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.”
Friday, February 1, 2019
Sunday, September 23, 2018
FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding
The U.S. Food and Drug Administration permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.
“The device provides an additional, non-surgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” said Binita Ashar, M.D., director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health.
GI bleeding can occur in the upper GI tract (esophagus, stomach or small intestine) or the lower GI tract (colon and rectum). Causes of GI bleeding include gastric ulcers, artery or vein (arteriovenous) malformations, diverticulosis, cancer or inflammatory bowel disease. Older patients are at a higher risk of death from severe GI bleeding.
The Hemospray device is intended to treat most types of upper or lower GI bleeding. The device is an aerosolized spray that delivers a mineral blend to the bleeding site. The device is applied during an endoscopic procedure and can cover large areas such as large ulcers or tumors. The device is not intended for use in patients with variceal bleeding, which is bleeding that comes from enlarged veins that develop in certain medical conditions like alcoholic liver disease.
The FDA reviewed data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with real world evidence from medical literature reports including an additional 522 patients. The Hemospray device stopped GI bleeding in 95 percent of patients within five minutes of device usage. Re-bleeding, usually within 72 hours, but up to 30 days following device usage, was observed in 20 percent of these patients. One serious side effect, bowel perforation, was observed in approximately 1 percent of patients. Hemospray is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation.
The FDA permitted marketing of the Hemospray device to Wilson-Cook Medical Inc.
“The device provides an additional, non-surgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” said Binita Ashar, M.D., director, division of surgical devices, in the FDA’s Center for Devices and Radiological Health.
GI bleeding can occur in the upper GI tract (esophagus, stomach or small intestine) or the lower GI tract (colon and rectum). Causes of GI bleeding include gastric ulcers, artery or vein (arteriovenous) malformations, diverticulosis, cancer or inflammatory bowel disease. Older patients are at a higher risk of death from severe GI bleeding.
The Hemospray device is intended to treat most types of upper or lower GI bleeding. The device is an aerosolized spray that delivers a mineral blend to the bleeding site. The device is applied during an endoscopic procedure and can cover large areas such as large ulcers or tumors. The device is not intended for use in patients with variceal bleeding, which is bleeding that comes from enlarged veins that develop in certain medical conditions like alcoholic liver disease.
The FDA reviewed data from clinical studies consisting of 228 patients with upper and lower GI bleeding, supplemented with real world evidence from medical literature reports including an additional 522 patients. The Hemospray device stopped GI bleeding in 95 percent of patients within five minutes of device usage. Re-bleeding, usually within 72 hours, but up to 30 days following device usage, was observed in 20 percent of these patients. One serious side effect, bowel perforation, was observed in approximately 1 percent of patients. Hemospray is contraindicated in patients who have a gastrointestinal fistula or are at high risk for experiencing a gastrointestinal perforation.
The FDA permitted marketing of the Hemospray device to Wilson-Cook Medical Inc.
Wednesday, April 25, 2018
Cohera Medical Inc.® Awarded Patent on its Biodegradable Sealant Technology
Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, today announced that the U.S. Patent and Trademark Office (USPTO) has issued the Company a notice of allowance on its patent application, titled “SILANE-CONTAINING MOISTURE-CURABLE TISSUE SEALANT”.
The patent relates to a novel 100% synthetic sealant with several potential surgical applications. The sealant covered by the patent, Sylys® Surgical Sealant, is highly elastic, and has good bonding strength to internal tissues. In addition, the sealant is easy to prepare and apply in the operating theatre and is biocompatible for internal human use. The patent covers the unique chemistry of the sealant allowing for variations that allow for multiple products with varying elasticity and bonding properties, thereby enabling the development of products for multiple clinical applications.
“The unique chemistry of this synthetic sealant is a breakthrough discovery in the field of medical sealants,” said Dottie Clower, PhD, Chief Scientific Officer of Cohera Medical and the patent’s primary inventor. “The development of this technology has taken many years to perfect, and this patent is the culmination of a significant research effort by the company.”
“We are excited to add this patent to our growing intellectual property portfolio, which solidifies our leadership position in internal surgical adhesives and sealants," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “This patent protects the core of our sealant technology as well as the key features of our sealant products that make them commercially and clinically viable.”
Cohera Medical is currently developing Sylys Surgical Sealant intended to be used as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in colectomy procedures. Sylys is designed to help reduce anastomotic leakage by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur. Sylys may also have similar leak prevention characteristics in pancreatic resections, lung, and brain applications where there is a need for elimination of often catastrophic leaks of fluid or air during or after surgery. The product is currently undergoing clinical trials in the U.S. for the colectomy indication.
The market for Sylys Surgical Sealant is significant, with more than one million procedures per 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.
The patent relates to a novel 100% synthetic sealant with several potential surgical applications. The sealant covered by the patent, Sylys® Surgical Sealant, is highly elastic, and has good bonding strength to internal tissues. In addition, the sealant is easy to prepare and apply in the operating theatre and is biocompatible for internal human use. The patent covers the unique chemistry of the sealant allowing for variations that allow for multiple products with varying elasticity and bonding properties, thereby enabling the development of products for multiple clinical applications.
“The unique chemistry of this synthetic sealant is a breakthrough discovery in the field of medical sealants,” said Dottie Clower, PhD, Chief Scientific Officer of Cohera Medical and the patent’s primary inventor. “The development of this technology has taken many years to perfect, and this patent is the culmination of a significant research effort by the company.”
“We are excited to add this patent to our growing intellectual property portfolio, which solidifies our leadership position in internal surgical adhesives and sealants," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. “This patent protects the core of our sealant technology as well as the key features of our sealant products that make them commercially and clinically viable.”
Cohera Medical is currently developing Sylys Surgical Sealant intended to be used as an adjunct to standard closure techniques for the reinforcement and protection of anastomotic junctions in colectomy procedures. Sylys is designed to help reduce anastomotic leakage by providing additional support to the anastomosis during the first few days of healing, when the development of leaks is most likely to occur. Sylys may also have similar leak prevention characteristics in pancreatic resections, lung, and brain applications where there is a need for elimination of often catastrophic leaks of fluid or air during or after surgery. The product is currently undergoing clinical trials in the U.S. for the colectomy indication.
The market for Sylys Surgical Sealant is significant, with more than one million procedures per 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.
Tuesday, January 9, 2018
Baxter acquires surgical products
Baxter International Inc., a global medical products company, said Monday that it will acquire two hemostat and sealant products from Mallinckrodt.
It will acquire Recothrom Thrombin topical, the first and only stand-alone recombinant thrombin, and Preveleak Surgical Sealant, which is used in vascular reconstruction.
"Uncontrolled intraoperative bleeding can lead to a wide variety of clinical and economic complications for patients and hospitals. As a leading provider of advanced hemostats and sealants, Deerfield-based Baxter is focused on continually identifying solutions to help meet surgeons' varying needs," said Wil Boren, president of Baxter's Advanced Surgery business. "We are excited about the addition of Recothrom to help surgeons address less severe intraoperative bleeding and Preveleak to complement Baxter's existing portfolio of sealants for cardiovascular and other surgical specialties."
Thrombin is a proven blood coagulation agent -- used on its own or in combination with other hemostats -- that has been estimated to be used in more than one million patients per year in the United States to help surgeons address intraoperative bleeding.
Recothrom is a thrombin-based product indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. As the only topical hemostat from recombinant DNA origin approved in the United States and Canada, Recothrom can be used in pediatric and adult patients with or without antibodies to bovine-derived thrombin.
The acquisition also includes Preveleak, a surgical sealant designed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured connections between blood vessels. Preveleak augments Baxter's portfolio of complementary hemostats, sealants and tissue products used in cardiovascular and other surgeries, offering surgeons additional clinically differentiated products to address patients' varying needs. Preveleak is approved in the United States and European Union.
