Our client is currently developing a revolutionary new transdermal drug delivery system that leverages the benefits of ultrasound.
- This system generates ultrasonic transmissions of variable intensity and frequency on a programmed schedule, which dilate the skin pores and facilitate acceptance of drugs into the bloodstream.
- It can deliver both small and large compounds, as large as 75,000 Da, thereby increasing the number of possible drugs compatible with transdermal delivery to over 175.
Significant opportunities exist for this technology to deliver therapeutic molecules for a variety of indications including, but not limited to, Diabetes, Migraine, Multiple Sclerosis, and Parkinson’s Disease.
- This drug delivery system offers users a painless experience with more consistent and controlled delivery, alleviating many shortcomings of other routes of administration.
- One of the first applications for this system is the delivery of insulin to diabetic patients.
- Insulin is incorporated into a patch format, which can be loaded with different quantities of drug.
- After being placed on the patient’s skin, ultrasonic waveforms are applied to the patch. The ultrasound signal is varied between sawtooth and square waveforms.
- This varying waveform expands the skin pore diameter and drives the transport of insulin through the patient’s skin.
- Our client has achieved considerable regulatory advancement, having successfully completed a series of prior FDA-approved trials (five involving 300+ patients in total) and is currently conducting FDA-protocol-approved Phase III trials (both in the USA and Korea).
- In all human trials done to date over the past 5 years, no patient has reported harm or pain. Further, in the case of human trials involving the administering of insulin, the desired medical outcome has been achieved. All human trials have been performed by independent highly respected and accredited medical facilities.
- Extended-term human trials have not yet been undertaken. Such trials, requiring 15 days and 90 days each (as approved by the South Korean Ministry of Drug and Food Safety and the US FDA), are about to be undertaken.
- Our client wishes to apply their technology to the administration of prior “regulator approved drugs.” Accordingly, regulatory approval is only required for the application of this technology, not for the drug being administered.
- Intellectual Property covering our client’s technology platform includes 6 Granted U.S. Patents, 9 U.S. Utility Patent Applications, and an active WIPO PCT.
Our client is seeking partners to develop, license, and commercialize the technology in the following areas:
- Transdermal Insulin – Currently in Phase 3 clinical trials
- Parkinson’s Therapeutic Patch – Ready for Phase 1 clinical trials
- Development of Drug Screening Partners – Our client wishes to identify partners who will sponsor screening of selected drugs for ultrasonic delivery, utilizing their technology platform as proof-of-concept for transdermal delivery of these drugs.