Mauna Kea Technologies announces the first FDA 510 (k) clearance to use Cellvizio in a new class of molecular imaging guided endoscope, laparoscopic, and needle procedures.

Achieving key regulatory milestones in molecular imaging and precision medicine as part of ongoing collaboration

Paris & Boston – (Business Wire) – Regulatory News:

Mauna Kea Technologies (Euronext: MKEA) (Paris: MKEA) (OTCQX: MKEAY) The inventor of Cellvizio®, an interdisciplinary mini-probe and needle-based confocal laser scanning (p / nCLE) platform, today visualized. US FDA (K220477) on the use of this type of first Cellvizio 100 series platform with molecular markers for live In real time during endoscopic, laparoscopic and needle surgery.

This approval from the US FDA relates to a new clinical indication for the use of Cellvizio in fluorescence imaging of targeted tissues of the molecular marker Pafolacianin, sold under the name CYTALUX ™ and manufactured by On Target Laboratories. Administration method. In addition, the approval includes new clinical indications for the use of Cellvizio for fluorescence imaging and visualization of ICG (indocyanine green), either intravenously or interstitial, depending on the approved method of administration of ICG. It will be. The 510 (k) contains all Cellvizio ™ confocal miniprobes for all approved clinical indications.

Molecular ImageGuided Procedures (MIP), a new area of ​​medical procedure accessed by this new authorization, provides Cellvizio with the unique clinical ability to visualize the tissues to which molecular drugs bind, providing real-time vision of cancer in cells. Level during minimally invasive surgery. Using MIP during a bronchoscopic lung biopsy can improve the diagnostic accuracy of the biopsy, while reducing the number of procedures and the time and complications associated with obtaining a diagnosis.

“Tools for diagnosing and treating lung cancer have evolved over the past few decades, but the need to improve the rate of patient care after the discovery of lung nodules is such that cancer is addressed earlier. Is still very important, “says Nicholas Bouvier. , Interim CEO of MaunaKea Technologies. “This approval represents a major step forward in the collaboration between on-target and Mauna Kea to address critical unmet needs in interventional pulmonology and lung cancer. In addition, it represents interventional pulmonology and potential in particular. In other indications, it opens the door to a profound transformation of precision medicine. »»

This approval represents 20th 510 (k) approval for Mauna Kea’s Cellvizio® p / n CLE platform. This reflects Mauna Kea’s collaboration with the US FDA to develop a unique indication for Servigio. A ship and its organization or architecture. Imaging of blood flow in vascular areas including microvasculature and capillaries; Cellvizio’s infrared model provides fluorescence angiography and lymphatic system visualization. This includes fluorescent imaging of lymph vessels and lymph nodes using ICG and tissues that have absorbed CYTALUX molecules.

This latest authorization also reflects the success of the US FDA in some 21 implementations.st The Century Cures Act facilitates the provision of safe and effective device / drug combinations to healthcare professionals to improve patient care.

About lung cancer

Lung cancer is the leading cause of cancer deaths worldwide, killing more than 1.8 million people each year, more than the combined number of colorectal, breast and prostate cancers.Despite significant advances in diagnostic technology, its diagnosis remains difficult 1.. The number of lung nodules identified by chest CT scans continues to grow, and it is estimated that lung nodules were identified in approximately 1.6 million people who underwent a chest CT scan in 2015 in the United States alone.2.. Determining whether a suspicious lung nodule is malignant or benign remains difficult and time-consuming, often requiring multiple biopsy attempts and / or invasive procedures and is decisive. It can lead to results and complications. The growing field of molecular imaging aims to improve the detection of cancer cells through easier and more accurate visualizations.

About MaunaKea Technologies

Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, a real-time in vivo cellular imaging platform. This technology provides unique in vivo cell visualization that allows physicians to monitor disease progression over time, assess the reactions that occur, classify uncertain areas, and guide surgical interventions. Offers. The Cellvizio platform is used by many countries and several specialists around the world to transform the way physicians diagnose and treat patients. For more information, please visit www.maunakeatech.com.

caveat

This press release contains forward-looking statements about MaunaKea Technologies and its businesses. All statements other than historical facts contained in this press release include, but are limited to, the financial position, business, strategy, plans and objectives of Mauna Care Technologies’ management for future transactions. It will not be. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, it is set forth in these forward-looking statements subject to many risks and uncertainties, including those described in Chapter 3 of the Mauna Kea Technologies 2020 Universal Registration Document submitted to Autorité. We cannot guarantee the realization of the forecasts that are being made. Amendments to the desmarchés financiers (AMF) number D-21-0566 dated June 17, 2021 and the universal registration document submitted to AMF on September 17, 2021. Both are available on our website (www.maunakeatech.fr). ), As well as the risks associated with changing economic conditions, financial markets, and the markets in which Mauna Kea Technologies resides. The forward-looking statements contained in this press release also expose risks that Mauna Kea Technologies does not know about or that Mauna Kea Technologies does not consider materiality at this time. The realization of all or part of these risks is significant as a result of Mauna Kea Technologies’ actual results, financial condition, performance or performance being shown in these forward-looking statements, financial condition, performance or performance. Can lead to different things. This press release and the information contained therein do not constitute an offer to sell or subscribe, and an order to purchase or subscribe to shares of MaunaKea Technologies in a jurisdiction where such offer, solicitation, or sale is previously illegal. It does not constitute a solicitation for. Registration or qualification under the securities law of such jurisdiction. Distribution of this press release may be restricted by local law in some jurisdictions. The person who owns this document is responsible for complying with all local regulations that apply to this document.


1 International Agency for Research on Cancer, World Health Organization. Cancer Fact Sheet: All Cancers. http://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf. Accessed in May 2020.

2 Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE Recent trends in the identification of accidental lung nodules. This is J Respir Crit Care Med. November 15, 2015; 192 (10): 1208-14. Doi: 10.1164 / rccm.201505-0990 OC. PMID: 26214244.

contact address

Public relations activities for investors

NewCap – Financial Communication

Thomas Grojan

+33 (0) 1 44 71 94 94

[email protected]