Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.

Start Date01 Jan 2026

Sponsor / Collaborator

Lumicell, Inc.

NCT04440982 / TerminatedPhase 2

Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy

This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.

Start Date01 Sep 2020

Sponsor / Collaborator

Lumicell, Inc.

[+2]

NCT03686215 / CompletedPhase 3

Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer

This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients undergoing breast surgery in order to assist surgeons in reducing the rates of positive margins.
All enrolled subjects will be injected with LUM015 prior to surgery. Surgeons are blinded to whether a participant will be randomized into the device arm until after the standard of care lumpectomy is complete. Participants will then be randomized to receiving the device. Therapeutic (LUM guided) shaves will be removed based on the guidance of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

Start Date04 Nov 2019

Sponsor / Collaborator

Lumicell, Inc.

[+1]

100 Clinical Results associated with Lumicell, Inc.

0 Patents (Medical) associated with Lumicell, Inc.

Literatures (Medical) associated with Lumicell, Inc.

02 May 2024·Cancer Research

Abstract PO5-22-09: Positive pegulicianine fluorescence rate in the lumpectomy cavity correlates with tumor distance to margins in excised tissue

Author: Hunt, Kelly ; Carr, David ; Blumencranz, Peter ; Ferrer, Jorge ; Chang, Manna ; Wapnir, Irene ; Smith, Barbara ; Smith, Kate ; Hwang, E Shelley

AbstractTitle: Positive pegulicianine fluorescence rate in the lumpectomy cavity correlates with tumor distance to margins in excised tissueBackground: A randomized, two-arm pivotal study of pegulicianine fluorescence guided surgery (pFGS) at 14 US sites was conducted using the Lumicell Direct Visualization System (DVS) to identify residual cancer in the lumpectomy cavity after the standard of care (SoC) tumor excision. We reported that the Lumicell DVS detects residual cancer in the lumpectomy cavity, including in orientations pathologically negative on the SoC specimen. In addition, 15% (9 of 62) of patients with positive SoC margins were converted to final negative margins by taking Lumicell DVS directed cavity margins, avoiding a second unnecessary surgery. Interestingly, 8 of these 9 patients had no tumor found in the Lumicell DVS guided specimens. We hypothesize that fluorescence decreases as the distance from the tumor boundary increases. We analyzed data from the pivotal study (NCT03686215) to assess correlation of pegulicianine signal with tumor-to-margin distance, and its potential clinical value.Methods: The pivotal study enrolled 406 patients undergoing breast conserving surgery (BCS) for stage 0-III breast cancers. Patients received an IV injection of pegulicianine 2-6 hours prior to surgery. After the standard of care lumpectomy was completed, additional Lumicell DVS-guided cavity margins were excised at sites of positive pegulicianine fluorescence signal in the lumpectomy cavity walls using a hand-held imaging device and patient-calibrated cancer detection software. The positive fluorescence rate, that is, the rate at which the Lumicell DVS indicates areas suspected to contain cancer, was calculated as the ratio of orientations with positive pegulicianine signal to the total number of orientations with (1) negative margins, (2) positive margins and (3) positive margins with ink on tumor, on the initial SoC lumpectomy specimen. Calculations were made on a per-margin basis. Positive margins were defined as ink on tumor for invasive cancer and tumor less than 2 mm from the margin for ductal carcinoma in situ (DCIS) alone.Results: Results are presented in Table 1. We found a statistically significant higher positive fluorescence rate in orientations with positive margins (p=0.044). The positive fluorescence rate was even higher (21.1%) when only considering cases with ink on tumor (a subset of the positive margin group).Discussion: By design, pegulicianine is activated by enzymes within the tumor and in stromal cells at the invasive front surrounding the tumor. Thus, when tumor is closer to the edge of the lumpectomy specimen, the rate of positive pegulicianine fluorescence in the cavity increases, being highest when there is tumor present at the inked margin. This feature of pegulicianine fluorescence guides the surgeon to resect more tissue in these areas in order to achieve a negative margin of the required width. The conversion of positive margins after the SoC lumpectomy to appropriately wide final negative margins prevents a second surgery, even when there is no tumor in the DVS guided margins. These findings have strengthened our understanding of the utility of this technology.Table 1 Positive cavity wall fluorescence rate for SoC lumpectomy positive margins, SoC lumpectomy negative margins and SoC lumpectomy ink on tumor marginsCitation Format: Irene Wapnir, E Shelley Hwang, Kelly Hunt, David Carr, Peter Blumencranz, Manna Chang, Kate Smith, Jorge Ferrer, Barbara Smith. Positive pegulicianine fluorescence rate in the lumpectomy cavity correlates with tumor distance to margins in excised tissue [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-22-09.

