Sunday, June 14, 2009

Vascular Solutions to Participate in Jefferies 3rd Annual Healthcare Conference

Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to participate in the Jefferies 3rd Annual Healthcare Conference being held this week in New York City. Howard Root, Chief Executive Officer of Vascular Solutions, will present on Wednesday, June 17th at 4:15pm (EDT). To hear the live audio webcast of the panel discussion, go to the investor relations page of the Company's web site http://www.vascularsolutions.com and click on the "IR Conferences" icon a few minutes prior to start time to download any necessary software.

Bovie Medical Corporation Announces FDA Submission Of Laparoscopic Device For Solid Organ Resection


Bovie Medical Corporation (the "Company") (NYSE-AMEX Symbol: BVX), a manufacturer and marketer of electrosurgical products, announced a 510K submission to the FDA seeking pre-market clearance for a laparoscopic SEER device for solid organ resection. The laparoscopic SEER is a line extension of the Saline Enhance Electrosurgical Resection (SEER) device that Bovie launched earlier this year and will address the growing market of minimally invasive liver resection.
The laparoscopic SEER allows the surgeon to dissect and achieve hemostasis with a single device resulting in less instrument utilization and fewer instrument changes in a minimally invasive approach. The laparoscopic SEER is the second developed product in a series of new products under development based on the sintered steel technology.
Andrew Makrides, president of Bovie, stated, "Surgeons response to the SEER has been very positive and this new device will allow us to address their requests for a laparoscopic version."

Tuesday, June 9, 2009

CPC Strengthens Foundation as a Closure Products Company with its Vertically Integrated Product Pipeline

 CPC of America, Inc. (OTC Bulletin Board: CPCF), announced today that its first patent filing of a synthetic sealant for its specific application to the MedClose(TM) Vascular Closure System (VCS) -- previously announced May 21, 2009 -- represents a much broader foundation and basis for its new strategic plan as a Closure Products Company. CPC is presently focused on the development and testing of the MedClose(TM) VCS, which is an internal puncture-closing system for use in percutaneous intravascular diagnostic and interventional procedures, and announced today it will alsi gueo design and develop new vascular closure applications based upon a broader range of French sizes (i.e., introducer sheath diameters). The MedClose(TM) VCS design has the capabilities to be rapidly adapted to not only focus on its core VCS application for vascular closure following diagnostic or interventional procedures (coronary, carotid, cerebral, peripheral) with 6-9 French (Fr) catheters but also for:

  • 4-5Fr for applications such as vascular closure following catheterization procedures in pediatric populations, closure of central line access points for chemo-therapy patients, hemostasis after arteriovenous fistulae access and peripheral arterial and/or venous closure after diagnostic and interventional electrophysiology procedures.
  • 10-12Fr for applications such as iliac and abdominal aortic aneurysm (AAA) stent/graft implants.
  • 15-20Fr for applications such as existing designs for percutaneous aortic and mitral valve replacement, endovascular stent grafts.

Importantly, the synthetic sealant and its characteristics also have potential future applications such as internal and external bonding and coating of tissue and instruments, (e.g., temporary coatings for burn victims, grafting of artificial skin, adhesion prevention, coatings on polymers, or coatings on implant devices such as stents or grafts), biopsy sealing) with or without drug delivery (e.g., the delivery of glucosamine and chondroitin sulfate into the spine area or other body organs), stem cell or growth factor delivery (e.g., the delivery of stem cells and/or growth factors into the spine area or other body regions), tissue sealants/adhesives to control of bleeding or fluid leakage in body tissue (e.g., lung sealing or hemostasis, tissue, muscle, and bone growth and regeneration) and dermatology (e.g., collagen restoration/replacement, topical application or void-filling by injection to fill wrinkles).

We believe that our sealant offers some important potential advantages over other sealants in several respects. First, as a synthetic sealant, our product is free from the risk of blood-borne and other pathogens. Second, testing to date indicates excellent adhesive strengths when applied to wet areas of tissue which could offer a tremendous competitive advantage due to the fact that vascular closure sites are normally initially wet due to the presence of blood or body fluids. And finally, the synthetic sealant appears to perform independently with respect to the level of anti-coagulation present.

We believe the MedClose(TM) VCS System has the potential to represent multiple product lines in multiple market segments, enhancing the value to such intellectual property. We are no longer one dimensional but believe in the original vision we had with the acquisition in November 1999 of closure technology with broad applications as stated above. We continue to improve the MedClose(TM) VCS by strengthening the platform of regulatory, quality, manufacturing, etc. capabilities for new product development and sustaining engineering.

CSL Limited and Talecris Biotherapeutics Agree to Terminate Merger Agreement

CSL Limited (ASX: CSL) and Talecris Biotherapeutics, Inc. announced today that they have mutually agreed to terminate their merger agreement, announced on August 12, 2008, under which CSL agreed to acquire Talecris for US$3.1 billion in cash.

