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.

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

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

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

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

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

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

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

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

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

References:


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

Clinical Papers Hemostats Reviewed - Oxi Cell, Gelatin, Collagen, Thrombin, Polysaccharide Powders

A lot of our earlier embedded  document links have gone since our previous embedding agency sold (these things happen in 5 years of blogging). Now Google have this facility I am happy to provide you clinical data for your interest in the links below. 

European Medicines Agency Updates Advice for Spraying Fibrin Sealants During Surgery

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued new instructions to promote safe use of the fibrin sealants Tisseel, Tissucol, Artiss, and Beriplast P during surgery. This advice follows that issued for two other fibrin sealants, Evicel and Quixil, in November 2012. Employed to help reduce local bleeding, these sealants are typically dripped or sprayed onto bleeding tissue to form a fibrin clot.

Reports of gas embolism with Evicel and Quixil in association with the use of spray devices that use a pressure regulator prompted a review of fibrin sealants. These events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in closer-than-recommended proximity to the tissue surface, EMA stated in a press release.

Although EMA reports that risk of gas embolism with Tisseel, Tissucol, and Artiss when applied as spray during surgery was considered to be very low, the Committee concluded that the risk cannot be excluded. It urges that product information for these medicines be updated with new instructions to optimise their safe use. EMA stated the following: 

• The product information should be updated with clear and consistent advice for healthcare professionals regarding recommended pressure and distance to use during spraying application.
• The marketing-authorisation holders for these medicines should ensure that they are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that they contain labels stating the recommended pressure and distance.
• The product information should include a warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2, and patients should be closely monitored for signs of gas embolism.
• Healthcare professionals in the European Union (EU) will receive a letter outlining the updated information on the safe use of these medicines.

For the fibrin sealant Beriplast P (and associated names), however, the CHMP concluded that "there is no risk associated with this product because it does not require a gas-assisted spray device during application, therefore there is no risk of gas embolism with this product when used in accordance with prescribing advice and with the recommended device."

Omrix, a Johnson & Johnson unit, obtains FDA approval for fibrin sealant

Johnson & Johnson (NYSE: JNJ) unit Omrix Biopharmaceuticals Ltd. has obtained US Food and Drug Administration (FDA) approval for its fibrin human sealant patch, one of Omrix's most interest products and the reason why Johnson and Johnson acquired it for $438 million in 2007.

The product, now called Evarrest, is based on Omrix's biological sealant for stopping problematic bleeding during surgery. "Unexpected and uncontrollable bleeding during surgery poses a significant challenge to surgeons, and in some surgical procedures can raise the patient's mortality rate to 20%," says Ethicon Biosurgery (the J&J division which includes Omrix) in its press release.

Omrix's biological sealant is currently used to stop bleeding during surgery or from wounds, but the Evarrest patch Evarrest is easier to use. To stop bleeding, the surgeon places the sealant over the wound and manually compresses it in place for three minutes. The sealant becomes part of the body, gradually degrading over several days or weeks.

The sealant is based on the production of clotting substances in human blood plasma. Ethicon Biosurgery says, "Clinical studies demonstrate that Evarrest is 98% effective in stopping bleeding and maintaining hemostasis compared to the current standard of care at 53%, potentially minimizing disruption to the surgical procedure."

The FDA approval is good news for Johnson & Johnson and for Israel's life sciences industry, and the company will produce Evarrest in Israel, at least over the next few years.

Johnson & Johnson unit Ethicon Inc., which is responsible for hemostasis and sealing solutions to which Omrix belongs, is also considering other options for producing Evarrest and other products later on. It is in talks with Swiss's Octapharma AG, founded by Omrix founder Robert Taub, for this purpose. Omrix was a spin-off of Octapharma, a producer of human plasma products.

In 2009, the State of Israel sued Omrix's founders and Johnson & Johnson for not paying royalties on the acquisition of the intellectual property of the inventor of Omrix's products, a doctor at Sheba Medical Center Tel Hashomer. Omrix and Johnson & Johnson say Omrix was responsible for most of the invention, or that which it received it from Octapharma. The case is still pending, and while it has not yet affected Ormix's thriving operations in Israel to date, it may affect them in the future.

