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Pantec Biosolutions' P.L.E.A.S.E. Professional® Receives Marketing Authorisation



Tuesday, June 1, 2010 12:00 am



Ruggell, Liechtenstein, 1 June 2010- Pantec Biosolutions AG, a privately-owned company developing innovative technologies for transdermal drug delivery, today announced that it has received a CE mark in the EU for the new professional product line of the Company's transdermal delivery device: P.L.E.A.S.E.® (Painless Laser Epidermal System).



P.L.E.A.S.E. Professional® is an affordable portable benchtop system with a diode pumped Er:YAG fractional ablative laser. Compared with the currently marketed lamp pumped systems, P.L.E.A.S.E. Professional® is a small, lightweight and very cost efficient device with a variety of applications in conventional and aesthetic dermatology and in general medicine. P.L.E.A.S.E. Professional® allows precise intraepidermal microporation in connection with improved transdermal drug delivery of new or existing drugs. This class 1 laser device requires little maintenance and clinicians using it have no need for safety protection.



"P.L.E.A.S.E.® has already demonstrated its clinical utility and we are delighted now to have a CE Mark that will allow us to make the technology available widely in the form of P.L.E.A.S.E. Professional®," said Christof Boehler, CEO of Pantec Biosolutions. "This is an important milestone for Pantec as this device will unlock therapeutic areas with high unmet need for easy-to-use, efficient, and painless application of biologicals. We plan to start a number of clinical studies looking at a variety of applications in the coming months including trials looking at the more efficient delivery of small molecule drugs."



The rigorous audit that must be completed before awarding a CE Mark 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).



About Pantec Biosolutions and P.L.E.A.S.E.®

Pantec Biosolutions AG 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.