Friday, June 9, 2017

TissuGlu® Surgical Adhesive enables drain-free recovery in patients undergoing DIEP flap breast reconstruction

RALEIGH, N.C., June 08, 2017 -- Outcomes of the SANA Gerresheim series demonstrated that effective donor-site flap closure with TissuGlu Surgical Adhesive is a viable alternative to post-surgical drains.  Dr. Sonia Fertsch presented the series, which included 41 DIEP flap breast reconstructions, at the EURAPS Research Council Meeting in Pisa last month. The annual event allows young surgeons to present top research initiatives to an audience of plastic surgeons and researchers from around the world. 
During a DIEP flap reconstruction, blood vessels, skin and fat of the lower abdomen are removed and utilized to reconstruct a breast following mastectomy.  The technique is widely recognized as the top option for autologous tissue breast reconstruction, but typically requires the use of several surgical drains at the donor site during recovery.  Drains may cause discomfort, anxiety and limited mobility during recovery and are often a deterrent for patients when considering treatment options.
The Department of Plastic Surgery at the SANA Clinic in Gerresheim, Germany, headed up by Prof. Christoph Andree, is a top center for reconstruction and performs approximately 200 DIEP procedures per year. The group, dedicated to improving recovery and acceptance of DIEP flap reconstructions, began evaluating TissuGlu® Surgical Adhesive in 2015 with hopes it would enable drain-free donor site recovery.
“The choice of using a patient’s own tissue for breast reconstruction has clear benefits with respect to implant based reconstruction, and patients who are candidates for DIEP flap-based reconstruction appreciate the reduction in abdominal skin and fatty tissue,” says Prof. Christoph Andree. “Being able to offer this procedure without the use of donor site drains improves the patient experience in the early recovery period and leads to earlier mobilization – one of the key milestones in postoperative recovery.” 
Dr. Fertsch, who led the observational series, said: “Many of our patients have had experience with post-surgical drains in the past and they are very enthusiastic about the possibility that they may be able to avoid having them as part of the DIEP flap breast reconstruction procedure. It is not for all patients, but it is a welcome option for those who meet the criteria we have developed based on our clinical outcomes data.”  
Mart Pearson, VP Europe for Cohera Medical, Inc. added: “We were very pleased that this series report on drain-free donor site closure with TissuGlu was selected for presentation at such a high-level meeting. Prof. Andree and his team at the SANA Clinic in Gerresheim have been very attentive to the patient perspective with regards to the post-surgical recovery period and it is exciting to have their experience discussed at this venue.” 

Snake venom is key ingredient in experimental drug for heart patients

An experimental antiplatelet drug has surprising bite. Based on a protein found in snake venom, the new drug prevented blood clotting in mice without causing excessive bleeding after an injury, according to research published Thursday in the journal Arteriosclerosis, Thrombosis and Vascular Biology. The drug has yet to be tested in humans.

Bleeding is a common side effect in the current crop of available antiplatelet drugs, which are usually prescribed for heart patients to prevent blood cells, called platelets, from clumping together and forming clots. Depending on where they occur, clots can lead to a stroke or heart attack.

“As a scientist, it is always intriguing to learn from our mother nature,” wrote Y. Jane Tseng, co-lead author of the study and a professor at the Genomics Center School of Pharmacy at National Taiwan University, in an email.

“There is a long history of using snake venom as a tool to study blood clotting mechanism,” Tseng said, adding that the only available antiplatelet drugs used for thrombosis — in which a clot occurs in a blood vessel and obstructs circulation — are also based on venom, though not the same one used in her study.

Tur-Fu Huang, co-lead author of the study and a professor at the Graduate Institute of Pharmacology at National Taiwan University, said some snake venoms are neurotoxic — poisonous to the brain — while others are hemorrhagic and “affect blood coagulation and platelet function profoundly.” The new research concentrated on venom that is hemorrhagic in nature.

