Ra
Medical Systems, Inc. (NYSE: RMED) Elias Kassab, MD, presented his
successful experience using the DABRA laser system. “We have found that
DABRA is successful in treating
challenging lesions including long and severely calcified lesions, both
above and below the knee.” The presentation was delivered on Wednesday,
May 29, 2019, at the annual New Cardiovascular
Horizons (NCVH) conference in New Orleans.
Dr. Kassab, FACC, FSCAI, FACP. FASA, RPVI, FAHA, FSVM, President & CEO
of Michigan Outpatient Vascular Institute, Dearborn, Michigan,
continued, “The device has an innate tendency to stay intraluminal in
all vessels, is versatile as a single debulking device, is easy to use
and is cost-effective. In our experience, DABRA has a very low
complication rate and we have not seen any angiographic or clinical
evidence of distal embolization.”
Dr. Kassab and Ashok Kondur, MD, recently reported that DABRA achieved a
98% lesion success rate in a 52-patient, single-center study that was
summarized in the 2019 LINC Review. “Although these findings are
from just 52 patients, they are very promising and strengthen the case
for more extensive study of DABRA,” said Dr. Kassab.
DABRA (Destruction of Arteriosclerotic Blockages by laser Radiation
Ablation) is a novel, minimally invasive excimer laser system that
non-thermally and photochemically ablates channels in vascular
blockages. The technology reduces all plaque types into their
fundamental chemistry, such as proteins, lipids, and other chemical
compounds, eliminating blockages by dissolving them without generating
potentially harmful particulates. Unlike many mechanical, acoustic, or
thermal treatments for peripheral artery disease (PAD) that may damage
the arterial wall, DABRA treats blockages with minimal vascular trauma.
“DABRA quickly, safely, and efficiently restores blood flow, often in
very difficult cases, enabling physicians to save patients’ limbs and
lives,” added Dean Irwin, CEO, Ra Medical Systems.
For more information, please visit Ra Medical Systems at Booth No. 106
at NCVH or go to www.ramed.com.
Each year, the NCVH annual conference assembles over 1,500 attendees and
features live case transmissions, scientific lectures and faculty who
are considered preeminent in the field of medicine.
About Ra Medical Systems
Ra 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
and is CE marked for the indication of the endovascular treatment of
infrainguinal arteries via atherectomy, and for crossing total
occlusions. 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 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 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 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
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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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