Tepha - case study

Tepha Inc. is a medical device firm that develops and commercializes innovative products based on the company’s proprietary PHA (polyhydroxyalkanoate) bioaterial technology. Tepha began working with POS in 2002 to develop its biopolymer resin production processes. These novel process had not yet been demonstrated at the pilot plant scale when the company started working with POS. Today, TephaFLEX polymer is the first of the company’s PHA materials to be used in FDA-cleared medical devices.

Tepha, Inc. (Tepha) is a medical device firm that develops and commercializes innovative products based on the company`s proprietary PHA (polyhydroxyalkanoate) biomaterial technology.

Tepha began working with POS Bio-Sciences (POS) in 2002 to develop its biopolymer resin production processes. These novel processes had not yet been demonstrated at the pilot plant scale when POS  began  its work for Tepha.

As David Martin. PhD. Vice President of Re- search and Development for Tepha describes, "POS had the knowledge and expertise we needed in the early years. We appreciated that we were able to consistently work with the same key staff throughout several projects."

In 2007. POS also assisted Tepha with the design  and  selection  of equipment for  its commercial scale processing lines.

Tepha has received a number of United States Food and Drug Administration (FDA) 510(k) clearances for medical  devices made from its  lead  biomaterial.  TephaFLEX    polymer. Tepha`s corporate partners have also received 510(k)   clearances   for   TephaFLEX -based devices.

TephaFLEX    biopolymer is the first of the company`s PHA materials to be used in FDA cleared medical devices. Products made from TephaFLEX    polymer  include   surgical   su- tures, surgical mesh, surgical film, and com- posite mesh.

Tepha`s novel, biosynthetically produced PHA materials can provide much-needed solutions for medical devices in multiple fields. PHA is a superior product in its flexibility, ductility, and biocompatibility, with excellent tensile strength and strength retention.