Attached files
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| 8-K - FORM 8-K - REVA Medical, Inc. | c23622e8vk.htm |
Exhibit 99.1
Chairman & CEO Letter to Shareholders
25 October 2011
25 October 2011
San Diego, California and Sydney, Australia (Tuesday 25 October 2011, AEDT) — REVA Medical, Inc.
(ASX: RVA) (“REVA” or the “Company”) is pleased to provide an update on the Company’s activities in
the attached letter from its Chairman and Chief Executive Officer, Mr. Robert Stockman, to its
shareholders.
About REVA
REVA is a development stage medical device company incorporated in Delaware, USA, that is focused
on the development and eventual commercialisation of its proprietary, bioresorbable stent products.
REVA’s lead product, the ReZolve™ stent, combines REVA’s proprietary stent design with a
proprietary polymer that is metabolised and cleared from the body. The ReZolve stent is designed to
offer full x-ray visibility, clinically relevant sizing and a controlled and safe resorption rate.
In addition, by early encapsulation of the stent in the artery tissue coupled with the loss of
stent structure over time, the ReZolve stent may reduce the incidence of late forming blood clots,
or thrombosis, a rare but serious problem associated with drug-eluting metal stents currently on
the market. REVA is in the process of finalising the design of its ReZolve stent and will require
clinical results and regulatory approval before it can begin selling the ReZolve stent.
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 address operating performance, events or developments that we expect or anticipate
will occur in the future are forward-looking statements, including without limitation our
expectations with respect to regulatory submissions and approvals; our expectations with respect to
our clinical trials, including enrolment in or completion of our clinical trials; our expectations
with respect to the integrity or capabilities of our intellectual property position; our ability to
commercialize our existing products; our ability to develop and commercialize new products; and our
estimates regarding our capital requirements and financial performance, including profitability.
Management believes that these forward-looking statements are reasonable as and when made. You
should not place undue reliance on forward-looking statements because they speak only as of the
date when made. REVA does not assume any obligation to publicly update or revise any
forward-
HEAD OFFICE: 5751 Copley Drive, Suite B, San Diego, CA 92111 • +1 (858) 966-3000 • +1 (858) 966-3099 (FAX) • www.revamedical.com
AUSTRALIAN OFFICE: Level 6, 175 Macquarie Street, Sydney, NSW 2000 • +61 2 9231 3322 • +61 9229 2727 (FAX) • ARBN 146 505 777
REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability.
AUSTRALIAN OFFICE: Level 6, 175 Macquarie Street, Sydney, NSW 2000 • +61 2 9231 3322 • +61 9229 2727 (FAX) • ARBN 146 505 777
REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability.
| REVA Medical, Inc. — ASX Announcement | Page 2 |
looking
statements, whether as a result of new information, future events or otherwise. REVA may not actually achieve the plans, projections or expectations
disclosed in forward-looking statements, and actual results, developments or events could differ
materially from those disclosed in the forward-looking statements. Forward-looking statements are
subject to a number of risks and uncertainties, described in “Risk Factors” in our Annual Report on
Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on 30 March
2011, as updated in our Quarterly Reports on Form 10-Q filed with the SEC for the periods ended 31
March 2011 and 30 June 2011. We may update our risk factors from time to time in our periodic
reports or other current reports filed with the SEC.
United States
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Australia | |
Investor and Media Enquiries:
|
Investor Enquiries: | |
Cheryl Liberatore
|
David Allen or Alan Taylor | |
Director, Investor Relations and Marketing
|
Inteq Limited | |
REVA Medical, Inc.
|
+61 2 9231 3322 | |
+1 858 966-3045 |
||
| Media Enquiries: | ||
| Kyahn Williamson & Rebecca Wilson | ||
| Buchan Consulting | ||
| + 61 3 9866 4722 |
HEAD OFFICE: 5751 Copley Drive, Suite B, San Diego, CA 92111 • +1 (858) 966-3000 • +1 (858) 966-3099 (FAX) • www.revamedical.com
AUSTRALIAN OFFICE: Level 6, 175 Macquarie Street, Sydney, NSW 2000 • +61 2 9231 3322 • +61 9229 2727 (FAX) • ARBN 146 505 777
REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability.
