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.
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.
The Company’s 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.
For further details please contact:
At the Company Pantec Biosolutions AG
Dr. Christof Boehler, Chief Executive Officer
Tel: +423 377 1390
Media Relations College Hill Life Sciences
Tristan Jervis/Robert Mayer/Claire Mosley
Tel: +44 (0) 20 7457 2020
pantec@collegehill.com