Bioelectronics Corp (OTCMKTS:BIEL) Engages Southeast Asia Distributor
Bioelectronics Corp (OTCMKTS:BIEL) has appointed engaged PharmEvo as its ‘ActiPatch®’ Musculoskeletal Pain Therapy supplier for Cambodia, Myanmar, Vietnam, Sri Lanka and Kenya. PharmEvo, established in 1999, has yearly sales of more than $300 million and a team of 850 people. Its corporate headquarter offices are in Karachi, with 9 places in Pakistan and global market coverage in Kenya, Philippines, Vietnam, Cambodia, Guatemala, Kenya, Myanmar, Sri Lanka, Kazakhstan, Uzbekistan and Tanzania.
PharmEvo engaged in the advancement, manufacture, marketing and creation of pharmaceutical products, comprising OTC medicines, infant formulas and medical equipment. PharmEvo associates with many global groups for bringing premium products to its consumers: Lactalis (France), Bioton (Poland), Becton Dickson (USA), Omron (Japan), etc.
Nadeem Rehmat of PharmaEvo has shown his confidence that ‘ActiPatch’ therapy is a notable addition to their OTC line. Erin Sanders, the Sales Manager of BioElectronics, said that they are delighted to have PharmEvo as ActiPatch products distributor in Southeast Asia. They believe that their exclusive cost effective drug-free pain treatment will have outstanding market acceptance in Asia.
In unrelated news, BioElectronics reported that on October 3, it talked to senior management from the U.S. FDA’s Division of Neurological & Physical Medicine Devices. The meeting was pertaining that discussion on the data requirements to back a musculoskeletal pain indication for its device.
The company reported that in the 51O(k) notification for the ‘ActiPatch®’, they included osteoarthritis of the plantar fasciitis and knee clinical trials, along with a description of the device’s action mechanism, to support musculoskeletal pain relief indication. The entity has requested clinical report from an additional anatomical application segment.
They are prepared to offer real world evidence representing use of the ActiPatch® for cure of chronic back pain from their large UK chronic pain registry. They are evaluating whether the registry report, along with the 2 controlled clinical trials, would be sufficient for the indicated purpose, and FDA has specified certain criteria that it believes relevant to this evaluation; they are preparing to file the relevant data for the agency’s review.© Copyright 2016 OTC News Magazine. All rights reserved.