TraumaCure Receives Prestigious ISO 13485 Certification

BETHESDA, Md.--(BUSINESS WIRE)--TraumaCure Inc. – makers of the ground-breaking hemostatic agent, WoundStat™ – today announced that the company has received the prestigious international ISO 13485 certification for its quality system for design, development, production and sales of medical devices. The company received FDA clearance to sell WoundStat in August 2007
With ISO 13485 certification, TraumaCure meets global quality design and manufacturing requirements. ISO certification is a base-line requirement in many key markets for approval to sell a medical device and therefore supports TraumaCure’s plans to market WoundStat to nations around the world.
“As the only hemostatic agent proven to be 100% effective in four different studies, we are seeing worldwide demand for WoundStat,” said Devinder Bawa, CEO of TraumaCure. “TraumaCure has put the processes and procedures in place to ensure the global availability of a consistent, safe, and effective product that is ready to save lives, anytime and anywhere it is needed.”
ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO has more than 16,500 International Standards in its current portfolio, ranging from standards for traditional activities, such as agriculture and construction, through mechanical engineering, manufacturing and distribution, to transport, medical devices, the environment, safety, information and communication technologies, and to standards for good practice and for services.
ISO 13485 is an internationally recognized quality standard for the design, development, production, and sales of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
TraumaCure was certified after rigorous audits and extensive document reviews to ensure that TraumaCure’s quality management system (QMS) is run in accordance with the globally recognized standard.

CSMG Technologies Subsidiary Live Tissue Connect Presents Its Bipolar Continuous Welding of Tissue at the 2008 Future Medical Forum

CORPUS CHRISTI, Texas--(BUSINESS WIRE)--CSMG Technologies, Inc. (OTCBB: CTGI) a technology management company, announced Mr. Frank D’Amelio, President of Live Tissue Connect (LTC), a subsidiary of CSMG Technologies, presented at the 2008 Virtus International Future Medical Forum in Tampa, Florida. This medical forum focuses on the impact new technologies and materials have on the discovery, development, and design of medical devices. The Future Medical Forum is a significant medical device event, as it brings together some of the leading minds and decision makers in the medical device industry for a two day conference.
Mr. Donald S. Robbins, President and CEO of CSMG Technologies, said, “We are pleased that LTC’s President, Frank D’Amelio, has been invited back to the Future Medical Forum for a second consecutive year. Since last year, Live Tissue Connect has made significant technological advancements and is excited to introduce them to the world’s leading medical organizations and ancillary support companies.”

GlaxoSmithKline: FDA extends priority review period for Promacta

SAN FRANCISCO, Jun 21, 2008 (Thomson Financial via COMTEX) - GlaxoSmithKline late Friday said the Food and Drug Administration has extended to Sept. 19 the priority review period for Promacta, a short-term treatment for idiopathic thrombocytopenic purpura.
ITP is a condition in which the blood doesn't clot properly because patients don't have sufficient platelets.
The FDA's oncology drugs advisory committee May 30 unanimously voted that Promacta demonstrated a favorable risk-benefit profile for the short-term treatment of patients with chronic ITP, GlaxoSmithKline said.
U.S.-listed shares of the UK-based pharmaceutical company down 27 cents at $43.37. Brigid Gaffikin bg/gm

Neomend Inc.

IRVINE, Calif., June 17 /PRNewswire/ -- NeoMend, Inc. today announced that its ProGEL(TM) Surgical Sealant has received a recommendation for approval from the U.S. Food and Drug Administration's (FDA) Anesthesiology andRespiratory Therapy Devices Advisory Panel.The panel's recommendation will be considered by the FDA during completion of its review of the Premarket Approval (PMA) for ProGEL. The panel's recommendation for FDA approval was conditioned principally on NeoMend conducting a post approval study to gather more safety data.

While Neomend products are for sealing, and anti-adhesion they also are conducting trials of a vascular closure product ProGEL-VS

Haemacure Raises $7.8 Million and is Fully Funded Beyond First-Patient-In-Clinic

MONTREAL, June 16 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value humanplasma-derived protein products for commercialization, announces that it has raised $7.8 million through the exercise of amended Series B warrants and broker warrants issued as part of the private placement concluded in January 2007.

