14 Oct 2016
Cellvizio platform from Mauna Kea Technologies under evaluation in NIH-backed study.
Cellvizio, the confocal laser endomicroscope platform developed by French firm Mauna Kea Technologies, is being prepared for a clinical trial in child heart surgery, through a new study funded by the US National Institutes of Health (NIH).
It is hoped that the photonics technology will prove that it can help heart surgeons avoid damaging critical cardiac tissues when operating on very young children with congenital heart disease. According to Mauna Kea, damage to the heart’s conduction system is a major risk in pediatric cardiac surgery – potentially requiring intervention with a pacemaker.
Beyond optical biopsies
Cellvizio has already been used in a number of trials, although typically as an “optical biopsy” technique for identifying malignant cells, including breast and brain cancer. Applications in the gastrointestinal tract and to distinguish benign pancreatic cysts and more dangerous pre-cancerous lesions are also under investigation.
The new cardiac surgery study will be led by researchers at the University of Utah School of Medicine and the Harvard Medical School. Robert Hitchcock and Frank Sachse, both associate professors in the Department of Bioengineering at the University of Utah, will collaborate with Aditya Kaza, assistant professor of surgery at Harvard Medical School and also director of the Neonatal Cardiac Surgery Program at Boston Children’s Hospital.
Kaza said in a Mauna Kea statement: “As a surgeon I know the difference this technology will make in the smallest and most vulnerable patients. Intraoperative confocal microscopy is a powerful new tool for cardiac surgeons and I am anxious to continue working with my colleagues in Utah to bring this imaging technology into the operating room.”
Hitchcock added: “This collaboration is a perfect example of a multidisciplinary approach to bringing new technology to the clinic. We’ve been working diligently on this new approach for pediatric congenital heart surgery since 2010.
“We are now beginning this pre-clinical research phase, which should pave the way for our first human clinical trials in 2018.”
Congenital heart disease is a relatively common defect in newborns, and estimated to affect at least 40,000 infants each year in the US. In around a quarter of those cases, the defect is severe enough to require invasive treatment before the child is a year old and approximately 25,000 pediatric cardiac surgery procedures are performed in the US each year.
One example of a defect that can be fixed with surgery is “coarctation” of the aorta, where part of the main artery in the body is very narrow, meaning that the heart is unable to deliver blood and oxygen to the lower parts of the body effectively.
Another is where babies are born with their main arteries transposed, so that the aorta comes from the right side of the heart, instead of the normal left side. This defect requires surgery to switch the connections of the aorta and coronary and pulmonary arteries back to their correct positions.
Mauna Kea founder and CEO - and former NASA astrophysicist - Sacha Loiseau said of the latest project: “Cellvizio’s unique ability to provide real-time, in vivo microscopic imaging makes it well suited to add value to a wide range of surgical procedures where it is important to discriminate between tissue types.
“We are excited to be partnering with researchers from the University of Utah and Harvard to apply these capabilities in pediatric cardiac surgery to help surgeons avoid damaging important areas of the heart that could impact the health of these very young patients for the rest of their lives.”
Earlier this year, the Paris-headquartered company raised €4.4 million in equity finance to support product development, clinical trials and regulatory approval work. Around a year ago the company revised its commercialization strategy to adopt a licensing model, signing deals with Cook Medical and FujiFilm.