Hemostasis Solution Controls Bleeding during Surgery

A novel handheld device delivers a powder based on collagen to help surgeons achieve hemostatic bleeding control during surgical procedures.

The Biom’Up (Saint-Priest, France) HemoBlast Bellows is a sterile delivery device that is preloaded with a dry, sterile powder made of highly purified porcine collagen, glucose, chondroitin sulfate, and thrombin. The hemostatic powder is applied to the source of the bleeding by squeezing the bellows. Once applied, the powdered collagen and glucose components start the coagulation process by absorbing blood, concentrating coagulation factors and platelets, and providing a surface for autologous coagulation to begin.

In addition to collagen, the thrombin component, collected from pooled human plasma (an ancillary blood derivative) is included in the powder to boost the effect of the hemostatic agent. The thrombin facilitates the conversion of fibrinogen to fibrin, which allows the blood to clot. The chondroitin sulfate powder component provides cohesion between the hemostatic wound and the surrounding tissue. Users do not need to thaw, mix, or heat the powder, which is absorbed by the body within four weeks.

“As the first active hemostatic powder, it will support surgeons in their care for their patients with a simple, effective, and holistic solution for the management of bleeding” said Etienne Binant, CEO of Biom’up. “Biom'up has created innovative and clinically proven products that cover many different surgical specialties - orthopedics, spinal, cardiac, general, and maxillo-facial and dental.”

Studies have shown that during general surgical procedures, the HemoBlast Bellows device achieved 93% efficacy for hemostasis within six minutes, with a significantly shorter preparation time. Common adverse events included abnormal bloodwork, anemia, arrhythmia, and pain, none of which were related to the device itself. No unanticipated adverse device effects occurred.

Collagen is the main structural protein of connective tissue, making up 25-35% of the whole-body protein content. It is one of the body’s key natural resources and a component of skin tissue that can benefit all stages of the wound healing process. The importance of re-establishing a functional extracellular matrix (ECM) in chronic wounds has led to a renewed interest in collagen-based wound healing products, which can be applied either in the surgical or clinical setting, serving as a natural wound dressing with properties that artificial wound dressings do not possess.

European Medicines Agency Accepts Marketing Authorization Application for The Medicines Company's Fibrocaps

PARSIPPANY, NJ--(Nov 21, 2013) - The Medicines Company (MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational hemostatic agent Fibrocaps (human plasma-derived fibrinogen and thrombin). Fibrocaps was studied in the 719-patient Phase III FINISH-3 clinical trial as an adjunct to hemostasis in patients undergoing surgical procedures when control of mild or moderate bleeding by conventional surgical techniques is ineffective or impractical. 
The acceptance of the MAA marks the beginning of the review process in the European Union for Fibrocaps. The Company anticipates submitting a biologics license application (BLA) with the United States Food and Drug Administration in the first quarter of 2014. The Company also plans to submit a 510(k) application with the FDA for the complementary spray delivery device to assist surgeons in the accurate application of the dry powder Fibrocaps. The device was recently granted a European CE mark. 
"We believe Fibrocaps can become an important hemostatic solution within our surgery and perioperative care portfolio upon regulatory approval," said Jan Ohrstrom, MD, Senior Vice President Global Launch Leader, Hemostasis Solutions of The Medicines Company. "We are expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare."
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Forward-looking Statements
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "plans, "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Registration Statement on Form 10-Q filed on November 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

BioCer Launch of HaemoCer Plus versus Arista, Perclot and unknown other as presented at EACTS in Vienna

Clearly demonstrated without question German technology continues to impress as "THE" device developer in the powdered plant based starch market. In the video you see from left to right Arista, Perclot, Unknown and the radical new polysaccharide agent HaemoCer Plus.

