Israeli company LifeBond has received CE approval allowing it to sell its LifeSeal product in Europe. LifeSeal prevents leakages in the digestive system after surgery. According to the company, this is the only biological glue currently permitted for use in this situation. It will be used by surgeons in combination with the traditional methods of staples and stitching.
LifeBond was founded in 2008, and has so far raised $59 million.
Ittai Harel, chairman of the company on behalf of venture capital firm Pitango, says that it will not seek to market its product in all of Europe at once, but will choose 2-3 countries in which it is already active in clinical trials, and initially launch the product there. It has still not been decided whether sales will be through distributors or through partners.
Meanwhile, the US Food and Drug Administration (FDA) has allowed the company to file its application for marketing approval under the Expedited Access Pathway (EAP) program. The requirements in this program are the same as for a new product in the Premarket Approval (PMA) track, but the FDA works with the company to shorten bureaucratic procedures. LifeBond will shortly embark on a clinical trial in US and European centers in order to obtain FDA approval, in addition to the two trials it has already carried out in order to obtain the CE approval. Harel says that acceptance to the EAP program indicates the importance of the product for the market in the FDA's view.
"At the same time as our work on testing the safety and efficacy of the product, in the past few years we have also carried out a very extensive study of the product's ease of use and the simplicity of its integration into existing surgical procedures, and we have examined pricing as well," Harel says. In this way, the company hopes to avoid the mistakes made by many medical device companies at the market penetration stage.
Does the transition to the commercial stage mean you need to raise money?
Harel: "The company is not currently in need of cash to start market penetration in Europe. When we come to the US market, we'll consider all our options, including an IPO."
Published by Globes [online], Israel business news - www.globes-online.com - on April 25, 2016
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