Commercialization – Innovation Pilot Awardees

C-Lift: A Smart and Equitable Approach to Sleep-Disordered Breathing

$25,000 Awardee

Team: William W. Clark, PhD, A Murat Kaynar, MD (PI), Kirill Kiselyov, PhD (Co-PI), Sanjay Patel, MD

Abstract: Sleep-disordered breathing (SDB), manifesting as snoring and sleep apnea, causes daytime sleepiness, anxiety, and cardiovascular complications, affects 25% of the population, and costs the US economy over $400B yearly. SDB is predominantly treated using continuous positive airway pressure (CPAP) devices. US CPAP sales (including consumables) exceeded $8 billion in 2021. However, CPAP is uncomfortable to many people, compliance is ~50% in general and under 20% in some populations. Therefore, such low compliance rates require new approaches to SDB as a matter of equitable health. C-lift is an SDB device that uses a set of pneumatically actuated, computer-controlled bellows inside a neck pillow, to imitate a medical maneuver called chin-lift head-tilt. C-lift monitors the patient’s breathing and measures blood oxygen saturation and head position; in response to apnea/hypopnea events, C-lift inflates individual bellows to gently adjust the head position until breathing is normalized. C-lift does not require uncomfortable masks and immediately responds to the individual patient’s needs.

Microneedle Array Metal Organic Framework Vaccine Biocomposites

$25,000 Awardee

Team: Emrullah Korkmaz, PhD (PI), Nathaniel Rosi, PhD (Co-PI), Louis D. Falo, Jr, MD, PhD

Abstract: The overarching goal of this project is to develop a next-generation vaccine technology that will bring significant advantages over current vaccine platforms and delivery systems to address the existing bottlenecks in the vaccine supply chain. We propose to engineer and validate clinically translatable microneedle array (MNA)-metal-organic framework (MOF)-vaccine (VAX) biocomposites as a universal vaccine technology that will transform the state-of-the-art of immunization against infectious pathogens. MNA-MOF-VAX biocomposites will constitute a versatile single-unit combination product that will be applicable to vaccine antigen constructs and immune adjuvants for the development of innovative, self-administered, needle free skin-targeted vaccines. MNA-MOF-VAX biocomposites will retain key benefits of existing MNA platforms (including our own previously patented dissolvable MNAs) over conventional needle-and-syringe vaccines, while providing significant delivery, immunogenicity, and stability advantages compared to existing vaccine-loaded MNA platforms via multifaceted MOFs that will biomineralize vaccine components in biodegradable nanoscale frameworks. The objective of this project is to demonstrate a successful proof of concept of MNA-MOF-VAX biocomposites with a biodegradable class of MOFs, zeolitic imidazolate frameworks-8 (ZIF-8), and with different vaccine antigen constructs (subunit protein, mRNA, and recombinant viral vector) as effective, safe, and broadly deployable skin-targeted vaccines. The expected outcome of this project will be in vivo demonstration of the superior vaccine delivery characteristics, immunogenicity, and stability of MNA-ZIF-8-VAX biocomposites compared to vaccine-loaded dissolvable MNAs, providing strong supporting data for the development and commercialization of MNA-MOF-VAX platform. MNAZIF-8-VAX biocomposites will enable effective, sustainable, and equitable global vaccination campaigns against infectious diseases, facilitating dual market use in both high-income and low-and-middle-income countries.

DNA-Patterned Antibacterial Plastics

$25,000 Awardee

Team: Haitao Liu, PhD (PI)

Abstract: This proposal will develop a low-cost approach to create nanoscale patterns on mass- produced plastic products. Our approach is to deposit DNA nanostructures, which can be made into arbitrary shapes, onto large substrates and use them as template for nanoimprinting during plastic injection molding and/or roll-to-roll printing. The target application of our technology is large scale nanoimprinting of plastic products, specifically, bacteria-resistant consumer products and medical consumables. Success of this project will provide key results for a future SBIR/STTR proposal. The long-term objective of this project is to develop a low-cost method to create designer nanoscale features on the surface of plastic products. These nanoscale features will bring desirable surface properties, including but not limited to bacteria-resistance, stain resistance, and water repellency, to the plastic products. Our overall approach is to use DNA nanostructure as nanoscale mold to imprint such features. The following specific aims will address key gaps in technology development and demonstrate the proof of concept. Success of these two aims will provide key results for a future SBIR/STTR proposal.

