In the ever-changing, unstable business of non-invasive glucose meters only one thing seems certain: nothing is certain.
The meters, which are expected to make it onto the American market by late 1997 or early 1998, will be a welcomed replacement to the current models of blood glucose testers used by people with diabetes, which require painful finger-sticks as many as 8 times a day, but the non-invasive companies have their work cut out for them before then.
Biocontrol Technologies, Inc. has had a hectic year as they attempted to get the Diasensor 1000 approved for sale in the U.S.
In January, 1994, they filed a 501(k) application to the FDA. This is a pre-market notification that requires a manufacturer to demonstrate that its machine is equal to or better than the other glucose meters on the market.
The 501(k) application was given a processing number in late February, a stage that 33% of 501(k) applicants never reach.
In April, 1994, Biocontrol announced that it had successfully raised $12 million in capitol to fund the manufacturing of the Diasensor, which is expected to cost $7,950 when it reaches the American market.
In December, 1994, Diasense, Inc., the company in charge of marketing the Diasensor 1000, held a meeting in New York to drum up investor interest in the company, and, though the company was not yet traded on an exchange, was offering stock at $3.50 a share. The company was hoping to sell 1.54 million shares in this offering.
While the company was focusing its efforts on FDA approval, they also opened offices in Mexico City and London, where the company was accepting orders for the product.
On December 13, 1994 the Biocontrol technology team and medical advisors met with the FDA to discuss the 501(k) application. Fred E. Cooper, Chief Executive Officer at Biocontrol, said of the meeting, “We addressed various technological and medical questions asked by the FDA representatives. The FDA requested some additional data that we are in the process of providing to them through subjects being tested at our testing facility in Indiana, Pennsylvania. In addition, the FDA requested testing data from two additional locations. We have commenced testing in West Lafayette, Indiana, and are in the process of selecting a third location.”
Though there can be no guarantees, Biocontrol said in a press release that the management felt optimistic that the FDA would approve the application after they completed the additional testing they requested.
When, and if, the Diasensor 1000 makes it onto the market, it will be an 11″x18.5″x11″ machine, much larger than the pocket-sized meters currently available.
The goal for most non-invasive meter companies is to make a machine comparable in size to the blood glucose meters in use now. Biotronics has been working on a spectrum analyzer which is capable of measuring nine different blood components, including glucose.
The large machine is already in use at a navy hospital in San Diego, but the goal is to get the machine shrunk down to a size that would be usable in the battlefield. This smaller-sized unit would also be more feasible for every-day use by people with diabetes.
The original machine was not specifically developed as a glucose meter, Biotronics has formed a spin-off company to market a meter exclusively for glucose.
The Biotronics machine differs from the Biocontrol machine in that it uses reflective near infrared spectroscopy, bouncing light off the capillary bed, as opposed to the near infrared spectroscopy used in the Biocontrol product which involves the light passing through the arm.
Over 1,000 patients have been tested with the large machine and, though they were not concentrating on blood glucose, some people with diabetes did come in to be tested, and those results correlated well with blood glucose levels, according to Ken Schlagger at Biotronics.
Boston Advanced Technologies also had been working with a non-invasive meter, and had licensed marketing rights to Cascade Medical, a blood glucose meter company which suspended operations the end of 1994. The company’s technology is now being developed by a company called AngioMedics.
Sandia National Laboratories, a government-run research and development laboratory whose investors include LifeScan, has been involved in working out a calibration system for non-invasive meters. Sandia has licensed its technology to Rio Grande Medical Technologies. Both companies are in the process of developing the technology.
It seems there are new advances, and retreats, almost every week in the race to get non-invasive meters on the market. It will remain to be seen who, if anyone, wins that race.