Microporation: an innovative laser replaces jabs
People who are afraid of needles now have something to celebrate: hypodermic needles, which have long been the key instrument for administering drugs used to treat allergies and diseases as well as for vaccinations, now have a serious competitor. The minimally invasive P.L.E.A.S.E. ® platform developed by Pantec Biosolutions AG combines a laser device and stick-on patches to deliver drugs transdermally and painlessly into the bloodstream. The device can also be used in aesthetic and conventional medicine. Pantec Biosolutions has now established a partnership with a Liechtenstein-based company that is part of the BioLAGO network.
For many decades, hypodermic needles have played a key role in treating multiple sclerosis, in hyposensitizing people to reduce or eliminate allergic reactions and for vaccinations. Up until now, hypodermic needles have been the only way to deliver large-molecule drugs through the skin into the human body – and a slightly painful and hence rather unpopular one as well. Pantec Biosolutions based in the city of Ruggell in Liechtenstein in the greater Lake Constance region has developed an alternative to jabs, which is non-invasive and painless.
The precise laser epidermal system platform, P.L.E.A.S.E. ® for short, is an easy-to-handle tabletop device. It operates using a novel diode-pumped laser to create micropores in the surface of the skin and thus making it permeable to pharmaceutical substances. The device creates micropores in the upper layer of the epidermis through which a stick-on patch delivers drugs into the body; the depth and density of the micropores can be adjusted to the drug dose that needs to be delivered. The pores do not reach the dermis layer where blood vessels and nerves are located. So no pain or bleeding is involved. “A stick-on patch delivers drugs with a molecular weight of up to 150 kD into skin layers below the dermis, from where they enter the blood circulation,” explains Dr. Christof Böhler, CEO of Pantec Biosolutions AG. The micropores close again within 24 hours.
New method for treating skin cancer?
The platform is not just for delivering pharmaceuticals; it can also be applied in conventional and aesthetic dermatology, where it can be used to reduce acne scars, stretch marks and keloids. Keloids are benign tumours that can arise spontaneously or as a result of injuries or operations. “Animal experiments have shown that keloid scars can be treated with siRNA molecules that silence the gene coding for a connective tissue growth factor,” Böhler explained. However, up until now, the siRNA had to be applied directly into the scar using a hypodermic needle. It goes without saying that this is a rather painful procedure. “In-vitro experiments with microporated pig skin have shown that the siRNA is not only transferred to the dermis, but is also taken up by the dermal fibroblasts,” Böhler said, going on to add, “I am sure that P.L.E.A.S.E. ® would be an effective way to deliver such siRNA molecules.”
The device can also be used for the treatment of skin cancer. A clinical study was carried out to test whether the use of P.L.E.A.S.E. ® to deliver imiquimod topical was safe for malignoma patients and whether the treatment time could be reduced and patient compliance increased. “Standard therapy involves several 8-week cycles, while the use of P.L.E.A.S.E. ® for delivering imiquimod reduces treatment time to around one week,” said Böhler going on to report that the treatment has led to visible results within a few days of treatment and to the complete eradication of the cancer after eight weeks.
P.L.E.A.S.E. enables effective in-vitro fertilisation
Pantec Biosolutions has carried out three trials using transdermal drug delivery for women undergoing infertility treatment. At present, women undergoing infertility treatment endure around 100 painful and stressful injections over a rather long period of time in order to achieve pregnancy. The treatment of female volunteers undergoing microporation of the skin using P.L.E.A.S.E. ® and a stick-on patch to deliver fertility peptides or hormones has led to a positive outcome. “We have been able to show that follicle-stimulating hormones could be delivered using a patch and follicles started to grow. The treatment has also led to one pregnancy,” said Böhler. 80 per cent of the volunteers undergoing P.L.E.A.S.E. ® treatment and the transdermal delivery of hormones using a patch stated that they would prefer this type of IVF treatment to the injection of fertility hormones.
High mobility of the device enables home care use
Numerous studies have shown that patients prefer to use non-invasive methods when undergoing long-term medical treatment at home. However, P.L.E.A.S.E. ® is currently the only easy-to-use device on the market that can be used at home. “So-called diode-pumped ablative lasers are currently used for the fractional treatment of wrinkles and scars,” explained Böhler. “However, these systems are usually very big and require a lot of maintenance, which is why they are unsuitable for home care applications. Our system has decisive advantages as far as mobility is concerned. The system combines the advantages of a diode-pumped Er:YAG laser which is used for the removal of pigment alterations and those of a CO2 laser which is very powerful but normally associated with thermal damage and tissue carbonization. The new system has the same depth penetration as CO2 lasers and the safety, precision and recovery time of Er:YAG lasers,” highlighted Dr. Christof Böhler. In addition, the company’s new device guards against a broad range of risks; it has a built-in evacuation system for ablated pieces of skin which prevents the skin fragments from being blown into the environment. The system is hermetically linked with the skin by way of an exchangeable CleanTech insert, which allows users to operate the device without having to take extensive safety precautions. In addition, the system can also be used by a qualified assistant or nurse.
Pocket-size follow-up models
The company is working on the optimization of the P.L.E.A.S.E. ® platform with the aim of making it suitable for mobile applications, for example for the delivery of vaccines, anti-allergy drugs, pain relievers and many other applications. Pantec hopes that it will soon be able to place on the market a laser system for the home care sector that is barely bigger than a smartphone,” said Dr. Christof Böhler. Pantec also plans to work with other partners in order to further develop the P.L.E.A.S.E. ® platform for use in new fields of application. “We are already working with partners from the Lake Constance region, including companies from the medical technology sector. We hope that our BioLAGO membership will help us get further partners on board in order to jointly drive our developments forward,” said Böhler.
Pantec Biosolutions AG
Dr. Christof Böhler
Tel.: +423 377 78 00
Fax: +423 377 78 99