J&J's EVARREST Fibrin Sealant Patch Approved by FDA

Ethicon Biosurgery, Division of Ethicon, Inc., a worldwide leader in hemostasis and sealing solutions, announced today that the U.S. Food and Drug Administration (FDA) has approved EVARREST™ Fibrin Sealant Patch, a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery.  Unexpected and uncontrollable bleeding during surgery poses a significant challenge to surgeons, and in some surgical procedures can raise the patient's mortality rate to 20%.

EVARREST™ has been indicated for use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic and non-cardiac thoracic surgery, when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical.  It is not for use in children under one month of age and it cannot safely or effectively be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding.

"The FDA approval of EVARREST™ is a significant milestone in advancing patient care.  We believe this technology has the potential to drive a paradigm shift in the treatment of problematic bleeding during surgery," said Dan Wildman, Worldwide President, Ethicon Biosurgery.  "EVARREST™ combines the company's expertise in biomaterials and plasma-derived biologics to bring true innovation to surgeons and their patients."

EVARREST™ consists of a coating of biologics and a flexible patch that, when combined, form a distinct delivery system that will raise the standard of care for surgeons and their patients.  Each component of EVARREST™ ^ plays an active role in the hemostasis process -- the biologics (human thrombin and fibrinogen) react and initiate a fibrin clot, which then integrate into the patch, providing mechanical support and adherence to the wound site.

To use the product, surgeons place EVARREST™ upon the bleeding wound surface and apply manual compression for approximately three minutes.  EVARREST™ remains in the patient's body once surgery has been completed as it is fully bio-absorbable.

DuraSeal™ Sealants vs. Tisseel™ Fibrin Sealant

Baxter Announces FDA Approval of Expanded Indication for TISSEEL

DEERFIELD, Ill., Jan 30, 2012 (BUSINESS WIRE) -- Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved TISSEEL [Fibrin Sealant] to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical. TISSEEL is effective in heparinized patients. TISSEEL mimics the final stages of the body's own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis.

"The expanded indication for TISSEEL offers more surgeons an effective tool for controlling bleeding across a wider variety of surgical procedures," said Sibu Saha, M.D., Professor of Surgery, University of Kentucky. "This includes patients who have been treated with heparin who may have unique treatment challenges, which was the case for some of the patients involved in Baxter's clinical trials."
A Phase III clinical study assessed the safety and efficacy of TISSEEL in peripheral vascular surgery compared with manual compression, a standard of care, in 140 evaluable patients (70 patients per treatment arm). In the study, TISSEEL was shown to be statistically significantly better than manual compression in achieving hemostasis. These study results complement a clinical data package showing the safety and effectiveness of the use of TISSEEL as an adjunct to hemostasis.
"TISSEEL and its multiple application devices make it well-suited for a variety of surgical situations, such as open and laparoscopic procedures, reinforcing Baxter's commitment to supporting solutions to the surgical community," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience busines

Important Risk Information

For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, may result in life-threatening thromboembolic events and may increase the likelihood of acute hypersensitivity reactions in susceptible patients. Exercise caution to minimize the risk of intravascular application when using TISSEEL in surgery.

Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.

Do not use TISSEEL for the treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.

Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.

Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.

Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.

Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This may occur if a spray device is used at higher than recommended pressures and in close proximity to the tissue surface.

When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.

TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.

Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness may negatively interfere with wound healing.

The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.

TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Fibrinogen and Hemostasis: A Primary Hemostatic Target for the Management of Acquired Bleeding

Jerrold H. Levy, MD, FAHA,
Fania Szlam, MMSc,
Kenichi A. Tanaka, MDand
Roman M. Sniecienski, MD

+Author Affiliations
From the Department of Anesthesiology, Emory University School of Medicine, Cardiothoracic Anesthesiology and Critical Care, Emory Healthcare, Atlanta, Georgia.
Address correspondence to Jerrold H. Levy, MD, FAHA, Department of Anesthesiology, Emory University School of Medicine, Cardiothoracic Anesthesiology and Critical Care, Emory Healthcare, Atlanta, GA.

