Boehringer Ingelheim, the manufacturer of the blood-thinning drug Pradaxa, was concerned that releasing the results of an internal research paper on the drug would damage drug sales, records recently made public show. The company was so worried about the results of the study that some employees pressured the author to revise it, and the company recommended it be thrown out, according to a recent report by the New York Times.
Records recently made public by a federal judge in Illinois presiding over thousands of lawsuits against the maker of Pradaxa, including emails, internal memos, and presentations, centered on the research project and whether it would be damaging to Pradaxa’s main selling point: that users of the drug aren’t required to undergo regular blood work while taking Pradaxa.
Pradaxa (dabigatran) was approved in 2010 as an alternative to an existing anti-clotting drug, warfarin. Both are anticoagulants used to prevent and treat blood clots and reduce the risk of stroke, but Boehringer Ingelheim marketed its drug as less of a nuisance than warfarin, which requires frequent blood tests and careful monitoring.
Unfortunately, Pradaxa has been linked to more than 1,000 deaths in the United States. Since 2010, an unprecedented number of adverse events related to the drug have been reported to the FDA. Experts have also questioned the reliability of an FDA study affirming the safety of Pradaxa.
Pradaxa has claimed superiority to warfarin. However, documents prepared by the FDA clearly state that “It is important… not to provide dabigatran with a superiority claim to warfarin, because it would imply that even those well-treated with warfarin should be switched to dabigatran. Clearly, that is not the case.”
Furthermore, a research paper written by Paul. A. Reilly, a clinical program director with Boehringer Ingelheim indicates that patients could benefit from having their blood monitored while taking Pradaxa. Reilly states that some patients absorb too little of the drug, rendering it ineffective, while some absorb so much that their risk for bleeding increases.
According to the New York Times, after Reilly’s paper was circulated within the company, Dr. Jutta Heinrich-Nols, a company supervisor, sent an email stating that she couldn’t believe the company was planning to publish Reilly’s work. She warned that publishing his results could make it “extremely difficult” for the company to maintain its claims that patients taking Pradaxa do not need regular blood tests.
Heinrich-Nols also noted that Reilly’s research could “undermine” the company’s efforts to compete with other new anticoagulants like Xarelto and Eliquis. The marketing of Pradaxa is yet another example of the dangers that consumers face when safety information is regulated by pharmaceutical companies primarily concerned with profit.
Boehringer Ingelheim issued a statement saying that the recently-released documents “represent small fragments of the robust discussion and debate that is a vital component in all scientific inquiry and in the research and development of any important medication such as Pradaxa.”
Unlike warfarin, Pradaxa has no antidote to reverse its blood-thinning effects. Despite issues with the FDA’s approach to approving the drug, as well as numerous patient bleeding deaths and adverse event reports, Pradaxa remains on the market as a safe drug.
Friday, February 7, 2014
Arch Therapeutics offers $2.9M in private stock placement
Massachusetts-based Arch Therapeutics hopes to sell over 11 million shares to raise close to $3 million in support of its medical sealants and hemostasis products.
Arch Therapeutics brings in nearly $3M in private stock placement
Arch Therapeutics launched a private placement fundraising effort, offering 11.4 million shares of common stock in hopes of raising $2.9 million.
Wellesley, Mass.-based Arch Therapeutics develops medical sealants and hemostasis products for use during surgeries. The company's marquee device is the AC5 Surgical Hemostatic for minimally invasive and open surgical procedures.
Arch is offering unnamed "institutional and high net worth" investors 11.4 million shares of common stock at a price of 25¢ per share. Investors will also receive warrants to purchase up to 11.4 million additional shares at an exercise price of either 30¢, 35¢ or 40¢ apiece, depending on whether investors purchase from the Series A, B or C warrants, according to a press release.
Arch Therapeutics completed a share swap and reverse merger, to expand into a life sciences company. Arch reported a $7.3 million financing through a share-swap related to its reverse merger with Arch Biosurgery, which expanded the company's range of products and services.
Arch Therapeutics brings in nearly $3M in private stock placement
Arch Therapeutics launched a private placement fundraising effort, offering 11.4 million shares of common stock in hopes of raising $2.9 million.
Wellesley, Mass.-based Arch Therapeutics develops medical sealants and hemostasis products for use during surgeries. The company's marquee device is the AC5 Surgical Hemostatic for minimally invasive and open surgical procedures.
