Tuesday, May 3, 2011

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."