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Performance
of 50 Completed ATP Projects
Status
Report - Number 2
NIST SP 950-2
Chapter
3 - Biotechnology
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Tissue
Engineering, Inc. (TE)
Prostheses Made of Biomaterials
That Regenerate Body Parts
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| From
its beginning, the field of bioengineering has focused on providing
the best artificial devices — hearing aids, artificial limbs
and other prostheses — to replace body parts that are missing,
broken, or dysfunctional. This ATP project with Tissue Engineering
(TE), a biotechnology start-up company, takes bioengineering far beyond
artificial replacements to a technology that regenerates, rather than
replaces, lost or damaged tissues. Although this claim sounds like
science fiction, it is in fact quite real. And it promises to produce
real medical benefits in the very near future. |
COMPOSITE
PERFORMANCE SCORE
(Based on a four star rating.)
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Technology to Regenerate
Lost or Damaged Body Parts
TE is pioneering a new class of biomaterials called ADMAT (animal-derived
extracellular matrix). The idea behind the company’s ATP project
is to use ADMAT materials in collagen-scaffold prostheses to replace damaged
or dysfunctional tissues and organs. The prostheses are designed to provide
templates that mobilize the body’s own cells and induce them to rebuild
the lost tissue, gradually replacing the prosthesis itself. Regeneration
of body parts requires a biomaterial with a structure, components and
chemical signals that allow the body’s tissue cells to recognize,
respond to, and remodel the material without rejecting it as foreign.
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| Collagen fiber
and braided structures from collagen fiber: (a) single collagen fiber,
(b) 8-ply collagen fiber braid, (c) 64-ply collagen fiber braid, (d)
512-ply collagen fiber braid. |
Demand for ADMAT Materials
ADMAT materials are derived from the byproducts of land and marine animals
processed for food. The material can be spun into fibers and woven into
fabrics using techniques borrowed from the textile industry, or it can
be formed into foams, sheets, and films. ADMAT can be used to enhance
collagen scaffolds for vascular grafts, ligaments, tendons, periodontal
tissue, and similar reconstructions.
During the ATP project,
TE successfully developed techniques and procedures for extracting and
storing a mixture of collagens and for preserving the desired characteristics
of the extracellular matrix. The company developed new materials for hosting
the matrix and a process for adding the matrix to collagen fibers in the
course of spinning.
The demand for products
the company plans to offer clearly exists. The lag time, however, between
technology conception and market availability — particularly for
medical treatments — is long. Tissue-engineered products face clinical
trials and other regulatory hurdles, in addition to technical and market-introduction
barriers. The company is making good progress in navigating these barriers
in accord with its technical and business plans.
Commercialization
is in progress. TE has placed periodontal prosthesis prototypes with potential
customers for testing. It has created other products for research, testing
and diagnostic applications. These activities are not regulated, so commercialization
can happen more speedily. In
addition, it has formed a venture with Wright Medical Technology for commercialization
of orthopedic applications. TE is also in discussions with several other
companies to commercialize other applications, such as a line of skin
and wound-healing products.
Large Potential Benefits
for Society
The eventual successful commercial introduction of the ATP-funded technologies
will bring large health gains to patients with many forms of medical problems,
ranging from dental to cardiovascular. Procedures and materials that would
enable the regrowth of ligaments and cartilage in knees and enable dental
tissue to regenerate with a single surgery — at costs lower than
those offered by alternative medical approaches today, and that one day
may even facilitate organ regeneration — would have great benefits
for society.
These potential benefits
are likely to be huge because of the large number of patients who could
use these prostheses, the advantages the TE approach has over currently
available alternatives, and improvements in
the ability of patients to function as a result of using the new technology.
The ATP award is playing an important role in bringing these benefits
to society, because applications of the new technology are about two years
ahead of where they would have been without ATP funding.
Collagen fiber
decorated with ADMAT microparticulates via ATP-funded patented process. |
A recent detailed
case study by the Research Triangle Institute estimated that TE’s
ADMAT technology could be expected to generate about $33 billion (in present
value dollars) in net benefits for society in a single med-ical application
area: anterior cruciate ligament repair.
The study estimated
that about 100,000 patients per year with ligament damage would be eligible
for the new treatment, that the number using the Tissue Engineering technology
would start at 9,000 in the first year of availability and grow to 72,000
ten years later, supplanting an increasing percentage of alternative technologies
currently in use. The study incorporated estimated benefits from quality-of-life
improvements, using a “quality-adjusted-life-years” index value.
It estimated that about $15 billion of the expected benefits would be
attributable to ATP’s accelerating the technology development by
two years.
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Project
Highlights
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PROJECT:
To develop techniques and procedures for processing tissue, extracting
and storing collagen, and spinning and weaving collagen fibers into
fabrics and other forms suitable for human prostheses that could
induce the body’s own cells to rebuild lost tissue while gradually
replacing the prosthesis.
Duration: 3/1/1993 — 2/28/1996
ATP Number: 92-01-0133
FUNDING (in
thousands):
| ATP |
$1,999
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48%
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| Company |
2,128
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52%
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| Total |
$4,127
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ACCOMPLISHMENTS:
TE accomplished its technical goals. The company developed procedures
for processing a tissue-specific extracellular matrix rich in cytokines
(cell-generated proteins), extracting and storing type I collagen
(a material present in all tissues), and spinning collagen into
fibers that can be woven into prosthetic fabrics. The company:
- received
two patents for technologies related to the ATP project: “Apparatus
and Method for Spinning and Processing Collagen Fiber”
(No. 5,562,946: filed 11/2/1994, granted 10/8/1996) and “Bipolymer
Foams Having Extracellular Matrix Particulates”
(No. 5,709,934: filed 11/22/1994, granted 1/20/1998);
- applied for
three other patents related to the technology;
- made several
presentations at conferences and workshops; and
- formed a
joint venture with Wright Medical Technology, Arlington, Tenn.,
to develop and distribute products based on the ATP-funded technology
for applications involving ligaments, tendons, cartilage, and
other musculoskeletal parts.
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CITATIONS
BY OTHERS OF PROJECT’S PATENTS: See Figure
3.3.
COMMERCIALIZATION
STATUS:
Prototypes are in testing, although no product has yet entered the
market. Patent disclosures and a joint venture to commercialize
the technology may be providing useful knowledge to other researchers
in the field.
OUTLOOK:
This project is on track for market entry in the very near future.
The technology is scheduled to be used first in the fabrication
of periodontal prostheses and orthopedic applications. Ideas for
skin and wound-healing products are also being explored by the company
with potential customers.
Composite
Performance Score:
COMPANY:
Tissue Engineering, Inc. (TE)
451 D St., Suite 807
Boston, MA 02210
Contact:
Eugene Bell
Phone: (617) 946-0520
Number of Employees: 1 at project start, 18 at the end of
1997
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of Contents or go to next section.
Date created: April
2002
Last updated:
April 12, 2005
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