Celox - Trauma Gauze Video

Poll Result - Which Geographical Manufacturing Area for Hemostatic Devices Causes Concern?

Poll Result - Hemostatic Agents are utilized by myself or my customers primarily as?

Data is rounded to nearest full number.

New Strain of H.I.V. Is Discovered

European scientists have discovered a new strain of the virus that causes AIDS and linked it to gorillas, creating a mystery about when and how the first patient found to have the strain became infected.It is thought to be likely that this is the first time scientists have documented the jump of a simian immunodeficiency virus to humans from a gorilla. All three other known strains of the human immunodeficiency virus, H.I.V.-1, have been linked to chimpanzee's. But genetic tests showed that the new virus was closely related to a recently recognized gorilla virus. The most likely explanation for the new virus’s emergence is gorilla-to-human transmission, probably a result of humans slaughtering apes or handling or eating their meat. But the scientists said they could not dismiss the possibility that the chimpanzee virus linked to H.I.V.-1 was transmitted to gorillas and then to humans, or was directly transmitted to humans and then to gorillas. The new virus strain was isolated in 2004 from a 62-year-old woman upon her arrival in Paris from Cameroon in West Africa. She has not been treated for AIDS and has no signs of the syndrome, the scientists said. The woman had lost weight in 2003 and had been ill with number of times, the scientists said in reporting the discovery, in the Aug. 2 issue of the journal Her husband died in 1984 from complications of a stroke. It is not known if he was infected with H.I.V. The woman had six children, all born before 1980, a year before doctors first recognized AIDS; two of the children died of noninfectious causes, and none of the surviving children have H.I.V.

The authors of the report said they presumed that she had been infected through sex. The woman told her doctors that she had sexual partners in Cameroon after her husband’s death, but there was no information about whether any were infected — or, if they were, how they had contracted the virus. The amount of virus in her blood is high, reported the French and British scientific team, which was led by Jean-Christophe Plantier of the University of Rouen in France. But the number of CD-4 blood cells, a key laboratory measure of the progression of AIDS, is stable at about 300 per cubic millimeter. The scientists suspect that there are additional undetected cases because the patient lived in a semiurban area of Yaoundé, the capital of Cameroon, and she said she had no contact with apes or their meat. More studies are needed to determine how often the new virus infects people. The discovery was part of continued monitoring for new viruses. The goal is to identify a simian or other virus before it can cause another epidemic like AIDS, which has affected more than 33 million people worldwide. The new virus may escape detection by standard blood and laboratory tests for H.I.V.-1. New testing methods developed in recent years have allowed scientists to detect subtypes of H.I.V.-1. The three others are known as H.I.V.-1 Groups M, N and O. Dr. Plantier’s team calls the new one H.I.V.-1 Group P.

Sorry UK..........vCJD Filter to expensive!

A medical breakthrough that prevents the spread of the human form of mad cow disease via blood transfusions may be denied to NHS patients because it costs too much.

More than 60 adults having surgery have received blood free of the risk of variant CJD in trials overseen by the National Blood and Transplant Authority.

The advance centres on a filter that can remove the rogue vCJD protein, called a prion, from blood in just 30 minutes - eliminating the patient’s risk of catching the brain disease.

The filter could restore faith in British blood supplies which are proven to be tainted with vCJD after several deaths related to transfusions.

But documents reveal it has been branded ‘not cost-effective’ and experts warn it will double the price of producing red blood cells, leaving a bill for an extra £100million.

Donors who do not realise they are carrying the disease, which can have an incubation period of up to 50 years before showing symptoms, risk passing on vCJD when they give blood. It is feared as many as one in 4,000 could be carriers. There is no reliable way of testing stored blood to see if it is infected.

The filter simply clips on to the blood collection bag and red cells are slowly dripped through it into an empty bag underneath. Any prions are captured in a mesh containing resins that are designed to ‘attract’ amino acids found on the surface of vCJD proteins.

Animal studies have proved it prevents transmission of the deadly disease through blood transfusions.

