Winsford, UK, 31 January 2019: Advanced Medical Solutions Group plc (AIM: AMS), the surgical and advanced wound care specialist company, today announces it has acquired Sealantis Limited (“Sealantis”), a developer of an alginate-based tissue adhesive technology platform, for $US 25m (approximately £19m) in cash with royalties due until December 2027 on sales of any of its products that are currently in development.
Overview of Sealantis
Sealantis is an Israeli-based medical device company with a patent-protected alga-mimetic sealants technology platform with a wide range of potential surgical indications under development. Its two most advanced surgical sealant products are Seal-G, an open surgery device already CE marked for reinforcement of the staple / suture line to minimise anastomotic leaks following gastrointestinal surgery, and Seal-G MIST (Minimally Invasive Spray Technology) the equivalent laparoscopic device for the same indication but performed through keyhole surgery.
For the year ended 31 December 2017, Sealantis reported gross assets of approximately £0.5m
(ILS 2.1m) and a net loss of approximately £1.5m (ILS 6.6m).
Acquisition benefits
As well as a world class extension of our longer-term product development capability, strategically, the acquisition provides AMS with a technology platform and delivery systems that have significant potential across a range of applications in the high-margin internal surgery market which includes the $1 billion internal sealant market. These include the existing CE marked product to reinforce and protect gastrointestinal anastomoses, of which there are more than 6 million procedures performed annually worldwide1, with additional significant potential in Neuro, Orthopaedic, and Cardiovascular surgery indications.
Being alginate based, the technology and products have significant competitive advantages over existing market leading products in this space. Importantly, the products do not need refrigerated transport or storage, can be delivered by spreading or spraying, do not require advanced preparation and do not contain proteins so carry lower risk of infection or adverse reaction.
The Sealantis technology platform has multiple synergies with AMS, most notably within the sales, marketing, regulatory and operational areas, and the acquisition significantly strengthens the Company’s product portfolio for internal sealants and fixation devices, sitting alongside AMS’s LiquiBandFix8® laparoscopic and LiquiBandFix8® open fixation devices. The addition of the Sealantis products and indications will open up much larger parts of the surgery market for AMS to exploit commercially and significant sales synergies are anticipated once commercialisation commences from H1 2021.
AMS plans to rapidly maximise the value of the investment by continuing to invest in the existing Sealantis innovation centre and accelerate the commercialisation of the laparoscopic and open variants of Seal-G by running clinical trials for anastomotic leak prevention as well as obtaining approval for new indications. The Company expects to make a total investment of approximately £8m in R&D, regulatory and clinical costs which will be fairly evenly spread over the next three years, depending on clinical trial progress. Seal G will initially be targeted within Europe using AMS’s existing regulatory expertise and the Group’s extensive commercial footprint.
Sealantis operates a state-of-the-art innovation and manufacturing facility, which includes an ISO class 6 clean room, at the world-renowned Technion – Israel Institute of Technology, in Haifa, Israel. AMS intends to retain Sealantis’ team of 12 R&D staff, who will become a key part of AMS’s surgical R&D capability.
Terms of the transaction
AMS is acquiring Sealantis for an initial consideration of $US 25m (approximately £19m) in cash, to be funded from existing cash resources, which were £71m at 30 June 2018. In addition, AMS will pay royalties, in-line with market rates, on future sales of existing products in development until the end of 2027.
Until the commencement of product sales, which are expected in H1 2021, the acquisition is expected to be earnings dilutive due to the aforementioned investment in R&D, regulatory costs, and clinical studies.
Commenting on the acquisition, Chris Meredith, CEO of AMS, said: “This acquisition is in line with our strategy to acquire technologies that are complementary to our surgical portfolio as well as allowing us to leverage our global routes to market. The acquisition enhances our access to a significant and high-margin market in internal surgery, which includes areas of unmet need for effective and absorbable internal sealants, a market estimated at $1 billion. We are particularly excited to welcome Sealantis’ innovation team of R&D experts to AMS and look forward to working alongside them to develop the technology in a wide range of potential applications and indications. As we work towards the commercialisation of Seal-G Surgical Sealant over the next 18 months, we expect to maximise the full value of the platform and this innovative technology. AMS continues to actively monitor and evaluate other acquisition opportunities to capitalise on its strong financial and strategic position.”
Showing posts with label sealant. Show all posts
Showing posts with label sealant. Show all posts
Friday, February 1, 2019
Wednesday, October 25, 2017
Scientists Develop Squirtable Glue That Seals Wounds In Seconds
A potentially life-saving surgical glue that is highly elastic and adhesive can quickly seal wounds in seconds without the need for common staples or sutures.
The surgical glue, called MeTro, is a development from biomedical engineers at the University of Sydney and biomedical engineers from Harvard University.
MeTro has a high elasticity that can seal wounds in body tissues that need to expand and contract continuously, like the lungs, heart and arteries. Wounds on these types of tissues are prone to re-opening after sealing with staples and sutures.
The glue is also beneficial for wounds that are in hard-to-reach places that have traditionally needed staples or sutures because of body fluids interfering with other sealants.
“MeTro seems to remain stable over the period that wounds need to heal in demanding mechanical conditions and later it degrades without any signs of toxicity; it checks off all the boxes of a highly versatile and efficient surgical sealant with potential also beyond pulmonary and vascular suture and staple-less applications,” director of the Biomaterials Innovation Research Center at Harvard Medical School professor Ali Khademhosseini said in a press release.
When treated with UV light, MeTro takes just 60 seconds to set. It has a built-in degrading enzyme that can customized for the amount of time needed to allow a wound to heal.
“The beauty of the MeTro formulation is that, as soon as it comes in contact with tissue surfaces, it solidifies into a gel-like phase without running away,” Nasim Annabi, lead author of the study, said. “We then further stabilize it by curling it on-site with a short light-mediated cross linking treatment. This allows the sealant to be very accurately place and to tightly bond and interlock with structures on the tissue surface.”
So far, MeTro has quickly and successfully sealed artery incisions in the lungs of rodents and pigs without the use of sutures and staples.
