Baxter Introduces Hemostat in Europe

DEERFIELD, Ill., Oct 23, 2013 (BUSINESS WIRE) -- Baxter International Inc. BAX -0.04%  today announced the launch of HEMOPATCH Sealing Hemostat, a novel collagen-based hemostatic device, following CE mark approval in Europe. HEMOPATCH is a resorbable hemostatic device used for surgical procedures when control of bleeding by pressure, ligature or conventional procedures is either ineffective or impractical. The development of HEMOPATCH combined Baxter's expertise in collagen, internal coagulation processes, and PEG (polyethylene glycol) technology platforms.

''HEMOPATCH is a valuable addition to the tools in the surgical suite, as it provides fast hemostasis and strong tissue adherence. Surgeons will appreciate that the product works quickly and effectively, does not require preparation time, and can be used in a range of surgical settings,'' said Frank Ulrich, M.D., head of surgical oncology at Goethe University in Frankfurt, Germany.

HEMOPATCH is a soft, thin and flexible collagen pad that is designed to allow surgeons control during application to gain hemostasis and firm adherence of the hemostatic pad to the bleeding tissue surface. In preclinical tests, HEMOPATCH achieved fast and effective hemostasis, reaching 97.5 percent success by fully controlling bleeding at two minutes.

The pad consists of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG). This gives the pad a dual-method mechanism of action, in which two components interact to achieve hemostasis by sealing off the bleeding surface and initiating the body's own clotting mechanisms. Significant preclinical testing was conducted to confirm its hemostatic performance, biocompatibility, and safety profile.

''HEMOPATCH is a significant innovation in the field of surgical hemostasis and is a valuable enhancement to the portfolio of biosurgical products offered by Baxter,'' said Russell Holscher, vice president of research and development in Baxter's BioSurgery business. ''Importantly, the robust development process, including evaluation of more than 400 prototypes with feedback from more than 200 surgeons, exemplifies the company's commitment to customer-centric innovation. This hemostat will offer surgeons a valuable new tool. We plan to support the registration and launch of HEMOPATCH in additional countries in the coming years.''

About HEMOPATCH

HEMOPATCH Sealing Hemostat is intended as a hemostatic device for surgical procedures when control of bleeding by pressure, ligature, or conventional procedures is either ineffective or impractical.

Important Risk Information

HEMOPATCH Sealing Hemostat is not intended to be used in pulsatile, severe bleedings. The use of HEMOPATCH Sealing Hemostat is not recommended in the presence of an active infection. When used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm, care should be exercised to avoid overpacking (collagens do expand upon absorption of liquid, and may create the potential of nerve damage). HEMOPATCH Sealing Hemostat is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.

Do not compress HEMOPATCH Sealing Hemostat into blood vessels or use intravascularly. The device must not be used in patients with known hypersensitivity to bovine proteins or brilliant blue (FD&C #1, blue dye).

