(BFM Bourse) – Cellvizio, the inventor of the world’s smallest microscope (which can be used to examine patients’ tissues during diagnostic or surgical procedures), received 20th approval from the US FDA for its equipment to produce molecular images. – guided procedures.
After a month-long bearish trend (-27% over the past thirty days), the Mauna Kea Technologies action is experiencing a new rebound on Wednesday, the company behind the implantable microscope Cellvizio has received approval from the American health authority. Use of the platform during molecular image-guided (or MIP) surgical procedures. After an hour of trading, the cap rose 17.74% to 0.637 euros, more than 70% above the historic low reached at the beginning of March.
The US Food and Drug Administration has given the green light to the use of the Cellvizio platform (100 Series) with a molecular marker, making visualization possible. livei.e. in patient’s tissues in real time during endoscopic, laparoscopic and needle-based procedures.
More specifically, this FDA authorization relates to a new clinical indication for the use of Cellvizio in fluorescent imaging of tissues targeted by a molecular marker, pafolacianin (marketed under the brand name Cytalux and manufactured by On Target Laboratories). In addition, clearance includes a new clinical indication for the use of Cellvizio for fluorescent imaging and visualization of ICG (or indocyanine green) intravenously or interstitial.
Visualize cancer cells in real time
The new field of medical procedures this new authorization provides access to, molecular image-guided procedures – gives Cellvizio the unique clinical ability to visualize tissues to which molecular agents bind, enabling real-time imaging at the cellular level during cancer. minimally invasive procedures. Mauna Kea says using MIP during bronchoscopic lung biopsy can improve the accuracy of biopsies while reducing the number of procedures and the time and complications associated with getting a diagnosis.
“Although the tools for diagnosing and treating lung cancer have evolved over the past decade, the need to improve the pace of treatment of patients after the discovery of the pulmonary nodule remains crucial to addressing cancers at an earlier stage,” he explained. Nicolas Bouvier, acting general manager of Mauna Kea Technologies. “This endorsement represents a major step forward in the collaboration between On Target and Mauna Kea to address the important unmet needs in interventional pulmonology and lung cancer. It also opens the door to a profound transformation in precision medicine, particularly in interventional pulmonology and potentially in other indications. “.
This authorization is also a significant milestone as it marks the twentieth “510(k)” (in American medical device terminology) achieved for the Cellvizio platform in the US, and reflects “Mauna Kea’s continued work with the US. FDA is unique to Cellvizio.” will develop a range of indications: imaging of the internal microstructure of tissues, including but not limited to the identification of cells, vessels, and their organization or architecture; imaging of blood flow in vascular spaces, including the microvasculature and capillaries; and Cellvizio’s infrared model, fluorescent angiography, and the same also visualization of the lymphatic system, including lymph vessels and lymph nodes, with ICG, and fluorescent imaging of tissues that absorb the Cytalux molecule,” the company explains.
Guillaume Bayre – ©2022 BFM Exchange