Polymer Technology Systems, Inc. Granted Conditional Approval of CFC BioScanner System by The Food and Drug Administration.

Jan 07, 2000, 00:00 ET from Polymer Technology Systems, Inc.

    INDIANAPOLIS, Jan. 7 /PRNewswire/ -- Polymer Technology Systems, Inc. has
 been granted conditional approval by the Food and Drug Administration approval
 to begin investigational testing of its CFC (Capillary Filtrate Collector)
 BioScanner System(TM).  The conditional approval, based on the submission of
 the investigational device exemptions (IDE #G990251) application, allows
 Polymer Technology Systems, Inc. to begin testing subjects in accordance with
 the FDA's investigational site waiver.
     The CFC BioScanner System(TM) is an implantable device for testing of body
 fluid collected subcutaneously. It is a combination of:
     1. A device called the Capillary Filtrate Collector (CFC), which collects
        body fluid subcutaneously and,
     2. An electro-mechanical device called the Filtrate BioScanner that
        measures glucose levels in the ultrafiltrate collected via the CFC.
     The Polymer Technology Systems CFC device will be used on hospital based
 patients initially.  The system can be programmed to run a test as often as
 every 2 minutes.  The initial clinical studies will be performed on diabetic
 surgical patients.  The CFC will be inserted in pre-op, follow the patient
 with correlating fingerstick glucose in the operating room, and then follow
 the patient for an additional 2 hours in post-op.
     Due to the high vacuum used to remove the filtrate from the proximity of
 the capillary bed, the actual static interstitial fluid will be "removed" by
 early sampling and almost real time (5 - 10 minutes) correlation with actual
 blood glucose could then occur.  This type of fluid sampling system will not
 be impacted by surface skin "sweat" as other "Outside the body sample
 collection" device systems.
     Second generation product will include the measurement of ketone
 simultaneously with glucose in the emergency room environment for the
 treatment of diabetic keto-acidosis (DKA).
     This second generation product will next be introduced to help diabetics
 monitor blood glucose at home, work or play without the several times daily
 current regimen of sticking ones finger to draw blood.  Furthermore,
 inadequate monitoring of glucose levels leading to poor glucose control in the
 patient is the causative factor in the long-term complications associated with
 diabetes such as renal disease, amputations and blindness.  Currently, the
 most common method available to the diabetics for monitoring their glucose
 levels is to prick their fingers to obtain a blood sample to be tested with an
 instrument such as a Glucometer.  This is a painful method for the patient,
 especially when multiple tests must be performed every day.  Hence, few
 patients follow the recommended schedule exactly and the noncompliance leads
 to the failure in self-monitoring of blood glucose in the patient.  An
 implantable glucose sensor that can be worn continuously by the patient and
 provide constant monitoring of glucose levels could significantly improve
 control of diabetes in the patient.
     Much discussion has taken place recently on the subjects of non-invasive
 and minimally invasive testing of glucose levels in diabetics, but the fact is
 that these systems will not be available in the near future or have not yet
 been proven viable for a home system, respectively.  This year's Oak Ridge
 Conference (an internationally known conference held every year and attended
 by top scientists in the field from around the world to assess and present
 studies and review the status of new technologies) main topic was "On the Road
 to Non-Invasive Testing."  The conspicuous absence of the companies that have
 been claiming great progress in the non-invasive area was noticeable to this
 year's attendees.  The panel's conclusion regarding non-invasive testing noted
 that it might be possible, but not until spectrophotometric technologies are
 improved, and it might even have to be a combination of technologies.  It will
 not happen in the near future.
     Comments at the Oakridge Conference on other procedures for the
 measurement of interstitial fluids are as follows:
     Non-Invasive using Patch method or interstitial fluid:
       A number of presentations were given; one presentation stated that due
       to the variation of sweat mixing with interstitial fluid the patch
       method was probably useful for qualitative tests but would not be useful
       for glucose.
     Two presentations on minimally-invasive testing using interstitial fluid
 were from presented:
       One system consisted of an electro-chemical sensor implanted under the
       skin and left in place for three days.  Its use would be by physician
       only and would only be useful for supplemental data since it has to be
       calibrated by at least 4 regular finger sticks with a strip and meter
       system each day.
       The other system presented was good but only included fasting glucose
       values.  No data was presented using real world data on a final
       prototype where the extraction portion and testing portion were
     Polymer Technology Systems, Inc., is a privately owned company located on
 the northwest side of Indianapolis.  Incorporated in 1992, PTS delivers
 leading edge, point of care diagnostics to the health care market catering to
 both physicians' offices and the home consumer.

SOURCE Polymer Technology Systems, Inc.