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