Arch is offering unnamed "institutional and high net worth" investors 11.4 million shares of common stock at a price of 25¢ per share. Investors will also receive warrants to purchase up to 11.4 million additional shares at an exercise price of either 30¢, 35¢ or 40¢ apiece, depending on whether investors purchase from the Series A, B or C warrants, according to a press release.
Arch Therapeutics completed a share swap and reverse merger, to expand into a life sciences company. Arch reported a $7.3 million financing through a share-swap related to its reverse merger with Arch Biosurgery, which expanded the company's range of products and services.
Tuesday, January 28, 2014
Baxter sues Johnson & Johnson over FloSeal patents
Baxter (NYSE:BAX) accused Johnson & Johnson (NYSE:JNJ) of infringing 6 patents covering its FloSeal line with the Ethicon SurgiFlo line of competing surgical hemostasis products.
In a lawsuit filed last week in the U.S. District Court for Northern Illinois, Baxter said the alleged infringement is willful and asked Judge Sharon Johnson Coleman for triple damages, pre- and post-judgment interest, legal costs and a jury trial.
"Defendants' SurgiFlo products directly compete with Baxter's biosurgery products, including the Floseal family of products, which practice the Patents-in-Suit. On information and belief, defendants are aware of Floseal's established position in the hemostatic products market and carefully track Baxter's marketing and other activities related to the Floseal products in the United States and worldwide. For example, one or more of Defendants have repeatedly communicated with Baxter regarding competitive marketing issues in the United States and abroad pertaining to Floseal and SurgiFlo," Baxter alleged, according to court documents. "Defendants have infringed and will continue to infringe Baxter's intellectual property rights by making, using, selling, offering for sale within the United States and/or importing into the United States delivery products for hemostasis such as the SurgiFlo family of products."
In a lawsuit filed last week in the U.S. District Court for Northern Illinois, Baxter said the alleged infringement is willful and asked Judge Sharon Johnson Coleman for triple damages, pre- and post-judgment interest, legal costs and a jury trial.
"Defendants' SurgiFlo products directly compete with Baxter's biosurgery products, including the Floseal family of products, which practice the Patents-in-Suit. On information and belief, defendants are aware of Floseal's established position in the hemostatic products market and carefully track Baxter's marketing and other activities related to the Floseal products in the United States and worldwide. For example, one or more of Defendants have repeatedly communicated with Baxter regarding competitive marketing issues in the United States and abroad pertaining to Floseal and SurgiFlo," Baxter alleged, according to court documents. "Defendants have infringed and will continue to infringe Baxter's intellectual property rights by making, using, selling, offering for sale within the United States and/or importing into the United States delivery products for hemostasis such as the SurgiFlo family of products."
Thursday, January 9, 2014
Sealant Inspired By Beach Worm Could Become Surgical Superglue
Remember that wacky glue commercial from the 1980s? "Krazy Glue, you crazy rat," the narrator says. "Strong enough to hold this man suspended in mid-air." He promises the stuff can bond almost anything: a plastic knob, a plastic plug, a rubber boot, a door knob, and even a flashlight case.
Heck, a version of the everlasting adhesive is even approved by the Food and Drug Administration to seal skin wounds.
But superglue can't fix a broken heart — or even a torn artery. Yet.
Now a team of doctors and engineers at Brigham and Women's Hospital in Boston are getting close to changing that. Their unlikely inspiration is a 3-inch worm that lives off the coast of California.
Cardiac surgeon Pedro del Nido and his colleagues have developed a biodegradable adhesive that can patch a hole in a pig's heart or artery. The experimental glue is nontoxic and is strong enough to hold up under the high pressures in the human heart, the team report Wednesday in the journal Science Translational Medicine.
So far, they've tested the glue only in animals. So the sealant is far from reaching the operating room or battlefield. But del Nido hopes the adhesive will eventually replace traditional sutures and staples for some operations, especially heart surgery.
"A glue is the holy grail for repairing hearts," del Nido tells Shots. "Right now we use sutures. Every time the needle and thread enter normal tissue, they do a little bit of damage. Usually it doesn't matter. But I repair children's hearts. For those, this damage can really be a problem."
Regular superglues don't work well inside the body. "It's a skin glue," del Nido says. "You can't use it internally because it hardens as soon as it comes into contact with water." And the glues are made from a compound called cyanoacrylate, which can be toxic.
