Fluoron is a company that takes close contact with customers very seriously. This is why Christian Lingenfelder and his team frequently pack their suitcases to travel from place to place visiting Russian or Chinese operating theatres. Thousands of kilometres from the company’s production site in Ulm, the Fluoron team exchanges information with the retina surgeons for whom the company develops and produces highly pure biomaterials for use in ophthalmic surgery.
The company is currently developing products specially designed for the emerging Chinese market whose requirements for retinal surgery are very different from those of Germany. To hear Fluoron CEO Christian Lingenfelder speak is to realise that his research-driven SME is going through a turbo-charged growth phase in terms of the manufacture of new products against the background of a cautious strategy of diversification.
Fluoron GmbH has a staff of 17 and achieved revenues of around 2.5 million euros in 2010. The company’s product portfolio comprises highly pure liquids and dyes required by retina surgeons for eye operations. The company has no difficulty at all selling its products simply because the number of eye operations is increasing: we are faced with the phenomenon of an ageing population and the incidences of lifestyle diseases such as diabetic retinopathy are increasing enormously. In Germany alone, around 80,000 people every year need to undergo surgery of the posterior part of the eye. The company was established in 1996 and initially focused on perfluorocarbons, chemically highly stable and colourless liquids with a higher density than water and that are resistant to human enzymes. Perfluorocarbons are used in eye surgery as temporary tamponades to stabilise the retina following the removal of the vitreous body (vitrectomy). They are removed from the retina after surgery.
The Ulm-based company also markets tamponades that can remain for longer periods in the eye. These tamponades are made from silicone oils that are purified using a proprietary process designed to remove toxic short-chain silicone molecules. Thanks to their surface tension these highly pure biomaterials, which are offered in different degrees of viscosity, stabilise the retina, thus contributing to the adhesion of the retina by substituting the vitreous body that is removed during retinal surgery. The company has strengthened its research activities since 2007, which has led to the development of a new product that enables eye surgeons to safely remove a very fine transparent membrane (ILM, inner limiting membrane) without compromising the patients’ eyesight. The biocompatible dye Brilliant Peel, which has recently been granted marketing authorisation, enables surgeons to clearly differentiate ILM from other retinal tissues and membranes. Cell biologists have long used this substance, which belongs to the huge family of triphenyl methanes, to stain proteins.
Up until now, says Fluoron CEO Lingenfelder, surgeons had to use tiny tweezers to lift the inner limiting membrane (ILM, Membrana limitans interna) from the retina in order to prevent the macular damage that could occur if small pieces of the vitreous body remained in the eye. These pieces can also prevent complete healing. The ILM is a very fine transparent membrane that is just two to three micrometres thick.
It is normally removed either using the naked eye, which is associated with the risk of missing damaging vitreous body remainders, or by using toxic dyes that need to be mixed in a time-consuming process and can only be used for a limited period of time. The new dye enables surgeons to selectively stain the ILM, which greatly facilitates the operation.
The company also have high hopes for the development of a vitreous body substitute based on sodium hyaluronate. If everything goes to plan, patients will no longer need a second surgical intervention. The development of a sodium hyaluronate-based substitute is being pursued as part of a BMBF-funded cooperative project which involves the participation of Fluoron. At present, when the vitreous body is removed, oil tamponades or gauze are used to stabilise the retina. However, these substances need to be surgically removed some time after the intervention, said Lingenfelder explaining that the vitreous body substitute would mean that patients would no longer have to undergo the second surgical intervention that is required to remove the oil tamponades or gauze.The company’s intensive research programme is paying off: Fluoron plans to launch as many as six new products on the international market in 2011. In 2010, the company launched its latest innovation, i.e. the optimised Brilliant Peel dye, which was granted orphan drug status by the American FDA.
Due to the major sums that need to be invested for gaining marketing authorisation on the American and Japanese markets, Fluoron has not yet sought such approvals. The company’s website shows the international commitment of the SME: the site contains information for retina surgeons in Chinese, Russian, Turkish, Arabic, English, Spanish, French, Portuguese and German.
The company’s stated aim is to closely involve its clients in product development. A large number of the company’s staff therefore spend time organising training seminars and participating in conferences and trade fairs. The scientific exchange with the users of the company’s products also lead to doctoral and post-doctoral theses as well as further developments that are awarded highest academic distinctions, all of which reflects favourably on Fluoron.
Fluoron’s high-speed development would of course be impossible without strong sales partners, which is why the company has always worked with strong partners ever since it was founded in 1996 by Hasso Meinert, a former chemistry professor at Ulm University. Shortly after, Fluoron was sold to Heidelberg-based Geuder AG, a specialist in ophthalmic instruments and devices. Fluoron thus gained a strong partner with a huge product portfolio and subsidiaries in 50 international markets. The Geuder Group also owns Geuder Asia-Pacific and Novalique, a Fluoron start-up company with which Fluoron has entered a strategic research and development alliance in the field of semifluorated alkanes.The company headquarters were originally located in the city of Neu-Ulm, before relocating to the north of the city of Ulm in 2009, where there is ample space for further expansion. Dr. Christian Lingenfelder, economic engineer and human biologist with an MBA degree, has been at the helm of the company since 2007 and was one of the main people responsible for the company’s relocation to its new premises.
When Christian Lingenfelder became CEO of Fluoron, he instigated comprehensive changes: he was responsible for automating the manual production processes in so far as was possible, increasing the company’s research and development resources, and successfully acquiring the additional funds that enabled the company to expand its product pipeline. Lingenfelder (“I am always looking beyond my own field of expertise”) is always ready to take on the challenge of pursuing unusual paths and this has resulted in numerous prizes. He recruited mechatronics apprentices and their vocational schools and employers to automate the production process.Lingenfelder is convinced that his profitable company has an excellent future ahead. He believes that the fact that banks supported Fluoron throughout the crisis in 2010 by continuing to provide capital is a sign of trust and confidence in the company’s activities. Nevertheless, the company is currently focusing on a kind of diversification, a reorientation Lingenfelder believes is necessary due to the enormous number of regulatory requirements that are particularly difficult for small companies to manage.
Fluoron is increasingly thinking of ways in which it can use its biomaterial developments for new platforms, which would enable the company to also provide other surgical disciplines such as orthopaedics or dermatology with products. The factories that are required to serve these markets have been developed and the first negotiations with partners are underway.In order to stabilise its business, Fluoron also plans to enter the field of contract manufacturing, providing clients who have a product idea with documentation, approval, production and packaging support. Such a broad range of services, along with greater financial resources, would help Fluoron to not only enter other surgical disciplines, but also focus on obtaining marketing authorisation for products in the USA, which is the largest market in this field.
Lingenfelder also believes that an orientation towards the pharmaceutical sector is another long-term option. The Ulm-based company regards itself as being in a good position to tackle future demands. The orientation towards the pharmaceutical sector is frequently referred to as the “biologisation of medical technology”, meaning the development of bioactive surfaces, drug delivery systems or products that combine a medical device and a pharmaceutical drug.