TS-003440 — The Continuous Pulse Oximeter (CPO-2) is a conceptual wearable device designed for infants with Bronchopulmonary Dysplasia (BPD) and other patient populations requiring continuous oxygen monitoring. The National Institutes of Health estimates that 10,000-15,000 babies born in the United States develop BPD each year. Inspired by the concept of continuous glucose monitors (CGMs), the CPO-2 aims to offer a wireless, adhesive solution to address the challenges associated with traditional pulse oximeters. The intellectual property involves creating a device that is capable of reading oxygen saturations (spO2) without the need for a separate machine. Unlike current pulse oximeters that are minimally adhesive and connected to a machine via a cord, the CPO-2 would transmit information directly to a smartphone, eliminating the machine and cord, thereby reducing the risk of strangulation and skin breakdown issues. The adhesive component is expected to last for an extended period, potentially 7-10 days or more, reducing the need for frequent probe replacements. Potential applications include adoption by home care companies, which could provide the CPO-2 to families taking infants or children home on oxygen. The device could find utility across various age groups, offering a less cumbersome method for continuous oxygen saturation monitoring. RINCH has filed a provisional application (63/533,946) and the inventor continues to develop and refine this technology.

TS-003439 — The Predictive Model of Sudden Cardiac Death in Anomalous Aortic Origin of Coronary Artery (AAOCA) is a patient-specific computational modeling approach to predict ischemia risk in individuals with anomalous coronaries. Anomalous coronaries are variations or abnormalities in the anatomy of the coronary arteries. These anomalies can differ in presentation and severity, with some increasing the risk of heart problems, such as myocardial ischemia (reduced blood flow to the heart muscle), arrhythmias or sudden cardiac arrest. According to The Cleveland Clinic, up to 1% of the population has an anomalous coronary artery, and most cases are not dangerous. This predictive model utilizes morphological risk factors derived from advanced imaging data to offer a validated method for risk stratification, determining the need for surgery, selecting the type of surgery, assessing the effectiveness of surgery, and evaluating residual ischemia post-surgery. Because there are no effective risk stratification approaches for AAOCA individuals, predicting these life-threatening events is challenging. AAOCA is a significant cause of sudden death in children, and current understanding of the mechanisms leading to ischemia and sudden cardiac death (SCD) is limited. According to the Nora Eccles Harrison Cardiovascular Research and Training Institute, "SCD is one of the most significant causes of natural deaths globally. Annually, just over 300,000 US adult deaths are a result of sudden cardiac death. Roughly half of all cardiovascular disease deaths are from SCD." The proposed model addresses these gaps, potentially shifting the AAOCA field from uncertainty to clinical solutions. RINCH has filed a provisional application (63/502,524) for this technology. The inventors are planning additional refinement of the methodology and a clinical trial to validate the model in a prospective patient population. This technology is jointly owned with Georgia Institute of Technology.

TS-003438 — The Parent-Implemented Oral Nutrition, Eating and Esophageal Regulation (PIONEER) Products enhance development of oral-pharyngeal-esophageal motility in infants. This technology is a novel approach for training muscles in non-verbal patients, including neonates, infants, and individuals who have lost skills due to stroke, trauma, or developmental neuropathology. Unlike existing methods, these products stimulate muscles involved in esophageal peristalsis and airway protection without electrical stimulation. By engaging and pre-conditioning select muscles and nerves, the approach helps prevent developmental delays, cerebral palsy, and chronic eating and swallowing difficulties. Approximately half a million infants are admitted to NICUs in the USA annually, thus, the technology’s impact on infant feeding and airway issues could be significant. Potential applications range from diagnostic and therapeutic purposes to rehabilitative therapy for chronic tube-fed infants in Neonatal Intensive Care Units (NICUs) and post-discharge. RINCH has filed a patent application (PCT/US23/81696) and the inventor is continuing to conduct clinical investigations.