02 May 2024·Cancer Research

Abstract PO4-11-12: Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS)

Author: Ferrer, Jorge ; Hwang, E Shelley ; Carr, David ; Chang, Manna ; Blumencranz, Peter ; Wapnir, Irene ; Smith, Kate ; Hunt, Kelly ; Smith, Barbara

AbstractBackground: In pegulicianine fluorescence guided surgery (pFGS), a standard of care lumpectomy procedure is performed, and additional tissue is taken from cavity walls at sites of high pFGS signal. This approach been shown to reduce 2nd surgeries and remove additional tumor left by standard surgery, but may remove more tissue, potentially worsening cosmetic outcomes. Patient breast satisfaction surveys were used to assess cosmesis after pFGS.Methods: A prospective Pivotal trial of pFGS in women undergoing lumpectomy surgery for stage 0-III breast cancer was conducted at 14 US sites (NCT03686215). We assessed the safety and efficacy of the Lumicell DVS in identifying and removing residual cancer from the lumpectomy cavity in real time. Patient Reported Outcome Measures (PROM) data was collected as an exploratory endpoint. The BREAST-Q, a validated tool that measures patient perspectives after different breast procedures, was used to collect PROM data. An 11-question BREAST-Q survey was used to measure patients’ breast satisfaction at baseline (pre-surgery) and at multiple timepoints through 6-months post lumpectomy.Descriptive statistics of participating patients’ responses were collected and analyzed. Survey results were analyzed by the distribution of patient ratings for each question and the change in the distribution of ratings over time, with comparison of baseline to post-lumpectomy. Comparison of patient satisfaction with or without additional pFGS-directed tissue removal was performed with Item Response Theory assuming all items equally discriminative of responding patients. For each timeframe, responses to BREAST-Q items were used to create a response score for each patient. Scaled factor scores (0-100) were compared between groups with and without additional tissue removed during pFGS.Results: Of the 357 patients evaluated for efficacy in the primary Pivotal study analysis, 255 patients agreed to participate in the PROM surveys (71%). Approximately 60% of the participating respondents completed a pre- and initial post-lumpectomy survey while only 34% of the participating patients completed a pre- and 6-month post-lumpectomy survey. Most patients responded either “Very Satisfied” or “Somewhat Satisfied” across all surveyed timeframes. No significant difference in patient breast satisfaction was found at any time point between the groups with and without additional pFGS-guided shaves removed (p >0.05). There were 4 patients with scores of 3 or higher pre-surgery but 2 or lower post-surgery. Among these, 1 had no pFGS-guided shaves taken. The remaining 3 had had pFGS-guided shaves taken, but 2 required a second lumpectomy surgery and 1 underwent mastectomy, these additional surgeries likely accounting for decreased cosmetic outcomes.Discussion: Patient perspective of breast satisfaction was not decreased by the amount of extra tissue removed by pFGS. These data suggest that pFGS using the Lumicell DVS does not significantly decrease breast cosmesis. Three of 4 patients with decreased satisfaction had 2nd surgeries, confirming the importance of finding approaches to decrease 2nd surgeries.This data was collected during the COVID-19 pandemic, which may have adversely impacted the compliance rate of survey completion.Studies in larger cohorts with longer follow up are required to better assess the relative impact of 2nd surgeries, radiation, and systemic therapy on breast satisfaction PROM scores after lumpectomy.Citation Format: Kelly Hunt, Irene Wapnir, E Shelley Hwang, David Carr, Peter Blumencranz, Kate Smith, Manna Chang, Jorge Ferrer, Barbara Smith. Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-12.

