It took his grandfather’s brush with death to turn Leonid Glushchenko into an innovator.
He was a fresh-faced, 21-year-old medical student at a university on the Volga River when the pensioner developed a life-threatening blood clot.
Saving Pyotr Ivanovich would take a cava filter, a special steel implant in the vein that unfolds like an umbrella to catch and break up clots before they race away through the bloodstream toward the heart and lungs.
Glushchenko, training as an endoscopic surgeon, knew this meant two operations, the second of which – removing the device – was notorious for causing complications such as bleeding, perforations and new clots which can leave the patient permanently disabled and even result in loss of life.
That gnawed away at Glushchenko: Did it have to be that way?
“I wanted to help families dealing with the same reality that our family faced,” he recalled in an interview to sk.ru.
“After I started reading around cava filters, I discovered how many complications there were and what people needed to do in order to cope with these complications for the rest of their lives.”
Of roughly 5,000 operations performed every year in Russia to remove steel cava filters, such complications have been observed in up to 40 percent of cases - a statistic that compelled Glushchenko to become an innovator once and for all.
The classical steel cava filter. Photo: Flickr
Close call
As it turned out, Glushchenko’s grandfather recovered from the blood clot without needing the implant. But by then there was no turning back, and now, five years on and with Skolkovo’s help, the student from Ulyanovsk has developed a potentially game-changing innovation: a soluble cava filter, made from a self-expanding, shape-memory polymer that is implanted in the same way as a steel filter.
The big selling point is that it is 100 percent biocompatible, simply dissolving away in vivo, eliminating the need for further surgery and thereby delivering the patient from the associated life-threatening complications.
The filter’s shape-memory polymer structure can be squashed down to 3 or 4 millimeters in order to fit inside the catheter. Once the catheter is inserted into the inferior vena cava, the filter emerges and the polymer resumes its original shape, unfolding to ensure a maximum possible area of contact with the vein walls to prevent perforation, without losing any of its mechanical rigidity.
Developing a device to exhibit this behavior, however, required perseverance. Lacking expertise in high-tech materials, Glushchenko required a research partner and eventually found one at the Russian Academy of Sciences’ Institute of Synthetic Polymeric Materials.
“To start with, we used an osteosynthesis polymer and explored what could be made from it. I made small cava filters that I implanted in rabbits and other small animals and I saw how they dissolved and generally behaved,” Glushchenko said.
“After that, we remodeled and modernized the construction to fit our needs better: so that filter dissolved quicker, so that it retained its shape better, and so on. The last feature we worked on the memory characteristic, so that the device would scrunch up into the catheter and then tuck nicely into the inferior vena cava.”
The inferior vena cava is the body’s superhighway for deoxygenated blood, carrying it from the lower half of the body to the heart’s right atrium. The word cava is Latin for “hollow.”
New opportunities
Glushchenko's soluble cava filter. Photo: Sovremennie Tekhnologii
With a prototype finalized by the end of 2013, the invention was among several winners at the Ulyanovsk stage of the 2014 Russian Startup Tour, securing the project a Skolkovo mini-grant. Four months later they attended the Skolkovo Startup Village but failed to make the finals of the pitch sessions. Here, Glushchenko’s inherent persistence kicked in again.
“This [failure] gave us the push we needed to look again at the concept of cava filters and tweak the design and method of construction,” he said.
On the strength of the new design, Glushchenko’s application for Skolkovo residency was accepted. Now his team is in constant contact with the Biomed Cluster to discuss the progress of the project, including the findings of the preclinical trials currently being carried out on pigs and sheep in Shanghai by Gateway Medical. At stake is a slice of a global market predicted to hit $800 million by 2016.
“If I could turn back the clock, we would have started our preclinical trials these animals even earlier,” he says.
“Pigs are far more similar to humans than rabbits, for example, and their size allows us to use full-scale cava filters in the trials.”
Eagerly awaiting the trial results are potential investors in China, South Korea and America, whom Glushchenko met as a participant on the Startup Tour.
“Skolkovo gives us new opportunities. They have connected us with investors whom they have agreements in place with,” he says. “Thanks to the Startup Tour and Startup Village, we have found the partners we need.”
Young innovator Leonid Glushchenko
Serious potential
Ruslan Altaev, head of foresight in medical products and equipment at Skolkovo, explained the competitive advantage of the product.
“Glushchenko’s cava filter is unique,” he said. “Most multinationals are now focusing on stents to treat embolisms, as opposed to filters. One Irish competitor has developed a stent that is partially soluble, but we don’t consider this to be the solution. If it’s only partially soluble, then a foreign object remains in the body, and the consequences are clear,” Altaev added.
“The soluble cava filter is an entirely new approach, and this is precisely why it has serious potential to impact the health care industry.”
Indeed, Glushchenko expects that the product, anticipated to hit the market in 2017, will halve the number of complications associated with the use of its steel counterpart.
“In Russia, the resulting decrease in the incidence of hospitalization will save 20,000 rubles per patient and the absence of a second operation to remove the cava filter will save 80,000 rubles,” he says.
“The numbers are big – every 1,000th person is a sufferer [of clots]. That’s huge sums of money for a hospital’s budget.”
The potential gain for Glushchenko is high, too, with the scientist set to make $340 profit from every $1,200 unit sold, when it eventually enters the market. He hopes for a return on investment just two years after market entry.
Glushchenko, meanwhile, is humble when met with praise for developing such an intricate and complex device at such an early age, noting: “Well, I’m not on my own.”
That’s a reference to his collective of four people including technologist Vladislav Shchepochkin and economist Oleg Leibel, the strategic development director – all working out of a lab in Moscow under the company name Sovremennie Tekhnologii (Modern Technologies). They subcontract work out to preclinical trial specialists, computer specialists and chemical researchers.
“I think with such a large and varied team, we can achieve success in the market,” he says.
Biomed Cluster research assistant Jennifer Millar contributed to this article.