Ra Medical Systems Provides Enrollment Update for its Pivotal Atherectomy Clinical Trial
April 20 2021 - 6:05AM
Business Wire
42 total subjects enrolled as of April 19,
2021
12 subjects enrolled since mid-March
Ra Medical Systems, Inc. (NYSE American: RMED), a medical device
company focused on commercializing excimer laser systems to treat
vascular and dermatological diseases, announces an increase in
enrollment in its pivotal clinical trial to evaluate the safety and
effectiveness of the DABRA excimer laser system as an atherectomy
device for the treatment of peripheral arterial disease (PAD). A
total of 42 subjects have been enrolled as of April 19, 2021.
“We are encouraged by recent progress in our atherectomy trial
with 12 subjects enrolled since our last update in mid-March,” said
Will McGuire, Ra Medical Systems CEO. “Five clinical sites are
cleared for enrollment in this study with two additional sites
currently in various stages of the qualification process.”
The DABRA excimer laser system received U.S. FDA 510(k)
clearance in May 2017 for crossing chronic total occlusions, or
CTOs, in patients with symptomatic infrainguinal lower extremity
vascular disease with an intended use for ablating a channel in
occlusive peripheral vascular disease. The FDA defines atherectomy
to include a prespecified improvement in luminal patency.
Third-party research estimates the value of the combined CTO and
atherectomy markets in the U.S. at approximately $900 million for
2021, with atherectomy representing more than $750 million.
The open-label pivotal atherectomy clinical trial can enroll up
to 100 subjects with symptoms of PAD (Rutherford Class 2-5) at up
to 10 sites. 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 post-procedure.
About Ra Medical Systems
Ra Medical Systems commercializes excimer lasers and catheters
for the treatment of vascular and dermatological diseases. The
Pharos excimer laser system is FDA-cleared and is used as a tool in
the treatment of psoriasis, vitiligo, atopic dermatitis and
leukoderma. DABRA and Pharos are both based on Ra Medical’s core
excimer laser technology platform and deploy similar mechanisms of
action. Ra Medical manufactures DABRA and Pharos excimer lasers and
catheters in a 32,000-square-foot facility located in Carlsbad,
Calif. The vertically integrated facility is ISO 13485 certified
and is licensed by the State of California to manufacture sterile,
single-use catheters in controlled 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
the timing and potential outcome of the DABRA atherectomy clinical
study. 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 Pharos and
procedures performed using such devices 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; 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. 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/20210420005512/en/
At the Company: Andrew Jackson Chief Financial Officer,
Ra Medical Systems 760-496-9540 ajackson@ramed.com
Investors: LHA Investor Relations Jody Cain 310-691-7100
jcain@lhai.com
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