Powder Hemostatic Medical Devices Segment

To date there are many types of Hemostatic Medical Devices on the market, there are also a plethora of formats utilized e.g. gauze, liquid, pastes and powders. Today I will introduce a list of powders, and while not comprehensive it is indicative of current technologies available to the surgeon. Initially Oxi Cell, Gelatin and Avitene powders were the main products. However now Chitin, and Starch/polysacharides have increased in visibility originally, and now with a very large program of out-licensing of the same technologies under different names. Powders face application and procedural technique issues, as do all formats. Over the following weeks I would like to explore needs, demands and evaluate these systems. Repetitive technology re-branding is also something I hope Blog followers will offer further thoughts on, another item to be considered is sourcing, manufacturing source such as China and due diligence of some of these companies. If you wish to contribute experience or thoughts please feel free to contact me at hemostatguy@gmail.com. We will also explore geographic factors, manufacturing,. distribution and due diligence

Pro Fibrix - Fibrocaps thrombin fibrinogen
 A dry powder based on a mixture of fibrinogen and thrombin, Fibrocaps is a ready-to-use preparation designed to be stable at room temperature and applied in different formats. This is a product and company that shows innovation! Pro Fibrix feel free to contact me.....hemostatguy@gmail.com

HemostasisLLC - Starch

BioCer Entwicklungs-GmbH is a Bayreuth, Germany based company which commercializes innovative technologies developed in conjunction with leading German Research Institutes and Universities.
Biocer have the most powerful of the plant based Starch products with HaemoCer Plus which was commercialized in Q3 2013. The video shows HaemoCer Pl;us compared to the other powdered polysaccharides with double speed and double absorbency. 

Starch Medical - PerClot Starch (AKA OrthoClot)
Absorbable Modified Polymer (AMP™) Chinese technology is a proprietary engineering process that modifies plant starch into ultra-hydrophilic, adhesive forming hemostatic polymers. AMP™ materials are biocompatible, absorbable polysaccharides containing no animal or human components. 

ClotPlus - OrthoClot Starch (AKA PerClot)
OrthoClot™ China made Polysaccharide Haemostatic System Administrator (PHS) is a natural plant-based haemostatic system composed of Absorbable Modified Polymer (AMP™). OrthoClot™ is intended as an absorbable haemostatic system

Medafor - Arista Starch (Outlicensed as Hemostase and Vitasure)
Arista™AH is an absorbable hemostat, based on Medafor's patented MPH® (Microporous Polysaccharide Hemospheres) Technology that is used in the control of profuse bleeding in general surgery when conventional procedures are ineffective or impractical.

CryoLife - Hemostase starch (AKA Arista and Vitasure) 
HemoStase is a plant-based powder that rapidly dehydrates blood and promotes clotting on contact.

Orthovita - Vitasure Starch (AKA Arista, Hemostase)
Vitasure Absorbable Hemostat is comprised of many powerful polysaccharide spheres packaged within a bellows applicator.






Celox - Chitin
Celox™ is made with chitosan, a natural polysaccharide. Chitosan has a known metabolic pathway. That means any left in the body is broken down by the bodies normal enzymes and converted into materials normally present in the body.

Hemcon (Alltracel) - Oxi Cell

Davol - Avitene

Ethicon - Gelatin Powder

Transfusion may do more harm than good..........

Watch the full episode. See more Need To Know.

Uni of Alabama at Birmingham Hospital reduced blood use by at least 25%...and slashed blood-related costs by $3.5 million annually

The results from such centres as the Englewood Medical Centre in the USA show that bloodless cardiac surgery is not only as good, but the results are actually better for those who avoid blood transfusion than those who are transfused. Murphy and colleagues in 2007 concluded that “Red blood cell transfusion in patients having cardiac surgery is strongly associated with both infection and ischemic postoperative morbidity, hospital stay, increased early and late mortality, and hospital costs.” (Murphy GJ Reeves BC Rogers CA et al Increased Mortality, Postoperative Morbidity, and Cost After Red Blood Cell Transfusion in Patients Having Cardiac Surgery.Circulation. 2007;116:2544-2552.)
More recently, Patient Blood Management programs have been introduced in many US hospitals and the Australian National Blood Service has set up a Patient Blood Management Steering Company. Commenting in their 19th August 2010 Daily Briefing, the Advisory Board Company also noted the cost savings available through Patient Blood Management: “About 110 hospitals currently have blood management programs, up from about 70 facilities in 2002 ... One program at the University of Alabama at Birmingham Hospital reduced blood use by at least 25% since 2003 and slashed blood-related costs by $3.5 million annually.”
The next generation of medical practitioners will no longer consider transfusion a free, helpful expedient. Instead they will seek ways to ensure that all uncomplicated elective surgery is achieved without any blood being transfused. That will save the precious gift of blood donors for those who really need it.

