April 17, 2014 11:22am EDT
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Inspiromatic™ Improves Drug Delivery, Monitors Patient Inhalation and
Provides Real-Time Patient Feedback
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK )
has entered into a definitive agreement to acquire Inspiro Medical Ltd.
(“Inspiro”), an Israeli medical device company developing a new platform
to deliver small molecule drugs such as corticosteroids and beta
agonists or larger molecules to treat respiratory diseases. Inspiro’s
Inspiromatic™ is a “smart” easy-to-use dry powder inhaler with several
advantages over existing devices.
Inspiromatic™ offers improved drug deposition to the lower airways of
patients and real time data for patient compliance monitoring. The
device has an internal microcontroller and flow sensor that controls the
delivery of the medication and, using micro-pump technology, dispenses
the drug particles at the right speed without the need for forceful
inhalation. It also provides instant feedback to the patient with a
green or red flasher light to indicate proper inhalation and a beeper
after the dose has been delivered. For physicians, Inspiromatic™
provides a built-in logger that stores patient use data for easy access
and transmission by electronic devices such as smart phones.
In a recently completed, First In Man double blinded clinical study
conducted in 30 asthmatic children comparing Inspiromatic™ to a market
leading dry powder inhaler, Inspiromatic™ demonstrated superior
pulmonary delivery of the active drug.
"We are pleased to add this next generation inhaler to OPKO’s growing
product portfolio," stated Phillip Frost, M.D., OPKO’s CEO and Chairman.
"We expect this innovative device to play a valuable role in the
improvement of therapy for asthma, chronic obstructive pulmonary
disease, cystic fibrosis and other respiratory diseases. We plan to use
the Inspiromatic™ device to test the inhaled form of OPKO’s new sulfated
disaccharide drug against these disorders. This drug product is still
undergoing pre-clinical testing prior to submission of an IND, but
animal data indicates safety and efficacy for both inhaled and orally
delivered forms. Of course, we believe that Inspiromatic™ can improve
outcomes of treatment with other drugs, those presently available in
more 'standard' type inhalers, as well as new inhalation drugs being
developed. This acquisition fits our strategy of developing new products
that address large markets in need of more effective therapeutic
solutions."
Nimrod Kaufmann, CEO and Co-Founder of Inspiro, commented, “We are
extremely proud of Inspiro’s success in bringing our smart Inspiromatic™
respiratory drug-delivery device to market. With Inspiro now a part of
OPKO, we will be able to help more people faster. Inspiro joining OPKO
is a big win for the shareholders of both Inspiro and OPKO, as well as
good news for our patients and physicians."
Eran Feldhay, M.D., CEO of Trendlines Medical, Inspiro’s largest
shareholder, added, “The acquisition of Inspiro is our third exit in
eight months, all to U.S.-based multinational corporations. This success
brings continuing confirmation of the strength of the Trendlines team in
fulfilling our vision of creating and developing companies to improve
the human condition. We are very pleased to see OPKO take the Inspiro
opportunity forward.”
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that
seeks to establish industry leading positions in large, rapidly growing
markets by leveraging its discovery, development and commercialization
expertise and novel and proprietary technologies.
About Inspiro Medical Ltd.
Inspiro Medical Ltd. is a medical device company dedicated to the
development of a next-generation dry powder inhaler platform. The
Inspiromatic™ dry powder inhaler, developed by Inspiro, is the first
active dry powder inhaler (DPI) that delivers drugs effectively at
extremely low inhalation flow rates, instructs the patient in real time
and enables efficient physician follow-up to substantially improve
medication delivery and compliance.
About Trendlines
The Trendlines Group ( www.trendlines.com )
invests in, incubates, and supports early-stage, high-promise medical
and agricultural technology companies in Israel, a global leader in
start-up ingenuity. Trendlines Medical, our investment unit for medical
innovation, works in partnership with innovators and investors, in an
environment that encourages curiosity and fosters collaboration. Simply
stated, Trendlines creates and develops companies to improve the human
condition.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding the intended acquisition of
Inspiro Medical, the expected benefits of the Inspiromatic™ inhaler,
whether it will offer improved drug deposition to the lower airways of
patients and real time data for patient compliance monitoring, whether
it will provide superior delivery of active drug over other inhalers,
whether it will play a valuable role in the improvement of therapy for
asthma, chronic obstructive pulmonary disease, cystic fibrosis and other
respiratory diseases, whether OPKO will use the Inspiromatic™ device to
test the inhaled form of OPKO’s new sulfated disaccharide drug against
certain disorders, whether the Inspiromatic™ or OPKO’s new sulfated
disaccharide drug product will ever be successfully developed or
commercialized, whether the Inspiromatic™ can improve outcomes of
treatment with other drugs, those presently available in more “standard”
type inhalers, as well as new inhalation drugs being developed, that
earlier clinical results of effectiveness and safety may not be
reproducible or indicative of future results, that the Inspiromatic™
and/or any of our compounds or products under development may fail, may
not achieve the expected results or effectiveness and may not generate
data that would support the approval or marketing of products for the
indications being studied or for other indications, that currently
available over-the-counter and prescription products, as well as
products under development by others, may prove to be as or more
effective than our products for the indications being studied, as well
as other non-historical statements about our expectations, beliefs or
intentions regarding our business, technologies and products, financial
condition, strategies or prospects. Many factors could cause our actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements. These factors include
those described in our filings with the Securities and Exchange
Commission, that the various conditions to the closing of the
transaction with Inspiro Medical may not be met, as well as risks
inherent in funding, developing and obtaining regulatory approvals of
new, commercially-viable and competitive products and treatments. In
addition, forward-looking statements may also be adversely affected by
general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We intend
that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin, 305-575-4100
or
Adam
Logal, 305-575-4100
Source: OPKO Health, Inc.
Released April 17, 2014
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