Baxter International has filed an application to the US Food and Drug Administration (FDA) for a pediatric indication for Rixubis [Coagulation Factor IX (Recombinant)] to treat hemophilia B.
The submission was based on a Phase II/III clinical trial, designed to assess the efficacy and safety of Rixubis in 23 previously-treated male patients less than 12 years of age with severe or moderately severe hemophilia B.
In 2013, the company had secured FDA approval for Rixubis in the US for adults with hemophilia B and it had filed for marketing approval in Europe in November.
During the trial, patients were treated with a twice-weekly Rixubis prophylaxis regimen (median dose 56 IU/kg) over six months or for a minimum of 50 exposure days (EDs).
The company said that the median annualized bleeding rate (ABR) was 2.0 (0.0 for spontaneous bleeds and joint bleeds).
In the trial nine patients (39.1%) experienced no bleeds and 23 patients (88.5%) were treated with 1-2 infusions.
The company said that out of the 26 bleeds seen in the trial, only two (in two patients) were spontaneous and no reports of inhibitor development, no allergic reactions, and no thrombotic or treatment-related adverse events were observed among the study participants.
Baxter BioScience vice president of global research and development Anders Ullman said the positive results among a pediatric patient population are consistent with those observed in the Rixubis pivotal study among adult patients with hemophilia B.
"We submitted these data as part of our application for a pediatric indication for RIXUBIS to advance effective therapeutic solutions for children with hemophilia B," Ullman said.
Wednesday, December 11, 2013
New dissolving patch delivers clotting factor directly to injury to stop bleeding faster
Hemorrhage is a primary cause of mortality in trauma patients even though most injuries suffered are potentially survivable. Increasing survival is simply a matter of effectively controlling hemorrhage. Current hemostatic dressings range from simple gauze to aluminosilicates from natural or synthetic clay Combat GauzeTM, or chitosan from shellfish or algae (CeloxTM). These dressings stop the bleeding by direct compression of injured vessels and/or activation of the intrinsic coagulation pathway. In trauma patients however, this system is often compromised.
Current dressings are also unstable, which increases the chance of rebleeding due to movement. The next generation of advanced dressings will likely incorporate plasma-coagulation factors such as fibrinogen that would directly form fibrin clots and seal injured vessels. Hemostasis would be independent of a person’s injuries, and re-bleeding would be less likely also.
St. Teresa Medical, Inc., a medical device company in Minnesota, is commercializing this kind of hemostatic technology platform called FASTCLOT®. The patent-pending FASTCLOT products use an electrospun nano-fiber dextran matrix carrier along with fibrin producing proteins such as thrombin and fibrinogen. The carrier in all FASTCLOT products dissolves in seconds to minutes when in contact with fluid, effectively releasing the clot forming proteins at the bleeding site. As a result, the clotting cascade is accelerated, generating a quick and robust clot in both arterial and venous bleeding, preventing excess blood loss. Most importantly, the FASTCLOT platform technology is the only completely dissolvable and absorbable fibrin sealant that will be available in the market. As opposed to other fibrin sealants, FASTCLOT products leave nothing behind in the patient’s body, eliminating the risk for scarring, inflammation and re operative surgery.
The FASTCLOT technology was developed by a research team at Virginia Commonwealth University and is exclusively licensed by St Teresa Medical. The company is developing products for both surgery (SURGICLOT®) and trauma (WRAPCLOT®), for civilian and military markets. St. Teresa Medical also owns a subsidiary, St. Francis Veterinary Medical, where the product ANIMALCLOT® designed for animal use and developed using the same FASTCLOT technology is currently being sold.
Fibrin dressings have great life-saving potential but their use is limited by availability, cost and safety. CEO and co-founder Phil Messina said St Teresa Medical products can overcome these limitations. St Teresa has completed several pre-clinical animal studies demonstrating the safety and efficacy of the technology. All studies indicated no allergic, immunogenic or thrombolytic events. The FASTCLOT products are reliable, robust and inexpensive hemostatic agents, Messina said.
“We create value for the patient, surgeon, hospital and payer delivering better clinical outcomes,” he said.
St. Teresa Medical products have an estimated global market potential of several billion dollars. Surgical applications represent the single largest market. The company has raised up to $4 million since its inception. St Teresa Medical expects a CE Mark approval on its SURGICLOT fibrin sealant in mid 2014 in Europe and subsequent approval in the US through a Biologics License Application (BLA) submission approximately 18 months later.
Current dressings are also unstable, which increases the chance of rebleeding due to movement. The next generation of advanced dressings will likely incorporate plasma-coagulation factors such as fibrinogen that would directly form fibrin clots and seal injured vessels. Hemostasis would be independent of a person’s injuries, and re-bleeding would be less likely also.
St. Teresa Medical, Inc., a medical device company in Minnesota, is commercializing this kind of hemostatic technology platform called FASTCLOT®. The patent-pending FASTCLOT products use an electrospun nano-fiber dextran matrix carrier along with fibrin producing proteins such as thrombin and fibrinogen. The carrier in all FASTCLOT products dissolves in seconds to minutes when in contact with fluid, effectively releasing the clot forming proteins at the bleeding site. As a result, the clotting cascade is accelerated, generating a quick and robust clot in both arterial and venous bleeding, preventing excess blood loss. Most importantly, the FASTCLOT platform technology is the only completely dissolvable and absorbable fibrin sealant that will be available in the market. As opposed to other fibrin sealants, FASTCLOT products leave nothing behind in the patient’s body, eliminating the risk for scarring, inflammation and re operative surgery.
The FASTCLOT technology was developed by a research team at Virginia Commonwealth University and is exclusively licensed by St Teresa Medical. The company is developing products for both surgery (SURGICLOT®) and trauma (WRAPCLOT®), for civilian and military markets. St. Teresa Medical also owns a subsidiary, St. Francis Veterinary Medical, where the product ANIMALCLOT® designed for animal use and developed using the same FASTCLOT technology is currently being sold.
Fibrin dressings have great life-saving potential but their use is limited by availability, cost and safety. CEO and co-founder Phil Messina said St Teresa Medical products can overcome these limitations. St Teresa has completed several pre-clinical animal studies demonstrating the safety and efficacy of the technology. All studies indicated no allergic, immunogenic or thrombolytic events. The FASTCLOT products are reliable, robust and inexpensive hemostatic agents, Messina said.
“We create value for the patient, surgeon, hospital and payer delivering better clinical outcomes,” he said.
St. Teresa Medical products have an estimated global market potential of several billion dollars. Surgical applications represent the single largest market. The company has raised up to $4 million since its inception. St Teresa Medical expects a CE Mark approval on its SURGICLOT fibrin sealant in mid 2014 in Europe and subsequent approval in the US through a Biologics License Application (BLA) submission approximately 18 months later.
Cohera Medical, Inc.® Successfully Completes Clinical Trial and Confirms Safety of Sylys® Surgical Sealant
PITTSBURGH, Dec. 10, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has successfully completed a clinical trial confirming the safety of Sylys®Surgical Sealant designed to significantly reduce anastomotic leakage in intestinal procedures. The European study included patients enrolled at two sites in the Netherlands.
Sylys is one of the first synthetic sealants specifically designed to significantly reduce anastomotic leakage in intestinal anastomosis procedures. Used in conjunction with standard anastomotic closure techniques, Sylys protects the suture or staple line, supporting the anastomosis during the first few days of healing, when leaks are most likely to occur.
"Sylys enhances standard closure techniques, advancing the healing process and reducing post-operative complications," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "With the completion of this study, we are a step closer to providing patients with the best opportunity for a successful outcome following intestinal anastomosis procedures."
On average, anastomotic leaks occur in 3-15% of colorectal procedures, and are the cause of one-third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1-4B market.
Thursday, November 21, 2013
European Medicines Agency Accepts Marketing Authorization Application for The Medicines Company's Fibrocaps
PARSIPPANY, NJ--(Nov 21, 2013) - The Medicines Company (MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational hemostatic agent Fibrocaps (human plasma-derived fibrinogen and thrombin). Fibrocaps was studied in the 719-patient Phase III FINISH-3 clinical trial as an adjunct to hemostasis in patients undergoing surgical procedures when control of mild or moderate bleeding by conventional surgical techniques is ineffective or impractical.
The acceptance of the MAA marks the beginning of the review process in the European Union for Fibrocaps. The Company anticipates submitting a biologics license application (BLA) with the United States Food and Drug Administration in the first quarter of 2014. The Company also plans to submit a 510(k) application with the FDA for the complementary spray delivery device to assist surgeons in the accurate application of the dry powder Fibrocaps. The device was recently granted a European CE mark.