Integra LifeSciences to Acquire DuraSeal(TM) Product Lines From Covidien

PLAINSBORO, N.J., Oct. 28, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today it has entered into a definitive agreement with Covidien to acquire the Confluent Surgical product lines, including surgical sealants, adhesion barrier, and, most importantly, DuraSeal(TM). The companies expect to complete this transaction by the end of the first calendar quarter of 2014, subject to receipt of regulatory approvals.
Under the terms of the agreement, Covidien will receive an initial cash payment of $235 million from Integra upon the closing of the transaction. Additionally, Covidien may receive up to $30 million, contingent upon the achievement of certain performance measures related to the transition of the Confluent Surgical business to Integra.
"The addition of the DuraSeal(TM) product lines enables our sales force and distributor partners to provide their customers with a best-in-class dural sealant as they seek to support surgeon's efforts to minimize cerebrospinal fluid leaks upon completion of the surgical procedure," said Robert Davis, President of Integra's U.S. Neurosurgery division. "This acquisition perfectly complements our global Neurosurgery growth strategy aimed at providing a broader set of solutions for surgical procedures in the head. Together with our broad DuraGen(R) product line we are fortunate to have even more options to serve our customers and the individual needs of their patients."
"This transaction allows Covidien to better focus on its global strategic priorities," said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. "Based on Integra's presence in neurosurgery and spine surgery combined with a strong portfolio of clinical evidence, we believe these products will thrive under Integra's ownership. We express our sincere gratitude to our dedicated employees and the clinicians who have partnered with us throughout the years."
Confluent Surgical products include: DuraSeal(TM), DuraSeal(TM) Exact/Xact, VascuSeal(TM) and SprayShield(TM). These products generated approximately $65 million in revenue (unaudited) during 2012 and gross margin comparable to Integra's regenerative medicine product portfolio. Integra expects to provide detailed guidance regarding the financial impacts of this transaction upon closing. Preliminarily, Integra would expect the acquisition to add $57 million to $60 million in revenue in the first full year of the combination, and to then grow 3% to 5% longer term.
"This transaction adds scale to our business, leverages one of our strongest customer call points, and drives accretion to our gross margins," said Jack Henneman, Integra's Chief Financial Officer. "Upon completion of the transaction, we expect this deal to be accretive to both GAAP and adjusted earnings per share in the first year after considering the financing costs of the transaction."
Integra expects that revenues acquired through this transaction would be reported in its U.S. Neurosurgery and International divisions.

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.

BioCer Present Newly EU Approved Super Rapid Plant-based Hemostat at EACTS

BAYREUTH, Germany, September 24, 2013 /PRNewswire via COMTEX/ -- BioCer Entwicklungs GmbH (BCE) a German implantable biological medical device development and manufacturing company announced today that it has achieved commercial approval to begin distribution in the EU, and international markets where CE mark is accepted of HaemoCer Plus. HaemoCer Plus is an Absorbable Polysaccharide Hemostat (APH) and an innovative powerful hemostatic technology that exhibits exceptional speed and ratio of absorbency.

"HaemoCer Plus follows 2 years of development and is a huge technological milestone with clear efficiency benefits. In comparative testing with our first agent HaemoCer the accelerated absorbent product nature is significant, and clearly evident to a far greater extreme with older plant-based powdered agents. As surgeons experience the rapid mode of action of HaemoCer Plus we expect they will convert, and this product will rapidly dominate this market segment," stated Dr. Markus Heinlein, Managing Director BCE. "As problematic bleeding in cardiac surgery is a constant challenge, BioCer are pleased to present and launch HaemoCer Plus at the EACTS."

Haemocer Plus APH is a plant-based hemostatic agent that utilizes the same raw material as BCE's flagship product HaemoCer. HaemoCer Plus APH technology is delivered in a powder format developed utilizing a new modification to Biocer's Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) manufacturing process. The new highly absorptive, biocompatible agent now performs at exceedingly fast absorptive speeds achieving results twice as fast and at double the capacity of HaemoCer.

HaemoCer Plus will be presented at the EACTS 5th-9th October 2013 in Vienna, Austria. Other meetings in 2013 include Medica (Germany) and Asia Pacific Hernia Society (Hong Kong) at BioCer's booth. BioCer also plan to attend Arab Health and welcome expressions of interest in distribution or licensing queries to please visit http://www.biocer-gmbh.de or email info@biocer-gmbh.de.

FDA Accepts Biomedica MC Investigational New Drug Filing for ClotFoam®

The U.S. Food and Drug Administration (FDA) has accepted Biomedica’s Investigational New Drug (IND) application for ClotFoam, a novel hemostat for intraoperative hemorrhage. The company is developing ClotFoam as the leading agent of a portfolio of hemostatic products based on its proprietary “CLOT” technology. The company will now conduct clinical trials supported by the National Heart Lung and Blood Institute of the National Institutes of Health.

