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General

Materials

Device Research



What is The Polymer Technology Group?

The Polymer Technology Group has staff and facilities for the synthesis, characterization, processing, regulatory approval and manufacturing of new polymer products and device components. This vertically-integrated research and development approach permits the entire process to be performed within one organization, from invention to initial market launch.

PTG's contract research and development activities principally involve unconfigured (pellets, powders, liquids, etc.) and semi-configured polymer products (e.g., film, tubing, membranes), but also include configured products and components which employ the Company's proprietary polymers. Medical devices, in particular, are emphasized due to the experience of the founders in medical device and biomaterials development and manufacture.

The Company's goal is to be the industry leader in the commercialization of specialty and biomedical polymer products through continuous research and development activities.

The Company was founded in July 1989. Three of the founders include Robert Ward, Kathleen White and Robert Devaney. The Company is privately held.

PTG is made up of two legal entities. All employees are part of the "Polymer Technology Group, Inc." legal entity. PTG, Inc. includes also the research and development activities related to polymers and polymer materials. PTG Medical, LLC includes the manufacturing activities related to polymer material and medical components made from polymers. Purchases and activities that are part of PTG Medical, LLC must comply with ISO 9001:2000 regulations.

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Are PTG materials available internationally?

PTG works with international clients, in most cases, directly from our offices in Berkeley, CA, USA. Please contact us.

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Is PTG ISO 9000 certified?

PTG is certified to ISO 9001:2000 as of October, 2004.

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What is PTG's Quality Policy

The Polymer Technology Group provides leadership and excellence in the design and manufacture of biomedical polymers and medical device components. We provide our employees with training and resources to satisfy customer requirements. We monitor our processes and products to identify opportunities for continuous improvement and support a Quality System that promotes an environment of defect and loss prevention through employee understanding of company goals, teamwork and individual job requirements.

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Does PTG require signed confidentiality agreements (CDAs)?


PTG requires a signed CDA before entering into a contract research agreement or before providing any proprietary information. A simple Materials Evaluation Form is required prior to our supplying any polyurethane that uses PTG's proprietary chemistries. These materials include PurSil™ silicone-polyether-urethanes, CarboSil™ silicone-polycarbonate-urethanes, and any polyurethane with Surface-Modifying End Groups (SME™) technology.

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Which PTG polyurethane biomaterials are available commercially?

PTG currently manufactures nine commercial-grade medical polyurethanes. These materials are produced using PTG's proprietary continuous reactor technology or by traditional batch processes, and are identified on this web site by purple shading on the polyurethane product tree. These materials are generally in stock, with samples and purchases shipping within one week. All of the other materials are developmental and are available by special order in limited quantities.

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How can I get samples of PTG's polyurethane biomaterials?

PTG offers half-pound samples of our commercial thermoplastic polyurethanes in pellet form, including Bionate® polycarbonate-urethane, Elasthane™ polyetherurethane, PurSil™ silicone-polyether-urethane, and CarboSil™ silicone-polycarbonate-urethane at no charge. We also offer cast film samples from BioSpan® segmented polyurethane. These samples are available upon request (and completion of a CDA or Materials Evaluation Form, if applicable). All other requests for samples will be charged at the regular price and minimum order quantities will apply. Samples of developmental polyurethanes are available by arrangement.

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What are the minimum order quantities of PTG's polyurethane biomaterials?

A five-pound minimum applies to all orders of PTG's thermoplastic polyurethanes. BioSpan® segmented polyurethane (all variations) comes in solution and the minimum order quantity is one quart.

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Which PTG materials have been evaluated under clinical studies?

PTG's BioSpan® segmented polyurethane and Bionate® polycarbonate-urethane are two of the most extensively tested (in clinical studies) biomaterials available today. Each is backed by a comprehensive FDA Masterfile. PurSil™ silicone-polyether-urethane and CarboSil™ silicone-polycarbonate-urethane have each been tested in limited trials. PTG is compiling an FDA Masterfile for each of these materials.

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How can I access the FDA Masterfile for BioSpan® and/or Bionate®?

To obtain access to FDA Masterfile data for these materials, mail or fax a request with your name, company name, and title to the attention of the Quality Assurance Director. See our Contact Us page for PTG's contact information.

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Where can I get pricing information for PTG products?

Prices for commercial materials are immediately available through our customer service and inside sales staff. Developmental, compounded, and configured materials will require quotations, which may also be requested through customer service.

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Are PTG Polyurethanes suitable for human implantation?

FDA and foreign regulatory authorities have approved a variety of chronically implanted devices using BioSpan® and Bionate polyurethanes. PTG's BioSpan® segmented polyurethane and Bionate® polycarbonate-urethane are two of the most extensively tested biomaterials available today, and each is backed by a comprehensive FDA Masterfile. Ultimately, only the FDA and foreign regulatory bodies can determine if a device is suitable for human implantation.

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What if I want a material that is different from the PTG Polyurethanes listed?

Please contact us. We frequently synthesize variations of our commercial materials. We offer custom polymer design, synthesis, and characterization services. We also offer application and device development services. These capabilities, combined with PTG's in-house compounding and processing facilities, enable us to offer uniquely integrated polymer and device development services.

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What are PTG's standard shipping and payment terms?

Materials are shipped Monday through Thursday via Fed Ex 2nd day air. Orders are shipped freight prepaid by PTG and billed to the customer, and samples are shipped freight paid by PTG. Upon request, shipments will be made by overnight service and billed directly to the customer.

Payment terms are net 10 days.

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What are some key applications for PTG's Polyurethanes?

PTG polyurethanes are used medical devices and other applications where adherence to stringent quality guidelines is critical. Materials developed and produced by PTG are most often used in chronically implanted medical devices such as pacemakers, sensing devices, ventricular assist devices and blood pumps, spinal fixation and treatment devices, central venous catheters and other catheters. PTG's client list includes many of the world's leading suppliers of medical devices.

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What research services does PTG offer?

PTG offers research services in two general areas: polymers/materials and devices.

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Why would PTG be my best choice for device development projects?

Several important devices on the market today were developed by PTG, either on behalf of client companies or in collaboration with them. Our founders and staff bring many years of biomaterials, polymer, and device-related experience to each project. We are unique in our ability to offer a fully-integrated approach to materials-intensive device development programs. We can also work with you to compliment your own in-house capabilities by providing services targeted to your specific needs, whether they be polymer design, synthesis and characterization, materials selection, process development, compounding services and/or device development, prototyping and manufacturing.

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