In earlier work, Huang, Tseng and their colleagues found that trowaglerix from the venom of Tropidolaemus wagleri, commonly known as Wagler’s pit viper, latched onto glycoprotein VI, a protein that sits on the surface of platelets.

“Not every snake venom acts in similar mode on platelets,” Tseng said.

This attachment to glycoprotein VI is how trowaglerix stimulates platelets to form blood clots, the researchers learned. Platelets that are missing glycoprotein VI do not form blood clots and do not lead to severe bleeding.

If glycoprotein VI could be blocked, the research team hypothesized, would that prevent prolonged bleeding?

Putting this theory to the test, the researchers designed a molecule that could prevent clotting, and with added properties of trowaglerix, it did not cause severe bleeding. When this experimental drug was given to mice, the rodents showed slower blood clot formation, yet they also did not bleed longer than untreated mice, Tseng and her colleagues found.

“We successfully transformed trowaglerix into an anti-thrombotic agent,” said Huang, who noted that the experimental drug was both effective and safe. Still, it needs further testing in animals and humans, which will take some time.

In the meantime, he said, it can be modified and optimized “to a more potent and stable agent” with potential for use in patients. Ultimately, he and his colleagues hope their work could yield an entire class of effective antiplatelet drugs with limited side effects.

‘Of course there are safety issues’

Dr. Leslie Boyer, director of the VIPER Institute in Tucson, Arizona, said the new study “doesn’t automatically mean that you have a drug, because of course there are safety issues.”

“If they could find a very perfectly tuned molecule that a snake makes and give just the right dose,” Boyer said, it might be “of therapeutic benefit to certain people.”

“Venom contains many, many toxins. Even a single snake might have a 100 different types of venom molecules in their repertoire,” said Boyer, who was not involved in the new study. She added that even though the modest dose of venom delivered when a snake bites is “quite toxic.” But if you took that same poisonous venom, teased out the ingredients, scaled them down and used only a low dose, there are a lot of ingredients “that could be put to good use.”

Toxicologists don’t really distinguish one molecule as poisonous and another as benign, she said.

“It’s all a matter of dose,” Boyer said. “So a small dose of something might be a medicine, and a large dose becomes a poison.”

Snakes have venom for all kinds of reasons, she said, though the biggest reason, perhaps, is “to make lunch hold still.”

“A lot of snakes are relatively slow-moving creatures. They’re ambush predators or they only travel a short distance to get their prey,” Boyer said, noting that snakes “have one chance, one quick strike, to administer something that’s going to make very fast-moving prey, like a bird or a rodent, hold still — fall down and wait to be eaten.”

The molecules in snake venom, then, interact with the nervous system or with the cardiovascular system and represent “potential drugs” that might act on the nervous system to lessen pain or relax muscles, she said. The venom molecules that interact with the cardiovascular system, as Tseng, Huang and their co-authors show, “have the potential to be used for blood pressure problems or for heart rate situations, things like that,” Boyer said.

There are other toxins that have a direct effect on the tissues next to where the fang goes in that can digest proteins, which along with fat is what animals are made of, so “those molecules have all kinds of potential also,” she said. “For instance, breaking down specific proteins is something that might be useful not only for drugs but maybe for laundry detergent or things that remove stains. Maybe they’re good for recycling.”

But, caution is required, Boyer said: The reason we know anything about venom at all is that snake bites make people sick.

Friday, June 2, 2017

Hemostatic agents market is estimated to reach USD 8,347.9 Million by 2022

Surgery is a foundational component of health-care systems. Over 51 million hospital-based surgical procedures are performed annually worldwide. The effective management of bleeding to achieve hemostasis during surgical procedures is essential to promote positive outcomes. As surgical procedures evolve to be more refined and noninvasive, the utilization of fast acting biologically and synthetically derived hemostats, encompassing fibrin sealants, flowable gelatins and adhesives, is becoming increasingly prevalent. Some of the parameters for choosing a hemostatic agent includes efficiency, type of surgery, patient condition, need for quicker results, active bleeding tissue VS pooled blood sites and cost. Global hemostatic agents market is estimated to grow at a rate of 7.1% CAGR to reach $8,347.9m by 2022.