Sales of the proposed acquired products totaled approximately $56 million in the twelve months preceding Sept. 29. Upon closing, the deal is expected to be modestly accretive to Baxter's 2018 adjusted earnings and increasingly accretive thereafter. Under the terms of the agreement, Baxter will acquire Recothrom and Preveleak for an upfront payment of approximately $153 million and potential contingent payments in the future.
The transaction is expected to close in the first half of 2018, subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
It will acquire Recothrom Thrombin topical, the first and only stand-alone recombinant thrombin, and Preveleak Surgical Sealant, which is used in vascular reconstruction.
"Uncontrolled intraoperative bleeding can lead to a wide variety of clinical and economic complications for patients and hospitals. As a leading provider of advanced hemostats and sealants, Deerfield-based Baxter is focused on continually identifying solutions to help meet surgeons' varying needs," said Wil Boren, president of Baxter's Advanced Surgery business. "We are excited about the addition of Recothrom to help surgeons address less severe intraoperative bleeding and Preveleak to complement Baxter's existing portfolio of sealants for cardiovascular and other surgical specialties."
Thrombin is a proven blood coagulation agent -- used on its own or in combination with other hemostats -- that has been estimated to be used in more than one million patients per year in the United States to help surgeons address intraoperative bleeding.
Recothrom is a thrombin-based product indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. As the only topical hemostat from recombinant DNA origin approved in the United States and Canada, Recothrom can be used in pediatric and adult patients with or without antibodies to bovine-derived thrombin.
The acquisition also includes Preveleak, a surgical sealant designed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured connections between blood vessels. Preveleak augments Baxter's portfolio of complementary hemostats, sealants and tissue products used in cardiovascular and other surgeries, offering surgeons additional clinically differentiated products to address patients' varying needs. Preveleak is approved in the United States and European Union.
Sales of the proposed acquired products totaled approximately $56 million in the twelve months preceding Sept. 29. Upon closing, the deal is expected to be modestly accretive to Baxter's 2018 adjusted earnings and increasingly accretive thereafter. Under the terms of the agreement, Baxter will acquire Recothrom and Preveleak for an upfront payment of approximately $153 million and potential contingent payments in the future.
The transaction is expected to close in the first half of 2018, subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
Tuesday, January 2, 2018
Hemostasis Solution Controls Bleeding during Surgery
A novel handheld device delivers a powder based on collagen to help surgeons achieve hemostatic bleeding control during surgical procedures.
The Biom’Up (Saint-Priest, France) HemoBlast Bellows is a sterile delivery device that is preloaded with a dry, sterile powder made of highly purified porcine collagen, glucose, chondroitin sulfate, and thrombin. The hemostatic powder is applied to the source of the bleeding by squeezing the bellows. Once applied, the powdered collagen and glucose components start the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for autologous coagulation to begin.
In addition to collagen, the thrombin component, collected from pooled human plasma (an ancillary blood derivative) is included in the powder to boost the effect of the hemostatic agent. The thrombin facilitates the conversion of fibrinogen to fibrin, which allows the blood to clot. The chondroitin sulfate powder component provides cohesion between the hemostatic wound and the surrounding tissue. Users do not need to thaw, mix, or heat the powder, which is absorbed by the body within four weeks.
“As the first active hemostatic powder, it will support surgeons in their care for their patients with a simple, effective, and holistic solution for the management of bleeding” said Etienne Binant, CEO of Biom’up. “Biom'up has created innovative and clinically proven products that cover many different surgical specialties - orthopedics, spinal, cardiac, general, and maxillo-facial and dental.”
Studies have shown that during general surgical procedures, the HemoBlast Bellows device achieved 93% efficacy for hemostasis within six minutes, with a significantly shorter preparation time. Common adverse events included abnormal bloodwork, anemia, arrhythmia, and pain, none of which were related to the device itself. No unanticipated adverse device effects occurred.
Collagen is the main structural protein of connective tissue, making up 25-35% of the whole-body protein content. It is one of the body’s key natural resources and a component of skin tissue that can benefit all stages of the wound healing process. The importance of re-establishing a functional extracellular matrix (ECM) in chronic wounds has led to a renewed interest in collagen-based wound healing products, which can be applied either in the surgical or clinical setting, serving as a natural wound dressing with properties that artificial wound dressings do not possess.
The Biom’Up (Saint-Priest, France) HemoBlast Bellows is a sterile delivery device that is preloaded with a dry, sterile powder made of highly purified porcine collagen, glucose, chondroitin sulfate, and thrombin. The hemostatic powder is applied to the source of the bleeding by squeezing the bellows. Once applied, the powdered collagen and glucose components start the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for autologous coagulation to begin.
In addition to collagen, the thrombin component, collected from pooled human plasma (an ancillary blood derivative) is included in the powder to boost the effect of the hemostatic agent. The thrombin facilitates the conversion of fibrinogen to fibrin, which allows the blood to clot. The chondroitin sulfate powder component provides cohesion between the hemostatic wound and the surrounding tissue. Users do not need to thaw, mix, or heat the powder, which is absorbed by the body within four weeks.
“As the first active hemostatic powder, it will support surgeons in their care for their patients with a simple, effective, and holistic solution for the management of bleeding” said Etienne Binant, CEO of Biom’up. “Biom'up has created innovative and clinically proven products that cover many different surgical specialties - orthopedics, spinal, cardiac, general, and maxillo-facial and dental.”
Studies have shown that during general surgical procedures, the HemoBlast Bellows device achieved 93% efficacy for hemostasis within six minutes, with a significantly shorter preparation time. Common adverse events included abnormal bloodwork, anemia, arrhythmia, and pain, none of which were related to the device itself. No unanticipated adverse device effects occurred.
Collagen is the main structural protein of connective tissue, making up 25-35% of the whole-body protein content. It is one of the body’s key natural resources and a component of skin tissue that can benefit all stages of the wound healing process. The importance of re-establishing a functional extracellular matrix (ECM) in chronic wounds has led to a renewed interest in collagen-based wound healing products, which can be applied either in the surgical or clinical setting, serving as a natural wound dressing with properties that artificial wound dressings do not possess.
Wednesday, November 8, 2017
SAN JOSE, Calif.--(BUSINESS WIRE)--Starch Medical Inc. a privately held manufacturer and marketer of polysaccharide based hemostatic products for use in controlling bleeding in surgery and trauma applications has expanded its product portfolio with the launch of SuperClot® Hemostat in Europe.
Starch Medical received CE Approval earlier this year for SuperClot® and will utilize their existing network of distribution partners along with new strategic partners to bring this innovative new polymer hemostat solution to surgical teams and hospitals throughout Europe. Next week Starch Medical will exhibit and hold distributor meetings at MEDICA the world's leading trade fair for the medical industry held in Düsseldorf, Germany from November 13-16, 2017.
“The market for economical, safe and effective polysaccharide hemostats is growing rapidly worldwide and especially in Europe. Our exclusive agreement to market Starch Medical’s SuperClot® Hemostat in Italy provides us with the opportunity to better serve our hospitals and their patients,” said Giovanni Capello, Chief Executive Officer of Medix. “In addition to rapid and effective hemostasis, our surgeons are attracted by the wide variety of surgical applications where SuperClot® can be used. We believe that Starch Medical’s hemostat product line including SealFoam®, SealFoam® Sternal and now SuperClot® will become the standard to control the majority of surgical bleeding in the future.”
“Surgeons and hospitals around the world are rapidly adopting the benefits of our hemostatic platform technology to enhance their performance in addressing various bleeding scenarios,” stated Stephen Heniges, President at Starch Medical. “Since our products contain no human or animal components the safety profile is excellent. The ability of SuperClot® to rapidly penetrate blood and form an adhesive gel to help seal the wound will be greatly appreciated by our customers.”
Starch Medical will continue to expand its product portfolio and pursue strategic partners in key markets globally and expects to further penetrate Asia, Europe and The Middle East in the near future.
