neil777
- 06 Nov 2006 16:20
Looks cheap at this price.
and the technology looks sound, one for the future perhaps.
neil777
- 06 Sep 2007 09:16
- 9 of 15
And going!
Inion Oy
06 September 2007
Inion Receives First Regulatory Clearance for Inion BioRestore(TM) - A New
Synthetic Bioactive and Biodegradable Material for Filling Bone Defects
510(k) Clearance Received in the USA for Dental and Cranio-Maxillofacial
Applications
Tampere, Finland and Guildford, UK. 6 September 2007...Inion (LSE: IIN.L), a
company focused on the development of novel biodegradable medical implants, has
received 510(k) regulatory clearance from the US Food and Drug Administration
(FDA) for its newest implant material, Inion BioRestore(TM). This new product is
a synthetic bioactive and biodegradable bone grafting substitute material made
from bioactive glass fibres and is designed to fill bony voids or gaps in the
skeleton that may result from surgery or from traumatic injury, a market worth
an estimated $158 million in the US in 2007 (see below).
Inion BioRestore(TM) can be cut or shaped precisely to fit the defect and
provides a highly porous scaffold onto which the patient's new bone will grow,
allowing complete repair of the defect. A key property of Inion BioRestore(TM)
material is its bioactivity; in preclinical studies, it demonstrated
osteoconductive and osteostimulative properties, accelerating new bone formation
while gradually degrading over approximately six months to allow bone to fill
the void.
Inion BioRestore(TM) is designed to replace current bone grafting techniques in
certain surgical procedures, where it offers other important advantages,
primarily in that its synthetic origin excludes risks of disease transmission
and overcomes the limitations in quantity and quality of available bone graft.
Initially Inion BioRestore(TM) is approved for use in dental and
cranio-maxillofacial (CMF) applications, e.g. alveolar ridge augmentation
(sinusotomy, osteotomy, cystectomy), dental extraction sites (ridge maintenance,
implant preparation/placement), sinus lifts and craniofacial augmentation. It is
also being reviewed currently by FDA for use in orthopaedic trauma indications,
which represent key areas of focus for the Company.
Inion BioRestore(TM) is also under review in Europe for use in orthopaedic, CMF
and dental applications and Inion expects to receive decisions on these filings
during the second half of 2007. The Company plans to launch Inion BioRestore(TM)
in these markets as soon as possible thereafter.
Chris Lee, Inion's CEO, said: 'Inion BioRestore(TM) is an exciting new
biomaterial with significant and increasing commercial appeal as it can be used
in many applications where bone grafting or filling is necessary to repair bone
injuries or defects. This new state-of-the-art biomaterial developed by Inion
can be used alone or in conjunction with Inion's other biodegradable products
across a range of indications, offering many clinical advantages to surgeons and
patients, and will complement our focused product offering in the orthopaedic
trauma and spine areas.'
According to Millennium Research Group and Knowledge Enterprises, the US market
for bone graft substitutes is estimated at $1.5 billion between 2007 and 2011.
The market for synthetic bone graft substitutes is approximately $158 million
and is growing at a compound annual rate of 10%. Bone graft substitutes are
used in the following application areas: spine (approximately 63% of market
value), orthopaedic trauma (17%), dental (17%), reconstructive surgery (i.e.
hips, knees, 2%), cranio-maxillofacial (CMF, 1%) (NB: numbers do not add to 100%
due to rounding). The market outside the US is estimated to be worth 36% of the
US market.
-Ends-
Inion Oy
06 September 2007
Inion Announces Results of its Proof of Principle Clinical Study Evaluating the
Ability of Inion OptimaPLUS(TM) Bioactive Material to Accelerate Bone Growth
Following Surgery
Tampere, Finland and Guildford, UK. 6 September 2007...Inion (LSE: IIN.L), a
company focused on the development of novel biodegradable medical implants,
announces that results of the first of its two pilot clinical proof of principle
studies with Inion OptimaPLUS(TM) bioactive material, have proved inconclusive
with respect to its ability to accelerate bone growth, compared to the state of
the art guided bone regeneration membrane. The second proof of principle interim
clinical trial results, evaluating bone quality following the use of Inion
OptimaPLUS(TM) in a different surgical model, will be announced in October 2007.
