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TransPharma Medical’s implementation of its innovative RF-MicroChannel Technology is the ViaDerm drug delivery system. Intended for home use, the system consists of a reusable battery-operated handheld electronic control unit, a disposable low-cost microelectrode array and a patch containing a drug.

The reusable device, with disposable microelectrode array attached, creates the RF MicroChannels preparing the skin site for application of a proprietary patch containing a drug. The drug then passively diffuses through the RF-MicroChannels into the inner skin layer and from there to the systemic circulation. The ViaDerm system is designed for an easy, seamless, one-handed application.

The ViaDerm device is available in three sizes, depending on the desired dose of drug to be delivered. All require only minimal initial patient training.

A ViaDerm System Walk-Through

	1. The 1 cm2 microelectrode array is snapped onto the control unit.
	2. The proprietary one-handed patch is then coupled with the control unit.
	3. The ViaDerm assembly is then gently placed on the skin. Applying light pressure on the treatment site creates the RF-MicroChannels within one second. Upon completion, a green LED and beeping tone indicate that the RF-MicroChannels have been successfully created.
	4. After removing the ViaDerm from the treatment site, the patch is folded gently over the frame. At this time, the microelectrode array is disposed of using a quick release button which ejects the used array. The drug patch is now securely affixed to the treatment site, and the medication can now easily travel into the viable skin layers via the RF-MicroChannels that have been formed.

The completely functional ViaDerm drug delivery system is available for use in clinical trials.

An Excellent Safety Profile
 
Six human studies conducted on a total of 136 healthy, adult volunteers were conducted to assess the safety of the ViaDerm system.

Men and women of several age groups participated in the studies. The ViaDerm system was applied to either the abdomen, upper arm or thighs of the participants. The safety of the ViaDerm system was evaluated by measuring irritation (erythema and edema) at the application site using the Draize irritation index, and skin tolerability by measuring pain on a 100mm Visual Analogue Scale (VAS) following ViaDerm treatment. In addition, the study evaluated MicroChannel (MC) depth, assessed by a skin confocal microscope, amongst various skin types and age groups.

The results demonstrated an excellent safety and tolerability profile with only slight erythema and edema and negligible pain. In addition, average MC depth was found to be nearly identical to that of the electrode length with a low standard deviation. High uniformity in MC depth was also found across various skin types, in all three age groups and both genders.