TransPharma Medical, a specialty pharmaceutical company, has received European CE Mark approval for its ViaDerm, a transdermal drug delivery device.
According to the company, the ViaDerm system provides a self-administered solution that enables the safe, reproducible and accurate delivery of a broad range of product candidates, including hydrophilic small molecules peptides and proteins.
The device incorporates a reusable, battery-operated handheld electronic control unit and a disposable microelectrode array that together with a patch containing a drug comprises the ViaDerm system.
The company’s lead product is ViaDerm-hPTH (1-34), a transdermal hPTH (1-34) drug-product, for the treatment of osteoporosis, currently in phase II clinical studies. This drug-product will enable patients to better manage their disease by eliminating the need for daily painful injections while easing handling and administration, the company said.
Daphna Heffetz, CEO of TransPharma Medical, said: “We are excited about receiving the European CE approval for our unique ViaDerm device. This achievement confirms the safety of the ViaDerm device and brings us closer to offering patients a method for the accurate delivery of biologics, thus avoiding the need for injections.”