The results were deemed inconclusive as the accelerated bone growth trial was
stopped prematurely following five patients experiencing inflammatory events in
the Hong Kong arm of the trial. These events do not appear to be related to the
Inion OptimaPLUS(TM) bioactive material as surgical controls in the Hong Kong
arm also experienced the same inflammatory events. Furthermore, no similar
events were observed at the second trial site in Zurich, Switzerland. The
reduction in the total number of evaluable patients included in the trial,
however, means that it has not been possible to complete the study or to
generate efficacy results that are statistically significant.
The trial, which began in Q4 2006, aimed to recruit 20 patients across two
centres in Hong Kong and in Zurich. The study was designed to evaluate a number
of measures of bone growth following the use of Inion OptimaPLUS(TM) after
wisdom tooth extraction. Previous preclinical studies have shown the active
ingredient in Inion OptimaPLUS(TM), N-methyl-pyrrolidone (NMP), can increase the
rate of bone growth significantly compared to surgical controls.
Inion is conducting a thorough evaluation of the trial and all results generated
to date in order to better understand the different experiences observed at the
two sites. As noted above, the Company is also undertaking a clinical trial
evaluating the quality of new bone growth resulting from the use of Inion
OptimaPLUS(TM) in a different surgical model involving dental implants. The
interim results from this bone quality trial, expected in October, together with
the full evaluation of the first trial to assess accelerated bone growth, will
inform the Company's decision on how to proceed with the clinical programme for
Inion OptimaPLUS(TM).
Chris Lee, Inion's CEO said: 'Inion is committed to properly assessing the
potential of the bioactive compound NMP, as a component in Inion OptimaPLUS(TM)
medical implants, to accelerate bone growth following surgery. While the results
we have seen to date have proved inconclusive, we will conduct a full evaluation
of the trial and data collected so far to determine whether NMP can reproduce in
the clinic the accelerated bone growth we have seen in preclinical trials. This,
together with the results of our ongoing bone quality trial, will provide
important input into our decision about the next steps of the clinical programme
for Inion OptimaPLUS(TM).'
- Ends -
neil777
- 11 Sep 2007 15:06
- 10 of 15
Inion Oy
11 September 2007
Inion Receives CE Mark Regulatory Clearance for Extended Indications for
Inion Hexalon(TM) Implant
Tampere, Finland and Guildford, UK. 11 September 2007...Inion (LSE: IIN.L), a
company focused on the development of novel biodegradable medical implants, has
received CE Mark(*) from the British Standards Institution (BSI) for its Inion
Hexalon(TM) biodegradable screw for an extended range of clinical procedures
including soft tissue fixation to bone in surgeries for foot, ankle, hand and
wrist. This product received equivalent 510(k) regulatory clearance for
marketing in the USA in August 2007.
The Inion Hexalon(TM) biodegradable screw is the world's first coloured
biodegradable screw for the surgical fixation of soft tissue (including ligament
and tendon) to bone. It was originally developed and launched for the repair of
injuries to the anterior and posterior cruciate ligament in the knee where it
allows clear visibility during arthroscopic insertion (keyhole surgery).
In addition to knee surgeries, Inion Hexalon(TM) has now received both CE Mark
and 510(k) clearance for use in surgeries of the shoulder, elbow, ankle, foot,
hand and wrist, thereby greatly extending the range of trauma injuries it can be
used to treat.
