P.L.E.A.S.E. – a painless way to deliver drugs through skin
Most of us have wished for a painless way to receive shots when we were younger (and some still do). Fortunately for new generations, Pantec Biosolutions AG, a privately-owned company, developed innovative technology for transdermal drug delivery. A few days ago they received a CE mark in the EU for the new professional product line of the P.L.E.A.S.E. (Painless Laser Epidermal System) device.
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.
It uses a transdermal delivery method for high molecular weight drugs. A handheld laser device creates controlled aqueous micropores in the epidermis. Due to the special features of the device the micropores do not reach the dermis, where nerves and blood vessels reside. An intelligent graphical user interface guarantees simple and safe use by the medical personnel or the patient, who could use the device without supervision.
P.L.E.A.S.E. Professional allows precise intraepidermal microporation in connection with improved transdermal drug delivery of new or existing drugs. The device allows fine tuning of pore properties (number and depth) to a therapeutic need for a specific drug dose. Since it uses short pulses, it practically eliminates potential thermal damage from the laser. Hence, there is no carbonization of the tissue, only fast ablation of skin tissue. It uses variable laser deflection allows flexible formation of pore arrays and very accurate skin ablation in 5-10 µm steps. 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).