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Mauna Kea Technologies (MKEAY) drives innovation in real-time cellular imaging through its flagship Cellvizio platform, transforming endoscopic diagnostics worldwide. This page aggregates essential updates about the company's medical advancements, regulatory progress, and strategic partnerships.
Investors and healthcare professionals will find curated press releases covering clinical trial results, FDA clearances, and technology deployments. Track developments in optical biopsy applications across gastroenterology, pulmonology, and urology specialties.
Key updates include quarterly financial disclosures, research collaborations with leading medical institutions, and international market entries. All content is sourced directly from company filings and verified industry publications.
Bookmark this page for streamlined access to MKEAY's latest milestones in medical imaging technology. Check back regularly for objective reporting on innovations that shape modern diagnostic practices.
Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) reported a 5% decline in total revenues to €4.8 million for the first nine months of 2022. U.S. sales grew by 23%, though Q3 sales dipped 20% year-on-year. Sales by category showed a significant 58% drop in systems, while consumables and services rose 8% and 17%, respectively. The U.S. faced a fluorescein shortage affecting procedures, but recovery is anticipated. The company aims to enhance efficiency and capitalize on growth opportunities moving forward.
Mauna Kea Technologies has appointed Sacha Loiseau, its Founder and current Chairman, as the new Chief Executive Officer, effective immediately. He replaces interim CEO Nicolas Bouvier and will hold both roles concurrently. The Board believes Loiseau's expertise will help the company capitalize on the commercial potential of its Cellvizio platform. Mauna Kea is focused on enhancing its partnerships in the medical field, aiming to provide significant clinical value globally. Loiseau has a rich history with the company, having led it for over 18 years and taking it public in 2011.
Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) has postponed its 2022 Half-Year Results release from September 22, 2022, to no later than October 31, 2022. This delay is due to the allocation of management resources towards implementing a joint venture with Tasly Pharmaceutical. The company will announce a new financial calendar shortly.
Mauna Kea Technologies develops Cellvizio®, a platform for real-time in vivo cell imaging, which is crucial for disease monitoring and surgical guidance.
The study published in the European Journal of Nuclear Medicine and Molecular Imaging showcases a high diagnostic accuracy for lung cancer using a combination of On Target Laboratories' CYTALUX™ and Mauna Kea's Cellvizio® system. Conducted by the University of Pennsylvania, the ex vivo study on 20 patients revealed a sensitivity of 98% and specificity of 97% in detecting malignancy in small pulmonary nodules. This innovative approach may enhance real-time cancer cell detection during biopsies, potentially improving diagnostic yields for early-stage lung cancer, which remains a significant global health challenge.
Mauna Kea Technologies (MKEAY) reported a 2% increase in 1H 2022 revenues to €3,397K. U.S. sales grew 35% year-on-year, but overall sales declined 13% in Q2 due to a drop in systems sales (-42%). Consumables experienced a 10% decline, partly due to a fluorescein shortage. The company is shifting focus towards strategic partnerships, exemplified by a joint venture with Tasly Pharmaceuticals. The next financial release is scheduled for September 22, 2022.
Mauna Kea Technologies announces a joint venture with Tasly Pharmaceuticals to develop, manufacture, and commercialize Cellvizio in China, as well as globally in neurology and neurosurgery. Mauna Kea will hold a 44% equity interest and receive $10 million in cash payments, along with purchasing commitments for five years. This partnership aims to enhance market access and leverage each partner's strengths in the medical field, while accelerating Mauna Kea's strategic repositioning efforts.
Mauna Kea Technologies (OTCQX:MKEAY) announced the publication of a meta-analysis in Techniques and Innovations in Gastrointestinal Endoscopy, highlighting the efficacy of its Cellvizio device in detecting neoplasia in patients with Barrett’s esophagus. The study revealed a 243% increase in neoplasia detection rates when using Cellvizio alongside standard biopsies. Furthermore, it indicated a reduction in overall healthcare utilization, with significantly fewer endoscopic procedures needed. This positions Cellvizio as a revolutionary tool in combating the rising rates of esophageal cancer.
Mauna Kea Technologies and On Target Laboratories announced a study published in Nature Communications showcasing a new molecular imaging agent, CYTALUX™, paired with the Cellvizio® platform for enhanced lung cancer detection during biopsies.
The study demonstrated 100% sensitivity and 92% specificity in identifying cancerous cells, even in challenging cases like ground glass opacities. This approach aims to improve diagnostic accuracy in pulmonary nodule assessments, potentially revolutionizing lung cancer diagnostics.
Mauna Kea Technologies (OTCQX:MKEAY) reported its 2021 financial results, revealing a revenue increase to €7,700K, up 18% year-on-year. The gross margin improved to 74.2%, compared to 67.1% in 2020, primarily due to a favorable sales mix. Operating losses were reduced by €632K to €11,327K, while net loss decreased by €654K to €13,445K. As of year-end 2021, cash stood at €11.8 million against long-term debt of €26.9 million. In Q1 2022, sales rose 20% to €1,886K, boosted by a 115% increase in U.S. sales, despite challenges in Asia due to COVID-19.
Mauna Kea Technologies has achieved a significant milestone by obtaining U.S. FDA 510(k) clearance for its Cellvizio 100 Series platform. This clearance allows the use of Cellvizio with the molecular imaging agent Pafolacianine (CYTALUX™) and ICG for real-time imaging during minimally invasive procedures. It introduces a new category, Molecular Image-guided Procedures (MIP), aimed at enhancing diagnostic accuracy for lung biopsies, potentially reducing complications. This marks Mauna Kea’s 20th FDA clearance for the Cellvizio platform.