ClotFoam was originally conceived to control severe hemorrhage without need of compression in order to address unmet needs in gynecology, combat trauma and emergency medicine, as well as treatment of trauma in the operating room. Current trials are designed to prove the safety and efficacy of the product as an adjunct in solid organ hemorrhage. Once the agent is approved for this indication, the company will conduct additional trials as a primary treatment in trauma patients.

ClotFoam’s ability to control bleeding is based on rapid and powerful activity of fibrin monomer carried by a foam with high affinity to endothelial tissue. ClotFoam has shown promising results in animal models of large organ resection without need of compression and with minimally invasive application methods. Preliminary assays indicate that the agent is also effective in controlling severe acute menstrual cycle disorders (i.e. menorraghia) and post-partum hemorrhage, which is the most common cause of perinatal maternal death in the developed world and is a major cause of maternal morbidity worldwide. These types of severe clinical situations are well adapted for the ClotFoam technology because of it’s self-expanding and non-compressible hemostatic action, unlike common hemostats available in the operating room today.

Biomedica plans to complete Phase I in the course of 2013 and initiate Phase 2 clinical trials as an adjunct to hemostasis in the first quarter of 2014. The company has requested Fast Track Designation for ClotFoam. This designation is reserved for drugs that advance novel technologies, and are expected to provide significant therapeutic advantages over existing products while addressing unmet medical needs. Fast Track designation benefits form priority review status. Orphan Drug Status will be requested for the ClotFoam Battlefield special formulation. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for orphan drug grants; and waiver of certain administrative fees.

About Biomedica’s CLOT development Program. The Clot technology
uses fibrin monomer manufactured under proprietary methods that produce stronger, faster, less expensive and purer hemostats. Clot bypasses the conversion of fibrinogen by thrombin allowing for instant polymerization at lower concentration. Clot products resist degradation, do not contain thrombin, and can be shaped as a foam, a gel, a patch, a pellet, a screw or a spray.

Biomedica’s proprietary technology has produced ClotGel, ClotBlock, ClotCut, EyeClot and ClotSpray. While ClotGel is similar in appearance and efficacy to the leading hemostatic agent Floseal, it does not contain thrombin allowing for intraoperative blood salvage and minimal swelling. ClotBlock has important applications in orthopedic surgery as well as in persistent solid organ bleeding. ClotCut is a promising solution of cutaneous bleeding in emergency medicine, and ClotSpray may replace many of the current fibrin sealant applications with a more simple one-component solution stored at refrigerated conditions (compared to frozen fibrin sealant), faster polymerization times, and easier-to-use surgeon application characteristics.

About Biomedica Management Corporation. Biomedica is a clinical-stage federally funded research and development company headquartered at the SUNY Downstate Biotech Center in Brooklyn, NY, with biochemistry laboratories at the UMBC TechCenter in Baltimore, MD. The company was funded in 1999 as a collaborative effort between scientists in the fields of biochemistry, immunology, and trauma surgery The Company operates under an innovative business model that fosters the development of critical technologies with the vision of academic scientists and the guidance of marketing experts. Biomedica brings to the market affordable and effective technologies targeting unmet needs in coagulopathic-related conditions, inflammation, sepsis and wound healing. The Company’s most clinically advanced product candidate ClotFoam is derived from its proprietary Clot ™ platform designed to improve hemostasis in patients undergoing a wide range of surgical and medical procedures. The product development has been supported by the National Institutes of Health, the US Army Medical Research and Materiel Command and by TEDCO, the Technology Corporation of Maryland.

Cohera Medical Completes Sylys® Surgical Sealant Clinical Trial

Cohera Medical, Inc.^®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced it has treated its last patient for the clinical trial for Sylys^®, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures. The results of the study will be released later this fall.

The European study is evaluating the safety of Sylys as an adjunct to standard closure techniques following bowel resections. The study included patients enrolled at two sites in the Netherlands.

Anastomotic leaks, on average, occur in 3 - 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 - 4B market.