"We believe Fibrocaps can become an important hemostatic solution within our surgery and perioperative care portfolio upon regulatory approval," said Jan Ohrstrom, MD, Senior Vice President Global Launch Leader, Hemostasis Solutions of The Medicines Company. "We are expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare."
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Forward-looking Statements
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "plans, "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Registration Statement on Form 10-Q filed on November 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The acceptance of the MAA marks the beginning of the review process in the European Union for Fibrocaps. The Company anticipates submitting a biologics license application (BLA) with the United States Food and Drug Administration in the first quarter of 2014. The Company also plans to submit a 510(k) application with the FDA for the complementary spray delivery device to assist surgeons in the accurate application of the dry powder Fibrocaps. The device was recently granted a European CE mark.
"We believe Fibrocaps can become an important hemostatic solution within our surgery and perioperative care portfolio upon regulatory approval," said Jan Ohrstrom, MD, Senior Vice President Global Launch Leader, Hemostasis Solutions of The Medicines Company. "We are expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare."
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Forward-looking Statements
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "plans, "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Registration Statement on Form 10-Q filed on November 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Study: Closure devices cut complications after cardiac procedure (VIDEO)
The use of vascular closure devices significantly reduced complications and the need for transfusions in obese and overweight patients undergoing transfemoral percutaneous coronary intervention (PCI), but the benefit over manual closure was not seen in lean and normal-weight patients or in those treated with a glycoprotein IIb/IIIa inhibitor, researchers reported.
The benefit was also counterbalanced by a small increase in risk of retroperitoneal bleeding, Hitinder S. Gurm, MD, of the University of Michigan Cardiovascular Center in Ann Arbor, and colleagues, wrote online in the Annals of Internal Medicine.
Vascular closure devices (VCDs) are designed to prevent arterial bleeding, especially after PCI performed by the transfemoral route, which is still the most common route in the U.S.
The devices permit closure of the arteriotomy site using sutures, plugs, or metallic clips, but the role of these devices in preventing vascular complications remains controversial, the researchers noted.
"Most randomized trials evaluating VCDs have been small and underpowered, and the largest meta-analysis on the subject raised concerns that these devices may be associated with an increase in vascular complications," they wrote. "These devices are commonly used in clinical practice, and a recent large observational study suggested that they may be associated with a reduction in bleeding complications."
The newly published study is among the first to compare the efficacy of VCDs to manual closure in the real-world PCI practice setting, with the focus on specific subgroups with the highest risk for complications.
Researchers collected data on 92,000 patients who had PCI procedures at 32 Michigan hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) between 2007 and 2009.
Of the 85,048 PCIs that met study inclusion criteria, 28,528 (37%) used VCDs.
A main study endpoint was vascular complications, including acute thrombosis, loss of limb, retroperitoneal bleeding, need for surgical repair, pseudoaneurysm, or hematoma requiring transfusion or arteriovenous fistula. Other endpoints included transfusion or in-hospital death.
Using propensity score-matched analysis, the use of VCDs was found to be associated with reductions in vascular complications (OR 0.78, 95% CI 0.67-0.90, P=0.001) and post-procedure transfusions (OR 0.85 CI 0.74-0.96, P=0.011).
"These findings were consistent across many prespecified subgroups except for patients with a BMI less than 25 kg/m2 and those treated with platelet glycoprotein IIb/IIIa inhibitors, in whom the benefit of VCDs over manual closure was attenuated," the researchers wrote.
When specific subtypes of vascular complications were evaluated, VCDs were associated with fewer hematomas (OR 0.69 CI 0.58-0.83, P<0 .001="" 0.38-0.76="" 0.54="" 1.12-2.20="" 1.57="" also="" an="" associated="" bleeding="" but="" ci="" in="" increase="" odds="" of="" or="" p="0.009).</span" pseudoaneurysms="" retroperitoneal="" the="" they="" were="" with="">
"Our sudy supports the conclusion that VCDs are associated with reduced vascular complications and transfusions," Gurm and colleagues wrote, adding that the benefit of these devices was evident only in obese and overweight patients in whom manual control of access site is usually difficult.
The study also confirmed that VCD use is particularly beneficial in patients treated with bivalirudin and that its use was associated with a significantly increased risk for retroperitoneal bleeding, which negated any benefit in patients who received GP IIb/IIIa.
"Our data suggest that physicians contemplating VCD use should carefully weigh this increased risk for retroperitoneal bleeding against the expected reduction in pseudoaneurysms and hematomas," the researchers wrote. "The decision to use these devices needs to be individualized for each patient."
Tuesday, November 19, 2013
Cohera Medical, Inc.® Completes Fourth and Final Module in the Premarket Approval (PMA) Application for TissuGlu® Surgical Adhesive
PITTSBURGH, Nov. 19, 2013 -- PITTSBURGH, Nov. 19, 2013 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today it has submitted its fourth and final module for TissuGlu® Surgical Adhesive in the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).
"We are pleased to have submitted the final module of the PMA application for TissuGlu," said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. "This module culminates substantial work by the Cohera team and our investigational partners."
A modular PMA submission is one in which the contents of a PMA are broken into several clearly defined parts or modules. These modules are submitted separately over time and comprise a complete PMA when all of them have been submitted. FDA reviews each module separately which may allow for a more efficient review when the last components are submitted because much of the review work will have already been completed. Cohera Medical has already successfully submitted the first three modules of the PMA application: biocompatibility, design control and manufacturing.
The fourth and final module submitted is comprised of data from Cohera Medical's 'No Drain' study, confirming that TissuGlu is a clinically superior alternative to closed-suction drains for fluid management in large flap procedures such as abdominoplasty. In the pivotal clinical trial, when TissuGlu was used, patients required fewer post-operative treatments and resumed normal activities, such as going to work, showering and using the stairs, more quickly.
"Submitting the final module to FDA is a critical milestone in making TissuGlu Surgical Adhesive available to surgeons and patients in the U.S.," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "The successful completion of this module represents a huge effort on the part of the entire company and we look forward to continuing our work with FDA."
Currently, most patients who undergo abdominoplasty procedures or other large flap procedures, such as mastectomy or inguinal lymph node dissection, require the insertion of drains to remove fluid that accumulates under the skin at the surgical site. Drains are often uncomfortable for the patient and can lead to additional complications. TissuGlu forms a strong bond between tissue layers, helping to reduce the fluid that can accumulate during healing.
Clinical Papers Hemostats Reviewed - Oxi Cell, Gelatin, Collagen, Thrombin, Polysaccharide Powders
A lot of our earlier embedded document links have gone since our previous embedding agency sold (these things happen in 5 years of blogging). Now Google have this facility I am happy to provide you clinical data for your interest in the links below.
Friday, November 15, 2013
Baxter completes patient enrollment in phase III trial of BAX 855, extended half-life rFVIII to treat haemophilia A
Baxter International Inc. has completed enrollment in its phase III clinical trial of BAX 855, an investigational extended half-life, recombinant factor VIII (rFVIII) treatment for haemophilia A. The ongoing trial is aimed at assessing the efficacy of the compound in reducing annualized bleed rates (ABR) in both prophylaxis and on-demand treatment schedules, and will also evaluate its safety and pharmacokinetic profile.
BAX 855 was designed based on the full-length ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] molecule, a product with 10 years of real-world experience. The BAX 855 molecule was modified with PEGylation technology designed to extend its duration of activity in the body.
"The BAX 855 development programme is a priority for Baxter as we evaluate the potential to provide an efficacious and safe treatment with an extended half-life for patients with hemophilia," said Anders Ullman, MD, Ph.D., vice president of global research and development in Baxter's BioScience business. "We are focused first and foremost on strategies to address optimal efficacy and minimize patients' bleeding episodes, while at the same time delivering on the convenience of less frequent dosing for this population with severe disease."
The phase II/III multi-centre, open-label study called PROLONG-ATE is evaluating BAX 855 among 146 adult patients with previously-treated severe haemophilia A. Patients participating in PROLONG-ATE receive treatment twice weekly (45 IU/kg) and are followed for six months. The primary endpoint of the study is the annualized bleed rate (ABR) during the treatment period. The study is also evaluating the safety and immunogenicity of the compound when administered on either prophylaxis and on-demand treatment regimens. Other outcome measures include number of infusions needed to treat bleeding episodes, time intervals between these episodes, pharmacokinetics and patient reported outcomes. To date, no inhibitors or safety issues have been reported in the study.
Based upon the results of the study, the company expects to complete the trial and file for regulatory approval late in 2014. Baxter is also initiating a continuation study for all patients who complete the pivotal phase II/III study, and expects to initiate a study of BAX 855 among pediatric patients in 2014.