Abstract

Fibrinogen plays several key roles in the maintenance of hemostasis. Its cleavage by thrombin and subsequent polymerization to form fibrin strands provides the structural network required for effective clot formation. During cases of acute blood loss, attempts to maintain circulating volume and tissue perfusion often involve the infusion of crystalloids, colloids, and red blood cells. Intravascular volume resuscitation, although vital, frequently results in dilution of the remaining clotting factors and onset of dilutional coagulopathy. In such cases, fibrinogen is the first coagulation factor to decrease to critically low levels. There currently is a lack of awareness among physicians regarding the significance of fibrinogen during acute bleeding and, at many centers, fibrinogen is not monitored routinely during treatment. We reviewed current studies that demonstrate the importance of considering fibrinogen replacement during the treatment of acquired bleeding across clinical settings. If depleted, the supplementation of fibrinogen is key for the rescue and maintenance of hemostatic function; however, the threshold at which such intervention should be triggered is currently poorly defined. Although traditionally performed via administration of fresh frozen plasma or cryoprecipitate, the use of lyophilized fibrinogen (concentrate) is becoming more prevalent in some countries. Recent reports relating to the efficacy of fibrinogen concentrate suggest that it is a viable alternative to traditional hemostatic approaches, which should be considered. The prospective study of fibrinogen supplementation in acquired bleeding is needed to accurately assess the range of clinical settings in which this management strategy is appropriate, the most effective method of supplementation and a comprehensive safety profile of fibrinogen concentrate used for such an approach.
Accepted July 11, 2011.

Ethicon Inc announces submission of BLA for Fibrin Pad

Ethicon Inc, a Johnson & Johnson (NYSE: JNJ) company, reported on Thursday the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for the Fibrin Pad to aid in stopping soft tissue bleeding during surgery.

The company's BLA submission includes efficacy and safety data from a randomised, controlled clinical study in which the Fibrin Pad was used as an adjunct to hemostasis in soft tissue bleeding. According to Ethicon the Fibrin Pad is a novel product candidate that combines two methods of action: biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin).The Fibrin Pad is intended for use by surgeons as an adjunct to hemostasis when surgical methods are ineffective or impractical to control bleeding.

Air/Gas Embolisms with Pressurized Spray Devices for Hemostasis

FDA Warns on Fibrin Sealant Problem

Air embolisms can occur with some gas- or air-pressurized spray devices used for applying fibrin-based bleeding control products when used improperly during surgery, the FDA warned.
At least seven types of fibrin sealant sprayers were associated with air or gas embolisms, which appear to have occurred when pressure settings were too high or the sprayer tip was too close to the bleeding site.
The FDA emphasized that clinicians should follow manufacturers’ recommendations for pressure control settings and the minimum distance for applying the sealants.
“Although rare, the reports describe air embolisms that are life threatening and include one fatality,” the FDA said.
The bureau listed seven product series that have been affected:
EasySpray and spray set used with Duploject system (Baxter Healthcare)Tissomat and spray set used with Duploject system (Baxter Healthcare)Evicel application device (Omrix Medical)FibriJet Aerosol Applicator (MicroMedics)HemaMyst Surgical Applicator System (Haemacure)MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)Vitagel Hemostat Spray Set (Orthovita)
Label instructions for all fibrin sealants have been rewritten to note the risk of air embolismsassociated with improper sprayer use.
In addition to following the listed recommendations for pressure settings and proper distances for application, clinicians should be sure to monitor patients’ blood pressure, pulse, oxygen saturation, and end-tidal CO2 levels for signs of embolism, the FDA noted.
The sprayers should also be maintained and tested regularly, the bureau said.

Department of Defense Funding Shows Continued and Bi-Partisan Support for STB® Lifesaving Technologies' Products

ROCKVILLE, Md., July 7 /PRNewswire/ -- For the third consecutive year the Department of Defense demonstrated its commitment to help save the lives of our troops by providing STB Lifesaving Technologies® with $2.85 million of funding.
The award is to further advance the development of STB®'s Fibrin Adhesive STat (FAST®) dressing, designed to be effective against the full spectrum of blood loss, including severe arterial and venous bleeding. Fifty percent or more combat-related deaths are attributable to uncontrolled hemorrhaging, and with products such as this, thousands of military and civilian lives could be saved.
"We are most appreciative of the support we have continued to receive from the Department of Defense and members of both the Senate and House. This funding is not only invaluable; it serves as a strong statement of their belief in our Fibrin Adhesive STat (FAST®) dressing and their commitment to help us bring our products to the battlefield, emergency responders and operating rooms," said STB® CEO, Richard Moscarello.
Funding for the grant was included in the FY2009 U.S. Department of Defense appropriations bill and received bipartisan support from Senators Richard Burr (R-NC), Ben Cardin (D-MD), Barbara Mikulski (D-MD), Charles Schumer (D-NY) and former Senator Elizabeth Dole (R-NC) and Representatives Bob Etheridge (D-NC), David Price (D-NC) and Chris Van Hollen (D-MD).
"We've all been encouraged by the pre-clinical studies, but it's particularly gratifying that support for our science is backed with significant monetary commitments as well," said STB®'s Moscarello.

