Ra Medical Systems Announces Enrollment of First Patient in Pivotal Atherectomy Clinical Study
February 27 2020 - 7:00AM
Business Wire
Ra Medical Systems, Inc. (NYSE: RMED), a medical device company
focused on commercializing excimer laser systems to treat vascular
and dermatological diseases, announces enrollment of the first
patient in its pivotal study to evaluate the safety and
effectiveness of the DABRA excimer laser system for use as an
atherectomy device for the treatment of peripheral vascular
stenoses.
“My extensive experience with DABRA in treating infrainguinal
vascular occlusions gives me confidence in the safety and efficacy
of the device,” said Athar Ansari, MD, FACC, Director of the
California Heart & Vascular Clinic in El Centro, Calif. and the
study chairman. “We are thrilled to be the first center to begin
enrollment in the atherectomy study, which represents an important
next step in expanding the DABRA indications for use.”
“We are committed to the successful commercialization of DABRA
and we believe that initiating patient enrollment in this study is
a significant step forward in achieving this goal,” said Andrew
Jackson, Ra Medical Systems CFO and Interim CEO. “Furthermore, we
have built a team of experienced, motivated and enthusiastic
physician partners and employees to execute on this goal and we
look forward to providing updates on our progress.”
Ra Medical received investigational device exemption (IDE)
approval for the study from the FDA in January 2020. This
multicenter, open-label pivotal atherectomy clinical study will
enroll up to 100 patients with symptoms of PAD (Rutherford Class
2-4). 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, before any adjunctive treatment. Major adverse events
at 30 days and incidence of primary target lesion revascularization
(TLR) at six months will be the safety and clinical success
endpoints.
About DABRA
DABRA is Ra Medical’s minimally invasive excimer laser system
used by physicians as a tool in the endovascular treatment of
vascular blockages resulting from lower extremity vascular disease,
a form of PAD, both above and below the knee. DABRA reduces all
plaque types into their fundamental chemistry, such as proteins,
lipids and other chemical compounds, eliminating blockages by
essentially dissolving them without generating potentially harmful
particulates. DABRA employs photoablation, or the removal of
arterial tissue by using photons to clear blockages by breaking the
bonds of the obstructing plaque.
About Ra Medical Systems
Ra Medical Systems commercializes excimer lasers and catheters
for the treatment of vascular and dermatological diseases. In May
2017, the DABRA excimer laser system received FDA 510(k) clearance
in the U.S. 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. 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, and the successful commercialization of DABRA. 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, 2018 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/20200227005151/en/
At the Company: Jeffrey Kraws
President, Ra Medical Systems 760-496-9008 jkraws@ramed.com
Investors and Media: LHA Investor
Relations Jody Cain / Kevin McCabe 310-691-7100 jcain@lhai.com / kmccabe@lhai.com
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