Sontra eases the pain of needles
its ultrasonic skin permeation system, making the application of
anaesthesia even more comfortable and less painful for the patient.
SonoPrep 1.75 employs low frequency ultrasound to penetrate the skin's outermost layer, creating an imperceptible window through the skin that enables molecules to pass through with 100 times greater efficiency than intact skin.
This means that an anaesthetic such as lidocaine can be applied topically with minimal or no pain in a procedure that lasts on average 15 seconds.
What is more, SonoPrep has been shown to shorten the effective onset of topical anaesthetics from as long as 60 minutes to 5 minutes or less while improving the therapeutic effect over the traditional application.
The device also offers real-time skin conductance feedback as it measures the decrease in skin impedance during the application of ultrasound and stops the sonocation procedure when the desired level of conductance is achieved.
It requires only 10 per cent of the amount of lidocaine used traditionally and, since the skin remains permeable for up to 24 hours, Sotra is investigating the potential for continuous non-invasive diagnostics such as glucose monitoring and transdermal drug delivery, though clinical trials have not been made on that front and such usage is not approved by the FDA.
As far as SonoPrep's basic scope is concerned, Sontra has been marketing it as an adjunct to IV therapy, anaesthesia, and pain management since 2004 but its uptake has been slow in the $100m (€83m) US market for topical anaesthesia - the company says that only 10 hospitals in the US are currently using it.
So In-PharmaTechnologist.com asked the company's chief scientific officer Sean Moran how their product can be profitable if health professionals don't see a financial incentive to provide pain relief for their patients.
"Some people will pay for it, some people won't, hospitals tend to be slow in changing their ways and obviously most are happy not to use lidocaine or administer it with traditional methods," he said.
"We believe many nurses and doctors take into account the anxiety caused to patients when rating their performance, and we feel the paediatric sector is particularly promising."
The company also argues that their device allows for new routes for continuous transdermal drug delivery, continuous diagnosis and data collection and improved patient compliance to treatment, all of which can reduce health costs.
SonoPrep works by applying ultrasonic energy to the skin to disorganize the lipid-bilayer of the stratum corneum, creating reversible micro channels in the skin through which fluids and analytes can be extracted and large molecules can be delivered with 100 times greater efficiency than intact skin.
The new device will be incorporated into the company's second generation SonoPrep skin permeation device scheduled to be introduced in May 2006.
Last month Sontra sent a letter to rival medical device firm Dermisonics threatening legal action if the company does not address "patent infringement" issues with its U-Strip ultrasonic transdermal delivery system for insulin and other drugs.
Dermisonics disputes the allegations and has referred this matter to its patent counsel.