It's Perclot AMP.......No, It's Endoclot AMP

Cryolife last month announced that finally they had some good news regarding the litigation with Medafor, and under terms of the settlement, Medafor has agreed to pay CryoLife $3.5 million in cash. However the Atlanta based CryoLife foray into the powdered Hemostat market segment may still prove "interesting". When making their arrangement with Chinese Starch Medical for rights to Perclot in all territories worldwide excluding China, Hong Kong, Macau, Taiwan, North Korea, Iran and Syria. They also included the following in the contract:

  1.5 Product Applicators, Etc. SMI agrees to promptly notify CryoLife of all improvements to applicators, tips and other accessories included within or used in connection with the Products, including all new applicators, tips and other accessories. All such improvements and any such new applicators, tips or accessories to the Products shall be included within the Products and the Parties shall adjust the catalog of Products to reflect these new products, with any transfer price to be negotiated in good faith, but based solely on costs to SMI for such improvements and/or new applicators, tips and accessories. The Parties agree that the Endoscopic applicator system used for powder delivery via gastrointestinal endoscope, as further described on Schedule 2.1 is not an improvement or new applicator and is not included in this Agreement.

2.   Distribution

    2.1  Limitations on SMI Activities. During the term of this Agreement SMI agrees (i) to sell the Products exclusively to CryoLife for use in Permitted Clinical Applications within the Territory, (ii) to refrain from selling or licensing any Products to any Existing Distributor or Third Party for sale or distribution in Permitted Clinical Applications within the Territory, (iii) to refrain from directly or indirectly marketing, promoting, or encouraging any Third Party to market, promote or Distribute the Products for any of the Permitted Clinical Applications within the Territory, (iv) to refrain from licensing or transferring any AMP™ Technology to any Third Party within the Territory for the purpose of manufacturing any Products upon terms or conditions that would enable or allow such Third Party to sell any Products for Permitted Clinical Applications within the Territory. In addition, SMI agrees that it shall refrain until January 1, 2015 from (A) directly, or indirectly selling, permitting to sell, market, promote or encouraging third parties to sell, permit to sell, market or promote any Competitive Product (defined below) for any Permitted Clinical Application within the Territory or (B) licensing or transferring to any Third Party technology that would enable or allow any Third Party to manufacture any Competitive Product within the Territory. The provisions of the foregoing sentence shall be deemed further modified so that SMI may only take the actions described therein if SMI complies with Section 1.4 (and therefore CryoLife does not match the right of first refusal set forth therein). As used herein, “Competitive Product” means any powdered absorbable surgical hemostat that is intended for or could be used for a Permitted Clinical Application. The foregoing limitations do not apply to sales by SMI of those products described on Schedule 2.1.

Read the full document HERE

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Now Cryolife and their partners face the interesting prospect of Chinese made Perclot AMP particles meeting them in the EU re-branded as "Endoclot".  

As can be seen HERE the original Chinese Xijing Hospital trial changes for the use of AMP show the changes from perclot to "endoclot", but the endoclot webpage discusses AMP particles....see HERE. 

The CRY Q2 Earnings Conference Call is scheduled for 7/31/2012. 
Click the images below to enlarge

Hemostatic Powder Market - Cook Rollout of Endoscopic Application

Novel application of powder could eventually replace endoscopic surgical procedure

TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.

German Company Biocer, Advances Plant Based Hemostatic Powder Technologies

BioCer Entwicklungs GmbH is a young and innovative company. Now on the basis of its comprehensive knowledge our developer team succeeded to provide health care with two seminal products according to the model of the nature.
With the help of a nanotechnological surface coating, implant materials are modified in a way that the medical devices grow in faster and more optimized. These biocom-patible coatings are now applied for the first time to polymer meshes, which are used as soft tissue reinforcement for hernia repair. In cooperation with experts from the textile branch BioCer Entwicklungs GmbH managed to develop a medical device which fulfills together with its optimized surface all demands of a modern mesh im-plant.
Also the development of our innovative hemostatic powder HaemoCer® was per-formed according to nature. HaemoCer® consists of plant based particles with an extremely high hygroscopicity, so that the natural coagulation cascade is accelerated. Hemostasis occurs within short time and HaemoCer® will be completely absorbed from the body within a few days.
With its new products BioCer Entwicklungs GmbH supports the surgeon as well as the patient in healing and restoration of the health.
Click Thumbnail Below for Presentation (note this presentation has been updated at the companies request)