Harvard researchers were also recently inspired by slug mucus to to create an adhesive to eliminate the need for staples and sutures.
One of the researchers, University of Sydney professor Anthony Weiss, suggests that the process in which MeTro works is similar to how silicone sealants work around bathroom and kitchen tiles.
“When you watch MeTro, you can see it act like a liquid, filling the gaps and conforming to the shape of the wound,” Weiss said. “It responds well biologically and interfaces closely with human tissue to promote healing. The gel is easily stored and can b squirted directly onto a wound or cavity.”
The researchers also suggest that the concept of MeTro could be used in emergency situations in addition to in surgical procedures and hopes to start clinical testing soon.
“The potential applications are powerful – from treating serious internal wounds at emergency sites such as following car accidents and in war zones, as well as improving hospital surgeries,” Weiss said.
The surgical glue, called MeTro, is a development from biomedical engineers at the University of Sydney and biomedical engineers from Harvard University.
MeTro has a high elasticity that can seal wounds in body tissues that need to expand and contract continuously, like the lungs, heart and arteries. Wounds on these types of tissues are prone to re-opening after sealing with staples and sutures.
The glue is also beneficial for wounds that are in hard-to-reach places that have traditionally needed staples or sutures because of body fluids interfering with other sealants.
“MeTro seems to remain stable over the period that wounds need to heal in demanding mechanical conditions and later it degrades without any signs of toxicity; it checks off all the boxes of a highly versatile and efficient surgical sealant with potential also beyond pulmonary and vascular suture and staple-less applications,” director of the Biomaterials Innovation Research Center at Harvard Medical School professor Ali Khademhosseini said in a press release.
When treated with UV light, MeTro takes just 60 seconds to set. It has a built-in degrading enzyme that can customized for the amount of time needed to allow a wound to heal.
“The beauty of the MeTro formulation is that, as soon as it comes in contact with tissue surfaces, it solidifies into a gel-like phase without running away,” Nasim Annabi, lead author of the study, said. “We then further stabilize it by curling it on-site with a short light-mediated cross linking treatment. This allows the sealant to be very accurately place and to tightly bond and interlock with structures on the tissue surface.”
So far, MeTro has quickly and successfully sealed artery incisions in the lungs of rodents and pigs without the use of sutures and staples.
Harvard researchers were also recently inspired by slug mucus to to create an adhesive to eliminate the need for staples and sutures.
One of the researchers, University of Sydney professor Anthony Weiss, suggests that the process in which MeTro works is similar to how silicone sealants work around bathroom and kitchen tiles.
“When you watch MeTro, you can see it act like a liquid, filling the gaps and conforming to the shape of the wound,” Weiss said. “It responds well biologically and interfaces closely with human tissue to promote healing. The gel is easily stored and can b squirted directly onto a wound or cavity.”
The researchers also suggest that the concept of MeTro could be used in emergency situations in addition to in surgical procedures and hopes to start clinical testing soon.
“The potential applications are powerful – from treating serious internal wounds at emergency sites such as following car accidents and in war zones, as well as improving hospital surgeries,” Weiss said.
Gecko Biomedical receives CE Mark Approval for SETALUM™ Sealant
Paris, France, September 11, 2017 – Gecko Biomedical (“Gecko”), a medical device company developing innovative polymers to support tissue reconstruction, announced today that it has received CE Mark approval for its SETALUM™ Sealant allowing the company to market its technology in Europe.
The SETALUM™ Sealant is a biocompatible, bioresorbable and on-demand activated sealant usable in wet and dynamic environments as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.
The technology at the foundation of the SETALUM™ Sealant was developed at The Massachusetts Institute of Technology, Harvard Medical School, and Brigham and Women’s Hospital. SETALUM™ Sealant is the most recent successful example of bio-inspired technology in medicine, and is based on the adhesive mechanisms found in nature that work in wet and dynamic environments.
The grant of the CE Mark for the vascular sealant is the first regulatory validation of the safety and performance of Gecko Biomedical’s scalable and innovative polymer platform.
“The SETALUM™ sealant can be precisely and easily applied thanks to its viscosity and hydrophobicity and then activated at will to provide an instant hermetic barrier and effective hemostasis. The key features of this polymer technology were selected with physicians and patients in mind, and significantly improves upon the latest generation of hemostatic agents to become a gold standard in vascular surgery,” said Jean-Marc Alsac, MD, PhD, vascular surgeon at the Hôpital Européen Georges Pompidou in Paris, France and the principal investigator of Gecko Biomedical’s BlueSeal clinical study.
The BlueSeal clinical study was a prospective, single-arm and multi-center clinical investigation performed at four French university hospitals and undertaken in patients necessitating a carotid endarterectomy. Performance of the sealant was evaluated by the percentage of immediate hemostasis following clamp removal. Based on a sequential Bayesian design, the recruitment was stopped at 22 enrolled patients given the fulfilled performance criteria and the optimal safety profile of the sealant. Immediate hemostasis was achieved in 85% of patients and all recorded adverse events were found to be representative of those commonly occurring in patients necessitating vascular reconstruction with none considered as related to the sealant.
Christophe Bancel, Gecko’s CEO, said: “We are delighted to receive the CE Mark for our first product, SETALUM™ Sealant, as this will allow us to bring new and innovative solutions to the market to improve patient care. As a result, we are now ramping up our manufacturing capabilities and selection of strategic partners to bring this innovation to patients.”
The company is swiftly expanding its applications, targeting new functionalities and tissue types to develop solutions for new clinical indications and geographic markets.
“Our ability to bring an entire new family of innovative polymers from the bench to the bedside in less than two and a half years, is a testimony of the versatility and scalability of our platform. We are now ready to fully expand, internally and through partnerships, into new therapeutic areas to design disruptive, surgical solutions for patients,” Bancel added.
The SETALUM™ Sealant is a biocompatible, bioresorbable and on-demand activated sealant usable in wet and dynamic environments as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.
