Ra Medical Systems was founded in 2002 to design, develop, and commercialize excimer lasers as tools for the treatment of vascular and dermatological diseases. The Company was incorporated in California on September 4, 2002 and reincorporated in Delaware in July 2018.
Pharos excimer laser system was launched in October 2004 and is used as a tool in the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
In May 2017, DABRA laser system and disposable DABRA catheter received FDA 510(k) clearance in the U.S. for the intended use of ablating a channel in occlusive peripheral vascular disease.
DABRA and Pharos are both based on our core excimer laser technology platform and deploy similar mechanisms of action. Independent in vivo and in vitro research studies have demonstrated that 308 nanometer excimer laser light, which is the same wavelength used in DABRA and Pharos, increases T-cell apoptosis, or cell death, which may produce an immunosuppressive effect.
We manufacture our DABRA and Pharos excimer lasers and catheters in our approximately 32,000-square-foot facility located in Carlsbad, California. Our vertically integrated facility is ISO 13485 certified and is licensed by the state of California to manufacture our sterile, single-use catheters in our controlled environments.
Commitment to Compliance
Ra Medical Systems, Inc. (“Ra Medical”) recognizes the importance of conducting business in an ethical, lawful, and socially responsible manner and strives to maintain the highest legal and ethical business standards in conducting its business. In developing, implementing, and applying its Compliance Policies for operations in and related to the United States, Ra Medical shall abide by the Advanced Medical Technology Association (AdvaMed) Code of Ethics on Interactions with Healthcare Professionals and be guided by the voluntary compliance guidance issued by the Department of Health and Human Services Office of the Inspector General (HHS-OIG), as well as the applicable provisions of the Federal Food Drug and Cosmetics Act, regulations and guidance issued by the Food and Drug Administration (FDA) and the Federal Trade Commission and applicable case law. To that end, Ra Medical has adopted these Compliance Policies to facilitate lawful and ethical interactions with Customers.
Ra Medical will not tolerate any form of unlawful or unethical behavior by anyone associated with the organization. We expect and require all employees, contractors, and board members to be law-abiding, honest, trustworthy, and fair in all of their business dealings. To ensure that these expectations are met, Ra Medical has developed and implemented a comprehensive Compliance Program and Code of Conduct. The Compliance Program and Code of Conduct are designed to assist all impacted individuals in navigating the various compliance obligations of the highly regulated industry in which we do business.
If you believe someone unintentionally or intentionally violated the law, the Compliance Program or Ra Medical’s Code of Conduct, report the known or suspected violations by contacting:
If you would like to notify the board of directors of a suspected violation, contact the Chairman of the Audit Committee:
Richard Mejia, Jr
Chairman of the Ra Medical Audit Committee
c/o Ra Medical Systems, Inc
2070 Las Palmas Drive
Carlsbad, California 92011
You may also report suspected violations anonymously using Ra Medical’s toll-free hotline number at 1-800-916-7037, company identifier 7633 (“Hotline”), or Ra Medical employees may submit a report through the company intranet (resource-secure.adp.com), which may be made on an anonymous basis if desired by the employee or contractor.
The Compliance Officer will promptly and thoroughly investigate each report of a known or suspected violation. If a violation has occurred, Ra Medical Systems will take appropriate actions to prevent similar violations. Ra Medical strictly prohibits retaliation against individuals for reports made in good faith. Anyone who retaliates against an employee(s) for reporting actual or suspected violations will be subject to appropriate disciplinary action up to and including termination.
National Physician Payment Transparency Program
Ra Medical complies with the tracking and reporting obligations under the Federal Open Payments program, also commonly known as the Sunshine Act (“Open Payments”). Ra Medical collaborates with physicians, hospitals, and medical offices in various ways in the development, clinical use, and training on the safe and effective uses of Ra Medical products. Ra Medical will track and report annually to the Centers for Medicare and Medicaid Services (“CMS”) certain direct and indirect payments and transfers of value provided by Ra Medical to physicians, hospitals, and medical offices (“Covered Recipient”) or made at the request of or designated on behalf of a Covered Recipient (collectively “Transfers of Value”), as well as any ownership or investment interests in Ra Medical held by a Physician or immediate family member(s) of a Physician.
The following is a non-exhaustive list of types of Transfers of Value that Ra Medical may make and that may be reportable under Open Payments: consulting fees; compensation for services other than consulting; food and beverage; travel and lodging; research-related payments and items; charitable contributions; debt forgiveness; royalties and licenses; grants; space rental or facility fees; acquisitions; long-term medical supply or device loan; and current or prospective ownership or investment interest. This data is then made available to the public each year at www.cms.gov/openpayments.
To find specific data on payments made by Ra Medical Systems, use the search tool located at https://openpaymentsdata.cms.gov and enter “Ra Medical Systems Inc.” as the company name.