FRANKLIN LAKES, N.J.,
July 9, 2018 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced it has completed the
acquisition of TVA Medical, Inc., a company that develops minimally
invasive vascular access solutions for patients with chronic kidney
disease requiring hemodialysis.
In the U.S. alone, there are more than 440,000 patients with
End-Stage Renal Disease (ESRD) who are surviving on
hemodialysisi. The addition of TVA Medical enables BD to
offer the everlinQ™ endoAVF System, a new endovascular
arteriovenous (AV) fistula creation technology that adds to the
company's ESRD portfolio of dialysis catheters, drug coated
balloons, standard angioplasty balloons and endovascular stent
graft products. This technology will further improve BD's ability
to serve physicians and their patients by providing a minimally
invasive option for creating critical AV fistulas (joining arteries
to veins to create a circuit) for hemodialysis procedures.
"The addition of TVA Medical allows BD to provide another
innovative device to physicians who treat patients suffering from
chronic kidney disease requiring hemodialysis," said Steve Williamson, worldwide president of
Peripheral Intervention at BD. "This technology is highly
complementary to our Peripheral Intervention offerings, and we will
continue to bring new technologies to market that improve our
category-leading ESRD portfolio. This is a great example of our
continued strategy to use tuck-in acquisitions to advance category
leadership."
Hemodialysis, a form of treatment for kidney failure patients,
is a procedure that removes wastes, salts, and fluid from a
patient's blood when the kidneys can no longer perform these
functions. Vascular access is considered a "lifeline" for
hemodialysis patients. Options for vascular access include central
venous catheters, AV grafts and surgical AV fistulas. Surgical
fistulas are currently the preferred vascular access option for
hemodialysis patients, resulting in lower mortality rates, fewer
infections and lower cost of dialysis delivery compared to central
venous cathetersii,iii,iv.
On June 22, the U.S. Food and Drug
Administration (FDA) announced De Novo marketing authorization for
the everlinQ endoAVF System. The system uses two, thin, flexible,
magnetic catheters that are inserted into the ulnar artery and the
ulnar vein in the arm through a small puncture. When placed close
to each other, the magnets in each catheter attract, pulling the
vessels together. After confirming alignment, an electrode from the
venous catheter delivers radiofrequency energy to create the
connection between the artery and vein. Embolization of the
brachial vein is then recommended. The fistula is confirmed with an
angiogram (X-ray image of the vascular system) to show that
arterial blood is flowing to the low-pressure venous system. The
procedure minimizes the amount of vessel and skin trauma compared
to traditional fistula creation using open surgery. The everlinQ
endoAVF System enables an additional AV fistula location for
patients than what is typically done surgically. The device is
already commercially available in Europe and Canada. For more information on the everlinQ
endoAVF System, visit http://tvamedical.com/product/. The product
name will be transitioned to WavelinQ™ EndoAVF System during integration.
"The FDA's authorization and joining BD are the culmination of
many years of hard work by a dedicated team of innovators at TVA
Medical, and I'd like to thank them for their tireless efforts to
get us to these important milestones," said Adam L. Berman, co-founder of TVA Medical. "BD
will enable us to deliver to physicians and patients what we
believe is a highly-desirable and transformative endovascular
technology as an integral part of a broader ESRD-focused portfolio
of solutions. I look forward to the next chapter of our history as
part of the BD family."
This transaction is not expected to have a material impact on BD
results for fiscal 2018 or 2019. Future results for TVA Medical
will be reported under the Peripheral Intervention business within
the Interventional Segment at BD. The company used cash on hand to
finance the transaction. This transaction does not impact the
company's previously-communicated commitment to deleverage as part
of the Bard acquisition. Terms of the transaction were not
disclosed.
