◎Chocolate PTCAバルーンカテーテルにFDA認可

AsiaNet 56966

共同JBN 0624 （2014.6.6）

【シンガポール2014年6月5日PRN＝共同JBN】

＊Chocolate（登録商標）PTCAのFDA認可獲得で新たな市場機会が大きく開ける

QT Vascular Ltdは5日、全面所有米国子会社のTriReme Medical LLCが2014年6月4日に米食品医薬品局（FDA）からChocolate PTCAバルーンカテーテルを冠動脈の狭窄部分のバルーン拡張、心筋血流改善を目的とする移植組織狭窄のバイパス用に米国で販売する510（K）条認可を受けたと発表した。

コロンビア大学血管インターベンション療法センターのマーティン・レオン博士は「Chocolate PTCAはインターベンション心臓専門医にとってエキサイティングな新製品である。Chocolate PTAバルーンカテーテルのすぐれた臨床結果と低い解離率を活用する一方で、いまでは冠動脈で使用できる重要な新ツールを提供している」と語っている。

現在、Chocolate PTAは末梢動脈疾患として知られている両足に血管疾患を持つ患者の治療に使われている。Chocolate PTAは臨床研究で解離と離脱ステント使用の率が低いことを示している（1）。Chocolate PTCAは同様の製造原則で設計されており、冠動脈血管の予測可能な均一的拡張の提供を目指している。現時点ではChocolate PTCAについて入手可能な臨床データはない。

冠動脈性心疾患（CHD）としても知られる冠動脈疾患は、最も一般的な形態の心臓血管疾患であり米国、欧州で最も多い死因である。米国心臓協会によると、20歳以上の米国人1540万人が冠動脈性心疾患にかかっていると推定されている。CHDは2010年に米国でほぼ6人に1人の基本的な死因だった（2）。

QT Vascularのエイタン・コンスタンティーノ最高経営責任者（CEO）は「冠動脈事業はわが社の2015年の成長の重要な要素である。この新生品承認はわが社のマイルストーンに関するチームの効果的な執行能力を示している。医師たちと緊密に協力して臨床データを作成し、より大きな患者グループに奉仕したい」と語っている。

▽冠動脈疾患について

冠動脈疾患は冠動脈（心臓を取り巻く動脈）がコレステロール、脂肪性沈着物、カルシウムなどの物質を含むプラーク（血塊）の集積によって狭まることから起こる。プラークが時間とともに増大すると、動脈内腔の内径が狭まり、その結果、血流が低下ないし停止する。血液を心臓に供給する動脈でこれが起こると胸痛、心臓発作、さらには死を引き起こす。

▽QT Vascularについて

QT Vascular Ltdは複雑な心臓疾患を治療する次世代の最低侵襲製品の開発と商業化の新興リーダーである。同社は処置、臨床結果を改善する差異化された機器をつくり出すため、世界各地の有力な医師、科学者と緊密に協力している。QT Vascularはシンガポールに本社を置き、米カリフォルニア州プレザントンに米国子会社のTriReme Medical LLCがある。同社の株式は2014年4月29日にthe Singapore Exchange Securities Trading LimitedのCatalistに上場された。

（注）

(1) Das T for Mustapha J. Chocolate(R) Bar, Leipzig Interventional Course,

        28-31 January, 2014.

(2) Heart disease and stroke statistics-2014 update: a report from the

        American Heart Association. Circulation. 2014;129:e28-e292.

同社の株式は2014年4月29日にthe Singapore Exchange Securities Trading Limited（SGX-ST）のCatalistに上場された。同社の新規株式公募はPrimePartners Corporate Finance Pte. Ltd（「スポンサー」）がスポンサーとなって実施された。

このプレスリリースは同社によって準備され、その内容はSGX-STの関連法規順守のため、スポンサーによって審査された。スポンサーはこのプレスリリースの内容を独自に確認したわけではない。

このプレスリリースはSGX-STによって調査、承認されたものではなく、SGX-STはこのプレスリリースで表明される声明、意見あるいはプレスリリースに含まれる報告の正しさを含め、このプレスリリースの内容に責任を負うものではない。

ソース：QT Vascular

▽問い合わせ先

Mr Mark Liew

Managing Director

Corporate Finance

20 Cecil Street

#21-02 Equity Plaza

Singapore 049705

Telephone: +65-6229-8088

QT Vascular Announces FDA Clearance of Chocolate PTCA Balloon Catheter

PR56966

SINGAPORE, June 5, 2014/PRN=KYODO JBN/--

      Chocolate(R) PTCA FDA clearance opens large new market opportunity

    QT Vascular Ltd. (QT Vascular) is pleased to announce that on 4 June 2014,

its wholly owned US subsidiary, TriReme Medical LLC, received notification from

the United States Food and Drug Administration (FDA) of 510(K) clearance to

market the Chocolate(R) PTCA Balloon Catheter (Chocolate PTCA) in the United

States, for balloon dilatation of the stenotic portion of coronary artery or

bypass graft stenosis for the purpose of improving myocardial perfusion.