The treatment protocol is based on the results of a phase I trial of BAX 855, assessing its safety, tolerability and pharmacokinetics. That trial found that the half-life (measuring the duration of activity of the drug in the body) of the investigational compound was approximately 1.5-fold higher compared to ADVATE. An extended half-life was achieved in all patients in the study using BAX 855, no patients developed inhibitors to either the base molecule, BAX 855 or to PEG, and no patients had allergic reactions. No treatment-related or serious adverse events were reported, and no patients withdrew from the study due to adverse events.
BAX 855 is built from the same native FVIII protein used in the production of ADVATE, and employs proprietary PEGylation technology from Nektar Therapeutics designed to extend the duration of activity of proteins. PEGylation technology has been widely used in various approved treatments.
ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with haemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with haemophilia A. ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy profile and a low rate of inhibitor development. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE is approved in 60 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.
BAX 855 was designed based on the full-length ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] molecule, a product with 10 years of real-world experience. The BAX 855 molecule was modified with PEGylation technology designed to extend its duration of activity in the body.
"The BAX 855 development programme is a priority for Baxter as we evaluate the potential to provide an efficacious and safe treatment with an extended half-life for patients with hemophilia," said Anders Ullman, MD, Ph.D., vice president of global research and development in Baxter's BioScience business. "We are focused first and foremost on strategies to address optimal efficacy and minimize patients' bleeding episodes, while at the same time delivering on the convenience of less frequent dosing for this population with severe disease."
The phase II/III multi-centre, open-label study called PROLONG-ATE is evaluating BAX 855 among 146 adult patients with previously-treated severe haemophilia A. Patients participating in PROLONG-ATE receive treatment twice weekly (45 IU/kg) and are followed for six months. The primary endpoint of the study is the annualized bleed rate (ABR) during the treatment period. The study is also evaluating the safety and immunogenicity of the compound when administered on either prophylaxis and on-demand treatment regimens. Other outcome measures include number of infusions needed to treat bleeding episodes, time intervals between these episodes, pharmacokinetics and patient reported outcomes. To date, no inhibitors or safety issues have been reported in the study.
Based upon the results of the study, the company expects to complete the trial and file for regulatory approval late in 2014. Baxter is also initiating a continuation study for all patients who complete the pivotal phase II/III study, and expects to initiate a study of BAX 855 among pediatric patients in 2014.
The treatment protocol is based on the results of a phase I trial of BAX 855, assessing its safety, tolerability and pharmacokinetics. That trial found that the half-life (measuring the duration of activity of the drug in the body) of the investigational compound was approximately 1.5-fold higher compared to ADVATE. An extended half-life was achieved in all patients in the study using BAX 855, no patients developed inhibitors to either the base molecule, BAX 855 or to PEG, and no patients had allergic reactions. No treatment-related or serious adverse events were reported, and no patients withdrew from the study due to adverse events.
BAX 855 is built from the same native FVIII protein used in the production of ADVATE, and employs proprietary PEGylation technology from Nektar Therapeutics designed to extend the duration of activity of proteins. PEGylation technology has been widely used in various approved treatments.
ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with haemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with haemophilia A. ADVATE is not indicated for the treatment of von Willebrand disease.
ADVATE has a demonstrated efficacy profile and a low rate of inhibitor development. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE is approved in 60 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.
Tuesday, November 12, 2013
Racial Difference in Blood Clotting Warrants a Closer Look at Heart Attack Medications
(PHILADELPHIA) Thomas Jefferson University researchers have discovered that the formation of blood clots follows a different molecular route in African Americans versus European Americans, providing a new understanding of the effects of race on heart disease. The finding could one day help doctors provide more individualized treatment of heart disease and other blood-clot-related illnesses, according to research publishing online November 10th in Nature Medicine.
The finding may also provide an additional explanation for the disparity between outcomes in black and white patients with heart disease, which is the most common killer of white and black Americans. Compared to white patients, blacks have a two-fold increased incidence of heart disease and have a lower long-term survival. The reasons for this racial disparity are complex, and include racial bias, a higher prevalence of traditional risk factors such in blacks, and differences in socioeconomic status, management and environment. However, even when these factors are considered, the survival of black heart attack patients is 2 and a half times lower than white patients. This suggests there are yet-to-be identified factors accounting for the racial disparity in heart disease.
“We may need to consider our patient’s race when using certain heart disease therapies,” said lead author of the research Paul Bray, M.D., Director of Thomas Jefferson University’s Cardeza Foundation for Hematologic Research.
Anti-platelet medications, such as aspirin, are commonly prescribed to prevent heart attack or stroke. These medications function by blocking the clot-forming activity of platelets – small cells that normally circulate in the blood stream and congeal around damaged or atherosclerotic blood vessels. The plaques in atherosclerotic vessels can occasionally rupture, causing the formation of a platelet plug that clogs blood vessels and can lead to heart attack or stroke. However, there is considerable variability in how patients respond to these medications, which confounds physicians who must deduce the appropriate drug and proper dose for each patient. Now, researchers from Thomas Jefferson University have identified some of the genetic differences behind these variations, which could help doctors treat racial groups with a more personalized and effective approach.
“Differences in platelet biology could be part of the explanation of the disparity,” says Dr. Bray.
To investigate whether the variation among different individuals had a racial component, Dr. Bray and collaborators from Baylor Medical College, Harvard Medical School and the New York and Puget Sound Blood Centers analyzed platelets from blood samples of 154 young healthy subjects that included 70 blacks and 84 whites. Self-reported race was confirmed with genetic tests that verified geographic (African or European) ancestry. Unexpectedly, the researchers found that platelets from black donors clotted faster and to a greater extent in response to the naturally occurring clotting agent, thrombin that specifically triggered one of the platelet-activating receptors, called PAR4. No racial differences were seen with other clotting agents.
Thrombin is the most potent platelet activator in the body, and it is targeted for suppression by numerous blood-thinning medications. However, newer drugs that target thrombin inhibit specific members of the PAR family of receptors. For example, the drug vorapaxar, currently in development for patients with a history of heart disease, specifically inhibits the PAR1 receptor. If PAR1 is blocked by vorapaxar, then PAR4 is the only means by which thrombin can activate platelets, and the Jefferson scientists showed that in this setting thrombin more potently activated platelets from blacks. It remains to be determined how or if these findings relate to drugs that are currently prescribed or to those currently in development.
Further molecular studies identified a novel gene called PCTP that mediated platelet activation through PAR4. PCTP was expressed at higher levels in platelets from blacks and appears to be a major contributor to the racial difference in blood clotting. Furthermore, a microRNA was identified that silenced the expression of PCTP; this microRNA was expressed at higher levels in platelets from whites than blacks and may contribute to the lower levels of thrombin activation through the PAR4 receptor in whites.
In fact, the researchers found many silencing microRNAs were more actively expressed in whites than in blacks, at least in platelets, suggesting that other aspects of platelet biology may be regulated differently depending on race. Uncovering the genes that these microRNAs suppress could help researchers hone in on individual differences in platelet function, and eventually how these differences contribute to disease and response to anti-clotting treatments.
“In this age where there is such a focus on delivering personalized medicine, we should embrace these differences to try to give our patients better care,” says Dr. Bray.
“We may need to consider our patient’s race when using certain heart disease therapies,” said lead author of the research Paul Bray, M.D., Director of Thomas Jefferson University’s Cardeza Foundation for Hematologic Research.
Anti-platelet medications, such as aspirin, are commonly prescribed to prevent heart attack or stroke. These medications function by blocking the clot-forming activity of platelets – small cells that normally circulate in the blood stream and congeal around damaged or atherosclerotic blood vessels. The plaques in atherosclerotic vessels can occasionally rupture, causing the formation of a platelet plug that clogs blood vessels and can lead to heart attack or stroke. However, there is considerable variability in how patients respond to these medications, which confounds physicians who must deduce the appropriate drug and proper dose for each patient. Now, researchers from Thomas Jefferson University have identified some of the genetic differences behind these variations, which could help doctors treat racial groups with a more personalized and effective approach.
“Differences in platelet biology could be part of the explanation of the disparity,” says Dr. Bray.
To investigate whether the variation among different individuals had a racial component, Dr. Bray and collaborators from Baylor Medical College, Harvard Medical School and the New York and Puget Sound Blood Centers analyzed platelets from blood samples of 154 young healthy subjects that included 70 blacks and 84 whites. Self-reported race was confirmed with genetic tests that verified geographic (African or European) ancestry. Unexpectedly, the researchers found that platelets from black donors clotted faster and to a greater extent in response to the naturally occurring clotting agent, thrombin that specifically triggered one of the platelet-activating receptors, called PAR4. No racial differences were seen with other clotting agents.
