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Bioimplant Systems provides analysis of current information obtained
from the United States Patent and Trademark Office and the Food and Drug
Administration, as well as data and reports contributed by medical device
manufacturers that are on the leading edge of developments for biocompatible
implants.
BIOSPHERE Online Market Intelligence Tool
BIOSPHERE
is Bioimplant Systems’ next online market
intelligence tool. BIOSPHERE
will provide independent analysis of research results and an array of
relevant metrics in a unified, searchable database.
The database architecture will include integration with a real-time
system designed to track regulatory processes and patent rights implicated
by biocompatible, implantable technologies currently on the market and
other products under development. BIOSPHERE should enable the generation of reports comparing
specific companies, product lines and market segments.
The legal framework module is being designed to include a system
to track pending patents and existing patent rights. Access to the new database will be structured as a
subscription-based service.
Premier
customers will have the option to request customized reports that assess
their respective product pipelines. BIOSPHERE
is being designed as an intelligent market intelligence tool. Access
to Bioimplant Systems' BIOSPHERE system will be monitored and controlled
with encryption and other advanced security measures. Medical
device manufacturers will not have access to their competitors'
proprietary data through BIOSPHERE. The scope
of analysis anticipated to be offered will cover recent clinical studies
and published data relating to market share, revenue potential, time
to market, regulatory issues involving efficacy, risks and related
information.
A specific area of untapped value is in the market segments
for drug eluting coronary stent devices and hernia repair devices.
Recently issued patents have the potential to substantially shift
the balance of market share in these spaces.
For example, BIOSPHERE analysts are currently reviewing patents
and patent applications for drug-eluting coronary stents invented by
Rodney G. Wolff, Vincent W. Hull, Walter J. Ledergerber, Qiyi Luo,
Yi Zhuang, Zhirong Tang, and Orhan Soykan.” It was clarified: “Bioimplant
Systems’ value
proposition rests on its team of analysts who will collaborate with research
laboratories to verify the results of clinical studies. Specialized
legal teams will be assembled to review pending and existing patents
and to identify prospects for IP licensing and potential assignments. Bioimplant
Systems’ BIOSPHERE online market intelligence tool is anticipated
to launch in Q4 2007.”
Featured Inventor: Walter
J. Ledergerber
Click
here to see list of patents filed by and issued to Walter J. Ledergerber
Drug Eluting Coronary Stents
Bioimplant Systems / February 2006 - WO
2004/105639 A3 (PDF: 67 kb)
Republished by
WIPO on February 24, 2005, this PCT application has gained considerable
interest by biotechnology investors.
"The present invention provides for reinforced and drug
eluting stent-grafts (100) and related methods of implanting and manufacturing
the stent-grafts. A stent-graft (100) of the present invention may include
a tubular stent (110), a biocompatible covering (140) surrounding the
stent and a supporting collar (130) coupled to the proximal end of the
stent-graft. A drug agent may be applied to a textured external surface
layer of the biocompatible covering, or alternatively to a space between
the textured external surface (120) and a smooth (122) luminal surface
layer of the biocompatible covering, and allowed to elute over time into
a wall of a body lumen after the stent-graft is deployed. The collar
(130) of the stent-graft absorbs pressure exerted on the stent-graft
by fluid flow within the body lumen in order to minimize potential damage
to the stent-graft, and may also include barbs to further secure the
stent-graft to the body lumen."
Products and Patents Under the Microscope
Bioimplant
Systems / January 2006 -
Cellular and tissue-based products are relatively
new entrants into the medical device market and these types of products
face regulatory hurdles, clinical risks, and related legislative concerns. Legal
issues implicated by the use of cellular and tissue-based products present
numerous financial obstacles and market risks. The legal landscape
around the world is not consistent.
For example, the use of stem cells is acceptable in some countries for
some purposes but only under certain circumstances. In other
countries, the use of stem cells poses no moral questions or concerns. Yet,
some countries prohibit the derivation of embryonic stem cells, but do
not specifically prohibit such research using existing lines.
The
United States, China, and Brazil are the only countries that currently
have consistent policies. In the United
States' medical device market, the Food and Drug
Administration, National Institutes of Health, Centers for Disease
Control, and state regulators directly affect the outcome of development
and a product lifecycle. Research that touches these legal issues
is also regulated. Moreover, the safety and efficacy of drug-eluting
stents has been the subject of recent litigation between major medical
device manufacturers in the United States.
Synthetic, biocompatible materials used for prostheses have been used in
successful medical device products for many years. Stent restenosis
in the coronary artery of the average patient could be substantially
mitigated by a combination of existing inventions.
Recent double-blind studies and follow up studies thereto have confirmed
that the use of synthetic, biocompatible materials in the design of
drug-eluting stents are potentially safer than alternative product
designs. BIOSPHERE examines products
currently available in the market, patented ideas, and ideas for products
in the pipeline to offer device manufacturers, scientists, and physicians
a synthesized, cross-sectional view of the core medical and legal
issues.
BIOSPHERE
is committed to its review and analysis of the medical device market
in an effort to substantially mitigate stent restenosis. Other segments of the medical device market will also
be fully examined. Every month Bioimplant
Systems features a medical challenge and an inventor who has contributed
to the relevant body of knowledge and fostered meaningful improvements
for relevant medical devices. This month our featured inventor is
Walter J. Ledergerber. Bioimplant Systems will undertake a comprehensive
review of all patented ideas relating to drug-eluting stents. Many
other inventors have also made valuable contributions in these areas.
Bioimplant Systems plans to include current, relevant data and analysis
about drug-eluting stents in its BIOSPHERE online application.
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