Ra Medical Systems Achieves Milestone of 100 Subjects Enrolled in its Pivotal Atherectomy Clinical Study
28 Mars 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 achievement of a milestone
with the enrollment of 100 subjects in its pivotal clinical study
to evaluate the safety and effectiveness of the DABRA excimer laser
system as an atherectomy device for the treatment of peripheral
arterial disease (PAD). This pivotal atherectomy study is cleared
to enroll up to 125 subjects.
“I want to recognize the support from our Ra Medical team and
our physician investigators and staff for their diligence in
reaching this significant enrollment milestone, particularly given
the daunting challenges that arose from the COVID-19 pandemic,”
said Will McGuire, Ra Medical Systems CEO. “Securing clearance for
the atherectomy indication is a top priority for Ra Medical as we
believe it will expand our addressable market beyond the existing
clearance for crossing chronic total occlusions, or CTOs.
Third-party research estimates that the combined CTO and
atherectomy markets in the U.S. will approximate $900 million this
year.
“Due to the unpredictable nature of the pandemic, we are unable
to accurately predict when we will complete study enrollment.
However, our goal is to reach full enrollment during the third
quarter of this year and to complete six-month follow-up in early
2023,” he added.
The open-label pivotal atherectomy clinical trial can enroll
subjects with symptoms of PAD (Rutherford Class 2-5) at up to 10
sites. Seven sites have been cleared for enrollment and one
additional site is in the final phase of qualification. Outcome
measures include safety, acute technical success and clinical
success. The trial’s primary efficacy endpoint is the mean
reduction in percent diameter stenosis in each patient’s primary
lesion as measured by angiography immediately following treatment
with DABRA and before any adjunctive treatment. The trial’s safety
and clinical success endpoints are major adverse events at 30 days
post-procedure and incidence of primary target lesion
revascularization at six months.
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 regarding
Ra Medical’s business strategy, the potential of the DABRA system
for new applications of use, the market opportunity and growth of
current and potential markets and its ability to continue to manage
expenses and cash burn rate at sustainable levels. 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 or new applications of use;
risks associated with acceptance of DABRA devices for current and
potential applications of use and procedures performed using such
devices by physicians, payors, and other third parties; development
and acceptance of new products, product enhancements or
applications of use; 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 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; adverse outcome of regulatory
inspections; impacts from public health crises, such as the
Covid-19 pandemic, geopolitical conflicts, such as Russia’s
invasion of Ukraine and related sanctions against Russia and
Belarus, 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, 2021 and in its other filings 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 (www.ramed.com), our
investor relations website (https://ir.ramed.com/), 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/20220328005098/en/
Investor Relations Contact: LHA Investor Relations Jody Cain
310-691-7100 jcain@lhai.com
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