Thrombin is the most potent platelet activator in the body, and it is targeted for suppression by numerous blood-thinning medications. However, newer drugs that target thrombin inhibit specific members of the PAR family of receptors. For example, the drug vorapaxar, currently in development for patients with a history of heart disease, specifically inhibits the PAR1 receptor. If PAR1 is blocked by vorapaxar, then PAR4 is the only means by which thrombin can activate platelets, and the Jefferson scientists showed that in this setting thrombin more potently activated platelets from blacks. It remains to be determined how or if these findings relate to drugs that are currently prescribed or to those currently in development.
Further molecular studies identified a novel gene called PCTP that mediated platelet activation through PAR4. PCTP was expressed at higher levels in platelets from blacks and appears to be a major contributor to the racial difference in blood clotting. Furthermore, a microRNA was identified that silenced the expression of PCTP; this microRNA was expressed at higher levels in platelets from whites than blacks and may contribute to the lower levels of thrombin activation through the PAR4 receptor in whites.
In fact, the researchers found many silencing microRNAs were more actively expressed in whites than in blacks, at least in platelets, suggesting that other aspects of platelet biology may be regulated differently depending on race. Uncovering the genes that these microRNAs suppress could help researchers hone in on individual differences in platelet function, and eventually how these differences contribute to disease and response to anti-clotting treatments.
“In this age where there is such a focus on delivering personalized medicine, we should embrace these differences to try to give our patients better care,” says Dr. Bray.
Monday, October 28, 2013
Baxter Introduces Hemostat in Europe
DEERFIELD, Ill., Oct 23, 2013 (BUSINESS WIRE) -- Baxter International Inc. BAX -0.04% today announced the launch of HEMOPATCH Sealing Hemostat, a novel collagen-based hemostatic device, following CE mark approval in Europe. HEMOPATCH is a resorbable hemostatic device used for surgical procedures when control of bleeding by pressure, ligature or conventional procedures is either ineffective or impractical. The development of HEMOPATCH combined Baxter's expertise in collagen, internal coagulation processes, and PEG (polyethylene glycol) technology platforms.
''HEMOPATCH is a valuable addition to the tools in the surgical suite, as it provides fast hemostasis and strong tissue adherence. Surgeons will appreciate that the product works quickly and effectively, does not require preparation time, and can be used in a range of surgical settings,'' said Frank Ulrich, M.D., head of surgical oncology at Goethe University in Frankfurt, Germany.
HEMOPATCH is a soft, thin and flexible collagen pad that is designed to allow surgeons control during application to gain hemostasis and firm adherence of the hemostatic pad to the bleeding tissue surface. In preclinical tests, HEMOPATCH achieved fast and effective hemostasis, reaching 97.5 percent success by fully controlling bleeding at two minutes.
The pad consists of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG). This gives the pad a dual-method mechanism of action, in which two components interact to achieve hemostasis by sealing off the bleeding surface and initiating the body's own clotting mechanisms. Significant preclinical testing was conducted to confirm its hemostatic performance, biocompatibility, and safety profile.
''HEMOPATCH is a significant innovation in the field of surgical hemostasis and is a valuable enhancement to the portfolio of biosurgical products offered by Baxter,'' said Russell Holscher, vice president of research and development in Baxter's BioSurgery business. ''Importantly, the robust development process, including evaluation of more than 400 prototypes with feedback from more than 200 surgeons, exemplifies the company's commitment to customer-centric innovation. This hemostat will offer surgeons a valuable new tool. We plan to support the registration and launch of HEMOPATCH in additional countries in the coming years.''
About HEMOPATCH
HEMOPATCH Sealing Hemostat is intended as a hemostatic device for surgical procedures when control of bleeding by pressure, ligature, or conventional procedures is either ineffective or impractical.
Important Risk Information
HEMOPATCH Sealing Hemostat is not intended to be used in pulsatile, severe bleedings. The use of HEMOPATCH Sealing Hemostat is not recommended in the presence of an active infection. When used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm, care should be exercised to avoid overpacking (collagens do expand upon absorption of liquid, and may create the potential of nerve damage). HEMOPATCH Sealing Hemostat is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
Do not compress HEMOPATCH Sealing Hemostat into blood vessels or use intravascularly. The device must not be used in patients with known hypersensitivity to bovine proteins or brilliant blue (FD&C #1, blue dye).
''HEMOPATCH is a valuable addition to the tools in the surgical suite, as it provides fast hemostasis and strong tissue adherence. Surgeons will appreciate that the product works quickly and effectively, does not require preparation time, and can be used in a range of surgical settings,'' said Frank Ulrich, M.D., head of surgical oncology at Goethe University in Frankfurt, Germany.
HEMOPATCH is a soft, thin and flexible collagen pad that is designed to allow surgeons control during application to gain hemostasis and firm adherence of the hemostatic pad to the bleeding tissue surface. In preclinical tests, HEMOPATCH achieved fast and effective hemostasis, reaching 97.5 percent success by fully controlling bleeding at two minutes.
The pad consists of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG). This gives the pad a dual-method mechanism of action, in which two components interact to achieve hemostasis by sealing off the bleeding surface and initiating the body's own clotting mechanisms. Significant preclinical testing was conducted to confirm its hemostatic performance, biocompatibility, and safety profile.
''HEMOPATCH is a significant innovation in the field of surgical hemostasis and is a valuable enhancement to the portfolio of biosurgical products offered by Baxter,'' said Russell Holscher, vice president of research and development in Baxter's BioSurgery business. ''Importantly, the robust development process, including evaluation of more than 400 prototypes with feedback from more than 200 surgeons, exemplifies the company's commitment to customer-centric innovation. This hemostat will offer surgeons a valuable new tool. We plan to support the registration and launch of HEMOPATCH in additional countries in the coming years.''
About HEMOPATCH
HEMOPATCH Sealing Hemostat is intended as a hemostatic device for surgical procedures when control of bleeding by pressure, ligature, or conventional procedures is either ineffective or impractical.
Important Risk Information
HEMOPATCH Sealing Hemostat is not intended to be used in pulsatile, severe bleedings. The use of HEMOPATCH Sealing Hemostat is not recommended in the presence of an active infection. When used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm, care should be exercised to avoid overpacking (collagens do expand upon absorption of liquid, and may create the potential of nerve damage). HEMOPATCH Sealing Hemostat is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
Do not compress HEMOPATCH Sealing Hemostat into blood vessels or use intravascularly. The device must not be used in patients with known hypersensitivity to bovine proteins or brilliant blue (FD&C #1, blue dye).
Integra LifeSciences to Acquire DuraSeal(TM) Product Lines From Covidien
PLAINSBORO, N.J., Oct. 28, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today it has entered into a definitive agreement with Covidien to acquire the Confluent Surgical product lines, including surgical sealants, adhesion barrier, and, most importantly, DuraSeal(TM). The companies expect to complete this transaction by the end of the first calendar quarter of 2014, subject to receipt of regulatory approvals.
Under the terms of the agreement, Covidien will receive an initial cash payment of $235 million from Integra upon the closing of the transaction. Additionally, Covidien may receive up to $30 million, contingent upon the achievement of certain performance measures related to the transition of the Confluent Surgical business to Integra.
"The addition of the DuraSeal(TM) product lines enables our sales force and distributor partners to provide their customers with a best-in-class dural sealant as they seek to support surgeon's efforts to minimize cerebrospinal fluid leaks upon completion of the surgical procedure," said Robert Davis, President of Integra's U.S. Neurosurgery division. "This acquisition perfectly complements our global Neurosurgery growth strategy aimed at providing a broader set of solutions for surgical procedures in the head. Together with our broad DuraGen(R) product line we are fortunate to have even more options to serve our customers and the individual needs of their patients."
"This transaction allows Covidien to better focus on its global strategic priorities," said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. "Based on Integra's presence in neurosurgery and spine surgery combined with a strong portfolio of clinical evidence, we believe these products will thrive under Integra's ownership. We express our sincere gratitude to our dedicated employees and the clinicians who have partnered with us throughout the years."
Confluent Surgical products include: DuraSeal(TM), DuraSeal(TM) Exact/Xact, VascuSeal(TM) and SprayShield(TM). These products generated approximately $65 million in revenue (unaudited) during 2012 and gross margin comparable to Integra's regenerative medicine product portfolio. Integra expects to provide detailed guidance regarding the financial impacts of this transaction upon closing. Preliminarily, Integra would expect the acquisition to add $57 million to $60 million in revenue in the first full year of the combination, and to then grow 3% to 5% longer term.
