BioLargo made progress on multiple fronts during Q3 and subsequently toward becoming a fully fledged, diversified technology company. First, it announced that Clyra had received feedback from the FDA regarding the data necessary to complete the 510(k) application process, which should be finished in the next six months. Second, the company broke revenue records in October with BioLargo Engineering, Science & Technologies (BLEST) having its first break-even month. Finally, progress continues toward the 2019 launch of the AOS with the independent validation of the system’s capacity to eliminate micropollutants.
Already over the $1m sales hurdle for 2018
The company announced shortly after its earnings release in November 2018 that it had surpassed $1m in revenue for the year to date, in line with previous guidance. Revenue reported for Q3 was slightly down sequentially ($277,026 from $326,738), although this likely represents some lumpiness, as October subsequently broke records: the highest single month revenue for Odor-No-More revenue ($133,000), and BLEST ($89,000). Additionally, the company noted that BLEST revenue exceeded costs for the first time. The company noted that it plans to hire additional salespeople to support continued growth in 2019.
510(k) process moving forward for Clyra
The company provided an update on the regulatory process for its wound care product developed by Clyra. It previously initiated a 510(k) application with the FDA in June, which should allow for an expedited path to market. The most recent update confirmed that the FDA has asked for feedback on labelling and systemic toxicity to advance the process. The latter will require an animal study, which the company will engage a third party to perform. It believes that the process should be completed in the following six months.
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