The technology at the foundation of the SETALUM™ Sealant was developed at The Massachusetts Institute of Technology, Harvard Medical School, and Brigham and Women’s Hospital. SETALUM™ Sealant is the most recent successful example of bio-inspired technology in medicine, and is based on the adhesive mechanisms found in nature that work in wet and dynamic environments.
The grant of the CE Mark for the vascular sealant is the first regulatory validation of the safety and performance of Gecko Biomedical’s scalable and innovative polymer platform.
“The SETALUM™ sealant can be precisely and easily applied thanks to its viscosity and hydrophobicity and then activated at will to provide an instant hermetic barrier and effective hemostasis. The key features of this polymer technology were selected with physicians and patients in mind, and significantly improves upon the latest generation of hemostatic agents to become a gold standard in vascular surgery,” said Jean-Marc Alsac, MD, PhD, vascular surgeon at the Hôpital Européen Georges Pompidou in Paris, France and the principal investigator of Gecko Biomedical’s BlueSeal clinical study.
The BlueSeal clinical study was a prospective, single-arm and multi-center clinical investigation performed at four French university hospitals and undertaken in patients necessitating a carotid endarterectomy. Performance of the sealant was evaluated by the percentage of immediate hemostasis following clamp removal. Based on a sequential Bayesian design, the recruitment was stopped at 22 enrolled patients given the fulfilled performance criteria and the optimal safety profile of the sealant. Immediate hemostasis was achieved in 85% of patients and all recorded adverse events were found to be representative of those commonly occurring in patients necessitating vascular reconstruction with none considered as related to the sealant.
Christophe Bancel, Gecko’s CEO, said: “We are delighted to receive the CE Mark for our first product, SETALUM™ Sealant, as this will allow us to bring new and innovative solutions to the market to improve patient care. As a result, we are now ramping up our manufacturing capabilities and selection of strategic partners to bring this innovation to patients.”
The company is swiftly expanding its applications, targeting new functionalities and tissue types to develop solutions for new clinical indications and geographic markets.
“Our ability to bring an entire new family of innovative polymers from the bench to the bedside in less than two and a half years, is a testimony of the versatility and scalability of our platform. We are now ready to fully expand, internally and through partnerships, into new therapeutic areas to design disruptive, surgical solutions for patients,” Bancel added.
Friday, June 9, 2017
TissuGlu® Surgical Adhesive enables drain-free recovery in patients undergoing DIEP flap breast reconstruction
RALEIGH, N.C., June 08, 2017 -- Outcomes of the SANA Gerresheim series demonstrated that effective donor-site flap closure with TissuGlu Surgical Adhesive is a viable alternative to post-surgical drains. Dr. Sonia Fertsch presented the series, which included 41 DIEP flap breast reconstructions, at the EURAPS Research Council Meeting in Pisa last month. The annual event allows young surgeons to present top research initiatives to an audience of plastic surgeons and researchers from around the world.
During a DIEP flap reconstruction, blood vessels, skin and fat of the lower abdomen are removed and utilized to reconstruct a breast following mastectomy. The technique is widely recognized as the top option for autologous tissue breast reconstruction, but typically requires the use of several surgical drains at the donor site during recovery. Drains may cause discomfort, anxiety and limited mobility during recovery and are often a deterrent for patients when considering treatment options.
The Department of Plastic Surgery at the SANA Clinic in Gerresheim, Germany, headed up by Prof. Christoph Andree, is a top center for reconstruction and performs approximately 200 DIEP procedures per year. The group, dedicated to improving recovery and acceptance of DIEP flap reconstructions, began evaluating TissuGlu® Surgical Adhesive in 2015 with hopes it would enable drain-free donor site recovery.
“The choice of using a patient’s own tissue for breast reconstruction has clear benefits with respect to implant based reconstruction, and patients who are candidates for DIEP flap-based reconstruction appreciate the reduction in abdominal skin and fatty tissue,” says Prof. Christoph Andree. “Being able to offer this procedure without the use of donor site drains improves the patient experience in the early recovery period and leads to earlier mobilization – one of the key milestones in postoperative recovery.”
Dr. Fertsch, who led the observational series, said: “Many of our patients have had experience with post-surgical drains in the past and they are very enthusiastic about the possibility that they may be able to avoid having them as part of the DIEP flap breast reconstruction procedure. It is not for all patients, but it is a welcome option for those who meet the criteria we have developed based on our clinical outcomes data.”
Mart Pearson, VP Europe for Cohera Medical, Inc. added: “We were very pleased that this series report on drain-free donor site closure with TissuGlu was selected for presentation at such a high-level meeting. Prof. Andree and his team at the SANA Clinic in Gerresheim have been very attentive to the patient perspective with regards to the post-surgical recovery period and it is exciting to have their experience discussed at this venue.”
Monday, April 6, 2015
Johnson & Johnson (JNJ) Announces Additional FDA Indication for EVARREST Fibrin Sealant Patch
Johnson & Johnson (NYSE: JNJ) announced the following Monday:
Unexpected and uncontrollable bleeding is an ongoing challenge for surgeons, including those who perform liver surgery. Based on recent data, the U.S. Food and Drug Administration has approved an additional indication for Ethicon's EVARREST Fibrin Sealant Patch, as an adjunct to hemostasis for control of bleeding during adult liver surgery. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients.
A problematic bleeding situation—involving bleeding that is more than routine and resistant to conventional means of control—is one of the most threatening complications of surgery1 and a frequent cause of negative patient outcomes, posing significant clinical and economic challenges.2,3 First attempts to control surgical bleeding using current hemostatic agents can fail up to 50 percent of the time.3
"The liver is a particularly hard-to-control bleed site during surgery, as blood loss is often higher and hemostasis may be difficult to achieve," said Krishna Athota, M.D.*, trauma and critical care surgeon at the University of Cincinnati College of Medicine. "This expanded indication for EVARREST reinforces this innovation's potential to make problematic bleeding situations routine, and could result in a paradigm shift in the treatment of bleeding during surgery."