"This transaction adds scale to our business, leverages one of our strongest customer call points, and drives accretion to our gross margins," said Jack Henneman, Integra's Chief Financial Officer. "Upon completion of the transaction, we expect this deal to be accretive to both GAAP and adjusted earnings per share in the first year after considering the financing costs of the transaction."
Integra expects that revenues acquired through this transaction would be reported in its U.S. Neurosurgery and International divisions.
Under the terms of the agreement, Covidien will receive an initial cash payment of $235 million from Integra upon the closing of the transaction. Additionally, Covidien may receive up to $30 million, contingent upon the achievement of certain performance measures related to the transition of the Confluent Surgical business to Integra.
"The addition of the DuraSeal(TM) product lines enables our sales force and distributor partners to provide their customers with a best-in-class dural sealant as they seek to support surgeon's efforts to minimize cerebrospinal fluid leaks upon completion of the surgical procedure," said Robert Davis, President of Integra's U.S. Neurosurgery division. "This acquisition perfectly complements our global Neurosurgery growth strategy aimed at providing a broader set of solutions for surgical procedures in the head. Together with our broad DuraGen(R) product line we are fortunate to have even more options to serve our customers and the individual needs of their patients."
"This transaction allows Covidien to better focus on its global strategic priorities," said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. "Based on Integra's presence in neurosurgery and spine surgery combined with a strong portfolio of clinical evidence, we believe these products will thrive under Integra's ownership. We express our sincere gratitude to our dedicated employees and the clinicians who have partnered with us throughout the years."
Confluent Surgical products include: DuraSeal(TM), DuraSeal(TM) Exact/Xact, VascuSeal(TM) and SprayShield(TM). These products generated approximately $65 million in revenue (unaudited) during 2012 and gross margin comparable to Integra's regenerative medicine product portfolio. Integra expects to provide detailed guidance regarding the financial impacts of this transaction upon closing. Preliminarily, Integra would expect the acquisition to add $57 million to $60 million in revenue in the first full year of the combination, and to then grow 3% to 5% longer term.
"This transaction adds scale to our business, leverages one of our strongest customer call points, and drives accretion to our gross margins," said Jack Henneman, Integra's Chief Financial Officer. "Upon completion of the transaction, we expect this deal to be accretive to both GAAP and adjusted earnings per share in the first year after considering the financing costs of the transaction."
Integra expects that revenues acquired through this transaction would be reported in its U.S. Neurosurgery and International divisions.
Friday, October 11, 2013
BioCer Launch of HaemoCer Plus versus Arista, Perclot and unknown other as presented at EACTS in Vienna
Tuesday, September 24, 2013
BioCer Present Newly EU Approved Super Rapid Plant-based Hemostat at EACTS
BAYREUTH, Germany, September 24, 2013 /PRNewswire via COMTEX/ -- BioCer Entwicklungs GmbH (BCE) a German implantable biological medical device development and manufacturing company announced today that it has achieved commercial approval to begin distribution in the EU, and international markets where CE mark is accepted of HaemoCer Plus. HaemoCer Plus is an Absorbable Polysaccharide Hemostat (APH) and an innovative powerful hemostatic technology that exhibits exceptional speed and ratio of absorbency.
"HaemoCer Plus follows 2 years of development and is a huge technological milestone with clear efficiency benefits. In comparative testing with our first agent HaemoCer the accelerated absorbent product nature is significant, and clearly evident to a far greater extreme with older plant-based powdered agents. As surgeons experience the rapid mode of action of HaemoCer Plus we expect they will convert, and this product will rapidly dominate this market segment," stated Dr. Markus Heinlein, Managing Director BCE. "As problematic bleeding in cardiac surgery is a constant challenge, BioCer are pleased to present and launch HaemoCer Plus at the EACTS."
Haemocer Plus APH is a plant-based hemostatic agent that utilizes the same raw material as BCE's flagship product HaemoCer. HaemoCer Plus APH technology is delivered in a powder format developed utilizing a new modification to Biocer's Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) manufacturing process. The new highly absorptive, biocompatible agent now performs at exceedingly fast absorptive speeds achieving results twice as fast and at double the capacity of HaemoCer.
HaemoCer Plus will be presented at the EACTS 5th-9th October 2013 in Vienna, Austria. Other meetings in 2013 include Medica (Germany) and Asia Pacific Hernia Society (Hong Kong) at BioCer's booth. BioCer also plan to attend Arab Health and welcome expressions of interest in distribution or licensing queries to please visit http://www.biocer-gmbh.de or email info@biocer-gmbh.de.
Monday, September 9, 2013
FDA Accepts Biomedica MC Investigational New Drug Filing for ClotFoam®
ClotFoam was originally conceived to control severe hemorrhage without need of compression in order to address unmet needs in gynecology, combat trauma and emergency medicine, as well as treatment of trauma in the operating room. Current trials are designed to prove the safety and efficacy of the product as an adjunct in solid organ hemorrhage. Once the agent is approved for this indication, the company will conduct additional trials as a primary treatment in trauma patients.
ClotFoam’s ability to control bleeding is based on rapid and powerful activity of fibrin monomer carried by a foam with high affinity to endothelial tissue. ClotFoam has shown promising results in animal models of large organ resection without need of compression and with minimally invasive application methods. Preliminary assays indicate that the agent is also effective in controlling severe acute menstrual cycle disorders (i.e. menorraghia) and post-partum hemorrhage, which is the most common cause of perinatal maternal death in the developed world and is a major cause of maternal morbidity worldwide. These types of severe clinical situations are well adapted for the ClotFoam technology because of it’s self-expanding and non-compressible hemostatic action, unlike common hemostats available in the operating room today.
Biomedica plans to complete Phase I in the course of 2013 and initiate Phase 2 clinical trials as an adjunct to hemostasis in the first quarter of 2014. The company has requested Fast Track Designation for ClotFoam. This designation is reserved for drugs that advance novel technologies, and are expected to provide significant therapeutic advantages over existing products while addressing unmet medical needs. Fast Track designation benefits form priority review status. Orphan Drug Status will be requested for the ClotFoam Battlefield special formulation. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for orphan drug grants; and waiver of certain administrative fees.
About Biomedica’s CLOT development Program. The Clot technology
uses fibrin monomer manufactured under proprietary methods that produce stronger, faster, less expensive and purer hemostats. Clot bypasses the conversion of fibrinogen by thrombin allowing for instant polymerization at lower concentration. Clot products resist degradation, do not contain thrombin, and can be shaped as a foam, a gel, a patch, a pellet, a screw or a spray.
Biomedica’s proprietary technology has produced ClotGel, ClotBlock, ClotCut, EyeClot and ClotSpray. While ClotGel is similar in appearance and efficacy to the leading hemostatic agent Floseal, it does not contain thrombin allowing for intraoperative blood salvage and minimal swelling. ClotBlock has important applications in orthopedic surgery as well as in persistent solid organ bleeding. ClotCut is a promising solution of cutaneous bleeding in emergency medicine, and ClotSpray may replace many of the current fibrin sealant applications with a more simple one-component solution stored at refrigerated conditions (compared to frozen fibrin sealant), faster polymerization times, and easier-to-use surgeon application characteristics.
About Biomedica Management Corporation. Biomedica is a clinical-stage federally funded research and development company headquartered at the SUNY Downstate Biotech Center in Brooklyn, NY, with biochemistry laboratories at the UMBC TechCenter in Baltimore, MD. The company was funded in 1999 as a collaborative effort between scientists in the fields of biochemistry, immunology, and trauma surgery The Company operates under an innovative business model that fosters the development of critical technologies with the vision of academic scientists and the guidance of marketing experts. Biomedica brings to the market affordable and effective technologies targeting unmet needs in coagulopathic-related conditions, inflammation, sepsis and wound healing. The Company’s most clinically advanced product candidate ClotFoam is derived from its proprietary Clot ™ platform designed to improve hemostasis in patients undergoing a wide range of surgical and medical procedures. The product development has been supported by the National Institutes of Health, the US Army Medical Research and Materiel Command and by TEDCO, the Technology Corporation of Maryland.
Tuesday, September 3, 2013
Cohera Medical Completes Sylys® Surgical Sealant Clinical Trial
Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced it has treated its last patient for the clinical trial for Sylys®, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures. The results of the study will be released later this fall.
The European study is evaluating the safety of Sylys as an adjunct to standard closure techniques following bowel resections. The study included patients enrolled at two sites in the Netherlands.
Anastomotic leaks, on average, occur in 3 - 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 - 4B market.
