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Mauna Kea Technologies (MKEAY) is a global medical device company that specializes in optical biopsy. The company's flagship product, Cellvizio, provides real-time cellular imaging during endoscopic procedures, revolutionizing the way diseases are diagnosed and monitored. Mauna Kea Technologies has established itself as a leader in the field of in vivo cellular imaging, with a strong focus on research and development to drive innovation in the medical industry.

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On April 5, 2023, the Board of Directors of Mauna Kea Technologies (Euronext Paris: MKEA, OTCQX: MKEAY) proposed to transfer its share listing from the regulated market of Euronext Paris to the Euronext Growth Paris. This move aims to simplify operations and reduce listing costs while retaining market benefits. The transfer requires shareholder approval at the General Meeting on June 2, 2023. If approved, existing shares will be directly listed on Euronext Growth without issuing new shares, following accelerated procedures. The company's market capitalization is under €1 billion, and it meets the necessary eligibility criteria. The transfer may affect share liquidity and impose longer reporting timelines for financial statements, yet it allows flexibility in accounting standards. Notably, shareholder thresholds for disclosures will change after a three-year period.

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Mauna Kea Technologies (Euronext: MKEA) reported a substantial increase in revenues for Q1 2023, reaching €4,168k, a growth of 121% from the previous year. The surge in revenue was primarily driven by €2.8m recognized from licensing and technology fees from its joint venture with Tasly Pharmaceutical. However, excluding this, product sales dropped by 28% to €1,367k. Key highlights include a 39% decline in sales in the U.S. market, attributed to fewer systems sold, while consumables saw a 4% rise. Asia-Pacific revenues increased by 65%, reflecting growth outside of China. Total systems sold increased to 8, with 5 placed under pay-per-use programs. Despite the revenue boost, significant challenges remain, particularly in the U.S. market.

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Mauna Kea Technologies (MKEAY) reported 2022 sales of €7.5 million, a 3% decline from 2021, aligning with expectations. The company maintained a stable gross margin of 73%, despite global supply chain challenges. Operating losses were reduced by 26% to €9.06 million, showcasing progress from a reorganization in late 2021. Cash as of December 31, 2022, stood at €3.1 million, bolstered to €9.1 million by a €6 million payment from a joint venture with Tasly Pharmaceutical. The company's commitment to strategic partnerships and operational discipline suggests potential for future growth.

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Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) has announced that Portzamparc – Groupe BNP Paribas has initiated coverage of its stock, recommending a 'Buy' in its report titled: 'The emergence of a new model'. This development suggests a positive outlook for the company, particularly surrounding its Cellvizio® platform, which is used for in vivo cellular imaging across various medical specialties. Investors will be awaiting the upcoming financial results for the year 2022, scheduled for release on April 6, 2023, after market close.

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Mauna Kea Technologies (OTCQX: MKEAY) reported Q4 2022 sales of €2.7 million, matching expectations, while full-year sales totaled €7.5 million, down 3% from 2021. U.S. sales were stable at €4.2 million, despite a 60% reduction in sales personnel. A €6 million cash payment from a joint venture with Tasly was received in January 2023. Key growth was observed in EMEA, with a 289% increase in Q4 sales, offsetting declines in the Asia-Pacific region. The company’s cash position was €3.2 million at year-end, compared to €11.8 million in 2021, demonstrating a need for financial vigilance as they transition to the new partnership.

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Mauna Kea Technologies (OTCQX:MKEAY) announced its 2023 Financial Calendar, outlining key financial events for the year. Notable dates include:

  • Fourth Quarter and Fiscal Year 2022 Sales on January 26, 2023
  • 2022 Financial Results on April 6, 2023
  • First Quarter 2023 Sales on April 20, 2023
  • Annual General Meeting on June 2, 2023
  • Second Quarter and First Half 2023 Sales on July 20, 2023
  • 2023 Half-Year Financial Results on September 28, 2023
  • Third Quarter 2023 Sales on October 19, 2023

All dates are subject to modification, with press releases issued post market closes.

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Mauna Kea Technologies (MKEAY) announced the publication of results from a clinical study in Respirology, showcasing the effectiveness of Cellvizio in robotic-assisted bronchoscopy for diagnosing peripheral lung nodules. The study included 20 patients, demonstrating a diagnostic yield of 80%. Notably, nCLE imaging confirmed lung cancer in 94% of malignancies. No complications occurred, highlighting the safety of the procedure. CEO Sacha Loiseau emphasized the potential of adopting Cellvizio for improved lung cancer diagnoses.

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Mauna Kea Technologies reported financial results for H1 2022, highlighting a gross margin increase to 73%, up from 71% in H1 2021. Current operating losses decreased by 19% to €4,957K, with a net loss of €6,212K, an improvement from €6,691K in H1 2021. Total revenues reached €3,391K, up 2% year-over-year, despite a 4% decline compared to the prior year's first half. The company's cash position stood at €5.3 million as of June 30, 2022, amid a total long-term debt of €26.4 million.

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Tasly Mauna Kea Medical Engineering Technology Co. Ltd is expanding the reach of Cellvizio into China and launching a dedicated neurosurgical platform globally. This joint venture with Tasly Pharmaceutical Group includes a registered capital of RMB 250 million (EUR 35 million). Mauna Kea Technologies aims to leverage Tasly's commercial strength for market penetration. CEO Sacha Loiseau emphasized the significance of this milestone for achieving shared commercial ambitions with Tasly.

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Mauna Kea Technologies announced the successful results of the ERIca trial, demonstrating that Confocal Laser Endomicroscopy with Cellvizio is superior to traditional endoscopic methods in predicting long-term outcomes for Inflammatory Bowel Disease (IBD) patients. The study found that patients with confirmed barrier healing had significantly higher probabilities of MAO-free survival: 81% for ulcerative colitis and 70.4% for Crohn's disease. These findings, published in the journal Gastroenterology, could transform patient monitoring and treatment strategies.

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FAQ

What is Mauna Kea Technologies known for?

Mauna Kea Technologies is known for its expertise in optical biopsy and its flagship product, Cellvizio, which provides real-time cellular imaging during endoscopic procedures.

What is Cellvizio?

Cellvizio is a cutting-edge technology developed by Mauna Kea Technologies that allows for real-time cellular imaging, enabling improved diagnostic accuracy and monitoring of diseases.

What sets Mauna Kea Technologies apart in the medical device industry?

Mauna Kea Technologies stands out for its focus on in vivo cellular imaging, research, and development efforts to drive innovation in diagnosing and monitoring diseases.

How does Mauna Kea Technologies contribute to the medical field?

Mauna Kea Technologies contributes to the medical field by providing advanced optical biopsy solutions that improve diagnostic accuracy and patient outcomes, revolutionizing the way diseases are diagnosed and monitored.

What is Mauna Kea Technologies' mission?

Mauna Kea Technologies' mission is to enhance patient care by offering innovative optical biopsy solutions that enable real-time cellular imaging during endoscopic procedures, ultimately improving diagnostic accuracy and clinical outcomes.

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Surgical and Medical Instrument Manufacturing
Manufacturing
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France
Paris