Starch Medical received CE Approval earlier this year for SuperClot® and will utilize their existing network of distribution partners along with new strategic partners to bring this innovative new polymer hemostat solution to surgical teams and hospitals throughout Europe. Next week Starch Medical will exhibit and hold distributor meetings at MEDICA the world's leading trade fair for the medical industry held in Düsseldorf, Germany from November 13-16, 2017.
“The market for economical, safe and effective polysaccharide hemostats is growing rapidly worldwide and especially in Europe. Our exclusive agreement to market Starch Medical’s SuperClot® Hemostat in Italy provides us with the opportunity to better serve our hospitals and their patients,” said Giovanni Capello, Chief Executive Officer of Medix. “In addition to rapid and effective hemostasis, our surgeons are attracted by the wide variety of surgical applications where SuperClot® can be used. We believe that Starch Medical’s hemostat product line including SealFoam®, SealFoam® Sternal and now SuperClot® will become the standard to control the majority of surgical bleeding in the future.”
“Surgeons and hospitals around the world are rapidly adopting the benefits of our hemostatic platform technology to enhance their performance in addressing various bleeding scenarios,” stated Stephen Heniges, President at Starch Medical. “Since our products contain no human or animal components the safety profile is excellent. The ability of SuperClot® to rapidly penetrate blood and form an adhesive gel to help seal the wound will be greatly appreciated by our customers.”
Starch Medical will continue to expand its product portfolio and pursue strategic partners in key markets globally and expects to further penetrate Asia, Europe and The Middle East in the near future.
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.”
Snake venom is key ingredient in experimental drug for heart patients
An experimental antiplatelet drug has surprising bite. Based on a protein found in snake venom, the new drug prevented blood clotting in mice without causing excessive bleeding after an injury, according to research published Thursday in the journal Arteriosclerosis, Thrombosis and Vascular Biology. The drug has yet to be tested in humans.
Bleeding is a common side effect in the current crop of available antiplatelet drugs, which are usually prescribed for heart patients to prevent blood cells, called platelets, from clumping together and forming clots. Depending on where they occur, clots can lead to a stroke or heart attack.
“As a scientist, it is always intriguing to learn from our mother nature,” wrote Y. Jane Tseng, co-lead author of the study and a professor at the Genomics Center School of Pharmacy at National Taiwan University, in an email.
“There is a long history of using snake venom as a tool to study blood clotting mechanism,” Tseng said, adding that the only available antiplatelet drugs used for thrombosis — in which a clot occurs in a blood vessel and obstructs circulation — are also based on venom, though not the same one used in her study.
Tur-Fu Huang, co-lead author of the study and a professor at the Graduate Institute of Pharmacology at National Taiwan University, said some snake venoms are neurotoxic — poisonous to the brain — while others are hemorrhagic and “affect blood coagulation and platelet function profoundly.” The new research concentrated on venom that is hemorrhagic in nature.
In earlier work, Huang, Tseng and their colleagues found that trowaglerix from the venom of Tropidolaemus wagleri, commonly known as Wagler’s pit viper, latched onto glycoprotein VI, a protein that sits on the surface of platelets.
“Not every snake venom acts in similar mode on platelets,” Tseng said.
This attachment to glycoprotein VI is how trowaglerix stimulates platelets to form blood clots, the researchers learned. Platelets that are missing glycoprotein VI do not form blood clots and do not lead to severe bleeding.
If glycoprotein VI could be blocked, the research team hypothesized, would that prevent prolonged bleeding?
Putting this theory to the test, the researchers designed a molecule that could prevent clotting, and with added properties of trowaglerix, it did not cause severe bleeding. When this experimental drug was given to mice, the rodents showed slower blood clot formation, yet they also did not bleed longer than untreated mice, Tseng and her colleagues found.
“We successfully transformed trowaglerix into an anti-thrombotic agent,” said Huang, who noted that the experimental drug was both effective and safe. Still, it needs further testing in animals and humans, which will take some time.
In the meantime, he said, it can be modified and optimized “to a more potent and stable agent” with potential for use in patients. Ultimately, he and his colleagues hope their work could yield an entire class of effective antiplatelet drugs with limited side effects.
‘Of course there are safety issues’
Dr. Leslie Boyer, director of the VIPER Institute in Tucson, Arizona, said the new study “doesn’t automatically mean that you have a drug, because of course there are safety issues.”
“If they could find a very perfectly tuned molecule that a snake makes and give just the right dose,” Boyer said, it might be “of therapeutic benefit to certain people.”
“Venom contains many, many toxins. Even a single snake might have a 100 different types of venom molecules in their repertoire,” said Boyer, who was not involved in the new study. She added that even though the modest dose of venom delivered when a snake bites is “quite toxic.” But if you took that same poisonous venom, teased out the ingredients, scaled them down and used only a low dose, there are a lot of ingredients “that could be put to good use.”
Toxicologists don’t really distinguish one molecule as poisonous and another as benign, she said.
“It’s all a matter of dose,” Boyer said. “So a small dose of something might be a medicine, and a large dose becomes a poison.”
Snakes have venom for all kinds of reasons, she said, though the biggest reason, perhaps, is “to make lunch hold still.”
“A lot of snakes are relatively slow-moving creatures. They’re ambush predators or they only travel a short distance to get their prey,” Boyer said, noting that snakes “have one chance, one quick strike, to administer something that’s going to make very fast-moving prey, like a bird or a rodent, hold still — fall down and wait to be eaten.”
The molecules in snake venom, then, interact with the nervous system or with the cardiovascular system and represent “potential drugs” that might act on the nervous system to lessen pain or relax muscles, she said. The venom molecules that interact with the cardiovascular system, as Tseng, Huang and their co-authors show, “have the potential to be used for blood pressure problems or for heart rate situations, things like that,” Boyer said.
There are other toxins that have a direct effect on the tissues next to where the fang goes in that can digest proteins, which along with fat is what animals are made of, so “those molecules have all kinds of potential also,” she said. “For instance, breaking down specific proteins is something that might be useful not only for drugs but maybe for laundry detergent or things that remove stains. Maybe they’re good for recycling.”
But, caution is required, Boyer said: The reason we know anything about venom at all is that snake bites make people sick.
Bleeding is a common side effect in the current crop of available antiplatelet drugs, which are usually prescribed for heart patients to prevent blood cells, called platelets, from clumping together and forming clots. Depending on where they occur, clots can lead to a stroke or heart attack.
“As a scientist, it is always intriguing to learn from our mother nature,” wrote Y. Jane Tseng, co-lead author of the study and a professor at the Genomics Center School of Pharmacy at National Taiwan University, in an email.
“There is a long history of using snake venom as a tool to study blood clotting mechanism,” Tseng said, adding that the only available antiplatelet drugs used for thrombosis — in which a clot occurs in a blood vessel and obstructs circulation — are also based on venom, though not the same one used in her study.
Tur-Fu Huang, co-lead author of the study and a professor at the Graduate Institute of Pharmacology at National Taiwan University, said some snake venoms are neurotoxic — poisonous to the brain — while others are hemorrhagic and “affect blood coagulation and platelet function profoundly.” The new research concentrated on venom that is hemorrhagic in nature.
In earlier work, Huang, Tseng and their colleagues found that trowaglerix from the venom of Tropidolaemus wagleri, commonly known as Wagler’s pit viper, latched onto glycoprotein VI, a protein that sits on the surface of platelets.
“Not every snake venom acts in similar mode on platelets,” Tseng said.
This attachment to glycoprotein VI is how trowaglerix stimulates platelets to form blood clots, the researchers learned. Platelets that are missing glycoprotein VI do not form blood clots and do not lead to severe bleeding.
If glycoprotein VI could be blocked, the research team hypothesized, would that prevent prolonged bleeding?
Putting this theory to the test, the researchers designed a molecule that could prevent clotting, and with added properties of trowaglerix, it did not cause severe bleeding. When this experimental drug was given to mice, the rodents showed slower blood clot formation, yet they also did not bleed longer than untreated mice, Tseng and her colleagues found.