EVARREST is a novel, bioabsorbable hemostat that delivers a powerful combination of hemostatic efficacy, adherence and mechanical strength.4,5,6 The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation by augmenting the human coagulation system. The technology is comprised of a flexible composite patch, which contains embedded human biologics (human thrombin and fibrinogen), which are proteins involved in the natural clotting process.
Clinical studies demonstrate that EVARREST is greater than 94 percent effective in controlling bleeding across challenging patient types and surgical situations, compared to current standard of care (less than 53 percent).7,8,9 EVARREST provides a rapid, predictable solution for problematic bleeding, minimizing surgical procedure disruption.3,7,8
"We see EVARREST as a game changer—better equipping surgeons to handle bleeding, thereby potentially improving patient outcomes, reducing OR costs and providing peace of mind for the entire surgical staff," said Dan Wildman, Vice President of Global Franchise Strategy and Innovation for Ethicon.
EVARREST has been shown to deliver a cost savings compared with current standard of care, when taking into account hemostat cost, OR time, transfusion requirements and retreatment. The low rate of re-bleeding with EVARREST reduces the need for other hemostatic therapies.10
References:
1 Schreiber MA, Neveleff DJ. Achieving hemostasis with topical hemostats: making clinically and economically appropriate decisions in the surgical and trauma settings. AORN J. 2011;94(5):S4-S20.2 Stokes, et al. Impact Of Bleeding-Related Complications And/Or Blood Product Transfusions On Hospital Costs In Inpatient Surgical Patients. BMC Health Services Research 2011, 11:135.3 Data on File, Ethicon, Inc. Global Health Economics and Market Access. EVARREST® Fibrin Sealant Patch. Global Value Dossier Slide Deck.4 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93.5 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.6 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.7 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93.8 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.9 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.10 Corral M et al. Cost Analysis of a Fibrin Sealant Patch for Mild, Moderate and Problematic Soft Tissue Surgical Bleeding: A Hospital Perspective, Cornerstone Research Group.
Unexpected and uncontrollable bleeding is an ongoing challenge for surgeons, including those who perform liver surgery. Based on recent data, the U.S. Food and Drug Administration has approved an additional indication for Ethicon's EVARREST Fibrin Sealant Patch, as an adjunct to hemostasis for control of bleeding during adult liver surgery. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients.
A problematic bleeding situation—involving bleeding that is more than routine and resistant to conventional means of control—is one of the most threatening complications of surgery1 and a frequent cause of negative patient outcomes, posing significant clinical and economic challenges.2,3 First attempts to control surgical bleeding using current hemostatic agents can fail up to 50 percent of the time.3
"The liver is a particularly hard-to-control bleed site during surgery, as blood loss is often higher and hemostasis may be difficult to achieve," said Krishna Athota, M.D.*, trauma and critical care surgeon at the University of Cincinnati College of Medicine. "This expanded indication for EVARREST reinforces this innovation's potential to make problematic bleeding situations routine, and could result in a paradigm shift in the treatment of bleeding during surgery."
EVARREST is a novel, bioabsorbable hemostat that delivers a powerful combination of hemostatic efficacy, adherence and mechanical strength.4,5,6 The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation by augmenting the human coagulation system. The technology is comprised of a flexible composite patch, which contains embedded human biologics (human thrombin and fibrinogen), which are proteins involved in the natural clotting process.
Clinical studies demonstrate that EVARREST is greater than 94 percent effective in controlling bleeding across challenging patient types and surgical situations, compared to current standard of care (less than 53 percent).7,8,9 EVARREST provides a rapid, predictable solution for problematic bleeding, minimizing surgical procedure disruption.3,7,8
"We see EVARREST as a game changer—better equipping surgeons to handle bleeding, thereby potentially improving patient outcomes, reducing OR costs and providing peace of mind for the entire surgical staff," said Dan Wildman, Vice President of Global Franchise Strategy and Innovation for Ethicon.
EVARREST has been shown to deliver a cost savings compared with current standard of care, when taking into account hemostat cost, OR time, transfusion requirements and retreatment. The low rate of re-bleeding with EVARREST reduces the need for other hemostatic therapies.10
References:
1 Schreiber MA, Neveleff DJ. Achieving hemostasis with topical hemostats: making clinically and economically appropriate decisions in the surgical and trauma settings. AORN J. 2011;94(5):S4-S20.2 Stokes, et al. Impact Of Bleeding-Related Complications And/Or Blood Product Transfusions On Hospital Costs In Inpatient Surgical Patients. BMC Health Services Research 2011, 11:135.3 Data on File, Ethicon, Inc. Global Health Economics and Market Access. EVARREST® Fibrin Sealant Patch. Global Value Dossier Slide Deck.4 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93.5 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.6 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.7 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93.8 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.9 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.10 Corral M et al. Cost Analysis of a Fibrin Sealant Patch for Mild, Moderate and Problematic Soft Tissue Surgical Bleeding: A Hospital Perspective, Cornerstone Research Group.
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.
Sunday, May 18, 2014
Cohera Medical, Inc.® Files for CE Mark Approval for Sylys® Surgical Sealant
PITTSBURGH, May 15, 2014 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has applied for CE Mark approval for Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks in gastrointestinal procedures. CE Mark approval, expected by the end of 2014 based on this filing, will allow for marketing of the product in the European Union and other countries.
Sylys is applied during gastrointestinal procedures to help prevent the occurrence of anastomotic leaks – a serious complication that occurs in up to 23 percent of patients undergoing colorectal surgery. At least one-third of the post-surgical mortality after colorectal surgery is attributed to leaks, and survivors generally have protracted recoveries. The additional care required to manage this serious complication can cause up to a five-fold increase in patient management costs.
"Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality," said James McCormick, DO, FACS, FASCRS, Chief, Division of Colorectal Surgery, The Western Pennsylvania Hospital. "We have made tremendous strides in curtailing the risk associated with intestinal anastomosis, but we are always striving for further improvement and greater patient safety."
Sylys is designed to help reduce anastomotic leakage in intestinal procedures by providing additional support during the first few days of healing, when the development of leaks is most likely to occur. The sealant is applied as a viscous fluid that cures rapidly to create a flexible, elastic seal over the anastomosis site.
