Mauna Kea Technologies (MKEAY) reported a 22% increase in total revenue for H1 2021, reaching €3.9 million. Sales also rose by 58% year-over-year to €3.3 million. However, the company faced a current operating loss of €6.1 million, slightly improved from €6.2 million in H1 2020. Net loss remained flat at €6.7 million. As of June 30, 2021, cash stood at €3.4 million against total debt of €28.2 million. Notable highlights included FDA clearance for the next-generation Cellvizio platform and a new collaboration with Johnson & Johnson's Lung Cancer Initiative.
Mauna Kea Technologies has announced a share capital increase of approximately €12.5 million, aimed at strategic growth including the expansion of its Cellvizio® platform. The investment is backed by notable shareholders including Johnson & Johnson Innovation and Armistice Capital Master Fund. The company plans to use about €11.5 million of the net proceeds for the development of Cellvizio®, clinical studies, and marketing efforts in the U.S. Following this transaction, shareholders may face dilution, with holdings potentially decreasing by 25% if they do not participate in the offering.
Mauna Kea Technologies (MKEAY) has entered into a research collaboration with the Lung Cancer Initiative at Johnson & Johnson to validate its Cellvizio as a real-time biopsy guidance tool during robotic-assisted bronchoscopy. The prospective, multi-center clinical feasibility study will assess Cellvizio's capability in diagnosing peripheral lung nodules, funded by LCI at €978,375, contingent on certain milestones. Additionally, LCI received a right of first refusal for future transactions regarding Mauna Kea's nCLE variant related to lung applications. This collaboration aims to reduce the near-miss rate of lung cancer diagnosis.
Mauna Kea Technologies has received FDA 510(k) clearance for its next-generation Cellvizio® platform, allowing it to visualize blood flow in microvasculature using fluorescein dye. This marks the 19th FDA clearance for the platform, which enhances cellular imaging across gastroenterology, pulmonology, and urology. The new system features improved connectivity, AI capabilities for pattern recognition, and a compact design. The formal commercial launch is set to coincide with presentations at major medical conferences in September 2023.