Showing posts with label TissuGlu. Show all posts
Showing posts with label TissuGlu. Show all posts
Wednesday, February 11, 2015
Tuesday, January 6, 2015
Cohera Medical, Inc.® Receives PMA Approvable Letter from U.S. FDA for TissuGlu® Surgical Adhesive
PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesive is Approvable. The receipt of the Approvable Letter means that the FDA has largely approved all parts of the PMA. The Company expects to work with the FDA to reach a final approval on the application within a few weeks.
"The receipt of the PMA Approvable Letter is a truly significant milestone for the Company," said Patrick Daly, Cohera Medical President and CEO. "We are excited about the pending approval for TissuGlu and are looking forward to making TissuGlu available to surgeons and patients throughout the United States."
TissuGlu is indicated for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in abdominoplasty. Upon approval, TissuGlu will be the first internal surgical adhesive of its kind approved in the United States.
Mr. Daly will be presenting on this latest milestone and other significant updates at the J.P. Morgan Healthcare Conference on January 13th at 4:00pm PST.
TissuGlu is designed to meet a surgeon's need for a strong, biocompatible, and easy-to-use surgical adhesive. The Approvable PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in abdominoplasty procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.
"TissuGlu, which has the potential to eliminate wound drainage issues from abdominoplasty procedures, represents a major advance in helping patients recover faster and more comfortably following these procedures," said Joseph P. Hunstad MD, FACS, of The Hunstad-Kortesis Center, Charlotte, N.C. "When approved, it will bring great benefits to both patients and surgeons."
"Having the PMA approved, minus a few small labeling changes, signifies the FDA has approved the years of scientific, engineering, manufacturing, quality, and clinical work conducted by the Cohera Medical team," said Chad Coberly, JD, Vice President of Clinical, Regulatory & Legal Affairs for Cohera.
TissuGlu is targeted for use in abdominoplasty procedures in which drains are used to control fluid output and seroma formation. There are approximately 175,000 US-based abdominoplasty procedures per year, growing at an annual rate of 7.7 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 with TissuGlu 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 in the EU 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.
"The receipt of the PMA Approvable Letter is a truly significant milestone for the Company," said Patrick Daly, Cohera Medical President and CEO. "We are excited about the pending approval for TissuGlu and are looking forward to making TissuGlu available to surgeons and patients throughout the United States."
TissuGlu is indicated for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in abdominoplasty. Upon approval, TissuGlu will be the first internal surgical adhesive of its kind approved in the United States.
Mr. Daly will be presenting on this latest milestone and other significant updates at the J.P. Morgan Healthcare Conference on January 13th at 4:00pm PST.
TissuGlu is designed to meet a surgeon's need for a strong, biocompatible, and easy-to-use surgical adhesive. The Approvable PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in abdominoplasty procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.
"TissuGlu, which has the potential to eliminate wound drainage issues from abdominoplasty procedures, represents a major advance in helping patients recover faster and more comfortably following these procedures," said Joseph P. Hunstad MD, FACS, of The Hunstad-Kortesis Center, Charlotte, N.C. "When approved, it will bring great benefits to both patients and surgeons."
"Having the PMA approved, minus a few small labeling changes, signifies the FDA has approved the years of scientific, engineering, manufacturing, quality, and clinical work conducted by the Cohera Medical team," said Chad Coberly, JD, Vice President of Clinical, Regulatory & Legal Affairs for Cohera.
TissuGlu is targeted for use in abdominoplasty procedures in which drains are used to control fluid output and seroma formation. There are approximately 175,000 US-based abdominoplasty procedures per year, growing at an annual rate of 7.7 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 with TissuGlu 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 in the EU 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.
Tuesday, November 19, 2013
Cohera Medical, Inc.® Completes Fourth and Final Module in the Premarket Approval (PMA) Application for TissuGlu® Surgical Adhesive
PITTSBURGH, Nov. 19, 2013 -- PITTSBURGH, Nov. 19, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today it has submitted its fourth and final module for TissuGlu® Surgical Adhesive in the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).
"We are pleased to have submitted the final module of the PMA application for TissuGlu," said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. "This module culminates substantial work by the Cohera team and our investigational partners."
A modular PMA submission is one in which the contents of a PMA are broken into several clearly defined parts or modules. These modules are submitted separately over time and comprise a complete PMA when all of them have been submitted. FDA reviews each module separately which may allow for a more efficient review when the last components are submitted because much of the review work will have already been completed. Cohera Medical has already successfully submitted the first three modules of the PMA application: biocompatibility, design control and manufacturing.
