NEWSWIRE) — Transdermal Specialties Inc., a pioneer in painless,
injection-free ultrasonic transdermal drug-delivery systems for the
pharmaceutical industry, will unveil its breakthrough Insulin Patch Technology
at the American Diabetes Association’s 72nd Annual Scientific Meeting, June 9
-11, 2012 in Philadelphia.
Cutting Edge Technology — The U-Strip is an active
transdermal delivery system using a patented alternating ultrasonic waveform
process to enlarge the diameter of the skin pores, enabling large molecule
drugs to permeate through the skin (Stratum Corneum) into the Dermis through
the sweat pores and then into the blood stream – All Non-invasively.
- Delivers Insulin for Both Basal and Bolus Needs.
- Patches Available In Four Different Doses, 25, 50, 100 And
- Electronic Delivery System Tracks Dosing History and Glucose
Downloads Data to Physician for Progress Monitoring
How it Works – The Special Ultrasound System expands the
skin pores to enable large molecule drugs like insulin to be passed
transdermally into the skin- No Needles. The U-Strip Technology expands the
number of Drugs which could be delivered transdermally.
Confocal Imaging – The photograph of the skin below shows
the before & after pore expansion effect of the ultrasound.
Standard Pore size Expanded via Alternating Ultrasound
The U-STRIP (TM) with its Programmable Transdermal Insulin Patch is Totally Non-invasive
and Comparable to an Insulin Pump
Extensive Clinical Program Underway – Transdermal
Specialties is currently pursuing clinical trials of its U-Strip Insulin Patch.
The Company’s goal is to complete the last two clinical trials needed for FDA
approval in the next 18 months. 12 clinical trials have already been
successfully completed, with over 125 diabetics screened so far.
The results will be showcased at the American Diabetes
Convention. The next planned clinical trials will involve over 500 diabetic
patients in two trials before heading to the FDA. The HPT- 6 trial (summer
2012) will examine the tendency of the Insulin Patch to reach the same glucose
level as a pump with less insulin. This implies a higher efficiency for the
Patch. This trial will also compare the speed of delivery vs. Injection to
determine if the Patch can be more effective in Morning Glucose Reduction for
those patients waking with high glucose numbers. The HPT-7 trial (2013) will
focus on a real-world study of 500 Type-2 diabetics, who will conduct an
at-home study over 4 months to track their A1C levels.
Gateway to Improved Diabetes Care – Commented Bruce K.
Redding, Jr., “The Company’s U-Strip system is being designed to blend
Transdermal and Electronic control systems for improved diabetes care”.
The Insulin Patch component offers a safe and painless alternative to
injections with the promise of reduced side effects and improved insulin uptake
efficiencies for the patient. The ultrasound actually reduces the quantity of
insulin needed for effective glucose control and speeds the delivery over a
pump or even direct injection. Improved patient monitoring and reporting of the
Control Device enables better tracking of treatment programs and the new
“Set-it and Forget-It” function means more regular glucose control
during both evening and daytime hours. The U-Strip represents a major advance
in diabetes care.”
“We believe the Transdermal Specialties’ platform
technology has the potential to increase the number of pharmaceuticals which
may be delivered transdermally from a number less than 20 currently expanding
past the 175 formulations already modeled by Transdermal Specialties.
The U-Strip technology expands the number of pharmaceuticals
capable of transdermal delivery both for short term use and for solutions to
the chronically ill” The Insulin and expanded transdermal profile
pharmaceuticals currently represent sales of $24 billion. The transdermal
version of these drugs, many of which are loosing patent protection in the next
few years, offers a major Line Extension potential”.
About Transdermal Specialties, Inc – Transdermal
Specialties, Inc, has been developing the U-Strip technology for drug delivery
in general, with insulin delivery as the market focus, and a sister technology
for improved skin care (the U-Wand) since 2004. The Company expects its
patented ultrasonic delivery systems to be commercialized in late 2012 with the
U-Wand Anti-Acne system and the earliest opportunity for Insulin Delivery in