Ruggell, Liechtenstein, 01 December 2008 - Pantec Biosolutions AG, a privately-owned company developing innovative technologies for transdermal drug delivery, today announced that it has received CE marking for the company's lead product P.L.E.A.S.E.® (Painless Laser Epidermal System) to apply micropores into the human skin prior to transdermal large molecular weight drug administration.
The rigorous audit is based on a conformity assessment procedure and thoroughly scrutinizes product development and production documentation to ensure compliance to the medical device directive (MDD). 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 Pantec Biosolutions. "Pantec's P.L.E.A.S.E.® is now cleared for a wide range of transdermal drug delivery opportunities in Europe, and this represents another development milestone we have hit as planned during 2008."
About Pantec Biosolutions and P.L.E.A.S.E.®
Pantec Biosolutions is a private drug delivery company specialised in using laser microporation technology to deliver large molecular weight drugs into the epidermis for local or systemic uptake. Its proprietary P.L.E.A.S.E.® (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 billion.
Pantec Biosolutions' P.L.E.A.S.E.® platform is available both for the development of the company's own pipeline and for penetration into new markets through strategic partnerships. Pantec Biosolutions is based in Ruggell, Liechtenstein.
Further Information:
Dr. Christof Boehler
CEO
Pantec Biosolutions AG
t: +423 377 7800
e: info@pantec-biosolutions.com
Dr. Robert Mayer
Account Manager
College Hill Life Sciences
t: +49 (0)89 5238 8030
e: robert.mayer@collegehill.com