About STB®

Founded in 2005, STB Lifesaving Technologies® (STB®) is a privately held, pre-clinical stage, biotechnology development company located in Rockville, Maryland. STB® which stands for "stop the bleeding", is focused on developing a comprehensive suite of products to stop serious and life threatening bleeding in trauma and surgical settings. With a strong proprietary position using its all-natural protein technology with five patents and one provisional patent pending, STB®'s products will be indispensable to both the military and civilian medical markets.

J&J comment on EU market and the US release of Fibrin Pad

Johnson & Johnson's (JNJ) big medical devices and diagnostics unit anticipates that pressure on product prices in Europe will rise over the long term but not immediately, the unit's top official said Thursday.
J&J also said it expects the portion of the $350 billion devices and diagnostics market it competes in to grow at a faster rate than the overall market.
Additionally, the company anticipates that unit will make about 80 "significant" regulatory filings between 2010 and 2010.
J&J, which is dealing with fallout from the recent recall of children's medicines, is holding an all-day review Thursday for the devices and diagnostics unit. That unit grew sales by 2% to $23.6 billion last year and became J&J's largest segment, eclipsing a pharmaceutical business that has been pressured by competition from generic drugs.
The segment derived more than half of its sales last year from outside the U.S. A big question for device and drug companies these days is how the European debt crisis will affect product prices as governments try to rein in health spending.
"I think longer term we clearly see there being increased pricing pressure," Alex Gorsky, worldwide chairman for J&J's devices and diagnostics unit, said during the meeting. But there are reasons to believe it won't be an "immediate" issue, and doesn't mirror the situation with drug prices, he said.
These reasons include the tendering systems used to purchase devices and the dynamics between hospitals and governments, he said.
Pricing in Europe remained a top issue when analysts asked questions. Gorsky told them the pricing issue is difficult to forecast. He also said J&J hasn't seen a slowdown in procedure volumes that could also impact sales, but added "we'll have to watch closely."

Healthcare company Johnson & Johnson (JNJ), Thursday revealed growth strategies and product pipeline information for its Medical Devices & Diagnostics Segment. The company said the segment was its largest, and that new products and acquisitions would help sustain its market-leading position in the $350 billion, worldwide medical device and diagnostics market.
The New Brunswick, New Jersey-based company provided information on products that have been launched already or are on the anvil for the current fiscal, from its seven global franchises.
Ethicon Endo-Surgery, a maker of surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products is rolling out a host of new products, J&J said. They include new energy instruments as part of its HARMONIC family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency.
Further, Ethicon continued to focus on patient comfort and surgeon ease-of-use as it built its portfolio of hernia repair products with ETHICON PHYSIOMESH Flexible Composite Mesh and its first entry into the hernia mesh fixation market with ETHICON SECURESTRAP 5mm Strap Fixation Device.
Ethicon Endo-Surgery would make a BLA filing in the U.S for its Fibrin Pad in the fourth quarter. The product combines two biomaterials and two biologics to stop bleeding during surgical procedures.

Researchers Study Molecular Architecture of Fibrin Networks

The research, published by Cell Press in Biophysical Journal on May 18th, provides insight into how the molecular architecture of a fibrin network contributes to its resilience and may help to explain what causes the failure of a clot, which can lead to a stroke or heart attack.

Fibrin is a fibrous protein which assembles into a remarkably strong spider web-like gel that forms the structural framework of blood clots. Previous work has shown that fibrin networks, thought to be among the most resilient proteins in the natural world, stiffen when deformed and become increasingly resistant to further strain. Although this extraordinary resilience appears to be crucial for the biological function of blood clots, the molecular basis of this resilience is not well understood.

