Mauna Kea Technologies Announces the Publication of Results of the First in Human Clinical Study Combining Robotic-Assisted Bronchoscopy and Needle-Based Confocal Laser Endomicroscopy for Lung Cancer

Rhea-AI Summary

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.

Positive

• Published results support Cellvizio's effectiveness in robotic-assisted bronchoscopy.
• Achieved a diagnostic yield of 80% in lung nodule assessments.
• No complications reported during the clinical study, evidencing safety.
• High accuracy in confirming lung cancer diagnoses (94% for malignancies).

Negative

• None.

Results were published in Respirology and provide further evidence supporting Cellvizio as a key complementary technology to robotic-assisted bronchoscopy, potentially impacting patient management and improving outcomes in patients with lung cancer

PARIS & BOSTON--(BUSINESS WIRE)-- Regulatory News:

Mauna Kea Technologies (Euronext: MKEA) (Paris:MKEA) (OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces that the results of the first in human clinical study combining nCLE and robotic-assisted bronchoscopy (Clinicaltrials.gov: NCT04441749) have been published in the international peer-reviewed journal Respirology¹.

This clinical study, co-funded by the Lung Cancer Initiative at Johnson & Johnson², combines needle-based confocal laser endomicroscopy and robotic-assisted bronchoscopy using both Cellvizio® and the Monarch™ Platform from Ethicon³ for the diagnosis of peripheral lung nodules.

Twenty patients with a median lung nodule size of 14.5mm (range 8-28mm) were enrolled. This study demonstrated that robotic-assisted bronchoscopic nCLE-imaging in small peripheral lung lesions is feasible and safe and provides real-time feedback on correct needle positioning. Bronchoscopic nCLE-imaging provided tool-in-nodule confirmation in 19 of 20 patients (95%) whereas corresponding rapid on-site evaluation (ROSE) confirmed representative material in only 9 of 20 patients (45%) and no complications were reported during the study. With nCLE real-time in vivo cellular imaging feedback, the needle was repositioned in 45% of the patients (9/20 patients) to reach a diagnostic yield across all nodule sizes and locations of 80%. Of the 17 patients with malignancy, 16 (94%) had the final diagnosis of lung cancer confirmed by nCLE imaging, including two patients with negative TBNA and biopsies. Blinded raters accurately and consistently distinguished malignant nCLE videos from airway/lung parenchyma.

Christopher Manley, M.D., Director of Interventional Pulmonology, Medical Director of Research and Development Alliances, and Associate Professor of Medicine at Fox Chase Cancer Center in Philadelphia, Pennsylvania, the principal investigator of this study, commented on the results: “This was a collaborative effort between Fox Chase Cancer Center and Amsterdam UMC. Our study combined the dexterity of robotic assisted bronchoscopy and nCLE with real-time in vivo cellular imaging feedback to precisely target small lung lesions. Our data show the potential of robotic bronchoscopic nCLE-imaging as a safe, improved strategy to diagnose small difficult-to-access lung nodules.”

“These results support the potential of nCLE to reduce the current near-miss rate, improve diagnostic yield and avoid false negatives during bronchoscopic evaluations of lung nodules. We look forward to broadening the adoption of Cellvizio in the Interventional Pulmonology community,” said Sacha Loiseau, Ph.D., Chief Executive Officer of Mauna Kea Technologies.

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit www.maunakeatech.com.

Disclaimer

This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Techonologies' financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described in Chapter 3 of Mauna Kea Technologies' 2021 Universal Registration Document filed with the Autorité des marchés financiers (AMF) on October 18, 2022 under number D-22-0773, which is available on the Company's website (www.maunakeatech.fr), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.

¹ DOI: 10.1111/resp.14438 https://doi.org/10.1111/resp.14438
² The legal entity of the Lung Cancer Initiative at Johnson & Johnson is Johnson & Johnson Enterprise Innovation Inc.
³ Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230112005627/en/

NewCap - Investor Relations

Thomas Grojean

+33 (0)1 44 71 94 94

maunakea@newcap.eu

Source: Mauna Kea Technologies

FAQ

What are the results of the latest clinical study for MKEAY?

The study demonstrated an 80% diagnostic yield using Cellvizio in robotic-assisted bronchoscopy.

How many patients were involved in the MKEAY clinical study?

The study enrolled 20 patients with peripheral lung nodules.

What journal published the MKEAY study results?

The results were published in the peer-reviewed journal Respirology.

What is the significance of the MKEAY study findings for lung cancer diagnostics?

The findings indicate that Cellvizio can significantly enhance diagnostic accuracy and reduce false negatives.

What potential future steps are indicated for MKEAY following the study results?

The company aims to broaden the adoption of Cellvizio technology in the interventional pulmonology community.