On 24/25 October 1994 I attended in Brussels a meeting of the drug-device-borderline issues working group of the European Commission. One of the subjects on the agenda was whether to classify hyaluronan containing products for medical use as drugs or as medical devices under the new European Medical Devices Directive 93/42/EEC (MDD). Pharmacia was interested in staying with the current regulation of Healon® as a drug, whereas, other manufacturers were in favor of regulation as a medical device, because one CE mark would grant them free market access to all countries within the European Economic Area. I was interested in the decision because since the mid-1980s several hyaluronan manufacturers had been clients of my test house, I had achieved personal knowledge on and was interested in hyaluronan, and my own Notified Body had been accredited in 1994. One of the experts who had been invited to share his opinion was Professor Dr. Endre A. Balasz, the father of medical grade hyaluronan, inventor of Healon®, and CEO of BIOMATRIX. Professor Balazs had anticipated the background of his audience, and had therefore brought a vial containing hyaluronan gel to demonstrate the viscoelastic properties of this viscosurgical tool. He charmed away the arguments of other experts about interaction of hyaluronan with receptors by stressing that the main intended action of hyaluronan gels and solutions is of physical nature. I really enjoyed and was amused by his presentation and the discussion of the experts. After hearing all experts, the working group concluded that hyaluronan containing products for medical use will be regulated as medical devices unless the manufacturer claims a pharmacological, immunological or metabolic action as the main intended activity.
After the working group session I discussed with Professor Balazs (friends call him Bandi) the product portfolio of BIOMATRIX and how he planned to achieve approval as medical devices in Europe. The products were now regulated as class III medical devices, because they contained material of animal origin. BIOMATRIX had been in contact with major European Notified Bodies, and obtained the advice to go through the certification process for the production (MDD, Annex V, product quality assurance) in combination with the type examination of the product (MDD, Annex III). Annex III requires that the Notified Body actually tests the product, and I shared my doubt about the ability of most Notified Bodies to do so. I recommended Professor Balazs rather to go through a certification process according to MDD, Annex II (full quality assurance system in combination with the examination of the design of the product). This approach seemed more adequate for a research based company with full in-house test facilities. Professor Balasz listened to my arguments and proposed to send his son-in-law to go into more details. Johann Scheidt visited me on 17 November 1994 in Munich. We developed the outline of a plan to accompany BIOMATRIX to certification, and Johann Scheidt invited me to see BIOMATRIX’ facilities in Montreal, Canada and Ridgefield, NJ, United States.
I followed this invitation in February 1995. On 14 February I had a meeting in South Dakota, and had booked a flight on 15 February from Sioux Falls via Chicago to Montreal. A snow storm inhibited my plan. I missed my connecting flight in Chicago and flew the next day directly to Newark to meet Professor Balazs and his team at their facility in Ridgefield. From then on I regularly visited Ridgefield to coach BIOMATRIX in introducing a full quality management system including R&D, and consult the company on regulatory affairs. Unnecessary to say that I learnt a lot on hyaluronan during that period. In late 1995 BIOMATRIX achieved CE approval of its product Synvisc® for the treatment of osteoarthritis. This achievement created the basis for the listing of BIOMATIX on the New York Stock Exchange (NYSE) in July 1998.
Bandi included me in his group of ‘friends and family’, and during summer time regularly invited me to his home (Villa NifNaHA) at the Côte d’Azur near St. Tropez. During one of my visits Bandi told me about his love to the Côte d’Azur and his dream to study in Marseille. The study in Marseille was prevented in 1939 by the break-out of world war II, but in 1984 he could realize his love by purchasing Villa NifNaHA, thanks to his license income from Healon®. The name NifNaHA stands for ‘non-inflammatory fraction of sodium hyaluronic acid’.
In 1997 I approached Bandi with the question whether or not he would agree to support me in introducing Hylan A (very high molecular weight hyaluronan) eye drops in Europe. Being a generous person who appreciated my contribution to the success of BIOMATRIX, Bandi spontaneously agreed. I knew that BIOMATRIX had created an eye drop formulation containing Hylan A under the tradename Hyla-Shield, and Bandi agreed to provide my company with the Hylan A bulk solution to set-up our manufacturing in Europe. Moreover, Bandi helped me to compose the technical file for our product. This was the birth of Comfort Shield® eye drops. Comfort Shield® received approval as class III medical device in October 1999. For years we shipped the sterile bulk solution in pressurized 200 liter tanks by air freight from Ridgefield to our manufacturing plant in Germany.