Currently, fibrin sealants are the most effective tissue adhesives used in surgeries. Additionally, the properties such as biocompatibility and biodegradability of this sealants are set to drive the growth of hemostatic agents market. Fibrin sealants are widely employed in various surgical specialties such as cardiovascular surgery, thoracic surgery, neurosurgery, plastic and reconstructive surgery, and dental surgery and others. Hemostasis is a complex method requiring the delicately coordinated activation of platelets as well as plasma clotting factors to form a platelet-fibrin clot. Hemostatic agents such as Thrombin Based Hemostats, Gelatin Based Hemostats, Collagen Based Hemostats and many more are used to control the flow of blood during a surgery or dressing an injury. These hemostatic agents are required in hospitals, surgery centers, nursing homes and other centers during the operations.

Cardiovascular surgery is the key treatment with regards to hemostatic agents market. Risk of cardiovascular diseases generally increases with the increase in age. Globally cardiovascular disease related deaths surged in developed nations including the U.S. and Europe where chronic diseases being the major contributor of death. Hemostatic agents are also considered and used majorly to improve clinical outcome, whereas aesthetics and cost effectiveness have less importance. The other surgeries where hemostats are utilized primarily include cosmetic, orthopedic, urological and arthroscopic surgeries. The rising cosmetic surgeries globally has been a one of the major driver for the growing usage of hemostats among the others segment.

Key Players in this Market Include: -

Johnson and Johnson Services Inc (U.S.)
B.Braun Melsungen AG (Germany)
C.R. Bard Incorporation (U.S.)
Mallinckrodt Plc (U.S.)
Integra Life Sciences Corporation (U.S.)
Americas held a major share in the market in 2016 whereas Asia-Pacific region is projected to witness the fastest growth during the forecast period. Global Hemostatic agents market is quite consolidated with key medical consumable and surgical technology players having significant presence. Frequent product launches, acquisitions and expansion are a few of the growth strategies the key players in the industry are adopting to increase their market share.

Sunday, November 20, 2016

Fibrin Glue Market: Asia is expected to witness high growth rates in the next five years, 2021

Fibrin glue is a unique adhesion material used in surgeries for closure of wounds. Fibrin glues are mainly extracted from collective plasma and contain different amounts of purified and virally-inactivated human proteins. Fibrin glue is composed of two components, including fibrinogen and factor XIII. These concentrated ingredients interact with a solution of thrombin and calcium to form coagulum. As the thrombin and fibrinogen/factor XIII solution combine, a clot of a blood protein called fibrin develops in a few seconds, depending on the dilute form of thrombin is used. Some of the characteristics of fibrin glue include high internal bond strength, high surface adherence strength, and ability to enhance tissue regeneration and clot formation. Fibrin glue is mainly used in cardiac, vascular, and pulmonary surgeries, burn bleeding, and lacerations of liver and spleen. It is also used in other surgeries such as neurosurgeries, plastic surgeries, wound management, and general and orthopedic surgeries. Fibrin glue lowers the risk of infection, provides early hemostasis on the treated area, and improves cosmesis. It also promotes natural tissue healing. However, one of the disadvantages of fibrin glue is the risk of transmission of infectious organisms from human bodies to the glue. Tisseel, biocol, and beriplast are some of the commercially-prepared fibrin sealants.

Surgical sealants are used after surgeries or traumatic injuries to bind or hold the external and internal tissues. Some of the major surgical sealants based on their composition are collagen-based compounds, fibrin sealants, synthetic sealants such as cyanoacrylates, and tissue adhesive glues such as hydogels and glutaraldehyde glues. Fibrin sealants, also known as fibrin glue, are a hemostatic agent.

