Reports Q revenue $113K, consensus $150K….Mark Pomeranz, Chief Executive Officer, commented, “We remain on track with the planned submission of a special 510(k) to the FDA in the coming months, which will bring us one step closer to being able to bring our next generation system to the market, expanding upon the Pure-Vu platform’s capabilities into supporting upper GI procedures. The Pure-Vu Gen 4 Gastro and Colon will offer several enhancements compared to our current system, resulting in minimized training requirements and reducing the cost of goods by approximately 50%. In order to support the expected commercial launch of the Pure-Vu Gen 4 Gastro and Colon, pending regulatory clearance, we are working with well-respected research hospitals both in the U.S. and abroad to generate preclinical and clinical data that show the value this system offers patients and hospitals. This includes Dr. Carlos Robles-Medranda, Head of the Endoscopy Service at the Ecuadorian Institute of Digestive Diseases and Director of the Pentax Training Center Ecuador, who recently helped highlight the Pure-Vu Gen 4 Gastro and Colon system during the 9th Ecuadorian Institute of Digestive Diseases (IECED) Live Endoscopy Course 2023.”
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