SBIR-STTR Award

Of the 4 million babies born in the US each year, 120,000 (3%) have a complex birth defect. Some defects, such as spina bifida, warrant in utero interventions to improve fetal outcomes. Spina bifida is a condition where there is incomplete closing of the backbone and membranes around the spinal cord. Texas Children’s Hospital has pioneered a fetoscopic method to address spina bifida. While much of the surgery can be performed through ports, the uterus currently needs to be exteriorized in order to position the fetus appropriately and place sutures to anchor the chorioamniotic membranes to the uterine wall. The sutures are placed to prevent preterm premature rupture of membranes (pPROM) which leads to both maternal and fetal complications. PPROM is a common complication of fetal surgery, occurring in about 30% of minimally invasive cases. The risk of pPROM, both maternal and fetal, often offsets the benefits of fetal treatment. Innovation: The Uterine wall-Membrane Anchor (UMA) is a linear device that facilitates the percutaneous suturing of chorioamniotic membranes to the uterine wall during fetoscopic surgery. Two cylindrical anchors are deployed on either side of the uterine wall and connected by a knotted suture that can be tightened to secure the membranes. This solution facilitates the conversion of existing open fetal procedures to percutaneous procedures and potentially the development of new fetal interventions. Approach: In this SBIR Phase I project, Fannin Innovation Studio will optimize the prototype device design and test it in benchtop and animal models. Aim 1 is focused on refining and optimizing the UMA prototype and developing the surgical procedure to deploy the device. This will accelerate our progress towards clinical implementation and commercialization. In Aim 2, the optimized prototype developed in Aim 1 will be tested in pregnant rabbit chronic studies and pregnant sheep acute studies. We believe that the UMA device will bring value to patients, doctors, and children’s hospitals by providing a solution that reduces maternal and fetal complications, expands patient population through the development of a safer percutaneous procedure, and leads to better outcomes for children with spina bifida.

Public Health Relevance Statement:
Fetoscopic surgeries are performed in utero to address complex birth defects and improve fetal outcomes. However, preterm premature rupture of membranes is a major complication of fetal surgery, occurring in about 30% of minimally invasive surgical cases. In some fetal surgeries, such as spina bifida procedures, the uterus is exteriorized to place sutures to secure the chorioamniotic membranes to the uterine wall and thus prevent rupture. The UMA device allows for the percutaneous deployment of a dual-anchor suture system, improving maternal outcomes through a safer procedure while simultaneously improving fetal outcomes by preventing membrane rupture.

Project Terms:
Acute; Address; Affect; Amnioscopic Surgical Procedures; Animal Model; Animals; Area; base; Blood Vessels; Child; Chronic; Clinical; commercialization; Complex; Complication; Congenital Abnormality; Congenital diaphragmatic hernia; Defect; design; Development; Device Designs; Devices; Documentation; Evaluation Reports; fetal; Fetus; fetus surgery; human tissue; improved; in utero; innovation; Intervention; intraamniotic infection; Lead; Membrane; Meningomyelocele; Methods; minimally invasive; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; patient population; Patients; Pediatric Hospitals; Performance; Phase; Placenta; Positioning Attribute; preclinical study; Pregnancy; pregnant; Pregnant Uterus; Premature Birth; Premature Labor; preterm premature rupture of membranes; prevent; Prevention; Procedures; prototype; Provider; Risk; Rupture; Safety; Secure; Sepsis; Sheep; Side; Small Business Innovation Research Grant; Spinal; Spinal Cord; Spinal Dysraphism; standard care; standard of care; Surgical sutures; System; Testing; Texas; Tissues; Ultrasonography; United States; Uterus; Vertebral column

