Pantec Biosolutions Receives Clearance for Transdermal Delivery System
Pantec Biosolutions AG (Ruggell, Liechtenstein), a privately owned company developing innovative technologies for transdermal drug delivery, has received CE marking for the company's lead product, P.L.E.A.S.E. (painless laser epidermal system), design which applies micropores into the human skin for the transdermal delivery of large molecular weight drugs.
Pantec Biosolutions AG (Ruggell, Liechtenstein), a privately owned company developing innovative technologies for transdermal drug delivery, has received CE marking for the company's lead product, P.L.E.A.S.E. (painless laser epidermal system), design which applies micropores into the human skin for the transdermal delivery of large molecular weight drugs.
Pantec specializes 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. platform enables needle-free and painless administration of biopharmaceutical drugs, in varying and individualized 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 $1.5–2 billion.
The rigorous audits required to obtain the CE mark is based on a conformity assessment procedure in which product development and production documentation are thoroughly scrutinized to ensure compliance to the medical device directive. Medical devices are required to bear a CE mark before they can be sold in member countries of the European Economic Area (EEA).
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