Cotton candy-like glass nanofibers appear to speed healing in initial venous stasis wound trial

Imagine a battlefield medic or emergency medical technician providing first aid with a special wad of cottony glass fibers that simultaneously slows bleeding, fights bacteria (and other sources of infection), stimulates the body's natural healing mechanisms, resists scarring, and-because it is quickly absorbed by surrounding tissue - may never have to be removed in follow-up care.Or, imagine diabetics with hard-to-heal wounds finding a source of relief from the battle against infections and limb amputation.Those scenarios are the hope of the developers of a revolutionary borate glass nanofiber material, which appears have sped and helped the final of healing long-term wounds in eight out of 12 venous stasis wound sufferers in a recent clinical trial held at a medical center in Rolla, Mo.Details about the trials and the glass fiber material were published today in the May issue of the American Ceramic Society's Bulletin magazine.The story reports on the discovery of the fibers and on an empirical study that began late in the fall of 2010 supervised by the internal review board of the Phelps County Regional Medical Center. The trial groups originally had 13 volunteer members, but one dropped out during the early stages.According to Peggy Taylor, the PCRMC registered nurse who administered the treatments, all of the volunteers in the trial are enthusiastic about the use of the glass fiber product, which she says "looks like cotton candy.""All of the participants had diabetes and several of them had wounds that had been unhealed for more than a year," says Taylor, a specialist in wound care. "One patient had the same wound for three years. After using the glass fiber product for a few months, we were able to repair the skin in eight of the patients. Remarkably, the other four have made a lot of progress and all of their wounds should be healed soon, too."All of the patients suffered from problems associated with venous stasis, a condition where blood circulation in extremities is poor. As the blood pools, typically in lower legs, fluids accumulate causing unusual pressure on skin tissues. Sores and wounds can then develop when the fluid "weeps" from skin cracks, cuts or abrasions.Because of an enzyme in the weeping fluid, the skin surrounding small venous stasis injuries can quickly erode and turn into large and deep wounds. Even small bruises can eventually develop into bone-deep openings.The goal of the PCRMC trial was to provide an initial evaluation of the effects of the novel fibrous glass material produced by the Mo-Sci Corporation, a Rolla company already known for creating glass-based materials for medical applications."Bioglass" materials aren't particularly new to the medical field, but thus far all bioglass has been formed from a silica-based glass composition, and these primarily have been used in hard-tissue regeneration, such as bone repair.Glass scientist Steve Jung, who helped develop the new material, says he and co-developer Delbert Day had wondered whether a different type of bioactive glass material could be used for soft-tissue regeneration. "We felt from our in-vitro studies that bioactive glasses containing boron would react to body fluids much faster than silicate glasses," says Jung, who obtained his Ph.D from Missouri University of Science and Technology, where he conducted his research with Day, a professor at the university. "We also knew that an in-vitro study of lithium borate glasses had showed it to have beneficial effects against bacteria, such as E. coli, salmonella and staphylococcus microbes."Lastly, Jung and Day recall they were interested in a composition that was rich in calcium. "Previously, investigators have reported that calcium is important for wound healing. It appears to assist the migration of epidermal cells and help the body regulate the healing process of open wounds," says Jung.Besides composition, Jung and Day thought the structure of the material may be important to consider, too, and suspected that providing a healing "scaffold" might be beneficial. "We thought it might be advantageous to have a material that could mimic the microstructure of fibrin that forms the basis of a blood clot. We reasoned that if the structure could imitate fibrin, it might trap blood platelets and allow the formation of a wound cover that could support the healing process."Jung and Day finally settled on a particular borate glass composition - called 13-93B3 glass - one that Mo-Sci, a company founded by Day, already knew how to form into cottony glass fibers, 300 nanometers to 5 micrometers in diameter.

