BBI

There are more than 15 million people in Europe suffer from various levels of loss of hearing, with around 55% (over 8 million) having a hearing loss of 20 decibels (dB) to 40 decibels, 33% with a loss level of 40 dB to 70 dB, 9% with severe deafness (loss of 70 dB to 90 dB and 3% (450,000) suffering from deep deafness (over 90 dB hearing loss). Almost 2 million are younger than 18, with an estimated 80% of genetic origin.

"For many years, the hereditary component of childhood deafness was regarded as small. Today, as a result of recent progress, we know that over 80% of congenital deafness is of genetic origin," said Christine Petit, director of the genetic laboratory of sensory deficits at the Institut Pasteur (Paris). She explained, "A majority of these cases of deafness result from a single mutated gene. In total about 100 genes, if carrying a mutation, can result in deafness. Up to now, 17 of them have been identified."

One of these genes particularly interesting for researchers is associated with a protein named connexine 26. "The gene of connexine 26 accounts for 40% to 50% of congenital deafness in developed countries," Petit said. Research at her laboratory has shown that 1 million to 2 million people in France carry a mutation in one of the two copies of the gene. If two parents are carriers of a mutation, they hear normally, but any child who receives two mutated copies (one from each parent) is likely to be deaf.

It is important to detect as early as possible hearing problems in babies, said Lucien Moatti at the Armand-Trousseau Children's Hospital (also Paris). Moatti feels that all infants at risk should be tested (because of family history of deafness, pregnancy or delivery problems, etc.), but he said that only about 10% of babies are tested. At present the average age for confirmation of deafness is around 12 – much too late to avoid psychological and learning problems.

High-resolution magnetic resonance imaging (MRI) is increasingly being used as an alternative to high-resolution computed tomography to investigate structural abnormalities in children with hearing loss. The absence of radiation exposure, no need for contrast medium and lower costs all are positive advantages, although there may be a loss of bone detail in the image, according to a recent study at the University of Utah School of Medicine (Salt Lake City, Utah). The researchers said high-resolution MRI also can help in assessing the feasibility of cochlear implantation.

Around 200 cochlear implant procedures take place each year in France, and worldwide the number of cochlear implants in use can still be measured in thousands. Cochlear (Sydney, Australia), a major supplier of cochlear implants, earlier this year acquired Philips Hearing Implants (Antwerp, Belgium), which also develops cochlear implants. The Belgian facility, which has been renamed Cochlear Technology Centre Europe, provides Cochlear with complementary cochlear implant technology and expertise, the company said.

Otospongiosis, another audio disease of genetic susceptibility which affects around 2% of the population in Europe, affects the third ossicle of the middle ear, the stirrup-bone, which softens and can no longer transmit acoustic vibrations. Didier Boaccara, ear, nose and throat surgical specialist at the Hopital Beaujon (Clichy, France), said that spectacular results can be obtained using microsurgical techniques under general anesthesia to replace the stirrup bone with a Teflon prosthesis.

"The availability in Europe of more sophisticated digital hearing aids is a considerable evolution," Moatti said. "These new devices treat the audio signals to extract the spoken message from background noise." A substantial limitation in market growth for these improved hearing aids is price. In France, only 600,000 to 800,000 people from an estimated 4 million with hearing difficulties use a device. The price of a hearing aid in France varies from $650 to $1,200 for analogue technology. Digital technology hearing aids, like the Senso from Widex (Vaerloese, Denmark), can cost up to $1,600 each.

Reimbursement by the French Social Security system is only $172 and is limited to one device only, although complementary insurance through a "Mutuelle" can raise the level somewhat. Under the age of 16, hearing aids are supplied free of charge.

In Britain, the National Health Service has decided not to consider providing digital hearing aids, at least until the next review by the National Institute for Clinical Excellence in 2002. Until then, only analogue devices will be available.

Although numbers of deaf people are increasing as the European population ages, it is unlikely that reimbursement levels or regulations will increase much in the future. More likely is the availability of lower-cost prostheses, in spite of objections by retail audiologists. Songbird Medical (Cranbury, New Jersey) is planning a full U.S. launch this fall of its disposable analogue hearing aid, for $39, which is designed to be thrown away after 40 days. An early launch in Europe is planned soon thereafter.

PDT gets European go-ahead

Visudyne verteporfin treatment for the wet form of age-related macular degeneration (AMD) has been approved by the Committee for Proprietory Medicinal Products (CPMP) for European sale.