"To better understand the superior elasticity of fibrin networks, we measured the mechanical behavior of purified fibrin gels on multiple scales," says senior study author, Dr. Gijsje H. Koenderink from the Biological Soft Matter Group at the FOM Institute AMOLF in The Netherlands. "We found that the fibrin has a series of molecular domains that are stretched out sequentially, on smaller and smaller scales, when clots are deformed. This stretching leads to gel stiffening, which protects the clots from damage"

Specifically, Dr. Koenderink's group made the surprising discovery that the fibrin fibers are very porous loose bundles of thin filaments that are connected by flexible crosslinkers. This open structure (containing 80% water) makes the fibers 100-fold more flexible than previously thought, and enables sequential stiffening due to straightening out of the bundles between network crosslinks followed by straightening out of flexible protein domains inside the bundles. "We found that it is this bundle-like structure of fibrin fibers that is ultimately responsible for the superior mechanical properties of fibrin gels," explains Dr. Koenderink.

The researchers presented a theoretical model that explained their observations in terms of this unique hierarchical architecture of the fibers. "Our data reveal molecular design principles that allow blood clots to recover from large forces, such as shear forces from blood flow, furthering our understanding of how pathological alterations in fibrin cause clot rupture and bleeding or thrombosis," concludes Dr. Koenderink. "Moreover, our findings suggest a new design concept for resilient bio-inspired materials with potential applications in drug delivery and tissue repair."

Individual Fibrin Fibers Distribute Strain Across A Network

A new study shows that when it comes to networks of protein fibers, individual fibers play a substantial role in effectively strengthening an entire network of fibers. The research, published by Cell Press in the April 20th issue of the Biophysical Journal,describes a mechanism that explains how individual fibrin fibers subjected to significant strain can respond by stiffening to resist stretch and helping to equitably distribute the strain load across the network.

Fibrin is a fibrous protein that assembles into a remarkably strong mesh-like network and forms the structural framework of a blood clot. Failure of a clot can have fatal consequences. For example, if a portion of the clot breaks away and is carried downstream by the flowing blood, it can cause a stroke or heart attack. Although previous research has characterized the mechanical properties and behavior of fibrin networks on a macroscopic level, much less is known about the behavior of individual fibrin fibers and the distribution of strain from one fiber to the next.

"We know that network strength is determined in part by the maximum strain individual fibers can withstand, so it is of particular interest to determine how the high strain and failure characteristics of single fibrin fibers affect the overall strength of the network," says senior study author Dr. Michael R. Falvo from the Department of Physics and Astronomy at the University of North Carolina at Chapel Hill. "Further, determining how strain is shared among the constituent fiber segments in a network under imposed stress is crucial to understanding failure modes of networks and their strength."

Dr. Falvo and colleagues used a combined fluorescence/atomic force microscope nanomanipulation system to stretch two dimensional fibrin networks to the point of failure while recording the strain of individual fibers. "Specifically, we observed that as fibers were stretched, they became stiffer than the surrounding fibers at lower strains; this allowed the more strained, stiffer fibers, to distribute the strain load to the less strained fibers and reduce strain concentrations," explains Dr. Falvo. "So in effect, strain stiffening in the individual fibers acts to distribute strain equitably throughout the network and thereby strengthen it."

The strain concentration reduction effect described in this study may be part of an important physiological mechanism to strengthen blood clots under high shear conditions in the blood stream. The authors note that along with this physiological insight, their findings bring about a better understanding of this remarkable strengthening mechanism and may help to guide new design strategies for engineered materials