AUSTRALIAN OFFICE: Level 6, 175 Macquarie Street, Sydney, NSW 2000 • +61 2 9231 3322 • +61 9229 2727 (FAX) • ARBN 146 505 777
REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability.
Letter from the Chairman & CEO
25 October 2011
25 October 2011
Dear Shareholder,
I am pleased to provide an update of our operations, clinical timing, and upcoming events. We have
made significant progress since we last communicated in August, as we aim to begin patient
enrollment in our 50 patient pilot clinical trial this quarter.
Operations Update and Clinical Program
REVA in final preparations to begin pilot clinical study
REVA in final preparations to begin pilot clinical study
We reported in August that during scale-up of manufacturing that we encountered non-uniform
deployments of the ReZolve™ stent. It was critical to remedy this issue to ensure safe and
effective performance of the stent in order to deliver the desired clinical outcomes in our pilot
clinical study.
Over the past two months, we have successfully identified and overcome the underlying causes of our
deployment issues, and have implemented the final subtle design and process changes that were
required. Initial testing of these final adjustments has gone well in rigorous bench and
preclinical tests; we believe the ReZolve stent is ready to be evaluated in patients with coronary
artery disease. We are completing final confirmatory bench and preclinical tests to verify that the
changes we have put into place will result in reliable performance of the stent. All regulatory
approvals are in place in Brazil and Germany to commence the trial.
As you might expect, the two-quarter delay to the start of our pilot clinical study may result in a
similar delay to the start of the CE Mark trial. We will pursue appropriate clinical and strategic
avenues to minimize the delay and remain as close to our commercialization timeline as possible.
To that end, we have been preparing additional clinical sites where patients in the pilot study
will be treated. This study will involve eleven hospital sites in Brazil and Europe to expedite
patient enrollment and the collection of clinical data. We will evaluate data from these first
clinical patients to determine when we initiate the larger pivotal trial. Our cash position appears
sufficient to meet our timeline objectives.
| REVA Medical, Inc. — ASX Announcement | Page 2 |
REVA Events
In September we presented at the UBS Global Life Sciences Conference in New York City, and we will
be presenting at the ASX Small to Mid Caps Asia Conference that takes place in Singapore and Hong
Kong on 25 and 27 October 2011, respectively. These presentations profile REVA well in the lead up
to our industry’s major tradeshow and convention, the Transcatheter Cardiovascular Therapeutics
(“TCT”) 2011 conference, which takes place in San Francisco 7 to 11 November 2011. We also will be
presenting at the Piper Jaffray Healthcare Conference on 29 November in New York City and at the JP
Morgan Healthcare Conference in San Francisco in January 2012.
In Summary
We look forward to announcing enrollment of our first clinical patients within this quarter so that
we may proceed with the expansion of our clinical program in 2012 with the aim to gain CE Mark
approval in order to commercialize Reva’s exciting stent technology. As always, we urge any
investor to contact us with questions.
Kindest regards,
Robert Stockman
Chairman & Chief Executive Officer
HEAD OFFICE: 5751 Copley Drive, Suite B, San Diego, CA 92111 • +1 (858) 966-3000 • +1 (858) 966-3099 (FAX) • www.revamedical.com
AUSTRALIAN OFFICE: Level 6, 175 Macquarie Street, Sydney, NSW 2000 • +61 2 9231 3322 • +61 9229 2727 (FAX) • ARBN 146 505 777
REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability.
AUSTRALIAN OFFICE: Level 6, 175 Macquarie Street, Sydney, NSW 2000 • +61 2 9231 3322 • +61 9229 2727 (FAX) • ARBN 146 505 777
REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability.