Published On: Wed, Jun 29th, 2016

Bioelectronics Corp (OTCMKTS:BIEL) Aims To Pursue 510(k) Path For ActiPatch

Bioelectronics Corp (OTCMKTS:BIEL) has provided an update on its official company website, stating that a representative from the US FDA had met with the company and updated that the 510(k) pathway might now be available for the approval of the company’s ActiPatch device. It should be noted here that initially the FDA had asked the company to pursue the de novo path for the approval of ActiPatch.

The ActiPatch from Bioelectronics is a musculoskeletal pain therapy device, which recently underwent a clinical study in the UK. The FDA had initially questioned the company about the trials and the 5,000 ActiPatch users. It should be noted here that these questions were in response to the review of the company’s 510(k) application. The Director for research at BIEL, Ian Rawe, had hoped that the management was somewhat successful in satisfying the inquiries.

However, the FDA was concerned about the company’s OTC status. The agency believed that since there were no non-thermal shortwave therapy devices for OTC use, the 510(k) pathway was inappropriate. Bioelectronics had hoped that it had been successful in explaining its position on the matter. Now it seems like the company has had some success in making the FDA see its point-of-view. Although the news had rallied the investors behind the stock, but BIEL was unable to maintain its gains.

It is believed that Bioelectronics financial position is largely to blame for its losses in the market. The company’s most recent financial report, 1Q2016, had revealed that BIEL had a cash position of $22,000, with a sales figure of $528,000. Unfortunately, this had not been enough for the company to meet its operational expenses, as BIEL reported a net loss of $457,000 for the quarter. Even though the company has significantly lowered its losses and improved sales, its ability to continue with the current capital deficit and cash position remains questionable.

Bioelectronics Corp (OTCMKTS:BIEL) completed the June 28 trading session, with a trade volume of 72.24 million, to reach a close at $0.0011 per share.

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