Feb 22 2022
PARIS AND BOSTON, February 22, 2022 – 5:45 PM CET – Mauna Kea Technologies (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces that, as part of its collaboration with the Lung Cancer Initiative (“LCI”) at Johnson & Johnson 1, initial enrollment of patients has begun in a prospective, multi-center, open-label, single-arm clinical feasibility study sponsored by LCI. The study will combine nCLE and robotic-assisted bronchoscopy, using both Cellvizio and the Monarch® Platform from Auris Health, Inc., a subsidiary of Ethicon, Inc., part of the Johnson & Johnson Medical Devices Companies, to assess the capability of nCLE to accurately confirm needle position for the diagnosis of peripheral lung nodules (Clinicaltrials.gov: NCT05231278).
The primary objective of this study, named CLEAR (Confocal Laser Endomicroscopy nodule locAlization by Robotic Bronchoscopy), is to evaluate the ability of nCLE to confirm successful navigation of the biopsy needle (“tool-in-lesion”) during peripheral lung nodule procedures, as confirmed by cone beam CT. The secondary objectives are to evaluate the reproducibility of using nCLE across multiple facilities and to evaluate the ability of nCLE to diagnose malignancy vs. non-malignancy, including exploring diagnostic yield at the index procedure. This study will include up to 75 patients with peripheral lung nodules in at least 3 U.S. centers.
“I am very excited to start the CLEAR study, which combines two breakthrough technologies,” said Sandeep Bansal, MD, Medical Director of The Lung Center and Interventional Pulmonology at Penn Highlands Healthcare, DuBois, Pennsylvania. “The Monarch Platform is designed to provide vision, precision, and stability during peripheral lung nodule biopsy procedures. With its unique capability to visualize individual cells and structures at the tip of the needle during bronchoscopy, Cellvizio could provide real-time tool-in-lesion confirmation and potentially reduce the current near-miss rate of peripheral lung nodules.”
“We are pleased to announce the start of this important clinical study in collaboration with the LCI,” said Nicolas Bouvier, interim Chief Executive Officer of Mauna Kea Technologies. “This builds on the recent completion of enrollment of the first in human clinical study combining robotic-assisted bronchoscopy and nCLE for the diagnosis of peripheral lung nodules and we look forward to validating further Cellvizio’s role in this critical and strategic indication.”
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 concerning Mauna Kea Technologies and its activities. All statements other than statements of historical fact included in this press release, including, without limitation, those regarding Mauna Kea Technologies’ financial condition, business, strategies, plans and objectives of management for future operations are forward-looking statements. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties, including the risks set forth in Chapter 3 of the 2020 Universal Registration Document of Mauna Kea Technologies registered by the French Financial Markets Authority (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, which are both available on the Company's website (www.maunakeatech.com), and risks relating the economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. The distribution of this document may, in certain jurisdictions, be restricted by local regulations. Persons who come into possession of this document are required to observe all applicable local regulations relating to this document.
1 The legal entity of the Lung Cancer Initiative at Johnson & Johnson is Johnson & Johnson Enterprise Innovation, Inc.
2 Clinicaltrials.gov: NCT04441749
Complications from bronchoscopy are rare and most often minor, but if they occur, may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. Only rarely do patients experience other more serious complications (for example, collapsed lung, respiratory failure, heart attack and/or cardiac arrhythmia).
Adverse effects from both Mini-PCNL and Ureteroscopy include pain, urinary tract infection, fever, hematuria (presence of blood in urine), exposure to low levels of radiation, retained or residual stones.
Adverse effects from ureteroscopy may include pain, perforation or injury to the ureter, resulting in extravasation of fluid and urine (urinoma), stricture of the ureter with risk of subsequent obstruction (hydronephrosis needing further repair), rare avulsion of the ureter, urinary blood clots, residual stones.
PCNL access may result in minor and major adverse effects. Minor effects include fever and nephrostomy leak. Major adverse effects may include injuries to pleura, liver, spleen, large vessels with related bleeding, gallbladder, duodenum, jejunum, colon with related cutaneous fistula, fever, pain, ileus, elevated counts.
Major adverse effects related to stone removal may include infection and urosepsis, intravascular fluid overload, extravasation of fluid, and post percutaneous nephrolithotomy bleeding.