Wednesday, October 8, 2014

HaemoCer approved for use in China and Canada

BioCer Entwicklungs GmbH (BCE), a German implantable biological medical device development and manufacturing company, announced today that it has achieved approval to commence sales of HaemoCer™, an Absorbable Polysaccharide Hemostat (APH), in the People's Republic of China.
"BioCer has now achieved near comprehensive Asia-Pacific regional representation, and the addition of the PRC approval of HaemoCer™ is a significant milestone," Dr Markus Heinlein, Managing Director stated. "The entry into China of our first product HaemoCer™ has been assisted by the early establishment of regional sales representation in the Asia-Pacific region. BCE are pleased Chinese surgeons and patients will now share the benefits of our technology. Our new Health Canada approval is also further evidence of strong international acceptance of our technology."
The PRC approval of HaemoCer™ expands an international sales network encompassing AustraliaHong KongIndia, Korea,MalaysiaNew ZealandSingapore and Thailand within the APEC region. BCE will be exhibiting at the EACTS, Milan, Italy, 11-15thOctober and the CMEF, Chongqing, China, 23-26th October 2014

Tuesday, August 19, 2014

Cardiva Medical, Inc. Announces Completion of the first two tranches of Series 3 Private Equity Financing and the Closing of a Senior Secured Debt Facility with GE Capital

SUNNYVALE, Calif.Aug. 19, 2014 /PRNewswire/ -- Cardiva Medical, Inc. announced today that it has closed the first two tranches of a$16.5 million Series 3 private equity financing and a $12.5 million senior secured facility with GE Capital. The Company will use the proceeds of the Series 3 private equity financing and debt facility to expand commercial efforts for its VASCADE® Vascular Closure System in the United States.
Investing in Series 3 private equity financing was a new investor, Canepa Advanced Healthcare Fund, L.P., who joined existing investors PTV Sciences, AmKey Ventures and TriVentures II Fund L.P.  Mr. Paul Enever from Canepa U.S., LLC, which serves as Investment Advisor to Canepa Advanced Healthcare Fund, L.P., has joined the Cardiva Board of Directors.
"We are extremely pleased that Canepa Advanced Healthcare, L.P. has joined Cardiva's current investors in this financing and that Paul Enever has joined our Board of Directors," said Charles Maroney, CEO. Maroney continued, "With the Series 3 equity financing and GE debt facility, Cardiva now has the financial resources to establish VASCADE as a leading extravascular closure technology which we believe can benefit both patients and healthcare providers in the United States by minimizing complications and associated costs and improving patient care when compared to conventional vascular closure devices."
"Cardiva's product platform offers the potential to transform the vascular closure market by improving both patient safety and comfort", said Paul Enever of Canepa U.S., LLC. Enever continued, "VASCADE leverages Cardiva's Catalyst® platform that has been utilized effectively in more than 400,000 procedures since its initial launch into the U.S. market in 2007". We are delighted to add Cardiva to our investment portfolio of emerging growth medical device companies that are focused on improving patient outcomes while reducing the cost of medical care."

Tuesday, August 5, 2014

Transluminal Tech’s velox CD Arterial Closure Device Gets EU Approval

velox CD Transluminal Techs velox CD Arterial Closure Device Gets EU Approval (VIDEO)
squeeze velox CD Transluminal Techs velox CD Arterial Closure Device Gets EU Approval (VIDEO)Transluminal Technologies LLC. out of Syracuse, New York won the CE Mark for its velox CD Vascular Closure Device used to close arteriotomies following percutaneous femoral procedures. Closing arteries can be a challenge, eating up surgeons’ time just when it’s optimal to move the patient out of the OR. The velox CD device speeds up this process by delivering an implant that plugs the vessel wall from within.
The implant consists of an intraluminal footplate that absorbs within about 24 hours and a extraluminal plug that takes two weeks to absorb. The components are made of a proprietary magnesium alloy that breaks up and bioabsorbs safely into the body, leaving a clean repaired artery without the surgeon having to manually apply pressure during closure.
Here’s a video from a real procedure utilizing the velox CD:

