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 that the Centers for Medicare & Medicaid Services (CMS) has approved its application for transitional pass-through (TPT) status for LUMISIGHT™ (pegulicianine) under the Medicare hospital outpatient prospective payment system (OPPS).
The new Healthcare Common Procedure Coding System (HCPCS) drug TPT code (C9171 Injection, pegulicianine, 1 mg) may be used to bill CMS for LUMISIGHT when it is used in the treatment of Medicare beneficiaries in the hospital outpatient setting starting October 1, 2024.
The TPT payment is a mechanism created by the CMS to increase patient access to new and truly innovative technologies, such as LUMISIGHT, by facilitating adequate payment of new technologies. TPT will provide additional Medicare payment for LUMISIGHT for 2 to 3 years, and during this time, Medicare will collect and assess the data in consideration of future payments.
“We are proud that the country's largest payer for health care recognizes the importance of our truly innovative fluorescence-guided imaging technology," said Howard Hechler, President and COO, “enhancing patient access to LUMISIGHT while helping surgeons to find cancer that might otherwise go undetected.”
Up to 36% of patients with breast cancer have follow-up surgeries due to positive margins and 14% of patients with negative margins after lumpectomy have cancer remaining according to clinical studies.1 When LUMISIGHT is used with Lumicell DVS during lumpectomy, together referred to as LumiSystem™, surgeons can detect and resect residual breast cancer with 84% diagnostic accuracy as an adjunct to the procedure.2
LUMISIGHT (pegulicianine) received FDA approval in April of 2024 and will be commercially available in Q4 of this year.
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 LUMISIGHT (pegulicianine) and Lumicell DVS?
- LUMISIGHT (pegulicianine), an optical fluorescence imaging agent, and Lumicell DVS, an imaging device, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.
What is the most important information I should know about LUMISIGHT?
- Hypersensitivity Reactions: 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 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 additional important information I should know about LUMISIGHT and 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 use of dyes before imaging the lumpectomy cavity who have received LUMISIGHT.
- Tissue perforation or damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the Lumicell DVS handheld probe while inside the cavity as it can cause tissue perforation or damage.
- Infection risk: To avoid infection risk, the reusable Lumicell DVS handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover.
- Eye discomfort: Your healthcare provider should avoid direct eye exposure to Lumicell DVS 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.
1 Dupont, et al., Ann Surg 2021; 273(5): 876-881
2 Smith, et al., NEJM Evidence 2023; 2(7)
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