- EUCOMED, the European Confederation of Medical Devices
Associations, and IAPM, the International Association of Prosthesis
Manufacturers, merged during November 1999. IAPM dissolved and the new
organisation has retained the EUCOMED name. The Implants Sector Board
represents the largest industry group within EUCOMED. The
new EUCOMED Board consists of five corporate members (Giancarlo
Bigongiali Smith+Nephew, Malcolm Carlisle SIMS, Barry Wilson Medtronic,
Richard van Oostrom Guidant and Michael Mounier ELA Medical) and five
asssociations (Gerhard Barun BVMed Germany, Patryck Breitburd SNITEM France,
Georg Skøt DMDA Denmark, Alos Pal AMDM Hungary and Heikki Valimaa SAI-LAB
Finland).
- EUCOMED's latest market estimates are as follows: total
devices $150b, of which approx. 27% is in Europe, with the largest markets
in EU being Germany (13.7b Euro) and France (6.2 b Euro). About 7,500
companies are active in Europe, of which 70% have fewer than 250 employees
(that is, SMEs in the EU definition).
- Recent data on hip implant procedures gives a rate per
million population of 1700 for Germany, 1360 for Belgium, 630 for France and
510 for Spain. The differences may reflect the relative number of dedicated
centres for orthopaedic work. Hospital Episodes Statistics for the UK
suggest that over 42,000 cases of femoral fracture were hospitalised in the
year 1997/98, with almost 20,000 cases of hip arthrosis. On soft-tissue
biomaterials cases, coronary artery replacements have risen from approx
12,000 in 1989/90 to 21,000 in 97/98, and balloon angioplasties from 4,760
to 14,650 over the same period.
- Over 150,000 patients world-wide are estimated to be
waiting for a heart transplant at any one time, according to Professor
Michael Sefton of the University of Toronto, with palliative care costs of
over $9b in the 6 months before death if these patients do not receive a
transplant.
- First Chicago Equity Capital and Garrett Capital
Advisers have started activities in the devices and surgical area by buying
and consolidating three separate businesses involved in open heart surgery
and associated surgical systems. Bard has divested its open-heart surgery
business to the group, an oxygenator and heart-support system has been
acquired with purchase of Minntech, and special tubing pack company
Surgimedics is the third component. The two investment banks are looking to
expand their activities in the device, diagnosis and medical technology
areas.
- Corneal implants are now a viable competitor to contact
lenses and surgical or laser keratoplasty. US company KeraVision recently
received FDA approval for Intacs implants, which are inserted into the outer
area of the cornea to correct nearsightedness. Staar Surgical has
implantable polymer contact lenses undergoing Phase III studies in USA. For
correction of longsightedness, Anamed of Irvine, California, has developed
an intracorneal implant PermaVision, based on a biocompatible microporous
hydrogel, Nutrapore. The company was looking for $10m investment in 1999 to
push this development forward. Artificial lenses made of biocompatible
polymers are also available - Staar Surgical has a CE-marked intraocular
lens used for correction of cataracts.
- Collagen is still a very useful biomaterial. It is
being increasingly used as a matrix for surgical sealants, a market sector
for many years served only by alginate sponges. Fusion Medical Technologies
of Mountain View, California, uses collagen as a gel matrix in its FloSeal
product and, rather than fibrin as the haemostatic, uses thrombin.
- Sulzer Medica is a company on which there will be more
focus in 2000, partly because of its stated aim to merge or acquire, and
partly because its developments in tissue engineering are now getting closer
to market. Sulzer estimates that the global market for tissue repair
products exceeds $3b for hard tissues (orthopaedics and cartilage repair)
and $2b for cardiovascular repair. Sulzer's growth factor products are being
developed for all areas, including periodontal, cartilage, cardiac vessels,
spinal fusion and intervertebral disc. Sulzer has also taken a licence to
Fusion Medical's FloSeal for spinal and cranial use. During October 1999,
Sulzer bought Mitroflow Enterprise, a Canadian company selling heart valves
based on bovine pericardium, for $27m, staged according to Sulzer's success
in gaining FDA approval. Sulzer had distributed Mitroflow's valves since
1998. This consolidates Sulzer's position in tissue valves and extends its
overall activity. Sulzer estimates that the total valve replacement market
is about $700m, within which the total tissue valve sector is $250m and the
pericardial tissue valve sector approximately $95m of that. Though Sulzer
has 25% of the global mechanical valve market, it has some way to go in the
tissue sector.
- Medtronic received approval for its Hancock pig-origin
heart valve from the FDA during 1999. The Hancock, acquired from Johnson
& Johnson Cardiovascular in the late 1980s, was used for a long period
of time under an investigational exemption. Collection of long-term safety
and effectiveness information has been on-going for up to 14 years in some
of over 1000 US and Canadian patients included in the survey.