Monday, June 30, 2014

Clot-building nanoparticles raise survival rate following blast trauma Read more: Clot-building nanoparticles raise survival rate following blast trauma

A type of artificial platelet being developed to help natural blood platelets form clots faster offers promise for saving the lives of soldiers, as well as victims of car crashes and other severe trauma.
In preclinical tests led by a Case Western Reserve University researcher, the artificial platelets, called "hemostatic nanoparticles," when injected after blast trauma dramatically increased survival rates and showed no signs of interfering with healing or causing other complications weeks afterward.
"The nanoparticles have a huge impact on survival—not just in the short term, but in the long term," said Erin Lavik, an associate professor of biomedical engineering at Case Western Reserve. Other researchers had raised concerns that the foreign matter would interfere with healing, or form free-floating clots, but "we saw none of that."
The research, published in the Proceedings of the National Academy of Sciences this week ("Intravenously administered nanoparticles increase survival following blast trauma"), show the survival rate of mice models of blast trauma treated with the nanoparticles increased to 95, compared to 60 percent for those untreated.
Hemostatic Nanoparticles
Spherical hemostatic nanoparticles accumulate on a clot-stabilizing mesh of fibrin the body produces. (Image: Andrew Shoffstall)
Also, no unwanted side effects, such as accumulation of the nanoparticles, clot formation or aberrant healing, were found during examinations one ands three weeks after the injection.
Lavik worked with Margaret M. Lashof-Sullivan, Erin Shoffstall and Kristyn T. Atkins, of Case Western Reserve; Nickolas Keane and Cynthia Bir of Wayne State University and Pamela VandeVord of Virginia Tech.
Explosions account for 79 percent of combat-related injuries and are the leading cause of battlefield deaths, according to researchers at Veterans Affairs hospitals and the federally run Uniformed Services University of the Health Sciences.
The primary blast wave, flying shrapnel and being thrown to the ground cause the lungs, liver, kidneys and other organs to hemorrhage and bleed uncontrollably.
Such uncontrolled bleeding from collisions, blows and falls is also the leading cause of death among victims age 5 to 44 in the United States.
Natural blood platelets are the key ingredient to stopping bleeding, a process called hemostasis. The process works well for typical cuts and scrapes, but can be overwhelmed with serious injuries.
a schematic of hemostatic nanoparticles linking with blood platelets
This is a schematic of hemostatic nanoparticles linking with blood platelets. The nanoparticles significantly increased survival rate from blast trauma in preclinical testing. (Image: Erin Lavik)
Hospitals try to stem internal bleeding by giving trauma patients blood products or the hemophilia medicine called recombinant factor VIIa, but there isn't a good option for the battlefield or accident scenes. Recombinant factor VIIa must be refrigerated, costs up to tens of thousands of dollars per treatment and can cause clots in brain and spinal cord injuries, which are common from explosions.
Lavik's team has fine-tuned the nanoparticles to increase clotting efficiency. "They are incredibly simple… spheres with arms of peptides that react with activated blood platelets in damaged tissues to help clots form more quickly," she said.
The particles are made from short polymer chains already approved for other uses by the U.S. Food and Drug Administration. In earlier testing, rat models injected with the nanoparticles stopped bleeding faster than untreated models.
The dry particles remained viable after two weeks on a shelf. A medic in the field or an ambulance crew would add saline, shake and inject them, the researchers say.
Further research and testing are underway. Clinical trials on humans are likely at least five years out, Lavik said.

Tuesday, June 3, 2014

A device to control bleeding in brain surgery receives Phase 2 SBIR grant


EndomedixA medical device developer got a big boost in its efforts to develop a surgical sealant for brain surgery. Endomedix received a $1.49 million Phase 2 Small Business Innovation Research grant to help control bleeding for surgical procedures, according to a company statement. It received the grant from the National Institute of Neurological Disorders and Stroke.