North America dominates the global market for fibrin glue due to a large aging population and increasing number of surgical procedures. Asia is expected to witness high growth rates in the next five years in the global fibrin glue market. China and India are expected to be the fastest-growing fibrin glue markets in Asia Pacific. Some of the key driving factors of the fibrin glue market in emerging countries are a large pool of patients, increasing healthcare expenditure, and rising government funding.

In the recent years, the use of fibrin glue has increased due to increasing number of surgical procedures. Increasing aging population, rise in incidences of chronic wounds, venous ulcers, diabetic ulcers, and pressure sores, and the relatively-low chances of complication associated with these products are some of the key factors driving the growth of the global fibrin glue market. In addition, increasing healthcare awareness is also fueling the growth of the global fibrin glue market. However, economic slowdown and minimal invasive procedures, such as laparoscopic and endoscopic surgeries, are some of the major factors restraining the growth of the global fibrin glue market. In addition, unfavorable reimbursement policies would also restrain growth of the global fibrin glue market.

Sunday, December 20, 2015

Mallinckrodt Diversifies Hospital Growth Portfolio, Acquiring Three Commercial-Stage, Global Specialty Hemostasis Brands From The Medicines Company

CHESTERFIELD, United KingdomDec. 18, 2015 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced that it has entered into a purchase agreement with The Medicines Company (NASDAQ: MDCO) under which subsidiaries of Mallinckrodt plc will acquire a global portfolio of three commercial-stage topical hemostasis drugs – RECOTHROM® Thrombin topical (Recombinant), PreveLeak™ Surgical Sealant, and RAPLIXA™ (Fibrin Sealant) – for an initial payment of approximately $175 million, inclusive of existing inventory. The transaction also includes potential added future considerations in the form of payments for achieving certain milestones, and is expected to be financed from cash on hand.
"Addition of this innovative portfolio of branded hemostats to our hospital platform is another demonstration of Mallinckrodt's 'acquire to invest' business strategy. Products that help control bleeding are essential to the vast majority of surgical practices. Yet this category – a market that has been estimated at $750 million in the U.S. and at least $1 billion globally – is an area in hospital products that has seen relatively little innovation and investment in recent years," said Mark Trudeau, Chief Executive Officer and President of Mallinckrodt.
Trudeau continued, "Acquiring and promoting leading hemostasis brand RECOTHROM alongside OFIRMEV® (acetaminophen) injection broadens Mallinckrodt's impact in the surgical suite for patients and physicians, and creates a strong framework to broadly commercialize innovative, highly durable new agents PreveLeak and RAPLIXA, which carry intellectual property protection to 2028 and 2031, respectively. As we continue to further diversify our portfolio, we're excited about the volume growth opportunity these products will add to our hospital offering for years to come."
On a reported U.S. GAAP1 basis, Mallinckrodt expects the transaction to be dilutive to its fiscal 2016 earnings per share (EPS); however, on an adjusted basis, the company expects the transaction to be neutral to EPS in fiscal 2016. On both a U.S. GAAP and adjusted basis, the company expects the transaction to be accretive to EPS beginning in fiscal 2017. Assuming a closing in the second quarter of fiscal 2016, the company expects the new products will add between $40 million and $45 million in incremental revenue in fiscal 2016, and provide low double-digit organic growth starting in fiscal 2017.
Through this acquisition, the company is expected to capitalize on synergies with Mallinckrodt's current U.S. commercial team focused on pain management in hospital surgical practice with OFIRMEV, the company's intravenous acetaminophen product indicated for the management of mild to moderate pain, and management of moderate to severe pain with adjunctive opioid analgesics. With expanded product offerings including OFIRMEV, RECOTHROM, PreveLeak and RAPLIXA, and with focused promotion, the company's commercial organization – supported by Mallinckrodt's strong sales, market access, national accounts and medical affairs teams – is expected to broaden access for patients who would benefit from these analgesic and hemostasis drugs.
Hemostasis Products
Each of the three drugs being acquired is approved by the U.S. Food and Drug Administration (FDA) and also in a number of other countries.
Introduced in 2009, RECOTHROM is widely used in the U.S., and is the first and only recombinant topical thrombin approved for use in adult and pediatric patients. It is FDA-approved as a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM is also marketed internationally through distributors.
Upon closing, Mallinckrodt will invest in the commercial launch and ongoing market development of both PreveLeak and RAPLIXA in fiscal year 2016. Both have shorter preparation times and are easier to use and store than similar products in their categories. PreveLeak is more flexible than hemostasis glue products, is a surgical sealant and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. PreveLeak is currently marketed in Europe through distributors. 
RAPLIXA is the first and only powder fibrin sealant in ready-to-use room temperature form, with the RAPLIXASpray device allowing for even application over a diffuse bleeding site and greater versatility. RAPLIXA is comprised of human-plasma derived fibrinogen and thrombin and FDA-approved as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and is applied directly or by using the RAPLIXASpray device.

