HelioWave Technologies Inc.

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.

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