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Sagentia Undertakes Full 'Concept Through to Manufacture' Development of Acne Treatment Lamp
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MAPLE LAWN, MD -- (Marketwire) -- 12/01/08 -- Sagentia (LSE: SAG), the world leadingproduct development, technology consulting and IP exploitation company withU.S. offices in Maple Lawn, Maryland and corporate headquarters inCambridge, UK, has deployed its full concept through to manufacture serviceto deliver the rapid development of a new Photodynamic Treatment (PDT)lamp.
Norwegian-based pharmaceutical company Photocure had identified the needfor a new, large-area PDT lamp that could be used in combination with itsproprietary pharmaceutical Visonac™ for the treatment of moderate to severeacne. With time to market and cost of development as key issues, thecompany recognized that a highly focused development program would berequired. The goal was to achieve a production-ready device for plannedPhase III clinical trials starting in the first half of 2009.
Photocure chose Sagentia as its development partner due to the company'strack record in the medical device sector, its ability to offer a rapidconcept to manufacture development program and the assurance that Sagentiacould offer through its accreditation to ISO 13485 (the medical devicequality management standard).
The fully developed lamp -- known as Aktilite® CL512 -- comprises twolight panels with 512 Light Emitting Diodes (LEDs) that deliver acontrolled dose of red light. The panels can be adjusted to treat eitherthe face or flat areas such as the chest or back. A mobile stand andarticulating support arm are used to position the lamp over the treatmentarea.
Based on Photocure's Intellectual Property (IP) and product requirements,Sagentia undertook a complete concept to manufacture product developmentprogram comprising analytical modelling to identify the best technicalconcept; all mechanical, electronics, software and optical developmentwork; validation and optimisation of advanced design concepts with clinicalstakeholders; the establishment of an extended production supply chain inthe Far East; approvals testing for EU and U.S. regulatory requirements;and finally transfer to production using Photocure's existing Europeansub-contract manufacturer.
Photocure required a large area PDT lamp that could provide uniformillumination of the whole face. To meet this need, Sagentia developed a3-Dimensional (3D) optical model to simulate illumination across the entireface and investigate the performance of different product concepts.Sagentia's 3D model was able to determine that full face illumination couldbe achieved using just two angled lamp panels rather than the three to fivepreviously considered necessary.
At key points during the development program, Sagentia solicited feedbackfrom clinical / nursing professionals to ensure that user requirements werecorrectly identified and validated. This included one-to-one clinicianinterviews, focus groups to explore the range of product concepts andusability workshops to validate prototype designs.
One of the primary reasons for the rapid and successful conclusion of theproject was Sagentia's ability to manage and coordinate amulti-disciplinary in-house team of engineers, scientists andtechnologists, many with direct medical device development experience.This extended from initial product conceptualization through to theestablishment of a Far East network of suppliers. Sagentia's expertise inthis area enabled the company to build a supply chain for low volume, highquality mechanical parts at 40 per cent of the cost of equivalent Europeanitems.
Kjetil Hestdal, President and CEO of Photocure, said, "The Aktilite®CL512 lamp is an essential component of the Visonac™ photodynamic therapyprocedure and I am pleased that, as a result of Sagentia's swift andsuccessful product development program, it is available for use in thePhase III trials."
About Photocure
Photocure ASA is a Norwegian pharmaceutical company listed on the OsloStock Exchange. The company develops and sells pharmaceuticals and medicaldevices based on proprietary photodynamic technology, targeting keydermatological and oncology markets. Photocure develops Visonac(TM) atreatment for moderate to severe acne. The phase II studies have beencompleted in 2008 and the phase III program is scheduled to start in 2009after being discussed with EU/US regulatory authorities.
www.photocure.com
About Sagentia
Sagentia creates, develops and delivers business opportunities, productsand services for its clients.
Established in 1986, Sagentia operates in six global market sectors --medical, industrial products, consumer products, chemicals, materials &energy, telecoms & media and public sector -- developing new technologies,products and services that change the basis of competition. The companyalso assists business leaders to create strategies for technology,innovation and growth.