Chris Lee, Inion's CEO, said: 'Receiving US and European regulatory clearance
for the extended use of Inion Hexalon(TM) means that we are now able to offer a
full range of screw sizes appropriate to the particular surgery in these
applications, and custom instruments for conducting the procedure, across two of
our focus segments - foot and ankle and upper extremity. The extended range
means that more patients and surgeons will be able to benefit from the product's
key benefits: its unique enhanced visibility during surgical insertion, its
strength and its biodegradable properties.'
(*)CE Mark is issued by a number of accredited bodies to medical device
manufacturers prior to commercial distribution in the European Union.
-Ends-
neil777
- 10 Oct 2007 10:48
- 11 of 15
Still looking good (imo)
Inion Oy
10 October 2007
Inion announces interim results of its clinical study evaluating
bone quality following the use of Inion OptimaPLUSTM bioactive material
Tampere, Finland and Guildford, UK. 10 October 2007...Inion (LSE: IIN.L), a
company focused on the development of novel biodegradable medical implants,
announces interim results of its second clinical proof of principle study with
Inion OptimaPLUSTM bioactive material from the first 13 patients to have
completed the six-month clinical follow-up. This study, which is designed to
evaluate the quality of new bone generated following a dental implant surgical
procedure, has shown a positive trend towards improved bone quality from the
Inion OptimaPLUSTM bioactive material when compared to new bone resulting from
the use of a market-leading non-biodegradable competitor product. These results
have led Inion to support the continuation of the trial.
The current trial, which began in December 2006, is aiming to recruit 40
patients across four centres in Zurich, Switzerland. The study is designed to
evaluate a number of measures of bone quality in newly generated bone (such as
density and mineralization) following the use of Inion OptimaPLUSTM in
conjunction with a dental implant and standard bone filler.
The results to date are not statistically significant as they are based on data
from the first 13 patients to have completed the six-month follow-up. However
the results from these initial 13 patients favour the Inion OptimaPLUSTM test
group over the control group in each of the study's performance criteria. A
total of 31 patients are expected to have completed the six-month follow up by
Q1 2008 and further interim data will be released at that time. The recruitment
of the nine remaining patients needed to complete the study is on-going.
Chris Lee, Inion's CEO said: 'We are pleased that the first set of results from
this trial has shown a positive trend towards improved bone quality in patients
using Inion OptimaPLUS(TM). This gives us the confidence to continue with this
trial to its completion and using the information generated from both this and
the trial evaluating accelerated bone growth will enable us to determine our
strategy for the future development and commercialisation of OptimaPLUS(TM).'
- Ends -
neil777
- 17 Oct 2007 09:22
- 12 of 15
Inion Oy
17 October 2007
New Inion spinal implant system expands portfolio to cover applications across
the entire spine
Inion S-2(TM) biodegradable spinal fusion system receives European regulatory
clearance
Tampere, Finland and Guildford, UK. 17 October 2007...Inion (LSE: IIN.L), a
company focused on the development of novel biodegradable medical implants, has
received CE Mark* from the British Standards Institution (BSI) for its new Inion
S-2(TM) Anterior Lumbar Fusion System.
The new Inion S-2(TM) system is intended for use as a graft containment device
in spinal fusion procedures in the lumbar regions of the spine (lower back) in
combination with rigid fixation. It can also be used in thoracic regions
(mid-to-upper back) meaning that, in addition to the Inion S-1(TM) system (for
applications in the cervical or neck region), Inion now has biodegradable
implants for application over the whole spine.
Furthermore, the new system also incorporates Inion's new radiographic tracer
technology, which allows proper post-operative evaluation of healing at the
operated sites. The technology involves the incorporation of a radiographic
marker at the edges of the plates and on the tips of screws in the form of
dot-like markers, enabling surgeons to view the position of the implants in
post-operative x-ray without interfering with their assessment of the site of
surgery and its healing progress.
Chris Lee, Inion's CEO, said: 'This is an important new product approval for
Inion and significantly enhances our portfolio of biodegradable implants for
spinal applications. With full coverage of the spine for a range of surgical
procedures we believe we have an attractive product offering that will help us
build an increasing presence in the large and rapidly growing spinal implant
market.'
