REVA Announces Clinical Enrollment Progress and Anticipated $11.4 Million Cash Receipt
February 10 2016 - 06:21PM
REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”) is pleased
to announce that it has enrolled over 200 patients in a clinical
study of its Fantom® sirolimus-eluting bioresorbable coronary
scaffold and continues on track with its plans to commercialize
Fantom.
The Company previously announced the enrollment of
a first set of 110 patients, who are now undergoing a six-month
imaging assessment. The clinical data on these 110 patients is
planned to be collected during the second quarter and used in a CE
Mark application in the third quarter of this year. If approved,
the CE Mark would allow REVA to sell in Europe and other countries
that recognize the CE Mark. In addition to this first set of
patients, the Company began enrolling a second set of 110 patients
during the fourth quarter of 2015 and is poised to complete the
full enrollment of at least 220 patients by the end of this fiscal
quarter. Data from the second set of patients will be used for
market support and other commercial purposes.
The acute clinical data presented at the
Transcatheter Cardiovascular Therapeutics (“TCT”) conference last
October showed very good procedural success and low major adverse
cardiac events (“MACE”) rates for the limited data set that was
presented. Subsequent data released in January 2016 also showed
continued safety with low MACE rates. The next planned release of
clinical data will be at the Paris Course on Revascularization
(“EuroPCR”) in May and that data is anticipated to include an
important set of six-month imaging results.
REVA is also pleased to announce that Goldman Sachs
International, the holder of an option to purchase up to 4,375,000
shares of common stock, has indicated that it intends to exercise
the entire option. Upon exercise, the Company will receive cash
proceeds of approximately US$11.4 million. Combined with the
US$16.9 million cash balance as of 31 December 2015, the proceeds
of the exercise will provide operating funds of over US$28 million
in cash resources, which exceeds REVA’s near term capital
requirements and ensures the Company has adequate financial
resources to approach Fantom’s commercialization.
Additionally, the Company has negotiated certain
modifications to the Convertible Note Deed dated 25 September 2014
(the “Note Deed”) with the holders of the convertible notes issued
under the Note Deed. The modifications are subject to shareholder
approval, which will be sought at a meeting of the Company’s
shareholders to be held as soon as reasonably practical. The
proposed modifications are as follows:
- The Company’s outstanding convertible notes ("Notes") issued
under the Note Deed, in the face amount of $25.0 million, currently
automatically convert to common stock upon REVA’s receipt of a CE
Mark on Fantom combined with a CDI trading price of at least A$0.60
for at least twenty consecutive days. The proposed modification
would add a third condition that REVA also be listed on NASDAQ (or
other U.S. securities exchange) for an automatic conversion of the
Notes to take place.
- The Noteholders currently may elect to redeem some or all of
the Notes on 14 January 2017, if the Notes have not otherwise been
converted or redeemed. The proposed modification would delay this
early redemption election date to 30 June 2017, thereby providing
additional time for an automatic conversion of the Notes to
occur.
REVA’s Board of Directors have reviewed and
unanimously approved, and has determined to recommend that
shareholders vote in favor of, the proposed modifications to the
Note Deed.
About REVA
REVA is a clinical stage medical device company
located in San Diego, California, USA, that is working to
commercialize its proprietary bioresorbable stents, which are
called “scaffolds” because of their temporary nature. The Company’s
scaffolds have been developed as an alternative to metal stents,
which are small tube-like devices permanently implanted into an
artery to treat coronary artery disease. Scaffolds provide
restoration of blood flow, support the artery through the healing
process, then disappear (or “resorb”) from the body over a period
of time. This resorption allows the return of natural movement and
function of the artery, a result not attainable with permanent
metal stents. The Company’s initial product, the Fantom® scaffold,
has been designed to offer an ideal balance of thinness and
strength and distinct ease-of-use features including complete
scaffold visibility under x-ray, expansion with one continuous
inflation, and no procedural time limitations. REVA will require
successful clinical trial results and regulatory approval before it
can commercialize Fantom or any other products.
Forward-Looking Statements
This announcement contains or may contain
forward-looking statements that are based on management's beliefs,
assumptions and expectations and on information currently available
to management. All statements that are not statements of historical
fact, including those statements that address future operating
performance and events or developments that we expect or anticipate
will occur in the future, are forward-looking statements, such as
those statements regarding our ability to obtain regulatory
approvals, timely and successfully complete our clinical trials,
protect our intellectual property position, commercialize our
products if and when approved, develop and commercialize new
products, recruit and retain our key personnel, and estimates
regarding our capital requirements and financial performance. You
should not place undue reliance on forward-looking statements.
Although management believes forward-looking statements are
reasonable as and when made, forward-looking statements are subject
to a number of risks and uncertainties that may cause our actual
results to vary materially from those expressed in forward-looking
statements, including the risks and uncertainties that are
described in the "Risk Factors" section of our Annual Report on
Form 10-K filed with the US Securities and Exchange Commission (the
“SEC”) on March 30, 2015, and as may be updated in our periodic
reports thereafter. Any forward-looking statements in this
announcement speak only as of the date when made. REVA does not
assume any obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
United States
Investor & Media Enquiries:
REVA Medical, Inc.
Cheryl Liberatore
Director, Communications
+1 858-966-3045
Australia
Investor Enquiries:
Inteq Limited
Kim Jacobs
+61 2 9229 2700
Australia
Media Enquiries:
Buchan Consulting
Rebecca Wilson
+61 3 9866 4722