Transdermal technology receives CE mark
Pantec Biosolutions AG, a privately-owned company developing innovative technologies for transdermal drug delivery, has received CE marking for the company's lead product P.L.E.A.S.E. (Painless Laser Epidermal System). The system is used to apply micropores into the human skin prior to transdermal large molecular weight drug administration.
Pantec Biosolutions AG, a privately-owned company developing innovative technologies for transdermal drug delivery, has received CE marking for the company's lead product P.L.E.A.S.E. (Painless Laser Epidermal System). The system is used to apply micropores into the human skin prior to transdermal large molecular weight drug administration.
Medical devices are required to bear a CE mark before they can be sold in member countries of the European Economic Area (EEA).
"After getting the ISO 13485:2003 certification in September, the CE Mark provides us now with enormous versatility in our global strategy," said Christof Boehler, ceo of Liechtenstein-based Pantec Biosolutions. Pantec's P.L.E.A.S.E. is now cleared for a wide range of transdermal drug delivery opportunities in Europe. The Painless Laser Epidermal System platform enables efficient, needle-free and painless administration of biopharmaceutical drugs, in varying and individualised dosages, through partnered patch technology.
The technology is currently in clinical trials for the delivery of IVF hormone therapy, a market with an estimated value of US$1.5 - 2 bn. (Euro 1.19-1-6bn).
The platform is available both for the development of the company's own pipeline and for penetration into new markets through strategic partnerships.