"I sincerely thank our shareholders who demonstrated their strong supportby exercising their warrants. We now have the financial resources to execute on all of the necessary milestones to get our fibrin sealant into the clinicin Q1-09. This financing significantly reduces the financial risk. All of ourtime and attention will be focused on execution and getting a green light from the FDA to enter clinical trials." said Joseph Galli, Chairman and CEO ofHaemacure.

Recombinant collagens and synthetic gelatins

FibroGen is the only producer of highly purified, fully characterized recombinant collagens and synthetic gelatins intended to replace similar animal- or plasma-derived materials currently used in a variety of medical, pharmaceutical, and consumer applications. The company's fermentation system enables the large-scale production of medical-grade materials. FibroGen's collagens and gelatins are fully synthetic materials that eliminate the risk of contamination with disease-causing pathogens such as viruses and prions. Currently FibroGen's products are intended for laboratory research purposes only and are not to be used in humans or for any other purposes, including but not limited to, in vitro diagnostic purposes, foods, drugs, medical devices or cosmetics or animals or for commercial purposes.

Autologous Products

Scandanavian company Vivolution sells their product range the Vivostat® System in Europe comprising two groups of products that utilize the same patented technology. The Vivostat®System is an automated system for the on-site preparation and application of patient-derived fibrin sealant or platelet rich fibrin (PRF®). It incorporates a unique and patented biochemical process that produces an autologous sealant from 120 ml of the patient’s own blood in only 23 minutes.
Vivostat® autologous fibrin sealant is used during surgery to prevent and stop bleedings and oozing of body fluids.
Vivostat® PRF® autologous platelet rich fibrin is used to promote cell growth for a range of procedures e.g. orthopaedic surgery and wound healing.

PlasmaSeal has designed three devices (called Cebus, Ateles, and Proteus) that produce Platelet Plasma Concentrate from the patient's own blood. From a regulatory perspective PPC is an autologous blood product. PlasmaSeal PPC technology is remarkably simple to use. Depending on the extent of wounded area 10 to 100 cc of blood is withdrawn from the patient and immediately mixed with standard citrate anticoagulant. The platelet plasma is separated from whole blood by centrifugation, then it is concentrated by removing some of the salt water. This second step can be accomplished in many ways. A simple method, called hollow fiber concentration uses small tubes with special walls, which are porous to salt water but not to the larger proteins and platelets in blood. It is this basic procedure and two step method that is used in all the devices.

Thermogenesis offer the advanced CryoSeal® FS System a new generation of performance for the production of fibrin sealant. The system safely and conveniently extracts high-quality fibrinogen-rich cryoprecipitate and thrombin from a single unit of autologous or allogenic plasma in approximately 60 minutes. Also the advanced Thrombin Processing Device (TPD™) provides busy operating rooms and other fast-paced environments with a rapid, safe, easy-to-use method for producing active human thrombin from either plasma or whole blood.

.

.

Inoteb has developed what it believes to be the world's first fully autologous biological glue. This Autologous Biological Glue is prepared using the patient's own blood, in a closed system, eliminating immunologic problems and the risk of blood-borne disease transmission such as, for example, HIV and hepatitis. In contrast, all surgical glues currently on the market (whether autologous or homologous) require foreign proteins such as thrombin or antifibrinolitic agents. Clinical trials have been done especially for skin replacement and skin grafts eliminating the need for protein based skin grafts.In its use to date in European trials, the Autologous Biological Glue has been shown to be clinically safe and effective. Biocoral, Inc. will continue to push through the clinical trials examining the use of the Autologous Biological Glue for cosmetic applications, utilizing well-known plastic surgeons in Europe and the United States.

Novo stops NovoSeven trauma Phase III trial

COPENHAGEN, June 11 (Reuters) - Denmark's Novo Nordisk (NOVOb.CO: Quote, Profile, Research) said on Wednesday it stopped a Phase III trial with its NovoSeven drug for treatment of bleeding in severe trauma, but added the decision was not due to safety concerns.
It said the study population had a mortality rate of 10 percent compared to more than 25 percent in the preceding Phase II trial. The study, it said, was unlikely to determine whether NovoSeven would be successful in this treatment area.
"Of course it's not positive but I had not factored in an additional (indication) for NovoSeven," said Sydbank analyst Rune Dahl. "The way to view NovoSeven currently is as (a drug with) stable sales in its existing area, and nothing more." NovoSeven is a haemophilia drug with total sales of 5.9 billion Danish crowns ($1.23 billion) last year.
By 1302 GMT, Novo shares were down 1 percent at 310 crowns on the Copenhagen exchange after briefly falling as much as 4 percent.
A Novo Nordisk spokesman said that the company had not yet decided whether to design a new Phase III study with NovoSeven for bleeding in severe trauma.
In February 2007, Novo Nordisk halted regulatory filing for the drug for bleeding in the brain after initial results from a Phase III clinical trial showed NovoSeven reduces bleeding in the brain but does not improve long-term clinical outcomes.