Thursday, August 27, 2015

Most Don't Need 'Bridging' When They Stop Warfarin Temporarily

 Heart patients on the clot-preventing drug warfarin usually have to stop the medication before having surgery. Now, a new study shows they can safely do that without taking another anti-clotting drug -- and they may even be better off.

The study, reported in the Aug. 27 New England Journal of Medicine, helps answer long-standing questions about how to manage patients taking warfarin (Coumadin) for an irregular heart rhythm known as atrial fibrillation.

Because warfarin is a powerful anticoagulant -- which means it prevents blood clots -- it can also raise the risk of internal bleeding. That's why people typically have to stop using warfarin in the days before and after an elective surgery.

But it hadn't been clear whether those patients need what doctors call "bridging anticoagulation." That means taking another type of anti-clotting medication that is short-acting -- usually heparin.

For years, it's been up to individual doctors and patients to decide, said Dr. Thomas Ortel, the senior researcher on the new study, and a professor of medicine at Duke University Medical Center, in Durham, N.C.

"We've had no clinical trial to tell us whether we need to be [bridging] at all," Ortel explained.

Now that clinical trial is done. And, it shows that for most atrial fibrillation patients, bridging with heparin is unnecessary, Ortel said.

In fact, the study found, bridging with heparin appears to raise the risk of major internal bleeding -- without any reduction in the risk of blood clots.

"For years, we've thought that bridging would be beneficial," said Dr. Alfonso Tafur, a vascular medicine specialist at NorthShore University Health System, in Chicago.

"But this study shows that for the majority of (atrial fibrillation) patients, bridging puts them at unnecessary risk," said Tafur, who was not involved in the research.

The study included nearly 1,900 patients who were having elective surgery or other invasive procedures and were taking warfarin to treat atrial fibrillation.

Atrial fibrillation is an irregular heart rhythm in which the heart's upper chambers quiver instead of efficiently pumping blood into the lower chambers, according to the American Heart Association. It's not immediately life-threatening, but it boosts the risk of blood clots forming in the heart. Those clots can then be pumped out of the heart and into an artery supplying the brain, causing a stroke. That's why these patients usually take an anti-clotting drug like warfarin to prevent these clots.

A problem with warfarin is that its effects take time to kick in, and time to wear off once a person stops using it. So when warfarin patients need surgery, they typically go off the drug about five days beforehand; once they restart, it takes another five to 10 days for the warfarin to be effective again, according to background information in the study.

In this study, Ortel's team randomly assigned patients to take either heparin or an inactive placebo during that time window.

In the end, heparin showed no effect on blood-clot risk. Just 0.3 percent of treated patients developed a clot within a month of their procedure, versus 0.4 percent of patients given the placebo, the study found.

On the other hand, heparin did boost the odds of serious bleeding. Just over 3 percent of patients developed "major" bleeding, compared with just over 1 percent of placebo patients, the study found.

The findings suggest that bridging is unnecessary for most atrial fibrillation patients, Ortel said, but there are some who still might benefit.

Tafur agreed. He said that patients who are at particularly high risk of a blood clot -- such as those who've had a stroke in the past -- might still need heparin when they go off warfarin.