To find a safe adhesive that could work on hearts, arteries and other organ surfaces, del Nido teamed up with bioengineer Jeffrey Karp, also at Brigham and Women's Hospital.
"In our lab, we look to nature for inspiration in designing materials," Karp tells Shots. "Solutions are really all around us." Karp's lab has been looking at porcupine quills for insights that could lead to better surgical needles.
The barbs on porcupine quills make it easier from them to penetrate the skin.
For the heart glue, Karp and his team turned their attention to critters that stick to slippery surfaces, such as slugs, spiders and a bristly little worm that glues itself rocks in tidal pools, called thesandcastle worm.
To eat, chitons use their teeth, which look like black bulbs with bluish highlights, to grind up rock.
"We started looking at how creatures, like the sandcastle worm, could attach to wet surfaces," Karp says. After years of experimenting with various chemical cocktails, he and his team finally stumbled upon an adhesive that's biodegradable and nontoxic.
"Cells and tissues can grow over the material and into it," he says. Eventually it just dissolves into the body. And the glue only hardens when UV light shines on it. So a surgeon can put the glue in exactly the right place before it seals up.
Although Karp and del Nido haven't tested the experimental glue on people yet, they've put the adhesive through a whole battery of tests in animals.
"We made a hole in the heart of a living rat and showed that we can seal it up without removing the blood," Karp says. "The animals were fine six months later."
They also patched a pig's heart and carotid artery with the glue. Even after the pig was given a shot of adrenaline and its heart pressure shot through the roof, the patched stayed on the tissue.
Of course, humans are more complicated than pigs and rats. And the glue has to be safe for decades in people, not months.
But Karp is so confident that the adhesive will one day reach surgeon's toolbox that he has procured $11 million to start a company to manufacture and test the glue. "It appears that the glue is safe," he says. "But we do need to do more studies. We'll repeat the animal tests and then move forward in humans."
Heck, a version of the everlasting adhesive is even approved by the Food and Drug Administration to seal skin wounds.
But superglue can't fix a broken heart — or even a torn artery. Yet.
Now a team of doctors and engineers at Brigham and Women's Hospital in Boston are getting close to changing that. Their unlikely inspiration is a 3-inch worm that lives off the coast of California.
Cardiac surgeon Pedro del Nido and his colleagues have developed a biodegradable adhesive that can patch a hole in a pig's heart or artery. The experimental glue is nontoxic and is strong enough to hold up under the high pressures in the human heart, the team report Wednesday in the journal Science Translational Medicine.
So far, they've tested the glue only in animals. So the sealant is far from reaching the operating room or battlefield. But del Nido hopes the adhesive will eventually replace traditional sutures and staples for some operations, especially heart surgery.
"A glue is the holy grail for repairing hearts," del Nido tells Shots. "Right now we use sutures. Every time the needle and thread enter normal tissue, they do a little bit of damage. Usually it doesn't matter. But I repair children's hearts. For those, this damage can really be a problem."
Regular superglues don't work well inside the body. "It's a skin glue," del Nido says. "You can't use it internally because it hardens as soon as it comes into contact with water." And the glues are made from a compound called cyanoacrylate, which can be toxic.
To find a safe adhesive that could work on hearts, arteries and other organ surfaces, del Nido teamed up with bioengineer Jeffrey Karp, also at Brigham and Women's Hospital.
"In our lab, we look to nature for inspiration in designing materials," Karp tells Shots. "Solutions are really all around us." Karp's lab has been looking at porcupine quills for insights that could lead to better surgical needles.
The barbs on porcupine quills make it easier from them to penetrate the skin.
For the heart glue, Karp and his team turned their attention to critters that stick to slippery surfaces, such as slugs, spiders and a bristly little worm that glues itself rocks in tidal pools, called thesandcastle worm.
To eat, chitons use their teeth, which look like black bulbs with bluish highlights, to grind up rock.
"We started looking at how creatures, like the sandcastle worm, could attach to wet surfaces," Karp says. After years of experimenting with various chemical cocktails, he and his team finally stumbled upon an adhesive that's biodegradable and nontoxic.
"Cells and tissues can grow over the material and into it," he says. Eventually it just dissolves into the body. And the glue only hardens when UV light shines on it. So a surgeon can put the glue in exactly the right place before it seals up.
Although Karp and del Nido haven't tested the experimental glue on people yet, they've put the adhesive through a whole battery of tests in animals.
