Pegulicianine

NEWTON, Mass.--( BUSINESS WIRE )-- Lumicell, Inc ., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the American Medical Association has granted a Category III, Current Procedural Terminology (CPT) add-on code 0945T specifically for intraoperative fluorescence imaging margin assessment following breast cancer lumpectomy. 3 The new CPT code is expected to become effective on Jan. 1, 2025. The purpose of CPT coding is to provide a uniform language that accurately describes medical, diagnostic, and testing services for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties such as payors. The granting of this add-on code will allow physicians to report their usage of LUMISIGHT™ and Lumicell™ DVS, together referred to as LumiSystem™, to help payors collect claims data for improved access. “This is an important milestone for providers who offer this new adjunctive treatment option to their patients with breast cancer undergoing lumpectomy,” said Howard Hechler, President and Chief Operating Officer, Lumicell. “The Category III code will enable wider commercial access to LumiSystem by facilitating future reimbursement from US government payors and commercial health insurance companies.” Clinical studies have shown that up to 36% of patients have re-excisions due to positive margins and 14% of patients with negative margins after lumpectomy have cancer remaining. 1 With 84% diagnostic accuracy, LumiSystem is the first and only system that enables surgeons to scan inside the breast cavity, in real-time, to detect and resect residual cancer that may have otherwise been left behind. 2 “This new CPT code demonstrates positive momentum towards improving patient access to LumiSystem, which will have significant impact on breast cancer surgical outcomes for patients,” said Peter Blumencranz, MD, Medical Director, BayCare Oncology Service Line and The Comprehensive Breast Care Center of Tampa Bay. LumiSystem will be commercially available in Q4 of this year. Please visit www.LumiSystem.com to learn more about LUMISIGHT and Lumicell DVS. About Lumicell Inc. Lumicell is a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology. The company’s lead products are LUMISIGHT™ (pegulicianine) and Lumicell™ DVS which are designed for use in combination to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell’s proprietary, pan-oncologic optical imaging agent, LUMISIGHT, is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit www.Lumicell.com and follow the company on Facebook , X , and LinkedIn . Indications for Use LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Important Safety Information What is the most important information I should know about LUMISIGHT? LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy. What other safety information should I know about LUMISIGHT? Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT. What are the most common side effects of LUMISIGHT? The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information , including Boxed Warning. What is the most important information I should know about Lumicell DVS? Adjunctive use : Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures. Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT. Tissue perforation or damage : During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage. Infection risk : To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover. Eye discomfort : Avoid direct eye exposure to handheld light probe as it may cause pain. Please see the LUMISIGHT Prescribing Information , including Boxed Warning, and Lumicell DVS Instructions for Use . For complete product information, visit www.LumiSystem.com . © 2024 Lumicell Inc. All Rights Reserved. MKT00246 1 Dupont, et al., Ann Surg 2021; 273(5): 876-881 2 Smith, et al., NEJM Evidence 2023; 2(7) 3 https://www-ama-assn-org.libproxy1.nus.edu.sg/system/files/cpt-category3-codes-long-descriptors.pdf

In a clinical trial, 27 of 357 patients undergoing surgery with LumiSystem had extra tumor tissue removed after a standard lumpectomy. The FDA has granted a groundbreaking approval to a fluorescent light system that illuminates leftover breast cancer tissue in real-time during surgery—to help ensure a thorough removal of the tumor and avoid the need for follow-up procedures. Lumicell’s approach starts with an injectable imaging agent, Lumisight (pegulicianine)—which is inactive at first but begins to glow when it interacts with particular enzymes found around tumor cells.  At the same time, the company’s computerized, handheld imaging probe scans the inside of the surgical cavity created during a breast-conserving lumpectomy and logs any signs of residual cancer hidden among the healthy cells. Lumisight was approved via the FDA’s pharmaceutical review pathway—after receiving a positive recommendation from an independent advisory committee in early March—while Lumicell’s Direct Visualization System hardware took a parallel track through the agency’s device center. “We are immensely proud of the dual approval of Lumisight and Lumicell DVS—we believe this is the first drug-device combination product approved in over a decade to have followed both of the FDA’s most stringent NDA and PMA review processes,” Lumicell’s president and chief operating officer Howard Hechler said in a statement. “With the FDA’s approval, LumiSystem is now the first and only imaging combination product capable of detecting cancerous tissue where it matters most, inside the breast cavity.” According to the company, about one-third of women who undergo the removal of a breast tumor have to return to the operating room for another surgery. Meanwhile, about two-thirds of those follow-up procedures end up not finding any residual cancer, leaving clinicians to wonder if previous assessments were wrong or if the cancer was simply missed a second time. Lumicell said its system—which previously received both the FDA’s pharmaceutical fast track and breakthrough device designations—can provide 84% diagnostic accuracy.  In a clinical trial of about 400 participants undergoing breast cancer surgery, follow-up procedures were avoided in 9 of 62 patients that had positive tumor margins. At the same time, 27 of 357 patients in the LumiSystem arm had extra tumor tissue removed after a standard lumpectomy, including 22 who were initially ascribed negative margins. Administration of the Lumisight imaging agent was halted due to side effects in six patients; two patients developed serious adverse events related to pegulicianine. The study’s results were published in April 2023 in the journal NEJM Evidence. Lumicell is also studying its combination imaging approach in gastrointestinal tumors, sarcomas and peritoneal metastases—the last of which can be difficult to detect with a CT, PET or MRI scan—as well as in brain and prostate cancers. Last October, Lumicell co-founder Moungi Bawendi shared the 2023 Nobel Prize in chemistry for his research in the discovery and synthesis of quantum dots—nano-sized particles used in optical electronics ranging from solar cells to LED displays to lasers, as well as biomedical imaging. The company’s fluorescent visualization system was developed in Bawendi’s lab at the Massachusetts Institute of Technology, where he serves as the Lester Wolfe Professor of Chemistry. According to Lumicell, Bawendi’s expertise in optics and tissue imaging helped guide the design of the device, while his work on the physio-chemical properties of fluorescent molecules led to the imaging agent. A separate company developing a similar injectable approach for lung and ovarian cancers, On Target Laboratories, raised $30 million in a series C round last November to help commercialize its Cytalux (pafolacianine) fluorescent agent and near-infrared imaging device.