Thursday, July 12, 2018 7:06:49 AM
PAVM CHART $1.28 best summer FDA play DD here..
https://finance.yahoo.com/news/pavmed-provides-business-123000030.html
Product Update June 27th
“CarpX™, our groundbreaking minimally invasive device to treat carpal tunnel syndrome and our most important lead product, is steadily moving through the U.S. Food and Drug Administration’s (FDA) 510(k) process,” said Dr. Aklog. “Several weeks ago, we filed a resubmission with the FDA including excellent results from an animal study the agency had requested, which documented that the device’s bipolar electrode design results in minimal spread of thermal energy, as we had expected. The pathologic specimens showed that the thermal injury was limited to less than one millimeter and thermal sensors showed no increase in tissue temperatures except directly over the cutting electrodes. We expect that there will be some delay in the review of our resubmission and, upon the advice of our regulatory consultant, we have elected to use that time to submit physician usability and design verification testing on the most current version of the device, which incorporates several performance-enhancing improvements. This development pushes the regulatory timeline back by about six weeks, with FDA review of the resubmission beginning in mid-to-late July and an expected FDA response in the late summer. We believe this strategy strengthens our submission and the prospects for clearance.
“In anticipation of receiving FDA clearance, we are accelerating preparations for the U.S. commercial launch of CarpX, which we estimate has an immediately addressable market opportunity of over $1 billion. We are recruiting a Chief Commercial Officer to oversee these activities and have held increasingly active discussions with several potential distribution partners. Our CarpX activities outside the United States have also progressed. We are on target for European CE Mark submission late in this year’s third quarter. We have pushed our anticipated first-in-man clinical series in New Zealand to the early fall to take advantage of the recently completed improvements in device, and are in active discussions with entities in Asia, Europe and South America seeking to commercially partner with us on CarpX in their regions.
https://finance.yahoo.com/news/pavmed-provides-business-123000030.html
Product Update June 27th
“CarpX™, our groundbreaking minimally invasive device to treat carpal tunnel syndrome and our most important lead product, is steadily moving through the U.S. Food and Drug Administration’s (FDA) 510(k) process,” said Dr. Aklog. “Several weeks ago, we filed a resubmission with the FDA including excellent results from an animal study the agency had requested, which documented that the device’s bipolar electrode design results in minimal spread of thermal energy, as we had expected. The pathologic specimens showed that the thermal injury was limited to less than one millimeter and thermal sensors showed no increase in tissue temperatures except directly over the cutting electrodes. We expect that there will be some delay in the review of our resubmission and, upon the advice of our regulatory consultant, we have elected to use that time to submit physician usability and design verification testing on the most current version of the device, which incorporates several performance-enhancing improvements. This development pushes the regulatory timeline back by about six weeks, with FDA review of the resubmission beginning in mid-to-late July and an expected FDA response in the late summer. We believe this strategy strengthens our submission and the prospects for clearance.
“In anticipation of receiving FDA clearance, we are accelerating preparations for the U.S. commercial launch of CarpX, which we estimate has an immediately addressable market opportunity of over $1 billion. We are recruiting a Chief Commercial Officer to oversee these activities and have held increasingly active discussions with several potential distribution partners. Our CarpX activities outside the United States have also progressed. We are on target for European CE Mark submission late in this year’s third quarter. We have pushed our anticipated first-in-man clinical series in New Zealand to the early fall to take advantage of the recently completed improvements in device, and are in active discussions with entities in Asia, Europe and South America seeking to commercially partner with us on CarpX in their regions.
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