Orthofix Provides eNeura $15 Million Collateralized Loan to Support
Commercialization of SpringTMS
LEWISVILLE, Texas & BALTIMORE, Md.--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ:OFIX) (the Company), a diversified,
global medical device company, today announced that it has entered into
an option agreement that provides the Company with an 18-month option to
acquire eNeura, Inc., a pioneer in the use of portable, non-invasive
Transcranial Magnetic Stimulation (TMS) devices for the treatment of
In May 2014, eNeura received U.S. Food and Drug Administration (FDA)
510(k) clearance for its SpringTMS® migraine treatment
device. SpringTMS is the first medical device available to patients in
the United States for the acute treatment of pain associated with
migraine headache with aura.
In consideration for the option to acquire eNeura, Orthofix has agreed
to provide a $15 million collateralized loan to support
commercialization of SpringTMS in the United States and Europe. If the
option to purchase eNeura is exercised, Orthofix will pay $65 million to
consummate the merger and eNeura will repay to Orthofix the unpaid
principal payable under the loan. In addition, Orthofix may make future
milestone and royalty payments to eNeura.
"This agreement underscores Orthofix's commitment to pursue new growth
opportunities in its BioStim strategic business unit that leverage our
core competencies in pulsed electromagnetic field ("PEMF") product
design and manufacturing as well as our third party billing expertise,"
said President and Chief Executive Officer Brad Mason. "We believe
eNeura's exciting application of electromagnetic field technology
delivers a therapy that addresses a significant unmet need for patients
and clinicians in the treatment of migraine headache."
"Orthofix is an ideal partner for eNeura to expand commercial
availability of SpringTMS to migraine patients in the United States and
Europe," commented Dr. David K. Rosen, President and CEO of eNeura. "We
look forward to utilizing this financing to advance our product
development and commercialization strategy for SpringTMS."
Wells Fargo Securities served as financial advisor to eNeura.
The World Health Organization (WHO) estimates that 10 percent of adults
worldwide suffer from migraine and 1.7 to 4 percent of adults have
headaches 15 or more days per month. Migraine ranks as one of the top 20
most disabling conditions in the world, according to WHO.
Orthofix International N.V. is a diversified, global medical device
company headquartered in Lewisville, TX. The Company has four strategic
business units that include BioStim, Biologics, Extremity Fixation and
Spine Fixation. Orthofix products are widely distributed via the
Company's sales representatives, distributors and its subsidiaries. In
addition, Orthofix is collaborating on research and development
activities with leading clinical organizations such as the
Musculoskeletal Transplant Foundation and the Texas Scottish Rite
Hospital for Children. For more information, please visit www.orthofix.com.
eNeura, Inc. is a privately held medical technology company that is
pioneering the use of portable, non-invasive Transcranial Magnetic
Stimulation devices for treatment of migraine. SpringTMS is a
prescription-only device that utilizes single-pulse Transcranial
Magnetic Stimulation (sTMS) to induce very mild electrical currents that
can depolarize neurons in the brain. This process is thought to
interrupt the abnormal hyperactivity associated with migraine. The
non-invasive, proprietary device is designed for convenient patient use.
To treat, the device is placed at the back of the head where the push of
a button generates a focused magnetic pulse with the intent to eliminate
the pain of a migraine headache. For more information about eNeura,
please visit http://www.eneura.com.
This communication contains certain forward-looking statements under the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements, which may include, but are not limited to, statements
concerning the projections, financial condition, results of operations
and businesses of Orthofix and its subsidiaries and are based on
management's current expectations and estimates and involve risks and
uncertainties that could cause actual results or outcomes to differ
materially from those contemplated by the forward-looking statements.
The forward-looking statements in this release do not constitute
guarantees or promises of future performance. Factors that could cause
or contribute to such differences may include, but are not limited to,
risks relating to the uncertain results and timing of our anticipated
filing of restated and revised financial statements for prior periods,
the anticipated magnitude and nature of error corrections reflected by
such filings, the timing of the filing of our late quarterly reports on
Form 10-Q, potential delisting of our securities from the Nasdaq Stock
Market, as well how these matters may impact our expenses, liquidity,
legal liability, borrowing ability, product sales, relationships with
customers, suppliers, strategic partners and third party reimbursement
providers, ongoing compliance obligations under our corporate integrity
agreement with the Office of Inspector General of the Department of
Health and Human Services, deferred prosecution agreement with the U.S.
Department of Justice and consent decree with the SEC, ability to remain
in compliance with covenants and other obligations under our senior
secured credit agreement, the cost and nature of our insurance coverage,
and other factors described in our annual report on Form 10-K/A for the
fiscal year ended December 31, 2013 and other subsequent periodic
reports filed by the Company with the SEC. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. The
Company undertakes no obligation to update or revise the information
contained in this press release.
Mark Quick, 214-937-2924
Tiberend Strategic Advisors, Inc.
Claire Sojda /
Jason Rando, 212-375-2686 / 2665
Source: Orthofix International N.V.
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