What is Tepha's
Technology?
Tepha's technology is based on a class of naturally derived, bioabsorbable polymers called PHAs (polyhydroxyalkanoates). Besides being well tolerated by the body (biocompatible), these materials degrade slowly and are eventually absorbed. A wide variety of non-permanent, implantable medical devices can be made from these materials, which are designed to be reabsorbed by the body and replaced with natural tissue.
What are PHA's?
PHAs are a class of naturally derived polyesters. The monomer building blocks are referred to as hydroxyalkanoates. When many of these hydroxyalkanoate monomers are bonded together, a polyhydroxyalkanoate (PHA) polymer is produced.
Some PHAs have material properties similar to more traditional plastic materials such as polyethylene and polypropylene. For instance, many PHAs are thermoplastic materials, meaning that they can be melted and molded into almost any shape.
What specifically are Tepha's biomaterials?
Tepha's biomaterials are simple (aliphatic) polyesters. The first two biomaterials developed by the company are TephaFLEX and TephELAST. While both materials are very strong and very flexible, the former is quite extensible while the latter is very elastomeric. Such physical properties allow an extensive design space for a variety of medical applications, including a number of novel devices that can take advantage of an elastomeric, absorbable biomaterial for the first time.
What other polymers are
used in this industry?
There are several classes of polymers used in medicine, including polyesters, polyolefins, polyurethanes, and silicones. In general, however, these polymers are intended for use in permanent implants (i.e. nonabsorbable applications).
The absorbable polymers form a special class of materials that are designed to degrade in the body and be absorbed over time, rather than to serve a permanent role. Most of the absorbable polymers in clinical use are polyesters. These are typically based on a few simple hydroxyacid building blocks, including glycolic acid, lactic acid, para-dioxanone, trimethylene carbonate, and caprolactone. The PHA materials are similar in structure to these absorbable polyesters, but are based on naturally occurring
hydroxyalkanoate monomers that already exist naturally in the body.
Are Tepha’s polymers
“cell-friendly”?
Yes. Unlike many of the polymers made from hydroxyacids, the PHA building blocks are naturally occurring metabolites in the human body, and the polymers do not hydrolyze into highly acidic metabolites as do other polymers. This allows for less
inflammation, and it forms an environment conducive for tissue regeneration. All testing to date has shown that Tepha’s polymers are safe for in vivo human use.
How are Tepha's
polymers produced?
Tepha's polymers are produced in a biosynthetic process. Specialized (genetically-engineered) microorganisms are used to produce these polymers in a tightly controlled fermentation process. The microorganisms are grown in a bioreactor during which
time they synthesize the polymer, which is then harvested form the cells and rigorously purified to yield the biomaterial.
What can Tepha's
biomaterials be used for?
Tepha's polymers may be used in a variety of applications and are not limited to use in medicine. PHA polymers possess material properties similar to many more traditional plastics and may be used in place of these materials in many instances. In fact, Tepha’s sister company, Metabolix, Inc, is pursuing many industrial and consumer product applications with similar technology.
What are the advantages
of Tepha's polymers for medical devices?
There are several advantages to the Tepha materials, including their unique material properties, less acidic degradation environment, and improved absorption profiles.
Each "advantage" will depend upon the specific application of use. For instance, Tepha's polymers are very strong yet very flexible. In some applications, fibers have been produced that are more flexible than currently available suturing materials and
thus offer an advantage over existing monofilament sutures, notably prolonged strength retention.
Some of Tepha's biomaterials are very elastic. While there are a number of nonabsorbable medical polymers that are elastic, there are no absorbable elastomers in common medical use. Tepha's elastomeric materials represent an opportunity for the creation of novel medical devices in a variety of areas not previously possible.
How long does it take the body to absorb a device made from Tepha's materials?
Constructs made from Tepha's polymers have been shown be absorb over a time ranging from six weeks to over a year, and most devices are expected to be engineered to reabsorb over a period of a few months. Factors that affect the absorption time
include: the size, density, porosity, and surface area of the device, the molecular weight and orientation of the polymer, as well as the site of implantation. We can design and modify our devices to tailor the absorption profiles as needed for a given
application.
How are medical devices
constructed?
Tepha's polymers are thermoplastic materials, which means that they can be readily melted and molded into a desired shape. As
such, plastic processing such as melt extrusion and injection molding can be used to convert Tepha's biomaterials into fibers and molded parts, respectively. Fibers may be processed into sutures or medical textiles, while molded parts could be used, for
example, as orthopedic pins, anchors, etc., depending upon their specific shape.
Who currently uses
Tepha's materials?
In addition to our internal product development programs, Tepha has also partnered with a number of other companies to develop medical devices utilizing Tepha’s proprietary polymers. Much of this work is currently confidential; but keep a lookout for product releases in the United States and European Union.
How can I obtain some
of Tepha's biomaterials?
Tepha is a medical device firm rather than a materials
supplier. Hence we do not sell our polymers to the
commercial public. However, we do collaborate with academic
institutions and corporations across the globe in product development partnerships. If you would like to learn
more, or if you are interested in potentially forming a
relationship with Tepha, please contact us or email us at contact@tepha.com.
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