    "Chocolate PTCA is an exciting new product for interventional

cardiologists," said Dr. Martin Leon of Columbia University Center for

Interventional Vascular Therapy. "It leverages the strong clinical outcomes and

low rates of dissections of the Chocolate PTA Balloon Catheter (Chocolate PTA)

while providing an important new tool that could be now used in coronary

arteries."

    Currently, the Chocolate PTA is used for the treatment of patients with

vascular disease in their legs, known as peripheral arterial disease. The

Chocolate PTA has demonstrated low rates of dissections and bail-out stenting

in clinical studies (1). The Chocolate PTCA was designed with similar

engineering principles and is aimed to provide predictable and uniform

dilatation of the coronary vasculature. There is no clinical data available for

the Chocolate PTCA at this point in time.

    Coronary artery disease, also known as coronary heart disease (CHD), is the

most common form of cardiovascular disease and the number one cause of death in

the United States and Europe. According to the American Heart Association, an

estimated 15.4 million Americans over 20 years of age suffer from coronary

heart disease. CHD was an underlying cause of death in approximately 1 of every

6 deaths in the United States in 2010 (2).

    "The coronary business is an important element of our 2015 growth. This new

product approval demonstrates the team's ability to effectively execute on our

milestones," said Dr. Eitan Konstantino, Chief Executive Officer of QT

Vascular. "We look forward to working closely with physicians to generate

clinical data and serve a larger patient population."

    About Coronary Artery Disease

    Coronary artery disease occurs when the coronary arteries (the arteries

surrounding the heart) become narrowed by a buildup of plaque, including

cholesterol, fatty deposits, calcium, and other substances. As plaque

accumulates over time, the diameter of the arterial lumen, or inner channel,

narrows, resulting in reduced or stopped blood flow. When this occurs in

arteries supplying blood to the heart, it can cause chest pain, a heart attack,

or even death.

    About QT Vascular

    QT Vascular Ltd. (QT Vascular) is an emerging leader in the development and

commercialization of next generation minimally invasive products for the

treatment of complex vascular disease. The Company works closely with leading

physicians and scientists from around the world to create differentiated

devices that improve procedural and clinical outcomes. QT Vascular is based in

Singapore with a US subsidiary, TriReme Medical LLC, in Pleasanton, California.

The Company was listed on the Catalist Board of the Singapore Exchange

Securities Trading Limited on 29 April 2014.

    References:

    (1) Das T for Mustapha J. Chocolate(R) Bar, Leipzig Interventional Course,

        28-31 January, 2014.

    (2) Heart disease and stroke statistics-2014 update: a report from the

        American Heart Association. Circulation. 2014;129:e28-e292.

    Cautionary Note on Forward-Looking Statements

    All statements other than statements of historical facts included in this

announcement are or may be forward-looking statements. Forward-looking

statements include but are not limited to those using words such as "expect",

"anticipate", "believe", "estimate", "intend", "project", "plan", "strategy",

"forecast" and similar expressions or future or conditional verbs such as "if",

"will", "would", "should", "could", "may" and "might". These statements reflect

the Company's current expectations, beliefs, hopes, intentions or strategies

regarding the future and assumptions in light of currently available

information. Such forward-looking statements are not guarantees of future

performance or events and involve known and unknown risks and uncertainties.

Accordingly, actual results may differ materially from those described in such

forward-looking statements. Shareholders should not place undue reliance on

such forward-looking statements, and the Company undertakes any obligation to

update publicly or revise any forward-looking statements, subject to compliance

with all applicable laws and regulations and/or the rules of the SGX-ST and/or

any other regulatory or supervisory body or agency.

    The Company was listed on Catalist board of the Singapore Exchange

Securities Trading Limited (the "SGX-ST") on 29 April 2014. The initial public

offering of the Company was sponsored by PrimePartners Corporate Finance Pte.

Ltd. (the "Sponsor").

    This press release has been prepared by the Company and its contents have

been reviewed by the Sponsor for compliance with the relevant rules of the

SGX-ST. The Sponsor has not independently verified the contents of this press

release.

    This press release has not been examined or approved by the SGX-ST and the

SGX-ST assumes no responsibility for the contents of this press release

including the correctness of any of the statements or opinions made or reports

contained in this press release.

    SOURCE: QT Vascular Ltd

   CONTACT: Mr Mark Liew

            Managing Director

            Corporate Finance

            20 Cecil Street

            #21-02 Equity Plaza

            Singapore 049705

            Telephone: +65-6229-8088