Increased Mortality, Postoperative Morbidity, and Cost After Red Blood Cell Transfusion in Patients Having Cardiac Surgery - Click Thumbnail to enlarge

Department of Defense awards Entegrion $8.2M to develop dried plasma

Life sciences company Entegrion has won a two-year, $8.2 million contract from the U.S. Department of Defense to continue development of a dried human plasma product that can be used for transfusions.
The Research Triangle Park-based company will deploy the funds to “scale-up” production and to develop efficient manufacturing processes for the production of the dried plasma, which has a longer shelf life than liquid plasma and does not have to be refrigerated, making it much easier to transport.
“This technology will help improve the safety and availability of blood and blood products for transfusion in domestic and global health applications, and we are pleased to see the military’s continued confidence and investment commitment to the technology,” said Joseph A. DaCorta, vice president and chief technology officer of Entegrion.
Entegrion develops products that help to control bleeding. Human blood contains proteins and clotting factors, is often used in situations in which patients suffer severe bleeding. Entegrion’s dried plasma product is designed to be quickly rehydrated, offering a time advantage of fresh frozen plasma, which can take time to thaw.

"There was...crap in that stuff. This stuff was manky, it was filthy, it was dirty ... but they still stuck it in the arms of children"

Patients have called for the inquiry into how people were given infected blood by the Scottish NHS to have a wider remit, as hundreds of pages of evidence were published.
Campaigners hailed the release yesterday of the preliminary report by Lord Penrose, who is chairing the probe, as a milestone.
It included a list of issues that he will investigate during the next year, among them the use of commercial blood products after it was realised internationally that they carried a risk of Aids and the acceptance of blood donations from prisoners.
Hundreds of people in Scotland were given contaminated blood in the 1970s and 1980s either as treatment for blood clotting disorders or through blood transfusions.
The plight of those who caught HIV or hepatitis C as a result is acknowledged in the opening of the preliminary report.
It says: “It would have been impossible for any person involved in this inquiry to have been unaware of and to have remained untouched by the physical, mental and emotional suffering of the individuals and families affected by these serious and potentially fatal diseases.”
Campaign groups including Haemophilia Scotland said that after years of frustration they were pleased to have such a substantial document.
However, they expressed concern that many of the victims and their families who want to be core participants with legal representation when the inquiry progresses to oral hearings will be disappointed.
About 70 patients and their relatives applied to Lord Penrose to be core participants, but so far it is understood about 14 have been accepted.
In addition, Bruce Norval, who has hepatitis C after receiving contaminated blood, complained the inquiry would not explore other infections – in addition to hepatitis C and HIV – to which haemophiliacs given clotting agents may have been exposed.
He said: “One thing that needs to be highlighted is that haemophiliacs are due a public, truthful account of the full toxic potential of the clotting agents we were treated with from childhood. At the moment, the remit would not fully allow for that.
“What we are trying to get is an understanding why this small group of people, which was 500 strong, are now down to half that number, with more dying on a monthly basis.
“There was all kinds of crap in that stuff. This stuff was manky, it was filthy, it was dirty and they knew it, but they still stuck it in the arms of children.”
The inquiry will examine how patients affected were tested for infections and informed about the results. According to the report, almost two-thirds of patient witnesses said they did not know they were being tested for hepatitis C or HIV and a number describe finding out they had hepatitis C years after tests were carried out.
Lord Penrose has been given accounts of doctors dismissing the illness as “nothing to worry about”, while one witness with HIV said the doctor who told his family was “quite blase”.
The report was released after the inquiry team analysed more than 80,000 documents and took more than 100 statements from patients and relatives.
Solicitor Advocate Patrick McGuire, of Thompsons solicitors, the recognised legal representative of families and sufferers, welcomed the report.
He said: “The document … is clearly very well reasoned and therefore a clear measure of the amount of work that has been put in by Lord Penrose and his team and for that I would personally like to thank him.”
He added that it was subject to consultation and he would be discussing some issues with Lord Penrose.
Lord Penrose said: “It is important to emphasise that I have not reached any conclusions on matters of fact or provided any recommendations at this stage and the list of topics that I have included for further investigation at the public hearings is not definitive.
“I am now inviting comments on these topics from interested individuals and organisations by the end of October.”