"We are thrilled to be collaborating with leading surgeons in the Netherlands to treat patients with our Sylys product, our second class III product designed to support more natural healing and help reduce post-operative complications," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "Completing the treatment of the last patient in this study brings us one step closer to putting this innovative sealant in the hands of surgeons and reducing anastomotic leakage after colorectal surgery."
Tuesday, August 20, 2013
Medafor sells to Bard for $200 million, plus incentives that could add another $80 million.
Officials at Medafor Inc., a Brooklyn Center-based maker of a novel blood clotting product, said they’ve been looking for ways to enhance shareholder value — be it an initial public offering, new business relationships or just continuing organic growth. The one thing they weren’t looking for was a buyer, leaders said Monday.
Then the folks at C.R. Bard Inc., a New Jersey-based medical equipment maker, came calling.
Their offer — $200 million in cash now and up to $80 million more if revenue targets are hit in the next two years — proved too attractive to pass up, said Medafor CEO Gary Shope.
Medafor on Monday announced that it has an agreement to be purchased by C.R. Bard’s Davol Inc. division. The transaction has been approved by both companies’ boards of directors, but is subject to approval by Medafor’s shareholders and customary regulatory review.
“The premium price underscores what we have been building on,” Shope said in an interview Monday. “I think the shareholders are being rewarded with a great price.”
Medafor’s appeal has been its plant-based microporous polysaccharide hemospheres technology, which is used in its Arista MPH hemostat product. The product rapidly dehydrates blood and accelerates the body’s natural blood-clotting process.
Sept. 24 is the target date for shareholder approval, Shope said. The deal values Medafor’s privately held shares at $6.37 per share. The revenue-based incentives are valued at up to $2.82 per share.
C.R. Bard said Medafor will add approximately 1 percent to its 2014 revenue.
The company, a maker of vascular, oncology and surgical products, had revenue of about $3 billion last year. Scott Lowry, C.R. Bard vice president and treasurer, said he expects Medafor, which has 33 employees, to have annual revenue of $30 million to $40 million by the end of 2013. Medafor’s products will complement C.R. Bard’s hemostasis unit and broaden its product portfolio, he said.
“We look at this as a growth opportunity,” Lowry said. “Our plan is to grow this business.”
He says it is premature to comment on status of Medafor’s management and employees since the deal still needs Medafor shareholder approval and to pass other regulatory requirements. Shope, the Medafor CEO, said he believes that Bard is considering keeping the Medafor organization intact but that “going forward, they will be making their own decisions.”
John Houston, an attorney at Fredrikson & Byron who served as Medafor’s lead legal counsel for the transaction, said: “This really was an offer that came out of left field. It was not solicited and it was not anticipated.”
Officials from Bard had met with two of Medafor’s senior officers at a conference in Spain less than a year ago, he said.
According to C.R. Bard’s statement on the acquisition, the global market for surgical hemostats is over $1.4 billion. “The Arista hemostat provides a great alternative to other commercially available hemostats while providing strong synergy with our Progel Sealant technology and sales channel,” said Timothy Ring, C.R. Bard’s chairman and CEO.
Sunday, August 18, 2013
Military, civilian medical experts emphasize investment in acute trauma care
FORT LAUDERDALE, Fla. (Aug. 13, 2013) -- From battlefield blasts to plane crashes, major advancements in acute trauma care are being seen in both the military and civilian health sectors, agreed experts during roundtable discussion at the 2013 Military Health System Research Symposium, Aug. 13, in Fort Lauderdale, Fla.
Funding in research and rapid implementation of best practices are paying off, and people with serious injuries are surviving and rehabilitating, said director of the U.S. Army's Combat Casualty Care Research, or CCCRP, Program Col. Dallas Hack. Joining him was Air Force Col. Todd Rasmussen, CCCRP deputy director.
"It's not an overstatement to say that trauma care has been transformed because of this investment," said Rasmussen. "This transformation has resulted in the lowest fatally rate for service members we have ever seen, and this investment has translated to civilians, including those injured on the streets of this country."
Roundtable participants included Navy Capt. Eric Elster, Uniformed Services University School of Medicine, Department of Surgery professor; Air Force Col. Jeffrey Bailey, Joint Trauma System director; and Dr. Margaret Knudson, chief of surgery at the San Francisco General Hospital and Trauma Center.
Bailey, who joined the event via phone from Afghanistan, talked about some of the technologies, tools, and education implemented over the past decade of war, including battlefield tourniquets, hemostat bandages to reduce blood loss, and education on first-aid care. Bailey said now it's time to "focus on the gaps."
"The greatest burden of death is not in the hospital; it is on the battlefield. So we have the greatest opportunity to make a difference in pre-hospital care," Bailey said to the group.
It was a point with which non-military doctors agreed. Knudson joined the group to share her recent experiences caring for victims during the San Francisco plane crash in July. Fifty-three of the plane crash patients were treated at San Francisco General.
Knudson explained that she had previously trained with military health care combat casualty teams and how she used that training during the mass casualty triage.
"We need to keep these collaborations going because it brings a value to both the military and the civilian sectors," said Knudson.
Elster added, "It's how we train the next generation."
Funding in research and rapid implementation of best practices are paying off, and people with serious injuries are surviving and rehabilitating, said director of the U.S. Army's Combat Casualty Care Research, or CCCRP, Program Col. Dallas Hack. Joining him was Air Force Col. Todd Rasmussen, CCCRP deputy director.
"It's not an overstatement to say that trauma care has been transformed because of this investment," said Rasmussen. "This transformation has resulted in the lowest fatally rate for service members we have ever seen, and this investment has translated to civilians, including those injured on the streets of this country."
Roundtable participants included Navy Capt. Eric Elster, Uniformed Services University School of Medicine, Department of Surgery professor; Air Force Col. Jeffrey Bailey, Joint Trauma System director; and Dr. Margaret Knudson, chief of surgery at the San Francisco General Hospital and Trauma Center.
Bailey, who joined the event via phone from Afghanistan, talked about some of the technologies, tools, and education implemented over the past decade of war, including battlefield tourniquets, hemostat bandages to reduce blood loss, and education on first-aid care. Bailey said now it's time to "focus on the gaps."
"The greatest burden of death is not in the hospital; it is on the battlefield. So we have the greatest opportunity to make a difference in pre-hospital care," Bailey said to the group.
It was a point with which non-military doctors agreed. Knudson joined the group to share her recent experiences caring for victims during the San Francisco plane crash in July. Fifty-three of the plane crash patients were treated at San Francisco General.
Knudson explained that she had previously trained with military health care combat casualty teams and how she used that training during the mass casualty triage.
"We need to keep these collaborations going because it brings a value to both the military and the civilian sectors," said Knudson.
Elster added, "It's how we train the next generation."
Thursday, August 8, 2013
Arch Therapeutics Announces Plans for Upcoming Activities
CAMBRIDGE, MA, Aug 06, 2013 (Marketwired via COMTEX) -- Arch Therapeutics, Inc. (otcqb:ARTH) ("Arch" or the "Company"), a life science company and developer of AC5(TM), a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to provide a brief review of proposed future activities.
Arch Therapeutics CEO Dr. Terrence Norchi states, "We are thrilled to be moving ahead with the development of our core technology. We envision the potential future customers in the marketplace for AC5(TM) and related products will include surgeons and other doctors, government agencies, hospital and operating room management, ambulances and trauma specialists. These market segments, even taken separately, present meaningful opportunities for the Company."
According to a 2012 report produced by MedMarket Diligence, LLC, approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the U.S. We estimate that 20-25% of those surgeries are performed laparoscopically. Additionally, there are many minor procedures and operations that may not be included in those figures. Those surgeries and other procedures could benefit from sealants and hemostatic agents, as surgical and trauma patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluid.
As a result of this demand, use of hemostatic agents and sealants is increasing. According to MedMarket Diligence, the market for these products achieved approximately $3.4 billion in 2010 worldwide sales and is projected to reach $4.5 billion in 2013 and surpass $6.5 billion in 2017. Over two-thirds of those sales are for hemostats. The growth rate for sealants is even higher than that for hemostats due to a general lack of available products and potentially larger unmet need.
The results of early data from preclinical tests have shown that AC5(TM) achieves hemostasis quickly and effectively. From a commercialization perspective, improvements in relevant synthetic manufacturing techniques in the past several years have reduced complexity and decreased materials cost. Further, AC5 will be made of naturally occurring ingredients that are not sourced from humans or other animals, but do exist in humans in their natural state. This type of ingredient is categorized as "generally recognized as safe," or "GRAS," by the U.S. Food and Drug Administration ("FDA"). Although the FDA and other regulatory authorities or related bodies will finally determine the classification of AC5(TM), the Company believes it meets the criteria for a medical device.
