Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for the LUMISIGHT™ Optical Imaging Agent and accepted the Premarket Approval (PMA) application for the Lumicell™ Direct Visualization System (DVS).

The Lumicell DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The Lumicell DVS is intended for use with the investigational optical imaging agent LUMISIGHT (pegulicianine) for fluorescence imaging of the lumpectomy cavity.

“The FDA acceptances of both the NDA and PMA submissions for our LUMISIGHT Optical Imaging Agent and Lumicell Direct Visualization System bring us one step closer to advancing care for women with breast cancer,” said Kevin Hershberger, president and chief executive officer of Lumicell. “Priority Review designation is further recognition of the potential of our system to significantly improve the effectiveness of breast cancer treatment. We look forward to the FDA’s review of our applications, and the potential to offer surgeons the first visualization system to enable a more complete cancer resection during the initial lumpectomy.”

These submissions are supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial were published in NEJM Evidence and the Phase C study in JAMA Surgery. The FDA previously granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of the potential important benefit of identifying residual cancer during the initial lumpectomy.

The standard of care for lumpectomy surgery involves breast surgeons and pathologists examining the margins of excised tissue to infer whether any residual cancer remains behind in the breast cavity. As a result, 20-40% of lumpectomies have positive margins only identified days after surgery, necessitating a second surgery to obtain clear margins.(1)(2) Moreover, as reported in published literature, approximately 14% of patients determined by pathology to have negative margins, implying that no cancer remained inside the cavity, had residual cancer left behind.(3) With future approval of our system, surgeons will be able to look inside the lumpectomy cavity to find, and remove residual cancer during the initial lumpectomy, and achieve a more complete cancer resection.

Medical Device News Magazine
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

LumiGuide, powered by Fiber Optic RealShape (FORS) technology, enables doctors to navigate through blood vessels using light, instead of X- ray. “[It’s] one of the most exciting changes that we’ve seen with imaging certainly throughout my career,” said Andres Schanzer, Vascular Surgeon, at UMass Memorial Medical Center, Worcester, MA, USA.
Carestream Health notes twenty-seven of the patents were awarded by the U.S. Patent and Trademark Office; an additional 43 patents were received in European and Asian countries.
According to an Insightec study, patients experienced significant reductions in upper limb tremor, tremor-related disability, and quality of life. The most common intraprocedural adverse events included dizziness, headache, nausea, and vomiting, which all resolved. Post-procedural adverse events included paraesthesia and gait disturbance, which were often transient or resolved within 12 months.
Chris Landon, Business Leader Image Guided Therapy Devices at Philips: “IVUS is a technology that has demonstrated an ability to both support safer procedures for patients and procedural staff alike including reductions in radiation exposure. As the global leader in IVUS solutions, we are grateful for the rigorous multidisciplinary approach to developing expert consensus on the value of IVUS and we look forward to working with all stakeholders to standardize the use of IVUS and reduce the barriers preventing utilization.”
"We are delighted to see our 3D solution CE-marked and available on the European market," says Ulrik Harrysson, CEO at SyntheticMR AB. "SyMRI 3D represents the next generation of quantitative MRI, offering unprecedented resolution and accuracy in brain imaging, revolutionizing the landscape of medical diagnostics."

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version