"We are thrilled to be collaborating with leading surgeons in the Netherlands to treat patients with our Sylys product, our second class III product designed to support more natural healing and help reduce post-operative complications," said Patrick Daly, President and Chief Executive Officer of Cohera Medical. "Completing the treatment of the last patient in this study brings us one step closer to putting this innovative sealant in the hands of surgeons and reducing anastomotic leakage after colorectal surgery."

Read more here: http://www.sacbee.com/2013/09/03/5702571/cohera-medical-completes-sylys.html#storylink=cpy

Medafor sells to Bard for $200 million, plus incentives that could add another $80 million.

Officials at Medafor Inc., a Brooklyn Center-based maker of a novel blood clotting product, said they’ve been looking for ways to enhance shareholder value — be it an initial public offering, new business relationships or just continuing organic growth. The one thing they weren’t looking for was a buyer, leaders said Monday.

Then the folks at C.R. Bard Inc., a New Jersey-based medical equipment maker, came calling.

Their offer — $200 million in cash now and up to $80 million more if revenue targets are hit in the next two years — proved too attractive to pass up, said Medafor CEO Gary Shope.

Medafor on Monday announced that it has an agreement to be purchased by C.R. Bard’s Davol Inc. division. The transaction has been approved by both companies’ boards of directors, but is subject to approval by Medafor’s shareholders and customary regulatory review.

“The premium price underscores what we have been building on,” Shope said in an interview Monday. “I think the shareholders are being rewarded with a great price.”

Medafor’s appeal has been its plant-based microporous polysaccharide hemospheres technology, which is used in its Arista MPH hemostat product. The product rapidly dehydrates blood and accelerates the body’s natural blood-­clotting process.

Sept. 24 is the target date for shareholder approval, Shope said. The deal values Medafor’s privately held shares at $6.37 per share. The revenue-based incentives are valued at up to $2.82 per share.

It’s a significantly better deal than the $2 per share that Atlanta-based CryoLife Inc. proposed in a takeover bid in 2010. At the time, the Medafor board called the bid “grossly inadequate.” CryoLife was an exclusive-rights distributor for Medafor’s blood-clotting technology in the United States and some international markets. It had also made offers for Medafor in 2008 and 2009, which Medafor also rebuffed.

C.R. Bard said Medafor will add approximately 1 percent to its 2014 revenue.

The company, a maker of vascular, oncology and surgical products, had revenue of about $3 billion last year. Scott Lowry, C.R. Bard vice president and treasurer, said he expects Medafor, which has 33 employees, to have annual revenue of $30 million to $40 million by the end of 2013. Medafor’s products will complement C.R. Bard’s hemostasis unit and broaden its product portfolio, he said.

“We look at this as a growth opportunity,” Lowry said. “Our plan is to grow this business.”

He says it is premature to comment on status of Medafor’s management and employees since the deal still needs Medafor shareholder approval and to pass other regulatory requirements. Shope, the Medafor CEO, said he believes that Bard is considering keeping the Medafor organization intact but that “going forward, they will be making their own decisions.”

John Houston, an attorney at Fredrikson & Byron who served as Medafor’s lead legal counsel for the transaction, said: “This really was an offer that came out of left field. It was not solicited and it was not anticipated.”

Officials from Bard had met with two of Medafor’s senior officers at a conference in Spain less than a year ago, he said.

According to C.R. Bard’s statement on the acquisition, the global market for surgical hemostats is over $1.4 billion. “The Arista hemostat provides a great alternative to other commercially available hemostats while providing strong synergy with our Progel Sealant technology and sales channel,” said Timothy Ring, C.R. Bard’s chairman and CEO.

Military, civilian medical experts emphasize investment in acute trauma care

FORT LAUDERDALE, Fla. (Aug. 13, 2013) -- From battlefield blasts to plane crashes, major advancements in acute trauma care are being seen in both the military and civilian health sectors, agreed experts during roundtable discussion at the 2013 Military Health System Research Symposium, Aug. 13, in Fort Lauderdale, Fla. 