"The preparation and filing of the CE Mark application for Sylys, a Class III implant technology, represents a significant milestone and achievement by all of the employees of Cohera Medical," said Chad A. Coberly, JD, Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. "The submission signifies that we have completed the rigorous clinical and pre-clinical testing, quality, and performance requirements of the EU authorities, and we look forward to working with our notified body during the approval process."
The market for Sylys is significant, with several hundred thousand procedures a year worldwide representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys would represent a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.
"Submitting the Sylys CE Mark application represents a significant milestone towards the commercialization of our second product and demonstrates the commitment we have to our future customers, partners, and investors," said Patrick Daly, Cohera Medical president and CEO. "We look forward to making Sylys available to surgeons and patients throughout the world."
Wednesday, April 23, 2014
The Medicines Company Adds Novel, Approved, Surgical Sealant to Its Surgical Hemostasis Portfolio Acquires Tenaxis Medical, Inc.
PARSIPPANY, NJ and MOUNTAIN VIEW, CA -- (Marketwired) -- 04/23/14 -- The Medicines Company (NASDAQ: MDCO) and Tenaxis Medical, Inc. (Tenaxis) today announced an agreement for The Medicines Company to acquire Tenaxis. Tenaxis's sole product, which mechanically seals both human tissue and artificial grafts is approved, but not launched in the US -- having received US PMA approval from the FDA in March 2013 as a vascular sealant. The product is also approved with a European CE Mark as a surgical sealant applicable to cardiovascular, general, urological, and thoracic surgery. The addition of the Tenaxis product adds another solution for surgical bleeding to The Medicines Company's portfolio which also includes the marketed product, RecoThrom (aqueous, recombinant human Thrombin) and the investigational product, Fibrocaps (a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery) which has completed phase III trials and is under FDA and EMA review.
Under the terms of the agreement, The Medicines Company will pay $58 million upfront on closing of the deal. The Medicines Company will also pay milestone payments of up to $112 million contingent upon achieving certain commercial and -- in pursuit of even broader indications -- regulatory approval milestones. The transaction is subject to the satisfaction of customary closing conditions.
"We continue to execute our strategy for growth, building our presence in surgery and perioperative care," said Clive Meanwell, Chairman and Chief Executive Officer of The Medicines Company.
Adam Sharkawy, Senior Vice President and Global Innovation Group Leader for Surgery and Perioperative Care added, "A robust portfolio of solutions for intra-operative bleeding is expected to drive growth for us in this sector of hospital medicine. This acquisition will allow us to leverage and build our activities in surgery centers at leading US and European hospitals. In the US, we expect to deploy approximately 100 of our current engagement managers across these surgical product offerings."
In a pivotal trial in vascular surgery, the Tenaxis sealant was effective when used as prophylactic treatment on native vessels and grafts, reducing the incidence of bleeding within the first minute after removal of vascular clamps. The Tenaxis sealant was compared to Gelfoam Plus, a topical hemostat containing a low concentration of thrombin (125 Units/mL), in the clinical trial used to support licensure (N=217; 1:1 randomization). The Tenaxis surgical sealant was shown to be superior to Gelfoam Plus based on a statistically significantly lower incidence of suture hole bleeding at the time of clamp release (60.5% vs. 39.6% of anastomotic sites at Time 0; p = 0.0001); the 20% difference at the time of clamp release persisted at 10 minutes (82% vs. 72%). Superiority was demonstrated in several types of surgical procedures (extremity bypass, hemodialysis access grafting, and other vascular procedures).
"We are excited to be involved in a transaction with The Medicines Company, which will allow more patients to have access to this beneficial technology," Ronald Dieck, President and CEO of Tenaxis commented. "We are proud of the surgical sealant technologies that we have developed and their impact on the wellbeing of patients. The Medicines Company is clearly committed to the area of intraoperative hemostasis and we look forward to working as a team to innovate in this area of medicine."
The Boards of Directors of both companies have unanimously approved the agreement.
Gibbons P.C. served as legal advisor for the transaction for The Medicines Company. Leerink Swann & Co. served as financial advisor and Wilson Sonsini Goodrich & Rosati, PC served as legal advisor for the transaction for Tenaxis Medical, Inc.
Conference Call Information
There will be a conference call with The Medicines Company management today at 8:30 a.m. Eastern Time to discuss the Tenaxis acquisition, first quarter 2014 financial results, operational developments, and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at www.themedicinescompany.com.
Domestic Dial In: +1 (877) 359-9508
International Dial In: +1 (224) 357-2393
Passcode for both dial in numbers: 27882505
Replay is available from 11:30 a.m. Eastern Time following the conference call through May 7, 2014. To hear a replay of the call dial +1 855 859-2056 (domestic) and +1 404 537-3406 (international). Passcode for both dial in numbers is 27882505.
Under the terms of the agreement, The Medicines Company will pay $58 million upfront on closing of the deal. The Medicines Company will also pay milestone payments of up to $112 million contingent upon achieving certain commercial and -- in pursuit of even broader indications -- regulatory approval milestones. The transaction is subject to the satisfaction of customary closing conditions.
"We continue to execute our strategy for growth, building our presence in surgery and perioperative care," said Clive Meanwell, Chairman and Chief Executive Officer of The Medicines Company.
Adam Sharkawy, Senior Vice President and Global Innovation Group Leader for Surgery and Perioperative Care added, "A robust portfolio of solutions for intra-operative bleeding is expected to drive growth for us in this sector of hospital medicine. This acquisition will allow us to leverage and build our activities in surgery centers at leading US and European hospitals. In the US, we expect to deploy approximately 100 of our current engagement managers across these surgical product offerings."
