New data suggests that patients were satisfied with their cosmetic outcomes following the removal of suspicious tissue detected by fluorescence-guided imaging during lumpectomy surgery, and prefer to avoid a second surgery
Adding LumiSystem to a lumpectomy procedure may lead to a reduction in targeted volume of radiation therapy for some patients and may lead to the option to omit radiation in other patients
NEWTON, Mass., Dec. 13, 2024 /PRNewswire/ — Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, presented posters demonstrating patient benefit of use with LumiSystem during the 2024 San Antonio Breast Cancer Symposium® (SABCS®) from Dec 10-13.
LUMISIGHT™ (pegulicianine) is approved for use as an optical imaging agent in combination with Lumicell™ Direct Visualization System (DVS) to detect cancerous tissue within the breast cavity as an adjunct during the lumpectomy procedure. LumiSystem is the combination of these two FDA-approved products.
“The patient survey feedback about the use of LumiSystem during their lumpectomy procedures has been very positive,” said Howard Hechler, CEO, Lumicell. “We’re excited to share these insights with providers so that their patients may be able to avoid a second surgery or minimize radiation, potentially improving the patient experience and outcomes.”
Poster Presentation Highlights
Presentation title: Does additional margin excision during LumiSystem (pegulicianine) fluorescence-guided lumpectomy surgery affect patient breast satisfaction?
Presenting author: Barbara Smith, M.D.
Poster number: P3-09-04
Key points:
- Post-operative breast satisfaction surveys were completed 6-12 months after surgery
- No significant difference in mean post-operative breast satisfaction scores between device and control arm patients (78.2 out of 100 for control arm patients versus 79.8 out of 100 for device arm patients, p = 0.359)
- 70.6% of surveyed participants strongly preferred or preferred avoiding a second surgery compared to optimizing cosmetic outcomes
- This analysis was limited by its small sample size due to enrollment ending early.
Presentation title: LumiSystem-guided lumpectomy enables informed customization of radiation therapy in select patients with breast cancer.
Presenting author: Simona Shaitelman, M.D.
Poster number: P5-09-13
Key points:
- 357 patients received LumiSystem-guided surgery, and a retrospective review was performed to evaluate patient eligibility for de-escalation or omission of radiotherapy
- Among patients who were eligible for omission of radiotherapy after standard of care negative margins, LumiSystem-guided excisions resulted in removal of unsuspected residual tumor.
- LumiSystem-guided wider negative margins (compared to standard of care procedures) led to the potential of a reduced targeting volume of radiation therapy and the option to omit radiation in some patients.
Healthcare providers are encouraged to contact 1-833-4LUMDVS for any questions about LUMISIGHT or 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 approved 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 imaging agent, and Lumicell DVS, a fluorescence 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 the 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.
- The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.
What additional important information should I 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.
- 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 in patients who have received LUMISIGHT.
- Other Risks: Using the Lumicell DVS handheld probe may cause tissue damage or infection.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information visit www.LumiSystem.com.
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