TS-003437 — According to the CDC, roughly 1.1 million COVID-19 cases have been reported in the past year, and 81.4% of the U.S. population have received the updated booster dose. This therapeutic agent utilizes the vesicular stomatitis virus (VSV) vector to protect against SARS-CoV-2 and its variants. This innovative approach resulted in heightened immunogenicity of the vaccines compared to currently available options. Specifically, the utilization of the prefusion Spike protein, stabilized with six prolines (preS-6P), component in the vaccine formulation demonstrates superior efficacy in eliciting a robust immune response. Two distinguishing features of this vaccine platform are the proposed intranasal administration and the live attenuated virus design, both of which induce robust mucosal immunity. In addition to the vaccine platform, the inventors used the platform to develop specific IgY antibodies to SARS-CoV-2 that might be used as a prophylactic, therapeutic or diagnostic antibody. This technology holds significant promise in the development of effective vaccines to combat SARS-CoV-2 and its variants long-term. RINCH has filed a provisional application (63/452,870) and the inventors continue to evaluate the efficacy of the vaccine candidates in animal models. This technology is jointly owned with The Ohio State University.

TS-003427 — The proposed cell phone application, currently in the pre-prototype stage, is designed to address the issue of Sudden Unexplained Infant Deaths (SUIDs). Tailored for parents, especially those with high-risk infants, the app integrates interactive features like safe sleep education, a daily checklist, and a secure photo submission mechanism for monitoring a baby’s safe sleep environment. There are devices on the market that parents can purchase, but they are not affordable or accessible. The proposed app would be a free alternative to the current expensive devices—with an incentivization feature for consistent household application following birthing center discharge. Beyond this, it serves as a tool to increase knowledge, instill safe sleep practices into caregivers’ daily routines, and directly shape safe behaviors. Aligned with Nationwide Children’s Hospital’s Safe Sleep Initiative taught in the Neonatal Intensive Care Unit (NICU), the app is not only educational, but also interactive, enhancing learning retainability. The device is marketable on a global scale, catering to every birthing center, NICU, and family worldwide. Emblazoned with the Nationwide Children’s logo, it sends a message that “Everyone Matters,” contributing to the publicization and awareness-building for Nationwide Children’s Hospital. In addition, the app aligns seamlessly with NCH’s inclusion and diversity initiatives by providing incentives, such as discount diapers and baby supplies, to all babies up to one year of age, irrespective of race, ethnicity, or gender identity. This comprehensive approach positions the app as not just a potential life-saving solution but also a valuable asset for companies interested in licensing products related to infant safety and well-being.

TS-003412 — 4,800 pediatric patients undergo tracheostomies annually in the U.S., with multiple caregivers throughout their lives requiring training in the appropriate care. Nationwide Children’s Hospital simulation professionals have developed an innovative Pediatric Tracheostomy Task Trainer model. The manikin offers advanced features for more hands-on training, replicating real-life experiences, including applications such as CPR training. Existing commercially available task trainers have limitations, and the new model addresses these issues. The portable trainer caters to a broad audience, including healthcare professionals and students with tracheostomy tubes. Key skills associated with the device cover suctioning (both open and closed techniques), stoma care, tracheostomy tie changes, and rescue breathing through tracheostomy/face, depending on insertion availability. Notable improvements include advanced airway management and haptic feedback. The developed prototype has undergone successful training sessions for hospital staff and caregivers at Nationwide Children’s Hospital. Additionally, a provisional patent application has been filed. We are actively seeking commercial partners to license this technology in the training manikin market, projected to reach $2.60 billion by 2028 with an 11.2% compound annual growth rate.

TS-002958 — Hip distraction, or arthrodiastasis, is a surgical option for end-stage diseases of the hip, such as Legg Calve Perthes disease, avascular necrosis, and end-stage osteoarthritis. The procedure improves mobility, decreases pain, and prevents further wear to avoid a total hip arthroplasty. However, the standard of care procedure requires an external device that uses large pins that are kept for 3-4 months which can be distressing for pediatric patients. NCH inventors have developed a completely internal hip-spanning device that allows for distraction and articulated hip motion. This device will likely reduce the problems associated with an external device such as infection, procedure failure, and psychosocial concerns.

TS-002957 — Available 3D spine models do not optimize properties to simulate real-life bones, ligaments, tendons, viscoelasticity, or resistance that is present in a patient. Spine models are used by both surgeons and researchers for surgical planning, simulation, training, research and medical device development. By optimizing 3D printing materials, NCH inventors can produce patient-specific spine models that replicate the viscoelastic properties of the spine for a more accurate rendition. In addition to precise surgical planning, another benefit of utilizing viscoelastic accurate models is further medical device innovation to optimize surgical outcomes.