For them, Tafur said, the increased bleeding risk may be offset by the anti-clotting benefit.

If your doctor does recommend bridging, Ortel said, feel free to ask why it's necessary.

There are times when warfarin patients may not have to stop the drug at all, Tafur pointed out. With relatively simple procedures, like tooth extractions and even catheter ablation -- which is sometimes used to treat atrial fibrillation -- a warfarin break may be unnecessary, he said.

And what about people who are on newer clot-preventing drugs, like dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixaban (Eliquis)? Those medications act differently from warfarin, Ortel said, and bridging should be unnecessary in most cases.

Tuesday, August 25, 2015

Hemostasis and Tissue Sealing Agents Market to Experience Significant Growth Due to Aggressive Marketing Strategies

The global hemostasis and tissue sealing agents market signifies the market for sophisticated hemostat medical devices. These devices are utilized to control excessive bleeding in operations and surgeries and have significant roles in assisting healing processes in surgical procedures. 

Introduction of New Products Driving Hemostasis and Tissue Sealing Agents Market

The hemostasis and tissue sealing agents market is going through a steady growth phase. The major companies in the hemostasis and tissue sealing agents industry are adopting aggressive marketing strategies to increase their product penetration rate in the market. 

New and innovative hemostat products are being introduced on regular intervals, which serve diverse applications and are ready-to-use. Such dynamics of the market are resulting in a boost to the global hemostasis and tissue sealing agents industry. In addition to this, the rising base of geriatric population, more prone to diseases and more likely to require surgeries, is also considered an important factor that would drive the market growth further.

On the other hand, stern regulatory requirements, high cost, and increasing off-label use of hemostat products impacts the global market growth of hemostasis and tissue sealing agents in a negative manner.

Market Leaders - Hemostasis and Tissue Sealing Agents Industry

The topical hemostats market is the market leader in the global hemostasis and tissue sealing agents market. In the current scenario, it is expected to develop at a 6% CAGR from 2014 to 2020. This development is mainly credited to the increase in usage of topical hemostats for a broader array of surgical procedures such as cardiovascular, vascular, and others.

The topical hemostats market has three categories, flowable hemostats or combination topical hemostats, active hemostats or thrombin-based topical hemostats, and mechanical hemostats. Medical practitioners such as surgeons prefer active hemostat products due to their high efficiency in controlling excessive bleeding. This factor is supporting the active hemostat market in the hemostasis and tissue sealing agents industry to expand at the highest CAGR.

The adhesive and tissue sealing agents market has three segments, natural tissue sealants including fibrin sealants and other natural sealants such as tissue sealants based on collagen and albumin, synthetic tissue sealants including tissue adhesives based on cynoacrylate and other synthetic tissue sealants such as polyethylene glycol and others, and adhesion barrier products.

The market for adhesive and tissue sealing agents held over 40% of the total market share of the hemostasis and tissue sealing agents industry in 2013. Natural tissue sealants held the largest market share in the adhesive and tissue sealing agents segment due to commercial availability of natural tissue sealants in large amounts.

North America held the largest share of the global hemostasis and tissue sealing agents market in 2013. It accounted for around 36% of the total hemostasis and tissue sealing agents market. Rising number of inpatient surgical procedures added with an increase in the use of hemostat products by end users such as physicians and surgeons is driving the growth of the hemostasis and tissue sealing agents market in North America. 

Europe held the second largest hemostasis and tissue sealing agents market share in 2013 owing to continued growth in geriatric population. 

Asia Pacific is likely to experience the fastest growth rate from 2014 to 2020. This is due to liberal regulatory environment and increase in investment by major enterprises such as Pfizer, Inc., CryoLife, Inc., and others, in this region.

The major players in the hemostasis and tissue sealing agents market are CryoLife, Inc., Johnson & Johnson, Baxter, Advance Medical Solution Group plc, and Cohera Medical, Inc.

