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Baxter International has announced that it will no longer be using PVC (polyvinylchloride) in its products, including the blood and intravenous fluid bags that have made Baxter’s name. Baxter will probably now increase the output from the Swiss company Bieffe Medital, acquired in 1997, which has been producing intravenous delivery products without PVC. Baxter has been the target of a number of organisations representing purchasing groups as well as environmentalists. The focus of complaint about PVC appears to have moved away from the risks of monomer exposure and dioxin production during disposal to the presence of di-ethylhexyl phthalates as plasticisers, and findings of tumours in laboratory animals exposed to certain phthalates. The plasticiser saga is expected to continue. Although in certain segments such as plastic films for packaging, metallocene polymers may provide adequate substitutes, PVC is still one of the most versatile polymers for use in the medical technology field and it is difficult to see what can easily and quickly replace it elsewhere.
HIMA, the US medical device manufacturers’ association, has recently produced a report on Emerging Markets. The report estimates market sizes for the top 10 established markets and the 13 Asian and South American markets that represent a large opportunity for devices and materials. It is impossible from the report to gauge the size and growth of product areas of interest to the European Biomaterials Network. However, estimates for overall growth suggest that most of the emerging markets, ranging from Hong Kong at $600m to Brasil at $2.2b, will have grown at 10-15% by the end of 1999, compared with 4-7% growth projected for the European, Japan and US markets. These however are much larger, ranging from $2.1b for Spain to $62.3b for USA. For more information contact kalcorn@himanet.com
At the same time as silicone implants appear to be receiving a clean bill of health from the USA and some other regulatory authorities, soya-bean oil-filled implants have been withdrawn from the UK market, due to complications following accidental rupture. This is a voluntary withdrawal by the manufacturers LipoMatrix AG, previously owned by Collagen Aesthetics and now owned by Sierra Medical Technologies. The Danish enforcement agency has also requested withdrawal of the Trilucent implants from the market.
Medtronic, one of the leading devices and biomaterials companies active in US and Europe, has bought the stent manufacturer Arterial Vascular Engineering, for $3.7 billion. This consolidates Medtronic’s presence in the cardiovascular area, following extensive purchases during 1998 of World Medical Manufacturing (aortic aneurysm management) and Bard’s coronary catheter division. Medtronic expects income of more than $1 billion from the combined vascular businesses in 1999-2000. Major competitors are Guidant and Boston Medical. Medtronic and Guidant have recently issued physician warning letters in USA following premature battery failures in pacemakers and cardiac defibrillators. The problem appears to be caused by abnormal metal-to-metal contact within the devices leading to accelerated discharge. At the moment, each company expects no more than 50 devices to be affected, out of 5,000 and 7,000 implants in place, respectively.
PricewaterhouseCoopers’ quarterly report for July-September 1998 revealed that about 4% of the total venture capital invested during the period in USA was put into medical device companies, amounting to just over $150 million. There are some indications that, though the sector is relatively small, it is attracting more attention from investors interested in longer-term potential in this area. The types of investment include advanced medical equipment for minimally-invasive surgery, cardiovascular surgery, cardiac arrest, heart-rate monitoring and intensive care monitoring, and new methods for drug delivery, lung-disease treatment and brain haemorrhage (stroke).
Some VC funds are also available for companies working in new biomaterials and prosthetics. One such is Spinal Concepts, which recently received over $8 million to help support its clinical trials of a spinal fusion system InFix and add to its marketing structure.
Fusion Medical Technologies, based in California, has been developing tissue sealants and materials to control bleeding. Its IPO (Initial Public Offering) took place in 1996 and it is planning to follow this up with share placings to yield over $9m for the next stage of development of FloSeal, a collagen-thrombin gel that can be introduced by syringe into surgical sites for haemorrhage control. In clinical studies, the gel stopped bleeding in 84% of patients within 3 minutes and 96% within 10 minutes, compared with 47% and 77% of patients treated with gelfoam sponge plus thrombin. Even heavy cardiac bleeding and wet sites are adequately handled. Fusion Medical Technologies hopes to gain its CE mark during 1999 and market the product in US from 2000 onwards.
A new biomaterial for soft tissue regeneration has been launched for veterinary use by Cook (UK) Ltd. VET BIOSIST is a collagen-based dry sheet that can be cut to the shape of a wound and moulded to the site, swelling as it rehydrates, to provide a biocompatible scaffold for the colonisation of the patient’s own cells. A recent report describes the successful use of the product on a dog that had been hit by a car. The damage was so severe that amputation or heroic skin graft was considered as an option before the product was used. The product is derived from porcine small intestinal submucosa and is being developed and marketed for use in humans by DePuy (see R&D Digest). Further information on veterinary use can be found at http://www.vetbiosist.com
Sulzer Orthopedics has developed an improved polymer material for use in hip prostheses. The polyethylene has undergone special processing to remove free radicals and induce high-density cross-linking for improved wear characteristics and reduced ageing.
Wedbush Morgan Securities has published a report focusing on wound-care, examining the likely impact of newer biomaterials and biotechnology-based products. Topics that are selected for special attention include tissue glues as a replacement for suture materials, fibrin glues for surgical haemostasis, and management of slow-healing or life threatening ulcers such as bedsores (decubitus ulcers), venous stasis and diabetic ulcers. Companies highlighted by the report include Chiron, Advanced Tissue Sciences, Organogenesis, BioSpecifics Technology, Magainin and ProCyte. How far these and another 20 or so companies will penetrate the $10 billion market for wound-care, 98% of which is currently devoted to low-technology products such as bandages and conventional surgical procedures including autografts and amputations.
A new medical technology incubator has been opened in Israel with a $15m investment fund to support entrepreneurial technology transfer and product development. The InnoMed Innovation Center will provide the business support for the start-ups, including management and marketing.
The UK-based investment management and funding group Merlin Ventures has established a new fund that may provide some support to biomedical start-ups and second-round companies in UK and Europe. Merlin is entering into closer relations with International Biotechnology Trust and with its biotechnology advisors, previously working in the Rothschild asset management stable.
Orquest Inc has received a CE marking for a mineralised collagen bone substitute for bone grafts and spinal fusion. It seems likely that there will soon be many alternatives for defect filling. Several companies have developed products based on different approached to the task; some are combinations of hydroxyapatite and mouldable polymeric material; others are based on sterilised sea-coral or bovine bone material. Interpore International of Irvine, California USA markets Pro Osteon as a porous support for bone growth into defects. The absorbable version is available in the EU and a product containing growth factors is in development.
Not all requirements for new body parts are high-tech: the Japanese company New Body Institute provides clients with silicone body parts such as fingers, ears and breasts, matching the prosthesis to the client using pigments for skin tone. Because the prostheses are not custom-made, but are generally ones that did not fit other clients or were rejected for other reasons, the service is faster and cheaper than either tailor-made or surgical correction. The owners are now thinking of setting up an express home delivery service to be called Every Body Rentals.
The US company Norian is marketing a new injectable setting bone cement for simple wrist fractures. Norian SRS is a biocompatible substitute for cancellous bone and is instilled as a paste into the fracture site. It can be used with other devices and implants if these are required.
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