Of the 4 million babies born in the US each year, 120,000 (3%) have a complex birth defect. Some defects, such as spina bifida, warrant in utero interventions to improve fetal outcomes. Spina bifida is a condition where there is incomplete closing of the backbone and membranes around the spinal cord. Texas Children’s Hospital has pioneered a fetoscopic method to address spina bifida. While much of the surgery can be performed through ports, the uterus currently needs to be exteriorized in order to position the fetus appropriately and place sutures to anchor the chorioamniotic membranes to the uterine wall. The sutures are placed to prevent preterm premature rupture of membranes (PPROM) which leads to both maternal and fetal complications. PPROM is a common complication of fetal surgery, occurring in about 30% of minimally invasive cases. The risk of PPROM, both maternal and fetal, often offsets the benefits of fetal treatment. Innovation: The ChorioAnchor device is a linear device that facilitates the percutaneous suturing of chorioamniotic membranes to the uterine wall during fetoscopic surgery. Two cylindrical anchors are deployed on either side of the uterine wall and connected by a knotted suture that can be tightened to secure the membranes. This solution facilitates the conversion of existing open fetal procedures to percutaneous procedures and potentially the development of new fetal interventions. Approach: In this SBIR Phase II project, Fannin Innovation Studio will begin manufacturing scale-up processes, gather data for regulatory submission, and continue commercialization milestones prior to HDE submission. Aim 1 focuses on transferring the deployment device to Biotex, our contract manufacturer, and polymer optimization with Texas A&M University. We will gather data in our design history file relevant for future regulatory filing. In Aim 2, the optimized device will arrive at a design freeze after undergoing further modifications and benchtop testing. Polymer refinement will continue based off of pilot biocompatibility testing performed by American Preclinical Services, Inc. Finally, Aim 3 will generate verification and validation testing data to be included in our design history file. These data will be used to prove initial safety and efficacy prior to entering HDE clinical trials. We believe that the ChorioAnchor device will bring value to patients, doctors, and children’s hospitals by providing a solution that reduces maternal and fetal complications, expands patient populations through the development of a safer percutaneous procedure, and leads to better outcomes for children with fetal conditions.

Public Health Relevance Statement:
Fetoscopic surgeries are performed in utero to address complex birth defects and improve fetal outcomes. However, preterm premature rupture of membranes is a major complication of fetal surgery, occurring in about 30% of minimally invasive surgical cases. In some fetal surgeries, such as spina bifida procedures, the uterus is exteriorized to place sutures to secure the chorioamniotic membranes to the uterine wall and thus prevent rupture. The ChorioAnchor device allows for the percutaneous deployment of a dual-anchor suture system, improving maternal outcomes through a safer procedure while simultaneously improving fetal outcomes by preventing membrane rupture. The Phase II project will facilitate data collection for regulatory filing as a Humanitarian Device Exemption (HDE) device.

Project Terms:
Address; American; Amnioscopic Surgical Procedures; Animal Model; Animal Testing; Animals; base; biomaterial compatibility; Businesses; Child; Clinical Trials; Collaborations; college; commercialization; Complex; Complication; Congenital Abnormality; Contracts; cytotoxic; Data; Data Collection; Defect; design; Development; Device Designs; Devices; Dimensions; Documentation; fetal; Fetus; fetus surgery; formative assessment; Freezing; Future; Hand; Human; improved; in utero; Inflammatory; innovation; Intervention; intraamniotic infection; Lead; Life; Manufacturer Name; manufacturing process; manufacturing process development; manufacturing scale-up; Medicine; meetings; Membrane; Meningomyelocele; Methods; minimally invasive; Modification; Operative Surgical Procedures; Outcome; patient population; Patients; Pediatric Hospitals; Performance; Phase; Polymer Chemistry; Polymers; Positioning Attribute; pre-clinical; Pregnancy; Premature Birth; Premature Labor; preterm premature rupture of membranes; prevent; Prevention; Procedures; Process; Protocols documentation; prototype; Provider; Recording of previous events; Risk; Risk Assessment; Rupture; Safety; Sampling; Secure; Sepsis; Services; Side; simulation; Small Business Innovation Research Grant; Spinal Cord; Spinal Dysraphism; standard care; standard of care; Sterility; Surgical sutures; System; Testing; Texas; tool; Universities; Update; usability; Uterus; verification and validation; Vertebral column