL BUSINESS INNOVATION AND RESEARCH (SBIR) PROPOSAL AIMS TO DEVELOP AND VALIDATE A SYNTHETIC SOFT-TISSUE OPERATIVE FEMALE TRAINING (SOFT) PLATFORM THAT IMPROVES TRAINING FOR COMPLEX AND HIGH-RISK PROCEDURES IN GYNECOLOGY. THE SEDENTARY LIFESTYLE OF AMERICANS IS EXPECTED TO INCREASE THE INCIDENCE OF GYNECOLOGICAL PATHOLOGIES TREATED SURGICALLY, INCLUDING UTERINE FIBROIDS (UF), ENDOMETRIOSIS (EM), AND ADENOMYOSIS (AM). MINIMALLY INVASIVE AND ROBOTIC-ASSISTED SURGERY (MIS, RAS) ARE BECOMING POPULAR CHOICES OF INTERVENTION FOR THEIR UNPARALLELED BENEFITS TO THE PATIENT. HOWEVER, THESE PROCEDURES HAVE A STEEP LEARNING CURVE, REQUIRING EXTENSIVE SURGICAL TRAINING. THE LACK OF READILY ACCESSIBLE TRAINING PLATFORMS HINDERS THE SAFE ACQUISITION AND MAINTENANCE OF RELEVANT TECHNICAL SKILLS. TO ADDRESS THIS CRISIS, SOFT WILL BE THE FIRST COMMERCIALLY AVAILABLE PLATFORM, PROVIDING HYPER-REALISTIC HANDS-ON TRAINING FOR MIS AND RAS IN GYNECOLOGY. UNLIKE CURRENT PLATFORMS, LAZARUS 3D'S TECHNOLOGY UTILIZES SOFT MATERIALS WITH TUNABLE MECHANICAL PROPERTIES, ALLOWING THE MATERIALS TO BE DISSECTED, CLAMPED, AND STITCHED BY THE SAME INSTRUMENTS USED IN ACTUAL OPERATIONS. THIS WORK WILL DEVELOP AND VALIDATE A SYNTHETIC TRAINING PLATFORM FOR COMMON PATHOLOGIES TREATED WITH RAS. IN AIM 1, LAZARUS 3D WILL OPTIMIZE SYNTHETIC POLYMERS TO MIMIC THE BIOMECHANICS OF THE FEMALE REPRODUCTIVE SYSTEM, INCLUDING THE UTERUS. THESE MATERIALS WILL BEHAVE SIMILARLY TO SOFT TISSUE WHEN OPERATED ON USING RAS. AIM 2, LAZARUS 3D WILL UTILIZE ITS PROPRIETARY 3D PRINTING TECHNOLOGY TO CREATE THE RELEVANT FEMALE ANATOMY AND PATHOLOGIES (UF, EM, AND AM). 3D MODELS OF THE FEMALE REPRODUCTIVE SYSTEM WILL BE DESIGNED USING PUBLICLY AVAILABLE RADIOLOGICAL DATA AND PRODUCED USING THE MATERIALS DEVELOPED IN AIM 1. THE EXPERT SURGICAL TEAM AT THE COLLABORATING MEDICAL INSTITUTES WILL PROVIDE INSIGHTFUL INPUT ON THE REALISM OF THE ANATOMY AND TISSUE PROPERTIES. AIM 3, FOCUS GROUPS OF 15 GYNECOLOGISTS IN TRAINING FROM THE PARTICIPATING INSTITUTES WILL ASSESS SOFT'S VALIDITY BY PERFORMING RAS PROCEDURES. THE PARTICIPANTS WILL DETERMINE THE REALISM AND VALIDITY OF THE PLATFORM USING A 5-POINT SCALE LIKERT SURVEY. THE CRITERIA FOR EVALUATING THE REALISM AND UTILITY OF THE PLATFORM WILL INCLUDE TECHNICAL SKILL ACQUISITION, CONFIDENCE LEVEL, AND PERCEIVED USEFULNESS. THE PROPOSED PHASE I PROJECT DRAWS ON LAZARUS 3D'S EXPERTISE IN THE DEVELOPMENT OF ACCURATE AND REALISTIC LIFELIKE SYNTHETIC ANATOMY. WE ANTICIPATE THE COMPLETION OF THIS PROJECT TO PROVIDE SURGEONS, FOR THE FIRST TIME, WITH A REALISTIC TRAINING PLATFORM THAT CAN SAFELY ACCOMMODATE ALL SURGICAL PROCEDURES AND STEPS USED IN RAS. THE SUCCESSFUL COMPLETION OF THIS PROJECT WILL LAY THE GROUNDWORK FOR A PHASE II RESEARCH PROJECT, IN WHICH THE SOFT PLATFORM WILL BE VALIDATED AS THE STANDARD OF TRAINING AND SKILL ASSESSMENT FOR GYNECOLOGICAL RAS PROCEDURES.