In a pivotal trial in vascular surgery, the Tenaxis sealant was effective when used as prophylactic treatment on native vessels and grafts, reducing the incidence of bleeding within the first minute after removal of vascular clamps. The Tenaxis sealant was compared to Gelfoam Plus, a topical hemostat containing a low concentration of thrombin (125 Units/mL), in the clinical trial used to support licensure (N=217; 1:1 randomization). The Tenaxis surgical sealant was shown to be superior to Gelfoam Plus based on a statistically significantly lower incidence of suture hole bleeding at the time of clamp release (60.5% vs. 39.6% of anastomotic sites at Time 0; p = 0.0001); the 20% difference at the time of clamp release persisted at 10 minutes (82% vs. 72%). Superiority was demonstrated in several types of surgical procedures (extremity bypass, hemodialysis access grafting, and other vascular procedures).
"We are excited to be involved in a transaction with The Medicines Company, which will allow more patients to have access to this beneficial technology," Ronald Dieck, President and CEO of Tenaxis commented. "We are proud of the surgical sealant technologies that we have developed and their impact on the wellbeing of patients. The Medicines Company is clearly committed to the area of intraoperative hemostasis and we look forward to working as a team to innovate in this area of medicine."
The Boards of Directors of both companies have unanimously approved the agreement.
Gibbons P.C. served as legal advisor for the transaction for The Medicines Company. Leerink Swann & Co. served as financial advisor and Wilson Sonsini Goodrich & Rosati, PC served as legal advisor for the transaction for Tenaxis Medical, Inc.
Conference Call Information
There will be a conference call with The Medicines Company management today at 8:30 a.m. Eastern Time to discuss the Tenaxis acquisition, first quarter 2014 financial results, operational developments, and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at www.themedicinescompany.com.
Domestic Dial In: +1 (877) 359-9508
International Dial In: +1 (224) 357-2393
Passcode for both dial in numbers: 27882505
Replay is available from 11:30 a.m. Eastern Time following the conference call through May 7, 2014. To hear a replay of the call dial +1 855 859-2056 (domestic) and +1 404 537-3406 (international). Passcode for both dial in numbers is 27882505.
Wednesday, December 11, 2013
Cohera Medical, Inc.® Successfully Completes Clinical Trial and Confirms Safety of Sylys® Surgical Sealant
PITTSBURGH, Dec. 10, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has successfully completed a clinical trial confirming the safety of Sylys®Surgical Sealant designed to significantly reduce anastomotic leakage in intestinal procedures. The European study included patients enrolled at two sites in the Netherlands.
Sylys is one of the first synthetic sealants specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures. Used in conjunction with standard anastomotic closure techniques, Sylys protects the suture or staple line, supporting the anastomosis during the first few days of healing, when leaks are most likely to occur.
"Sylys enhances standard closure techniques, advancing the healing process and reducing post-operative complications," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "With the completion of this study, we are a step closer to providing patients with the best opportunity for a successful outcome following intestinal anastomosis procedures."
On average, anastomotic leaks occur in 3-15% of colorectal procedures, and are the cause of one-third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1-4B market.
Tuesday, November 19, 2013
Clinical Papers Hemostats Reviewed - Oxi Cell, Gelatin, Collagen, Thrombin, Polysaccharide Powders
A lot of our earlier embedded document links have gone since our previous embedding agency sold (these things happen in 5 years of blogging). Now Google have this facility I am happy to provide you clinical data for your interest in the links below.
Monday, October 28, 2013
Integra LifeSciences to Acquire DuraSeal(TM) Product Lines From Covidien
PLAINSBORO, N.J., Oct. 28, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today it has entered into a definitive agreement with Covidien to acquire the Confluent Surgical product lines, including surgical sealants, adhesion barrier, and, most importantly, DuraSeal(TM). The companies expect to complete this transaction by the end of the first calendar quarter of 2014, subject to receipt of regulatory approvals.
Under the terms of the agreement, Covidien will receive an initial cash payment of $235 million from Integra upon the closing of the transaction. Additionally, Covidien may receive up to $30 million, contingent upon the achievement of certain performance measures related to the transition of the Confluent Surgical business to Integra.
"The addition of the DuraSeal(TM) product lines enables our sales force and distributor partners to provide their customers with a best-in-class dural sealant as they seek to support surgeon's efforts to minimize cerebrospinal fluid leaks upon completion of the surgical procedure," said Robert Davis, President of Integra's U.S. Neurosurgery division. "This acquisition perfectly complements our global Neurosurgery growth strategy aimed at providing a broader set of solutions for surgical procedures in the head. Together with our broad DuraGen(R) product line we are fortunate to have even more options to serve our customers and the individual needs of their patients."
"This transaction allows Covidien to better focus on its global strategic priorities," said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. "Based on Integra's presence in neurosurgery and spine surgery combined with a strong portfolio of clinical evidence, we believe these products will thrive under Integra's ownership. We express our sincere gratitude to our dedicated employees and the clinicians who have partnered with us throughout the years."
Confluent Surgical products include: DuraSeal(TM), DuraSeal(TM) Exact/Xact, VascuSeal(TM) and SprayShield(TM). These products generated approximately $65 million in revenue (unaudited) during 2012 and gross margin comparable to Integra's regenerative medicine product portfolio. Integra expects to provide detailed guidance regarding the financial impacts of this transaction upon closing. Preliminarily, Integra would expect the acquisition to add $57 million to $60 million in revenue in the first full year of the combination, and to then grow 3% to 5% longer term.
"This transaction adds scale to our business, leverages one of our strongest customer call points, and drives accretion to our gross margins," said Jack Henneman, Integra's Chief Financial Officer. "Upon completion of the transaction, we expect this deal to be accretive to both GAAP and adjusted earnings per share in the first year after considering the financing costs of the transaction."
Integra expects that revenues acquired through this transaction would be reported in its U.S. Neurosurgery and International divisions.
Under the terms of the agreement, Covidien will receive an initial cash payment of $235 million from Integra upon the closing of the transaction. Additionally, Covidien may receive up to $30 million, contingent upon the achievement of certain performance measures related to the transition of the Confluent Surgical business to Integra.
