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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.
Dr. Christof Boehler
Pantec Biosolutions AG
t: +423 377 7800
Dr. Douglas Pretsell
College Hill Life Sciences
t: +49 (0)89 57 00 18 06
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