Professors Joseph Kost of Ben-Gurion University demonstrates the SonoPrep. ‘It opens the door to all kinds of needle-less injections.’The next time you go to the doctor and you need to get a shot, tell him to get with the times and give you a SonoPrep instead. After eight years of technological development, a joint project by an Israeli and an American scientist has resulted in this futuristic device which could make needles a thing of the past.

The SonoPrep uses ultrasound to painlessly deliver medications, including local anesthesia, through microscopic pores in the skin – holes created by low-frequency vibrations instead of high-anxiety needles.

The device – created in collaboration by Professors Joseph Kost of Ben-Gurion University and Robert Langer of MIT, has been approved by the US Food and Drug Administration and put on the market in the United States.

“The SonoPrep got its start back in the early 80s when I did my post-doctoral work at MIT,” Kost told ISRAEL21c. “My collaboration with Bob Langer continued over the years as we developed the technology both at BGU and at MIT. It would be accurate to see this is a true U.S.-Israeli invention.”

SonoPrep applies ultrasound waves to the skin for 15 seconds, disrupting a protective membrane to allow fluids to enter or exit. The openings permit larger molecules, including those of many drugs, to pass quickly through the skin which, 24 hours later, returns to normal.

Manufactured by Sontra, a company based in Franklin, Massachusettes which was founded by Kost and Langer eight years ago to commercialize SonoPrep, the device will sell for $2,000. The company now trades on the Nasdaq according to a market value of $40 million.

“The company expects to start selling the product this month – at first to topical local anesthetics and to physicians and hospitals,” said Kost.

The FDA made it the first approved technology to use ultrasound for quickly anesthetizing the skin. Using the SonoPrep, it takes only five minutes for lidocaine cream to take effect, instead of the one hour needed to prepare patients for painful procedures like the insertion of catheters and infusion tube needles, and taking biopsies.

There are competing technologies for needle-free drug delivery, such as those with electric fields which require batteries, said Kost, but he believes his device is faster, more widely applicable to local pain relief, and can be applied to the later systemic delivery of medications.

“It’s incredibly promising,” Dr. Charles Berde, director of pain treatment services at Boston’s Children’s Hospital, told The Boston Globe. “I see it as a methodology of getting a variety of other drugs across the skin.”

Berde said the device could eliminate delays connected to blood testing and be especially useful for children who are afraid of needle procedures.

“The important point, to me, is not just that the FDA approved it – it’s a validation of the technique,” Langer told The Globe. “It opens the door to all kinds of needle-less injections… It’s kind of like ‘Star Trek.’ They zap people, and the stuff goes through.”

Berde said SonoPrep’s initial success probably would depend on whether hospitals would be willing to pay $2,000 for the ultrasound unit, but Sontra officials said the cost would be recouped if the unit is used frequently.
“The hospital will pay no more than it does for a single use of lidocaine today,” Sean Moran, the company’s chief financial officer, told The Globe.

Dr. Bruce Becker, a doctor who works in Rhode Island Hospital’s emergency room, tested the product on patients as part of the federal Food and Drug Administration approval process.
“It’s one thing to think something’s interesting [and] nice, but we want the hard science,” he said “Generally for adults, we’ve always thought this is nothing. So we measured a pain scale and some people thought the IV was 10 out of 10 for pain. So that’s really painful, and we’ve been ignoring that for years.”

According to Kost who is from BGU’s department of medical engineering, the SonoPrep also offers future applications in the fields of drug delivery and diagnostics – for continuous and painless testing of blood sugar in diabetics, speedy administration of pain medications to cancer patients, and influenza vaccines to the general public.

Sontra will test SonoPrep to administer painkillers such as the opiate fentanyl, which is often given to cancer patients, significantly reducing the current 18 hours it takes for the drug to have an effect on the brain.

“We are now able to focus on a whole series of new applications that replace needles with ultrasound technology. The technology also allows noninvasive checks of sugar levels for diabetics without needles,” Kost added, “which is being developed together with [pharmaceuticals and health-care company] Bayer.”

“In the current method of testing sugar levels, one can only get a discreet measurement – you have to prick some place to extract a droplet of blood, and you get one data point, but the diabetic won’t know what to do with this information. His glucose level might be either dropping rapidly or rising rapidly, and he wouldn’t know it unless he then extracts another droplet. Having a continuous sensing, you can display trends, and show on a screen with arrows going up or two arrows if it’s going up rapidly,” said Kost.

He emphasized the benefits that will be available to the parents of child diabetics.

“It will let them sleep better. You can put the sensor on the child, have a beeper in the parents’ room, and the alarm will go off if the blood glucose veers from the norm,” said Kost.

Sontra officials hope to have FDA approval for a continuous glucose monitor by 2007 or 2008. In the meantime, the next time your doctor tells you to prepare for a shot, just say to him ‘SonoPrep.’