Ra Medical Systems, Inc. (NYSE: RMED) is conducting a study to
demonstrate the DABRA Excimer Laser System delivers effective, long
lasting results and a low reintervention rate for patients with
peripheral artery disease (PAD). The study will gather data two
years post-treatment in up to 2,500 patients.
“Restenosis, or re-narrowing of an artery post-procedure, is a
major problem for my patients,” said C.V. Ramana, MD, principal
study investigator. “In my experience, DABRA has provided a highly
effective treatment, with minimal vascular trauma, which I believe
leads to lower rates of restenosis and longer lasting results,” Dr.
Ramana practices at NAADI Healthcare in Oklahoma City, OK.
Restenosis is a challenge for physicians, patients, and the
healthcare system, due to the additional cost and recovery time
required with re-treating arterial blockages. Recent studies have
reported the restenosis rate in peripheral interventions to be up
to 70 percent at one-year post-procedure.1, 2
“In my practice, we are seeing very positive clinical outcomes
using DABRA,” said Study Chairman Rajesh Dave, MD. “The goal of
this study is to demonstrate the lasting lumen patency achieved
with this exciting new technology.” Dr. Dave is Chairman of the
Department of Cardiology, Geisinger Holy Spirit Hospital in Camp
Hill, PA.
DABRA (Destruction of Arteriosclerotic Blockages by laser
Radiation Ablation) is a novel, minimally invasive excimer laser
photoablation system that non-thermally, photochemically ablates
channels in vascular blockages. Unlike many mechanical, acoustic,
or thermal treatments for peripheral artery disease that may
damage the arterial wall, DABRA treats blockages with minimal
vascular trauma.
“Our mission at Ra Medical Systems is to help physicians save
patients’ limbs and lives,” said Dean Irwin, CEO. “We believe the
clinical study will demonstrate that patients do not have to return
to their doctor to be re-treated for the same blockage, which
benefits that patient and the healthcare system as a whole.”
The study is named RESULTS (REvascularization RateS and Clinical OUtcomes with DABRA Laser: A Long-Term 2-year
Study). It is a multi-site registry
study, including up to 50 U.S. hospital or office-based lab sites
and 2,500 patients with Rutherford Classification 2-6. Each patient
will receive follow-up at six-month intervals for a total subject
participation of two years.
About Ra Medical SystemsRa Medical Systems is a
commercial medical device company developing and marketing
innovative excimer laser systems for the treatment of vascular and
dermatologic diseases. DABRA launched in 2017 for the endovascular
treatment of blockages resulting from lower extremity vascular
disease. Pharos launched in 2004 for the treatment of
dermatological disorders including psoriasis, vitiligo, and atopic
dermatitis. DABRA and Pharos are based on Ra Medical’s core excimer
laser technology platform that produces 308 nanometer light, a UVB
wavelength that studies have demonstrated increases T-cell
apoptosis, or cell death, which may produce a beneficial, targeted
immunosuppressive effect. Ra Medical manufactures DABRA and Pharos
excimer lasers and catheters 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 controlled
environments.
Cautionary Note Regarding Forward Looking StatementsThis
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 potential benefits to patients and physicians using the DABRA
catheter and laser system. 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, 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 Company’s ability to effectually 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
quarterly report on Form 10-Q for the quarter ended March 31, 2019
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.
1
https://www.sciencedirect.com/science/article/pii/S08905096173026252
https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.113.001811?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
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version on businesswire.com: https://www.businesswire.com/news/home/20190619005229/en/
Media ContactsCaitlin Kasunich / Tony FordeKCSA Strategic
Communications212.896.1241 / 347.487.6218ckasunich@kcsa.com /
tforde@kcsa.com
Investor ContactJeffrey KrawsPresident, Ra Medical
Systems760.707.7516investorrelations@ramed.com
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