Mauna Kea Technologies Announces First U.S. FDA 510(k) Clearance for Use of Cellvizio in a New Class of Molecular Image-Guided Endoscopic, Laparoscopic and Needle Procedures

PARIS & BOSTON–(BUSINESS WIRE)–Regulatory news:

Mauna Kea Technologies (Euronext: MKEA, “Mauna Kea”) inventor of Cellvizio®, the multidisciplinary probe and needle confocal laser endomicroscopy (p/nCLE) platform, today announced a new 510(k) clearance from the US FDA (K220477) for the use of the Cellvizio 100 Series platform with a molecular imaging agent, the first of its kind, for the live visualization during endoscopic, laparoscopic and needle procedures.

This US FDA clearance is for a new clinical indication for the use of Cellvizio to perform fluorescence imaging of tissues that have absorbed the drug Pafolacianin, marketed under the trade name CYTALUX™ and manufactured by On Target Laboratories, in accordance to its approved use and administration labeling. Additionally, the authorization includes a new clinical indication for the use of Cellvizio to perform fluorescence imaging and visualization of ICG (indocyanine green), intravenously or interstitially, in accordance with labeling. for use and administration approved by the ICG. The 510(k) includes all Cellvizio™ confocal miniprobes for all approved clinical indications.

The pioneering category of medical procedures expanded through this new clearance – Molecular Image-Guided Procedures (MIP) – is designed to provide Cellvizio with the unique clinical ability to visualize the tissues to which molecular agents bind, enabling the possibility real-time visualization of cancer at the cellular level during minimally invasive procedures. The use of MIP during bronchoscopic lung biopsy can improve the diagnostic accuracy of biopsies while reducing the number of procedures, time, and complications associated with obtaining a diagnosis.

“Although the suite of tools to diagnose and treat lung cancer has evolved over the past few decades, there remains a significant unmet need to improve the speed and accuracy with which patients can be staged and treated after detection of a pulmonary nodule,” said Nicolas Bouvier, Interim Chairman and CEO of Mauna Kea Technologies. “It is important to note that this clearance represents a major step forward in the collaboration between On Target Laboratories and Mauna Kea to address significant unmet needs in interventional pulmonology and lung cancer. Moreover, it opens the door to a transformational change in the application of precision medicine to interventional pulmonology and potentially to other indications as well.

Authorization represents 20 years of Mauna Keaand US FDA 510(k) for the Cellvizio® p/nCLE platform and reflects Mauna Kea Technologies’ ongoing work with the US FDA to build a unique range of indications for Cellvizio: imaging of internal tissue microstructure including, but not limited to, the identification of cells, vessels and their organization or architecture; imaging of blood flow in vascular areas, including microvasculature and capillaries; and for the near-infrared version of the Cellvizio, fluorescence angiography and visualization of the lymphatic system, including lymphatic vessels and lymph nodes with ICG and fluorescence imaging of tissues that have absorbed the drug CYTALUX.

This latest clearance also reflects the US FDA’s success in implementing parts of the 21st Century Cures Act and thereby facilitating the availability of safe and effective device/drug combination products for healthcare professionals to improve patient care.

About lung cancer

Lung cancer is the leading cause of cancer death worldwide, claiming more than 1.8 million lives each year, more than colorectal, breast and prostate cancers combined1. Its diagnosis remains difficult, despite significant advances in diagnostic and treatment technologies. The number of lung nodules identified on chest CT scans continues to rise with a study estimating that in the United States alone, nearly 1.6 million people who had a chest CT scan had a lung nodule identified2. Determining whether a suspected lung nodule is malignant or benign can be difficult and time-consuming, often requiring multiple biopsy attempts and/or invasive procedures that can lead to inconclusive results and complications. The rapidly growing field of molecular imaging aims to improve cancer cell detection through easier and more accurate visualization.

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 provides in vivo cellular visualization that allows physicians to monitor disease progression over time, assess punctual reactions as they occur in real time, classify undetermined areas of concern and to guide surgical interventions. The Cellvizio platform is used globally in a wide range of medical specialties and is bringing a step change in the way doctors diagnose and treat patients. For more information, visit www.maunakeatech.com.

Warning

Mauna Kea Technologies

This press release contains forward-looking statements regarding Mauna Kea Technologies and its business. All statements other than statements of historical facts included in this press release, including, without limitation, those regarding Mauna Kea Technologies’ financial condition, business, strategies, plans and management objectives for future transactions, are forward-looking statements. These forward-looking statements are based on assumptions that Mauna Kea Technologies believes to be reasonable. However, there can be no assurance that the anticipated events contained in these forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties, including the risks set out in Chapter 3 of Mauna Kea Technologies’ 2020 Universal Registration Document registered with the Autorité des marchés financiers (AMF) on June 17, 2021 under number D- 21-0566 and the amendment to the 2020 Universal Registration Document filed with the AMF on September 17, 2021, both available on the Company’s website (www.maunakeatech.com), and risks related to 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 unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The realization of all or part of these risks could lead to actual results, financial conditions, performance or achievements by Mauna Kea Technologies that differ materially from the results, financial conditions, performances or achievements expressed in these forward-looking statements. This press release and the information it contains do not constitute an offer to sell or subscribe, nor a solicitation of an order to buy or subscribe to Mauna Kea Technologies shares in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The distribution of this document may, in some jurisdictions, be restricted by local regulations. Persons into whose possession this document comes are responsible for complying with all applicable local regulations relating 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 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 pulmonary nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC. PMID: 26214244.

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