“We’re constantly having to raise money and then more money,” complains Dr. Joseph Kost of Ben Gurion University of the Negev. But in truth, Sontra Medical, the start-up he founded together with Dr. Robert Langer of MIT, has had an easier time than its counterparts in the medical devices sector, at least as far as financing is concerned. Since merging with Nasdaq-listed ChoiceTel Communications to form Sontra Medical Corp (Nadaq:SONT) last year, it has been a public company.
Since completing the merger in June 2002, Sontra has benefitted from cash reserves currently estimated at $3.6 million. Before that, Sontra, which was founded in 1998, was supported by venture capital, and raised $20 million, according to Kost.
The basic concept of Boston-based Sontra gives new meaning to the phrase “getting under one’s skin”. The company’s application permeates the skin after a short preliminary ultrasound treatment in order to carry out transdermal diagnosis or drug delivery. Kost says the noninvasive, painless ultrasound skin permeation takes only 15 seconds. The device comes in direct contact with 1 sq.cm of skin - “The size of a nickel,” says Kost. The application of ultrasonic energy creates reversible channels in the skin through which fluids and analytes can be extracted and large molecules can be delivered. The first application of the system was a blood sugar test with no need for a blood sample.
“The skin’s external layer is impermeable,” says Kost. “Its thickness is only 10-15 microns, which is enough to protect us from toxins and foreign substances. It is built of dead dermal cells surrounded by fatty molecules arranged in an impermeable structure.”
Kost goes on to explain that ultrasound temporarily disrupts and alters this structure of fatty molecules, which take time to reform. The process is completely reversible, but until the molecule structure reforms - a process that takes at least 12 hours - the skin is permeable. A glucose-sensitive electrode can be placed on the site, which can continuously test blood sugar levels.
“Unlike current measuring methods that give isolated readings,” says Kost, “the electrode can be kept in place for 12 hours, monitoring continuously. A patient’s blood sugar level is not fixed, so a single reading might give a normal level which can fall later on in the day. To overcome this problem, the measuring device gives a continuous digital readout, and the electrode can transmit the data by wireless, through a tiny monitor. We can also make sure that the moment the blood sugar level falls below a critical point, the patient will receive a warning. Continuous monitoring can also provide information while the patient is asleep, or for diabetic children".
The device, called SonoPrep, is undergoing clinical trials. The kit has two parts: an ultrasound application, for which a marketing permit has already been filed with the US Food and Drug Administration (FDA); and a sensor, that is now in clinical trials with diabetics. Sontra hopes to receive FDA marketing approval for the ultrasound application this year. “It will take time,” Kost admits. “Including regulations, we’ll need three years time to market.” He estimates Sontra will need $15-20 million in the interim.
What is forgiven in a start-up - operating without showing a profit - is a problem for a public company. Sontra posted a loss in its third quarter 2002 financial report, and lost $2.9 million in the first three quarters of 2002.
Kost, who appeared this week at BioAcademy Israel 2003, the Israel BioResearch Convention at the Tel Aviv Fairgrounds, says SonoPrep is a platform, not a single product. The next application will be the delivery of protein treatments by large molecules, which usually require injections. The question is how to commercialize so many products. “Major pharmaceutical companies are interested in the technology,” says Kost. “We’ll develop ourselves if don’t have a choice, but there are three to four very large companies in this market, and we’re in contact with them.”
So if and when more news comes from Sontra Medical, it might be linked to big pharma.
Published by Globes [online] - www.globes.co.il - on January 23, 2003