The funding will go toward safety studies, in vivo performance studies and developing an applicator device. The sealant is a hydrogel that includes two processed biocompatible polysaccharides. They are simultaneously mixed and sprayed onto a surgical site.

Typically, a Phase 2 SBIR grant doesn’t exceed $1 million over a two-year period.

The market value for sealants and related devices is expected to top $4.2 billion in 2018. But some factors that could impact the size of the market include the efforts to limit expensive hospital admissions, shift procedures to outpatient settings and reduce rates of re-admissions.

Endomedix has won six SBIR Phase I grants totaling more than $1.1 million to advance its sealants program.

The Newark medical device company is based at the Enterprise Development Center incubator at the New Jersey Institute of Technology.

Sunday, May 18, 2014

Cohera Medical, Inc.® Files for CE Mark Approval for Sylys® Surgical Sealant

PITTSBURGHMay 15, 2014 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has applied for CE Mark approval for Sylys® Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks in gastrointestinal procedures.  CE Mark approval, expected by the end of 2014 based on this filing, will allow for marketing of the product in the European Union and other countries.
Sylys is applied during gastrointestinal procedures to help prevent the occurrence of anastomotic leaks – a serious complication that occurs in up to 23 percent of patients undergoing colorectal surgery. At least one-third of the post-surgical mortality after colorectal surgery is attributed to leaks, and survivors generally have protracted recoveries. The additional care required to manage this serious complication can cause up to a five-fold increase in patient management costs.
"Anastomotic leakage is the most devastating complication associated with intestinal resection, contributing to morbidity and mortality," said James McCormick, DO, FACS, FASCRS, Chief, Division of Colorectal Surgery, The Western Pennsylvania Hospital. "We have made tremendous strides in curtailing the risk associated with intestinal anastomosis, but we are always striving for further improvement and greater patient safety."
Sylys is designed to help reduce anastomotic leakage in intestinal procedures by providing additional support during the first few days of healing, when the development of leaks is most likely to occur.  The sealant is applied as a viscous fluid that cures rapidly to create a flexible, elastic seal over the anastomosis site.
"The preparation and filing of the CE Mark application for Sylys, a Class III implant technology, represents a significant milestone and achievement by all of the employees of Cohera Medical," said Chad A. Coberly, JD, Vice President of Clinical, Regulatory and Legal Affairs for Cohera Medical. "The submission signifies that we have completed the rigorous clinical and pre-clinical testing, quality, and performance requirements of the EU authorities, and we look forward to working with our notified body during the approval process."
The market for Sylys is significant, with several hundred thousand procedures a year worldwide representing a multi-billion dollar opportunity. Due to the unmet clinical need, Sylys would represent a breakthrough in this market that will lead to improved patient outcomes as well as reduced patient management costs for healthcare providers.
"Submitting the Sylys CE Mark application represents a significant milestone towards the commercialization of our second product and demonstrates the commitment we have to our future customers, partners, and investors," said Patrick Daly, Cohera Medical president and CEO. "We look forward to making Sylys available to surgeons and patients throughout the world."

Monday, May 5, 2014

Z-Medica Bolsters Hemostatic Product Line with Acquisition of Novacol®

WALLINGFORD, CONN. — Z-Medica, a leading developer and marketer of hemostatic agents, today announced that they have signed a definitive agreement with TAUREON, headquartered in The Netherlands, to acquire Novacol®, a Class III resorbable hemostatic product.

Novacol is currently sold in Europe and South Korea. Z-Medica will continue to support that marketing strategy while making plans to expand the product offering into other countries.

“Given our QuikClot portfolio of hemostatic dressings, it was a natural fit for us to augment both our product line and our international presence with Novacol,” said Z-Medica’s President and CEO Stephen J. Fanning. “Our current products are gauze-based and non-resorbable. Acquiring Novacol, which is a resorbable hemostat, is the first step towards expanding the Z-Medica portfolio and providing a wider range of innovative, safe, and effective products to the broader healthcare market.”