ProFibrix Secures Funding for Progression of Lead Product Into Late Stage Clinical Development and Announces Management and Supervisory Board Appointments

LEIDEN, The Netherlands and SEATTLE, May 3, 2011 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products that help stop bleeding (hemostasis) after surgery, today announced the successful closing of a series B follow-on financing. In conjunction with the financing and to support the company's next stage of development towards commercialization, ProFibrix also announced several management and Supervisory Board appointments.
The Supervisory Board will be chaired by independent director Leonard Kruimer, Chief Financial Officer of Crucell. Over the past decade, Mr. Kruimer has been instrumental in building Crucell from an entrepreneurial start-up into a global vaccine company, taking the company public and leading a number of large and successful M&A transactions. Also joining the Supervisory Board as an independent director is Vic Schmitt. Mr. Schmitt has been a long-time senior executive at Baxter International, a key player in the hemostasis market, where he last served as President of Venture Management.
In addition to these high profile appointments to the Supervisory Board, Jan Ohrstrom, has been named Chief Executive Officer. Before joining ProFibrix, Dr. Ohrstrom was a senior executive at ZymoGenetics, where he was responsible for the development of several products, and a member of the team that took the company public. Dr. Ohrstrom started his career at Novo Nordisk.Jaap Koopman, founding CEO of ProFibrix, will become Chief Scientific Officer.
In addition to the private funding the company was awarded a government credit, bringing the total new funds available to the company for the progression of Fibrocaps(TM) to EUR 15 million (USD 22 million). New investors Vesalius Biocapital and INKEF Capital co-led the financing round, while existing investors Index Ventures and Gilde Healthcare Partners also participated. Alain Parthoens from Vesalius Biocapital, Dirk Kersten from Gilde Healthcare Partners, and Francesco De Rubertis from Index Ventures will also hold seats on the board of ProFibrix.
The proceeds of the financing will be used to progress the company's lead product Fibrocaps into late stage clinical development, as well as to support the company's other pipeline programs. Fibrocaps is currently being investigated in a prospective, multi-center Phase II study in multiple surgical indications at up to 20 sites, including major U.S. and Dutch academic medical centers. If this study confirms the positive results of the first Phase II trial, ProFibrix anticipates initiating a pivotal Phase III trial in early 2012, and file for approval by the U.S. Food and Drug Administration in early 2013.
Jan Ohrstrom, MD, said: "We are very pleased to welcome Vesalius Biocapital and INKEF Capital to our investor base. Our successful financing and strengthened Supervisory Board and leadership team should put ProFibrix in an excellent position to continue the development of Fibrocaps and prepare for its commercial launch. We would like to extend our gratitude to the parting board members for their contribution and commitment to the early development of ProFibrix."
Jaap Koopman said: "Jan Ohrstrom has played a key role in transitioning ProFibrix to a market-focused company. He has the capabilities and skills to take ProFibrix through its next stages of growth to become a leading hemostasis company. I look forward to seconding him in his new role as CEO, and to continue to contribute to the development of new products based on our fibrinogen technology platform."

CryoLife, Inc. (CRY) Downgraded by The Benchmark Company to “Hold”‎

CRY executives say no more Hemostats....

PerClot and HemoStase [More on that HERE and HERE]

Revenues from the sale of PerClot and HemoStase increased 17% for the three months ended March 31, 2011 as compared to the three months ended March 31, 2010. This increase was primarily due to a 40% increase in the volume of grams sold, which increased revenues by 34%, partially offset by a decrease in average selling prices, which decreased revenues by 17%...

CryoLife may begin manufacturing PerClot from plant starch modified by Starch Medical Inc. under the terms of the License Agreement, which is anticipated to occur sometime in late 2011 or in 2012. The License Agreement extends for an indefinite period. Following the start of manufacturing and U.S. regulatory approval... [after transition from the current Chinese site of manufacture].

Excerpt Benchmark Cryolife Q1

Operator

Our next question comes from Raymond Myers with Benchmark. Please proceed with your question.

Raymond Myers – Benchmark

Great, thank you. Most of my questions have been answered, but let me ask this one. PerClot revenue in Q1 was 660,000. We’ll have a lot to compare that with except for Q4 where……(technical difficulty)

Steve Anderson

We lost you.

Ashley Lee

We lost you Ray.

