New Data Presented at LINC 2019 Demonstrates Acute Success with DABRA Excimer Laser System for the Treatment of Peripheral Artery Disease
Study achieved a statistically significant difference in pre- and post-percent stenosis and ABI values
CARLSBAD, Calif.--(BUSINESS WIRE)-- 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.
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Source: Ra Medical Systems, Inc.
Released February 20, 2019