Concerns Raised About Synthetic Glue for Hernia Repair

Boston—A study showing adverse effects from a synthetic cyanoacrylate tissue sealant used in an animal hernia model won the award for best paper in general surgery at the 2006 annual meeting of the Society of Laparoendoscopic Surgeons. Although the brand of synthetic surgical glue tested in the study is approved for use only in Europe, at least one other manufacturer of cyanoacrylate sealant is seeking approval from the FDA for its use in vascular surgery.
The study, in 16 rats, found that in all cases, the glue prevented tissue from adhering to or integrating with the mesh, impaired tissue flexibility and resulted in a severe inflammatory response marked by large seroma formations.
The cyanoacrylate examined in the study was Glubran 2, made by the Italian firm GEM S.r.l. (Viareggio, Italy) and approved for use in Europe in both traditional and laparoscopic surgery.
“It seems not very appropriate for hernia repair in an experimental model, to say the least,” said the lead author of the study, Alexander H. Petter-Puchner, MD, a surgical resident at the Ludwig Boltzmann Institute for Experimental and Clinical Traumatology in Vienna, Austria.
Surgeons who heard the report said it comes amid a welcomed stream of studies into novel means for fixing mesh during hernia repair.
“There are a bunch of these cyanoacrylates that have been used clinically or investigationally as tissue adhesives,” said Raymond J. Lanzafame, MD, the immediate past president of the Society of Laparoendoscopic Surgeons. “The good news is that some of the the cyanoacrylate compounds are hydrophilic. But they, like the currently available cyanoacrylates, do generate a pretty intense inflammatory response. If it’s a version that isn’t broken down by the body in some way, it can turn out as bad as, if not worse than, a suture granuloma in terms of producing pain and irritation.”
Phillip Shadduck, MD, of Regional Surgical Associates in Durham, N.C., said in an interview after Dr. Petter-Puchner’s presentation that while a strong inflammatory response was seen in the study, newer cyanoacrylates might not evoke the same reaction. “We’ve learned in the abdomen, and now in the abdominal wall, that the chemistry of the cyanoacrylates makes a big difference in the inflammatory response it activates,” he said. “There are newer cyanoacrylates coming out in an effort to elicit less of an inflammatory response.”
One such cyanoacrylate, designed to be biodegradable, was approved for use in Europe in February 2005 as an adjunct to sutures during peripheral vascular reconstructions. The product, Omnex, is made by Closure Medical Corporation in Raleigh, N.C., which was recently acquired by Johnson & Johnson. (Dr. Shadduck reported that he has done consulting on the Omnex product.)
In March at the annual meeting of the Society for Clinical Vascular Surgery, results from a trial of 150 patients at 15 centers in the United States and Europe showed significant benefits for Omnex as an adjunctive sealant for vascular anastomoses compared with Surgicel Nu-Knit Absorbable Hemostat (Johnson & Johnson). The study found a statistically significant difference in time to hemostasis between the sealant, with a mean of 119.3 seconds, compared with Surgicel, with a mean of 403.8 seconds (P<0.001). Among patients in the Omnex group, 54.5% had immediate hemostasis, compared with only 10% in the Surgicel group (P<0.001). No significant difference in incidence of adverse events occurred between the two groups (P=0.60).
Using a compound similar to the one approved for external use in the United States under the trade name Dermabond, Omnex is under consideration by the FDA for internal use during vascular surgery.
Whether Omnex would have the kind of detrimental effects in hernia repair that were seen in Dr. Petter-Puchner’s study of Glubran 2 is unclear, but the chief of minimally invasive surgery at the department of surgery, Keck School of Medicine of USC, Los Angeles, said he would be “wary” of such a use.
“The artificial glues, or glues that have any artificial nature, stay around in the body and create a foreign body reaction,” said Namir Katkhouda, MD, who published the first study using a fibrin sealant, Tisseel, for mesh fixation in hernia repair (Ann Surg2001;233:18-25). “Some people have spun around the concept of using sealants in mesh fixation to these other adhesives [with artificial components]. I am absolutely wary of them. The important difference between the fibrin sealants and any artificial sealant is that the fibrin is naturally removed by the body at 10 days. That’s what you want.”
Tisseel, made by Baxter (Irvine, Calif.), is widely used in Europe for mesh fixation, but is currently approved in the United States only for cardiopulmonary bypass surgery, splenic repair and colostomy closure. A spokesman for Baxter said the company has a “strong desire” to broaden the indications for Tisseel in the United States.
In his award-winning paper, Dr. Petter-Puchner presented data on 20 Sprague Dawley rats, in which two defects per animal were created in the abdominal wall left and right of the linea alba (1.5 cm in diameter), with the peritoneum was spared. The lesions were left untreated for 10 days to achieve a chronic condition and then were covered with 2 cm×2 cm of mesh sealed with Glubran 2. Four of the animals were sacrificed after 17 days, eight after four weeks and another eight after 12 weeks. The meshes were then biomechanically tested and histology was performed.
At the 12-week mark, the hook-pull test revealed a loss of mesh adhesion wherever the sealant had been used. “There was no tissue integration through the mesh and histology revealed strong inflammation,” Dr. Petter-Puchner said during his presentation. “We also saw a huge seroma formation.”
Using a suction cone to test the elasticity of the tissue, his group found 4.2 mm of deformation in untreated areas, but just one-tenth that much in areas where Glubran had been applied, demonstrating a loss of flexibility.