In furtherance of its stated long-term business goals, the Company reiterated plans to focus on the following activities during the remainder of calendar year 2013 and calendar year 2014:
Arch Therapeutics CEO Dr. Terrence Norchi states, "We are thrilled to be moving ahead with the development of our core technology. We envision the potential future customers in the marketplace for AC5(TM) and related products will include surgeons and other doctors, government agencies, hospital and operating room management, ambulances and trauma specialists. These market segments, even taken separately, present meaningful opportunities for the Company."
According to a 2012 report produced by MedMarket Diligence, LLC, approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the U.S. We estimate that 20-25% of those surgeries are performed laparoscopically. Additionally, there are many minor procedures and operations that may not be included in those figures. Those surgeries and other procedures could benefit from sealants and hemostatic agents, as surgical and trauma patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluid.
As a result of this demand, use of hemostatic agents and sealants is increasing. According to MedMarket Diligence, the market for these products achieved approximately $3.4 billion in 2010 worldwide sales and is projected to reach $4.5 billion in 2013 and surpass $6.5 billion in 2017. Over two-thirds of those sales are for hemostats. The growth rate for sealants is even higher than that for hemostats due to a general lack of available products and potentially larger unmet need.
The results of early data from preclinical tests have shown that AC5(TM) achieves hemostasis quickly and effectively. From a commercialization perspective, improvements in relevant synthetic manufacturing techniques in the past several years have reduced complexity and decreased materials cost. Further, AC5 will be made of naturally occurring ingredients that are not sourced from humans or other animals, but do exist in humans in their natural state. This type of ingredient is categorized as "generally recognized as safe," or "GRAS," by the U.S. Food and Drug Administration ("FDA"). Although the FDA and other regulatory authorities or related bodies will finally determine the classification of AC5(TM), the Company believes it meets the criteria for a medical device.
In furtherance of its stated long-term business goals, the Company reiterated plans to focus on the following activities during the remainder of calendar year 2013 and calendar year 2014:
-- further developing and securing intellectual property rights; and
-- engaging a large scale manufacturing partner to produce cGMP product
for clinical trials;
-- participating in EU and, subsequently, U.S. regulatory meetings;
-- preparing for initial clinical trials, including developing clinical
trial protocols;
-- conducting formal biocompatibility studies;
-- commencing human clinical trials.
Company CEO Dr. Terrence Norchi further comments, "We believe that AC5(TM) will meet increasing demands, with anticipated market entry for use in laparoscopic, as well as open surgery. While open surgery represents the more established market for hemostatic agents, approximately one-quarter of surgeries are laparoscopic, and that number is growing. Many of the hemostasis products currently available do not possess certain features and handling characteristics that are ideal for the laparoscopic setting. Further, there seems to be increased pressure to perform more complex surgeries at reduced costs, including conducting operations in less expensive outpatient settings. We believe that the novel features and differentiating characteristics of our technology platform, starting with AC5(TM), will address the need for highly improved hemostatic and sealant products."
Additional details regarding Arch Therapeutics, Inc., its business, agreements and related matters are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission ("SEC"), and are available at the SEC's website at www.sec.gov. For more information, visit our website at www.archtherapeutics.com.
About Arch Therapeutics, Inc. (otcqb:ARTH) Arch Therapeutics, Inc. (otcqb:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch's goal is to develop and commercialize products based on our innovative technology platform that make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate known as AC5(TM) is being designed to elegantly achieve hemostasis in minimally invasive and open surgical procedures. Find out more at www.archtherapeutics.com.
Company CEO Dr. Terrence Norchi further comments, "We believe that AC5(TM) will meet increasing demands, with anticipated market entry for use in laparoscopic, as well as open surgery. While open surgery represents the more established market for hemostatic agents, approximately one-quarter of surgeries are laparoscopic, and that number is growing. Many of the hemostasis products currently available do not possess certain features and handling characteristics that are ideal for the laparoscopic setting. Further, there seems to be increased pressure to perform more complex surgeries at reduced costs, including conducting operations in less expensive outpatient settings. We believe that the novel features and differentiating characteristics of our technology platform, starting with AC5(TM), will address the need for highly improved hemostatic and sealant products."
Additional details regarding Arch Therapeutics, Inc., its business, agreements and related matters are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission ("SEC"), and are available at the SEC's website at www.sec.gov. For more information, visit our website at www.archtherapeutics.com.
About Arch Therapeutics, Inc. (otcqb:ARTH) Arch Therapeutics, Inc. (otcqb:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch's goal is to develop and commercialize products based on our innovative technology platform that make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate known as AC5(TM) is being designed to elegantly achieve hemostasis in minimally invasive and open surgical procedures. Find out more at www.archtherapeutics.com.
Monday, August 5, 2013
Medicines Co. wraps $240M deal to buy ProFibrix following PhIII success
The Medicines Company has swooped in to buy out the Dutch biotech ProFibrix, chipping in $90 million in cash on top of a $10 million option anted up in June as Phase III data on a lead surgical therapy loomed. And the buyer has agreed to pay up to $140 million more for a set of unspecified milestones.
The Medicines Company ($MDCO) is landing Fibrocaps in the deal, an easy-to-use dry-powder formulation of fibrinogen and thrombin that can be used to stop bleeding during surgery, a process referred to as hemostasis. In their release today the companies noted that the lead biologic hit all primary and secondary endpoints on four surgical indications: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. Investigators recruited 719 patients for the Phase III study.
The plan now is to file for EU approval in the fourth quarter of this year, with an FDA application following in the first quarter of 2014, commented ProFibrix CEO Jan Ohrstrom. And The Medicines Company believes it can earn more than $300 million a year on the product, provided it wins key approvals.
"The company was founded in 2007 with an A round from Index Ventures," adds Ohrstrom. Phase I was run in 2008 and investigators are now wrapping a 5-year clinical program, with more work scheduled on laparoscopic surgery as well as a pediatric program. The CEO says more indications are also being "toyed with," but he declined to elaborate. The company's lab in Leiden will stay operational, says Ohrstrom, the former chief medical officer of ZymoGenetics. ProFibrix currently has 25 employees in Leiden and Seattle, where it has a clinical development site.
"Subject to regulatory approval, we believe Fibrocaps can become an important hemostatic product--complementary to Recothrom (Thrombin, topical [Recombinant])," says Clive Meanwell, the CEO at The Medicines Co. "We anticipate leverage of our work with U.S. surgery centers and entry into the European market. … ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products. We plan to integrate the ProFibrix team with our existing Recothrom team--expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."
The market for hemostatic products has been busy with new developments for years. Just a few weeks ago Omrix Biopharmaceuticals won a recommendation from the CHMP in Europe for the sealant matrix Evarrest, which also combines fibrinogen and thrombin. But The Medicines Company is hoping that ProFibrix's off-the-shelf technology will quickly win converts.
The Medicines Company ($MDCO) is landing Fibrocaps in the deal, an easy-to-use dry-powder formulation of fibrinogen and thrombin that can be used to stop bleeding during surgery, a process referred to as hemostasis. In their release today the companies noted that the lead biologic hit all primary and secondary endpoints on four surgical indications: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. Investigators recruited 719 patients for the Phase III study.
The plan now is to file for EU approval in the fourth quarter of this year, with an FDA application following in the first quarter of 2014, commented ProFibrix CEO Jan Ohrstrom. And The Medicines Company believes it can earn more than $300 million a year on the product, provided it wins key approvals.
"The company was founded in 2007 with an A round from Index Ventures," adds Ohrstrom. Phase I was run in 2008 and investigators are now wrapping a 5-year clinical program, with more work scheduled on laparoscopic surgery as well as a pediatric program. The CEO says more indications are also being "toyed with," but he declined to elaborate. The company's lab in Leiden will stay operational, says Ohrstrom, the former chief medical officer of ZymoGenetics. ProFibrix currently has 25 employees in Leiden and Seattle, where it has a clinical development site.
"Subject to regulatory approval, we believe Fibrocaps can become an important hemostatic product--complementary to Recothrom (Thrombin, topical [Recombinant])," says Clive Meanwell, the CEO at The Medicines Co. "We anticipate leverage of our work with U.S. surgery centers and entry into the European market. … ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products. We plan to integrate the ProFibrix team with our existing Recothrom team--expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."
The market for hemostatic products has been busy with new developments for years. Just a few weeks ago Omrix Biopharmaceuticals won a recommendation from the CHMP in Europe for the sealant matrix Evarrest, which also combines fibrinogen and thrombin. But The Medicines Company is hoping that ProFibrix's off-the-shelf technology will quickly win converts.
