Clinical Trials – U-STRIP / INSULIN PATCH

Trial Description Conducted at: No of Human Volunteers IRB Status Outcome
1. Animal Trial-1 Preliminary Test Calvert Labs 0 None Compl. Theory Demo.
2. Animal Trial-2 Dosing Trial Calvert Labs 0 None Compl. Dosing Demo.
3. HPT-1A Saline Delivery Trial Encap. Systems 4 HN St.Davids Compl. Proof of Concept.
4. HPT-1B Humulin Insulin Human Test Diabetes & Glandular 4 HN St.Davids Compl. Proof of Concept.
5. HPT-2A Lispro Trial, Patch Vs. Pump Kessler Res. Inst. 6-TY-2 Chesapeake Compl. Test of Absorbent Pad Patch.
6. HPT-2B Patch Vs. Oral Meds, Fasting Kessler Res. Inst. 6-TY-2 Chesapeake Compl. Test of Absorbent Pad Patch.
7. HPT-2C Patch Vs. Oral Meds, Daytime Kessler Res. Inst. 6-TY-2 Chesapeake Compl. Test of Absorbent Pad Patch.
8. HPT-2D Patch Vs. Oral Meds, Night Time Kessler Res. Inst. 6-TY-2 Chesapeake Compl. Test of Absorbent Pad Patch.
9. HPT-2E Daytime Study Over 8 Hours Kessler Res. Inst. 125-TY-2 Chesapeake Compl. Test of Absorbent Pad Patch.
10. HPT-3A Skin Absorption Of Lispro Insulin KGL Skin Labs 6-TY-2 Chesapeake Compl. No Skin Irritation of Insulin.
11. HPT-3B Skin Sensitivity To Patch W Insulin KGL Skin Labs 25-TY-2 Allendale Compl. No Skin Irritation of Insulin.
12. HPT-4 Skin Sensitivity To Ultrasound KGL Skin Labs 25-TY-2 Allendale Compl. No skin irritation of constant Ultrasound over 5 hours.
13. HPT-5 Confocal Imaging Trial Lucid Tech 6 HN Allendale Compl. Delivery pathway test. Determined Pore Delivery.
14. HPT-6A PK with Desktop Wake Research 5 PD Quorum Compl. Low Limit Cutoff on glucose drop.
15. HPR-6B.1 PK : Mini Device/8 hrs. TSI 6 TY-2 Quorum Compl. Successful design of mini device & glucose stabilization.
16. HPR-6B.3 PK with mini U-Strip & Low Profile Patch Over 24 hour period. Thomas Jefferson Univ. 12 TY-2 Jefferson Compl. Successful demo of mini device & glucose stabilization.
15. HPT-7 Night Time Assist Device D&G, Wake, Joslin, Jefferson 250–500 TY-2 FDA, CDRH To Do Phase-3 trial
16. FDA-GO To Do

During the clinical trials to date the device and the patch were generally well tolerated
with no serious adverse events.

  • Compl.= Trial Completed, Positively
  • TY-1 = Type-1 Diabetic Volunteers
  • TY-2 = Type-2 Diabetic volunteers
  • HN = Healthy Normal Volunteers
  • PD = Pre-Diabetic

US Patent No: 7,440,798 / 6,908,448 and Other Patents Pending Internationally

Clinical Trials – U-Wand

Pre-Test Program

Severe Acne Condition Before

Severe Acne Condition Before

Cleared of Acne after 2 Weeks

Cleared of Acne after 2 Weeks

Unretouched Photos after Severe Acne test

Clinical Trial – 30 Days

U-Wand Clinical Trial Results

Clinical Trial Documentation & Results

TSI Compl.d its clinical trial on the U-Wand in early 2011. To monitor the trial, TSI used a company that is the industry leader in providing the imaging systems and support necessary for high definition photographic documentation in the medical and skincare fields. According to their analysis, the average reduction in facial lesions from the use of the U-Wand™ Anti-Acne Treatment System was 70.3% over all the volunteers in 4 weeks. The highest reduction score achieved by this Company prior to this clinical trial was a 20% reduction in lesion count.

Future U-Wand Application Opportunities

Age Spots Facial Moisturizers Treatment of Cold Sores
Cellulite Treatments Skin Lightening Treatment of Thinning Hair
Facial Cleansers Anti-aging Gels