“We successfully transformed trowaglerix into an anti-thrombotic agent,” said Huang, who noted that the experimental drug was both effective and safe. Still, it needs further testing in animals and humans, which will take some time.
In the meantime, he said, it can be modified and optimized “to a more potent and stable agent” with potential for use in patients. Ultimately, he and his colleagues hope their work could yield an entire class of effective antiplatelet drugs with limited side effects.
‘Of course there are safety issues’
Dr. Leslie Boyer, director of the VIPER Institute in Tucson, Arizona, said the new study “doesn’t automatically mean that you have a drug, because of course there are safety issues.”
“If they could find a very perfectly tuned molecule that a snake makes and give just the right dose,” Boyer said, it might be “of therapeutic benefit to certain people.”
“Venom contains many, many toxins. Even a single snake might have a 100 different types of venom molecules in their repertoire,” said Boyer, who was not involved in the new study. She added that even though the modest dose of venom delivered when a snake bites is “quite toxic.” But if you took that same poisonous venom, teased out the ingredients, scaled them down and used only a low dose, there are a lot of ingredients “that could be put to good use.”
Toxicologists don’t really distinguish one molecule as poisonous and another as benign, she said.
“It’s all a matter of dose,” Boyer said. “So a small dose of something might be a medicine, and a large dose becomes a poison.”
Snakes have venom for all kinds of reasons, she said, though the biggest reason, perhaps, is “to make lunch hold still.”
“A lot of snakes are relatively slow-moving creatures. They’re ambush predators or they only travel a short distance to get their prey,” Boyer said, noting that snakes “have one chance, one quick strike, to administer something that’s going to make very fast-moving prey, like a bird or a rodent, hold still — fall down and wait to be eaten.”
The molecules in snake venom, then, interact with the nervous system or with the cardiovascular system and represent “potential drugs” that might act on the nervous system to lessen pain or relax muscles, she said. The venom molecules that interact with the cardiovascular system, as Tseng, Huang and their co-authors show, “have the potential to be used for blood pressure problems or for heart rate situations, things like that,” Boyer said.
There are other toxins that have a direct effect on the tissues next to where the fang goes in that can digest proteins, which along with fat is what animals are made of, so “those molecules have all kinds of potential also,” she said. “For instance, breaking down specific proteins is something that might be useful not only for drugs but maybe for laundry detergent or things that remove stains. Maybe they’re good for recycling.”
But, caution is required, Boyer said: The reason we know anything about venom at all is that snake bites make people sick.
Friday, June 2, 2017
Hemostatic agents market is estimated to reach USD 8,347.9 Million by 2022
Surgery is a foundational component of health-care systems. Over 51 million hospital-based surgical procedures are performed annually worldwide. The effective management of bleeding to achieve hemostasis during surgical procedures is essential to promote positive outcomes. As surgical procedures evolve to be more refined and noninvasive, the utilization of fast acting biologically and synthetically derived hemostats, encompassing fibrin sealants, flowable gelatins and adhesives, is becoming increasingly prevalent. Some of the parameters for choosing a hemostatic agent includes efficiency, type of surgery, patient condition, need for quicker results, active bleeding tissue VS pooled blood sites and cost. Global hemostatic agents market is estimated to grow at a rate of 7.1% CAGR to reach $8,347.9m by 2022.
Currently, fibrin sealants are the most effective tissue adhesives used in surgeries. Additionally, the properties such as biocompatibility and biodegradability of this sealants are set to drive the growth of hemostatic agents market. Fibrin sealants are widely employed in various surgical specialties such as cardiovascular surgery, thoracic surgery, neurosurgery, plastic and reconstructive surgery, and dental surgery and others. Hemostasis is a complex method requiring the delicately coordinated activation of platelets as well as plasma clotting factors to form a platelet-fibrin clot. Hemostatic agents such as Thrombin Based Hemostats, Gelatin Based Hemostats, Collagen Based Hemostats and many more are used to control the flow of blood during a surgery or dressing an injury. These hemostatic agents are required in hospitals, surgery centers, nursing homes and other centers during the operations.
Cardiovascular surgery is the key treatment with regards to hemostatic agents market. Risk of cardiovascular diseases generally increases with the increase in age. Globally cardiovascular disease related deaths surged in developed nations including the U.S. and Europe where chronic diseases being the major contributor of death. Hemostatic agents are also considered and used majorly to improve clinical outcome, whereas aesthetics and cost effectiveness have less importance. The other surgeries where hemostats are utilized primarily include cosmetic, orthopedic, urological and arthroscopic surgeries. The rising cosmetic surgeries globally has been a one of the major driver for the growing usage of hemostats among the others segment.
Key Players in this Market Include: -
Johnson and Johnson Services Inc (U.S.)
B.Braun Melsungen AG (Germany)
C.R. Bard Incorporation (U.S.)
Mallinckrodt Plc (U.S.)
Integra Life Sciences Corporation (U.S.)
Americas held a major share in the market in 2016 whereas Asia-Pacific region is projected to witness the fastest growth during the forecast period. Global Hemostatic agents market is quite consolidated with key medical consumable and surgical technology players having significant presence. Frequent product launches, acquisitions and expansion are a few of the growth strategies the key players in the industry are adopting to increase their market share.
Currently, fibrin sealants are the most effective tissue adhesives used in surgeries. Additionally, the properties such as biocompatibility and biodegradability of this sealants are set to drive the growth of hemostatic agents market. Fibrin sealants are widely employed in various surgical specialties such as cardiovascular surgery, thoracic surgery, neurosurgery, plastic and reconstructive surgery, and dental surgery and others. Hemostasis is a complex method requiring the delicately coordinated activation of platelets as well as plasma clotting factors to form a platelet-fibrin clot. Hemostatic agents such as Thrombin Based Hemostats, Gelatin Based Hemostats, Collagen Based Hemostats and many more are used to control the flow of blood during a surgery or dressing an injury. These hemostatic agents are required in hospitals, surgery centers, nursing homes and other centers during the operations.
Cardiovascular surgery is the key treatment with regards to hemostatic agents market. Risk of cardiovascular diseases generally increases with the increase in age. Globally cardiovascular disease related deaths surged in developed nations including the U.S. and Europe where chronic diseases being the major contributor of death. Hemostatic agents are also considered and used majorly to improve clinical outcome, whereas aesthetics and cost effectiveness have less importance. The other surgeries where hemostats are utilized primarily include cosmetic, orthopedic, urological and arthroscopic surgeries. The rising cosmetic surgeries globally has been a one of the major driver for the growing usage of hemostats among the others segment.
Key Players in this Market Include: -
Johnson and Johnson Services Inc (U.S.)
B.Braun Melsungen AG (Germany)
C.R. Bard Incorporation (U.S.)
Mallinckrodt Plc (U.S.)
Integra Life Sciences Corporation (U.S.)
Americas held a major share in the market in 2016 whereas Asia-Pacific region is projected to witness the fastest growth during the forecast period. Global Hemostatic agents market is quite consolidated with key medical consumable and surgical technology players having significant presence. Frequent product launches, acquisitions and expansion are a few of the growth strategies the key players in the industry are adopting to increase their market share.
Sunday, November 20, 2016
Fibrin Glue Market: Asia is expected to witness high growth rates in the next five years, 2021
Fibrin glue is a unique adhesion material used in surgeries for closure of wounds. Fibrin glues are mainly extracted from collective plasma and contain different amounts of purified and virally-inactivated human proteins. Fibrin glue is composed of two components, including fibrinogen and factor XIII. These concentrated ingredients interact with a solution of thrombin and calcium to form coagulum. As the thrombin and fibrinogen/factor XIII solution combine, a clot of a blood protein called fibrin develops in a few seconds, depending on the dilute form of thrombin is used. Some of the characteristics of fibrin glue include high internal bond strength, high surface adherence strength, and ability to enhance tissue regeneration and clot formation. Fibrin glue is mainly used in cardiac, vascular, and pulmonary surgeries, burn bleeding, and lacerations of liver and spleen. It is also used in other surgeries such as neurosurgeries, plastic surgeries, wound management, and general and orthopedic surgeries. Fibrin glue lowers the risk of infection, provides early hemostasis on the treated area, and improves cosmesis. It also promotes natural tissue healing. However, one of the disadvantages of fibrin glue is the risk of transmission of infectious organisms from human bodies to the glue. Tisseel, biocol, and beriplast are some of the commercially-prepared fibrin sealants.