About BD
BD is one of the largest global medical
technology companies in the world and is advancing the world of
health by improving medical discovery, diagnostics and the delivery
of care. The company supports the heroes on the frontlines of
health care by developing innovative technology, services and
solutions that help advance both clinical therapy for patients and
clinical process for health care providers. BD and its 65,000
employees have a passion and commitment to help improve patient
outcomes, improve the safety and efficiency of clinicians' care
delivery process, enable laboratory scientists to better diagnose
disease and advance researchers' capabilities to develop the next
generation of diagnostics and therapeutics. BD has a presence in
virtually every country and partners with organizations around the
world to address some of the most challenging global health issues.
By working in close collaboration with customers, BD can help
enhance outcomes, lower costs, increase efficiencies, improve
safety and expand access to health care. In 2017, BD welcomed C. R.
Bard and its products into the BD family. For more information on
BD, please visit bd.com.
Forward Looking Statement
This press release contains
certain estimates and other forward-looking statements (as defined
under Federal securities laws), including regarding BD's future
performance and product development. All such statements are based
upon current expectations of BD and involve a number of business
risks and uncertainties. Actual results could vary materially from
anticipated results described, implied or projected in any
forward-looking statement. With respect to forward-looking
statements contained herein, a number of factors could cause actual
results to vary materially. These factors include, but are not
limited to: risks relating to the integration of the C.R. Bard
operations, products and employees into BD and the possibility that
the anticipated synergies and other benefits of the proposed
acquisition will not be realized or will not be realized within the
expected timeframe; our ability to successfully integrate TVA
Medical or any other businesses we acquire; the impact of the
recent U.S. tax reform; legislative or regulatory changes to the
U.S. health care system, potential cuts in governmental health care
spending or measures to contain health care costs, each of which
could result in reduced demand for our products or downward pricing
pressure; adverse changes in regional, national or foreign economic
conditions, particularly in emerging markets, including any impact
on our ability to access credit markets and finance our operations,
the demand for our products and services, utilization rates or
otherwise, or our suppliers' ability to provide products needed for
our operations; changes in interest or foreign currency exchange
rates; new or changing laws and regulations impacting our business
(including changes in laws impacting international trade) or
changes in enforcement practices with respect to such laws; the
adverse impact of cyber-attacks on our information systems or
products; competitive factors including technological advances and
new products introduced by competitors; interruptions in our supply
chain or manufacturing processes; pricing and market pressures;
difficulties inherent in product development, delays in product
introductions and uncertainty of market acceptance of new products;
adverse changes in geopolitical conditions; increases in energy
costs and their effect on, among other things, the cost of
producing BD's products; product efficacy or safety concerns
resulting in product recalls or actions being taken by the FDA or
other regulators; fluctuations in costs and availability of raw
materials and in BD's ability to maintain favorable supplier
arrangements and relationships; risks relating to our ability to
continue to successfully integrate CareFusion's operations in order
to fully obtain the benefits of the transaction; uncertainties of
litigation (as described in BD's filings with the Securities and
Exchange Commission); future health care reform outside the U.S.,
including changes in government pricing and reimbursement policies
or other cost containment reforms; and issuance of new or revised
accounting standards, as well as other factors discussed in BD's
filings with the Securities and Exchange Commission. We do not
intend to update any forward-looking statements to reflect events
or circumstances after the date hereof except as required by
applicable laws or regulations.
Contacts:
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Troy
Kirkpatrick
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Monique N.
Dolecki
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BD Public
Relations
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BD Investor
Relations
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858.617.2361
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201.847.5378
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troy.kirkpatrick@bd.com
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Monique_Dolecki@bd.com
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i United States Renal Data System (USRDS). 2017 USRDS
annual data report: Epidemiology of kidney disease in the United States. National Institutes of
Health, National Institute of Diabetes and Digestive and Kidney
Diseases, Bethesda, MD, 2017.
ii Woo K., et al. Influence of Vascular Access Type on
Sex and Ethnicity-Related Mortality in Hemodialysis-Dependent
Patients. Perm J 2012 Spring;16(2):4-9.
iii USRDS 2012 Annual Report.
iv USRDS 2010 Annual Report.
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SOURCE BD (Becton, Dickinson and Company)