Vascular Closure an interesting comparison

All VCDs have demonstrated rapid hemostasis and a decreased time to ambulation when compared to manual compression(1-4). Vasoseal™ has been associated with the highest risk of infection, while Angiolink™ and Starclose™ are felt to have the lowest risk (1-4). Angioseal™ theoretically has a higher risk of thromboembolic events due to the intravascular collagen anchor. The suture-mediated devices utilize primary healing (end to end anastomosis at the arteriotomy site), but are the most complex technically and have the highest rate of device and operator failure. Collagen and ProcoagulantsThe Vasoseal™ closure device (Datascope Corp., Montvale, NJ) was introduced in 1995 (revised in 1999and 2002) and utilizes an extravascular Type-1 collagen produced from bovine tendons. When deployed at the arteriotomy site the collagen initiates coagulation by activating platelets (secondary healing). Vasoseal™ isFDA approved for both diagnostic and interventional procedures, with a single device used for 5-8 French sheath sizes. The Angio-Seal™ device (St. Jude Medical, St. Paul, MN) achieves hemostasis by sandwiching the puncture site between an intravascular bio-absorbable (over 8-12 weeks) anchor and an extravascular bovine.......................Read more HERE (its a verified safe download from Adrive)

For Current US Vascular Closure Trials go HERE

Vascular Closure - Hemostasis of the femoral artery

Every year, millions of people worldwide undergo a femoral artery catheterization. The early discharge of these patients undergoing elective diagnostic and interventional procedures, such as angiography, percutaneous transluminal coronary angioplasty (PTCA), stenting, atherectomy, and catheter ablation, hinges on the lack of bleeding complications at the access site after the procedure sheath is removed from the femoral artery. The size of the access route, coupled with routine administration of anticoagulants, creates a strong need to stop bleeding at the puncture site as quickly as possible. However, hemostasis must be achieved without producing clotting in the vessels just treated in order to prevent a potentially fatal myocardial infarction or thrombosis. Simple compression – the use of hand pressure, clamps, and/or sandbags – is currently the standard of care for managing femoral vascular access sites following interventional cases. Under this conventional technique, anticoagulation therapy is discontinued for up to four hours prior to vascular closure in order to permit the patient’s clotting capability to return to a normal state.Throughout this period, the introducer sheath remains in place and the patient must remain immobilized to prevent bleeding. Upon sheath removal, direct compression is applied to prevent bleeding and formation of hematomas. While the patient lies flat, a nurse or technician holds direct manual pressure on the site for 20 to 60 minutes until thrombus forms to seal the access site. This monotonous and tiresome task often relies on trained hospital personnel to administer. Use of sandbags and other adjunctive mechanical compression devices like C-clamps may reduce the need for the nurse or other skilled individual to continuously hold initial manual pressure.There is the possibility for these compression devices to slip, necessitating close monitoring of the patient during this critical time to ensure correct compression of the access site. Additionally, these devices have failed to show measurable advantages over hand pressure and may increase patient discomfort. Once hemostasis has been achieved, the patient’s leg must remain motionless for a minimum of six and up to 24 hours (depending on the amount of anticoagulation drug therapy used and the particular procedure) in order to avoid dislodging of the clot, which can lead to internal or external bleeding.

Vascular Closure Products

Morris Innovative - FISH

St.Jude - Angioseal

Medtronic Inc. - EVS vascular stapling system, Clo-Sur PAD

Covidien - VascuSeal

Abbott - Closure S, Perclose A-T, Perclose ProGlide, Prostar, StarClose, Chitoseal

AccessClosure - Mynx

Cardiva - Boomerang

Medafor - MPatch

Sutura - SuperStitch

Vascular Solutions - Duett, Duett Pro, D-Stat

Radi Medical - FemoStop, RadiStop