July 2, 2018
Press Release
Nobelpharma Co., Ltd.
Announcing Sales Launch of TITANBRIDGE®
First Medical Device to Receive SAKIGAKE Designation
Medical Device for the Treatment of Adductor Spasmodic Dysphonia
Nobelpharma Co., Ltd. (Head Office: Chuo-ku, Tokyo; President and CEO: Jin Shiomura) is announcing thatsales of TITANBRIDGE®, a medical device to be used for type II thyroplasty for the treatment of adductor
spasmodic dysphonia (device generic name: device for thyroid cartilage fixation) were launched on July 2.

This device was the first medical device to be awarded the SAKIGAKE designation in February 2016, was thendesignated as an orphan device in September 2016, and obtained marketing approval on December 12, 2017.
The type II thyroplasty using TITANBRIDGE® is a unique medical technique that was developed in Japan aheadof the rest of the world in 2001 by Dr. Nobuhiko Isshiki, Professor Emeritus, Kyoto University, to achieve
continuing symptomatic relief in patients with adductor spasmodic dysphonia by preventing excessively tightclosure of the glottis and maintaining the glottic opening. Kumamoto University and the Translational ResearchInformatics Center of the Foundation for Biomedical Research and Innovation (now the Translational ResearchCenter for Medical Innovation of the Foundation for Biomedical Research and Innovation at Kobe) cooperated tolaunch an investigator initiated trial after being selected to conduct research on rare and intractable diseases underthe Health and Labor Sciences Research Grants in 2014 (continued until 2016 under the Japan Agency for Medical
Research and Development).

Adductor spasmodic dysphonia is a type of focal dystonia, an intractable neurological disease of unknown cause
common among young women. There has been no definitive treatment for this disease that would maintain a degreeof improvement in the vocal disorder previously established anywhere in the world, so the prompt practical use of thistherapeutic technique using the TITANBRIDGE® is expected to be a major ray of hope for patients who suffer fromadductor spasmodic dysphonia. Nobelpharma will continue to contribute to society by providing drugs and medical
devices for unmet needs in the future.

【Contact for more information】
Nobelpharma Co., Ltd.
Kozo Hayase, Executive Director, Head of Administrative Affairs & Corporate Planning
Tel: 03-5651-1160

There are 3 types of TITANBRIDGE®, a standard specification (M), one for patients with short thyroid cartilage(S), and one for patients with thick thyroid cartilage (L), and there are 7 specifications of opening widths for each ofthem.

Product nameOpening widths (mm)®

TITANBRIDGE S20～S60
TITANBRIDGE® M20～M60
TITANBRIDGE® L20～L60

High management medical device TITANBRIDGE®
Medical device approval number: 22900BZX00409000

2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0

About Nobelpharma
Nobelpharma has been contributing to the provision of necessary treatments for overlooked diseases
through development of medicines since 2003. Our development priority is on medicines andmedical devices for unmet needs that are strongly desired by patients associations and medical
associations. Currently, we have obtained marketing approval for 14 products, mostly focused on
medicines and medical devices for unmet needs, and of those 10 products have received the orphan
drug or device designation.