Aquavit Pharmaceuticals's iMicrotox (IMX-001) Study Receives IRB Approval
Published: Sep 01, 2017
LAS VEGAS, Sept. 1, 2017 /PRNewswire/ -- Aquavit Pharmaceuticals announced today that it has received a green light from the IRB, to conduct in-depth research for microchannel application of neurotoxins in the peri-orbital region (IMT-121).
This study includes the three currently FDA approved neurotoxins (onabotulinum toxinA, incobotulinumA and abobotulinumtoxinA) to be administered through AQT-001, Aquavits' patented microchannel drug delivery device, commercially known as AQUAGOLD fine touch. iMicrotox is a combination application of a neurotoxin with AQT-001 administered into the peri-orbital region.
The scope of the study will be measuring the efficacy of iMicrotox to treat mild-to-moderate peri-orbital rhytids. Performed by 6 world renowned key opinion leaders. A randomized split-peri-orbital trial will include a minimum of 120 patients. Patients will receive one treatment of iMicrotox to one peri-orbital side, while the other will remain controlled and untreated.
"Presently, it is very difficult to inject neurotoxins safely and effectively into the peri-orbital region. The successful implementation and outcome of the iMicrotox technique would be a revolutionary advancement from current industry standards and techniques," said Dr. David Shafer, Double Board Certified Plastic Surgeon, and Chief Medical Technology Officer at Aquavit.
The study is expected to span a 2 month period with treatment and follow-up protocols in place. The success of this development will potentially be the first FDA approved microchannel delivery of neurotoxins for the peri-orbital region in the US.
About Aquavit Pharmaceuticals, Inc.
Aquavit Pharmaceuticals is a multi-specialty healthcare company focused on discovering, developing and commercializing innovative pharmaceuticals, medical device, and health technologies. For more information, visit www.aquavitpharma.com.
SOURCE Aquavit Pharmaceuticals, Inc.