Dr. Brian McNamee, CEO and Managing Director of CSL Limited, said, "We are disappointed that the U.S. Federal Trade Commission (FTC) resolved to block the transaction. As we have previously stated we fundamentally disagree with the FTC case and matters included in their complaint. Although we continue to believe in the many customer benefits and significant financial synergies that supported the transaction, CSL's Board of Directors did not believe that entering into a protracted litigation process with the FTC, with its inherent risks, substantial costs, and lengthy distraction of CSL management and staff from planning and running our businesses would be in the best interests of our stakeholders."

Dr. McNamee continued, "While we regret that the transaction cannot be completed, CSL remains a well positioned global biopharmaceutical business and will continue to expand on its core strengths. We have consistently produced year-on-year growth for our shareholders and we are confident in the continued value and growth potential of our stand-alone business. We continue to have great respect for Talecris and wish them well in the future."

Lawrence D. Stern, Talecris' Chairman and Chief Executive Officer, said, "After discussions with CSL, we have mutually agreed that litigation regarding the antitrust issue was not the path forward. Based on a careful analysis of the situation and all alternatives available, we believe that termination of the merger agreement is in the best interest of all parties. We are disappointed that patients will not benefit from the efficiencies we saw in the proposed combination. Talecris continues to focus on its patient community and customers, and on building and realizing value for its employees and owners. Through the process, we developed an even greater appreciation for CSL's competencies, professionalism and integrity, and we wish Brian and his team well in their future endeavors."

Both parties will fulfill their obligations for termination contained in the merger agreement. As part of the agreement, CSL will pay Talecris a US$75 million break fee, and the plasma supply contract the parties entered into in connection with the merger agreement will remain in effect.

Monday, June 8, 2009

Poll Results - Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?


We asked "Will the Feb. '09 vCJD scare in the UK affect your consideration of using a human or bovine sourced hemostat or sealant?"

50% said YES
20% said NO
13% said DEPENDS ON THE COUNTRY OF ORIGIN OF PRODUCT
16% said MAYBE

Obviously human and animal sourced products do exhibit some concerns for many.

Sunday, June 7, 2009

Researchers Detect Blood-Clotting Mechanism

Ever wonder how your blood miraculously stops flowing and forms a scab after a cut? Researchers have now pinpointed the mechanism down to the molecular level.

"The human body has an incredible ability to heal from life's scrapes and bruises," study co-author Wesley P. Wong, a principal investigator at the Rowland Institute at Harvard University, said in a university news release.

"A central aspect of this response to damage is the ability to bring bleeding to an end, a process known as hemostasis," Wong said. "Yet regulating hemostasis is a complex balancing act."

If people have too much hemostatic activity, they can develop an excess of blood clots, resulting in thrombosis, which is a potentially deadly condition. On the other hand, if there is too little hemostatic activity, people could bleed to death, according to background information in the news release.

To achieve and maintain the right hemostatic balance, the body has a feedback system controlled by miniscule forces in the circulation system. The forces are applied to the highly-sensitive A2 domain of the blood-clotting protein called von Willebrand factor (VWF), which acts as a "force sensor," the researchers explained.

By manipulating single molecules, the researchers found that the tiniest force causes A2 molecules to unfold and lose much of their complex, three-dimensional organization. After the unfolding, the enzyme ADAMTS13 comes into play. The enzyme cuts the molecule, hence controlling the size of the blood clot, according to the study, in the June 5 issue ofScience.

"In the body, these cutting events decrease hemostatic potential and also enable blood clots to be trimmed in size," Wong said. "The system is so finely tuned that the A2 shear sensor is able to regulate the size of VWF within the bloodstream, maintaining the optimal size for responding properly to traumas."

To manipulate molecules, the researchers used "optical tweezers" developed in Wong's lab, which can apply miniscule forces to individual molecules while observing tiny changes in their length.

A better understanding of the mechanism of blot clotting could lead to new treatments for injuries or bleeding disorders, such as type 2A von Willebrand disease, the researchers noted.

Thursday, June 4, 2009

Angiotech Enters License, Distribution and Supply Agreements for Fibrin and Thrombin Technologies with Haemacure Corporation


Angiotech, a specialty pharmaceutical and medical device company, announced today the completion of a collaboration transaction with Haemacure Corporation (TSX:HAE), a specialty bio-therapeutics company, relating to certain of Haemacure's proprietary fibrin and thrombin technologies, both of which are currently in development.

As part of this collaboration, Angiotech has agreed to provide to Haemacure a senior secured bridge financing facility in the amount of US$2.5 million, with the option for Angiotech to invest an additional US$1 million in the facility.

