A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

Lumicell Submits NDA for LUMISIGHT Optical Imaging Agent for Breast Cancer Surgery

Lumicell, Inc. today announced FDA submission of the LUMISIGHT™ Optical Imaging Agent New Drug Application. LUMISIGHT is intended for use with their Lumicell™ Direct Visualization System (DVS), an investigational system designed to assist in the detection of residual cancerous tissue following removal of the primary specimen during the initial lumpectomy.

Data has shown that at least 20% of women undergoing breast conserving surgery require a second surgery due to incomplete tumor removal, and 6-10% end up experiencing a local recurrence of breast cancer. Technology like the Lumicell DVS can aid in detecting and removing residual cancer during the initial surgery, which has the potential to support improved outcomes.

The LUMISIGHT NDA submission is supported by data from 700+ breast cancer patients across five clinical studies, and results from its INSITE pivotal trial will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. LUMISIGHT was previously granted Fast Track designation by the FDA. Following its LUMISIGHT NDA submission, the company plans to submit the PMA for the Lumicell DVS in the second quarter of this year.

The Lumicell DVS is a combination product which includes the LUMISIGHT Optical Imaging Agent, a hand-held imaging probe designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer and enable a more complete resection.

By way of introduction, Lumicell is a Massachusetts-based private company reimagining the practice of cancer surgery by utilizing innovative fluorescence-guided surgical technologies to enable a more complete resection of cancer that may have otherwise been left behind. The first indication the company is pursuing is for breast cancer.

The Lumicell DVS is designed by engineers and scientists from MIT, in close partnership with leading breast cancer surgeons, to fit seamlessly within the existing surgical workflow.

SourceLumicell
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides 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!

Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”
To further understand the impact of platforms like TikTok on nutrition trends, MyFitnessPal partnered with Dublin City University on a research and experimental study that examined diet and nutrition content on TikTok. The study analyzed over 67,000 videos using Artificial Intelligence to compare them against public health and nutrition guidelines
Leveraging the power of Apple Vision Pro to seamlessly blend digital content with the physical world Osso Health brings the operating experience to life via detailed, clinically accurate workflows of common procedures.
“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preliminary safety profile consistent with its highly selective design. Not only did all evaluable patients have improved or stable BCR::ABL1 transcript levels, but, importantly, 89% of all patients enrolled remain on study. We believe the initial data demonstrate the potential clinical utility of ELVN-001 for all types of patients, including those that are earlier in the treatment paradigm.”
The partnership is with Health-HavenRx ™, an online pharmacy platform. This partnership enables a new, convenient channel for patients to access POGO Automatic by using their health insurance on Intuity Medical’s e-commerce website at www.GoodtoPogo.com.

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