In 2014, Cohera Medical, Inc. launched Sylys Surgical Sealant, which can be utilized in gastrointestinal surgery to decrease anastomotic leak. In the same year, Baxter also gained the FDA permission for TISSEEL fibrin sealant, which is used in almost all types of surgical procedures. However, in the present scenario, investing in developing countries provides a good platform for the players in the hemostasis and tissue sealing agents market to register high revenue.

Browse Full Global Hemostasis and Tissue Sealing Agents Market Report With Complete TOC @

Monday, June 15, 2015

Arch Developments Progress

Arch Therapeutics Inc (OTCBB:ARTH) is moving steadily higher on accelerating volume after the Company announced favorable preclinical data from an independent study of AC5 Surgical Hemostatic Device(TM) versus a popular Fibrin Sealant.

On May 18 ARTH said it will be featured as a presenting company at the LD MICRO Invitational conference on Monday, June 1, 2015 at 3:30 PM PDT. The conference will be held at the Luxe Sunset Hotel in Bel Air, California.

Chief Executive Officer Terrence W. Norchi, MD will provide a corporate update, discuss planned upcoming milestones, and highlight some of the differentiating features of AC5, which is in the late stages of development.

The stock was the subject of a significant promotion last summer shortly after hitting the bb’s from The Bedford Report, The Paragon Report and Five Star Equities also responsible for the fairly successful recent promotion of ECAU which managed gains of well over 500%.

Arch Therapeutics Inc (OTCBB:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch’s flagship development stage product candidate, known as the AC5 Surgical Hemostatic Device (TM), is being designed to achieve hemostasis in minimally invasive and open surgical procedures.

In April the Company announced an independent third party has obtained favorable data from a preclinical animal study that compared the hemostatic activity of AC5 with a popular and commercially available branded fibrin sealant that is indicated for use in controlling bleeding.

In this study, full thickness penetrating wounds were surgically created in rat livers, which are highly vascularized parenchymal organs, and then either AC5(TM) or the fibrin sealant was applied in order to stop the bleeding. The time to hemostasis (TTH), which is the time required to stop bleeding, was measured.

The average TTH after application of AC5 was significantly less than 30 seconds. The average TTH for the fibrin sealant was approximately 50% longer.

AC5 was maintained at room temperature without requiring cold storage, whereas the fibrin sealant was maintained frozen during storage, in accordance with its prescribing directions. This is a common constraint of many commercial hemostatic agents that are derived from blood-products. Such products also require a multi-step preparation procedure prior to use.

AC5 contains a self-assembling peptide comprising naturally occurring amino acids that are not sourced from humans or animals, whereas the fibrin sealant is made from pooled human plasma (blood product). Fibrin sealants and other products that are sourced from human or animal blood products can contain infectious agents, such as viruses and potentially the Creutzfeldt-Jakob disease (CJD) agent, which potentially can be transferred to a patient.

Monday, April 6, 2015

CryoLife Appeals Rare Injunction In Patent Case

CryoLife Inc. on Wednesday filed its notice of appeal to the Federal Circuit of a preliminary injunction barring its PerClot blood-clotting powder, one day after a Delaware federal judge ordered Medafor Inc. to pay CryoLife $100,000 in the event that any court finds the injunction was wrongly issued. 
C.R. Bard Inc. unit Medafor satisfied the test for securing a preliminary injunction, including showing a reasonable likelihood that it will succeed on the merits and would suffer irreparable harm if CryoLife's product remained on the market, U.S. District Judge Sue L. Robinson ruled last month, in a relatively rare instance of a judge granting a preliminary injunction in a patent case. On Wednesday, CryoLife filed its notice of appeal of the injunction to the Federal Circuit.

The judge said Medafor has represented that it is able to pay the $100,000 if the condition on the injunction is met and that CryoLife agreed with the representation, adding that the requirement was proper and adequate security for the injunction.