Raymond Myers – Benchmark:

…… after having a very strong $660,000 in Q1, is any of that due to stocking and what does that tell you about the potential for the product over the course of the year?

Ashley Lee

We have actually seen the majority of our distributors reorder already. So we remain very optimistic about PerClot revenues for the balance of this year and our expectations are included in the guidance that we gave for all powdered hemostats that we talked about earlier.

Raymond Myers – Benchmark

I guess what I’m driving at is trying to understand how contributed that guidance is. I’m assuming, for starters, we’re not going to sell any more hemostats, correct?

Steve Anderson

That is correct.

Raymond Myers – Benchmark

And PerClot increased by well over 200% sequentially from Q4 to Q1. Was any of that due to stocking orders that you don’t expect to repeat in Q2?

Steve Anderson

No, most of the distributors have reorders by this time. Not all, but most.

Raymond Myers – Benchmark

So with that kind of a quarter-on-quarter growth rate, what kind of PerClot revenue would we expect in Q2?

Ashley Lee

We don’t give quarterly guidance out Ray, but again we gave for powdered HemoStase, it could be as much as 5 million for the full year and we would expect to see sequential growth in PerClot revenues over the balance of this year, so we’ll leave it to that.

Steve Anderson

One of the things that we have pointed in the previous calls is that our R&D people feel that the PerClot absorbs two to three times the amount of fluid that the prior product absorbed and I can tell you that the difference in the activity of the product is striking, but you exhibit them side by side. Now it’s very hard to describe that conversationally. But what I would suggest is the next time we have a booth at a convention that you ask to personally see the demonstration of the two products side by side because the doctors’ reaction to the activity, the chemical activity of PerClot has been extraordinary, and we are very, very enthusiastic about that product.

Raymond Myers – Benchmark

Well, that sounds great. I’ll do that and look forward to growth in that area. Thanks.

Baxter Q1 Edited

Robert Parkinson

.......I'd like to take a moment just to update you on a few key programs and some recent highlights. First, during the quarter, we submitted a Biologics License Application or BLA to the FDA [Food and Drug Administration] for the U.S. approval of TISSEEL Fibrin Sealant as a hemostatic agent in vascular surgery. This is an expansion beyond the current marketed indications and completes the necessary clinical requirements for a broad hemostasis label, which represents a very significant opportunity for our Regenerative Medicine business.

Robert Hombach

.....Sales in Regenerative Medicine, which includes our BioSurgery products totaled $140 million and increased 18% on both the reported basis and after adjusting for foreign currency. These results reflect solid growth, particularly for FLOSEAL, and a benefit of just over $10 million in incremental sales related to the Apatech [ApaTech Inc.] acquisition, which was completed at the end of the first quarter last year. Excluding ApaTech, sales gross for the category was in high single digits.

Entegrion Licenses Stasilon Bleeding Control Dressing to Beeken BioMedical

Research Triangle Park, NC-based life sciences development company focused on expanding the therapeutic potential of the human vascular system signs agreement with new Chicago-based medical device company to continue development and commercialization of FDA-cleared hemostatic dressing.
Research Triangle Park, NC (PRWEB) April 20, 2011
Entegrion, the life sciences development company focused on expanding the therapeutic potential of the human vascular system, announces it has licensed Stasilon® to the Chicago-based medical device company Beeken BioMedical. Stasilon® is an FDA-cleared, single-use hemostatic dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.
“Beeken BioMedical is committed to continue the development and commercialization of Stasilon®,” said Richard A. Kendall, President and CEO of newly formed Beeken BioMedical. “This novel medical device that extends across all of healthcare gives our company an immediate presence in the healthcare industry with opportunities to expand our sales and distribution model.”
“We selected Stasilon® as the company's initial investment for many reasons, including technology innovation and the fact that it is a low cost but effective alternative to current hemostatic devices in the market and a strategic fit to our global distribution model,” said Peter Beemsterboer, Chairman of Beeken BioMedical. “We look forward to having Entegrion as a strategic partner to further develop our product portfolio.”
Entegrion, which developed the hemostatic woven dressing in collaboration with researchers at the University of North Carolina, commented on the agreement. “We are pleased to partner with Beeken BioMedical in the introduction of Stasilon® to the surgical and wound care community. We are confident they have the experience, drive and imagination to successfully represent the technology, and, as importantly, identify additional unmet medical needs that can be addressed by future generations of products,” said Joseph DaCorta, Entegrion's Vice President and Chief Technology Officer. “They are the ideal partners for us.”
Beemsterboer and Kendall are the co-founders of Beeken BioMedical. The entrepreneurs have diverse and extensive backgrounds in developing multi-million-dollar businesses that introduce new technologies and services into healthcare and non-healthcare-related industries. The company has selected an experienced management team to continue the development and growth of the company.
Regulated as a medical device, Stasilon® addresses the immediate need to control bleeding surfaces by treating wounds caused by trauma with a novel dual-fiber hemostatic dressing. Beeken BioMedical will focus on the unique features of Stasilon® to continue to be among the first choice of hemostasis devices selected in surgery, wound care, emergency medicine, industrial and consumer care. Potential market opportunities range from hospitals, clinics, physician offices, long term and emergency care facilities, municipalities, veterinary clinics, and athletics to over-the-counter use by consumers