The fourth and final module submitted is comprised of data from Cohera Medical's 'No Drain' study, confirming that TissuGlu is a clinically superior alternative to closed-suction drains for fluid management in large flap procedures such as abdominoplasty. In the pivotal clinical trial, when TissuGlu was used, patients required fewer post-operative treatments and resumed normal activities, such as going to work, showering and using the stairs, more quickly.
"Submitting the final module to FDA is a critical milestone in making TissuGlu Surgical Adhesive available to surgeons and patients in the U.S.," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "The successful completion of this module represents a huge effort on the part of the entire company and we look forward to continuing our work with FDA."
Currently, most patients who undergo abdominoplasty procedures or other large flap procedures, such as mastectomy or inguinal lymph node dissection, require the insertion of drains to remove fluid that accumulates under the skin at the surgical site. Drains are often uncomfortable for the patient and can lead to additional complications. TissuGlu forms a strong bond between tissue layers, helping to reduce the fluid that can accumulate during healing.
Friday, November 2, 2012
Cohera Medical's TissuGlu surgical adhesive product receives US FDA approval
Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, has received approval from the United States Food and Drug Administration (FDA) for the first of four modules of the company’s PMA filing plan for its TissuGlu Surgical Adhesive product.
Earlier this year, the company received approval of its modular approach to filing the PMA from the FDA, and submitted the first module pursuant to this plan.
The first module contained the pre-clinical testing profile for TissuGlu including extensive biocompatibility and toxicological testing information. The company expects to file the second module containing information related to the characterization and specifications of TissuGlu before the end of the year, and the remaining two modules describing the manufacturing, quality system and clinical study information in 2013.
“We are pleased to receive FDA approval for the first module of the PMA in which the biocompatibility and pre-clinical testing profile of TissuGlu is acceptable,” said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. “We appreciate the professional and interactive review by the FDA for this module and look forward to working with the Agency on the review of the future modules.”
“The first module approval of the TissuGlu PMA is another significant milestone for Cohera and its investors,” said Patrick Daly, president and chief executive officer of Cohera Medical. “The approval for this information confirms the basic safety profile of this important new product and allows the Company to proceed with its modular PMA filings on plan.”
Cohera Medical recently received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. The company plans to expand the commercial availability of TissuGlu in 2012.
Earlier this year, the company received approval of its modular approach to filing the PMA from the FDA, and submitted the first module pursuant to this plan.
The first module contained the pre-clinical testing profile for TissuGlu including extensive biocompatibility and toxicological testing information. The company expects to file the second module containing information related to the characterization and specifications of TissuGlu before the end of the year, and the remaining two modules describing the manufacturing, quality system and clinical study information in 2013.
“We are pleased to receive FDA approval for the first module of the PMA in which the biocompatibility and pre-clinical testing profile of TissuGlu is acceptable,” said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. “We appreciate the professional and interactive review by the FDA for this module and look forward to working with the Agency on the review of the future modules.”
“The first module approval of the TissuGlu PMA is another significant milestone for Cohera and its investors,” said Patrick Daly, president and chief executive officer of Cohera Medical. “The approval for this information confirms the basic safety profile of this important new product and allows the Company to proceed with its modular PMA filings on plan.”
Cohera Medical recently received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. The company plans to expand the commercial availability of TissuGlu in 2012.
Tuesday, August 7, 2012
Cohera Medical Completes Enrollment of U.S. Clinical Trial of TissuGlu® Surgical Adhesive
PITTSBURGH, Aug. 7, 2012 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the completion of enrollment of its prospective, multicenter, randomized clinical trial for its lead product, TissuGlu® Surgical Adhesive inthe United States.
The study is evaluating the effectiveness of TissuGlu on the reduction of wound drainage and post-surgical complications in abdominoplasty surgeries. The study included 150 patients enrolled at five sites throughout the U.S., including Atlanta, Baltimore, Charlotte, St. Louis, and Washington DC.
"We are delighted to complete enrollment in this critical trial for TissuGlu, which has the potential to eliminate wound drainage issues from large flap procedures," said Dr. Joseph Hunstad of the Hunstad-Kortesis Center for Plastic Surgery, Charlotte, NC. "The trial results so far are very promising for both the surgeons and the patients."
Completion of enrollment of the study marks a significant milestone in Cohera Medical's progression of its lead product toward commercialization in the United States. The Company will use the results from the study to submit a PMA application for TissuGlu with the FDA. There are currently no medical devices approved by the FDA, or in pivotal clinical trials, for a synthetic adhesive indicated for approximation of tissues in large flap surgeries.
