Year 1990
HYPRO – Research, development and production of biopolymeric preparations Otrokovice was registered by the District National Committee in Zlín on 17th July 1990. By then, thanks to the change in the political situation, private enterprise became possible. The business plan was to produce a haemostatic preparation which was an achievement of the technical cooperation with then senior consultant of Ophthalmic Department of Zlin Hospital, Doc. MUDr. Karel Kuběna, CSc. In the 80s, the method described by Dr. Li, an American doctor of Chinese origin, seemed to be promising in terms of decreasing intraocular pressure causing glaucoma. It was a surgically-made mini-bypass which allowed the aqueous humour to drain to a lymphatic vessel in the eye periphery. For such an operation, a collagen capillary tube was needed which, after having been implanted in the front chamber, provided permanent drainage. Since such a product was not on the market yet, Ing. A. Galatík CSc., who was already experienced in the preparation of clean collagens, endeavoured to develop it. The implantation in the sensitive eye tissue required perfect apyrogenity of the product. Therefore, it was decided from the beginning of the research that it should be based on atelocollagen, a substance which is made by a high-degree cleaning of collagen protein and removal of its telopeptide component – the carrier of antigen determinants which triggers the pyrogenic immune response of human tissue. The research resulted in a useful capillary whose properties were tested by a pre-clinical study. However, by then, a new intra-ocular pressure elimination method appeared – perforation of the trabecula using a laser. As the new method was non-surgical, outpatient and very effective, it soon became widely used. As a result, the development of atelocollagen tubes became useless. This material was applied well in health service and was registered under the trademark Hypro-Sorb as a haemostatic and a bioresorbable barrier. First it was used for the production of cornea covers, concave films or isolation covers in the therapy of injuries and the transplantations of cornea. Later these thin barriers were applied in dental surgery under the mark Hypro-Sorb F as a one layer barrier for guided tissue and bone regeneration. However, during pre-clinical tests, an intensive haemostatic effect of atelocallogen was observed. It was a new finding since, up to then, all similar haemostatics were made of collagen. Later, atelocallagen turned out to have even more favourable properties: apyrogenity and the ability of non-contribution to bacterial infection. The above mentioned properties are important in such cases where the haemostatic needs to be implanted in living tissue, as well as in traumatology where there is a risk of bacterial contamination. Thanks to the use of atelocollagen instead of collagen haemostatics, the new elements make for the improvement of the effectiveness and safety of haemostatic methods.
Year 1991
The production was started in premises leased by Moravan Otrokovice. First, it focused only on soluble biopolymers for cosmetic purposes. Atelocallagen gel, atelopeptidase enzyme and hyaluronan solution were produced. They were mainly used for the production of shampoos and components of cosmetic preparations by Biora. We gradually increased financial resources for the enhancement of the level of technological equipment and reimbursement of continuous clinical tests of the final product, which was given the name of Hypro-Sorb. Based on good clinical results achieved at four medical facilities in the Czech Republic and two in Slovakia, and after the inspection of the manufacturing practices area, the company was granted the Certificate in Pharmaceutical Production on 8th July.
Based on the Certificate and upon the submission of the clinical and technical documents, the Czech Ministry of Health, on behalf of RNDr. Petr Palouš, head of the Pharmacy Department, issued, on 11th September, an affirmative decision on the registration of Hypro-Sorb. Hypro-Sorb was classified as a medicine at that point. According to its notification, it was the first Czech private company that was authorized to produce medicines since 1948. Hypro-Sorb is mentioned in the publication Vademecum of certified medicaments under the registration number 89/301/91-C.
Year 1992
The Federal Office for Inventions in Prague issued, on 31st December 1992, a Patent Deed No. 276891 for atelocollagen haemostatics and the method of their preparation. Since the above mentioned date is also the last day of the existence of the then Czech and Slovak Federative Republic, it was probably the last federal patent.
Year 1997
The rented manufacturing premises were considered a temporary solution from the very beginning. Therefore, construction of a new manufacturing facility was started in Komárov in that year. The location was chosen for its suitable environment at the altitude of approx. 300 m, which provided favourable initial conditions for the achievement of the amount of technological particles in the air, known as a clean environment. Since the production is ecological and does not pollute the environment, we finally, after a number of meetings, arrived at an agreement with both the Municipal Council and the Building Authority. By the time production started, Otrokovice suffered from catastrophic floods, which strengthened our decision to build the new production facility in a flood-free area.
Year 2000
On 1st January, the company was transformed into Hypro Otrokovice, s.r.o. (limited company), which continued the production in the same premises with the same employees. In that year, the new production facility was completed. On 21st March, Hypro Otrokovice, s.r.o. registered its Internet domain www.hypro.cz.
Year 2001
Single layer homogenous barrier Hypro-Sorb F was in 2001 completed with bilayer variant created both by porous and impermeable layers. The development of these dental barriers was iniciated by ing. Miroslav Šťastný - CRESCO Prague. The barrier Hypro-Sorb F are made with chemical modification of one type of collagen, that means they consist of pure atelocollagen of type I. In contrast to other commonly used products Hypro-Sorb F barriers are not made of animal pericardium or other similar natural membrane formations which always are combinations of different collagen types and so are the sources of wider antigenicity. The barriers Hypro-Sorb F are made with the extraction of acid soluble atelocollagen of type I and following reconstitution of atelocollagen solutions to quite newly created barriers.
Year 2002
On 23rd January, Authorized Body No. 224 granted Type-Examination Certificate and Decision on the production of the medical devices of Class III – Hypro-Sorb.
Year 2004
On 30th September, Notified Body No. 1023 issued EC Type-Examination Certificate No. 04 0649 T/NB and EC Certificate No. 04 0648 QS/NB.
Thereby, sales to other European and extra-European countries increased. In that year, the reconstruction of a new dispatch facility was initiated.
Year 2005
On 9th December, after the registration of European domains was put in use, we asked for the allocation of domain: www.hypro.eu.
Year 2007
On 8th September, Hypro Otrokovice s.r.o. was granted ISO 13485:2003 a ISO 9001:2001 Quality Management System Certificates by Quality System Certification Body No. 3002.
Year 2008
Hypro-Sorb M is the result of many years experience and intensive research cooperation of Hypro Otrokovice s.r.o. and Cardiophil Ltd scientific team, Hypro-Sorb M is a soft bovine atelocollagen type I, non-cross linked membrane that has been especially prepared, purified and chemically modificated utilizing the proprietary technology of Hypro Otrokovice s.r.o, the material is biocompatible, apyrogenic, sterile for 5 years and fully resorbable in live tissue when implanted. Hypro-Sorb M membrans are used in dental surgery and implantology or for restitution of bone defects.
Year 2009
On 24th September, certification was obtained for the new resorbable Hypro-Flex dressing based on pure atelocollagen with hyaluronan bonded by complexation, developed for the prevention and treatment of bedsores, varicose ulcers, chronic skin inflammation, and burns. |
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