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.

Saturday, March 14, 2015

Medafor Injunction Holds Up US Perclot Topical

CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, today provided an update on its ongoing litigation with C.R. Bard, Inc. and certain of its subsidiaries regarding PerClot. The U.S. District Court for the District of Delaware (the "Court") has allowed CryoLife's declaratory judgment lawsuit against C.R. Bard's Medafor, Inc. subsidiary ("Medafor") to proceed. The Court also granted Medafor's motion for a preliminary injunction with respect to CryoLife's marketing and sale of PerClot Topical in the U.S. CryoLife is currently awaiting the Court's order, which it expects will provide details regarding the scope of the injunction.
Pat Mackin, CryoLife President and Chief Executive Officer, said, "While we are disappointed with the District Court's ruling on the preliminary injunction motion, we continue to believe we have a strong case and remain focused on securing the best long-term outcome in the litigation for our shareholders. We remain on track to begin enrollment in our PerClot IDE clinical trial for surgical applications during the first half of 2015, which would position us for potential FDA approval in the second half of 2017."
In April 2014, CryoLife filed a declaratory judgment lawsuit against C.R. Bard and certain of its subsidiaries, including Medafor, requesting that the Court declare that CryoLife's manufacture, use, offer for sale, and sale of PerClot in the U.S. does not and would not infringe Medafor's U.S. Patent No. 6,060,461 (the "'461 Patent"). In addition CryoLife requested that the Court declare that the claims of the '461 Patent are invalid. In September 2014, Medafor filed a motion for a preliminary injunction against CryoLife.
The preliminary injunction applies to PerClot Topical, which is in the early stages of launch in the U.S. CryoLife included approximately$1.5 million in PerClot Topical sales in its previously announced 2015 financial guidance. At this low-volume level, the Company was anticipating the gross margin for PerClot Topical to be approximately breakeven. The Company's previously announced earnings per share guidance for 2015 included $3 million to $4 million in expense related to the litigation with C.R. Bard. The Company continues to expect that this represents the high end of potential litigation expenses for the year related to this matter, and it will re-assess its litigation strategy and provide appropriate updates to its financial guidance, if any, after receiving the Court's order.
See official papers below....

Wednesday, February 11, 2015

Cohera Medical, Inc.® Enters Agreement with B. Braun Surgical, S.A. for Distribution of TissuGlu® Surgical Adhesive in Select European Countries

PITTSBURGHJan. 21, 2015 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has entered into an exclusive sales and marketing distribution agreement with B. Braun for its TissuGlu® Surgical Adhesive in GermanySpain and Portugal.
The Agreement outlines a relationship between the two companies wherein B. Braun Surgical, S.A. will exclusively market and sell TissuGlu in the territories of GermanySpain and Portugal through its existing Closure Technologies commercial teams. TissuGlu has been CE approved and for sale in Germany through a Cohera direct sales force since 2012 and has been used in over 2,000 surgical procedures since that time. TissuGlu is indicated in Europe for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in large flap surgical procedures such as abdominoplasty.
"Cohera is excited to enter the relationship with B. Braun for the marketing of TissuGlu in these European countries," said Patrick Daly, Cohera Medical President and CEO. "We are looking forward to working with such a great organization and to making our breakthrough TissuGlu product available to more surgeons and patients in Europe."
TissuGlu is designed to meet surgeons' need for a strong, biocompatible, and easy-to-use surgical adhesive. TissuGlu is targeted for use in large flap procedures in which drains are used to control fluid output and seroma formation. TissuGlu is currently being utilized in Europe to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures. Over 2,000 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.

Tuesday, January 6, 2015

Cohera Medical, Inc.® Receives PMA Approvable Letter from U.S. FDA for TissuGlu® Surgical Adhesive

PITTSBURGH, Jan. 6, 2015 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) that the pending Premarket Approval Application (PMA) for its TissuGlu® Surgical Adhesive is Approvable.  The receipt of the Approvable Letter means that the FDA has largely approved all parts of the PMA. The Company expects to work with the FDA to reach a final approval on the application within a few weeks.

"The receipt of the PMA Approvable Letter is a truly significant milestone for the Company," said Patrick Daly, Cohera Medical President and CEO. "We are excited about the pending approval for TissuGlu and are looking forward to making TissuGlu available to surgeons and patients throughout the United States."

TissuGlu is indicated for the approximation of tissue layers where subcutaneous dead space exists between tissue planes in abdominoplasty.  Upon approval, TissuGlu will be the first internal surgical adhesive of its kind approved in the United States.

Mr. Daly will be presenting on this latest milestone and other significant updates at the J.P. Morgan Healthcare Conference on January 13th at 4:00pm PST.