"We made a hole in the heart of a living rat and showed that we can seal it up without removing the blood," Karp says. "The animals were fine six months later."
They also patched a pig's heart and carotid artery with the glue. Even after the pig was given a shot of adrenaline and its heart pressure shot through the roof, the patched stayed on the tissue.
Of course, humans are more complicated than pigs and rats. And the glue has to be safe for decades in people, not months.
But Karp is so confident that the adhesive will one day reach surgeon's toolbox that he has procured $11 million to start a company to manufacture and test the glue. "It appears that the glue is safe," he says. "But we do need to do more studies. We'll repeat the animal tests and then move forward in humans."
Arch Therapeutics to Webcast Live From the Biotech Showcase Investor Conference
WELLESLEY, MA--(Marketwired - Jan 8, 2014) - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), a life sciences 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 announce that Terrence W. Norchi, M.D., CEO of Arch Therapeutics will present at The Biotech Showcase(TM) 2014 conference on Monday, January 13th, at 5:00PM PST. Attendees will find the presentation scheduled for "Track C" in the Mission II room at that time. Dr. Norchi's presentation will provide insights into the Company's ongoing activities to commercially develop novel technologies into a suite of new products targeting markets of unmet clinical need.
A live webcast of Dr. Norchi's Biotech Showcase presentation can be accessed at the following URL: http://www.media-server.com/m/p/8hcwd8zu.
The Biotech Showcase(TM) 2014 Conference (www.ebdgroup.com/bts) takes place January 13-15, 2014 at the Parc 55 Wyndham Hotel, located at Union Square, San Francisco, California. The Biotech Showcase(TM) is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies an opportunity to present to, and meet with, investors and pharmaceutical executives during the course of one of the industry's largest annual healthcare investor conferences. Now in its sixth year, Biotech Showcase is expected to attract upwards of 1,500 attendees.
About Arch Therapeutics, Inc. (OTCQB: ARTH)
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate, known as AC5(TM), is being designed to achieve hemostasis in minimally invasive and open surgical procedures. Find out more at www.archtherapeutics.com.
Tuesday, January 7, 2014
Z-Medica Signs HealthTrust Agreement
WALLINGFORD, Conn., Jan. 6, 2014 -- /PRNewswire/ -- Z-Medica, a leading developer and marketer of hemostatic agents, announced it has signed an agreement with HealthTrust, a group purchasing and total cost management solutions company, to provide its healthcare member facilities access to QuikClot® products under a vascular closure patch category, effective January 1, 2014.
"Controlling bleeding in a hospital setting is essential for minimizing the length of procedures, reducing the risk of complications, reducing the cost to patients and medical facilities and improving overall patient outcomes," said Jack McCarthy, vice president of U.S. healthcare sales at Z-Medica. "We are very pleased to be working with the experienced HealthTrust team in this important effort to bring QuikClot products to more healthcare providers and patients who can benefit from them."
QuikClot products are impregnated with a mineral called kaolin that has been clinically shown to accelerate the body's natural coagulation cascade, helping healthcare professionals, first responders, law enforcement officers, consumers and adventure and outdoor sports enthusiasts rapidly control bleeding. Kaolin is a naturally-occurring, inorganic mineral that does not contain any botanicals, biological material or shellfish products and does not cause any exothermic reaction or vascular complications. QuikClot products are credited with helping thousands of people survive traumatic blood loss every year.
"Controlling bleeding in a hospital setting is essential for minimizing the length of procedures, reducing the risk of complications, reducing the cost to patients and medical facilities and improving overall patient outcomes," said Jack McCarthy, vice president of U.S. healthcare sales at Z-Medica. "We are very pleased to be working with the experienced HealthTrust team in this important effort to bring QuikClot products to more healthcare providers and patients who can benefit from them."
QuikClot products are impregnated with a mineral called kaolin that has been clinically shown to accelerate the body's natural coagulation cascade, helping healthcare professionals, first responders, law enforcement officers, consumers and adventure and outdoor sports enthusiasts rapidly control bleeding. Kaolin is a naturally-occurring, inorganic mineral that does not contain any botanicals, biological material or shellfish products and does not cause any exothermic reaction or vascular complications. QuikClot products are credited with helping thousands of people survive traumatic blood loss every year.
Wednesday, December 11, 2013
Baxter submits application to FDA for pediatric indication of Rixubis to treat Hemophilia B
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.
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.
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.
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