SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
___________________
Date of Report (Date of earliest event reported) March 11, 1996
BIOCONTROL TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
Pennsylvania 0-1822 25-1229323
(State of other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification no.)
300 Indian Springs Road, Indiana, Pennsylvania 15701
(Address of principal executive offices) ( Zip Code)
Registrant's telephone number, including area code (412) 349-1811
_________________________________________________________________
(Former name or former address,
if changes since last report.)
<PAGE>
Item 1. Change in Control of Registrant.
Not applicable.
Item 2. Acquisition or Disposition of Assets.
Not applicable.
Item 3. Bankruptcy or Receivership.
Not applicable.
Item 4. Changes in Registrant's Certifying Accountant
Not applicable.
Item 5. Other Events.
On March 11, 1996, Biocontrol Technology, Inc. (NASDAQ:BICO)
sent an open letter to stockholders and diabetics. See
attached.
Item 6. Resignation of Registrant's Directors.
Not Applicable
Item 7. Financial Statement, Pro Forma Financial Information and Exhibits.
(a) Financial Statements and Businesses Acquired - Not Applicable.
(b) Pro Forma Financial Information - Not Applicable.
(c) Exhibits - letter to stockholders and diabetics
<PAGE>
SIGNATURES
Pursuant to the requirement of the Securities Exchange Act of 1934,
the Registrant has duly caused this Report to be signed on its behalf
by the undersigned hereunto duly authorized.
BIOCONTROL TECHNOLOGY, INC.
by /s/ Fred E. Cooper
Fred E. Cooper, CEO
DATED: March 11, 1996
<PAGE>
March, 1996
An open letter to stockholders and diabetics:
On February 26, 1996, an FDA Advisory Panel reviewed the marketability of the
Diasensor 1000, the world's first noninvasive glucose sensor developed by
Biocontrol and the only noninvasive glucose sensor to ever be submitted to the
FDA. Following this, much misleading, even outrightly erroneous, information
about the research data and the panel review results appeared.
We'd like to get the record straight.
First, the Diasensor 1000 is not yet the perfect noninvasive glucose sensor.
It is the world's first such technology, and as such will definitely need
continued research and development. However, the research data submitted to
the FDA more than adequately demonstrates that this sensor does safely and
accurately measure glucose for a certain percentage of the diabetic population.
Why didn't the FDA Advisory Panel think so? There are many factors at play
here, only one of which centered around the fact that the data was gathered and
presented using the Clarke Error Grid graphical method of assessing clinical
performance of blood glucose monitors. Devised in 1987, the method has been
gaining acceptance by clinicians who believe it does a better job of evaluating
clinical consequences of home-use blood glucose monitor errors than the
conventional analytical methods which better represent laboratory reference
devices. any of the panel stated that they were not familiar enough with the
Clarke Error Grid analysis method to be comfortable with it. To fairly
evaluate Biocontrol's data submission, this error grid analysis method must be
understood. The panel members should have been required to be familiar with it.
Second, eight patients were enough to gather sufficient data on the efficacy
and safety of the Diasensor 1000 monitor. It was enough because for those
eight patients, 263 data points (Diasensor reading compared to an industry
standard reading) were submitted to the FDA - that's an average of 32 data
points per patient. Currently used finger stick technology firms only submit
an average of 1 data point per patient for devices they are attempting to get
cleared. That means 100 data points submitted equals 100 patients studied.
Therefore, 263 data points submitted for the Diasensor 1000 is equal to having
tested 263 patients _ a substantial test size.
Consider also that it should not matter to the FDA whether the Diasensor 1000
sensor can help 8, 200, 2000, or 2 million people. If it works for only one
diabetic in the United States, that one person should be allowed to have the
machine. In that regard, what makes this product different from an
FDA-approved drug like Penicillin which definitely cannot help everyone yet it
is allowed on the market to help those who can use it.
To get to the eight patients, BICO began with 85 original patients. Of those
85 patients, 22 were eliminated due to a detector (critical part of the
machine) that failed at one test site and two were eliminated because their
glucose levels did not vary sufficiently to calibrate the machine to them.
Of the remaining 61 patients, 47 were successfully calibrated (necessary
algorithms were obtained) and Biocontrol chose, and the FDA did not object,
to follow 23 of these 47 patients to allow for a more rapid accumulation and
reporting of the data. At the time, the Company did not have sufficient
funds to purchase additional computers and software that would have allowed for
rapid processing of the test data. What it can process in a day or two now
took Biocontrol weeks to process at that time.
What BICO ended up with was a noninvasive sensor that worked well for eight of
the 23 patients calibrated, verified, tested, and followed for 30 days. For
35% of the diabetics who could calibrate to the sensor, the machine did its job
of measuring glucose noninvasively.
Third, how do we know it measured glucose and measured it effectively? Each
patient's glucose levels were also measured by the industry standard YSI
(Yellow Springs Instrument), which is, incidentally, the same measurement
reference device used to test and compare currently used invasive monitors.
Therefore, if these invasive monitors are held up as effectively measuring
glucose by parallel comparison to the YSI, then it must be accepted that the
Diasensor 1000 noninvasive sensor is also measuring glucose and measuring it
comparative to these currently used monitors.
