CHARLOTTE, N.C., Oct. 3 USHIFU, LLC, a privately heldhealthcare development company and the exclusive distributor of the minimallyinvasive Sonablate(R) 500 for prostate cancer treatment in North and SouthAmerica, the Caribbean and India, announced today the hiring of Dr. IanMillett on September 8, 2008, as Director of Regulatory Affairs of FocusSurgery, Inc. (FSI). FSI is the designer and manufacturer of the Sonablate(R)500 medical device. Both companies believe that this hire will accelerateFocus Surgery's ability to expand the FSI HIFU (high intensity focusedultrasound) technology platform.
"We are excited to announce the addition of Dr. Ian Millett as theDirector of Regulatory Affairs. With his extensive experience from inside theFDA as well as successful PMA and 510k track record, Ian will play an integralrole in building out our HIFU technology platform," said Steve Puckett, Jr.,CEO of USHIFU. "Ian shares our vision that the prostate modality is only thebeginning of major technological innovation in store for HIFU."
"Dr. Ian Millett will accelerate our organization's efforts for clearancefor both the recurrent and primary prostate cancer clinical trials," saidNarendra Sanghvi, President of FSI. "Dr. Millett's experience working with theFDA will also enhance our ability to effectively move forward with additionalapplications of HIFU that are under development at Focus Surgery and USHIFU."
As the Director of Regulatory Affairs, Dr. Ian Millett will be developingstrategies for regulatory approval of medical devices, coordinating submissionactivities for a variety of device regulatory approvals and leading FDAmeetings on the clinical activities and PMA submissions. Dr. Millett will alsobe serving as an internal consultant on general regulatory issues and managingassigned internal and external clinical activities.
Dr. Ian Millett received his B.S. in Chemistry from the University ofCalifornia, Berkeley, and his Ph.D. in Chemistry from Stanford University.Prior to joining FSI, Dr. Millett was in charge of development of regulatorystrategies for high risk, combination medical devices, development ofregulatory strategies for introducing innovative Class III medicaltechnologies and oversaw the preparations for submissions world-wide for aleading international medical device company. He has also worked with the FDAto approve and streamline the approval of medical devices and combinationmedical products.
The Sonablate(R) 500 is not approved for use in the U.S. The Sonablate(R)500 remains investigational in the U.S. and is being studied for the treatmentof prostate cancer in clinical trials in the U.S. FDA has made no decision asto the safety or efficacy of the Sonablate(R) 500 for the treatment ofprostate cancer. Currently, the device is available for the treatment ofprostate cancer in Canada, the Dominican Republic, Argentina, the Bahamas andMexico.
SOURCE USHIFU, LLC