Sagentia's resources are situated in state-of-the-art facilities in Europe,the U.S. and China. The Group is listed on AIM (LSE: SAG) and has morethan 200 employees.
www.sagentia.com
info@sagentia.com
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=883499
For more information please contact:Rita Thompson WhaleyDirector Communications & Public Relations - U.S.Sagentia, Inc.Email Contact240-547-6607443-996-0873Christian FeketeChief Financial OfficerEmail ContactTel: +47 22 06 22 10
Photocure chose Sagentia as its development partner due to the company'strack record in the medical device sector, its ability to offer a rapidconcept to manufacture development program and the assurance that Sagentiacould offer through its accreditation to ISO 13485 (the medical devicequality management standard).
The fully developed lamp -- known as Aktilite® CL512 -- comprises twolight panels with 512 Light Emitting Diodes (LEDs) that deliver acontrolled dose of red light. The panels can be adjusted to treat eitherthe face or flat areas such as the chest or back. A mobile stand andarticulating support arm are used to position the lamp over the treatmentarea.
Based on Photocure's Intellectual Property (IP) and product requirements,Sagentia undertook a complete concept to manufacture product developmentprogram comprising analytical modelling to identify the best technicalconcept; all mechanical, electronics, software and optical developmentwork; validation and optimisation of advanced design concepts with clinicalstakeholders; the establishment of an extended production supply chain inthe Far East; approvals testing for EU and U.S. regulatory requirements;and finally transfer to production using Photocure's existing Europeansub-contract manufacturer.
Photocure required a large area PDT lamp that could provide uniformillumination of the whole face. To meet this need, Sagentia developed a3-Dimensional (3D) optical model to simulate illumination across the entireface and investigate the performance of different product concepts.Sagentia's 3D model was able to determine that full face illumination couldbe achieved using just two angled lamp panels rather than the three to fivepreviously considered necessary.
At key points during the development program, Sagentia solicited feedbackfrom clinical / nursing professionals to ensure that user requirements werecorrectly identified and validated. This included one-to-one clinicianinterviews, focus groups to explore the range of product concepts andusability workshops to validate prototype designs.
One of the primary reasons for the rapid and successful conclusion of theproject was Sagentia's ability to manage and coordinate amulti-disciplinary in-house team of engineers, scientists andtechnologists, many with direct medical device development experience.This extended from initial product conceptualization through to theestablishment of a Far East network of suppliers. Sagentia's expertise inthis area enabled the company to build a supply chain for low volume, highquality mechanical parts at 40 per cent of the cost of equivalent Europeanitems.
Kjetil Hestdal, President and CEO of Photocure, said, "The Aktilite®CL512 lamp is an essential component of the Visonac™ photodynamic therapyprocedure and I am pleased that, as a result of Sagentia's swift andsuccessful product development program, it is available for use in thePhase III trials."
About Photocure
Photocure ASA is a Norwegian pharmaceutical company listed on the OsloStock Exchange. The company develops and sells pharmaceuticals and medicaldevices based on proprietary photodynamic technology, targeting keydermatological and oncology markets. Photocure develops Visonac(TM) atreatment for moderate to severe acne. The phase II studies have beencompleted in 2008 and the phase III program is scheduled to start in 2009after being discussed with EU/US regulatory authorities.
www.photocure.com
About Sagentia
Sagentia creates, develops and delivers business opportunities, productsand services for its clients.
Established in 1986, Sagentia operates in six global market sectors --medical, industrial products, consumer products, chemicals, materials &energy, telecoms & media and public sector -- developing new technologies,products and services that change the basis of competition. The companyalso assists business leaders to create strategies for technology,innovation and growth.
Sagentia's resources are situated in state-of-the-art facilities in Europe,the U.S. and China. The Group is listed on AIM (LSE: SAG) and has morethan 200 employees.
www.sagentia.com
info@sagentia.com
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=883499
For more information please contact:Rita Thompson WhaleyDirector Communications & Public Relations - U.S.Sagentia, Inc.Email Contact240-547-6607443-996-0873Christian FeketeChief Financial OfficerEmail ContactTel: +47 22 06 22 10
For more information, go to www.marketwire.com
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