Ra Medical Systems Announces NYSE Acceptance of Compliance Plan
March 05 2020 - 6:50AM
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 that the New York Stock
Exchange (the “NYSE”) has accepted the Company’s business plan to
regain compliance with the NYSE continued listing standards.
“We are pleased that our plan has been reviewed and accepted by
the exchange,” said Andrew Jackson, Ra Medical Systems CFO and
Interim CEO. “We view this as an affirmation that we are taking the
right steps to realize the commercial promise of our DABRA excimer
laser system and we look forward to keeping the NYSE and our
shareholders updated on our progress.”
On December 4, 2019, the Company received a letter from the NYSE
informing the Company of its non-compliance with the NYSE continued
listing standards because the Company’s average market
capitalization over a recent consecutive 30 day trading period had
been less than $50,000,000, and at the same time, stockholders’
equity was less than $50,000,000. With the acceptance of the
Company’s business plan, the Company is now within the 18-month
plan period to regain compliance, with the plan period expected to
conclude on or before June 4, 2021.
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 Company’s business strategy and its ability to remain in
compliance with the NYSE’s listing standards. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200305005198/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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