Blood transfusions increase fatal infections in heart surgery

The risk of dying during heart surgery is increased five-fold by infections carried in blood transfusions, according to research published in the journal BMC Medicine.

The Research (click Thumbnail below) reports a 0.13% increase in predicted infection rates for every 1% increase in the frequency of blood transfusions.

Infections included those of the urinary system, lungs, bloodstream, digestive tract and skin, as well as a significant number of Clostridium difficile cases.

The small minority of patients receiving ‘autologous’ transfusions - their own stored blood - fared far better, as did those who had no blood transfusion at all.

Says study leader Dr Mary Rogers, from the University of Michigan: ‘The safety of patients undergoing a coronary artery bypass graft (CABG) will likely be improved if hospitals … institute interventions to reduce inappropriate use of blood transfusions.’

The infection rate among those receiving donor blood was 18% compared with 9.7% of patients only receiving their own blood, and 6.6% when no transfusion was carried out. Overall, 16.2% suffered a hospital infection.

King offer little on Thrombin results for Q2 09

Net sales of Thrombin-JMI were $49 million in the second quarter of this year compared to $64 million last year. The decline in net sales was split evenly between lower price and lower volume levels.

Novo Nordisk expects to start a phase 1 trial with a recombinant long-acting factor IX compound

Within the area of haemostasis, Novo Nordisk has initiated a randomised, double-blinded, placebo-controlled, phase 2 trial with rFXIII in cardiac surgery. The aim of the trial is to investigate the safety and efficacy of rFXIII on transfusion needs in patients undergoing heart surgery. The trial is expected to enrol around 400 patients and results are expected early 2011.
The phase 1 trial with subcutaneous injection of rFVIIa has now been completed. While the study showed that subcutaneous dosing is possible, the bioavailability was lower than expected. Hence, Novo Nordisk has decided not to continue into phase 2 clinical development with this mode of administration for this compound and will instead focus on subcutaneous administration of a long-acting rFVIIa expected to enter clinical development this year.
In addition, Novo Nordisk expects to start phase 2 clinical development in the third quarter this year with the long-acting recombinant FVIIa derivative, NN7128, intended for prophylactic treatment of haemophilia patients with inhibitors. The phase 2 trial will involve around 24 patients and results are expected in 2011.
Furthermore, Novo Nordisk expects to start a phase 1 trial with a recombinant long-acting factor IX compound in the third quarter of 2009. The trial is expected to enrol around 20 patients in a dose-finding trial and the study is expected to be completed in mid-2010.

U.S. Navy Awards Entegrion Contracts for $4 Million

August 6, 2009 -- The U.S. Navy has awarded two additional contracts to the life sciences company Entegrion, Inc., for implementation of the company's proprietary technologies to improve the safety and availability of blood-derived products for treating combat injuries. Recent medical research has demonstrated that such blood component therapy is essential in responding to traumatic injury, especially on the battlefield. The base contracts total about $4 million, with an additional $2 million for expanded research.

"Our military does a heroic job in overcoming the logistical challenges of ensuring that critically needed blood supplies are available when and where they are needed," said Joseph DaCorta, Entegrion's Chief Technology Officer. "Trends in clinical practice are moving toward earlier and more aggressive use of blood components after serious injury. However, availability of such therapies is often seriously restricted by shelf-life limitations and storage requirements. Technologies like ours to produce blood-derived products that can be stored for longer periods, do not require refrigeration, and have fewer pathogens will support both military and civilian medical operations by ensuring both the safety and timely availability of blood products to treat serious injuries, particularly in remote and austere areas."

The first of the new contracts is for advanced development of Entegrion's Stasix®, a dehydrated platelet-derived hemostatic agent that can be reconstituted and transfused when needed for the control of non-compressible internal bleeding. The second contract is for advanced development of Entegrion's product, Resusix®, a dehydrated, pathogen-reduced, fresh human plasma for infusion in trauma patients to expand blood volume, correct abnormal coagulation function, and support hemostasis.

"We are honored to have been chosen by the Navy to assist them in meeting these critical requirements. For Entegrion, this represents the fourth major contract for such work over the last six years. We remain totally committed to building on our track record of providing timely and effective R&D to deliver these much needed therapeutics to both our military and the civilian markets that will follow," said Stan Eskridge, Chief Executive Officer of Entegrion.

