Ventripoint Announces Acceptance Notification From US-FDA of Recent 510(k) Submission
(firmenpresse) - SEATTLE, WASHINGTON -- (Marketwired) -- 03/27/15 -- Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company") (TSX VENTURE: VPT) is pleased to announce that it has received Acceptance Review Notification concerning the Company''s recent 510(k) submission () to the U.S. Food & Drug Administration ("US-FDA"). The Notification confirms that the submission contains all of the necessary elements and information needed to proceed with the substantive review. A lead reviewer has been assigned and the substantive review has begun. The US-FDA guidelines mandate that the Company receive its first communication regarding the submission within 60 days, with closure of the submission expected to occur within 90 days.
Dr. George Adams, CEO of Ventripoint states: "We are extremely pleased with how quickly this process has been going so far, which is a true testament to our development and regulatory team. We look forward to the US-FDA''s response in the next 60 days. This should be a very exciting time for Ventripoint shareholders."
About Ventripoint Diagnostics Ltd.
Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. VMS™ is the first cost-effective and accurate tool for measuring right ventricle heart function. The Company has a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure and normal hearts - a multi-billion dollar market potential.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
FORWARD-LOOKING STATEMENTS: The statements made in this news release that are not historical facts may contain forward-looking information that involves risk and uncertainties. All statements, other than statements of historical facts, which address Ventripoint''s expectations, should be considered forward-looking statements. Such statements are based on management''s exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Corporation''s filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. A description of assumptions used to develop such forward-looking information and a description of risk factors that may cause actual results to differ materially from forward-looking information can be found in Ventripoint''s disclosure documents on the SEDAR website at . The Corporation undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.
Contacts:
Ventripoint Diagnostics Ltd.
Dr. George Adams
CEO
(206) 910-9125
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 27.03.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 1347264
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
SEATTLE, WASHINGTON
Phone:
Kategorie:
Medical Devices
Anmerkungen:
Diese Pressemitteilung wurde bisher 196 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Ventripoint Announces Acceptance Notification From US-FDA of Recent 510(k) Submission
"
steht unter der journalistisch-redaktionellen Verantwortung von
Ventripoint Diagnostics Ltd. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