Bristol-Myers Squibb to Acquire ZymoGenetics

BMS to Pick Up ZymoGenetics for $885M
NEW YORK & SEATTLE, Sep 07, 2010 (BUSINESS WIRE) -- --Gains Full Rights to Promising Phase II Hepatitis C Biologic, Pegylated-Interferon Lambda

--Obtains FDA-Approved Specialty Surgical Biologic, RECOTHROM(R)

--Attains Early Clinical and Pre-clinical Programs in Oncology and Immunoscience

Bristol-Myers Squibb Company (BMY 26.78, +0.17, +0.64%) and ZymoGenetics, Inc.(ZGEN 9.76, +4.46, +84.06%) announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash. The transaction, with an aggregate purchase price of approximately $885 million, or approximately $735 million net of cash acquired, has been unanimously approved by the boards of directors of both companies. The board of directors of ZymoGenetics intends to recommend that ZymoGenetics' shareholders tender their shares in the tender offer. In addition, shareholders holding approximately 37% of the outstanding shares of ZymoGenetics' common stock have entered into agreements with Bristol-Myers Squibb to support the transaction and to tender their shares in the offer.

"The acquisition of ZymoGenetics brings us full ownership of a promising investigational biologic that strengthens our very diversified Hepatitis C portfolio. Building on our leadership in virology, we are developing a strong portfolio to help patients with Hepatitis C," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. "In addition, ZymoGenetics brings proven capabilities with therapeutic proteins and revenue from a marketed specialty surgical biologic. This acquisition is another example of our strategic, targeted approach to business development."

"By joining forces with Bristol-Myers Squibb, we believe we will enhance the long-term potential of ZymoGenetics' portfolio of assets, while providing a compelling valuation for our shareholders," said Douglas E. Williams, Ph.D., chief executive officer of ZymoGenetics. "Our collaboration with Bristol-Myers Squibb in the development of PEG-Interferon lambda has been extremely positive and it has given us an opportunity to fully appreciate their capabilities. We believe that this transaction will maximize the potential for our products and product candidates to make a meaningful difference for patients in need."

Bristol-Myers Squibb gains the following as a result of the acquisition:

-- Full ownership of pegylated-interferon lambda, a novel interferon in Phase IIb development for the treatment of Hepatitis C infection, which, if approved, could be an important contributor to Bristol-Myers Squibb's future growth. The companies have collaborated on the development of pegylated-interferon lambda since January 2009. Four-week and 12-week results from a Phase IIa study will be presented at the American Association for the Study of Liver Diseases meeting later this year.

-- RECOTHROM(R), a recombinant thrombin approved by the U.S. Food and Drug Administration for use as a topical hemostat to control non-arterial bleeding during surgical procedures.

-- IL-21 protein, a cytokine currently being tested in an open-label, Phase II clinical study as a potential immunotherapy treatment for metastatic melanoma.

-- An earlier-stage pipeline of six biologic drug candidates, including an anti-IL-31 antibody, currently in pre-clinical development for atopic dermatitis.

-- Potential milestone and royalty payments from six partnered programs in various stages of clinical development by EMD Serono, Inc., an affiliate of Merck KGaA, and Novo Nordisk.

"ZymoGenetics is a leader in advancing novel biologics, particularly genomics-based therapies," said Elliott Sigal, M.D., Ph.D., executive vice president and chief scientific officer, Bristol-Myers Squibb. "We expect ZymoGenetics' pipeline and biologics capabilities to complement and enhance our existing efforts in Hepatitis C, oncology and immunoscience."

Initially, the transaction is expected to be modestly dilutive to earnings per share (EPS) for Bristol-Myers Squibb. In 2010, the transaction is expected to be dilutive to EPS by approximately $0.03. In 2011, the transaction is expected to be dilutive to EPS by approximately $0.07.

Under the terms of the definitive agreement, Bristol-Myers Squibb will commence a cash tender offer on or about September 9, 2010 to purchase all of the outstanding shares of ZymoGenetics' common stock for $9.75 per share. The closing of the tender offer is subject to customary terms and conditions, including the tender of a number of shares which is equal to or greater than 48,282,192 shares (which represents approximately 56% of the outstanding shares as of August 31, 2010, which represent a majority of the shares on a fully-diluted basis, excluding certain shares underlying derivative securities that are significantly out-of-the-money), and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The agreement also provides for the parties to effect, subject to customary conditions, a merger to be completed following the completion of the tender offer which would result in all shares not tendered in the tender offer being converted into the right to receive $9.75 per share in cash. The merger agreement contains a provision under which ZymoGenetics has agreed not to solicit any competing offers for the company. Bristol-Myers Squibb will finance the acquisition from its existing cash resources. The companies expect the tender offer to close approximately thirty days after commencement of the tender offer.