- Medtronic's acquisition trail is extending. After
paying $7b in stock exchange deals for Sofamor Danek and Arterial Vascular
Engineering), Medtronic paid $800m for Xomed Surgical Products, giving it a
boost in the ear, nose and throat business and putting it into even further
conflict with Smith+Nephew. Xomed's sales, at over $980m, and profit, at
almost $10m, reflect the 20% share of the ENT device and instrumentation
market it had at the time of acquisition. And in late 1999, Medtronic
announced it has bought a part of an image-guided surgery company, Elekta
for about $12m. Medtronic also submitted a supplementary pre-market approval
to FDA for the implanted Synergy pain relief device, which neutralises
spinal cord impulses by electrical means, from a site under the abdominal
skin.
- Artificial skin products are now established in the
market and new uses are being investigated at regular intervals. A serious
problem for diabetics is foot ulcers, since these rarely heal and may lead
to amputation. Apligraf, the cultured skin made from preputial cells by US
company Organogenesis, has been successfully used for treatment of diabetic
foot ulcers, varicose ulcers and post-cancer skin wounds. Organogenesis
estimates that, in the USA, 50,000-60,000 of 600,000 diabetics with ulcers
undergo amputation annually (not all of these may follow ulcers, some may be
the result of vascular necrosis). Apligraf reduced healing time to 35 days
and increased healing rate to 83% compared with standard treatment, 91 days
and 48%, in over 200 patients in a multi-centre study in the USA. The market
for management of diabetic foot ulcers is variously estimated at $1.4-2b per
annum, and represents a huge opportunity for Organogenesis. Other companies,
such as Advanced Tissue Sciences and Ortec International, will provide
strong challenges to Organogenesis. Ortec's product, CCS (composite cultured
skin) incorporates layers of dermal and epidermal cells in a collagen matrix
and has recently started a trial of CCS in diabetic ulcers.
- Difficult-to-heal ulcers, including diabetic and
varicose, are estimated to cost the UK National Health Service around $3b (£2b)
annually in total management. Diabetic foot ulcers comprise about 50% of
this cost. Smith+Nephew, licensees of Dermagraft from Advanced Tissue
Sciences, have a leading product along with Organogenesis's Apligraf, in the
bioartificial skin wound-healing sector. In addition, some studies suggest
that Dermagraft actually stimulates the revascularisation of chronic ulcers.
- Theta Reports has published Soft Tissue Implant
Technology, which projects sales of devices for soft tissue repair of over
$700m by 2002 in the US alone. Tissue heart valves, vascular grafts,
cosmetic facial repair, urinary incontinence products and connective tissue
repair accounted for almost 85% of current sales, but innovative tissue
engineered products are expected to change both the structure and the size
of the market. The top ten companies are identified as Baxter, Cryolife,
Collagen Aesthetics, Medtronic, St Jude Medical, Bionx, CR Bard, Genzyme
Tissue Repair, LifeCell and Tutogen Medical, accounting for over 80% of the
current market but only about 70% of the 2002 market, as other small
companies and start-ups come on-stream.
- Biocompatibles, manufacturer of the BiodivYsio stent,
estimates that the global stent market is worth $2b annually (other data
suggests $2.5-3.0b), of which approx $400m represents stents for vessels
less than 3mm diameter (small-vessel sector). The company aimed to raise £18m
in mid-1999, to assure its longer-term prospects. Biocompatibles
subsequently acquired the outstanding stock of Divysio, the stent
manufacturer based in Canada on which the BiodivYsio stent is based, in a
$15m deal funded by a major collaborator. The coated stent will be launched
in the USA during 2000.
- AorTech, the Scotland-based heart valve developer,
increased its sales by over 50% between 1997/98 and 1998/99. It estimates
that sales will be worth $14m in 2004 and over $340m by 2008, when the
global heart valve replacement market will be $1b.
- Another UK company, Corin Medical, has obtained a
CE-mark for a new knee system that allows surgeons a choice of a fixed or a
mobile polyethylene meniscus on the tibial base plate. The Rotaglide 2000
also has stem extensions for both tibial and femoral components, to enable a
better tailoring of the prosthesis to individual knee topography. Corin is
also launching new bone cements, based on monomer-polymer mixtures,
available in different viscosities. Corin is currently developing a femoral
implant made from carbon-fibre reinforced polymer (see R&D Digest).
- A recent collaboration between US companies
OsteoBiologics (San Antonio, Texas) and Linvatec (Utica, New York State)
focuses on new methods of diagnosis of articular cartilage damage,
development of bioresorbable implants and matrices, and construction of
specialised minimal-access surgical instruments
- Datamonitor released a report in autumn 1999 focusing
on cartilage and meniscus repair. The company noted that only about $5m of
cartilage repair products were sold in 1999 but expects sales of products to
increase to $20m by 2003, mainly driven by cell culture based products.
These currently represent almost 60% of the market, dominated by Genzyme
with Carticel, with a strong local presence on the German market of products
from Verigen and Codon. A co-ordinator of two of the tissue engineering
projects in the European Biomaterials Network, FAB srl of Abano Terme, Italy
(BE-3524, BE-5063) is expected to launch Hyallograft G this year.
