HelioWave Technologies Inc.

HelioWave Technologies is an early-stage biotechnology start-up company that is leveraging innovations in microfluidics from Texas A&M University to revolutionize microbial contaminant testing in the pharmaceutical and biomanufacturing industries. To address these limitations from the conventional sterility testing pipeline, HelioWave has developed a line of sterility and bioburden testing device, that incorporates the latest innovations in our electronic-based cell manipulation and detection using label-free sensing techniques to dramatically lower the cost, increase the speed, improve the scalability, enhance the accuracy, and introduce automation to the sterility testing market. Primary target markets include vaccine and therapeutic manufacturing, targeted and emerging therapy manufacturing, and QC/QA of reagents products, with direct adjacencies in the food/beverage, hygiene, and cosmetic industries.

Primary vaccine and therapeutic manufacturing is typically conducted in a batch-process manner where final products are tested prior to release. Due to bottlenecks in sterility testing for product clearance, often times manufacturers do not know if their products being produced are contaminated in real-time, leading to the potential for the disposal of millions of dollars worth of contaminated products. Furthermore, decentralized manufacturing facilities for emerging therapeutic modalities (i.e., autologous cell therapies and oligonucleotide-based therapies) are becoming increasing prevalent as new ways to provide quality, targeted, and economical health care for the public. These new and emerging technology approaches have more constrained product release deadlines, more complex contamination cases, and entail complex product matrices, making standard testing difficult, time consuming, or error prone. Therefore an automated, robust, universal, rapid, and high resolution solution offers the most ideal case to ensure the quality assurance of emerging therapies in a scalable fashion.

DARPA SBIR Phase I/II/II Option (2021-present) NIH SBIR Phase I (2022-present) Jlabs Incubator Company (2024-present) Capital Factory Portfolio Company (2024 - present) HHS/BARDA BlueKnight Program (2024 - present) BD Engagement (Moderna, J&J, Mayo, BMS, Matica, FujiFilm, Pluri, Genevant) TNVC Pitch Competition BVEDC AWARD $10,000 (2021) Aggie Pitch Finalist $5,000 (2021) Aggie Growth Hacks Podcast (2021)