JnJ 2009 Earnings Call January 2010

We received FDA approval in October for the SURGIFLO Hemostatic Matrix chip, an advanced flowable hemostat for use in a broad range of surgical procedures. This is our first product launch resulting from Ethicon’s 2008 acquisition of Omrix. The regulatory knowledge gained from this combination product will be valuable as we continue to develop and commercialize other combination products in our pipeline like the Fibrin Pad, which I will address in a minute.......
As I mentioned earlier, Johnson & Johnson leads the industry in developing next-generation advanced hemostats to address the persistent clinical problems associated with bleeding in surgical settings, and we are very excited by the potential of the Fibrin Pad. With our human-plasma based biologics embedded directly into a proprietary matrix, the Fibrin Pad has the potential to uniquely and effectively address bleeding challenges that are hardly unmet by traditional hemostats. As Louise mentioned earlier, the BLI filing for the Fibrin Pad is now expected in the first half of this year.
And obviously, the best thing is to take the $7 billion we are investing and be able to generate products like Simponi or Stelara or Sedasys or the Fibrin Pad. Like, if we see other opportunities to license or to partner, partner may be an even more strategic investment than just a license. But, we will continue to take advantage of each of those in the areas where we see again the biggest opportunities for growth in the corporation.

J 'n J Q3 - Edited

Ethicon worldwide sales grew operationally by 9.4% with US up 18% and sales outside the US up 3.8% operationally. The acquisitions of Mentor and Omrix partially offset by the divestiture of the professional wound care business added approximately 3.5 points to the worldwide operational growth. Sales for our newly acquired aesthetics products for Mentor were in line with 2008. On a worldwide basis double digit operational growth was achieved in biosurgicals and meshes.
Johnson & Johnson leads the industry in developing and next generation of advanced hemostats to address the persistent clinical problems associated with bleeding in surgical settings. A truly unique example of convergence three Johnson & Johnson companies; Ethicon, [Senacore], and the recently acquired Omrix Biopharmaceuticals have been working together to develop one such hemostat that we call the Fibrin pad.
With our heman plasma based biologics embedded directly into proprietary matrix the fibrin pad has the potential to uniquely and effectively dress bleeding challenges that are currently unmet by traditional hemostats. It’s designed to combine the functions of mechanical sealing and biological hemostatis. Upon contact with blood the biodegradable device causes a clot to form rapidly and stop bleeding without any other action. A BLA for the fibron pad is targeted for submission by the end of 2009.

Patch Uses Stem Cells To Plug Holes in The Heart

They say only time heals a broken heart, but Duke University researchers think they can do better. Using embryonic stem cells from mice and their own novel molding technique, a team of researchers at Duke has developed a three-dimensional heart cell “patch” that conducts electrical impulses and contracts, two all important characteristics of heart tissue.

Cardiomyocytes, the heart muscle cells that keep the blood pumping, are difficult to grow effectively because left to their own devices, they will simply develop into a disorganized clump of cells. To get around this, the team coaxed embryonic stem cells to develop into cardiomyocytes by placing them in an environment much like the one in which they develop naturally. By encapsulating the cells in a gel made of fibrin, a blood-clotting protein, the researchers provided the mechanical support for the cells to form an organized, three-dimensional structure.
But the key ingredient for the researchers were helper cells called cardiac fibroblasts. These cells make up as much as 60 percent of the cells present in the heart, and when introduced to the mold they caused the cardiomyocytes to pull together as if they were growing in a developing human heart. The alignment of the cells in the correct direction allows them to contract and carry electrical signals as though they are native tissue, allowing them to function fairly seamlessly alongside existing heart tissue.
After being cast in the fibrin mold, the patches can be placed on the heart where the tissue is thin or compromised and injected with cells that would then generate new heart tissue. But obstacles remain; aside from the many regulatory hurdles a procedure like the heart patch must leap, engineering a blood vessel supply to sustain the patch also presents substantial challenges. The use of embryonic stem cells also invites controversy, so the Duke team also plans to test their patch using non-embryonic stem cells. Ethical and regulatory issues aside, the proof of concept is an important breakthrough for cardiac researchers who have a limited arsenal with which to battle heart disease, the leading cause of death in many developed countries. An effective non-embyronic stem cell heart patch would not only circumvent the problem of immune system reactions, but sidestep sensitive ethical land mines, clearing the way to put broken hearts on the mend.