BIOCER ENTWICKLUNGS-GMBH
Ludwig-Thoma Straße 36c
95447 Bayreuth
Telefone: +49 (0) 921 78 77 70 0
Telefax: +49 (0) 921 78 77 70 79
info@biocer-gmbh.de

CRYOLIFE ENTERS INTO WORLDWIDE DISTRIBUTION AND MANUFACTURING AGREEMENTS WITH STARCH MEDICAL

LATEST PERCLOT PATENT CLAIMS SHRINK - NEWS Please click HERE

ATLANTA, Sept. 28 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has entered into a worldwide distribution agreement and a manufacturing agreement with Starch Medical Inc. (SMI) of San Jose, California for Chinese manufactured PerClot®, a novel polysaccharide hemostatic agent used in surgery.  

Effects of an absorbable polysaccharide hemostat PerClot(r) on fracture healing of the cranial bone

PerClot is a unique, absorbable powder hemostat that has CE Mark designation allowing commercial distribution into the European Community and other markets.  It is indicated for use in surgical procedures, including cardiac, vascular, orthopedic (no mention of OrthoClot was made in the release), spinal, neurological, gynecological, ENT and trauma surgery as an adjunct hemostat when control of bleeding from capillary, venous, or arteriolar vessels by pressure, ligature, and other conventional means is either ineffective or impractical.  CryoLife plans to file an Investigational Device Exemption (IDE) with the United States Food and Drug Administration (FDA) to begin clinical trials for the purpose of obtaining Pre-Market Approval (PMA) to distribute PerClot in the U.S.
"PerClot is an exciting technology platform that has already seen significant success in Europe.  Its unique formulation allows for full and rapid absorption, while showing excellent hemostatic capabilities.  We are very pleased to have secured the rights to this second generation hemostatic agent and its laparoscopic delivery devices via an agreement that will allow us to serve a broader range of medical specialties and leverage the continued opportunities in the large and growing hemostatic agent market," said Steven G. Anderson, president and chief executive officer.
The U.S. hemostatic market is estimated to be $732 million in 2010 growing to approximately $1.1 billion in 2014, while the European market is estimated to be $279 million in 2010 growing to approximately $430 million in 2014.(1)
CryoLife intends to distribute both PerClot and HemoStase® until CryoLife can no longer sell HemoStase as a result of Medafor's termination of the parties' distribution agreement for HemoStase.  Alternatively, CryoLife believes that in accordance with the terms of the agreement, at its sole discretion, CryoLife can return its inventory of HemoStase to Medafor for reimbursement.  CryoLife anticipates that it will commence distribution of PerClot in several international markets in the fourth quarter of 2010 and will obtain U.S. FDA approval by the end of 2013.  
"We were restricted by Medafor's continued attempts to terminate our agreement, including interruptions in product shipments.  In addition, our agreement with Medafor limited our ability to sell HemoStase in all surgical specialties.  Our international and largely unrestricted distribution agreement with SMI for PerClot addresses these issues and allows us to remain active in this important market," said Mr. Anderson.
Transaction Terms
Under the terms of the agreements, CryoLife receives the worldwide rights, excluding China, Taiwan, Hong Kong, Macau, North Korea, Iran and Syria, to commercialize PerClot for all approved surgical indications and a license to manufacture the PerClot product, exclusive of rights to sell PerClot with an endoscope.
As part of the transaction, CryoLife will pay SMI $6.75 million in cash and $1.25 million in restricted CryoLife stock, which includes $1.5 million in prepaid royalties.  CryoLife will pay an additional $2.75 million to SMI if certain FDA regulatory and other commercial milestones are achieved, and will also pay royalties on sales of PerClot manufactured by CryoLife.
The PerClot distribution agreement contains certain minimum purchase requirements and has a term of 15 years.  CryoLife may begin manufacturing PerClot from plant starch modified by SMI once the technology transfer from SMI has been completed, which is anticipated to occur sometime in 2011 or 2012.  Following the technology transfer and U.S. regulatory approval, CryoLife may terminate the distribution agreement.  In addition to allowing CryoLife to manufacture PerClot, the license agreement grants CryoLife a three-year option to purchase the remaining technology from SMI.
CryoLife estimates that the costs to develop PerClot and gain U.S. FDA approval will be between $5.0 million and $6.0 million, of which up to $750,000 is expected to be incurred in the fourth quarter of 2010 and the remainder over the next six to eight quarters.  Additionally, the Company estimates that it will incur up to $300,000 in product launch and other costs related to PerClot in the fourth quarter of 2010.  The Company will update its 2010 financial guidance and issue its initial 2011 financial guidance on its third quarter financial conference call.
About PerClot
PerClot is a medical device composed of absorbable modified polymer (AMP®) particles and delivery applicators.  AMP particles are derived from purified plant starch.  PerClot contains no human or animal components.  It is intended for use as an absorbable hemostatic system to control bleeding during surgical procedures or following traumatic injuries.
PerClot is ready to use, requiring no mixing and/or other components and does not need special handling or storage conditions.  Pre-clinical evaluations, clinical studies and surgical use have shown the efficacy of PerClot to be comparable to the current popular choice of surgical hemostatic materials while its unique formulation allows for rapid absorption.  PerClot particles are readily dissolved by saline irrigation and are degraded rapidly by human enzymes, primarily amylase, within several days.
About CryoLife
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada.  The Company's CryoValve® SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves.  The Company's CryoPatch® SG pulmonary human cardiac patch has FDA 510(k) clearance for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia.  CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.  The Company's BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels.  BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair.  The Company's BioFoam® Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.  CryoLife currently distributes HemoStase®, a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in many international markets for cardiac, vascular, and general surgery, subject to certain exclusions, although CryoLife has received notice from Medafor that it has terminated its HemoStase distribution agreement with CryoLife.

