Advanced Medical Isotope Corp. (OTCMKTS:ADMD), a leading late-stage development company with the prime focus on developing brachytherapy devices, has decided to announce strategic and commercial plans.
As per the reports, it updated about the de novo submission of Y-90 RadioGel device to the FDA. Apart from it, the company also talked about financial matters.
Road So Far:
Previously, Advanced Medical Isotope Corp. provided a de novo submission to FDA for its Y-90 RadioGel device in December 2014. The prime objective of the company was to get this device reclassified as Class II device. Advanced Medical wanted to get marketing clearance for the device in the national market. However, FDA has refused to give marketing clearance as well as reclassification to Y-90 RadioGel, which simply means that the device will continue to be in Class III or premarket approval stage.
While analyzing the device, FDA asked for additional information from the company to evaluate the effectiveness and safety of the device and asked it to submit a new direct de novo. As a result, Advanced Medical Isotope has decided to partner with some of the leading companies to come up with optimal preclinical animal studies protocol.
As per the reports, Advanced Medical Isotope Corp. (OTCMKTS:ADMD) is planning to use Pre-Submission process before it meets FDA officials in 4Q2015 to review preclinical studies’ draft protocols so that it can generate additional protocols. These protocols will further support the company concerning its Class II reclassification. The most important objective of the company as of now is to get the regulatory approval for Y-90 RedioGel. The company is also looking for additional opportunities in Canadian, European and Asian markets for the device.
The senior management of the company is confident about the future proceedings and hopes that thing will turn fine in support of the company in the coming months.