"The addition of the DuraSeal(TM) product lines enables our sales force and distributor partners to provide their customers with a best-in-class dural sealant as they seek to support surgeon's efforts to minimize cerebrospinal fluid leaks upon completion of the surgical procedure," said Robert Davis, President of Integra's U.S. Neurosurgery division. "This acquisition perfectly complements our global Neurosurgery growth strategy aimed at providing a broader set of solutions for surgical procedures in the head. Together with our broad DuraGen(R) product line we are fortunate to have even more options to serve our customers and the individual needs of their patients."
"This transaction allows Covidien to better focus on its global strategic priorities," said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. "Based on Integra's presence in neurosurgery and spine surgery combined with a strong portfolio of clinical evidence, we believe these products will thrive under Integra's ownership. We express our sincere gratitude to our dedicated employees and the clinicians who have partnered with us throughout the years."
Confluent Surgical products include: DuraSeal(TM), DuraSeal(TM) Exact/Xact, VascuSeal(TM) and SprayShield(TM). These products generated approximately $65 million in revenue (unaudited) during 2012 and gross margin comparable to Integra's regenerative medicine product portfolio. Integra expects to provide detailed guidance regarding the financial impacts of this transaction upon closing. Preliminarily, Integra would expect the acquisition to add $57 million to $60 million in revenue in the first full year of the combination, and to then grow 3% to 5% longer term.
"This transaction adds scale to our business, leverages one of our strongest customer call points, and drives accretion to our gross margins," said Jack Henneman, Integra's Chief Financial Officer. "Upon completion of the transaction, we expect this deal to be accretive to both GAAP and adjusted earnings per share in the first year after considering the financing costs of the transaction."
Integra expects that revenues acquired through this transaction would be reported in its U.S. Neurosurgery and International divisions.
Tuesday, September 3, 2013
Cohera Medical Completes Sylys® Surgical Sealant Clinical Trial
Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced it has treated its last patient for the clinical trial for Sylys®, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures. The results of the study will be released later this fall.
The European study is evaluating the safety of Sylys as an adjunct to standard closure techniques following bowel resections. The study included patients enrolled at two sites in the Netherlands.
Anastomotic leaks, on average, occur in 3 - 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 - 4B market.
"We are thrilled to be collaborating with leading surgeons in the Netherlands to treat patients with our Sylys product, our second class III product designed to support more natural healing and help reduce post-operative complications," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "Completing the treatment of the last patient in this study brings us one step closer to putting this innovative sealant in the hands of surgeons and reducing anastomotic leakage after colorectal surgery."
Friday, May 31, 2013
Cohera Medical Completes Enrollment of Sylys™ Surgical Sealant Clinical Trial
PITTSBURGH, May 30, 2013 -- /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the completion of enrollment of its clinical trial for Sylys, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures.
Currently underway in Europe, the study is evaluating the safety of Sylys on the reduction of anastomotic leakage following bowel repair. The study included patients enrolled at two sites in the Netherlands.
"We are excited to conclude enrollment in this significant safety trial for Sylys, which has the potential to help reduce anastamotic leakage following colorectal procedures," said Dr. Consten of the Meander Medical Center, Amersfoort. "We look forward to following the enrolled patients and reporting the findings of this study."
"Cohera appreciates the fast enrollment by both Dr. Bemelman, at AMC Hospital and Dr. Consten at the Meander Medical Center" said Chad Coberly, JD, VP of Clinical, Regulatory and Legal Affairs of Cohera Medical. "We also greatly appreciate the assistance of the team at Factory CRO, in the Netherlands, to help us reach our timeline objectives on this important first in human study.
Anastomotic leaks, on average, occur in 3 – 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 – 4B market.
"Enrollment completion of this study is monumental for Cohera Medical, as this is our second class III product in humans," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "It is an indication of the remarkable surgeons we work with, who recognize the value of this sealant, and its ability to enhance standard closure techniques, supporting the healing process and reducing post-operative complications."
Sunday, December 16, 2012
European Medicines Agency Updates Advice for Spraying Fibrin Sealants During Surgery
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued new instructions to promote safe use of the fibrin sealants Tisseel, Tissucol, Artiss, and Beriplast P during surgery. This advice follows that issued for two other fibrin sealants, Evicel and Quixil, in November 2012. Employed to help reduce local bleeding, these sealants are typically dripped or sprayed onto bleeding tissue to form a fibrin clot.
Reports of gas embolism with Evicel and Quixil in association with the use of spray devices that use a pressure regulator prompted a review of fibrin sealants. These events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in closer-than-recommended proximity to the tissue surface, EMA stated in a press release.
Although EMA reports that risk of gas embolism with Tisseel, Tissucol, and Artiss when applied as spray during surgery was considered to be very low, the Committee concluded that the risk cannot be excluded. It urges that product information for these medicines be updated with new instructions to optimise their safe use. EMA stated the following:
- The product information should be updated with clear and consistent advice for healthcare professionals regarding recommended pressure and distance to use during spraying application.
- The marketing-authorisation holders for these medicines should ensure that they are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that they contain labels stating the recommended pressure and distance.
- The product information should include a warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2, and patients should be closely monitored for signs of gas embolism.
- Healthcare professionals in the European Union (EU) will receive a letter outlining the updated information on the safe use of these medicines.
For the fibrin sealant Beriplast P (and associated names), however, the CHMP concluded that "there is no risk associated with this product because it does not require a gas-assisted spray device during application, therefore there is no risk of gas embolism with this product when used in accordance with prescribing advice and with the recommended device."
Wednesday, February 29, 2012
Saturday, February 4, 2012
Baxter Announces FDA Approval of Expanded Indication for TISSEEL
DEERFIELD, Ill., Jan 30, 2012 (BUSINESS WIRE) -- Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved TISSEEL [Fibrin Sealant] to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical. TISSEEL is effective in heparinized patients. TISSEEL mimics the final stages of the body's own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis.
"The expanded indication for TISSEEL offers more surgeons an effective tool for controlling bleeding across a wider variety of surgical procedures," said Sibu Saha, M.D., Professor of Surgery, University of Kentucky. "This includes patients who have been treated with heparin who may have unique treatment challenges, which was the case for some of the patients involved in Baxter's clinical trials."
