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Venaxis’ APPY1 Test Passes Futility Analysis in Pivotal Clinical Study

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Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, recently announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company’s pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the first of two futility analyses included in the clinical trial design. Venaxis will host a conference call and webcast tomorrow morning, July 16, 2013, at 8:30 a.m. ET, to discuss the DSMB’s recommendation and to provide a general corporate update.

The futility analysis, which consisted of an independent review of the validity, integrity, and clinical and scientific relevance of the ongoing study, was performed on the first 579 patients to complete the study. The study will enroll a total of 2,000 evaluable patients. The next and final futility analysis will include data from the first approximately 1,200 patients.

Steve Lundy, President and CEO of Venaxis, stated, “While the results of the study remain blinded to Venaxis, we are very pleased that the pivotal clinical trial has passed this important interim analysis step successfully. The APPY1 Test performed very well in the previous 500-patient study, so we regard this outcome as encouraging and we look forward to the next assessment. Enrollment in the pivotal study continues to accelerate as our recently initiated sites ramp-up their enrollment. We expect to complete enrollment for the pivotal study by the end of 2013, and if the results are positive, file for FDA clearance in the first quarter 2014. In the meantime, we continue to execute on our commercial milestones in Europe, where we are preparing to initiate economic outcomes studies at leading hospitals. Importantly, with our recent financing, we have sufficient capital to achieve major regulatory and commercial milestones. While we remain prudent with the use of cash, we see no financial obstacles to reaching these significant value inflection points.”

Venaxis strengthened its financial position with an additional $14.4 million in gross proceeds from a May public offering led by Piper Jaffray & Company. The Company currently estimates cash, cash equivalents, and short-term investments to be approximately $20 million at the close of the second quarter 2013, which will be reflected in the Company’s Form 10-Q to be filed in the coming weeks.

Don Hurd, Senior Vice President and Chief Commercial Officer of Venaxis, stated, “We remain on track for a full-scale European launch for the APPY1 Test beginning in the fourth quarter of this year. We currently have four market development agreements in place and we are in the final process of selecting partners in additional target countries, including Germany, the UK, and France. In terms of our existing partner agreements, we are initiating and expect to complete several outcome studies by the end of the third quarter 2013 and anticipate leveraging robust data from those studies to demonstrate objectively the clinical and economic value of using the APPY1 Test in the hospital emergency room. We remain focused on laying a solid foundation as we continue onto full-scale commercialization of APPY1 in Europe and advance to commercialization in the United States.”

Source: Venaxis