TRANSDERMAL INSULIN
Insulin is too large a molecule to work with a conventional patch. The U-Strip™ uses a special, patented ultrasound technique to dilate the skin pores and push the compound into the blood stream. There are 37 million Diabetes patients in the US, with another 60 Million Pre-Diabetic. 90% are Type-2, who use Insulin needles, pumps or oral meds to control their glucose. The needle and the pumps are highly invasive. The orals are often hard to maintain on a dosing schedule and lead to other difficulties. The complexities and burden of current insulin regimens often result in an irregular control of the diabetic glucose condition. The U-Strip™ Transdermal Insulin Patch system makes for an easier maintenance of glucose, with a set-it-and-forget-it easy to use patch technology, all with no skin penetration and is especially aimed at the Needle Adverse much larger Type-2 market. The Trans-Insulin™ Patch Micro-Doses insulin to lower the patient’s glucose level to that of a Healthy Normal Non-Diabetic, then maintains that level throughout the day and night. The system avoids glucose spikes at night and counters spikes during a meal-just hit the Bolus Button-No Carb Counting- Press the button during the meal. Less Burdon on the Diabetic.
NO SKIN DAMAGE- No Needle or Catheter Wounds from using an insulin pump
KEY FEATURES / ADVANTAGES
- New 5-Day transdermal Insulin Patch provides week-long insulization for both Ty-1 and TY-2 diabetic patients.
- Trans-Insulin™ Patch is totally non-invasive-no needles and reduces the burden of diabetic care.
- Trans-Insulin™ Patch avoids glucose spikes, adjusts for meals and generally keeps the patient’s glucose between 85 – 110 mg/dl. with a A1c Range of 5.9 to 6.4.
- Uses a standard Lispro R-100 insulin in the patch with a shelf life of 8 months.
- System employs a special patented ultrasound delivery system for dilating the skin pores and delivering large molecule drugs to the Dermis.
- Uses a Unique Micro-Dosing algorithm which first lowers a high glucose to the range of a Healthy Normal, Non-Diabetic glucose level ( 85-110 mg/dl) and then delivers a maintenance stabilization timed dose to maintain that level during the day. For meals just press the Bolus button on the Controller and the unit delivers a counter dose of insulin to avoid glucose spikes.
TYPICAL GLUCOSE PATTERN: AUTOMATIC GLUCOSE CONTROL WITHOUT A CGM. JUST INPUT STARTING GLUCOSE AND SET-IT-AND-FORGET-IT.
CLINICAL PROGRESS AND THE FDA: Over 300 subjects tested over Phase 1 & 2 clinical trials. The Trans-Insulin™ Patch is now in Phase-3, currently conducting a Time in Range study in both the US and S. Korea. This trial will lead to final authorization from the FDA to complete the full Phase-3 in the United States (280 subjects) and S. Korea (150 subjects) using a reduced 14-day test period for each diabetic subject. Final FDA approval is expected in 2025.South Korea in 2024. Clinical studies planned for Diabetes & Glandular (San Antonio, TX), Univ. of Pennsylvania (Philadelphia, PA), Yale Medical School (New Haven, CT) Joslin Diabetes Center (Boston, MASS), Wake Research (Raleigh, NC), Medstar Hospital (Baltimore, MD), Severance Hospital (S.Korea & China). All total these Super Clinics have 755,000 Type-2 diabetic patients enrolled.
EVERYONE KNOWS SOMEONE WITH DIABETES.
If you are interested in learning more about this unique non-invasive insulin delivery system or would like to participate in our final phase-3 program please refer to www.u-strip.com