Visudyne has been co-developed by CIBA Vision (Duluth, Georgia) and QLT PhotoTherapeutics (Vancouver, British Columbia, Canada) and is a two-step procedure that can be performed in a physician's surgery. Verteporfin is injected intravenously and subsequently activated by shining a non-thermal laser into the patient's eye.

CPMP has approved the use of the Visudyne treatment for patients with predominantly classic subfoveal choroidal neovascularization (CNV), and ophthalmologists expect that around half of the 500,000 cases each year year in Europe will develop predominantly classic lesions.

Two lasers suitable for use with Visudyne already are CE-marked. They are from Coherent (Santa Clara, California) and Carl Zeiss (Oberkochen, Germany).

Positive PDT results on neck cancer

Scotia Pharmaceuticals (Stirling, Scotland) has announced additional positive interim results in three trials on the use of photodynamic therapy with Foscan. "Results indicate that PDT-Foscan could serve as a potentially effective and well-tolerated treatment in all stages of squamous cell carcinoma of the head and neck," said Merrill Biel, lead investigator in a trial of 96 patients with oral cancers of up to 4 cm diameter. His trial showed a 65% survival rate one year after treatment and 49% after two years.

In a second trial of 115 subjects, 86 showed complete response after one year and 79% after two years. A third trial assessing the palliative effect of PDT-Foscan on inoperable tumors reported palliation in one-third of 64 cases, with 11 showing complete tumor response.

Marketing applications for PDT-Foscan were submitted simultaneously to the FDA for U.S. marketing and to the European Medicines Evaluation Agency in London for European clearance one year ago, and these interim results will support these applications.

European deals

Bausch & Lomb (B&L; Rochester, New York), the ophthalmic major, has increased its European market coverage with the acquisition of Groupe Chauvin (Montpellier, France) at a price of $228 million in cash. Chauvin's main ophthalmic surgery products are used in cataract and vitroretinal surgery. Chauvin has existing subsidiaries in France, Germany, Britain, Switzerland, Benelux and Portugal. Its acquisition will substantially widen B&L's presence in Germany. In addition, B&L believes that the acquisition of Chauvin potentially will help accelerate commercialization of products in development for "back of the eye" diseases.

Aiming at taking advantage of opportunities in the sector, Instrumentarium (Helsinki, Finland) has established a new clinical information unit. The new company, headquartered in Helsinki, plans sales units in North America, Germany, France and Britain, with Instrumentarium retaining 100% of shares. The new, as-yet unnamed unit will have operating costs higher than revenues, but sales in the sector are growing at 20% annually, compared to 1999 sales growth overall of only 2% at Instrumentarium. "The growth opportunities for Instrumentarium in clinical information systems are immense, but can only be realized by giving a single dedicated organization a wide degree of freedom for fast business development," said Olli Riikkala, president and CEO.

Orion (Helsinki, Finland) has sold its intravenous infusion business in Helsinki to Baxter International (Deerfield, Illinois) for an undisclosed sum. Orion will continue production at Helsinki until March 2001 under the terms of the agreement. Sales of the Orion intravenous infusion unit have been around $8 million annually.

Community blood transfusions to grow

"It seems increasingly likely that more and more patient treatment will be transferred to a community setting," said Barry Hill, chief biomedical scientist at Britain's Blood Transfusion Service. "Out-of-hospital transfusion is one option that offers an exciting alternative to normal ward-based treatment," he added.

The concept of performing blood transfusions in an out-of-hospital environment is not a new one. As long ago as 1988, an American regional blood bank offered such a service to some infirm patients, but the National Health Service has been reluctant to provide similar programs in Britain. Hill said he feels this could soon be changing as more hospital trusts begin to realize the potential of this type of service.

In Bolton, England, a rapid-response nursing team has been providing "at-home" blood and platelet transfusion service successfully for the past three years, with more than 500 transfusions to date. A recent report by the Audit Commission cited the project as an example of "good practice" in nursing services and neighboring hospital trusts in Lancashire and Yorkshire are planning to offer similar services.

Leucodepleted blood is an essential component for out-of-hospital transfusions to reduce the possibility of white cell reactions. Since last November, when the UK blood supply became universally leucodepleted, this potential problem has disappeared.

Med-tech to grow 5% to 8% annually

EUCOMED (Brussels, Belgium), the European medical device industry association, says the European medical technology products market, currently valued at $35 billion, is growing at a rate of 5% to 8% a year. Europe represents 24.5% of a world market of some $143 billion.

Germany has a 36% share, followed by France with 19% and Britain with 10%. Although EUCOMED says there are some 7,000 medical technology businesses in Europe, around 70% have fewer than 50 employees.