INNOVATEX, INC. was founded by Stephen Chen in Weston, Massachusetts, USA in 2006 as a Small Business Research Initiative (SBRI) company and was awarded a U.S. Navy Air Systems Command (NAVAIR) research contract the following year. Since 2008, the company has engaged in medical device research and development. Its first product, Tear Duct OccluderTM, was granted a U.S patent in 2012 and approved by the FDA for prescription use on April 20, 2016.
Stephen Chen, President, CEO
Mr. Chen has served as our President, Chief Executive Officer, since September 2006. He has more than 25 years of technology experience including 9 years of experience in ophthalmic device research, development, FDA regulatory procedures, patent laws and manufacturing operation. Prior to founding Innovatex, Inc., he worked for Foster-Miller (defense), Polaroid (camera/film) and Union Carbide (Dow Chemicals). Mr. Chen received a B.S. degree from Chung Yuang University and an M.S. degree from Tufts University.
Bertha Ng, Vice President, CFO
Ms. Ng has served as our Vice President, Chief Financial Officer, since April 2010. She has more than 20 years of financial analysis and management experience at Fidelity Investments and Bank of America. Ms. Ng received a B.A. degree from UCLA and an M.S. degree from Simmons College.
Clara Fuchs, Vice President, Marketing
Ms. Fuchs has served as our Vice President, Marketing, since November 2014. She has more than 10 years of business experience including years of healthcare information consulting experience at IBM Innovation Services. Clara received a B.A. degree from University of Rochester.
Mark Chen, Consultant, Quality Assurance
Mr. Chen is a seasoned quality professional specialized in medical device quality system according to FDA/ISO and other International requirements.
November 6, 2020 – INNOVATEX received its first EU mail order from France.
July 24, 2019 – INNOVATEX received its first mail order from Cannada.
December 12, 2018 – INNOVATEX received its first mail order from UK.
June 27, 2018 – INNOVATEX received its first mail order from Japan.
June 7, 2018 – INNOVATEX shipped its first out of state prescription mail order to a dry-eye patient in San Gabriel, California.
May 21, 2018 – INNOVATEX launched a new beta site for Tear Duct Occluder at the Glaucoma Department of Massachusetts Eye and Ear (MEE). MEE is associated with Harvard Medical School and is one of the most renowned eye care institutes in the nation.
March 1, 2018 – INNOVATEX exibited Tear Duct Occluder at AGS 2018 Conference and went over the “one size fit all” device to more than 150 doctors.
July 27, 2017 – The “one size fit all” Tear Duct Occluder was developed and proven accurate after clinical trial on 14 patients over two months period.
July 14, 2017 – A serious glaucoma patient at Tufts New England Eye Center, who is in the verge of needing surgery, has used Tear Duct Occluder for 2 months and her eye pressure became low enough to postpone her glaucoma surgery.
May 3, 2017 – Innovatex started Tear Duct Occluder fitting services at Tufts New England Eye Center.
April 27,2017 – Won a big battle over FDA ruling (see Device labeling change) that Tear Duct Occluder can now be sold or prescribed by any licensed eye care professionals instead of by ophthalmologists only. This means not only ophthalmology clinics but also all optical shops in U.S. can now sell or prescribe this device.
March 5, 2017 – Tear Duct Occluder was successfully introduced in AGS 2017 Conference – we discussed Tear Duct Occluder applications with more than 50 glaucoma specialists of 11 countries in person from U.K, Canada, Israel, Iceland, Pakistan, India, Brasil, Columbia, Mexico, Peru and U.S.A. and distributed hundreds of device samples and patient brochures.
February 1, 2017 – “Drug and Device Digest” listed Tear Duct Occluder as: Regulation Number: 21 CFR 886.5838; Regulation Name: Nasolacrimal Compression Device; Regulatory Classification: Class I Exempt … https://druganddevicedigest.com/2017/02/
January 5, 2017 – Tear Duct Occluder marketing campaign has reached over 1,000 ophthalmologists who routinely treat glaucoma patients. Currently, this device is being evaluated by eye care clinics in East Coast, including MA, NY, MD, NC, TN and FL.
December 15, 2016 – The device is being examined and tried by several University Medical Centers across the United States, including Tufts University, Boston University, Duke University and University of Tennessee.
October 20, 2016 – Innovatex, Inc. filled the first Tear Duct Occluder prescription order from Tuft Medical Center.
October 1, 2016 -Tear Duct Occluder national campaign began.
September 19, 2016 – Tear Duct Occluder Massachusetts campaign began.
June 10, 2016 – Tufts New England Eye Center began prescribing free Tear Duct Occluder.
June 10, 2016 – Mass Device website posted that Innovatex wins down-classification (i.e. de novo request) for Tear Duct OccluderTM from FDA. http://www.massdevice.com/innovatex-wins-classification-tear-duct-occluder-fda/
June 10, 2016 – Federal Resister published FDA approval order on Tear Duct OccluderTM de novo request, DEN140022.
April 20, 2016 – (FDA) has completed its review of our de novo request for classification of our Nasolacrimal. Compression Device and granted us Class I classification for the device with Classification Name, Tear Duct OccluderTM , Regulation Name (or generic name), Nasolacrimal Compression Device, Regulation Number: 886.5838, Medical Specialty: Ophthalmic Therapeutic Device and De Novo Number: DEN140022.
April 3, 2012 – the first Tear Duct Occluder patent was granted by U.S. Patent Office.