*CE Mark is issued by a number of accredited bodies to medical device
manufacturers prior to commercial distribution in the European Union.
-Ends-
neil777
- 23 Oct 2007 08:08
- 13 of 15
More good news!
Inion Oy
23 October 2007
Inion Receives Regulatory Clearance for Inion BioRestore(TM) Synthetic Bioactive
and Biodegradable Bone Filler Material
510(k) Clearance Received in the USA for Orthopaedic and Spinal Applications
Tampere, Finland and Guildford, UK. 23 October 2007...Inion (LSE: IIN.L), a
company focused on the development of novel biodegradable medical implants, has
received 510(k) regulatory clearance from the US Food and Drug Administration
(FDA) for its newest implant material, Inion BioRestore(TM), for use in
orthopaedic trauma and spinal applications, which represent key areas of focus
for the Company.
Inion BioRestore(TM), which was cleared for use in dental and
cranio-maxillofacial (CMF) applications in September 2007, is a synthetic
bioactive and biodegradable bone grafting substitute material made from
bioactive glass fibres. The material is designed to fill bony voids or gaps in
the skeleton that may result from surgery or from traumatic injury, a market
worth an estimated $158 million in the US in 2007 (see below).
Chris Lee, Inion's CEO, said: 'The bone graft substitute market we are targeting
with this new bioactive and biodegradable material is substantial and one where
innovative materials are increasingly accepted. This latest approval will allow
us to market Inion BioRestore(TM) for applications in spinal and orthopaedic
surgery, which represent by far and away the largest segments of the overall
market.'
Inion BioRestore(TM) is a state-of-the-art biomaterial that can be used alone or
in conjunction with Inion's other biodegradable products, offering many clinical
advantages to surgeons and patients, and will complement the Company's focused
product offering in the orthopaedic trauma and spine areas.
Inion BioRestore(TM) can be cut or shaped precisely to fit the defect and
provides a highly porous scaffold onto which the patient's new bone can grow,
allowing complete repair of the defect. A key property of Inion BioRestore(TM)
material is its bioactivity; in preclinical studies, it demonstrated
osteoconductive and osteostimulative properties, accelerating new bone formation
while gradually degrading over approximately six months to allow bone to fill
the void.
Inion BioRestore(TM) is designed to replace current bone grafting techniques in
certain surgical procedures, where it offers other important advantages,
primarily in that its synthetic origin excludes risks of disease transmission
and overcomes the limitations in quantity and quality of available bone graft.
Inion BioRestore(TM) is also under review in Europe for use in orthopaedic, CMF
and dental applications and Inion expects to receive decisions on these filings
during the second half of 2007. The Company plans to launch Inion BioRestore(TM)
in these markets as soon as possible thereafter.
According to Millennium Research Group and Knowledge Enterprises, the US market
for bone graft substitutes is estimated at $1.5 billion between 2007 and 2011.
The market for synthetic bone graft substitutes is approximately $158 million
and is growing at a compound annual rate of 10%. Bone graft substitutes are
used in the following application areas: spine (approximately 63% of market
value), orthopaedic trauma (17%), dental (17%), reconstructive surgery (i.e.
hips, knees, 2%), cranio-maxillofacial (CMF, 1%) (NB: numbers do not add to 100%
due to rounding). The market outside the US is estimated to be worth 36% of the
US market.
-Ends-
neil777
- 29 Oct 2007 08:25
- 14 of 15
Inion Oy
29 October 2007
Inion Receives Marketing Clearance for Inion BioRestore(TM) Synthetic Bioactive
and Biodegradable Bone Filler Material in Europe
Tampere, Finland and Guildford, UK. 29 October 2007...Inion (LSE: IIN.L), a
company focused on the development of novel biodegradable medical implants, has
received CE Mark* from the British Standards Institution (BSI) for its Inion
BioRestore(TM) bioactive and biodegradable implant material. Inion BioRestore
(TM) has been approved for use in orthopaedic trauma, spine,
cranio-maxillofacial and dental procedures, to fill bony voids or gaps in the
skeleton that may result from surgery or from traumatic injury.
