Worth reading
45Recurring
0–100. This measures how worthwhile something is to read, not how good or bad the company is.Direction
Improvement
Direction inferred from the company’s description.Scale
—
Displayed only when the document provides numerical figures.Wording
Avoiding a definitive answer
How definitive the wording is.Announced details
PuraStat自己組織化ペプチド技術（RADA16）
Applicable field (uses covered by this announcement)
消化管の粘膜組織における創傷治癒耳鼻咽喉科（ENT）領域の術後癒着低減・疼痛軽減Gastrointestinal endoscopyRadiation proctitis血管性病変（GAVE等）泌尿器領域の放射線性膀胱炎
What the company reported numerically
Usage history
欧州においてPuraStatを販売中（数量・時点はNot disclosed）
Relationship between the counterparty and the company
3-D Matrix,Ltd.7777
Relationship with the Company
当社がCEマーク変更申請を行う相手先。資本関係・人的関係・通常の取引関係はNot disclosed。
Counterparty欧州の第三者認証機関
欧州の第三者認証機関。具体的な名称・所在地・事業内容等はNot disclosed。
Award/certification name
CEマーク（変更申請）
Awarding / certifying body
欧州の第三者認証機関（名称はNot disclosed）
Location (as indicated in this announcement)
東京都千代田区麹町三丁目2番4号（当社本社）
Impact on Business Performance
本件による通期業績予想への影響はない
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | PuraStat, 自己組織化ペプチド技術（RADA16） |
| Counterparty | 欧州の第三者認証機関 |
| Counterparty overview | 欧州の第三者認証機関。具体的な名称・所在地・事業内容等はNot disclosed。 |
| Relationship with the Company | 当社がCEマーク変更申請を行う相手先。資本関係・人的関係・通常の取引関係はNot disclosed。 |
| Applicable area | 消化管の粘膜組織における創傷治癒, 耳鼻咽喉科（ENT）領域の術後癒着低減・疼痛軽減, Gastrointestinal endoscopy, Radiation proctitis, 血管性病変（GAVE等）, 泌尿器領域の放射線性膀胱炎 |
| Award/certification name | CEマーク（変更申請） |
| Awarding / certifying body | 欧州の第三者認証機関（名称はNot disclosed） |
| Location | 東京都千代田区麹町三丁目2番4号（当社本社） |
| Usage history | 欧州においてPuraStatを販売中（数量・時点はNot disclosed） |
| Impact on Business Performance | 本件による通期業績予想への影響はない |
Items this document does not state (8)
Contract ValueOffering priceContract DateLaunch dateRegistration number and expiry dateLocation scaleQuantitative EffectsSource
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.自己組織化ペプチド技術（RADA16）の粘膜治癒能力に関する適応を追加し、消化管・耳鼻咽喉領域などでの臨床応用を広げるため。承認後は、止血・治癒・癒着防止・疼痛軽減を目指す多機能デバイスとして価値を確立し、欧州市場での普及を加速するとしている。
How to read this page
This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.