September 12, 2017
By Alex Keown, BioSpace.com Breaking News Staff
PARIS – In two years, Gecko Biomedical has gone from unknown startup to a company with an approved medical device ready to hit the market.
To say the company has worked around the clock for the past two years is an understatement, chief executive officer and company co-founder Christophe Bancel said. Monday morning, the company announced its Setalum vascular sealant received CE Mark approval from the European Medicines agency. The approval clears the way for Gecko to market the sealant in Europe. This sealant, which is biocompatible and bioresorbable, is usable as an add-on to sutures during vascular surgery.
During clinical trials, hemostasis was achieved in 85 percent of patients. All recorded adverse events were found to be “representative of those commonly occurring in patients necessitating vascular reconstruction with none considered as related to the sealant,” according to company data.
“Our ability to bring an entire new family of innovative polymers from the bench to the bedside in less than two and a half years is a testimony of the versatility and scalability of our platform. We are now ready to fully expand, internally and through partnerships, into new therapeutic areas to design disruptive, surgical solutions for patients,” Bancel said.
Bancel said there is a strong need for a superior vascular sealant on the market. Some of the available products, he said, are prone to leaking. In clinical studies, Setalum was used as a sealant for surgeries related to congenital heart defects. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.
“This is Gecko’s first product. We’ve been working 24 hours a day to get this ready. It can be used in a wet environment, which means it’s very easy to use. It’s very exciting,” Bancel told BioSpace in an exclusive interview from his Paris office.
The marketing approval means the company will grow a bit more over the next few months as it looks to scale up manufacturing. Bancel anticipates hiring about six more employees by the end of the year, which will bring the total number of Gecko workers to about 30.
Bancel said the company is ramping up its manufacturing so the sealant can be on the market by the end of 2018. Additionally, he said the company is seeking strategic partnerships to help market the product.
Europe is not the company’s end goal. Bancel said he plans to talk with the U.S. Food and Drug Administration about gaining marketing approval in the United States as well. Bancel said he hopes they will submit approval application in the U.S. by the end of this year.
Gaining approval in the United States isn’t the end game though. Now that the Gecko team knows the product works and is safe, Bancel said the R&D group will be looking at new applications for the sealant. In theory that should be easy to do as Setalum’s structure allows customization for various applications and tissue types, Bancel said.
“This is a good first step for us. It has been a way to demonstrate our innovation capabilities,” he said.
Setalum was developed from labs at Harvard Medical School, Brigham and Women’s Hospital and Massachusetts Institute of Technology. Maria Pereira, the co-inventor of the sealant, is Gecko Biomedical’s Chief Innovation Officer.
In the near term, Bancel said the company will continue to up its manufacturing. The company will also likely look at raising additional funding as researchers search for new ways to apply Setalum. Since its founding, Gecko has raised approximately $36 million. Bancel would not confirm his company’s plans but hinted at a funding round. The company’s most recent financing round was led by Sofinnova Partners and Bpifrance.
