17 Apr '14
Oleg Kouzbit, Online News Managing Editor
In a high-tech world that has seen an endless series of advanced attempts to harness the power of complex molecular combinations in a bid to fight systemic ‘killers’ such as cancer or cardiovascular diseases, paying attention to simple matters like skin injuries, cuts and burns sounds for many biotech developers a bit out of vogue. But not for a small university spin-out in Nizhny Novgorod, in the mid-Volga area, as it seems. The team has been working on its next gen hemostatic agent that should come soon in a variety of forms from gel to spray. The developers claim their solution called “Tectum” arrests bleeding faster than competition products, wards off germs, heals wounds and is effective on burns—a set of properties not so common for existing analogs both in Russia and internationally. The young company is already eyeing broad prospects, hoping to work its way into the vast U.S. market. With thousands losing their lives to excessive loss of blood and heavy burns each year this project, so small and unpresumptuous on the face of it, is an effort to watch.
Tectum is a new solution which the researchers say combines the properties of synthetic polymers and natural chitosan. Chitosan is a linear polysaccharide derived commercially from the chitin-rich shells of crabs, shrimps and some other crustaceans.
The remedial power of chitosan and silver nanoparticles brings about manifest hemostatic and wound-healing effect, the Tectum team told Marchmont News.
Its commercialization strategy calls for the development of four different forms of the agent, including gel, gel-saturated tissues, bandage, and spray, each selling at an estimated $1.5/apiece—a price that looks very competitive to Tectum’s Russian analogs (which sell at something between $2.5 and $5 per unit) and is at least 30 times lower than the existing competitors imported from the U.S. and the UK. With the easy-on-the-pocket price comes what the developers affirm is a set of noteworthy medicinal properties that appear to not only include and combine but also augment the advantages of Tectum’s domestic and global rivals.
In Russia alone, the demand for quality hemostatic agents is estimated to top 120 million units a year. In the U.S., the world’s largest market, customers from hospitals to households, to paramedics, to military and police forces need at least twice as many.
Several prototypes have been developed and basic tests completed. The Nizhny team needs more funding and time to wrap up advanced R&D and get ready for a full-blown start late next year.
Tectum is a one-year-old spin-out of the Lobachevsky State University of Nizhny Novgorod (UNN), a major fundamental research and education hub for the entire mid-Volga area since 1916 and the first government-sponsored academic institution in Russia to have formally adopted the time-tested international practice of supporting fledgling high-tech projects through a classical proof-of-concept (PoC) system. Its PoC being developed at UNN’s newly established Technology Commercialization Center is already busy packaging teams and ideas like Tectum.
According to official statistics, the loss of blood is responsible for something between 25% and 50% of the deaths of soldiers or police officers in the line of duty or of civilians injured at work, in traffic accidents or even at home.
The new chemical composition, being developed to change the stats considerably, includes an array of additives, such as reagents that act as gel formation catalysts in a wound, provide improved adhesive properties when in contact with tissue, and are biocompatible with the surface of a wound.
With a whole range of other agents across the world which help with profuse bleeding, especially from the U.S. and Great Britain as the leaders in the segment, the one originating from Nizhny Novgorod appears to be fast enough for experts to take a hard look at. During tests on mice, it took Tectum an average of just 30 seconds to completely arrest venous hemorrhage, the developers said, adding that their agent “prevents recurrent bleeding” as well.
Tectum is said to be able to stop bleeding even in extreme weather conditions—a property that is an obvious advantage for use at freezing or scorching temperatures, which few of the global rivals can boast, according to recent market research.
It is believed to possess strong antibacterial properties, too, preventing exposure of a wounded area to infection.
Taking care of your bleeding as fast and undeniably as the developing team promises sounds pretty good already; but there appears to be more to the story. Tectum is thought to also be able to step up the process of wound healing. Tests on small lab animals have shown a 50% reduction of the time a skin surface wound typically requires to mend. The agent can be applied to a wound that hasn’t been pre-treated—another side to note.
In an exchange with Marchmont News the UNN researchers pointed out that according to market research, very few competitors in the hemostatic segment reveal manifest wound-healing properties.
Being effective on a range of thermal burns seems to be yet another asset unparalleled in most hemostatic competitors. Some of those, on the contrary, could aggravate the situation if used on burns and therefore have contraindications for this kind of injuries.
As the Nizhny scientists assert, Tectum causes no scarring after burn treatment.
With what looks like a pretty impressive set of competitive advantages under their belt the developers are heading next week for the University of Maryland, College Park (UMD) to present the start-up and showcase their innovative product to international audiences from professors to local innovators to potential investors.
The visit has been facilitated by the US-Russia Innovation Corridor, a EURECA Program backed initiative offering Russian high-tech start-ups a fast track for their entry into the U.S. market. The main venue will be the Maryland International Incubator (MI2), a joint project between UMD and the state authorities for business promotion.
In addition to getting familiar with the vast U.S. market, the Tectum team hopes to develop a roadmap for seeking FDA 510(k) approval—a lengthy process that will follow the submission of all preclinical trial results and is expected to pave the way for licensing the technology to U.S. companies developing such solutions as their core business. Selling exclusive rights for a patent in the U.S. may also be an option, the start-up said.