Morgan Stanley & Co. Incorporated is serving as financial advisor to Bristol-Myers Squibb in connection with the acquisition, and Bristol-Myers Squibb is represented by Kirkland & Ellis LLP. Goldman, Sachs & Co. is serving as financial advisor to ZymoGenetics in connection with the acquisition, and ZymoGenetics is represented by Latham & Watkins LLP and Fenwick & West LLP.

Vascular Closure Devices’ Sharp Rise in Unit Sales Drives the Overall U.S. Peripheral Vascular Device Market

Vascular closure devices, which include both invasive and non-invasive products, are rapidly being adopted by the medical community. The market for VCDs is expected to exhibit strong growth through to 2016, thus driving the total U.S. market for peripheral vascular devices.

Vascular Closure Devices

VCDs are used in both coronary and peripheral vascular procedures, particularly if a catheter is used during an endovascular treatment. The traditional method for achieving vascular closure is manual compression, where a healthcare worker applies pressure to the site in order to achieve hemostasis. However, manual compression is not only time consuming for healthcare employees, but also requires the patient to remain immobile for an extended period of time.

With the rise of for-profit medical centers and a shortage of available nursing labor, the medical industry has sought a safe and effective alternative to manual compression. Since VCDs were approved for use in the U.S. in the 1990s, two types of devices have been developed: invasive and non-invasive. Invasive VCDs are used percutaneously and achieve hemostasis through the use of sealants, sutures or specialized sponges, while non-invasive VCDs involve the use of a compression pad or inflatable bulb at the surface of the site to mimic the effects of manual compression. In 2009, invasive VCDs represented 85.5% of the total VCD market revenues, while non-invasive devices comprised the remaining 14.2%. While the use of both types of VCDs is expected to rise, growth in non-invasive devices will outpace, but not overtake, invasive devices by 2016.

VCDs Are Cost-Effective and Time-Efficient

VCDs offer healthcare facilities a cost-effective option for vascular closure. While price was a limiter when the devices were launched, the average selling price of the devices has decreased dramatically in recent years, and will continue to decline. Furthermore,
non-invasive VCDs are, on average, four times less expensive than their invasive counterparts, boosting their popularity.

With the general shortage of nursing labor, many hospitals are finding it cost-effective and time-efficient to employ VCDs. Non-invasive VCDs remove the need for manual pressure by a healthcare worker and therefore also lessens labor costs. In addition, the use of invasive VCDs further reduces the time necessary to perform vascular closure. Interventional cardiologists are performing peripheral procedures at an increasing rate and are opting to use VCDs in order to reduce operation times and thereby maximize the number of procedures that can be performed per day. Furthermore, the use of VCDs has the potential to allow more procedures to be performed in outpatient settings, significantly increasing patient turnaround times and decreasing costs. The cost savings and reduced times will continue to encourage healthcare facilities to adopt VCDs, especially as hospital budgets become more constrained.

Device Improvements

The relative complexity of VCDs, particularly invasive products, was initially the source of complications due to improper use. However, VCDs have gone through many design configurations since their introduction and different closure methods have been developed. Abbott Laboratories’ StarClose™ and Perclose® invasive VCDs have reduced rates of complications, such as the migration of closure agents through the vascular system. These devices close the arterial hole with a nitinol clip on the exterior of the vessel, meaning that nothing remains in the artery after the procedure.

AccessClosure’s Mynx™ invasive VCD is another device that is designed to reduce procedural complications, such as trauma to the vessel and expansion of the tissue tract. The device applies a bio-inert sealant to the surface of the artery, closing both the arterial opening and the tissue tract. In addition, the Mynx™ can be deployed through an existing procedural sheath, which further eliminates the need for a sheath exchange. The device has increased its adoption rate in recent years and shows great potential.
As manufacturers, continue to address the concerns associated with using VCDs and develop innovative solutions, these devices will account for an ever increasing proportion of vascular closure procedures.

Growth Drivers

The aging population of the U.S. has led to an increase in the number of patients with peripheral arterial disease (PAD), resulting in increasing demand for peripheral vascular procedures. Furthermore, this increase in procedure demand coincides with the rise in the number of for-profit medical centers that have lower staffing levels and a higher preference for VCDs. Between 2005 and 2010, the number of VCDs used has risen more rapidly than the number of peripheral catheterization procedures. Growth of VCD use exceeded that of catheterization procedures due to the continuing shift from manual compression to VCD use. As a result of this growth, by 2016, it is expected that over one million VCDs will be used for peripheral vascular procedures, representing an approximately 50% increase in unit volume from 2009.

