About BioMers

BioMers is a medical device company that specializes in the development of novel polymer composite technology for biomedical applications.

Through its patented technological breakthrough, BioMers introduced SimpliClear, the world’s only completely clear orthodontic solution that can be used to treat a wide range of teeth irregularities, from mild to complex patient cases. With SimpliClear, patients can undergo orthodontic treatment without the embarrassment of unsightly metal braces.

The orthodontic industry has sought the development of an esthetic alternative to metal braces for over 30 years. However, past solutions have limited applicability to a wide range of cases. BioMers solved the problem through the development of a clinically proven clear orthodontic wire, the backbone of tooth movement.

ASTICS, the orthodontic retention system, is another innovation by BioMers. Available in both clear and colored variants, ASTICS offers patients the esthetic retention options without the concerns of relapse.

Founded as a spin-off from the National University of Singapore (NUS), BioMers is a Singapore-based company with a sales and distribution facility in Washington State, USA.

BioMers is driven by an unrelenting pursuit of technological advancement and is committed towards continuous product improvements and innovations. Our products meet all regulatory requirements as set out by the FDA, Health Canada and European Medical Device Directive. BioMers believes in offering quality services and owns an in-house orthodontic laboratory in Singapore to meet exacting needs of doctors.

David N. Edwards

CEO

David N. Edwards is Chief Executive Officer of BioMers Pte Ltd. He was named to this post in April 2011. Mr. Edwards is based in the BioMers’ Singapore headquarters and is responsible for the company’s worldwide business, reporting to the Board of Directors.

Mr. Edwards has an extensive background in global management and brand development in the consumer and med-tech industries spanning the US, Europe, Middle East, Africa and Asia. Before joining BioMers, Mr. Edwards was Corporate Vice President and President Asia Pacific for Bausch + Lomb. In this role, he was responsible for the development of Bausch + Lomb’s portfolio of eye care businesses including contact lenses and lens care solutions, cataract surgery, and ophthalmic pharmaceutical and OTC businesses for the Asia Pacific region including Japan. Prior to joining Bausch + Lomb, Mr. Edwards spent 10 years with Johnson & Johnson in a number of senior leadership roles. From 2006 to 2008, he was President, Europe, Middle East and Africa (EMEA), for Johnson & Johnson’s Lifescan diabetes business unit. From 2002 to 2006, he was Managing Director, Asia Pacific, for Johnson & Johnson Vision Care, the global leader in contact lenses marketed under the Acuvue brand. Prior to that, Mr. Edwards guided the start-up and growth of Johnson & Johnson’s McNeil Nutritionals Europe unit as Managing Director, and Vice President Marketing where he was responsible for the European introduction of the Benecol brand. Before joining Johnson & Johnson, he held management roles with NBA Europe S.A. (National Basketball Association) and spent 10 years with Nestle, including roles in Nestle’s Beverage Unit in the USA, the Fresh Products Division in Nestle Italiana in Milan, Italy, and at the Nestle world headquarters in Vevey, Switzerland.

Mr. Edwards earned his MBA from the Thunderbird School of Global Management, and holds a Bachelor’s Degree in Business Administration from Gonzaga University.

Dr. Mervyn Fathianathan

CTO

Dr. Fathianathan co-founded BioMers Pte Ltd in 2005. Prior to his current position as the CTO, he served as the CEO of the company from Q4 2009 to Q1 2011. During this period, he revised the company's strategy from selling preformed clear wires to offering a customized esthetic orthodontic solution. He also led the revision of the sales model from utilizing distributors to establishing a direct sales team. He was an inventor of the SimpliClear custom orthodontics solution and the ASTICS esthetic retention solution. He was formerly an Assistant Professor in the George W. Woodruff School of Mechanical Engineering at the Georgia Institute of Technology in the USA.

Dr. Fathianathan holds a PhD and B.Eng (Hons) in mechanical engineering from the National University of Singapore. Following his PhD, he was awarded the Chevening Fellowship to undergo training in technology commercialization at the London Business School in the UK. His expertise is in the area of product design and manufacturing. He has published articles in these areas in books and in the top journals and conferences. He received the 2010 Outstanding Young Manufacturing Engineer award from the Society of Manufacturing Engineers, an award for outstanding contributions to the field by a person under the age of 35.

George Aliphtiras

Vice President of Business Development

Mr. Aliphtiras holds a Bachelor of Science and Master of Science in Microbiology from the University of British Columbia. He is a former Chevening Fellow in New Technology Enterprise at the London Business School and University of Oxford in the UK.

He held several sales and marketing positions in the biotechnology sector working for the likes of Chemicon International, now part of Millipore Corp, and Aurora BioMed. At Chemicon, he grew sales by selectively targeting key research institutions and biotechnology companies in the US and Canada. He played an integral role in commercializing technology at Aurora BioMed and EnWave Corp, both University of British Columbia spin-off companies. During his time at Aurora BioMed, he established research collaborations with leading pharmaceutical companies such as Roche and Icagen, Inc., which led to the commercialization of novel assay services for drug development. At EnWave, he co-developed the commercialization of several high value consumer foods using the company’s patented vacuum microwave technology.

Dr. Renuga Gopal

Vice President of Product Development

Dr. Gopal holds a PhD in Mechanical Engineering, specializing in Nanotechnology and a M.Eng in Mechanical Engineering, specialising in Bioengineering from the National University of Singapore.

She is the principle inventor of the patented BioMers technology, which allows the development of micro-scaled polymer composites. She was awarded the Tan Kah Kee Young Inventors’ Merit Award (Open Section) in 2003, for the ‘Development of an Esthetic Orthodontic Archwire’. This award is awarded to inventors below the age of 35 for their innovation. She has published in the leading journals in the field of biomaterials on polymer composites and nanofibers. She also serves as a reviewer for several leading journals in the field of material science, membrane science and nanotechnology.

BioMers’ products have been rigorously tested for quality, safety and effectiveness. Only the finest raw materials are used in the development of the company’s products. The products are manufactured to the highest quality standards adhering to the U.S. FDA Good Manufacturing Practices (GMP) regulations and ISO 13485 quality management system for medical devices.

The products are compliant to all regulatory requirements as set out by the U.S. FDA, Health Canada, European Medical Device Directive, Australia’s TGA and Japan’s PMDA.

Regulatory Compliance – Certification and Approvals

All certifications and approvals pertaining to regulatory compliance are listed below:

Manufacturing Certification

• Quality Management System – ISO 13485 quality system certification
• U.S. FDA Good Manufacturing Practice (GMP)
• The company is fully compliant with 21 CFR Part 820, US FDA Quality
• Japan Ministry of Health, Labour and Welfare Inspection (MHLW)

Product Certifications and Approvals

• AUSTRALIA
• CANADA
• EUROPE
• JAPAN
• UNITED STATES
• SINGAPORE

To contact specific in-country regulatory representatives in Australia and Europe one may contact Emergo Group at the following:

AUSTRALIA – Sponsor Representative

Emergo Australia Pty. Ltd., Sydney, AUSTRALIA
Tel: +61 2 9006 1662

EUROPE – Authorized Representative

Emergo Europe, The Hague, NETHERLANDS
Tel: +31 70 345 8570