“Pursuant to Federal Rule of Civil Procedure 65(c), this court orders that if this court or another court of competent jurisdiction finds this preliminary injunction wrongfully enjoined CryoLife, Medafor shall pay CryoLife $100,000 within ten (10) days of the order vacating or reversing this injunction,” the judge said.

CryoLife's PerClot Topical, launched last fall, competes with a Medafor product called Arista that was approved by the U.S. Food and Drug Administration in 2006. Both are powders used to control bleeding when conventional methods are ineffective.

The dispute began in April, when CryoLife filed suit seeking declaratory judgment that PerClot Topical would not infringe Medafor's patent. Medafor responded by filing an infringement counterclaim and seeking a preliminary injunction. CryoLife began selling PerClot Topical last fall.

Judge Robinson found that Medafor had shown that CryoLife likely infringes and that CryoLife was unlikely to show that the patent is invalid.

Johnson & Johnson (JNJ) Announces Additional FDA Indication for EVARREST Fibrin Sealant Patch

Johnson & Johnson (NYSE: JNJ) announced the following Monday:

Unexpected and uncontrollable bleeding is an ongoing challenge for surgeons, including those who perform liver surgery. Based on recent data, the U.S. Food and Drug Administration has approved an additional indication for Ethicon's EVARREST Fibrin Sealant Patch, as an adjunct to hemostasis for control of bleeding during adult liver surgery. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients.

A problematic bleeding situation—involving bleeding that is more than routine and resistant to conventional means of control—is one of the most threatening complications of surgery1 and a frequent cause of negative patient outcomes, posing significant clinical and economic challenges.2,3 First attempts to control surgical bleeding using current hemostatic agents can fail up to 50 percent of the time.3

"The liver is a particularly hard-to-control bleed site during surgery, as blood loss is often higher and hemostasis may be difficult to achieve," said Krishna Athota, M.D.*, trauma and critical care surgeon at the University of Cincinnati College of Medicine. "This expanded indication for EVARREST reinforces this innovation's potential to make problematic bleeding situations routine, and could result in a paradigm shift in the treatment of bleeding during surgery."

EVARREST is a novel, bioabsorbable hemostat that delivers a powerful combination of hemostatic efficacy, adherence and mechanical strength.4,5,6 The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation by augmenting the human coagulation system. The technology is comprised of a flexible composite patch, which contains embedded human biologics (human thrombin and fibrinogen), which are proteins involved in the natural clotting process.

Clinical studies demonstrate that EVARREST is greater than 94 percent effective in controlling bleeding across challenging patient types and surgical situations, compared to current standard of care (less than 53 percent).7,8,9 EVARREST provides a rapid, predictable solution for problematic bleeding, minimizing surgical procedure disruption.3,7,8

"We see EVARREST as a game changer—better equipping surgeons to handle bleeding, thereby potentially improving patient outcomes, reducing OR costs and providing peace of mind for the entire surgical staff," said Dan Wildman, Vice President of Global Franchise Strategy and Innovation for Ethicon.

EVARREST has been shown to deliver a cost savings compared with current standard of care, when taking into account hemostat cost, OR time, transfusion requirements and retreatment. The low rate of re-bleeding with EVARREST reduces the need for other hemostatic therapies.10


1 Schreiber MA, Neveleff DJ. Achieving hemostasis with topical hemostats: making clinically and economically appropriate decisions in the surgical and trauma settings. AORN J. 2011;94(5):S4-S20.2 Stokes, et al. Impact Of Bleeding-Related Complications And/Or Blood Product Transfusions On Hospital Costs In Inpatient Surgical Patients. BMC Health Services Research 2011, 11:135.3 Data on File, Ethicon, Inc. Global Health Economics and Market Access. EVARREST® Fibrin Sealant Patch. Global Value Dossier Slide Deck.4 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93.5 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.6 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.7 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93.8 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.9 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.10 Corral M et al. Cost Analysis of a Fibrin Sealant Patch for Mild, Moderate and Problematic Soft Tissue Surgical Bleeding: A Hospital Perspective, Cornerstone Research Group.