Orlucent Demonstrates Accurate, Non-Invasive Detection in vivo of Melanoma-Related Activity Using First-in-Kind Handheld Mole Imaging System

LOS GATOS, Calif., Jan. 16, 2024 /PRNewswire/ — In a first-in-human study, researchers at Orlucent, Inc. have demonstrated the viability of a novel handheld point-of-care molecular Skin Fluorescence Imaging (mSFI) System to noninvasively identify and clinically assess the presence of biological tissue remodeling activity associated with the development of melanoma in adults. Read the PR Newswire article.

Discovery of Distinctive Set of Gene Expression Patterns Changes Understanding of Atypical Mole Development and Early Melanoma

LOS GATOS, Calif., June 20, 2023 /PRNewswire/ — Researchers evaluating and comparing the gene expression profiles of common (non-malignant) moles and melanoma, the most aggressive skin cancer, have found that the transition from benign tissue to early-stage melanoma involves the reorganizing or “remodeling” of the surrounding skin structural tissue, a process that also has its own distinctive patterns of gene expression. Read the PR Newswire article.

Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System

LOS GATOS, Calif., May 22, 2023 /PRNewswire/ — Orlucent, Inc., a company focused on clinical assessment of suspicious moles, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. Read the PRNewswire article.

Los Gatos, CA, January 19, 2023 – The U.S. Patent and Trademark Office has granted Orlucent® a registered trademark, allowing them to more clearly identify and distinguish their fluorescent molecular imaging test and secure legal protections for the brand. The Orlucent Fluorescent Molecular Imaging System is the first handheld molecular-based imaging system to provide the physician with greater certainty in the clinical assessment of suspicious moles. The in-office system uses a novel fluorescent biotag topically applied to non-invasively detect a biomarker of early tissue changes that occur during a mole’s transition from benign to atypia.

Los Gatos, CA, May 6, 2021 – Orlucent, Inc., a privately held medical device company, today announced that the AMA CPT issued a category III code applicable to its fluorescent molecular imaging test. Establishment of the code was granted with support of the CPT Advisors for the American Academy of Dermatology. Category III codes are designed for emerging technologies and can be established before FDA clearance is granted. There is growing acceptance of these codes among physicians and healthcare plans, and the AMA actively promotes their use. 0700T – Molecular fluorescent imaging of suspicious nevus; first lesion; 0701T – Molecular fluorescent imaging of suspicious nevus; each additional lesion

FDA License Awarded for Manufacture of the Orlucent Fluorescent Molecular Imaging System for Suspicious Moles

Los Gatos, CA, March 9, 2021 – Orlucent meets the requirements for California State FDA Manufacturing License, which demonstrates they are registered with the FDA as a manufacturing site and meet the standards of the FDA and the State of California.

International Organization for Standardization Awarded to Maker of Fluorescent Molecular Imaging Test for Suspicious Nevi

Los Gatos, CA, December 9, 2020 – Orlucent, Inc. has received International Organization for Standardization (ISO) certification, effective through 2023. This certification is a highly desired and recognized certification for medical device manufacturers. It helps to establish a company’s credibility among suppliers, customers, shareholders, and institutions by demonstrating the company’s commitment to quality and that its Quality Management System is compliant with established and recognized industry standards.

Orlucent® OBTAINS CE MARKING FOR ITS NONINVASIVE MOLE EVALUATION SYSTEM

First Physician Office System Using a Fluorescent Biomarker to Reveal Biological Activity Invisible to the Naked Eye

LOS GATOS, CA, April 3, 2018 — Orlucent, Inc., a privately held medical device company, today announced its Orlucent® system obtained CE Marking for noninvasive evaluation of moles suspicious for melanoma. The easy to use 3-part system yields rapid results in the physician office. The ORLUCENT topical biomarker, handheld imager, and software work in tandem to provide the physician with biological activity status from within a suspect mole prior to a decision to biopsy. The CE (Conformité Européenne, or “European Conformity”) Marking declares conformity that the product meets European safety, effectiveness, and quality requirements. The Orlucent system is supported by studies in over 500 patients. Additional clinical trials are underway in both the US and Europe.

Los Gatos, CA, December 9, 2020 – Orlucent, Inc. has received International Organization for Standardization (ISO) certification, effective through 2023. This certification is a highly desired and recognized certification for medical device manufacturers. It helps to establish a company’s credibility among suppliers, customers, shareholders, and institutions by demonstrating the company’s commitment to quality and that its Quality Management System is compliant with established and recognized industry standards.