E-QURE Corp. Issues 2014 – 2015 Update to Shareholders
Chairman Discusses Acquisition, and Commercialization of Electrical Stimulation Medical Device for Chronic Wound Care Treatment
MAY 5, 2015 - NEW YORK -- E-QURE (Electric Quick Ulcer Remedy) Corp. (OTCQB: EQUR; “E-QURE” or the “Company”), a premier provider of innovative medical devices in the field of advanced wound care treatment, today issued an update to shareholders and the investment community, covering 2014 - 2015 business developments including the financing and acquisition of the proprietary Bioelectrical Signal Therapy™ (BST) Device for advanced hard-to-heal wounds and ulcers, the completion of its S-1, as well as its plans for commercialization and sale of the device in the U.S. and in Europe.
Thank you in advance for your continued trust in E-QURE Corp and our non-invasive, painless, proprietary electrical stimulation (ES) medical device proven to heal chronic wounds and ulcers easier, faster and more effectively than ever before. We find ourselves positioned well to capitalize on a highly addressable global market which reaches into hundreds of millions of people suffering from very hard to heal, chronic wounds including Pressure Ulcers, Diabetic Foot Ulcers, and Venous Leg Ulcers.
The second half of 2014 was productive to say the least - characterized by the achievement of important milestones that include but are not limited to the completion of our private placement, successful capital raise of roughly $3.0 million, and the acquisition of the breakthrough, non-invasive wound care technology – the BST Device. The funds were used to cover the acquisition of all sample prototype devices and all proprietary intellectual property related to the device including the product manufacturing documents from third parties, as well as further product development initiatives and corporate expenses related to the public entity.
Since January, the team has been making inroads necessary to get the product federally approved for use in hospitals, clinics and/or home care settings throughout the U.S. FDA approval is our top priority for 2015 and 2016. Several prototype BST devices have already been converted to 110V, tested, re-packaged and shipped to the USA, to be used in our clinical trials once they are approved by the FDA. Trial documentations and applications, submitted to the FDA in early 2015, received regulatory comments, which we are now in the process of addressing and resubmitting for approval.
We expect to receive FDA approval to begin clinical trials in Q3 2015. Clinical trials, expected to last 12 months, will consist of 80 patients with Stage 2 and Stage 3 pressure ulcers, 40 of which will be treated with the BST Device and 40 with a placebo. Participating medical centers have already been identified. Together, we are eagerly awaiting federal approval and the launch of our first batch of patients here in the U.S.. Following the completion of a successful clinical trial period expected in Q4 2016, we should be on target to launch the device in the U.S. sometime in 2017.
In conjunction with our commercialization efforts in the U.S., we are focused on securing a production facility and distribution channels for our product in Europe, South America and Israel, where the BST Device has already been tested and previously approved. We are in the process of negotiating with potential manufacturers out of Israel to determine which is best fit for our device in terms of price, quality and durability standards, as well as several potential distributors in South America, Europe and Israel, whom have expressed interest in carrying the product. For European distribution, products must have a current and valid CE mark, the mandatory conformity marking for certain products sold within the European Economic Area (EEA). We’re currently in the process of renewing the BST device’s CE mark designation and hope to procure it in the near term to allow for reentry into the European market. Revenue generation from the sale of our BST device in these regions is expected to begin in 2016.
All in all, management is pleased at the significant progress made since the close of the acquisition in 2014 and remains confident that FDA approval of the BST Device will be achieved in the timeframe forecasted. We look forward to making great strides on the above described initiatives and will provide shareholders and the investment community with updates as these initiatives progress. For any additional questions or comments, please feel free to reach out directly.
About E-QURE Corp
E-QURE Corp., publicly traded on the OTCQB market under the symbol ‘EQUR’, is a premier provider of innovative medical devices in the field of advanced wound care treatment. E-QURE’s breakthrough noninvasive technology is aimed to treat and cure those who suffer from chronic wound in the most effective and cost-effective method – through Bioelectrical Signal Therapy (BST). The BST device treatment is clinically proven to heal chronic wounds in average period of 45 to 60 days and can be used in Hospitals, Clinics and Home care settings. The clinical use of the BST Device for the treatment of wounds and ulcers had been granted regulatory approvals in Europe, Canada, Brazil and Israel, which are currently being renewed. E-QURE, incorporated in the State of Delaware, USA, is a fully-reporting company with the United States Securities and Exchange Commission.