Surgical sealants are used after surgeries or traumatic injuries to bind or hold the external and internal tissues. Some of the major surgical sealants based on their composition are collagen-based compounds, fibrin sealants, synthetic sealants such as cyanoacrylates, and tissue adhesive glues such as hydogels and glutaraldehyde glues. Fibrin sealants, also known as fibrin glue, are a hemostatic agent.
North America dominates the global market for fibrin glue due to a large aging population and increasing number of surgical procedures. Asia is expected to witness high growth rates in the next five years in the global fibrin glue market. China and India are expected to be the fastest-growing fibrin glue markets in Asia Pacific. Some of the key driving factors of the fibrin glue market in emerging countries are a large pool of patients, increasing healthcare expenditure, and rising government funding.
In the recent years, the use of fibrin glue has increased due to increasing number of surgical procedures. Increasing aging population, rise in incidences of chronic wounds, venous ulcers, diabetic ulcers, and pressure sores, and the relatively-low chances of complication associated with these products are some of the key factors driving the growth of the global fibrin glue market. In addition, increasing healthcare awareness is also fueling the growth of the global fibrin glue market. However, economic slowdown and minimal invasive procedures, such as laparoscopic and endoscopic surgeries, are some of the major factors restraining the growth of the global fibrin glue market. In addition, unfavorable reimbursement policies would also restrain growth of the global fibrin glue market.
Surgical sealants are used after surgeries or traumatic injuries to bind or hold the external and internal tissues. Some of the major surgical sealants based on their composition are collagen-based compounds, fibrin sealants, synthetic sealants such as cyanoacrylates, and tissue adhesive glues such as hydogels and glutaraldehyde glues. Fibrin sealants, also known as fibrin glue, are a hemostatic agent.
North America dominates the global market for fibrin glue due to a large aging population and increasing number of surgical procedures. Asia is expected to witness high growth rates in the next five years in the global fibrin glue market. China and India are expected to be the fastest-growing fibrin glue markets in Asia Pacific. Some of the key driving factors of the fibrin glue market in emerging countries are a large pool of patients, increasing healthcare expenditure, and rising government funding.
In the recent years, the use of fibrin glue has increased due to increasing number of surgical procedures. Increasing aging population, rise in incidences of chronic wounds, venous ulcers, diabetic ulcers, and pressure sores, and the relatively-low chances of complication associated with these products are some of the key factors driving the growth of the global fibrin glue market. In addition, increasing healthcare awareness is also fueling the growth of the global fibrin glue market. However, economic slowdown and minimal invasive procedures, such as laparoscopic and endoscopic surgeries, are some of the major factors restraining the growth of the global fibrin glue market. In addition, unfavorable reimbursement policies would also restrain growth of the global fibrin glue market.
Sunday, December 20, 2015
Mallinckrodt Diversifies Hospital Growth Portfolio, Acquiring Three Commercial-Stage, Global Specialty Hemostasis Brands From The Medicines Company
CHESTERFIELD, United Kingdom, Dec. 18, 2015 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced that it has entered into a purchase agreement with The Medicines Company (NASDAQ: MDCO) under which subsidiaries of Mallinckrodt plc will acquire a global portfolio of three commercial-stage topical hemostasis drugs – RECOTHROM® Thrombin topical (Recombinant), PreveLeak™ Surgical Sealant, and RAPLIXA™ (Fibrin Sealant) – for an initial payment of approximately $175 million, inclusive of existing inventory. The transaction also includes potential added future considerations in the form of payments for achieving certain milestones, and is expected to be financed from cash on hand.
"Addition of this innovative portfolio of branded hemostats to our hospital platform is another demonstration of Mallinckrodt's 'acquire to invest' business strategy. Products that help control bleeding are essential to the vast majority of surgical practices. Yet this category – a market that has been estimated at $750 million in the U.S. and at least $1 billion globally – is an area in hospital products that has seen relatively little innovation and investment in recent years," said Mark Trudeau, Chief Executive Officer and President of Mallinckrodt.
Trudeau continued, "Acquiring and promoting leading hemostasis brand RECOTHROM alongside OFIRMEV® (acetaminophen) injection broadens Mallinckrodt's impact in the surgical suite for patients and physicians, and creates a strong framework to broadly commercialize innovative, highly durable new agents PreveLeak and RAPLIXA, which carry intellectual property protection to 2028 and 2031, respectively. As we continue to further diversify our portfolio, we're excited about the volume growth opportunity these products will add to our hospital offering for years to come."
On a reported U.S. GAAP1 basis, Mallinckrodt expects the transaction to be dilutive to its fiscal 2016 earnings per share (EPS); however, on an adjusted basis, the company expects the transaction to be neutral to EPS in fiscal 2016. On both a U.S. GAAP and adjusted basis, the company expects the transaction to be accretive to EPS beginning in fiscal 2017. Assuming a closing in the second quarter of fiscal 2016, the company expects the new products will add between $40 million and $45 million in incremental revenue in fiscal 2016, and provide low double-digit organic growth starting in fiscal 2017.
Through this acquisition, the company is expected to capitalize on synergies with Mallinckrodt's current U.S. commercial team focused on pain management in hospital surgical practice with OFIRMEV, the company's intravenous acetaminophen product indicated for the management of mild to moderate pain, and management of moderate to severe pain with adjunctive opioid analgesics. With expanded product offerings including OFIRMEV, RECOTHROM, PreveLeak and RAPLIXA, and with focused promotion, the company's commercial organization – supported by Mallinckrodt's strong sales, market access, national accounts and medical affairs teams – is expected to broaden access for patients who would benefit from these analgesic and hemostasis drugs.
Hemostasis Products
Each of the three drugs being acquired is approved by the U.S. Food and Drug Administration (FDA) and also in a number of other countries.
Introduced in 2009, RECOTHROM is widely used in the U.S., and is the first and only recombinant topical thrombin approved for use in adult and pediatric patients. It is FDA-approved as a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM is also marketed internationally through distributors.
Upon closing, Mallinckrodt will invest in the commercial launch and ongoing market development of both PreveLeak and RAPLIXA in fiscal year 2016. Both have shorter preparation times and are easier to use and store than similar products in their categories. PreveLeak is more flexible than hemostasis glue products, is a surgical sealant and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. PreveLeak is currently marketed in Europe through distributors.
RAPLIXA is the first and only powder fibrin sealant in ready-to-use room temperature form, with the RAPLIXASpray™ device allowing for even application over a diffuse bleeding site and greater versatility. RAPLIXA is comprised of human-plasma derived fibrinogen and thrombin and FDA-approved as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and is applied directly or by using the RAPLIXASpray device.
Thursday, August 27, 2015
Most Don't Need 'Bridging' When They Stop Warfarin Temporarily
Heart patients on the clot-preventing drug warfarin usually have to stop the medication before having surgery. Now, a new study shows they can safely do that without taking another anti-clotting drug -- and they may even be better off.
The study, reported in the Aug. 27 New England Journal of Medicine, helps answer long-standing questions about how to manage patients taking warfarin (Coumadin) for an irregular heart rhythm known as atrial fibrillation.
Because warfarin is a powerful anticoagulant -- which means it prevents blood clots -- it can also raise the risk of internal bleeding. That's why people typically have to stop using warfarin in the days before and after an elective surgery.
But it hadn't been clear whether those patients need what doctors call "bridging anticoagulation." That means taking another type of anti-clotting medication that is short-acting -- usually heparin.