Funding in research and rapid implementation of best practices are paying off, and people with serious injuries are surviving and rehabilitating, said director of the U.S. Army's Combat Casualty Care Research, or CCCRP, Program Col. Dallas Hack. Joining him was Air Force Col. Todd Rasmussen, CCCRP deputy director.

"It's not an overstatement to say that trauma care has been transformed because of this investment," said Rasmussen. "This transformation has resulted in the lowest fatally rate for service members we have ever seen, and this investment has translated to civilians, including those injured on the streets of this country."

Roundtable participants included Navy Capt. Eric Elster, Uniformed Services University School of Medicine, Department of Surgery professor; Air Force Col. Jeffrey Bailey, Joint Trauma System director; and Dr. Margaret Knudson, chief of surgery at the San Francisco General Hospital and Trauma Center.

Bailey, who joined the event via phone from Afghanistan, talked about some of the technologies, tools, and education implemented over the past decade of war, including battlefield tourniquets, hemostat bandages to reduce blood loss, and education on first-aid care. Bailey said now it's time to "focus on the gaps."

"The greatest burden of death is not in the hospital; it is on the battlefield. So we have the greatest opportunity to make a difference in pre-hospital care," Bailey said to the group.

It was a point with which non-military doctors agreed. Knudson joined the group to share her recent experiences caring for victims during the San Francisco plane crash in July. Fifty-three of the plane crash patients were treated at San Francisco General.

Knudson explained that she had previously trained with military health care combat casualty teams and how she used that training during the mass casualty triage. 

"We need to keep these collaborations going because it brings a value to both the military and the civilian sectors," said Knudson.

Elster added, "It's how we train the next generation."

Arch Therapeutics Announces Plans for Upcoming Activities

CAMBRIDGE, MA, Aug 06, 2013 (Marketwired via COMTEX) -- Arch Therapeutics, Inc. (otcqb:ARTH) ("Arch" or the "Company"), a life science company and developer of AC5(TM), a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to provide a brief review of proposed future activities.

Arch Therapeutics CEO Dr. Terrence Norchi states, "We are thrilled to be moving ahead with the development of our core technology. We envision the potential future customers in the marketplace for AC5(TM) and related products will include surgeons and other doctors, government agencies, hospital and operating room management, ambulances and trauma specialists. These market segments, even taken separately, present meaningful opportunities for the Company."

According to a 2012 report produced by MedMarket Diligence, LLC, approximately 114 million surgical and procedure-based wounds occur annually worldwide, including 36 million from surgery in the U.S. We estimate that 20-25% of those surgeries are performed laparoscopically. Additionally, there are many minor procedures and operations that may not be included in those figures. Those surgeries and other procedures could benefit from sealants and hemostatic agents, as surgical and trauma patients are at significant risk for morbidity and mortality from bleeding and/or leaking body fluid.

As a result of this demand, use of hemostatic agents and sealants is increasing. According to MedMarket Diligence, the market for these products achieved approximately $3.4 billion in 2010 worldwide sales and is projected to reach $4.5 billion in 2013 and surpass $6.5 billion in 2017. Over two-thirds of those sales are for hemostats. The growth rate for sealants is even higher than that for hemostats due to a general lack of available products and potentially larger unmet need.

The results of early data from preclinical tests have shown that AC5(TM) achieves hemostasis quickly and effectively. From a commercialization perspective, improvements in relevant synthetic manufacturing techniques in the past several years have reduced complexity and decreased materials cost. Further, AC5 will be made of naturally occurring ingredients that are not sourced from humans or other animals, but do exist in humans in their natural state. This type of ingredient is categorized as "generally recognized as safe," or "GRAS," by the U.S. Food and Drug Administration ("FDA"). Although the FDA and other regulatory authorities or related bodies will finally determine the classification of AC5(TM), the Company believes it meets the criteria for a medical device.