Recombinant Human Albumin for Use in Unique Sealant Technology

Novozymes Biopharma is pleased to announce that its recombinant human albumin, albucult®, is being used by Neomend in its ProGEL® PLATINUM surgical sealant.
This product will be commercially available in Europe beginning in the second quarter of 2011. Neomend is an innovator in sealant and adhesion prevention products for the surgical marketplace. The company utilises albucult as a key component in ProGEL PLATINUM, the only sealant of its kind developed to treat pleural air leaks following lung resection surgery. Neomend’s ProGEL is a hydrogel polymer consisting of Novozymes’ albucult and a cross-linking component of polyethylene glycol (PEG). When they are combined, a rapid cross-linking reaction creates a hydrogel matrix that results in the formation of a strong, adherent and flexible seal. The technology, which has received a European CE Mark, enables surgeons to more effectively treat lung air leaks during surgery and has already been used in more than 8,000 procedures in the US since April of last year.
David Renzi, Neomend’s President and CEO, commented: “Novozymes’ extensive experience in manufacturing, regulatory and global supply, combined with its commitment to innovation, makes the company the ideal partner for Neomend to work with on its unique sealant technology. We will launch ProGEL PLATINUM in Europe in the second quarter of this year, while also continuing the development of this platform technology into other clinical areas such as spine, general surgery and gynecology.”
“Novozymes is delighted that Neomend has selected albucult for use in its unique sealant technology”, said Dermot Pearson, Marketing Director, Novozymes Biopharma. “The partnership demonstrates Novozymes’ commitment to providing quality materials for use in the healthcare, pharmaceutical and biotechnology industries and allows the company to position itself as a reliable partner in the wound sealant and medical device markets.” The use of albucult in ProGEL PLATINUM and other medical devices confers a range of unique advantages not possible with animal-derived ingredients such as sustainability of supply, GMP compliance and improved biocompatibility. Albucult also delivers unprecedented performance and quality benefits to medical applications including sealants, device coating and cell therapy applications while ensuring batch-to-batch consistency, which can significantly reduce lot testing burdens for customers.

ORTHOCON Receives CE Mark and Health Canada Medical Device License for HEMASORB

IRVINGTON, New York, April 21, 2011 /PRNewswire/ - Absorbable Bone Hemostat Matrix Cleared For Clinical Use and Sale in Europe and Canada