"We are extremely pleased to have reached this very significant milestone in our clinical study," saidPatrick Daly, President and Chief Executive Officer of Cohera Medical. "It is a testament to the surgeons and the Cohera team to enroll 150 patients in 90 days. We are encouraged by the positive feedback from the TissuGlu investigators and look forward to our work with the FDA to make TissuGlu available to surgeons and patients throughout the U.S."
Cohera Medical received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. To date, TissuGlu has been used successfully in over 500 surgical procedures in Germany by leading plastic and reconstructive surgeons.
Currently, most patients who undergo abdominoplasty procedures and other large flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and the excess fluid accumulation (seroma) requires additional procedures for removal. TissuGlu adheres the tissue flap created during the procedure to the underlying tissue, helping to reduce the fluid that can accumulate in the space and ultimately reducing the time to drain removal. The use of TissuGlu may shorten the length of time that drains need to be in place, leading to a more comfortable recovery and a quicker return to normal activity for patients.
Thursday, July 12, 2012
Study to Investigate the Safety and Effectiveness of TissuGlu in Abdominoplasty Surgeries Without the Use of Postoperative Drains
Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the start of a no-drain clinical trial in 30 patients at two prominent surgery centers in Germany. The study will investigate the safety and effectiveness of TissuGlu® Surgical Adhesive in the reduction of wound drainage, post operative seroma and related complications in abdominoplasty patients without the use of drains.
Currently, most patients who undergo abdominoplasty procedures and other large flap procedures require the insertion of drains to remove fluids that accumulate under the skin at the surgical site. In some cases, drainage is inadequate and the excess fluid accumulation (seroma) requires additional procedures for removal. The drains are often painful for the patient, can lead to infection and can impact the recovery process.
TissuGlu adheres the tissue flap created during the surgical procedure to the underlying tissue, helping to reduce the space where fluids can accumulate thereby eliminating the need to use surgical drains. The ability to perform the procedure without drains would lead to a more comfortable recovery and a quicker return to normal activity for patients.
"We are excited to be part of this study utilizing TissuGlu to eliminate postoperative drains," said Dirk Richter, MD, of Wesseling, Germany. "We look forward to enrolling more patients and believe that conducting abdominoplasty procedures without the need for drains would represent a significant improvement in patient care and comfort in these procedures. The initial patients enrolled appear to be doing very well, with no seromas or complications reported in the first 48 hours after surgery."
"Initiation of this 'no drain' trial represents a major goal for TissuGlu," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "We continue to make positive patient outcomes a priority and believe the elimination of post-surgical drains is an important milestone."
Drain management and discomfort is the leading patient complaint for plastic surgery procedures according to the top plastic surgery publications. In addition, complication rates from seroma formation range from 15% to 52% following abdominoplasty procedures.
Wednesday, February 1, 2012
FDA Approves Surgical Adhesive for U.S. Study
The Food and Drug Administration has issued Investigational Device Exemption approval to Cohera Medical's TissuGlu surgical adhesive, opening the door for a prospective, multi-center, randomized clinical trial of the product in the U.S.
According to the Pittsburgh, Pa.-based manufacturer, the absorbable internal surgical adhesive, intended for the sealing of tissue in large-flap surgeries such as abdominoplasty, can prevent fluid accumulation in post-op wounds. This would reduce the need for surgical drains and possibly speed patients' recoveries.
At present, says Cohera Medical, no synthetic adhesive product is available or in clinical trials for use in large-flap tissue surgeries. TissuGlu received the European Union's safety and effectiveness approval last year, and is scheduled to begin U.S. testing in the first quarter of this year.
According to the Pittsburgh, Pa.-based manufacturer, the absorbable internal surgical adhesive, intended for the sealing of tissue in large-flap surgeries such as abdominoplasty, can prevent fluid accumulation in post-op wounds. This would reduce the need for surgical drains and possibly speed patients' recoveries.
At present, says Cohera Medical, no synthetic adhesive product is available or in clinical trials for use in large-flap tissue surgeries. TissuGlu received the European Union's safety and effectiveness approval last year, and is scheduled to begin U.S. testing in the first quarter of this year.
Monday, October 20, 2008
Cohera Medical Wins Pittsburgh Technology Council's 2008 Tech 50 Rising Star Award
PITTSBURGH, Oct. 20 /PRNewswire/ -- Cohera Medical Inc. today announced that it has received the Pittsburgh Technology Council's 2008 Tech 50 Rising Star Award. The Tech 50 Awards recognize accomplished technology-oriented companies in southwestern Pennsylvania. The Rising Star award is given to a young (less than three years old) entrepreneurial company that offers the most unique products or services among the contending companies and shows promise of becoming a significant economic force in the area. "We are extremely pleased that Cohera Medical's tissue adhesive technology has been recognized for its innovation and economic potential,"said Patrick Daly, chief executive officer of Cohera Medical. "TissuGlu(R),our lead product candidate for use in securing planes of tissue in plastic surgery procedures, is a truly novel product candidate that shows significant potential for improving clinical outcomes and patient care. We also look forward to developing our surgical adhesive technology for otherproducts as well."
