Sunshine Heart Announces Strategic Realignment
September 29 2016 - 8:30AM
Sunshine Heart, Inc. (NASDAQ:SSH) today announced that it is
implementing a strategic realignment of its near term strategy to
fully focus the Company’s resources on its recently acquired
Aquadex FlexFlow
® System. The Aquadex system
is indicated for temporary (up to eight hours) ultrafiltration
treatment of patients with fluid overload who have failed diuretic
therapy, and extended (longer than 8 hours) ultrafiltration
treatment of patients with fluid overload who have failed diuretic
therapy and require hospitalization.
“Aquadex was an important strategic investment, which allows
Sunshine Heart to strengthen its presence in the heart failure
market,” said John Erb, Sunshine’s Chairman and CEO. “We have been
very pleased with the reception and enthusiasm we have received
from many current and former Aquadex customers that depend on
Aquapheresis® Therapy to manage fluid overload,
including patients with congestive heart failure. Aquadex has shown
to help reduce the length of stay while in the hospital and the
number of unscheduled hospital visits in total.”
Key elements of the Company’s near-term strategy include:
- Pausing clinical evaluations of the neuromodulation
technology
- Reducing cash burn from $2 million per month in the fourth
quarter of 2015 to a targeted cash burn of $800,000 per month in
fourth quarter of 2016
- Continuing the Company’s ongoing review of potential
partnerships, strategic alliances, and the pursuit of financing
alternatives.
The above measures will help the Company to attain targeted
fourth quarter 2016 annualized revenue run-rate for the Aquadex
business of $5 million and fourth quarter 2017 annualized revenue
run-rate for the Aquadex business of $10 million.
Rx Only. All treatments must be administered by
a healthcare provider, under physician prescription, both of whom
having received training in extracorporeal therapies
About Sunshine® Heart
Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical
device company focused on developing, a product portfolio to treat
moderate to severe heart failure and related conditions. The
Company's main commercial product, the Aquadex system is indicated
for temporary (up to eight hours) ultrafiltration treatment of
patients with fluid overload who have failed diuretic therapy, and
extended (longer than 8 hours) ultrafiltration treatment of
patients with fluid overload who have failed diuretic therapy and
require hospitalization. Our objective is to improve the
quality of life for heart failure patients and halt the disease
progression. Sunshine Heart is a Delaware corporation
headquartered in Minneapolis with wholly owned subsidiaries in
Australia and Ireland. The Company has been listed on the NASDAQ
Capital Market since February 2012.
Forward-Looking Statements
Certain statements in this release are forward-looking
statements that are based on management’s beliefs, assumptions,
expectations, and information currently available to
management. All statements that address future operating
performance, events or developments that we expect or anticipate
will occur in the future are forward-looking statements, including
without limitation, clinical and pre-clinical study designs and
activities, expected timing for initiation, enrollment and
completion of clinical trials, research and development activities,
ultimate clinical outcomes and benefits of our products to
patients, design and development of future studies, site
activations, patient enrollment in studies, timing of
regulatory filings and approvals, regulatory acceptance of our
filings, our expectations with respect to product development and
commercialization efforts, market and physician acceptance of our
products, intellectual property protection, potentially
competitive product offerings, projected monthly cash burn rates,
projected annualized revenue run-rates, the pursuit of strategic
partnerships and alliances and financing alternatives and
anticipated business changes as a result of the new strategic
direction. The risk factors described in our filings with the SEC
could cause actual events to adversely differ from the expectations
indicated in these forward-looking statements. Management believes
that these forward-looking statements are reasonable as and when
made. However, you should not place undue reliance on
forward-looking statements because they speak only as of the date
when made. Sunshine Heart 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.
Sunshine Heart 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,
including without limitation, the possibility that regulatory
authorities do not accept our application or approve the marketing
of our therapy, the possibility we may be unable to raise the funds
necessary for the development and commercialization of our therapy
and other risks and uncertainties described in our filings with the
SEC. We do not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
For further information, please contact:
Claudia Drayton
Chief Financial Officer
Sunshine Heart, Inc.
T: +1-952-345-4205
Investor Relations
Sunshine Heart Inc.
ir@sunshineheart.com
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