TS-002302 — Acute myeloid leukemia (AML) causes myeloid cells to interfere with the production of healthy white blood cells, red blood cells and platelets; patients will experience fatigue, easy bruising, infections, etc. Due to expansion ex vivo with IL-15, AML patients and donors’ natural killer (NK) cells have an increase in glycogen synthase kinase 3 beta (GSK3β) from the loss of cytotoxicity and defective metabolism. Researchers at Nationwide Children’s Hospital targeted GSK3β in NK cells to promote antitumor activity by expanding NK cells with feeder cells expressing membrane-bound IL-21 without altering the GSK3β levels. They deleted GSK3β using the cas9/RNP and expanding paired-donor knock out and wild-type NK cells. When assessing transcriptional and functional alterations induced by the loss of GSK3β, GSK3β-KO cells demonstrated changes in gene expressions that suggested possible metabolic reprogramming and exhibited 150% higher spare respiratory capacity, a marker for metabolic fitness. By using mbIL21 expansion in the expansion of NK cells and GSK3β in these cells, the upregulation of GSK and drug inhibitors is prevented.

TS-002301 — CD38 regulates the metabolism and the immunomodulation of tumor microenvironments, making it an essential component to anti-cancer therapies. Researchers at Nationwide Children’s Hospital developed a novel technology using CD38 as a new insertion site for NK and T cells. They generated CAR-NK and CAR-T cells by integrating the DNA encoding CAR in the CD38 locus to enhance anti-tumor activity and improve metabolic function of NK and T cells. Additionally, this can be used in combination with CD38 monoclonal antibodies without risking fratricide.

TS-002300 — Hematologic cancers like leukemia, lymphoma and myeloma are found in 10% of adult cancer cases and 25% in pediatric cancer cases. Researchers at Nationwide Children’s Hospital’s Center for Childhood Cancer have developed a novel single-chain variable fragment (scFv) that targets and binds to CD38. The scFv can generate CD38 binding proteins, including chimeric antigen receptors (CAR), single-chain antibodies, multi-specific engagers, etc. Additionally, the single-chain variable fragments can be incorporated into polyfunctional proteins and have identical binding properties as CD38 antibodies which are used as anti-cancer therapeutics.

TS-002177 — Researchers at Nationwide Children's Hospital are in the process of developing an Adeno-Associated Virus (AAV) gene therapy for the Eukaryotic Initiation Factor 2B complex (EIF2B5) related Vanishing White Matter Disease (VWM), an inherited pediatric leukodystrophy disease resulting from autosomal recessive mutations in the five subunit genes of EIF2B5. VWM deteriorates the central nervous system’s white matter which affects the brain’s communication and function. Common symptoms include spasticity, ataxia, hypotonia, speech issues, dysphagia, vision and hearing impairments along with cognitive deficits. The research team is evaluating the CSF delivery of AAV serotype 9 that will target astrocytes which are central in VWM pathology in order to constitute potential therapeutic targets. The AAV vectors will provide wildtype copies of EIF2B5 to address the loss of function resultant from mutations.

TS-002176 — In order to effectively treat bacterial infections, a clear understanding of the bacterium’s antibiotic sensitivity is needed. Researchers at Nationwide Children’s Hospital’s Center for Microbial Pathogenesis created a new method to assist in prescribing antibiotics for infections caused by a biofilm to reduce the dosage and the length of antibiotic treatments.

TS-002175 — The third most common type of muscular dystrophy, Facioscapulohumeral Muscular Dystrophy (FSHD), affects over 870,000 individuals worldwide by causing debilitating pain, muscle weakness, fatigue along with many other symptoms in their face, shoulders, upper arms and lower legs. Researchers at Nationwide Children’s Hospital created a treatment using Salvianolic Acid (SAA) as a drug therapy for neuromuscular disorders including FSHD.

TS-002174 — Currently, no cure exists for Charcot-Marie tooth type 1B (CMT1B). Inventors and specialists in Gene Therapy at Nationwide Children’s Hospital invented a methodology along with sequences for using microRNAs (miRNA) to inhibit and replace abnormal expressions of the myelin protein zero (MPZ) gene. Affecting 1 in 30,000 people, CMT1B is caused by more than 200 mutations of the MPZ, the essential protein needed for a healthy and efficient peripheral nervous system. The accumulation of mutant MPZ genes will result in, but not limited to, muscle weakness, atrophy, lost of sensation in the lower legs and feet and sensory loss.