A Phase III clinical study assessed the safety and efficacy of TISSEEL in peripheral vascular surgery compared with manual compression, a standard of care, in 140 evaluable patients (70 patients per treatment arm). In the study, TISSEEL was shown to be statistically significantly better than manual compression in achieving hemostasis. These study results complement a clinical data package showing the safety and effectiveness of the use of TISSEEL as an adjunct to hemostasis.
"TISSEEL and its multiple application devices make it well-suited for a variety of surgical situations, such as open and laparoscopic procedures, reinforcing Baxter's commitment to supporting solutions to the surgical community," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience busines
Important Risk Information
For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, may result in life-threatening thromboembolic events and may increase the likelihood of acute hypersensitivity reactions in susceptible patients. Exercise caution to minimize the risk of intravascular application when using TISSEEL in surgery.
Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
Do not use TISSEEL for the treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.
Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.
Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.
Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.
Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This may occur if a spray device is used at higher than recommended pressures and in close proximity to the tissue surface.
When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.
TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.
Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness may negatively interfere with wound healing.
The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.
TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Tuesday, August 9, 2011
LifeBond, an Israeli maker of biosurgical products, raised over $20 million in a third round of financing led by Giza Venture Capital and Aurum Ventures, with Johnson & Johnson Development Corp joining the process
Johnson & Johnson (NYSE: JNJ) has invested in biological sealant developer Lifebond Ltd. as part of the company's $20 million third financing round. Giza Venture Capital and Aurum Ventures MKI Ltd. are leading the round alongside current investors Pitango Venture Capital, GlenRock Israel, the Zitelman Group, and Lifebond co-chairman Robert Taub.
Johnson & Johnson acquired Omrix Biopharmaceuticals, which Taub founded, for $425 million in 2006. It is interesting to see that Johnson & Johnson is investing in another company, which like Omrix, is developing a biological sealant.
Lifebond's flagship product is a surgical sealant for tissue after surgery to shorten the bowel. It partly competes with Omrix, and it seems that both Taub and Johnson & Johnson believe that Lifebond's products are as good as Omrix's products, but which Omrix's technology cannot produce.
Lifebond CEO Ishay Attar and COO Orahn Preiss-Bloom co-founded Lifebond in 2007, in the aftermath of the 2006 Second Lebanon War in order to develop next-generation would closure solutions for soldiers on the battlefield.
Lifebond will use proceeds from the financing round to complete preclinical trials of its LifeSeal sealant product to prevent life-threatening blood and fluid leakage from the intestine during surgery. Trials for LifeSeal for intestinal surgery under US Food and Drug Administration (FDA) will use premarket approval (PMA) protocols, the longer protocol for medical devices. Lifebond believes that it can bring the product to market within two years.
Lifebond is also developing hemostats that are in early clinical trials and a product to prevent hernias.
Johnson & Johnson acquired Omrix Biopharmaceuticals, which Taub founded, for $425 million in 2006. It is interesting to see that Johnson & Johnson is investing in another company, which like Omrix, is developing a biological sealant.
Lifebond's flagship product is a surgical sealant for tissue after surgery to shorten the bowel. It partly competes with Omrix, and it seems that both Taub and Johnson & Johnson believe that Lifebond's products are as good as Omrix's products, but which Omrix's technology cannot produce.
Lifebond CEO Ishay Attar and COO Orahn Preiss-Bloom co-founded Lifebond in 2007, in the aftermath of the 2006 Second Lebanon War in order to develop next-generation would closure solutions for soldiers on the battlefield.
Lifebond will use proceeds from the financing round to complete preclinical trials of its LifeSeal sealant product to prevent life-threatening blood and fluid leakage from the intestine during surgery. Trials for LifeSeal for intestinal surgery under US Food and Drug Administration (FDA) will use premarket approval (PMA) protocols, the longer protocol for medical devices. Lifebond believes that it can bring the product to market within two years.
Lifebond is also developing hemostats that are in early clinical trials and a product to prevent hernias.
Sunday, April 24, 2011
Recombinant Human Albumin for Use in Unique Sealant Technology
Novozymes Biopharma is pleased to announce that its recombinant human albumin, albucult®, is being used by Neomend in its ProGEL® PLATINUM surgical sealant.This product will be commercially available in Europe beginning in the second quarter of 2011. Neomend is an innovator in sealant and adhesion prevention products for the surgical marketplace. The company utilises albucult as a key component in ProGEL PLATINUM, the only sealant of its kind developed to treat pleural air leaks following lung resection surgery. Neomend’s ProGEL is a hydrogel polymer consisting of Novozymes’ albucult and a cross-linking component of polyethylene glycol (PEG). When they are combined, a rapid cross-linking reaction creates a hydrogel matrix that results in the formation of a strong, adherent and flexible seal. The technology, which has received a European CE Mark, enables surgeons to more effectively treat lung air leaks during surgery and has already been used in more than 8,000 procedures in the US since April of last year.
David Renzi, Neomend’s President and CEO, commented: “Novozymes’ extensive experience in manufacturing, regulatory and global supply, combined with its commitment to innovation, makes the company the ideal partner for Neomend to work with on its unique sealant technology. We will launch ProGEL PLATINUM in Europe in the second quarter of this year, while also continuing the development of this platform technology into other clinical areas such as spine, general surgery and gynecology.”
“Novozymes is delighted that Neomend has selected albucult for use in its unique sealant technology”, said Dermot Pearson, Marketing Director, Novozymes Biopharma. “The partnership demonstrates Novozymes’ commitment to providing quality materials for use in the healthcare, pharmaceutical and biotechnology industries and allows the company to position itself as a reliable partner in the wound sealant and medical device markets.” The use of albucult in ProGEL PLATINUM and other medical devices confers a range of unique advantages not possible with animal-derived ingredients such as sustainability of supply, GMP compliance and improved biocompatibility. Albucult also delivers unprecedented performance and quality benefits to medical applications including sealants, device coating and cell therapy applications while ensuring batch-to-batch consistency, which can significantly reduce lot testing burdens for customers.
Sunday, September 26, 2010
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