On April 20, 2026, Hemerion received approval from the EMA (European Medicines Agency) expert panel regarding Orphan Medical Device status for its Heliance illumination platform, used in photodynamic therapy (PDT) for the treatment of operable newly diagnosed glioblastoma.
Hemerion has become one of the first European healthtech companies to benefit from this new status, which confirms Heliance’s significant therapeutic potential and helps accelerate and secure the regulatory pathway toward marketing authorization.
Hemerion is now among the pioneering companies selected for the pilot phase of this European program, dedicated to breakthrough technologies targeting rare and life-threatening diseases.
This status allows our team to benefit from early access to guidance from the EMA’s expert panel in order to refine its clinical development strategy and prepare the submission of technical documentation for CE marking.
The EMA expert panel based its decision on an in-depth analysis of the data submitted by Hemerion, concluding that the device meets the strict criteria of Regulation MDCG 2024-10.
A promising therapy to advance the standard of care
For more than 20 years, the standard of care for glioblastoma has been based on maximal surgical resection followed by the Stupp protocol (chemoradiotherapy). However, median survival remains low (14.6 to 20.9 months), and residual tumor cells at the resection margins are the almost constant cause of recurrence.
The expert panel’s analysis highlighted the significant hope offered by the therapy developed by Hemerion, which targets these infiltrating tumor cells which evade conventional treatment and cause 85% of recurrences.
The opinion highlights the spectacular results of clinical trials already conducted, which show a median overall survival (OS) of 23.1 months for treated patients, compared to approximately 14.6 months for current treatments, all with a favorable safety profile and no serious adverse events related to the device.
A Decisive Step in the Regulatory Process
Obtaining this orphan device designation marks a decisive step in Hemerion’s regulatory journey.
This designation enables close and active collaboration with the EMA’s expert group to develop the clinical strategy and clarify the necessary steps prior to submitting a CE marking application.
These direct exchanges with EMA experts also provide valuable insight to finalize the clinical evaluation of the therapy and accelerate its rollout in the European market.
It also validates Heliance’s position in standard of care as a solution for the future in the face of the most aggressive and prevalent primary brain tumor today.