Used primarily in surgeries, Novacol is comprised of 100% high-quality, purified, natural long and short collagen fiber, which is resorbed by the body. The product is available as the soft, pliable Novacol® Pad, and Novacol® Fibrillar for use in cavities and irregular surfaces.

“Novacol is an effective product that will benefit from Z-Medica’s global distribution network,” said TAUREON CEO Dick van Kalkeren. “Z-Medica’s experience with QuikClot and their reputation as a leader in the hemostatic market ensures that Novacol will be able to compete favorably in the market. The transfer of Novacol also enables TAUREON to strengthen our focus in Europe on plastic and orthopedic surgery, human tissue and advanced wound care.”

Wednesday, April 23, 2014

The Medicines Company Adds Novel, Approved, Surgical Sealant to Its Surgical Hemostasis Portfolio Acquires Tenaxis Medical, Inc.

PARSIPPANY, NJ and MOUNTAIN VIEW, CA -- (Marketwired) -- 04/23/14 -- The Medicines Company (NASDAQ: MDCO) and Tenaxis Medical, Inc. (Tenaxis) today announced an agreement for The Medicines Company to acquire Tenaxis. Tenaxis's sole product, which mechanically seals both human tissue and artificial grafts is approved, but not launched in the US -- having received US PMA approval from the FDA in March 2013 as a vascular sealant. The product is also approved with a European CE Mark as a surgical sealant applicable to cardiovascular, general, urological, and thoracic surgery. The addition of the Tenaxis product adds another solution for surgical bleeding to The Medicines Company's portfolio which also includes the marketed product, RecoThrom (aqueous, recombinant human Thrombin) and the investigational product, Fibrocaps (a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery) which has completed phase III trials and is under FDA and EMA review.

Under the terms of the agreement, The Medicines Company will pay $58 million upfront on closing of the deal. The Medicines Company will also pay milestone payments of up to $112 million contingent upon achieving certain commercial and -- in pursuit of even broader indications -- regulatory approval milestones. The transaction is subject to the satisfaction of customary closing conditions.

"We continue to execute our strategy for growth, building our presence in surgery and perioperative care," said Clive Meanwell, Chairman and Chief Executive Officer of The Medicines Company.

Adam Sharkawy, Senior Vice President and Global Innovation Group Leader for Surgery and Perioperative Care added, "A robust portfolio of solutions for intra-operative bleeding is expected to drive growth for us in this sector of hospital medicine. This acquisition will allow us to leverage and build our activities in surgery centers at leading US and European hospitals. In the US, we expect to deploy approximately 100 of our current engagement managers across these surgical product offerings."

In a pivotal trial in vascular surgery, the Tenaxis sealant was effective when used as prophylactic treatment on native vessels and grafts, reducing the incidence of bleeding within the first minute after removal of vascular clamps. The Tenaxis sealant was compared to Gelfoam Plus, a topical hemostat containing a low concentration of thrombin (125 Units/mL), in the clinical trial used to support licensure (N=217; 1:1 randomization). The Tenaxis surgical sealant was shown to be superior to Gelfoam Plus based on a statistically significantly lower incidence of suture hole bleeding at the time of clamp release (60.5% vs. 39.6% of anastomotic sites at Time 0; p = 0.0001); the 20% difference at the time of clamp release persisted at 10 minutes (82% vs. 72%). Superiority was demonstrated in several types of surgical procedures (extremity bypass, hemodialysis access grafting, and other vascular procedures).

"We are excited to be involved in a transaction with The Medicines Company, which will allow more patients to have access to this beneficial technology," Ronald Dieck, President and CEO of Tenaxis commented. "We are proud of the surgical sealant technologies that we have developed and their impact on the wellbeing of patients. The Medicines Company is clearly committed to the area of intraoperative hemostasis and we look forward to working as a team to innovate in this area of medicine."