TissuGlu is designed to meet a surgeon's need for a strong, biocompatible, and easy-to-use surgical adhesive. The Approvable PMA supports the safety and effectiveness of TissuGlu as an alternative to the use of closed suction drains in abdominoplasty procedures, reducing the number of post-operative invasive treatments and improving the patient recovery process.

"TissuGlu, which has the potential to eliminate wound drainage issues from abdominoplasty procedures, represents a major advance in helping patients recover faster and more comfortably following these procedures," said Joseph P. Hunstad MD, FACS, of The Hunstad-Kortesis Center, Charlotte, N.C. "When approved, it will bring great benefits to both patients and surgeons."

"Having the PMA approved, minus a few small labeling changes, signifies the FDA has approved the years of scientific, engineering, manufacturing, quality, and clinical work conducted by the Cohera Medical team," said Chad Coberly, JD, Vice President of Clinical, Regulatory & Legal Affairs for Cohera.

TissuGlu is targeted for use in abdominoplasty procedures in which drains are used to control fluid output and seroma formation. There are approximately 175,000 US-based abdominoplasty procedures per year, growing at an annual rate of 7.7 percent that could utilize TissuGlu. The product has been on the market in the EU since 2011, and currently more than 1,500 procedures have been conducted with TissuGlu bringing great benefit to patients, surgeons, and caregivers.

About Cohera Medical Cohera Medical, Inc. is a rapidly growing medical device company that is actively developing a line of surgical adhesives and sealants. Cohera Medical's products are based on a unique chemical design that is resorbable, non-toxic, easy-to-use, and forms a strong bond between tissue layers. The Company's lead product, TissuGlu® Surgical Adhesive, is indicated in the EU for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.  TissuGlu is currently approved for sale in the EU and is being utilized to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty (tummy tuck), mastectomy, lymph node dissection, decubitus and latissimus dorsi flap procedures.  The Company's second product, Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, is currently under the CE Mark approval process.  TissuGlu and Sylys are the first in a pipeline of technology that includes surgical mesh adhesives, hemostatic foam, bone adhesives, and drug delivery. Outside of the EU, TissuGlu and the other Cohera Medical products are currently indicated for investigational use only and have not yet been approved for sale by the Food and Drug Administration (FDA) in the U.S. or in any other market.

Sunday, November 16, 2014

Comparison of methods to achieve artery closure following coronary angiography

Stefanie Schulz-Schupke, M.D., of the Deutsches Herzzentrum Munchen, Technische Universitat, Munich, Germany and colleagues assessed whether vascular closure devices are noninferior (not worse than) to manual compression in terms of access site-related vascular complications in patients undergoing diagnostic coronary angiography. The study appears in the November 19 issue of JAMA, a cardiovascular disease theme issue.

Percutaneous (through the skin) coronary angiography and interventions have become a cornerstone in the diagnosis and treatment of coronary artery disease. A substantial proportion of the adverse effects associated with these procedures is related to access-site complications. The common femoral artery (a large artery in the groin) is still the most frequently used access site. After the procedure, closure of the artery access site is usually achieved by manual compression. Since the mid-1990s, however, vascular closure devices (VCDs) have been introduced into clinical practice with the aim of improving efficacy and safety. Different types of VCDs have been developed, including intravascular and extravascular. However, concern exists about the safety of VCDs in comparison with manual compression, according to background information in the article.
For this study, conducted at four centers in Germany, 4,524 patients undergoing coronary angiography via the common femoral artery were randomly assigned to receive an intravascular VCD (n = 1,509), extravascular VCD (n = 1,506), or manual compression (n = 1,509) to achieve hemostasis (defined as no bleeding or only light superficial bleeding and no expanding hematoma [a localized swelling filled with blood]). Before hospital discharge, imaging of the access site was performed in 4,231 (94 percent) patients.
The primary end point (the composite of access site-related vascular complications at 30 days after randomization with a two percent noninferiority margin) was observed in 208 patients (6.9 percent) assigned to receive a VCD and 119 patients (7.9 percent) assigned to manual compression (difference, -1.0 percent). In addition, the time to hemostasis was significantly shorter with VCD compared with manual compression; time to hemostasis was shorter with intravascular VCD vs extravascular VCD; and device failures were less frequent with intravascular VCD vs extravascular VCD.
The authors write that the results of this trial may represent an important development for the clinical use of these devices. "Overall, the increase in efficacy of VCD use, with no trade-off in safety, provides a sound rationale for the use of VCD over manual compression in daily routine."

Start-up pitches high-tech glue for surgical leaks

TEL AVIV — An Israeli medical-device start-up is tackling one of the most dangerous occurrences in surgery — and it's doing it with glue.

LifeSeal is a glue-like substance that augments and, in some surgeries like hernias, replaces the traditional and painful sealing procedures of staples, tacks and sutures.

