[BREAKING] Hemerion obtains the FDA clearance for its next US clinical trial

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Heliance devices shipped to Pittsburgh for the next Hemerion clinical trial

Glioblastoma clinical trial in Pittsburgh: Heliance® devices shipped to the USA

Hemerion’s teams have taken the first step towards setting up a new clinical trial in the USA, with the shipment of a complete batch of Heliance® devices and its drug Pentalafen® for the treatment of glioblastoma patients.

At the end of July, Hemerion’s teams shipped to  the University of Pittsburgh Medical Center all the elements required to set up the Phase 1 / 2 clinical trial recently authorized by the FDA in the treatment of glioblastoma.

The shipment included two illumination platforms and 15 Heliance® single-use diffusers. These medical devices, together with the drug Pentalafen® also shipped to the investigator’s pharmacy, will be used to treat the first glioblastoma patients included in the clinical trial at the University of Pittsburgh Medical Center (UPMC).

Shipment of a complete batch of Heliance® devices and its drug Pentalafen® for the treatment of glioblastoma patients

This device/drug combination is the first GMP (Good Manufacturing Practice) industrialized version of the clinical concept first developed by INSERM, the University Hospital of Lille and the University of Lille.

Today, Heliance® devices benefit from a host of technological evolutions implemented by Hemerion since its launch in 2020: improved laser light control, ease of programming and illumination control, precise diffuser positioning, integration into the operating room, etc. These improvements should translate into even greater efficacy and efficiency for the patient. 

Next step: training and support for neurosurgery teams at the University Hospital of Pittsburgh in the use of the Heliance@ solution in the operating room, in preparation for the launch of the clinical trial.