For years, it's been up to individual doctors and patients to decide, said Dr. Thomas Ortel, the senior researcher on the new study, and a professor of medicine at Duke University Medical Center, in Durham, N.C.
"We've had no clinical trial to tell us whether we need to be [bridging] at all," Ortel explained.
Now that clinical trial is done. And, it shows that for most atrial fibrillation patients, bridging with heparin is unnecessary, Ortel said.
In fact, the study found, bridging with heparin appears to raise the risk of major internal bleeding -- without any reduction in the risk of blood clots.
"For years, we've thought that bridging would be beneficial," said Dr. Alfonso Tafur, a vascular medicine specialist at NorthShore University Health System, in Chicago.
"But this study shows that for the majority of (atrial fibrillation) patients, bridging puts them at unnecessary risk," said Tafur, who was not involved in the research.
The study included nearly 1,900 patients who were having elective surgery or other invasive procedures and were taking warfarin to treat atrial fibrillation.
Atrial fibrillation is an irregular heart rhythm in which the heart's upper chambers quiver instead of efficiently pumping blood into the lower chambers, according to the American Heart Association. It's not immediately life-threatening, but it boosts the risk of blood clots forming in the heart. Those clots can then be pumped out of the heart and into an artery supplying the brain, causing a stroke. That's why these patients usually take an anti-clotting drug like warfarin to prevent these clots.
A problem with warfarin is that its effects take time to kick in, and time to wear off once a person stops using it. So when warfarin patients need surgery, they typically go off the drug about five days beforehand; once they restart, it takes another five to 10 days for the warfarin to be effective again, according to background information in the study.
In this study, Ortel's team randomly assigned patients to take either heparin or an inactive placebo during that time window.
In the end, heparin showed no effect on blood-clot risk. Just 0.3 percent of treated patients developed a clot within a month of their procedure, versus 0.4 percent of patients given the placebo, the study found.
On the other hand, heparin did boost the odds of serious bleeding. Just over 3 percent of patients developed "major" bleeding, compared with just over 1 percent of placebo patients, the study found.
The findings suggest that bridging is unnecessary for most atrial fibrillation patients, Ortel said, but there are some who still might benefit.
Tafur agreed. He said that patients who are at particularly high risk of a blood clot -- such as those who've had a stroke in the past -- might still need heparin when they go off warfarin.
For them, Tafur said, the increased bleeding risk may be offset by the anti-clotting benefit.
If your doctor does recommend bridging, Ortel said, feel free to ask why it's necessary.
There are times when warfarin patients may not have to stop the drug at all, Tafur pointed out. With relatively simple procedures, like tooth extractions and even catheter ablation -- which is sometimes used to treat atrial fibrillation -- a warfarin break may be unnecessary, he said.
And what about people who are on newer clot-preventing drugs, like dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixaban (Eliquis)? Those medications act differently from warfarin, Ortel said, and bridging should be unnecessary in most cases.
The study, reported in the Aug. 27 New England Journal of Medicine, helps answer long-standing questions about how to manage patients taking warfarin (Coumadin) for an irregular heart rhythm known as atrial fibrillation.
Because warfarin is a powerful anticoagulant -- which means it prevents blood clots -- it can also raise the risk of internal bleeding. That's why people typically have to stop using warfarin in the days before and after an elective surgery.
But it hadn't been clear whether those patients need what doctors call "bridging anticoagulation." That means taking another type of anti-clotting medication that is short-acting -- usually heparin.
For years, it's been up to individual doctors and patients to decide, said Dr. Thomas Ortel, the senior researcher on the new study, and a professor of medicine at Duke University Medical Center, in Durham, N.C.
"We've had no clinical trial to tell us whether we need to be [bridging] at all," Ortel explained.
Now that clinical trial is done. And, it shows that for most atrial fibrillation patients, bridging with heparin is unnecessary, Ortel said.
In fact, the study found, bridging with heparin appears to raise the risk of major internal bleeding -- without any reduction in the risk of blood clots.
"For years, we've thought that bridging would be beneficial," said Dr. Alfonso Tafur, a vascular medicine specialist at NorthShore University Health System, in Chicago.
"But this study shows that for the majority of (atrial fibrillation) patients, bridging puts them at unnecessary risk," said Tafur, who was not involved in the research.
The study included nearly 1,900 patients who were having elective surgery or other invasive procedures and were taking warfarin to treat atrial fibrillation.
Atrial fibrillation is an irregular heart rhythm in which the heart's upper chambers quiver instead of efficiently pumping blood into the lower chambers, according to the American Heart Association. It's not immediately life-threatening, but it boosts the risk of blood clots forming in the heart. Those clots can then be pumped out of the heart and into an artery supplying the brain, causing a stroke. That's why these patients usually take an anti-clotting drug like warfarin to prevent these clots.
A problem with warfarin is that its effects take time to kick in, and time to wear off once a person stops using it. So when warfarin patients need surgery, they typically go off the drug about five days beforehand; once they restart, it takes another five to 10 days for the warfarin to be effective again, according to background information in the study.
In this study, Ortel's team randomly assigned patients to take either heparin or an inactive placebo during that time window.
In the end, heparin showed no effect on blood-clot risk. Just 0.3 percent of treated patients developed a clot within a month of their procedure, versus 0.4 percent of patients given the placebo, the study found.
On the other hand, heparin did boost the odds of serious bleeding. Just over 3 percent of patients developed "major" bleeding, compared with just over 1 percent of placebo patients, the study found.
The findings suggest that bridging is unnecessary for most atrial fibrillation patients, Ortel said, but there are some who still might benefit.
Tafur agreed. He said that patients who are at particularly high risk of a blood clot -- such as those who've had a stroke in the past -- might still need heparin when they go off warfarin.
For them, Tafur said, the increased bleeding risk may be offset by the anti-clotting benefit.
If your doctor does recommend bridging, Ortel said, feel free to ask why it's necessary.
There are times when warfarin patients may not have to stop the drug at all, Tafur pointed out. With relatively simple procedures, like tooth extractions and even catheter ablation -- which is sometimes used to treat atrial fibrillation -- a warfarin break may be unnecessary, he said.
And what about people who are on newer clot-preventing drugs, like dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixaban (Eliquis)? Those medications act differently from warfarin, Ortel said, and bridging should be unnecessary in most cases.
Tuesday, August 25, 2015
Hemostasis and Tissue Sealing Agents Market to Experience Significant Growth Due to Aggressive Marketing Strategies
The global hemostasis and tissue sealing agents market signifies the market for sophisticated hemostat medical devices. These devices are utilized to control excessive bleeding in operations and surgeries and have significant roles in assisting healing processes in surgical procedures.
Introduction of New Products Driving Hemostasis and Tissue Sealing Agents Market
The hemostasis and tissue sealing agents market is going through a steady growth phase. The major companies in the hemostasis and tissue sealing agents industry are adopting aggressive marketing strategies to increase their product penetration rate in the market.
New and innovative hemostat products are being introduced on regular intervals, which serve diverse applications and are ready-to-use. Such dynamics of the market are resulting in a boost to the global hemostasis and tissue sealing agents industry. In addition to this, the rising base of geriatric population, more prone to diseases and more likely to require surgeries, is also considered an important factor that would drive the market growth further.
On the other hand, stern regulatory requirements, high cost, and increasing off-label use of hemostat products impacts the global market growth of hemostasis and tissue sealing agents in a negative manner.
Market Leaders - Hemostasis and Tissue Sealing Agents Industry
The topical hemostats market is the market leader in the global hemostasis and tissue sealing agents market. In the current scenario, it is expected to develop at a 6% CAGR from 2014 to 2020. This development is mainly credited to the increase in usage of topical hemostats for a broader array of surgical procedures such as cardiovascular, vascular, and others.
