VentriPoint Announces Closing of Private Placement and Corporate Update

Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company") (TSX
VENTURE:VPT)(OTCQX:VPTDF) announces that it has completed a first closing of the
second of its two previously announced non-brokered private placements and is
providing a corporate update.


Corporate Update

The Company previously reported the Food and Drug Administration ("FDA") had
asked for additional information concerning the Company's 510(k) submission for
Pulmonary Arterial Hypertension ("PAH"). Through a dialogue with the FDA, the
Company has prepared a detailed statistical plan to obtain the information
required in collaboration with the Hospital for Sick Children, Toronto, which
will be re-analyzing the clinical studies. The Company has completed the
collection of an additional 21 clinical cases, which along with the 54 studies
used in the first analysis, yields 75 total cases, as originally planned in the
clinical trial. The new analysis, which will use all 75 cases, has begun and is
expected to take six to eight weeks to complete. The PAH clinical trial is now
completed and is closed.


The clinical trial for Tetralogy of Fallot (TOF) has finished recruitment with
the 75 required clinical cases and the study is now completed and closed. The
analysis of the data will begin as soon as the PAH analysis is completed. This
will also be done by the Hospital for Sick Children as the Ventripoint Medical
System ("VMS(TM)") core lab and Nationwide Hospital as the MRI core lab.


The Company has developed a clinical trial protocol in collaboration with a
major cardiac center that is interested in evaluating if VMS assessment of right
heart function and structure in patients admitted with congestive heart failure
can predict hospital readmission within 30 days of discharge (see CEO blog on
website http://ventripoint.com/index.php?Itemid=511). This study has the
potential to revolutionize how cardiac patients are assessed and save the
healthcare system billions of dollars.


Last week the Company exhibited, in collaboration with Toshiba Medical Systems
Europe, at the 11th International Symposium entitled "Echocardiography Today and
Tomorrow" in St. Wolfgang, Austria. The conference was focused on the right
heart and included a workshop, where case studies using the Ventripoint VMS were
presented by the group from Elisabethinen Hospital, Linz, Austria, which also
organized the conference.


From June 29-July 2, 2013 the Company will be exhibiting at the 24th Scientific
Sessions of the American Society of Echocardiology ("ASE") in Minneapolis,
Minnesota. There will be three scientific papers presented by three groups of
researchers discussing the clinical use of the VMS.


A multicentre group from the University of Chicago and Elisabethinen Hospital in
Linz, Austria will present a study entitled "Three-dimensional Modeling of the
Right Ventricle from Two-Dimensional Transthoracic Echocardiographic Images:
Utility of Knowledge-Based Reconstruction in Pulmonary Arterial Hypertension".
Dr. Lang from the University of Chicago and past President of the ASE stated;
"The VentriPoint 3D system provides reproducible measurements of RV volumes in
pulmonary arterial hypertension patients. The clinical accuracy of VMS helps
obtain valuable information that can impact patient care".


A group led by Dr. Laser from the Heart and Diabetes Center NRW (HDZ NRW), Bad
Oeynhausen, Germany will report on the first use of the prototype VMS-3DE(TM)
software, which analyses 3D ultrasound cardiac images in a paper entitled;
"Right ventricular volumetry in healthy children and young adults by RT3DE - New
axis, new quantification tool with promising results". 


A group led by Dr. Soriano from the Seattle Children's Hospital will report on
their early experiences with the VMS in a number of children with a broad range
of heart problems in a paper entitled; "Echocardiographic 3D Reconstruction
Accurately and Precisely Measures Right Ventricular End Diastolic Volumes:
Preliminary Pediatric Experience in a Single Institution". Dr. Sorino commented
"Our ongoing research experience with the Ventripoint equipment has been very
positive and we look forward to applying it routinely once it is available for
clinical usage in the USA".


The Company has been upgrading VMS systems to the new mobile VMS-Angelo(TM)
model and installing new systems for customer evaluation. By the end of this
quarter, there will be seven systems in clinical use, four of which are being
placed for a 30-day trial period prior to purchase. In addition, four
institution-sponsored clinical research studies have been completed and we are
working on favorable purchase terms with each of them to maintain clinical usage
of VMS. The company expects several sales to be agreed in the next quarter and
has a number of new cardiac centres requesting a VMS-Angelo system for
evaluation.


