Aptar Pharma wins CE marking for LuerVax intranasal vaccine device

AptarGroup, Inc. (NYSE: ATR) announced that its LuerVax intranasal delivery device and accompanying Spray Divider have received CE marking under the EU Medical Device Regulation, indicating the products meet European general safety and performance requirements for medical devices.

LuerVax is designed for administration of vaccines by healthcare professionals when connected to a compatible LuerLock syringe. The optional Spray Divider enables delivery of two sequential sprays, one per nostril, and is available in two sizes, 200 µL and 500 µL, for use with corresponding LuerLock syringes.

The devices are classified as Class I non-sterile, single-use medical devices under the MDR and are intended for use by healthcare professionals.

"Achieving CE marking for both LuerVax and the Spray Divider is an important step in strengthening our support of vaccine developers worldwide," said Alex Theodorakis, President of Aptar Pharma Prescription. "Customers are increasingly seeking established device platforms that can support regulatory pathways and enable efficient clinical and commercial development."

According to the company, the CE marking gives vaccine developers access to a certified intranasal delivery platform intended to support programs from early clinical studies through commercialization. Aptar Pharma states it also offers regulatory support, industrialization, and manufacturing services alongside the devices.

AptarGroup, headquartered in Crystal Lake, Illinois, employs approximately 14,000 people across 20 countries.

You May Also Be Interested In

• Moderna shares plunge on cancer vaccine data leak
• Elektros Charts an Ambitious Course Toward America's Critical-Minerals Future
• XTI Aerospace reports preliminary Q3 revenue of $35.3 million