The topical hemostats market has three categories, flowable hemostats or combination topical hemostats, active hemostats or thrombin-based topical hemostats, and mechanical hemostats. Medical practitioners such as surgeons prefer active hemostat products due to their high efficiency in controlling excessive bleeding. This factor is supporting the active hemostat market in the hemostasis and tissue sealing agents industry to expand at the highest CAGR.
The adhesive and tissue sealing agents market has three segments, natural tissue sealants including fibrin sealants and other natural sealants such as tissue sealants based on collagen and albumin, synthetic tissue sealants including tissue adhesives based on cynoacrylate and other synthetic tissue sealants such as polyethylene glycol and others, and adhesion barrier products.
The market for adhesive and tissue sealing agents held over 40% of the total market share of the hemostasis and tissue sealing agents industry in 2013. Natural tissue sealants held the largest market share in the adhesive and tissue sealing agents segment due to commercial availability of natural tissue sealants in large amounts.
North America held the largest share of the global hemostasis and tissue sealing agents market in 2013. It accounted for around 36% of the total hemostasis and tissue sealing agents market. Rising number of inpatient surgical procedures added with an increase in the use of hemostat products by end users such as physicians and surgeons is driving the growth of the hemostasis and tissue sealing agents market in North America.
Europe held the second largest hemostasis and tissue sealing agents market share in 2013 owing to continued growth in geriatric population.
Asia Pacific is likely to experience the fastest growth rate from 2014 to 2020. This is due to liberal regulatory environment and increase in investment by major enterprises such as Pfizer, Inc., CryoLife, Inc., and others, in this region.
The major players in the hemostasis and tissue sealing agents market are CryoLife, Inc., Johnson & Johnson, Baxter, Advance Medical Solution Group plc, and Cohera Medical, Inc.
In 2014, Cohera Medical, Inc. launched Sylys Surgical Sealant, which can be utilized in gastrointestinal surgery to decrease anastomotic leak. In the same year, Baxter also gained the FDA permission for TISSEEL fibrin sealant, which is used in almost all types of surgical procedures. However, in the present scenario, investing in developing countries provides a good platform for the players in the hemostasis and tissue sealing agents market to register high revenue.
Browse Full Global Hemostasis and Tissue Sealing Agents Market Report With Complete TOC @ http://www.transparencymarketresearch.com/hemostasis-tissue-sealing-agents-market.html
Introduction of New Products Driving Hemostasis and Tissue Sealing Agents Market
The hemostasis and tissue sealing agents market is going through a steady growth phase. The major companies in the hemostasis and tissue sealing agents industry are adopting aggressive marketing strategies to increase their product penetration rate in the market.
New and innovative hemostat products are being introduced on regular intervals, which serve diverse applications and are ready-to-use. Such dynamics of the market are resulting in a boost to the global hemostasis and tissue sealing agents industry. In addition to this, the rising base of geriatric population, more prone to diseases and more likely to require surgeries, is also considered an important factor that would drive the market growth further.
On the other hand, stern regulatory requirements, high cost, and increasing off-label use of hemostat products impacts the global market growth of hemostasis and tissue sealing agents in a negative manner.
Market Leaders - Hemostasis and Tissue Sealing Agents Industry
The topical hemostats market is the market leader in the global hemostasis and tissue sealing agents market. In the current scenario, it is expected to develop at a 6% CAGR from 2014 to 2020. This development is mainly credited to the increase in usage of topical hemostats for a broader array of surgical procedures such as cardiovascular, vascular, and others.
The topical hemostats market has three categories, flowable hemostats or combination topical hemostats, active hemostats or thrombin-based topical hemostats, and mechanical hemostats. Medical practitioners such as surgeons prefer active hemostat products due to their high efficiency in controlling excessive bleeding. This factor is supporting the active hemostat market in the hemostasis and tissue sealing agents industry to expand at the highest CAGR.
The adhesive and tissue sealing agents market has three segments, natural tissue sealants including fibrin sealants and other natural sealants such as tissue sealants based on collagen and albumin, synthetic tissue sealants including tissue adhesives based on cynoacrylate and other synthetic tissue sealants such as polyethylene glycol and others, and adhesion barrier products.
The market for adhesive and tissue sealing agents held over 40% of the total market share of the hemostasis and tissue sealing agents industry in 2013. Natural tissue sealants held the largest market share in the adhesive and tissue sealing agents segment due to commercial availability of natural tissue sealants in large amounts.
North America held the largest share of the global hemostasis and tissue sealing agents market in 2013. It accounted for around 36% of the total hemostasis and tissue sealing agents market. Rising number of inpatient surgical procedures added with an increase in the use of hemostat products by end users such as physicians and surgeons is driving the growth of the hemostasis and tissue sealing agents market in North America.
Europe held the second largest hemostasis and tissue sealing agents market share in 2013 owing to continued growth in geriatric population.
Asia Pacific is likely to experience the fastest growth rate from 2014 to 2020. This is due to liberal regulatory environment and increase in investment by major enterprises such as Pfizer, Inc., CryoLife, Inc., and others, in this region.
The major players in the hemostasis and tissue sealing agents market are CryoLife, Inc., Johnson & Johnson, Baxter, Advance Medical Solution Group plc, and Cohera Medical, Inc.
In 2014, Cohera Medical, Inc. launched Sylys Surgical Sealant, which can be utilized in gastrointestinal surgery to decrease anastomotic leak. In the same year, Baxter also gained the FDA permission for TISSEEL fibrin sealant, which is used in almost all types of surgical procedures. However, in the present scenario, investing in developing countries provides a good platform for the players in the hemostasis and tissue sealing agents market to register high revenue.
Browse Full Global Hemostasis and Tissue Sealing Agents Market Report With Complete TOC @ http://www.transparencymarketresearch.com/hemostasis-tissue-sealing-agents-market.html
Monday, June 15, 2015
Arch Developments Progress
Arch Therapeutics Inc (OTCBB:ARTH) is moving steadily higher on accelerating volume after the Company announced favorable preclinical data from an independent study of AC5 Surgical Hemostatic Device(TM) versus a popular Fibrin Sealant.
On May 18 ARTH said it will be featured as a presenting company at the LD MICRO Invitational conference on Monday, June 1, 2015 at 3:30 PM PDT. The conference will be held at the Luxe Sunset Hotel in Bel Air, California.
Chief Executive Officer Terrence W. Norchi, MD will provide a corporate update, discuss planned upcoming milestones, and highlight some of the differentiating features of AC5, which is in the late stages of development.
The stock was the subject of a significant promotion last summer shortly after hitting the bb’s from The Bedford Report, The Paragon Report and Five Star Equities also responsible for the fairly successful recent promotion of ECAU which managed gains of well over 500%.
Arch Therapeutics Inc (OTCBB:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch’s flagship development stage product candidate, known as the AC5 Surgical Hemostatic Device (TM), is being designed to achieve hemostasis in minimally invasive and open surgical procedures.
In April the Company announced an independent third party has obtained favorable data from a preclinical animal study that compared the hemostatic activity of AC5 with a popular and commercially available branded fibrin sealant that is indicated for use in controlling bleeding.
In this study, full thickness penetrating wounds were surgically created in rat livers, which are highly vascularized parenchymal organs, and then either AC5(TM) or the fibrin sealant was applied in order to stop the bleeding. The time to hemostasis (TTH), which is the time required to stop bleeding, was measured.
The average TTH after application of AC5 was significantly less than 30 seconds. The average TTH for the fibrin sealant was approximately 50% longer.
AC5 was maintained at room temperature without requiring cold storage, whereas the fibrin sealant was maintained frozen during storage, in accordance with its prescribing directions. This is a common constraint of many commercial hemostatic agents that are derived from blood-products. Such products also require a multi-step preparation procedure prior to use.
AC5 contains a self-assembling peptide comprising naturally occurring amino acids that are not sourced from humans or animals, whereas the fibrin sealant is made from pooled human plasma (blood product). Fibrin sealants and other products that are sourced from human or animal blood products can contain infectious agents, such as viruses and potentially the Creutzfeldt-Jakob disease (CJD) agent, which potentially can be transferred to a patient.