The Boards of Directors of both companies have unanimously approved the agreement.

Gibbons P.C. served as legal advisor for the transaction for The Medicines Company. Leerink Swann & Co. served as financial advisor and Wilson Sonsini Goodrich & Rosati, PC served as legal advisor for the transaction for Tenaxis Medical, Inc.

Conference Call Information

There will be a conference call with The Medicines Company management today at 8:30 a.m. Eastern Time to discuss the Tenaxis acquisition, first quarter 2014 financial results, operational developments, and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at www.themedicinescompany.com.

Domestic Dial In: +1 (877) 359-9508 
International Dial In: +1 (224) 357-2393 
Passcode for both dial in numbers: 27882505

Replay is available from 11:30 a.m. Eastern Time following the conference call through May 7, 2014. To hear a replay of the call dial +1 855 859-2056 (domestic) and +1 404 537-3406 (international). Passcode for both dial in numbers is 27882505.

Saturday, April 5, 2014

FDA Accepts Biologic License Application for Fibrocaps Hemostatic Agent

The Medicines Company has announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. The FDA action date (PDUFA date) for Fibrocaps is January 31, 2015. 

In August 2013, The Medicines Company announced that the Phase III trial, FINISH-3, which studied a total of 719 patients across 54 sites in the U.S. and Western Europe, met all of its primary and secondary hemostasis efficacy endpoints in each of four distinct populations: (1) spinal surgery; (2) hepatic resection; (3) soft tissue dissection; and (4) vascular surgery. 

"We believe Fibrocaps has the potential to become an important hemostatic product -- complementary to Recothrom® Thrombin, topical (Recombinant) -- which will allow us to continue to serve leading US hospitals, leveraging our existing operations. Our previously announced EMA filing also suggests that Fibrocaps can be our first hemostat product in the European market," said Adam Sharkawy, PhD, Senior Vice President, and Surgery and Perioperative Care Global Innovation Group Leader at The Medicines Company. 

"With the acceptance of the Fibrocaps BLA we now have 6 new molecular entity regulatory submissions under review at the FDA and the EMA," said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. "These applications span our three areas of focus in leading hospitals, namely: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. Each is designed to contribute to our purpose which is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on the needs of leading hospitals worldwide."

Sunday, March 23, 2014

Drug companies developing longer-acting clotting agents for hemophiliacs

Several drug companies, such as Biogen Idec and Novo Nordisk, are developing new, longer-acting versions of the blood clotting factors used by people with hemophilia. Patients with severe forms of the disease need regular infusions, lasting 30 minutes or more, of relatively short acting and very expensive clotting factors.

The new longer-lasting hemophilia B products can be given every 10 days or two weeks, offering significant advantages for patients, especially young children, who now need infusions every two or three days.

Hemophilia is hereditary, passed from parent to child through genes. People with hemophilia have little or no clotting factor. Hemophilia A and Hemophilia B have different clotting factors that are low or missing, but both can experience spontaneous bleeding, as well as severe bleeding following injuries or surgery.

Worldwide, about one in 5,000 men is born with hemophilia A and one in 25,000 men is born with hemophilia B each year. Since the gene is carried on the X chromosome, hemophilia is almost entirely a disease of men. Women can pass the gene to their offspring. Hemophilia has often been called the “Royal Disease” since it was carried by Britain’s Queen Victoria and affected many of the ruling families of Europe. Blood factor concentrates were not developed until the mid-20th century, and up until that time people with hemophilia had a life expectancy of less than 30 years.

The U.S. Food and Drug Administration is due to decide by mid-year whether to approve a new long-lasting hemophilia B clotting factor from Biogen Idec. Novo Nordisk expects to file next year for regulatory approval of its long-acting hemophilia B drug.

Some industry experts say these and other new treatments could help drive down the price of existing hemophilia products, which can total $300,000 or more a year for a single patient.