|
| Register for our Free Newsletters |
|
 |
|
|
|
|
|
|
|
|
| Other Carouselweb publications |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Aethlon’s Hemopurifier medical device is cleared to be exported to India
|
|
Aethlon Medical
: 09 March, 2011 (Company News) |
|
|
The US Food and Drug Administration (FDA) grants Aethlon’s request to export its Hemopurifier medical device to India. |
|
The FDA’s approval was granted under Section 801 (e) of the Federal Food, Drug, and Cosmetic Act, as amended (the Act). Section 801 (e) of the Act covers class III medical devices, such as the Hemopurifier, that have not yet received an approved Premarket Approval in the US by the FDA. Section 801 (e) applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices.
'The granting of our export license by FDA represents a critical step in our strategy to initiate future commercialization of our Hemopurifier in India,' said Jim Joyce, Aethlon Chairman and Chief Executive Officer.
Aethlon is currently conducting a clinical study entitled: 'Use of the Aethlon Hemopurifier in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy' at the Medicity Institute (Medicity) near Delhi, India.
The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier centre of medical tourism in India. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates.
Upon demonstration of treatment efficacy, Aethlon plans to commence commercialization of its Hemopurifier in India.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