Laser-activated tissue repair trumps standard surgical closure

Boston — Photochemical tissue bonding, or laser-assisted nanosuturing, is a new cutting-edge technology that may rewrite the surgical books in terms of standard surgical closure procedures.This novel technique allows the surgeon to close the epidermal defect with laser following the application of a light-sensitive dye to the wound edges eliminating the need for epidermal suture placement. Led by Sandy Tsao, M.D., the human clinical trial is based on novel photochemical concepts developed at Massachusetts General Hospital, Boston, by scientists Min Yao, M.D., Robert W. Redmond, Ph.D., and Irene E. Kochevar, Ph.D."Traditional closure techniques work well, but there is always an issue of scarring. Dermabond adhesive liquid techniques also work, but these closure methods do not necessarily have the tensile strength to close wounds when compared to the laser-assisted nanosuturing technique, particularly in areas which may be more prone to keloid formation or unattractive scars," Dr. Tsao says.
Photosensitizing dyesPhotosensitizing dyes have already been utilized in conjunction with lasers in other therapies. Rose Bengal (RB), the ophthalmological dye used in this procedure, is approved by the Food and Drug Administration (FDA).When applied to the skin, RB is activated by light and cross-links proteins such as collagen and epidermal keratins. This non-thermal "stitching" of molecules restores the normal collagenous cross-links that are disrupted during surgery.
Clinical trialIn a recent trial, Dr. Tsao set out to determine the efficacy of wound closure using the photosensitizing dye coupled with laser irradiation and compared it to standard epidermal-interrupted suture closure.In the 28-patient study, Dr. Tsao performed 31 excisions of skin lesions that clinically needed to be removed including dysplastic nevi, SCC and BCC.All defects were closed with vicryl dermal sutures. Half of each epidermal wound was closed using standard interrupted epidermal sutures. The other wound half was closed with laser assisted nanosuturing by applying the rosebengal dye for one minute just to the incision edges of the wound followed by irradiation of this epidermal wound edge with a 308 nm KTP laser for 200 seconds. This way, each patient served as a built-in control in which the quality of closure of each part could be compared.
Results showed that a vast majority of the patients preferred the laser-assisted approach. In all cases, the tensile strength was comparable if not better than the traditional closure technique, and the scar appearance of the laser-treated side in many of the patients was near imperceptible.Though in a few cases, the scar was not clinically and aesthetically attractive, Dr. Tsao says, the laser-treated side was always the better appearing side. There were no complications, infections or dehiscence associated with either the traditional or the laser-assisted treated wound edges.Patients were evaluated at two weeks, three months and at six months. Study endpoints included efficacy of wound closure, vascularity, pigmentation, elevation, atrophy and scar appearance. The surgical sites were evaluated by two blinded physicians and patients were also asked to make an evaluation based on the same attributes."This novel technique provides a very effective means of providing epidermal wound closure with comparable if not markedly better clinical outcome compared to suture closure when evaluating scar erythema, pigmentation, atrophy, keloid formation and track mark formation," Dr. Tsao says.The excisions were attained from non-facial multiple body sites, including the shoulders, chest, back, abdomen, thighs and arms including keloid-prone areas such as the deltoid and sternal regions.Dr. Tsao says that one patient had an SCC in situ on the sternal region requiring a larger excision margin, and on the laser assisted treated side, there is simply no perceptible scar.
‘Next frontier’"With the current technology and knowledge, we still do not have the ability to close the deep dermis yet using this technique which is our next frontier. Eventually, suturing all together may become unnecessary and be a relic of the past."I think the utility beyond the necessity of removing the lesion is in areas where cosmesis is a really critical aspect of the outcome such as the face," Dr. Tsao says.According to Dr. Tsao, this revolutionary technique will save patients, as well as physicians, a lot of valuable time, because there are no sutures to be removed translating into less follow-up, a greater ease for the patient to take care of the area as well as less use of surgical materials.