Unit Private Placement

The Company has issued an aggregate of 500 units ("Units") for gross proceeds of
US$500,000 (the "Unit Private Placement"). Each Unit consists of USD$1,100
principal amount of non-convertible secured debentures ("Unit Debentures"),
which shall mature three years from the date of issuance and 2,000 common shares
in the capital of the Company (the "Common Shares").


Each Unit Debenture is subject to a 10% capital discount premium to the
subscriber such that for every USD$1.00 Unit Debenture acquired, the Company
shall owe, on the maturity date, an amount equal to USD$1.10 to the subscriber
minus any payments of principal to date. Any interest due under the terms of the
Unit Debentures shall only be paid and calculated against the principal amount
actually provided to the Company (i.e. USD$1.00) by the subscriber and not
calculated against the inflated principal paid on the maturity date (i.e.
USD$1.10).


The Unit Debentures will bear interest at a rate of 12% per annum and shall be
calculated on the initial Unit Debenture amount. Any accrued but unpaid interest
under the Unit Debentures shall be due and payable on December 1st each calendar
year. The December 1, 2013 interest may, subject to the approval of the TSX
Venture Exchange ("Exchange"), be paid in Common Shares, with the number of
Common Shares being determined by using the preceding 10 day volume-weighted
average price of the Common Shares on the Exchange. All subsequent interest
payments shall be made in cash and the final payment of accrued interest shall
be payable upon maturity of the Unit Debentures.


If the Company prepays all of the outstanding principal on any of the Unit
Debentures prior to the second anniversary date of the Unit Debentures, the
Company shall pay any accrued interest and make an additional payment to the
Unit Debenture holder equal to one year's interest (the "Additional Interest
Payment").


The Unit Debenture holders shall receive a pro rata 20% first charge on gross
revenues (net of any third party billings, such as shipping or taxes) (the
"Revenue Payments") at the end of each calendar quarter from sales of VMS
machines until the Unit Debentures are retired. The Revenue Payments shall not
invoke the Additional Interest Payment and will be deducted from the principal
paid upon the maturity date of the Unit Debentures. 


The Unit Debentures are secured by a general security agreement against
substantially all of the assets of the Company's wholly-owned subsidiary,
Ventripoint, Inc., including its intellectual property, as a first charge. All
Unit Debentures rank equally with one another.


The Company intends to use the proceeds from the Unit Private Placement for: (i)
product and service commercialization of the VMS machines; (ii) clinical
validation of VMS functionality, including applications for additional diagnoses
and heart diseases; and (iii) for general working capital purposes and to repay
debt and outstanding payables. 


The Unit Private Placement is subject to the final approval of the Exchange. The
securities issued pursuant to the Unit Private Placement are subject to a
four-month hold period in accordance with applicable securities laws. 


Share for Debt

The Company also announces it has received approval from the Exchange and has
issued 694,425 Common Shares at a deemed price of $0.099 per Common Share in
payment of $68,748.09 of accrued interest owing to a holder of a debenture of
the Company. The 694,425 Common Shares have a hold period of four months from
the date of issuance in accordance with applicable securities legislation.


About Ventripoint Diagnostics Ltd.

Ventripoint has created a diagnostic ultrasound tool to monitor patients with
heart disease, a leading cause of death in developed countries. Management
believes that VMS is the first cost-effective and accurate diagnostic tool for
measuring right ventricle heart function. Congenital heart disease in children
and adults and Pulmonary Arterial Hypertension are the first applications in a
suite of applications for all major heart diseases including cardiovascular
disease and heart failure - a multi-billion dollar market potential. Canada and
Europe (CE Mark) have granted approval for the sale of its VMS tool and the
Company is pursuing the US-FDA marketing clearance through the 510(k) process. 


FORWARD-LOOKING STATEMENTS: This news release may contain certain
forward-looking information and statements, including without limitation,
statements pertaining to the closing of the private placements including the
Company's ability to obtain necessary approvals from the TSX Venture Exchange.
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 Company'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 www.sedar.com. The Company 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.


FOR FURTHER INFORMATION PLEASE CONTACT: 
VentriPoint Diagnostics Ltd.
Dr. George Adams
CEO
(206) 910-9125
gadams@ventripoint.com
www.ventripoint.com
(TSXV:ASE)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024