The privately-owned Israeli company behind the high-tech glue, LifeBond, says it should help in the treatment of post-operative leaks in closures of gastrointestinal and other surgical wounds. Patients get back up to speed more quickly and are more comfortable as they do.

Orahn Preiss-Bloom, one of LifeBond's co-founders, says the company's proprietary materials, which combine gelatin and an enzyme and are delivered by an applicator, were inspired by two sources: research by Professor Gregory Payne at the University of Maryland and the use of the enzyme for food applications in Asia.

The company is backed by some of Israel's top venture-capital firms as well as by Robert Taub, a prominent medical-innovation investor. And the idea is strong enough that Johnson & Johnson (TICKER: JNJ), the New Jersey-based international health-care giant, has put money down on LifeBond.

The technology is currently in European clinical trials. And with an eye to entering the U.S. market as well, CEO Gideon Sturlesi and Preiss-Bloom are looking for partners and raising capital.


Started in 2007 and employing 35 people from headquarters in Caesarea, Israel, LifeBond for now is focusing the technology's application on gastrointestinal surgery and bariatric weight-loss procedures as well as in hernia surgery.

Colon-cancer surgeries require what the doctors call anastomosis, removal of diseased intestine and reattachment to restore the gastronintestinal tract's functionality. The further down in the colon a surgeon must work, the higher the risk that a seal will leak, Sturlesi says. In some 15% to 25% of lower-colon operations, the seals leak, exposing the patients to infection and additional surgery, even death.

In such procedures, after a surgeon applies staples to close the colon, he or she spreads LifeSeal – using a glue-like applicator – along the line of the closure. The sealant provides a secure and elastic barrier to infection while the body heals. Tissue grows in and the sealant gradually dissipates.

LifeBond's second current major application, which the company calls LifeMesh, targets another very common surgery: hernias, the breaks in people's abdominal walls.

To secure a protruding intestine back into the abdomen, surgeons usually tack a mesh into place to close the break. These tacks cause inflammation and pain.

Here, the same proprietary material used in LifeSeal becomes an adhesive. In both open hernia surgery and procedures with a laparascope, the surgeon coats a standard mesh patch with LifeSeal and places it to secure the abdominal wall. The surgeon can reposition the mesh if and when necessary. LifeBond says the product keeps the patch in place as the body's tissues grow in and then dissipates.

LifeBond's two co-founders are Preiss-Bloom, 32, a New Yorker who is chief technology officer; and Ishay Attar, 42, who was vice president of business development at what is now Trendlines Medical, a tech-firm incubator. Both have master's degrees in biomedical engineering from the Technion, the Israel Institute of Technology. Attar remains a shareholder but doesn't hold a position with LifeBond.

CEO Sturlesi, 53, joined the company two years ago. Previously he was executive vice president at Lumenis, the producer of laser equipment for medical and cosmetic applications, and he was a co-founder of Galil Medical, a producer of cryosurgical technology. LifeBond's chairman is Ittai Harel, general partner of Pitango, a Herzliya, Israel, venture-capital firm and investor in LifeBond.

Worldwide market: $450 mln

LifeBond's first two target markets are substantial. The company estimates that annually in the U.S., 300,000 colorectal anastomosis procedures are done each year. The company pegs the worldwide market for this application at $450 million, a third of it in the U.S. And LifeBond says 2 million hernia repairs are done annually worldwide, half of them in the U.S. That's overall also a $450 million market.

LifeBond's investors include the Israeli venture-capital firms Aurum, Giza and Pitango. Also an investor, and a director, is Robert Taub, who founded Omrix, a producer of sealant used to control bleeding during surgery. J&J acquired Omrix in 2007.

In 2011, when LifeBond raised $20 million in a third-round financing, the New Brunswick, N.J., health-care giant J&J joined the round. Its specific investment hasn't been disclosed. LifeBond previously raised $1.5 million and $8.5 million in its Series A and Series B rounds respectively.

LifeBond is now in a Series D round, aiming to raise a total of $25 million by early 2015, and current investors have committed about half that figure.

In first-half 2013, LifeBond did a first clinical study in Sweden to test the application method for LifeSeal and to evaluate the product for safety. That study met its goals and this year LifeBond enrolled patients in a second study at eight centers in Belgium, Israel and Sweden. The company is expecting the results of that trial in November. The study's goal is to receive the CE Mark, which means that the product meets EU standards.

Sturlesi says the company has started the U.S. Food and Drug Administration process to develop the studies it needs to gain clearance to market LifeSeal in the U.S.

The company sees additional applications for LifeBond's system in surgeries involving the eye, brain, lungs, spine, urological system, and ear, nose and throat.

"We are there to support the natural healing process of the body," Sturlesi says.