Tuesday, July 2, 2013
US FDA clears Abyrx's absorbable haemostatic bone putty for clinical use
Abyrx, Inc., a privately-held therapeutic device company, has received the United States Food and Drug Administration (FDA) clearance for its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the state.
AHBP is provided ready-to-use (without requiring mixing or warming) and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery. Abyrx will offer AHBP in a multi-package configuration and in several sizes to accommodate hospital procurement requirements and to improve efficiency in a variety of surgical procedures across surgical specialties in which the product will be used.
AHBP complements Abyrx’s existing surgical hemostat product offerings which currently include Hemasorb and Hemasorb Apply. With this new product, Abyrx is executing its strategy of vertically integrating within the surgical hemostasis marketplace.
Commenting on Abyrx’s portfolio approach to the marketplace, John J Pacifico, the Company’s president and chief executive officer, stated, “Our team is committed to providing the most comprehensive bone hemostat product line in the operating room. AHBP and other products under development complement our Hemasorb products and will provide surgeons with more options to treat their patients and help enable hospitals to reduce costs.”
Richard Kronenthal, Ph.D., Abyrx’s chief scientific officer, offered his thoughts about the developmental challenge and the potential of the AHBP technology platform, “Our technical team evaluated dozens of subtle chemical and processing variables to specifically meet the surgical performance requirements of AHBP. Indeed, we continue to enjoy the challenge of further innovation by drawing on this new technology platform and our knowledge of the surgeon’s important needs.”
Abyrx’s surgical hemostat products are used by cardiothoracic, craniomaxillofacial, spine, orthopaedic, neurological, and trauma surgeons. The Company estimates that over 3.5 million patients undergoing surgical procedures each year could benefit from the intraoperative use of its products.
AHBP is provided ready-to-use (without requiring mixing or warming) and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery. Abyrx will offer AHBP in a multi-package configuration and in several sizes to accommodate hospital procurement requirements and to improve efficiency in a variety of surgical procedures across surgical specialties in which the product will be used.
AHBP complements Abyrx’s existing surgical hemostat product offerings which currently include Hemasorb and Hemasorb Apply. With this new product, Abyrx is executing its strategy of vertically integrating within the surgical hemostasis marketplace.
Commenting on Abyrx’s portfolio approach to the marketplace, John J Pacifico, the Company’s president and chief executive officer, stated, “Our team is committed to providing the most comprehensive bone hemostat product line in the operating room. AHBP and other products under development complement our Hemasorb products and will provide surgeons with more options to treat their patients and help enable hospitals to reduce costs.”
Richard Kronenthal, Ph.D., Abyrx’s chief scientific officer, offered his thoughts about the developmental challenge and the potential of the AHBP technology platform, “Our technical team evaluated dozens of subtle chemical and processing variables to specifically meet the surgical performance requirements of AHBP. Indeed, we continue to enjoy the challenge of further innovation by drawing on this new technology platform and our knowledge of the surgeon’s important needs.”
Abyrx’s surgical hemostat products are used by cardiothoracic, craniomaxillofacial, spine, orthopaedic, neurological, and trauma surgeons. The Company estimates that over 3.5 million patients undergoing surgical procedures each year could benefit from the intraoperative use of its products.
Wednesday, June 12, 2013
Court Enters Order Under Which Vascular Solutions Will Cease Manufacture, Sales and Distribution of R-Band
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In February, Terumo filed a patent infringement lawsuit alleging that the R Band™ Radial Hemostasis Device infringes on U.S. patent and trademark rights held by Terumo Medical Corporation for its proprietary TR Band™ Radial Compression Device. The R-Band is distributed in the U.S. by Vascular Solutions and manufactured by Lepu Medical Technology. Terumo sought an injunction against further sales of the infringing product.
"Terumo is extremely gratified with the Court's Order. We are thankful for the opportunity to successfully defend our TR Band™ device, which is a critical part of our transradial solutions portfolio," said James Rushworth, President, Terumo Interventional Systems and Onset Medical Corporation. "As a market leader, Terumo is committed to doing what is right for our business and, when appropriate, we will vigorously protect our investments, assets and intellectual property."
Terumo's market-leading TR Band™ Radial Compression Device is used to achieve patent hemostasis immediately following a transradial access diagnostic and intervention in the treatment of cardiac and vascular disease. The clear band is placed around the patient's wrist to effectively stop access-point bleeding. The TR Band™ features dual compression balloons that maintain precise pressure on the radial artery to ensure blood return without compromising local nerve structure. Transradial access interventions have been shown to significantly reduce bleeding complications by up to 75 percent when compared to femoral (through the groin) interventions.
Friday, May 31, 2013
Cohera Medical Completes Enrollment of Sylys™ Surgical Sealant Clinical Trial
PITTSBURGH, May 30, 2013 -- /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the completion of enrollment of its clinical trial for Sylys, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures.
Currently underway in Europe, the study is evaluating the safety of Sylys on the reduction of anastomotic leakage following bowel repair. The study included patients enrolled at two sites in the Netherlands.
"We are excited to conclude enrollment in this significant safety trial for Sylys, which has the potential to help reduce anastamotic leakage following colorectal procedures," said Dr. Consten of the Meander Medical Center, Amersfoort. "We look forward to following the enrolled patients and reporting the findings of this study."
"Cohera appreciates the fast enrollment by both Dr. Bemelman, at AMC Hospital and Dr. Consten at the Meander Medical Center" said Chad Coberly, JD, VP of Clinical, Regulatory and Legal Affairs of Cohera Medical. "We also greatly appreciate the assistance of the team at Factory CRO, in the Netherlands, to help us reach our timeline objectives on this important first in human study.
Anastomotic leaks, on average, occur in 3 – 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 – 4B market.
"Enrollment completion of this study is monumental for Cohera Medical, as this is our second class III product in humans," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "It is an indication of the remarkable surgeons we work with, who recognize the value of this sealant, and its ability to enhance standard closure techniques, supporting the healing process and reducing post-operative complications."
Wednesday, May 22, 2013
Chinese Starch Medicals Perclot Patent Claims Denied - Impact for Cryolife predicted
Recently denied claims for China based Perclot manufacturer Starch Medical have seen Starch re-file a dramatically reduced set of claims revised patent application published May 16, 2013 (see HERE).
The original 2009 filing which includes "Inventors" Ji Xin (James Ji), previously Chinese Distributor of Medafor's Arista, has now dropped Jianping Chen (Jane Chen) as an "Inventor".
Of more critical importance the patent has now shrunk in respect of claims made. Currently claims 1-53 have now been cancelled and it seems likely this patent is less than secure.
The EU search indicates denial regarding incorrect claims and scope of the claims regarding novelty, and inventive steps. Comments such as "the skilled person knows....this method does not support an inventive step" amongst others is available in the embedded document below.
In the meantime it will be interesting to see the reaction from Cryolife Shareholders who, having been subjected to the Medafor - Cryolife debacle, may now have serious due diligence queries of executives. The millions spent already on the CRY-Starch marriage may be a concern, but continued investments highlighted in the last quarterly report by executives such as Ashley Lee who announced Q1 2013 the intention of (after initial denial of the Perclot IDE) re-filing the IDE with the FDA in May. Ashley also stated further investment in Perclot with "a 320 patient study, randomized 1:1 with a 30-day follow up over across several medical specialties". CEO Steve Anderson commented when questioned about Perclot manufacturing "I think we’ve already spent the money that we’re going to spend to build out our manufacturing facility that frankly is up and ready to go".
The original 2009 filing which includes "Inventors" Ji Xin (James Ji), previously Chinese Distributor of Medafor's Arista, has now dropped Jianping Chen (Jane Chen) as an "Inventor".
Of more critical importance the patent has now shrunk in respect of claims made. Currently claims 1-53 have now been cancelled and it seems likely this patent is less than secure.
In the meantime it will be interesting to see the reaction from Cryolife Shareholders who, having been subjected to the Medafor - Cryolife debacle, may now have serious due diligence queries of executives. The millions spent already on the CRY-Starch marriage may be a concern, but continued investments highlighted in the last quarterly report by executives such as Ashley Lee who announced Q1 2013 the intention of (after initial denial of the Perclot IDE) re-filing the IDE with the FDA in May. Ashley also stated further investment in Perclot with "a 320 patient study, randomized 1:1 with a 30-day follow up over across several medical specialties". CEO Steve Anderson commented when questioned about Perclot manufacturing "I think we’ve already spent the money that we’re going to spend to build out our manufacturing facility that frankly is up and ready to go".
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