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

Hemostase - Medafor states CryoLife Press Release is Misleading and False

Please click the thumbnail to read.

PS - Happy Independence Day!

Hemostase: Medafor says its off...CryoLife its on.......

NOT SO FAST, MY FRIEND!

The continued quagmire that is the CryoLife/Medafor relationship appears set to continue according to This latest Press Release from CryoLife.

Background

After a failed takeover bid by CryoLife they encouraged Medafor shareholder's to withhold their votes at a recent Medafor shareholder meeting. This was rejected by 95% of the 70% of attendee's and one disappointed shareholder will no doubt be Jim Karerchersuch who commented "I say get rid of CryoLife and let investors make some money,".

Expenses in the tussle continue to escalate for both companies with Medafor CEO Shope stating... "The real problem for Medafor is the distraction and expense stemming from CryoLife's takeover bid and continuing litigation, Shope said. Had it not been for the $1.2 million the company shelled out for legal expenses last year, Medafor would have been profitable, ."

and another online source stating ...."Anderson, who launched the hostile takeover attempt of Medafor in 2009 and chose several public venues to prosecute his case, spent approximately $6 million in the effort."

Conclusions

For those on the sidelines this extremely public battle has been an intriguing insight. Lately barely concealed personal attacks are now appearing in certain news articles relating to CryoLife CEO Steven Andersons, age and absence from the shareholder meeting despite his residence in MN. Meanwhile Medafor management were brought under the spotlight with the CryoLife claim "that Medafor's CEO and chief financial officer earned a combined $700,000 last year." Medafor management also denied any issues related to the fact that Medafor senior executives, and Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. With Pasquale claiming it isn't necessary to live locally.

Investors and Distributors must be feeling unsettled by the lack of clarity in terms of supply, and without any public statement from Medafor or the courts (where both companies appear more comfortable communicating) the status quo appears confusing.

One positive indication from this mess is that plant-based hemostatic technology is certainly worth fighting for. Medafor partner Orthovita must have an eye on these occurences, as will other key China manufacturer Starch Medical.