In furtherance of its stated long-term business goals, the Company reiterated plans to focus on the following activities during the remainder of calendar year 2013 and calendar year 2014:

-- further developing and securing intellectual property rights; and 

-- engaging a large scale manufacturing partner to produce cGMP product for clinical trials;

-- participating in EU and, subsequently, U.S. regulatory meetings; 

-- preparing for initial clinical trials, including developing clinical trial protocols; 

-- conducting formal biocompatibility studies;

-- commencing human clinical trials.


Company CEO Dr. Terrence Norchi further comments, "We believe that AC5(TM) will meet increasing demands, with anticipated market entry for use in laparoscopic, as well as open surgery. While open surgery represents the more established market for hemostatic agents, approximately one-quarter of surgeries are laparoscopic, and that number is growing. Many of the hemostasis products currently available do not possess certain features and handling characteristics that are ideal for the laparoscopic setting. Further, there seems to be increased pressure to perform more complex surgeries at reduced costs, including conducting operations in less expensive outpatient settings. We believe that the novel features and differentiating characteristics of our technology platform, starting with AC5(TM), will address the need for highly improved hemostatic and sealant products."

Additional details regarding Arch Therapeutics, Inc., its business, agreements and related matters are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission ("SEC"), and are available at the SEC's website at www.sec.gov. For more information, visit our website at www.archtherapeutics.com.



About Arch Therapeutics, Inc. (otcqb:ARTH) Arch Therapeutics, Inc. (otcqb:ARTH) is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch's goal is to develop and commercialize products based on our innovative technology platform that make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate known as AC5(TM) is being designed to elegantly achieve hemostasis in minimally invasive and open surgical procedures. Find out more at www.archtherapeutics.com.

Medicines Co. wraps $240M deal to buy ProFibrix following PhIII success

The Medicines Company has swooped in to buy out the Dutch biotech ProFibrix, chipping in $90 million in cash on top of a $10 million option anted up in June as Phase III data on a lead surgical therapy loomed. And the buyer has agreed to pay up to $140 million more for a set of unspecified milestones.

The Medicines Company ($MDCO) is landing Fibrocaps in the deal, an easy-to-use dry-powder formulation of fibrinogen and thrombin that can be used to stop bleeding during surgery, a process referred to as hemostasis. In their release today the companies noted that the lead biologic hit all primary and secondary endpoints on four surgical indications: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. Investigators recruited 719 patients for the Phase III study.

The plan now is to file for EU approval in the fourth quarter of this year, with an FDA application following in the first quarter of 2014, commented ProFibrix CEO Jan Ohrstrom. And The Medicines Company believes it can earn more than $300 million a year on the product, provided it wins key approvals.

"The company was founded in 2007 with an A round from Index Ventures," adds Ohrstrom. Phase I was run in 2008 and investigators are now wrapping a 5-year clinical program, with more work scheduled on laparoscopic surgery as well as a pediatric program. The CEO says more indications are also being "toyed with," but he declined to elaborate. The company's lab in Leiden will stay operational, says Ohrstrom, the former chief medical officer of ZymoGenetics. ProFibrix currently has 25 employees in Leiden and Seattle, where it has a clinical development site.

"Subject to regulatory approval, we believe Fibrocaps can become an important hemostatic product--complementary to Recothrom (Thrombin, topical [Recombinant])," says Clive Meanwell, the CEO at The Medicines Co. "We anticipate leverage of our work with U.S. surgery centers and entry into the European market. … ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products. We plan to integrate the ProFibrix team with our existing Recothrom team--expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."

The market for hemostatic products has been busy with new developments for years. Just a few weeks ago Omrix Biopharmaceuticals won a recommendation from the CHMP in Europe for the sealant matrix Evarrest, which also combines fibrinogen and thrombin. But The Medicines Company is hoping that ProFibrix's off-the-shelf technology will quickly win converts.