"Our new collaboration with Haemacure provides Angiotech with access to critically important technology for certain of our surgical product candidates currently in preclinical development," said Dr. William Hunter, President and CEO of Angiotech. "We believe we have assembled the majority of the key components necessary to deliver on the next generation of innovations, adding to our proprietary Quill SRS franchise for our surgical business, and we will provide additional details as we prepare certain of these product candidates for the clinical development and regulatory approval process.The collaboration will consist principally of the following three agreements:
- Fibrin Sealant Distribution Agreement. The parties have entered into a Distribution Agreement whereby Angiotech is granted non-exclusive,world-wide distribution rights to Haemacure's fibrin sealant product candidate in selected surgical indications. The distribution agreement has a term on a country-by-country and product-by-product basis of 10 years from the date Haemacure receives United States Food and Drug Administration (FDA) approval or similar regulatory approval in countries outside of the United States of its fibrin selant, and has an option for Angiotech to renew for an additional five years, subject to certain performance adjustments. Any fibrin sealant product would be marketed and distributed by Angiotech's surgical sales organization upon regulatory approval. Haemacure will be responsible for all clinical development and related costs with respect to fibrin sealant product candidates.
- Drug-Loaded Fibrin Sealant License and Development Agreement. The parties have entered into a License and Development Agreement whereby Haemacure and Angiotech have agreed to jointly develop and commercialize a next generation, drug-loaded fibrin sealant product candidate. Angiotech and Haemacure will collaborate to create novel fibrin sealant technologies that, in addition to the haemastatic properties offered by the fibrin sealant itself, may target the prevention of infection, pain, or delivery of stem cells using Haemacure's fibrin sealant as a carrier of such therapies. The companies will jointly conduct research and clinical development, with each party contributing key personnel, technology and intellectual property. Collaboration costs will be shared based on each company's contribution to the program, and eventual profits will be shared pro-rata based on each company's contribution to collaboration expenses. This term of the agreement will expire on a collaboration product-by-collaboration product basis upon the later of 15 years after the first commercial sale of such collaboration product, and the last-to-expire valid claim applicable to such collaboration product.
- Thrombin Supply Agreement. The parties have entered into an exclusive Supply Agreement whereby Haemacure will supply thrombin to Angiotech for the development of certain Angiotech preclinical product candidates that may require thrombin. The Supply Agreement has a term of 10 years from the first commercial sale of an approved Angiotech product containing thrombin procured from Haemacure, and has an option for Angiotech to renew for an additional five years. The senior secured bridge loan from Angiotech to Haemacure will provide US$2.5 million to Haemacure in multiple drawdowns. The loan will be senior to all of Haemacure's existing and future indebtedness, subject to certain exceptions; will bear interest at an annual rate of 10%, compounded quarterly and have a term of two years. Angiotech may, at its sole discretion, advance during a period of two years up to an additional US$1 million to Haemacure from time to time, in multiple draw-downs, for a total loan of US$3.5 million. The senior secured bridge loan also has certain equity conversion features and rights to board representation, as described in detail in Haemacure's press release dated May 22, 2009

Wednesday, June 3, 2009

Omrix founder Taub in LifeBond $8m funding round


Biosurgical products developer LifeBond Ltd. has raised $8 million in its second financing round. Pitango Venture Capital and Robert Taub led the round. 

Taub founded Omrix Biopharmaceuticals Ltd. and led the company until it was sold to Johnson & Johnson (NYSE: JNJ) for $438 million in 2008. Following the sale, Taub said that he would seek new investment opportunities, and the investment in LifeBond is the first. 

About Lifebond.

LifeBond is developing a series of next-generation biosurgical products which incorporate a proprietary adhesive platform that mimics the biochemical cross-linking cascade of late stage blood coagulation.  The adhesive formulation forms a network similar to the fibrin network of blood clots but has demonstrated adhesive strength even greater than that of blood-derived fibrin sealants.  LifeBond’s technology functions through the rapid and biocompatible in situ cross-linking of structural proteins.  As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix.  The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.

Friday, May 29, 2009

TSX Delisting Review - Haemacure Corporation (HAE)

TSX is reviewing the common shares of the Company with respect to meeting the continued listing requirements. The Company has been granted 150 days in which to regain compliance with these requirements, pursuant to the Remedial Review Process.

Thursday, May 28, 2009

Surgical Adhesive Polymer Company Seeks Partners


Tissuemed has already brought to market the TissuePatch product family of multilaminate absorbable surgical sealant films. These are a range of thin, synthetic, highly adherent films that act as a barrier to air, blood and other fluids encountered in surgery.  More adherent than surgical glues, the films require no preparation and are effective within 30 seconds of contact. The technology demonstrated in these products has the ability to form the basis for new technologies or iterations of existing products. The Leeds based company is offering other companies the chance to benefit through a technology partnering initiative. The scheme, under the banner of Tissuemed Adhesive Biomaterials Technology Group, takes the form of a bespoke polymer design, synthesis and manufacturing programme that is open to third parties such as companies whose own medical devices could be enhanced by the incorporation of adhesive characteristics, surfaces or components. Examples of the types of surgical devices that may benefit from being self-adhesive to internal organs and structures include meshes, sutures and films as well as an array of implantable devices that may currently require physical means of anchoring. The programme offers companies and surgeons the chance to work with Tissuemed’s team of dedicated scientists to develop bespoke polymer designs and add new functionalities to their own products. It also offers support in a range of other areas including clinical and regulatory, physical and biochemical testing, intellectual property protection and sales and marketing expertise. Nick Woods, CEO of Tissuemed, comments, “In the same way that surgical staples revolutionised many surgical procedures in the eighties and nineties, we believe surgically effective adhesive compounds have the capability to drive advances in surgery in the foreseeable future.