《Cohera Medical, Inc.®’s TissuGlu® Surgical Adhesive Advances to Food and Drug Administration Advisory Panel Meeting》：
PITTSBURGH, June 10, 2014 /PRNewswire/ — Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that a meeting of the General and Plastic Surgery Devices Advisory Panel has been scheduled for August 1, 2014 to review its Premarket Approval (PMA) application for TissuGlu® Surgical Adhesive. The Panel, comprised of independent surgeons and experts, will review and vote on the safety, effectiveness, and risk-benefit of TissuGlu as part of the ongoing PMA review.
TissuGlu is designed to meet surgeons’ need for a strong, biocompatible, and easy to use surgical adhesive. TissuGlu is intended for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty. The clinical data submitted in the PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in large flap procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.
“The advancement of the PMA to the Panel meeting stage represents a large accomplishment – and one of the final steps – in the approval process by the Company,” said Chad A. Coberly, J.D., Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. “Over the last several months the FDA has largely finalized its review of our modular PMA submission, as well as its review of the Company and its major manufacturing and clinical partners. To date, all have passed the FDA preapproval inspections related to manufacturing, quality, and clinical trials, marking a great achievement in the PMA process.”
“The scheduling of the FDA Panel meeting represents a significant milestone towards the commercialization of TissuGlu in the U.S. and demonstrates the commitment we have to our future patients, partners, and investors,” said Patrick Daly, Cohera Medical president and CEO. “We look forward to the Panel meeting and working with the FDA during the remainder of the approval process to make TissuGlu available to surgeons and patients throughout the United States.”
TissuGlu is targeted for use in large flap surgery procedures in which drains are used to control fluid output and seroma formation. There are approximately 1M US-based large flap procedures per year, growing at an annual rate of 4.8 percent that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted bringing great benefit to patients, surgeons, and caregivers.
About Cohera Medical Cohera Medical, Inc.® is a rapidly growing medical device company that is actively developing a line of surgical adhesives and sealants. Cohera Medical’s products are based on a unique chemical design that is resorbable, non-toxic, easy-to-use, and forms a strong bond between tissue layers. The Company’s lead product, TissuGlu® Surgical Adhesive, is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty. TissuGlu® is currently approved for sale in the EU and is being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures. The Company’s second product, Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, is currently under the CE Mark approval process. TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. Outside of the EU, TissuGlu and the other Cohera Medical products are currently indicated for investigational use only and have not yet been approved for sale by the Food and Drug Administration (FDA) in the U.S. or in any other market.
For more information, visit www.coheramed.com .
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company’s future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
《Cohera Medical, Inc.®’s TissuGlu® Surgical Adhesive Advances to Food and Drug Administration Advisory Panel Meeting》：
PITTSBURGH, June 10, 2014 /PRNewswire/ — Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that a meeting of the General and Plastic Surgery Devices Advisory Panel has been scheduled for August 1, 2014 to review its Premarket Approval (PMA) application for TissuGlu® Surgical Adhesive. The Panel, comprised of independent surgeons and experts, will review and vote on the safety, effectiveness, and risk-benefit of TissuGlu as part of the ongoing PMA review.
TissuGlu is designed to meet surgeons’ need for a strong, biocompatible, and easy to use surgical adhesive. TissuGlu is intended for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty. The clinical data submitted in the PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in large flap procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.
“The advancement of the PMA to the Panel meeting stage represents a large accomplishment – and one of the final steps – in the approval process by the Company,” said Chad A. Coberly, J.D., Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. “Over the last several months the FDA has largely finalized its review of our modular PMA submission, as well as its review of the Company and its major manufacturing and clinical partners. To date, all have passed the FDA preapproval inspections related to manufacturing, quality, and clinical trials, marking a great achievement in the PMA process.”
“The scheduling of the FDA Panel meeting represents a significant milestone towards the commercialization of TissuGlu in the U.S. and demonstrates the commitment we have to our future patients, partners, and investors,” said Patrick Daly, Cohera Medical president and CEO. “We look forward to the Panel meeting and working with the FDA during the remainder of the approval process to make TissuGlu available to surgeons and patients throughout the United States.”
TissuGlu is targeted for use in large flap surgery procedures in which drains are used to control fluid output and seroma formation. There are approximately 1M US-based large flap procedures per year, growing at an annual rate of 4.8 percent that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted bringing great benefit to patients, surgeons, and caregivers.
About Cohera Medical Cohera Medical, Inc.® is a rapidly growing medical device company that is actively developing a line of surgical adhesives and sealants. Cohera Medical’s products are based on a unique chemical design that is resorbable, non-toxic, easy-to-use, and forms a strong bond between tissue layers. The Company’s lead product, TissuGlu® Surgical Adhesive, is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty. TissuGlu® is currently approved for sale in the EU and is being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures. The Company’s second product, Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, is currently under the CE Mark approval process. TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. Outside of the EU, TissuGlu and the other Cohera Medical products are currently indicated for investigational use only and have not yet been approved for sale by the Food and Drug Administration (FDA) in the U.S. or in any other market.
For more information, visit www.coheramed.com .
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company’s future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.