TS-002172 — Current myometers on the market provide inconsistent results, reducing their reliability. Lindsay Alfano, PT, DPT, PCS at Nationwide Children’s Hospital proposed the creation of a new system called Smart Myometry to limit variability and to make strength testing more reliable.

TS-002171 — Approximately 30% of children and adolescents experience chronic pain. Researcher, Vanessa Olbrecht, MD, at Nationwide Children’s Hospital developed the FOREVR VR, a device that aims to help patients learn how to regulate their nervous system by maintaining their breathing and heart rate variability.

TS-002170 — With the lack of replacement tissue for airway reconstruction, researchers at Nationwide Children’s Hospital developed the 3D Printed Tracheal Bioreactor for Partial Decellularization. Their new process, Partial Decellularization, treats allografts for tracheal replacement. During testing of small animal subjects, they found that allografts supported epithelial regeneration. They then 3D printed the Bioreactor for the translation and adaptation of Partial Decellularization to human-sized grafts. As a result, Partial Decellularization with the bioreactor simultaneously removed immunogenic cell types of the trachea while preserving the immunoprotected cartilage. This technology is easily accessible to medical centers who are interested. The creation and assembly of the Bioreactor through 3D printing allows it to be easily sealed, assembled and reduces the risks of contamination making it unlike any other bioreactor on the market.

TS-002169 — Existing models of Organ-on-a-Chip cost more to produce and have limited ability to functionally recapitulate human native tissues due to their limited incorporation of cell types. Researchers at Nationwide Children’s Hospital developed an improved model with their microfluidic Organ-on-a-chip fabrication based on 3D printing. This model optimizes and improves formulation of an extracellular matrix (ECM) that mimics the lamina propria (LP) to sustain the attachment and expansion of different cell types meaning this innovative model has cellular complexity that allows it to mimic human organs and replace animal models in various research settings.

TS-002168 — Children have a higher chance of morbidity and mortality from respiratory viral infections. Severe respiratory viral infections like Respiratory Syncytial Virus (RSV) and Parainfluenza viruses can lead to the development of asthma in patients. Clinical researchers at Nationwide Children’s Hospital found that neuregulin-1 (Nrg-1) may be an effective and protective treatment for patients diagnosed with severe respiratory viral infections. Their successful models with mice showed that Nrg-1 may prevent post-viral airway disease and reduce mortality if further studied and applied to human patients in the future.

TS-002167 — Research links increased expression of neuregulin-1 (NRG1) to neurological disorders (schizophrenia, bipolar disorder, autism spectrum disorder, epilepsy, etc.), cancers (breast, prostate, lung, gastric cancers), metabolic syndrome and multiple sclerosis. Researchers at Nationwide Children’s Hospital developed a treatment to manipulate mammalian gene expression with bacterial extracellular vesicles. This treatment based on outer membrane vesicles (OMV) modulates expression of NRG1 by using porphyromonas gingivalis (Pg) tRNA and NRG1 mRNA to reduce NRG1 translation. Pg and closely related pathogens produce OMVs that contain proteins, lipids, nucleic acids and cytosolic compounds. Through metagenomic sequencing, researchers found that Pg OMVs contain tRNA that complements mammalian NRG1 mRNA. They also found that the tRNA can potentially stop the translation of NRG1. This complementation indicates a direct interaction between Pg tRNA and NRG1 mRNA which results in the reduction of NRG1.

TS-002166 — Education and awareness about mental health increased the demand for better digital programs so health care professionals can reach patients outside the clinical setting. Researchers at Nationwide Children’s Hospital created a program that sends multimedia text messages to encourage positive thinking and to reduce chances of readmission to behavioral health hospitals.

TS-002165 — Children have higher self-esteem when their needs are supported, which includes hair care. In 2020, staff members reported their knowledge gaps and lack of confidence and supplies regarding patient hair care. As a result, the Hair Care Equity Project was created at Nationwide Children’s Hospital to combat these challenges and to create a more inclusive environment for patients through education and product research. The Hair Care Equity Committee worked with vendors and dermatologists to carefully select products for trials and final selection. Now, staff members can access and order supplies for patients with all hair types.

