Ra Medical Systems Receives FDA IDE Approval to Begin Pivotal Atherectomy Clinical Study
21 January 2020 - 10:50PM
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 approval from the U.S. Food
and Drug Administration (FDA) that the Company has provided
sufficient data to support initiating an investigational device
exemption (IDE) 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. In May 2017, DABRA
received FDA 510(k) clearance for use in ablating a channel in
occlusive peripheral vascular disease (PAD).
“We are delighted the FDA has granted this IDE allowing us to
pursue an atherectomy indication for DABRA and anticipate enrolling
the first patient into the trial in the next few months,” said
Andrew Jackson, Ra Medical Systems CFO and Interim CEO. “We believe
DABRA produces minimal vascular trauma due to its unique use of
photochemical ablation that dissolves plaque into its molecular
components, which may make DABRA a preferred treatment. Atherectomy
with mechanical devices can cause trauma to vessel walls, often
resulting in restenosis or a return of the blockage months
following the procedure.”
The multicenter, open-label trial 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
four 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 photochemical
ablation, or the removal of arterial tissue by using photons to
clear blockages by breaking the bonds of the obstructing plaque.
Unlike many treatments for PAD that may damage the arterial wall,
DABRA quickly and photochemically dissolves plaque with minimal
vascular trauma.
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. 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/20200121005348/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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