About Cohera Medical Cohera Medical Inc. is a Pittsburgh-based company that is developing are volutionary line of wound management products and surgical adhesives.Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is a sprayable bonding agent for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation and small bone fixation, which will fill similar market needs in both orthopedics and general surgery. For more information, visit http://www.coheramed.com. TissuGlu and the other Cohera products have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or by any other country's regulatory authority.
Wednesday, July 16, 2008
Cohera get grant for Tissuglu
Cohera Medical Inc. today announced that it has been selected to receive a Phase II Small Business Innovation Research (SBIR) grant of $1.5 million for the ongoing development of TissuGlu, a novel surgical adhesive for application in plastic surgery.
The Phase II SBIR grant, awarded by the National Institutes of Health (NIH), will fund work to finalize the pre-clinical testing that will support submission of an Investigational Device Exemption (IDE) to the Food and Drug Administration (FDA) for approval to initiate human clinical trials. In the second year of the award, human clinical trials will be initiated to establish the product's safety and efficacy.
"Cohera is honored to receive this prestigious and selective award in the current highly competitive environment," said Patrick Daly, president and CEO of Cohera Medical. "Through this award, the NIH acknowledges the innovative nature of Cohera's technology as well as the robust commercial potential of TissuGlu. Our ongoing plans for TissuGlu seek to establish its safety and efficacy as a surgical adhesive to reduce fluid accumulation and the need for drains after surgery. The grant follows the successful completion of the Phase I SBIR project, which established the efficacy of the product formulation and the dispenser device design in preliminary studies."
Wednesday, May 7, 2008
Cohera Medical, Inc. Announces Closing of Insider Round of Financing for Over $7.6 Million
PITTSBURGH, May 7 /PRNewswire/ -- Cohera Medical, Inc., a rapidly growing medical device company developing a suite of wound management systems and surgical adhesives, announced today that it has closed an insider round of financing for over $7.6 Million. The proceeds of this transaction will support the growth of the company through pilot clinical trials for its lead product, TissuGlu(R), a strong, resorbable surgical adhesive, as well as pre-clinical development of Cohera's product pipeline.
"Cohera has generated significant value since our last financing and this is reflected in the strong support from our shareholders," said Patrick Daly, President and CEO of Cohera Medical. "The team at Cohera is focused on developing world class products that improve patient care and we are excited about the future of the Company."
"As Cohera's largest investor through our affiliate Kern Medical, LLC, we are delighted to once again lead its investment round," said Jay Kern, Founder and General Partner of Kern Whelan Capital, LLC, and Manager of Kern Medical II. "Strong participation by existing investors in this financing reflects the significant accomplishments that Patrick and his team have made in developing Cohera's revolutionary line of adhesive products."
TissuGlu - Unlike “Superglue” products, TissuGlu® is biocompatible and biodegradable, making it safe for internal use. Unlike “fibrin glue” products, it is strong, easy to use, and contains no human or animal product derivatives. Studies in the laboratory have demonstrated that the bond created with TissuGlu® is as strong after one hour as a normal wound is after a week of healing. It works well on planar surfaces, binding tissue layers to eliminate the potential space between recently separated tissues in which fluid accumulates (potentially reducing the need for fluid drains).
"Cohera has generated significant value since our last financing and this is reflected in the strong support from our shareholders," said Patrick Daly, President and CEO of Cohera Medical. "The team at Cohera is focused on developing world class products that improve patient care and we are excited about the future of the Company."
"As Cohera's largest investor through our affiliate Kern Medical, LLC, we are delighted to once again lead its investment round," said Jay Kern, Founder and General Partner of Kern Whelan Capital, LLC, and Manager of Kern Medical II. "Strong participation by existing investors in this financing reflects the significant accomplishments that Patrick and his team have made in developing Cohera's revolutionary line of adhesive products."
TissuGlu - Unlike “Superglue” products, TissuGlu® is biocompatible and biodegradable, making it safe for internal use. Unlike “fibrin glue” products, it is strong, easy to use, and contains no human or animal product derivatives. Studies in the laboratory have demonstrated that the bond created with TissuGlu® is as strong after one hour as a normal wound is after a week of healing. It works well on planar surfaces, binding tissue layers to eliminate the potential space between recently separated tissues in which fluid accumulates (potentially reducing the need for fluid drains).
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