Chris Lee, Inion's CEO, said: 'Inion BioRestore(TM) is now cleared for this wide
range of surgical procedures in both the USA and Europe, and is another
development milestone we have hit as planned during 2007. This new product will
complement and enhance our focused product offering in our core orthopaedic
trauma and spine areas. It is particularly important in the spine area as we
also recently received CE Mark for our Inion S-2(TM) spinal fusion and graft
containment system, which combined with the previously cleared Inion S-1(TM)
system, means we can market our innovative biodegradable implants for
applications over the entire spine.'
*CE Mark is issued by a number of accredited bodies to medical device
manufacturers prior to commercial distribution in the European Union.
About Inion BioRestore(TM)
Inion BioRestore(TM) is a state-of-the-art synthetic bioactive and biodegradable
bone grafting substitute material made from bioactive glass fibres. It is
designed for use alone or in conjunction with Inion's other biodegradable
products, offering many clinical advantages to surgeons and patients.
Inion BioRestore(TM) can be cut or shaped precisely to fit the defect and
provides a highly porous scaffold onto which the patient's new bone can grow,
allowing complete repair of the defect. A key property of Inion BioRestore(TM)
material is its bioactivity; in preclinical studies, it demonstrated
osteoconductive and osteostimulative properties, accelerating new bone formation
while gradually degrading over approximately six months to allow bone to fill
the void.
Inion BioRestore(TM) is designed to replace current bone grafting techniques in
certain surgical procedures, where it offers other important advantages,
primarily in that its synthetic origin excludes risks of disease transmission
and overcomes the limitations in quantity and quality of available bone graft.
According to Millennium Research Group and Knowledge Enterprises, the US market
for bone graft substitutes is estimated at $1.5 billion between 2007 and 2011.
The market for synthetic bone graft substitutes is approximately $158 million
and is growing at a compound annual rate of 10%. Bone graft substitutes are
used in the following application areas: spine (approximately 63% of market
value), orthopaedic trauma (17%), dental (17%), reconstructive surgery (i.e.
hips, knees, 2%), cranio-maxillofacial (CMF, 1%) (NB: numbers do not add to 100%
due to rounding). The market outside the US is estimated to be worth 36% of the
US market.
-Ends-
neil777
- 08 Jan 2008 09:38
- 15 of 15
Inion Oy
08 January 2008
Inion stengthens international patent position for Inion OptimaPLUSTM bioactive
materials technology
Tampere, Finland and Guildford, UK. 8 January 2008...Inion Oy (LSE: IIN.L) ('
Inion'), a company focused on the development of novel biodegradable medical
implants, has been granted a patent in Australia covering a method for creating
its Inion OptimaPLUSTM bioactive and biodegradable material. Inion OptimaPLUSTM
is a material consisting of a specific solid matrix of resorbable polymer in
which N-methyl-2-pyrrolidone (NMP) is dispersed in amounts sufficient to
stimulate bone growth. This material can be fashioned into medical implants to
support and enhance bone fracture healing.
The Australian patent (AU 2002346767) also covers other polymer compositions
containing NMP and strengthens Inion's international patent position in this
area of next-generation bioactive biomaterials. The equivalent patent is
already issued in the USA (US 6 926 906) and additional patent applications for
this novel technology are in progress in Europe, Brazil, Canada, China, Korea
and Japan.
Mr Chris Lee, Inion's Chief Executive Officer, commented: 'This new patent is an
important enhancement of our IP portfolio in the development of novel
biomaterials with bioactive qualities for creating next-generation medical
implants.'
- ends -