Fusion Gene Technology for Diagnosis and Immunological Targeting

$25,000 Awardee

Team: Jianhua Luo, MD, PhD (PI), Yanping Yu, MD, PhD

Abstract: Liver cancer is one of the human malignancies with the highest mortality. Early detection and treatment of hepatocellular carcinoma (HCC) may procure up to 92% long-term survival because of the availability of several surgical interventions such as tumor resection or liver transplant. In contrast, the median survival time for advanced-stage HCC is only 12 months. As a result, early detection of liver cancer is urgently needed to reduce the mortality of this disease. Recently, we identified a panel of fusion genes in HCC. Most of these fusion genes are detected in the serum samples of HCC patients. Among these fusion genes, MAN2A1-FER was found to be present in a large number of HCC cancer samples. MAN2A1-FER replaces the C-terminus glycolytic hydrolase domain of MAN2A1 with an intact tyrosine kinase domain from FER while leaving the N-terminus glycosyl hydrolase domain unscathed. Expression of MAN2A1-FER was highly oncogenic in animals. MAN2A1-FER phosphorylates the extracellular domains of several membrane proteins, including PDGFR, to drive cancer development. One of the phosphorylation sites generated by MAN2A1-FER kinase activity is phosphotyrosine 288 (pY288) in the extracellular domain of PDGFRA. We recently developed a monoclonal antibody specific for pY288 of PDGFRA. This antibody blocked multiple signaling activations induced by MAN2A1-FER and induced cancer cell apoptosis. Based on these findings, we propose to 1) Determine whether serum fusion transcript detection enables early detection of HCC; And 2) determine whether monoclonal antibody against pY288 of PDGFRA is effective in treating liver cancer.

The Endoureteral Ostoplasty Stapler (EOS): Simplifying the Surgical Management of Ureteropelvic Junction Obstruction (UPJO) in Children with a Novel Instrument

$25,000 Awardee

Team: Michael C. Ost, MD (PI), Ulka Sachdev, MD, Anish Ghodadra, MD

Abstract: Ureteropelvic junction obstruction (UPJO) is the most common cause of obstructing hydronephrosis in children. In this congenital condition, aberrant ureteral development in utero leads to a narrowed and stenotic segment of proximal ureter. Ureteral obstruction is detrimental to kidney development if not remedied. Robotic Pyeloplasty is the mainstay surgical treatment; although successful, the procedure is costly, lengthy, and requires a hospital admission. This proposal describes novel IP in the development of a low-profile, catheter-based surgical stapler to definitively and efficiently treat UPJO endoscopically as a low-cost ambulatory procedure. The proposed Endoureteral Ostoplasty Stapler (EOS) is delivered to the ureter cystoscopically and positioned over a wire, across the UPJO in minutes. Under fluoroscopic guidance the EOS dilates the UPJO, excludes the stenotic segment, and staples healthy ureteral ends together to recreate a patent lumen. The design combines an “end-to-end” stapler used in intestinal surgery, and the “over-the-wire” capabilities of catheter-based devices in cardiology and vascular surgery. Using funds from this award, the prototype EOS will be created with 3-D printing, allowing for ex-vivo experimentation, modification, and scalability. There is no existing competitive product to treat primary congenital UPJO via endoluminal access. The EOS is a novel concept in UPJO treatment. We approximate the annual demand for EOS at scale would be 2,625 Units approximating a revenue of $3.9 million while decreasing the health care burden to treat UPJO by tens of millions of dollars annually.

A Real-Time Method for Nuclear Medicine Imaging

$25,000 Awardee

Team: Shandong Wu, PhD (PI), Nghi Nguyen, MD, PhD

Abstract: We invented a method and apparatus of automated, real-time tracking of radioactivity and calculation of organ functions in various nuclear medicine procedures for real-time data assessments and interventions to nuclear imaging procedures. The invention seeks to shorten the scan time by providing real-time evaluation of organ functions and aiding the imaging technologists in the decision making to stop or continue the scan, dependent on the individual clinical scenario. The invented workflow involves an artificial intelligence (AI)-enabled computational pipeline that combines computer vision, imaging processing, machine learning, and organ function calculation, which has not been utilized in current nuclear medicine practice. This method allows for instantaneous feedback to technologists and radiologists as well as to provide immediate imaging results while the patient is being scanned, as opposed to the current rigid, one-size-fits-all approach. This novel workflow enables real-time data analyses at an individual level, which is diagnostically interchangeable with existing workflows and can drastically improve procedure efficiency in terms of scan time and patient experience.