Fourth, following each patient for 30 days was considered entirely acceptable
as the physician's manual submitted to the FDA requires the sensor to be
brought back to the calibration centers every 30 days. Therefore, if the
sensor functioned accurately and safely for that period of time, it would be
rechecked and would then be used for another 30-day period.
Fifth, many features are built into the design and marketing plans of the
Diasensor 1000 noninvasive sensor to insure patient safety in use. The device
is to be available only by physician prescription. No one will buy the sensor
then take it home and pray that it functions properly. When the device is
prescribed, the patient will then be evaluated to determine calibration
potential. If it is possible to calibrate to the patient, it will be done
before the patient is permitted to take home the sensor. Most importantly, the
Diasensor 1000 must initially be used concurrently with an invasive monitor and
any inconsistencies by the Diasensor must be reported to the physician. Only
after successful 30-day use in the home and recheck at the calibration center,
will the patient purchase the machine. And even then, the pattern of 30-day
checks will be continued.
Yes, the sensor at this time only gives a reading 50% of the time because its
abilities to give a reading can be obstructed by hair, dirt, oil, etc. This
will get better and keep in mind that the sensor doesn't give an erroneous
report because of these interferences _ it just doesn't read at all. When that
happens, the patient can simply take another reading. Remember, for every
ten tries, five readings will be obtained; for every 20 attempts, ten will be
obtained, etc. Again, at this time, the Diasensor 1000 gives a reading 50% of
the time it is asked to do so. Of course, if the patient wishes, an invasive
monitor can be used if a reading is not obtained by the Diasensor 1000 sensor.
When the sensor does give a reading, it is as accurate as currently used
sensors. We have the data to prove it. Actually, the Diasensor 1000 can be
more accurate in the home setting than currently used invasive meters because
there is very little technique needed and, therefore, much less chance for
human error that causes inaccurate readings with the finger stick method.
And many of you with diabetes are "painfully" aware that invasive glucose
meters give erroneous readings, as several diabetics loudly pointed out to
the members of the FDA Advisory Panel on February 26. This fact was driven
home again recently by the father of a diabetic child, Ronald Brenners, who
called the company to relate such an incident that just happened a few days
ago. While Mr. Brenners' son, Ben, was playing baseball, his father checked
his glucose and got a reading of 50. Since Ben didn't show any signs of
hypoglycemia (low blood glucose), Mr. Brenners thought it wise to re-test him
immediately. This time, with the same meter, he received a reading of 300!
Evidently, FDA-approved invasive meters are not perfect either.
Sixth, it is true that the noninvasive sensor is not yet fully tested at the
hypoglycemic range. That is not a safety issue, however. When initially
calibrated and evaluated, a patient will be given his range of calibration.
The patient will be instructed to use his finger stick method of evaluation if
readings outside of his calibration range are given by the Diasensor 1000. In
upcoming testing, the Diasensor 1000 will be tested in the hypoglycemic range.
Lastly, the FDA did not reject the Diasensor 1000. Actually, to date, the FDA
has not reacted to the Advisory Panel at all _ the Company has not yet heard
their decision or recommendations based on the Panel Review. We can assure
you, however, even though we have reservations about this Panel Review,
Biocontrol will do whatever is necessary to get the Diasensor 1000
noninvasive glucose sensor to market.
For every 100 people with diabetes, about 78 can be identified as potential
users of the Diasensor 1000 and about 27 of those 78 will be "compatible" with
the sensor and therefore able to purchase and use it. That's on the research
model _ the production model Diasensor 1000, on which no data was permitted by
the FDA Advisory Panel, has demonstrated up to a 30-fold improvement in data
collection efficiency in bench tests.
To put the above information in perspective, consider that the Juvenile
Diabetes Foundation (JDF) estimates that worldwide there are about 110 million
people with diabetes. By the testing on our research model, approximately 78%
(or 85,800,000) of those people will be identified as potential users of the
Diasensor 1000 and about 35% (or 30,030,000) of them will be "compatible" with
the machine and able to purchase and use it. That is a lot of people who
can be helped.
No, the world's first noninvasive glucose sensor is not perfect, but as a
father of a diabetic recently put it, if we don't start somewhere, we won't
get anywhere. The Diasensor 1000 can safely and accurately work for a
percentage of the diabetic population NOW, while continued R & D makes it
ever better.
Which of you with diabetes does not want the chance to see if you fall into
that 35% for whom the Diasensor 1000 will eliminate many of those finger
pricks? Also, when asked, 80-90% of you with diabetes or who care for
someone with the disease, have emphatically said that a $170 monthly payment
for the sensor would not be too much and it doesn't matter if the sensor is
not yet small enough to go everywhere. The message here seems to be that
size and cost, in this case, are not the issues. Improvement to the quality
of life is. Those of you who do not have your lives touched by diabetes,
should ask any person with diabetes or any parent of a child with diabetes
about these issues.
Since Biocontrol developed the Diasensor 1000 noninvasive glucose sensor
for them, the diabetics of the US should have a voice regarding its use.
Many of them voiced their opinions on February 26th. They were not heard.
Frankly, in my opinion, they are truly the ones that count.
Sincerely,
Fred E. Cooper
Chief Executive Officer
