Ra Medical Systems Files 510(k) Application for the DABRA Catheter with Braided Overjacket and Six-Month Shelf Life
28 Février 2022 - 2:30PM
Business Wire
Ra Medical Systems, Inc. (NYSE American: RMED), a medical
device company focusing on developing its excimer laser system to
treat vascular diseases, announces the filing of a 510(k)
application with the U.S. Food and Drug Administration (FDA) for
the company’s next-generation DABRA catheter with a braided
overjacket and a six-month shelf life as a device for crossing
chronic total occlusions in patients with symptomatic infrainguinal
lower extremity vascular disease and with an intended use for
ablating a channel in occlusive peripheral vascular disease. The
overjacket design increases the overall catheter robustness for
improved kink-resistance and trackability to better navigate
tortuous anatomy.
“We are confident we’ve met our objective of designing a
next-generation DABRA catheter that will allow physicians to better
access difficult anatomy, which can be particularly challenging in
the vasculature below the knee,” said Will McGuire, Ra Medical
Systems CEO. “This 510(k) filing is a highly significant
engineering and regulatory steppingstone toward our flagship
commercial DABRA catheter, which will be a guidewire-compatible
design.
“I’m proud of our team’s execution given the challenges they
faced during these unprecedented times. I would like to thank the
entire Ra Medical team and our physician partners who have helped
us achieve this milestone,” he added.
About Ra Medical Systems
Ra Medical Systems manufactures the DABRA excimer laser and
catheters for the treatment of certain vascular diseases. DABRA has
been cleared by the FDA for crossing chronic total occlusions in
patients with symptomatic infrainguinal lower extremity vascular
disease and has an intended use for ablating a channel in occlusive
peripheral vascular disease. In addition, DABRA has been granted CE
mark clearance for the endovascular treatment of infrainguinal
arteries via atherectomy and for crossing total occlusions. DABRA
excimer lasers and catheters are manufactured in a
32,000-square-foot facility located in Carlsbad, California. The
vertically integrated facility is ISO 13485 certified and is
licensed by the State of California to manufacture sterile,
single-use catheters in clean room environments.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or Ra Medical’s future financial or operating performance. In some
cases, you can identify forward-looking statements because they
contain words such as “may,” “will,” “should,” “expects,” “plans,”
“anticipates,” “could,” “intends,” “target,” “projects,”
“contemplates,” “believes,” “estimates,” “predicts,” “potential” or
“continue” or the negative of these words or other similar terms or
expressions that concern Ra Medical’s future expectations,
strategy, plans or intentions. Forward-looking statements in this
press release include, but are not limited to, statements
concerning or implying future financial performance, anticipated
product performance and functionality of our products, and industry
trends and growth opportunities affecting Ra Medical, in particular
statements relating to Ra Medical’s support catheters, their
functionality and functionality in combination with the DABRA
ablation catheters, and the potential range of solutions for and
commercialization of the DABRA liquid core ablation catheters. Ra
Medical’s expectations and beliefs regarding these matters may not
materialize, and actual results in future periods are subject to
risks and uncertainties that could cause actual results to differ
materially from those projected or implied by such forward-looking
statements. The potential risks and uncertainties which contribute
to the uncertain nature of these statements include, among others,
challenges inherent in developing, manufacturing, launching,
marketing, and selling new products; risks associated with
acceptance of DABRA, and procedures performed using the device by
physicians, payors, and other third parties; development and
acceptance of new products or product enhancements; clinical and
statistical verification of the benefits achieved via the use of Ra
Medical’s products; the results from our clinical trials, which may
not support intended indications or may require Ra Medical to
conduct additional clinical trials or modify ongoing clinical
trials; challenges related to commencement, patient enrollment,
completion, an analysis of clinical trials; Ra Medical’s ability to
manage operating expenses; Ra Medical’s ability to effectively
manage inventory; Ra Medical’s ability to recruit and retain
management and key personnel; Ra Medical’s need to comply with
complex and evolving laws and regulations; intense and increasing
competition and consolidation in Ra Medical’s industry; the impact
of rapid technological change; costs and adverse results in any
ongoing or future legal proceedings; adverse outcome of regulatory
inspections; impacts from public health crises, such as the
Covid-19 pandemic, or natural disasters; and the other risks and
uncertainties described in Ra Medical’s news releases and filings
with the Securities and Exchange Commission. Information on these
and additional risks, uncertainties, and other information
affecting Ra Medical’s business and operating results is contained
in Ra Medical’s Annual Report on Form 10-K for the year ended
December 31, 2020 and in its other filings with the Securities and
Exchange Commission. Additional information is also set forth in Ra
Medical’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021, filed with the Securities and Exchange
Commission. The forward-looking statements in this press release
are based on information available to Ra Medical as of the date
hereof, and Ra Medical disclaims any obligation to update any
forward-looking statements, except as required by law.
Ra Medical investors and others should note that we announce
material information to the public about the company through a
variety of means, including our website, our investor relations
website, press releases, SEC filings, and public conference calls
in order to achieve broad, non-exclusionary distribution of
information to the public and to comply with our disclosure
obligations under Regulation FD. We encourage our investors and
others to monitor and review the information we make public in
these locations as such information could be deemed to be material
information. Please note that this list may be updated from time to
time.
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version on businesswire.com: https://www.businesswire.com/news/home/20220228005198/en/
Investor Relations Contact: LHA Investor Relations Jody Cain
310-691-7100 jcain@lhai.com
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