27 Jun 2023·NEJM Evidence

Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery

Article

Author: Smith, Kate Porta ; Dodge, Daleela ; Dyess, Donna L. ; Clark, Patricia ; Wapnir, Irene L. ; Harris, Daniel K. ; Carr, David ; Gadd, Michele A. ; Lesnikoski, Beth-Anne ; Hunt, Kelly K. ; Samiian, Laila ; Stone, Kimberly ; Chang, Manna ; Hwang, E. Shelley ; Dekhne, Nayana ; Clark, Lynne ; Smith, Barbara L. ; Schlossberg, Brian ; Ferrer, Jorge ; Lee, Marie Catherine ; Valente, Stephanie ; Blumencranz, Peter W.

BACKGROUND: Although lumpectomy and mastectomy provide equivalent survival for patients with breast cancer, local recurrence after lumpectomy increases breast cancer mortality. Positive lumpectomy margins, which imply incomplete tumor removal, are the strongest predictor of local recurrence and are identified days after surgery, necessitating a second surgery. METHODS: In this prospective trial, we assessed margin status with or without pegulicianine fluorescence-guided surgery (pFGS) for stages 0 to 3 breast cancers. To prevent surgeons from performing smaller than standard lumpectomies in anticipation of pFGS assistance, patients were randomly assigned 10:1 to pFGS or control groups, thus randomization was not designed to provide a control group for evaluating device performance. In patients undergoing pFGS, additional pFGS-guided cavity margins were excised at sites of pegulicianine signal. We evaluated three coprimary end points: the percentage of patients for whom pFGS-guided margins contained cancer, sensitivity, and specificity. RESULTS: Overall, 406 patients received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Among 392 patients randomly assigned, 316 had invasive cancers, and 76 had in situ cancers. In 27 of 357 patients undergoing pFGS, pFGS-guided margins removed tumor left behind after standard lumpectomy, 22 from cavity orientations deemed negative on standard margin evaluation. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins. On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. Pegulicianine administration was stopped for adverse events in six patients. Two patients had grade 3 serious adverse events related to pegulicianine. CONCLUSIONS: The use of pFGS in breast cancer surgery met prespecified thresholds for removal of residual tumor and specificity but did not meet the prespecified threshold for sensitivity. (Funded by Lumicell, Inc. and the National Institutes of Health; Clinicaltrials.gov number, NCT03686215.)

News (Medical) associated with Lumicell, Inc.

