Oct 04 2021
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 5 communications supporting Cellvizio® were presented during the recent European Respiratory Society (ERS) International Congress 2021. These presentations focused on the safety, efficacy, and feasibility of Cellvizio when used with manual and robotic-assisted bronchoscopy, fine-tuning sampling location and reduction of the bronchoscopic near-miss rate, and the application of Cellvizio in detecting fibrotic changes in vivo in patients diagnosed with COVID-19.
"Following the publication of the peer-reviewed article, 'Bronchoscopic needle based confocal laser endomicroscopy (nCLE) as a real-time detection tool for peripheral lung cancer' in Thorax1, we are pleased to have had the opportunity to share some of our clinical cases in greater detail and an exciting new study on robotic-assisted bronchoscopy during the ERS International Congress," said J. T. Annema, M.D. Ph.D., Professor of Pulmonary Endoscopy, Amsterdam University Medical Center. Professor Annema also added: "The studies' conclusions demonstrate that physicians can differentiate, with high reproducibility, between malignant tissue and airway/lung parenchyma, demonstrating the potential of nCLE imaging as a real-time biopsy guidance tool during manual and robotic-assisted bronchoscopy to reduce the near-miss rate of peripheral lung cancer."
The first results of the clinical study, co-funded by the Lung Cancer Initiative (LCI) at Johnson & Johnson2, combines needle-based confocal laser endomicroscopy and robotic-assisted bronchoscopy using both Cellvizio and the Monarch® Platform from Auris Health, Inc.3 to aid in diagnosing peripheral lung nodules. Christopher Manley, M.D., Director of Interventional Pulmonology and Associate Professor of Medicine at Fox Chase Cancer Center in Philadelphia and the principal investigator of this study, commented on the preliminary results: "In our study, the vision and stability of the robotic-assisted bronchoscope from the Monarch Platform allowed us to navigate farther into the lung to precisely target smaller lesions. Additionally, in vivo cellular imaging with nCLE provided very important real-time feedback to help identify abnormal tissue with nCLE imaging detecting a malignant pattern in 93% of patients with cancer."
As detailed in the study4 presentation during the ERS International Congress, one patient with a malignant nCLE image but a negative result during robotic-assisted bronchoscopic lesion sampling was diagnosed with malignancy after surgery, and in 6/17 (35%) of patients, nCLE guidance resulted in readjustment of the robotic bronchoscope with optimization of the sampling location."
The potential impact real-time in vivo cellular imaging with Cellvizio can have in the intervention of lung cancer early in the disease progression is well supported through these presentations and we look forward to broadening the adoption of Cellvizio in the Interventional Pulmonology community," said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies.
Needle based confocal laser endomicroscopy for the diagnosis of peripheral lung nodules by robotic navigational bronchoscopy Oral presentation by Dr. Christopher Manley(Clinicaltrials.gov: NCT04441749)
Robotic bronchoscopy combined with needle based confocal laser endomicroscopy (nCLE) for peripheral lung cancer Skills lab presented by Dr. Christopher Manley
Needle based confocal laser endomicroscopy: a novel real-time diagnostic approach for suspected peripheral lung lesions Challenging clinical cases and discussion presented by Dr. Tess Kramer
Lungs on fire: Respiratory critical care, COVID-19 Case review and discussion presented by Dr. Kirsten Kalverda
Correlation between probe-based confocal laser endomicroscopy (pCLE) and chest CT patterns inpulmonary tuberculosis E-poster by Dr. Igor Mamenko
For more information, view our ERS 2021 page: https://www.landing.maunakeatech.com/en/ers-2021
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 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 undernumber 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.
2 The legal entity of the Lung Cancer Initiative at Johnson & Johnson is Johnson & Johnson Enterprise Innovation, Inc.
3 Auris Health, Inc. is part of Johnson & Johnson Medical Devices Companies
4 Manley C, Kramer T, et al. Needle based confocal laserendomicroscopy for the diagnosis of peripheral lung nodules by robotic navigational bronchoscopy.ERS 2021
Bronchoscopy Important Safety Statement:
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).
Urology Important Safety Statement:
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.