Minnesotans Help Produce As Well As Benefit from Lifesaving Therapies

ANNAPOLIS, Md., Sept. 1 /PRNewswire/ -- This month, Minnesotans are recognized for their outstanding contributions to lifesaving therapies that treat critically ill individuals and for their donations of the blood component, plasma, that makes the creation of these unique therapies possible. Throughout September, Minnesota Gov. Tim Pawlenty is recognizing "Plasma Protein Therapies Month" in the North Star State, helping to raise awareness for the rare, genetic diseases treated with the therapies and valuing the contributions of voluntary plasma donors in the state.

Plasma protein therapies, which include plasma-derived therapies and recombinant blood clotting factors (a biotechnology product), are used every day to treat people with hemophilia, a blood clotting disorder that causes painful internal bleeding and debilitating joint damage; primary immunodeficiency diseases, which rob a person's ability to fight even common infections; and alpha-1 antitrypsin deficiency, also known as genetic chronic obstructive pulmonary disease (COPD). In addition, a plasma protein therapy, albumin, is used in critical care settings, when treating severe trauma, burns and during major surgery.

Plasma, a biological material that cannot be manufactured, is used to create lifesaving therapies that come solely from committed plasma donors. The state of Minnesota is home to 11 plasma collection centers. As Minnesota celebrates the generosity of its donors and raises awareness for the rare diseases that are treated with the therapies during Plasma Protein Therapies Month, we encourage everyone to donate and to help ensure a higher quality of life for patients across the United States and around the world.

"Always serious and often life-threatening, patients requiring plasma protein therapies suffer from serious diseases and disorders and need access to critical therapies manufactured from high-quality plasma from dedicated donors such as those in Minnesota," said Josh Penrod, Vice President, PPTA Source. "Donors continue to be recognized and valued as a critical component in the production of these therapies."

For more information about plasma protein therapies, the diseases they treat and donating plasma, please go to www.donatingplasma.org.

The Plasma Protein Therapeutics Association (PPTA) represents the world's leading manufacturers of plasma-derived and recombinant biological therapies, collectively known as plasma protein therapies and the collectors of source plasma. These critical therapies are infused or injected by more than 1 million people worldwide to treat a variety of rare, life threatening diseases and serious medical conditions. PPTA members produce in excess of 80 percent of the plasma protein therapies used in the United States today and more than 60 percent worldwide. PPTA is a global trade association that administers international, voluntary standards programs to help ensure the highest quality and safety of plasma protein therapies and the plasma collected to manufacture them. Additionally, PPTA works in partnership with the patient community and consumer advocates to help ensure continued access to lifesaving plasma protein therapies.

Baxter - Naughty advertisements say FDA

Federal regulators are warning Baxter Healthcare that it is overstating the benefits of Aralast, an emphysema drug, and say they have noticed that the company has a disturbing trend of overstating the effectiveness of its drugs and medical products. On August 3, the FDA sent a warning letter to Baxter CEO

Robert Parkinson, Jr., accusing the company of deceptive advertising in a physician brochure for Aralast NP. The FDA has determined that the brochure misbrands Aralast NP illegally, making overstated claims of efficacy. The FDA warning letter states that the Aralast brochure makes the drug appear to be more effective than has been demonstrated by implying that its alpha1 – antitrypsin levels have a protective effect and clinical benefits that have not actually been clinically proven. In an unusual move, the agency also admonishes the company for its trend toward misleading advertising. “[W]e are very concerned by your continued violative promotion of your products,” the letter states, and then points out that the FDA has cited Baxter for similar violations of overstated efficacy and “unsubstantiated claims of superiority” in letters on April 14, 2009 and July 7, 2008. The April 2009 warning letter cited the company for false and misleading advertising for TISSEEL, a hemostatic surgical tissue glue. Baxter claimed that TISSEEL was 97.5% effective in achieving hemostasis in patients undergoing a cardiopulmonary bypass while on Baxter’s blood thinner, Heparin. The FDA said that claim was unsubstantiated. The July 2008 warning letter chastised the company for also overstating the efficacy of FEIBA VH, a freeze-dried, sterile form of human plasma used to control bleeding in patients with hemophilia in an e-mail. The company claimed that the substance controlled bleeding in 60% of cases within 12 hours of the first infusion. The FDA said that was inconsistent with the prescribing information, which only noted a success rate of 36% with one infusion. The FDA also said the company understated the risk of serious thrombotic events. In its latest warning letter, the FDA has demanded that Baxter not only fix the misleading Aralast information, but is also requiring the company to come up with a plan in writing that will put policies and procedures in place in the company to prevent future misleading advertising problems. If the company fails to comply it could be subject to FDA regulatory action, including seizures and injunctions.

What is Recombinant - Molecular Engineering?