- 3M has sold its orthopaedic implants business to
Smith+Nephew and its surgical instruments business to Linvatec, a subsidiary
of Conmed. This marks a continuing shift of 3M from the materials and
devices sector towards the pharmaceutical and medical business. Currently,
3M is still strongly represented in the transdermal patch and
inhaler-delivery areas. A new feature of 3M's web-site is a TDD (transdermal
drug delivery) component selection guide, see www.3M.com
for more details.
- Innovasive Devices has been acquired by J&J to
enhance its position in the sports surgery and arthroscopy sectors.
Innovasive will be absorbed into Ethicon, which will continue to develop and
market its suture systems, cartilage and ligament repair products, Clearfix
meniscal repair product and the associated knee surgery kits. J&J
already holds 11% of the sports surgery market through Ethicon and another
J&J division Mitek. The total sports/arthroscopy market is estimated at
$1.6b, approximately 16% of the orthopaedics sector, and is growing over 5%
per annum.
- DePuy, purchased by J&J in 1998 for $3.5b, has
agreed to stop selling Dynagraft freeze-dried allograft material for bone
defects and spinal and oromaxillofacial grafts, in settlement of a patent
dispute between the licensor of Dynagraft, GenSci Regeneration Sciences, and
Osteotech. DePuy will have to pay Osteotech $2m plus a forfeit of $250k for
every 3 months it continues to sell Dynagraft. Osteotech's rival product,
Grafton, is a demineralised allograft sold as sheets, gel or mouldable
putty, selling between $40m and $50m per year.
- Medtronic's Sofamor subsidiary launched a new material
Osteofill for bone defects and graft work in 1999/2000.
- USBiomaterials of Alachua Florida, which has marketed
its bioglass since 1997 for periodontal defect repair, is looking for
strategic alliances, including mergers or, if funds allow, acquisitions, to
develop bioglass into areas such as woundcare, drug delivery, urology and
bone grafting. Pre-clinical work in orthopaedics has already been promising.
- Smith+Nephew gained a listing on the New York Stock
Exchange in November 1999, with a capitalisation of $3.5b.
- Alza Corporation, the longest-surviving independent US
drug-delivery company, was bought by Abbott Laboratories in a paper deal, in
which Alza shareholders received 1.2 Abbott shares for every Alza share,
valuing Alza at over $7b. Alza is active in human and animal drug delivery
and has established a long-term presence in push-melt and osmosis types of
systems. Alza's latest developments include an electrotransport system.
- Shortly afterwards, the FDA issued a warning on
persistent quality assurance issues to Abbott, with reference to diagnostic
tests and reagents manufactured by Abbott in Illinois USA. Abbott, which has
long held the dominant global position in diagnostics, suffered a
significant share price fall, which itself had an adverse impact on its
plans to acquire Perclose and on the Alza deal that had only just been
approved by Alza shareholders.
- Bioresorbable fixings for orthopaedic use are the
subject of one project in the European Biomaterials Network (BE-5086, co-ordinator
DTI Denmark). The Japanese company Takiron is using a combination of
poly-L-lactic acid and hydroxyapatite for fixation materials for Fixsorb-MX,
used in oral surgery since 1997, and Super-Fixsorb for long-bone fractures,
expected to be on the market from 2001.
- Interpore Cross International has launched its system
to collect autologous growth factors from blood, for use in bone growth and
healing. An automated cell separation machine prepares a platelet, fibrin
and growth-factor enriched fraction of a patient's own blood for mixture
with a malleable bone defect replacement material. The technique appears to
be particularly useful in cases of long-term mal-union.
- Wedbush Morgan estimates that the global wound care
market is worth $10b, of which the largest are management of venous stasis
($2.9b), decubitus ulcers ($1.9b) and diabetic foot ulcers ($1.4b). The
report mentions an emerging company AcryMed with its Flexigel Strands
hydrogel wound healing agent, currently being marketed by Smith+Nephew.
- The merger of Seton Scholl Healthcare and the London
International Group, SSL International, has acquired Silipos Inc of Niagara
Falls New York for just over $32m. Silipos makes woundcare and prosthetic
products based on gels.
- Post-operative adhesions can be a painful sequel of
abdominal and pelvic surgery, and there are several products now available
to prevent or reduce these. ML Laboratories, based in Cheshire UK, has
CE-marked a non-viscous isodextrin solution for adhesion prevention, easier
to use than comparably-effective viscous gels or pastes. ML is looking for
partners for international marketing, and estimates a $1.5b market for
anti-adhesion products.
- The investment community is beginning to look with more
interest at biomaterials and tissue engineering. At a recent conference in
New York, organised by Techvest, an overview of the tissue engineering
activities in US identified about 40 companies with over 2600 employees,
spending approximately $0.5b (500m Euro) a year and generating sales of
about $30m from products such as those for skin repair.
- The
German trade body BVMed has started a new interest group for active
implantable devices, as a result of the IAPM-EUCOMED merger and the closure
of the IAPM offices in Germany, who represented this sector.
  
|