TS-002164 — Congenital heart defects (CHD) are the most common birth defects with an occurrence rate of 1 in every 110 births. When transferring from pediatric to adult care, one-third of adolescents are in optimal cardiovascular health. Due to this, health behavior intervention is ideal in adolescence. This is especially crucial when youths report using e-cigarettes or the possibility of using one in the future. Researcher, Kristen Fox, at Nationwide Children’s Hospital created a tailored mHealth Vaping Prevention program for adolescents with CHD to reduce engagement with health risk behaviors. The curriculum is improved with added topics surrounding stress management and disease knowledge with the implementation of gamification and animations to facilitate knowledge and sustain engagement about tobacco product education.

TS-002163 — Researchers and professionals beginning their careers in pediatrics and/or rare disease clinical research sites may feel overwhelmed in the face of innovation, new territories and lifechanging research. A team of Certified Clinical Research Professionals at Nationwide Children’s Hospital created three additional modules for the Clinical Research Onboarding Program – The Survival Guide and an opportunity to access a Gene Therapy Immersion Program. Through this reference manual, the team hopes to share lessons and provide guidance on working in pediatrics clinical research for all learners.

TS-002162 — Dr. Jonathon Gisser, a pediatric gastroenterologist at Nationwide Children’s Hospital, researched and created a process called Gastric Secretion Reinfusion (GSR) to help salvage gastric fluids by reinfusing them into the jejunum. Gastrojejunostomy (GJ) tubes cause increased vomiting and/or gastric drainage in patients due to gastric outlet obstruction. The small intestine needs gastric fluids to prevent dehydration, dysmotility, malabsorption, malnutrition, electrolyte imbalances and increased gastric output because they are rich in electrolytes, enzymes and hormones. Currently, gastric fluids are typically discarded and replaced by nutrient-impoverished, exogenous fluids like intravenous fluids (IV). By implementing the Gastric Secretion Reinfusion technique, patients will experience decreased incidences of electrolyte abnormalities, vomiting and reliance on parenteral access and Total Parenteral Nutrition (TPN). Additionally, they will also experience an increase in tolerance of jejunal feeds and improved nutrition.

TS-002161 — The Staffing Analysis Tool helps organizations track and plan for staffing in the future. Inventors at Nationwide Children’s Hospital developed this smart spreadsheet for workplaces to effectively see staffing levels easily and automatically through its real time updates. Users only need to input staffing needs and staff information into its built-in functions. Once completed, the Staffing Analysis Tool will comprise the information to create an overall picture of staffing insufficiencies including planned leaves, resignations and other challenges. With the final picture calculated, workplaces can always ensure effective staffing.

TS-002160 — Dysphagia affects 300,000 to 700,000 Americans every year. Individuals of any age can suffer with dysphagia which increases the demand for education and information. Providers working with individuals with dysphagia require easy, quick access to education and information regarding implementing the International Dysphagia Diet Standardization Initiative (IDDSI). Clinicians at Nationwide Children’s Hospital created the IDDSI Implementation Manual and Education. The manual provides healthcare providers with specific implementation steps, instructions and details to guide teams to successfully integrate IDDSI in their healthcare organization quickly along with additional supplemental educational materials.

TS-002159 — Currently, there is no standard protocol for observing patient readiness for recreational therapy. Inventors at Nationwide Children’s Hospital created the Therapeutic Recreation (TR) Leisure Engagement tool to document and assess the needs of patients with developmental or physical disabilities to promote well-being and recovery. Through this technology, therapeutic recreation specialists will further help patients by measuring their readiness for sessions, emotional presentation and social functions while providing leisure education.

TS-002095 — About 3 of every 100,000 births are affected by Batten disease, a disorder that prevents the body from removing cellular waste like lipids and proteins. The build up of cellular waste throughout the body can cause seizures, vision loss, delays in thinking, abnormal movements and death. Researchers at Nationwide Children’s Hospital created a new intrathecal gene therapy using Adeno-Associated viral vectors for Batten Disease caused by mutations in the CLN8 gene. They generated an Adeno-Associated viral vector serotype 9 (AAV9) that contains the human CLN8 cDNA driven by a promoter.