On May 18 ARTH said it will be featured as a presenting company at the LD MICRO Invitational conference on Monday, June 1, 2015 at 3:30 PM PDT. The conference will be held at the Luxe Sunset Hotel in Bel Air, California.
Chief Executive Officer Terrence W. Norchi, MD will provide a corporate update, discuss planned upcoming milestones, and highlight some of the differentiating features of AC5, which is in the late stages of development.
The stock was the subject of a significant promotion last summer shortly after hitting the bb’s from The Bedford Report, The Paragon Report and Five Star Equities also responsible for the fairly successful recent promotion of ECAU which managed gains of well over 500%.
Arch Therapeutics Inc (OTCBB:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch’s flagship development stage product candidate, known as the AC5 Surgical Hemostatic Device (TM), is being designed to achieve hemostasis in minimally invasive and open surgical procedures.
In April the Company announced an independent third party has obtained favorable data from a preclinical animal study that compared the hemostatic activity of AC5 with a popular and commercially available branded fibrin sealant that is indicated for use in controlling bleeding.
In this study, full thickness penetrating wounds were surgically created in rat livers, which are highly vascularized parenchymal organs, and then either AC5(TM) or the fibrin sealant was applied in order to stop the bleeding. The time to hemostasis (TTH), which is the time required to stop bleeding, was measured.
The average TTH after application of AC5 was significantly less than 30 seconds. The average TTH for the fibrin sealant was approximately 50% longer.
AC5 was maintained at room temperature without requiring cold storage, whereas the fibrin sealant was maintained frozen during storage, in accordance with its prescribing directions. This is a common constraint of many commercial hemostatic agents that are derived from blood-products. Such products also require a multi-step preparation procedure prior to use.
AC5 contains a self-assembling peptide comprising naturally occurring amino acids that are not sourced from humans or animals, whereas the fibrin sealant is made from pooled human plasma (blood product). Fibrin sealants and other products that are sourced from human or animal blood products can contain infectious agents, such as viruses and potentially the Creutzfeldt-Jakob disease (CJD) agent, which potentially can be transferred to a patient.
Monday, April 6, 2015
CryoLife Appeals Rare Injunction In Patent Case
CryoLife Inc. on Wednesday filed its notice of appeal to the Federal Circuit of a preliminary injunction barring its PerClot blood-clotting powder, one day after a Delaware federal judge ordered Medafor Inc. to pay CryoLife $100,000 in the event that any court finds the injunction was wrongly issued.
C.R. Bard Inc. unit Medafor satisfied the test for securing a preliminary injunction, including showing a reasonable likelihood that it will succeed on the merits and would suffer irreparable harm if CryoLife's product remained on the market, U.S. District Judge Sue L. Robinson ruled last month, in a relatively rare instance of a judge granting a preliminary injunction in a patent case. On Wednesday, CryoLife filed its notice of appeal of the injunction to the Federal Circuit.
The judge said Medafor has represented that it is able to pay the $100,000 if the condition on the injunction is met and that CryoLife agreed with the representation, adding that the requirement was proper and adequate security for the injunction.
“Pursuant to Federal Rule of Civil Procedure 65(c), this court orders that if this court or another court of competent jurisdiction finds this preliminary injunction wrongfully enjoined CryoLife, Medafor shall pay CryoLife $100,000 within ten (10) days of the order vacating or reversing this injunction,” the judge said.
CryoLife's PerClot Topical, launched last fall, competes with a Medafor product called Arista that was approved by the U.S. Food and Drug Administration in 2006. Both are powders used to control bleeding when conventional methods are ineffective.
The dispute began in April, when CryoLife filed suit seeking declaratory judgment that PerClot Topical would not infringe Medafor's patent. Medafor responded by filing an infringement counterclaim and seeking a preliminary injunction. CryoLife began selling PerClot Topical last fall.
Judge Robinson found that Medafor had shown that CryoLife likely infringes and that CryoLife was unlikely to show that the patent is invalid.
C.R. Bard Inc. unit Medafor satisfied the test for securing a preliminary injunction, including showing a reasonable likelihood that it will succeed on the merits and would suffer irreparable harm if CryoLife's product remained on the market, U.S. District Judge Sue L. Robinson ruled last month, in a relatively rare instance of a judge granting a preliminary injunction in a patent case. On Wednesday, CryoLife filed its notice of appeal of the injunction to the Federal Circuit.
The judge said Medafor has represented that it is able to pay the $100,000 if the condition on the injunction is met and that CryoLife agreed with the representation, adding that the requirement was proper and adequate security for the injunction.
“Pursuant to Federal Rule of Civil Procedure 65(c), this court orders that if this court or another court of competent jurisdiction finds this preliminary injunction wrongfully enjoined CryoLife, Medafor shall pay CryoLife $100,000 within ten (10) days of the order vacating or reversing this injunction,” the judge said.
CryoLife's PerClot Topical, launched last fall, competes with a Medafor product called Arista that was approved by the U.S. Food and Drug Administration in 2006. Both are powders used to control bleeding when conventional methods are ineffective.
The dispute began in April, when CryoLife filed suit seeking declaratory judgment that PerClot Topical would not infringe Medafor's patent. Medafor responded by filing an infringement counterclaim and seeking a preliminary injunction. CryoLife began selling PerClot Topical last fall.
Judge Robinson found that Medafor had shown that CryoLife likely infringes and that CryoLife was unlikely to show that the patent is invalid.
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.
Saturday, March 14, 2015
Medafor Injunction Holds Up US Perclot Topical
CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, today provided an update on its ongoing litigation with C.R. Bard, Inc. and certain of its subsidiaries regarding PerClot. The U.S. District Court for the District of Delaware (the "Court") has allowed CryoLife's declaratory judgment lawsuit against C.R. Bard's Medafor, Inc. subsidiary ("Medafor") to proceed. The Court also granted Medafor's motion for a preliminary injunction with respect to CryoLife's marketing and sale of PerClot Topical in the U.S. CryoLife is currently awaiting the Court's order, which it expects will provide details regarding the scope of the injunction.
Pat Mackin, CryoLife President and Chief Executive Officer, said, "While we are disappointed with the District Court's ruling on the preliminary injunction motion, we continue to believe we have a strong case and remain focused on securing the best long-term outcome in the litigation for our shareholders. We remain on track to begin enrollment in our PerClot IDE clinical trial for surgical applications during the first half of 2015, which would position us for potential FDA approval in the second half of 2017."
In April 2014, CryoLife filed a declaratory judgment lawsuit against C.R. Bard and certain of its subsidiaries, including Medafor, requesting that the Court declare that CryoLife's manufacture, use, offer for sale, and sale of PerClot in the U.S. does not and would not infringe Medafor's U.S. Patent No. 6,060,461 (the "'461 Patent"). In addition CryoLife requested that the Court declare that the claims of the '461 Patent are invalid. In September 2014, Medafor filed a motion for a preliminary injunction against CryoLife.
The preliminary injunction applies to PerClot Topical, which is in the early stages of launch in the U.S. CryoLife included approximately$1.5 million in PerClot Topical sales in its previously announced 2015 financial guidance. At this low-volume level, the Company was anticipating the gross margin for PerClot Topical to be approximately breakeven. The Company's previously announced earnings per share guidance for 2015 included $3 million to $4 million in expense related to the litigation with C.R. Bard. The Company continues to expect that this represents the high end of potential litigation expenses for the year related to this matter, and it will re-assess its litigation strategy and provide appropriate updates to its financial guidance, if any, after receiving the Court's order.
See official papers below....
https://drive.google.com/file/d/0B6J8c60Kq5rVUVBka0ExTjdYaWc/view?usp=sharinghttps://drive.google.com/file/d/0B6J8c60Kq5rVSmhSWXVFd1daNWM/view?usp=sharing
Subscribe to:
Posts (Atom)