PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) (the “Company”), inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (“pCLE” and “nCLE”) platform, today announced that it has entered into a new research collaboration agreement with the Lung Cancer Initiative (“LCI”) at Johnson & Johnson1 to advance the validation of Cellvizio as a real-time biopsy guidance tool during robotic-assisted bronchoscopy to potentially reduce the near-miss rate of peripheral lung cancer.
Under the terms of the agreement, Mauna Kea Technologies will participate in a prospective, multi-center, open-label, single-arm clinical feasibility study (the “Study”) led by LCI. The Study will combine nCLE and robotic-assisted bronchoscopy, using both Cellvizio and the Monarch® Platform from Auris Health, 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. LCI will sponsor and fund the Study. In consideration of the Company’s resources and support to the Study, pursuant to the terms of the Agreement, LCI will provide total funding to the Company of 978,375 euros, a portion of which is contingent upon the successful completion of certain Study activities under the Agreement.
In addition, pursuant to the Agreement, the Company granted a right of first refusal (“ROFR”) to LCI (through JJEI) with respect to any transaction relating to Mauna Kea Technologies’ nCLE variant (i) for use in endoluminal robotic procedures for any lung applications, (ii) for the application of machine learning, artificial intelligence solutions and learning models for diagnosis, risk stratification, and treatment associated with lung disease and (iii) for use for endoluminal or transthoracic intra-tumoral drug delivery procedures for lung. The ROFR is effective for the term of the Study plus an additional four months thereafter.
"We are pleased to announce this important clinical study and expanded agreement as part of our collaboration with the Lung Cancer Initiative at Johnson & Johnson," said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. "We are also pleased with the progress we have made in our strategic collaboration with LCI and the potential impact of real-time in vivo cellular imaging with Cellvizio, combined with the Monarch Platform, particularly as it relates to using Cellvizio for real-time tool-in-lesion confirmation during robotic-assisted bronchoscopy procedures.”
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.
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 Techonologies’ 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.
The legal entity of the Lung Cancer Initiative at Johnson & Johnson is Johnson & Johnson Enterprise Innovation Inc.