Doing something a little different is one way for a new company to draw some notice, and a Swiss developmental firm is starting with little children.
That's the strategy for Bioring SA (Lonay, Switzerland), a relatively new cardiovascular company looking to harness a share of the heart ring market with its Kalangos Biodegradable Ring, a heart ring device designed to reinforce the valvular orifices of the heart, even in the very young.
The product is named for one of the company's founders, Dr. Afksendyios Kalangos, chief of the cardiac surgery department at the Geneva University Hospital (Geneva, Switzerland). Nearly two years ago, Kalangos teamed with biomedical engineer Raymond Andrieu, and the two launched the company based on the new technology. "We founded the company in April of 2000, for the purpose of bringing together the idea of a cardiac surgeon and a biochemist," said Andrieu, the company's chairman and CEO. "The FDA did not allow rings below a certain size on babies, meaning there was no real solution for newborns in pediatric surgery," he told Cardiovascular Device Update's sister publication, Medical Device Daily. "So we developed a product that will grow with the baby, with no need to reoperate."
Heart rings are nothing new, but according to Bioring, none are biodegradable. "We had the idea to use a biodegradable polymer, one that has been approved for 20 years," Andrieu said. "The polymer creates a scar, which then acts as a natural part of a valve."
He said animal studies on the polymer were not necessary, as that research was conducted some time before. So the company jumped into a clinical study, the results of which were presented at last June's World Pediatric Cardiology and Cardiac Surgery Meeting in Toronto, Ontario, and two European medical meetings in Lisbon, Portugal, in September."We received a marvelous [response] from cardiovascular surgeons worldwide," Andrieu said. "All the countries are asking us to import this technology."
In the study, 17 patients were implanted with the device at the Geneva University Hospital. The patients – eight girls, nine boys – ranged in age from 7 months to 14 years old, with a mean age just over 6 years.
"There were not so many solutions for them," Andrieu said. Based on a scale of heart defect severity, eight of the patients were part of the New York Heart Association Class IV group, the most severe classification. Eight were NYHA Class III, and the final patient was a NYHA Class II case. After four years of follow-up on the patients, Andrieu and his Bioring colleagues are more than pleased with the results."The results are absolutely convincing," he said. "All the patients post-operatively are now functional in Class I – 100%."
The company in June of last year received IS0 9001, ISO 13485, EN 46001 and Swiss certification, and has set up a manufacturing center to produce the Kalangos Ring."We have set up a manufacturing plant to produce the ring in 11 different sizes, to fit a very small baby [up] to a very big NBA basketball player," Andrieu said. "With the basic know-how of this polymer, we [can] make it last a certain lifetime within the body, from three months to 10 years."
While the ring was originally designed with infants in mind – to reduce the high mortality rates of multiple surgeries to replace outgrown rings – it also has applications in adults. Bioring is not far from commercialization, and the company has turned its attention toward gaining CE mark approval, which it expects to achieve by the end of January.
A further hurdle is FDA clearance to take the Kalangos Ring to the U.S. market. To do this, Andrieu said Bioring is in negotiations with unnamed companies to partner in the FDA submission process or purchase the technology outright.Andrieu has been a part of three other companies that have developed cardiology and immunology products in the past, going through the approval steps along the way, so the process is not new to those at Bioring.
The company expects the product to cover the complete pediatric market, which offers no comparable technology, Andrieu said. In the adult market, it expects the Kalangos Ring to penetrate an established valve repair market. The company also is developing other products based on the polymer used in the ring."We believe there are other applications in cardiac and vascular surgeries," Andrieu said. "That is where we have our maximum knowledge."
Without getting into specifics, he said the company has five or six other products in various stages of development, from animal studies to clinical trials. But for now, Bioring's priority is launching the Kalangos Ring. Andrieu expects the company to sell 4,000 rings during their first year on the market, a number he said should jump to 25,000 the following year. "But we cannot go everywhere at once," Andrieu said.
Success with the FDA should help Bioring draw plenty of notice.