CARLSBAD, Calif.--(BUSINESS WIRE)--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 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. 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
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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
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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.
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1 https://www.sciencedirect.com/science/article/pii/S0890509617302625
2
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
