FDA Approves Lumicell's Imaging Drug for Enhanced Cancer Detection After Lumpectomy

SciFocus/April 30, 2024 -- In a groundbreaking move, Lumicell , Inc. has achieved a historic milestone with the FDA's approval of its innovative LUMISIGHT? optical imaging agent and Lumicell? Direct Visualization System (DVS), collectively known as LumiSystem?. This approval signifies a significant advancement in fluorescence-guided imaging technologies for detecting cancerous tissue during lumpectomy surgery. Here are the key highlights and insights from this landmark approval:

- Lumicell's cutting-edge imaging platform, LumiSystem, has received FDA approval for aiding in the detection of residual breast cancer post-lumpectomy.

- LumiSystem offers 84% diagnostic accuracy in real-time detection of residual cancer, potentially reducing the need for second surgeries.

Key Highlights:

- Accurate Detection: LumiSystem's 84% diagnostic accuracy empowers surgeons to identify and resect residual cancer, thus enhancing the completeness of tumor resection during lumpectomy surgery.

- Fast-Track and Breakthrough Designations: LUMISIGHT and Lumicell DVS received FDA Fast Track and Breakthrough Device designations, respectively, underscoring their innovative and impactful nature.

Expert Perspectives:

- Dr. Kelly Hunt from MD Anderson Cancer Center emphasizes the challenges in achieving complete tumor resection during lumpectomy and highlights LumiSystem's potential to reduce the need for second surgeries.

- Dr. Irene Wapnir from Stanford University School of Medicine discusses the uncertainties in current surgical tools and the significance of LumiSystem in improving cancer resection outcomes.

Clinical Validation:

- The safety and efficacy of LumiSystem were established through extensive clinical trials involving over 700 breast cancer patients across top cancer centers in the U.S.

- Common side effects of LUMISIGHT include hypersensitivity and changes in urine color, while Lumicell DVS comes with safety considerations regarding proper use and infection risk.

Company Statements:

- Lumicell's President and COO, Howard Hechler, expresses pride in achieving the dual FDA approvals, highlighting LumiSystem's unique capabilities in detecting cancerous tissue within the breast cavity.

- Jorge Ferrer, Lumicell's Chief Scientific Officer, extends gratitude to clinical investigators and patients for their contributions to LumiSystem's development and approval.

About Lumicell Inc.:

- Lumicell is dedicated to advancing fluorescence-guided surgery technology for cancer detection and resection.

- LUMISIGHT and Lumicell DVS are designed to enhance cancerous tissue visualization during lumpectomy procedures, offering a valuable adjunct to the standard of care.

Important Safety Information:

- LUMISIGHT may cause serious hypersensitivity reactions, and Lumicell DVS comes with considerations regarding misdiagnosis and infection risks.

- Healthcare providers must be trained on proper use of LumiSystem components to ensure patient safety and optimal outcomes.

Conclusion:

The FDA's approval of LumiSystem represents a significant leap forward in intraoperative cancer detection and resection, promising improved outcomes for patients undergoing lumpectomy surgery.

For comprehensive product information and safety details, visit www.LumiSystem.com .

References:

1. Lumicell Inc. Press Release. April 18, 2024.

2. Lumicell DVS Instructions for Use.

3. NEJM Evidence publication on Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial.

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