ORTHOCON, Inc., a privately-held therapeutic device company, today announced that DEKRA and Health Canada have cleared its HEMASORB Absorbable Bone Hemostat Matrix for clinical use and sale in Europe and Canada.
HEMASORB is a ready-to-use, biocompatible, water resistant, and absorbable putty designed to rapidly stop bleeding when applied to damaged or cut bone. Control of bleeding from cut bone is a problem in many operative procedures including spine, orthopedic, cardiac, and craniomaxillofacial surgeries. Excessive bleeding during surgery may impair the surgeon's view of the operative field, may result in the need for blood transfusions, and may be associated with post-operative complications. ORTHOCON estimates that over 3.5 million patients undergoing surgeries in the United States, Europe, and Canada each year could benefit from the intra-operative use of HEMASORB.
"We are pleased that HEMASORB has been cleared for clinical use and sale in Europe and Canada," said John J. Pacifico, President and Chief Executive Officer of ORTHOCON. "We are confident HEMASORB will provide surgeons in Europe and Canada with an innovative and cost-effective tool to assist in their management of intra-operative bone bleeding, and we fully expect HEMASORB to become the standard of care for bone hemostasis."
HEMASORB, previously cleared by the Food and Drug Administration (FDA) via the 510(k) premarket notification process, was first introduced in the U.S. in 2010. The product has been approved for sale at leading hospitals throughout the United States and is used successfully by hundreds of surgeons. ORTHOCON will continue to focus its efforts on increasing adoption of HEMASORB in the U.S. and is actively pursuing product distribution partnerships in Europe and Canada to ensure HEMASORB becomes widely available to surgical patients in these markets.

About ORTHOCON
Founded in 2005, ORTHOCON develops, manufactures, markets, and sells implantable products that stop bone bleeding. ORTHOCON's technology platform is also being developed to enable controlled, local drug delivery to the treatment site.
ORTHOCON is funded by leading international venture capital investment firms. The company occupies 8,000 square feet at its state-of-the-art facility in Irvington, New York. For more information, please visit http://www.orthocon.com.

Unethical Device Sales Activities Exposed - Corporate Goals 1, Patient Safety 0

The healthcare giant was charged by the US Securities and Exchange Commission with violating the Foreign Corrupt Practices Act by bribing public doctors in several European countries - and paying kickbacks to Iraq - to illegally obtain business. The FCPA forbids US companies from bribing foreign government officials (read here).

Specifically, various Johnson & Johnson (JNJ) units paid bribes to public doctors in Greece who chose J&J surgical implants; public doctors and hospital administrators in Poland who awarded contracts to J&J, and public doctors in Romania to prescribe J&J meds. The subsidiaries - including DePuy and Janssen Pharmaceutica - also paid kickbacks to Iraq to obtain 19 contracts under the United Nations Oil for Food Program, according to the SEC complaint (pdf).

To settle charges, J&J agreed to pay $48.6 million in disgorgement and prejudgment interest, and another $21.4 to settle parallel criminal charges that were announced by the US Department of Justice. Meanwhile, J&J is also paying $8 million to resolve an investigation by the United Kingdom Serious Fraud Office into its DePuy unit (see this).

Why did the docs agree? The doctors and administrators working for public entities in Greece, Poland, and Romania, who ordered or prescribed J&J products, were rewarded with cash and inappropriate travel, among other goodies. And J&J subsidiaries, employees and agents used slush funds, sham civil contracts with doctors, and off-shore companies in the Isle of Man to carry out the bribery.

The charges are not a huge surprise, however. Last summer, the feds announced they have begun paying closer attention to interactions between the pharmaceutical industry and foreign governments (background). And several months ago, at least five big drugmakers received letters as the federal government seeks to uncover any violations of the FCPA.

Four years ago, by the way, the healthcare giant made a “voluntary disclosure” to US authorities about improper payments, which were made by unspecified foreign subsidiaries in connection with the sale of medical devices in a pair of unnamed countries. And the worldwide chairman of medical devices and diagnostics retired (read this). In this disclosure, the SEC noted that J&J also conducted an internal probe, according to an SEC statement.

"The Justice Department “will be intensely focused on rooting out foreign bribery in your industry. That will mean investigation and, if warranted, prosecution of corporations, to be sure, but also it will involve investigation and prosecution of senior executives,” Breuer told the crowd, adding that individuals will be held accountable, according to The Legal Times.

“I don’t care if you’re a physician and I don’t care if you’re the clerical worker. It has to do with what you do. But if you do it, your MD degree is not going to be a shield,” Breuer said. Overall, he said, the Justice Department is pursuing more than 120 FCPA investigations in cooperation with the FBI and the Securities and Exchange Commission.

