New Data Presented at LINC 2019 Demonstrates Acute Success with DABRA Excimer Laser System for the Treatment of Peripheral Artery Disease
A statistically significant difference was demonstrated in pre- and post-diameter stenosis (p
Ra
Medical Systems, Inc. (NYSE: RMED), a leading developer and
manufacturer of commercial excimer laser systems to treat vascular and
dermatological diseases, today announced a 98% success rate in the
results from a 52-patient study using the company’s groundbreaking DABRA
System for the treatment of above- and below-the-knee peripheral artery
disease (PAD) in a presentation titled, “Acute Results of a 52-Patient
Cohort at a Single Center with the DABRA Atherectomy System,” by Ashok
Kondur, MD, FACC, FSCAI.
The study results were overwhelmingly positive, given the inclusion of a
challenging sample of patients, all Rutherford class 4 to 6 with a high
presence of calcium (80% of lesions had moderate to severe
calcification) and 93% median lesion stenosis. A statistically
significant difference was demonstrated in pre- and post-diameter
stenosis (p<0.001), and lesion success, defined as ≤30% post diameter
stenosis, was 98%. Furthermore, the results demonstrated statistically
significant improvements in limb hemodynamic measures.
“The results of this study are extremely promising and demonstrate the
positive clinical outcomes we have seen with DABRA,” said Dr. Kondur,
Chair, Division of Cardiology, Garden City Hospital/MSU and Associate
Program Director, Interventional Cardiology Fellowship Program, DMC
Harper University Hospital, Wayne State University.
The purpose of the study was to evaluate the use of DABRA (Destruction
of Arteriosclerotic Blockages by laser Radiation Ablation) in patients
with above-the-knee and below-the-knee disease in a cohort of 52
patients and 111 collective lesions. Patients were treated solely with
DABRA plus PTA, with no adjunctive stenting. Intravascular ultrasound
and / or angiography was used pre- and post-treatment.
“We have seen significant changes in pre- and post-ABIs and a very low
complication rate with no distinct clinically or angiographically
observed distal embolization,” said study lead investigator Elias
Kassab, MD, FACC, FSCAI, FACP, FASA, RPVI, FAHA, FSVM, President & CEO
of Michigan Outpatient Vascular Institute and Assistant Professor of
Medicine, Wayne State University.
DABRA is a safe, versatile and simple catheter and laser system for the
treatment of mixed morphology vascular blockages above- and
below-the-knee. Its unique photochemical plaque ablating mechanism of
action reduces all plaque types (calcium, thrombus and atheroma) into
their fundamental chemistry with reduced mechanical, thermal and
barometric trauma and minimized downstream debris.
Dean Irwin, CEO of Ra Medical Systems, Inc., added: “Dr. Kondur’s
presentation at this year’s prestigious LINC conference demonstrates the
clinical efficacy of the DABRA laser system and highlights how Ra
Medical Systems is at the forefront of life-saving innovation for the
treatment of peripheral artery disease.” This positive product
performance is reaffirmed by Athar Ansari, MD, DTM&H, MRCP, FACC,
in his case report, Treatment
of a Long, Heavily Calcified left SFA Lesion with Single-Vessel Runoff
Via an Ipsilateral Antegrade Approach, published in the January
issue of Endovascular Today. In the article, Dr. Ansari highlights
the product’s fast and easy use with no distal embolization in yet
another challenging case.
The Leipzig Interventional Course (LINC) is an interdisciplinary live
course, designed to provide a global platform, permitting the discussion
of vascular patients by integrating colleagues of different specialties
who are performing endovascular interventions. LINC is strongly
committed to contributing to a systematic scientific evaluation and
interdisciplinary discussion of new methods, allowing conclusions for
daily interventional practice.
About Ra Medical Systems
Ra Medical Systems was founded in 2002 and is a commercial-stage medical
device company leveraging its advanced excimer laser-based platform for
use in the treatment of dermatologic and vascular diseases. DABRA,
launched in 2017, is used by physicians as a tool in the endovascular
treatment of vascular blockages resulting from lower extremity vascular
disease. DABRA quickly, photochemically dissolves plaque to the
components of its fundamental chemistry. Pharos launched in 2004 and is
used as a tool in the treatment of dermatological skin disorders,
including psoriasis and vitiligo.
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 patient outcomes 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 final prospectus relating
to its initial public offering 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/20190220005123/en/