PARIS--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced the presentation of new data demonstrating the applicability of Cellvizio in assessing acute lung rejection (ALR) following transplant at the 2017 American Thoracic Society (ATS) International Conference, being held May 19-24 in Washington, D.C. The 2017 ATS conference draws more than 15,000 investigators, educators, and clinicians focused on pediatric and adult pulmonary, critical care, and sleep medicine.
The study, titled “Probe-based Confocal Laser Endomicroscopy in the Diagnosis of Acute Lung Rejection: Results of a Prospective Multicenter Trial,” was summarized in an oral presentation by lead investigator, Cesar A. Keller, M.D. of the Mayo Clinic in Jacksonville, Florida, on Monday, May 22. The key highlights from the study include:
- In a follow-up exam of 24 lung transplant patients (16 double and 8 single), CLE video-imaging was obtained immediately prior to tissue sampling, and the Cellvizio endomicroscopy video-images were blindly reviewed by 4 pulmonologists (1 expert and 3 junior endomicroscopy readers), initially independently and then following a consensus meeting.
- The reproducibility, as assessed by calculating IntraClass Correlation Coefficient (ICC) and Fleiss Kappa (K) before and after a consensus meeting, were 0.77 and 0.39 respectively before consensus, and 0.96 and 0.77 respectively after consensus (p<0.001).
- The study concluded that PeriVascular Cellularity observed with Cellvizio provides a feasible and reproducible criterion to assess Acute Lung Rejection (ALR) in vivo. This requires a learning curve for image interpretation.
Dr. Keller stated, “Probe-based Confocal Laser Endomicroscopy represents a potential new tool to provide a less-invasive diagnosis of acute lung rejection in lung transplant recipients requiring trans-bronchial biopsies. The results from our study suggest that pCLE could potentially save patients from unnecessary invasive biopsies. We look forward to further studying this endomicroscopy application in order to better enhance the treatment continuum for lung transplant patients.”
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, added, “This study provides further evidence of the broad potential of the Cellvizio platform to improve diagnostic and treatment outcomes. We thank Dr. Keller and his colleagues for conducting this unique study sponsored by Mauna Kea Technologies and demonstrating that with proper training, the procedure is effective and reproducible. We are optimistic that Cellvizio will increasingly be used in a variety of applications that can benefit from its unique ability to provide real-time diagnostic information at the cellular level. Moreover, image interpretation automation with artificial intelligence will contribute to the performance and adoption of Cellvizio in this and other applications. ”
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on eliminating uncertainties related to the diagnosis and treatment of cancer and other diseases thanks to real time in vivo microscopic visualization. The Company’s flagship product, Cellvizio, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, visit www.maunakeatech.com
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