And Tony West, an assistant attorney general and chief of the department’s Civil Division, noted that he recently told the Senate Judiciary Committee that enforcement will not be limited to companies."

Preoperative Fibrinogen Plasma Concentration Is Associated With Perioperative Bleeding and Transfusion Requirements in Scoliosis Surgery

Study Design. Prospective observational study.

Objective. To investigate the potential association between fibrinogen, bleeding, and transfusion requirements after scoliosis surgery.

Summary of Background Data. Bleeding complications during and after orthopedic surgery are associated with increased morbidity and mortality. Early identification of patients with increased risk of excessive bleeding offers the possibility to initiate countermeasures. Fibrinogen is a key protein in the coagulation cascade, and thus a potential biomarker for bleeding risk.

Methods. A total of 82 otherwise healthy patients (mean age: 15 ± 3 years, 85% girls) undergoing surgery for adolescent idiopathic scoliosis were included in the study. Patient variables (age, gender, operation time, and thrombosis prophylaxis), preoperative laboratory variables (hemoglobin, platelet count, activated partial thromboplastin time [aPTT], prothrombin time [PT], and fibrinogen), peroperative and postoperative bleeding volume, and transfusions were registered. Correlations between laboratory variables and bleeding volume were calculated with Pearson test. Patient variables and laboratory variables were compared with Student t test between patients with bleeding volume in the upper quartile (“bleeders”) and the remaining patients, and between patients with extensive transfusion (defined as >2 U of packed red cells) and no or limited transfusions (≤2 U).

Results. Mean fibrinogen concentration was 3.0 ± 0.7 g/L (range, 1.3– 4.9). Mean total perioperative bleeding volume was 1552 ± 1019 mL (range, 100–5800 mL). Total bleeding volume correlated significantly with preoperative fibrinogen concentration (r = −0.31, P = 0.005) but neither with platelet count, aPTT, nor PT (P = 0.61, 0.46, and 0.57, respectively). Bleeders had significantly lower preoperative fibrinogen plasma concentration (2.6 ± 0.6 vs. 3.1 ± 0.6 g/L, P = 0.002). Of total, 16% (13/82) of the patients were transfused with >2 U of packed red cells. Patients with extensive transfusions had significantly lower preoperative fibrinogen plasma concentration (2.5 ± 0.7 vs. 3.1 ± 0.6 g/L, P = 0.002), while preoperative platelet count, aPTT, and PT did not differ.

Conclusion. The results indicate that preoperative fibrinogen concentration is a limiting factor for postoperative hemostasis during and after scoliosis surgery. Preoperative measurement of fibrinogen concentration provides more information about bleeding volume and transfusion requirements than standard screening tests.

FDA "increasingly concerned with the number of imported medical devices"...Made in the USA ???

Please see our Poll results HERE
Important new recommendations have been issued by the US Food and Drug Administration (FDA) pertaining to medical device import entry review processes.
The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of their products into the US market. The letter and other detailed information about the FDA import review process is available on the FDA website.
"These recommendations will directly impact your company's ability to import medical devices, electronic product components, parts and finished products into the US," states the letter.
Specifically, the FDA recommends better adherence by importers to correct Affirmation of Compliance (AofC) data in order to avoid significant entry delays. An appendix of medical device AofC codes has been included with the FDA's Letter to Industry.
When a product enters the United States, medical device importers should make sure to include AofC codes for the following information:

• Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
• Device Listing (LST)
• Device Initial Importer (DII)
• Premarket Notification (PMN) 510(k) number, if relevant
• Investigational Device Exemption (IDE)

The agency emphasizes that although use of AofC codes remains voluntary, firms that do make use of them greatly increase their chances of having their devices cleared for import entry faster.
A separate Letter to Industry focusing on the import entry filing process for medical devices that also qualify as electronic radiation products is forthcoming, according to the CDRH.
Any questions regarding the FDA’s import entry review process should be sent to the CDRH’s Office of Compliance Import/Export Safety Staff at cdrhocimport@fda.hhs.gov.

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