04 Oct 2024

·www.massdevice.com

The top 10 women’s health stories of the year so far

It has been a blockbuster year for women’s health as the federal government and medtech place particular focus on the wellbeing of women. At the start of the year, President Joe Biden announced the federal government would focus its health initiatives on improving women’s health outcomes. Since then, his administration has announced two other federal initiatives to improve the care continuum for women. The medical device industry has also had many wins this year for women’s health. Several studies focused on women’s heart health and how TAVI affects them. Some companies launched improved breast cancer locator and imaging systems, and surgical robotics companies started using robots in gynecological procedures. At DeviceTalks West in Santa Clara, California, Oct. 16–17, a wide range of women’s health technologies will be featured. (Learn more about the event and register at West.DeviceTalks.com.) As we enter the last quarter of the year, here are ten women’s health stories that caught the attention of our MassDevice readers: Jill Biden launches $100M initiative to transform women’s health research First Lady Jill Biden and the White House in February announced that $100 million in federal funding will go toward research and development into women’s health. The First Lady said the funding is part of a White House Initiative on Women’s Health Research that the White House announced in November 2023. The Federal Department of Health and Human Services set aside money from the Advanced Research Projects Agency for Health (ARPA-H) for this initiative. ARPA-H’s $100 million funding will go toward early investment in “life-changing” work by women’s health researchers and startup companies. The “Sprint for Women’s Health” initiative will invest in discoveries early when private companies are less likely to take the investment risk. Read the full story here >> Biden signs executive order for women’s health research and innovation President Joe Biden signed an executive order in March that will direct funds and actions toward expanding and improving research on women’s health. Biden’s executive order will create directives that will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, according to the White House. It will also motivate new research on a wide range of topics in women’s health. It also intends to integrate women’s health across the federal research portfolio, prioritize investments in women’s health research, galvanize new research on women’s midlife health and assess unmet needs to support women’s health research. about the administration’s initiatives >> Edwards reports ‘excellent’ outcomes for TAVI in women Edwards Lifesciences announced positive results in August from its RHEIA trial, showing superior outcomes for women who received transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR). The findings involved female patients treated with Edwards’ Sapien 3 and Sapien 3 Ultra valves. The independently-run RHEIA trial included 443 women, aged 73 on average, with severe symptomatic aortic stenosis. One year after treatment, 8.9% of TAVI patients experienced death, stroke, or rehospitalization, compared to 15.6% in the SAVR group, highlighting TAVI’s advantages for this demographic. Edwards continues to focus on improving heart valve replacement outcomes for women. Dr. Hélène Eltchaninoff, a cardiology expert, noted that women are often underrepresented in severe aortic stenosis treatment, emphasizing the significance of this trial’s findings. Get the full story >> Melodi Health raises $10.75M, enrolls first patient in study of absorbable mesh for breast cancer patients Melodi Health raised $10.75 million in an oversubscribed Series A round and launched a clinical trial for its Matrix mesh technology. The Minneapolis-based company began its ARIA FDA investigational device exemption (IDE) trial to improve outcomes for women undergoing breast reconstruction after mastectomy, enrolling the first patient at University of Utah Health. Melodi has raised $15 million, with Series A funding led by HM Venture Partners, Engage Venture Partners, Southeast Minnesota Capital Fund, and Three Bridges Private Capital. The funds will support clinical activities and further product development for its innovative implantable medical device. The Matrix mesh is an absorbable device that supports soft tissue while releasing antibiotics to reduce post-surgical infections. Co-founder and CEO Sarah Worrell said the device addresses a significant unmet need, as no FDA-approved soft tissue support products with antibiotic properties currently exist for breast surgery. about the fundraising >> Cairn Surgical raises $4.5M for breast cancer locator system Cairn Surgical announced it closed a $4.5 million Series A2 financing round to advance its Breast Cancer Locator (BCL) System. The funds will support completing a U.S. pivotal trial and initiate a limited commercial launch in Europe. The BCL system aims to improve the accuracy of breast-conserving surgeries by providing surgeons with detailed information about the tumor’s size, shape, and precise location. Current tumor localization methods often fail to remove the entire tumor in 20% of cases, leading to additional surgeries. Mick Sawka, investment advisor at Morningside Ventures, which led the funding round, highlighted the system’s promising results in European trials, noting its potential to improve patient care and reduce healthcare costs. Cairn Surgical’s approach is expected to transform the surgical experience for both patients and healthcare providers, he said. Get the full story >> GE HealthCare, UCSD to collab on female-specific imaging GE HealthCare is collaborating with the University of California San Diego School of Medicine to advance imaging technology for female-specific pelvic disease. The partnership focuses on developing new magnetic resonance imaging protocols and educational materials to improve diagnoses and access to care for women’s pelvic health. The project, led by Dr. Rebecca Rakow-Penner at UCSD’s Center for Translational Imaging and Precision Medicine (CTIPM), covers conditions like endometriosis and ovarian cancer. It aims to enhance visualization using MRI in both clinical and academic research settings. GE HealthCare plans to distribute the protocols and educational materials globally to its MRI users. about the partnership >> Virtual Incision announces first completed hysterectomy with MIRA surgical robot Virtual Incision completed the first surgery in a study evaluating its MIRA robotic-assisted system for hysterectomy procedures. The clinical study focused on the safety and efficacy of MIRA, a miniaturized robotic system the company designed to reduce hospital stays, blood loss and complications associated with open surgery for benign hysterectomies. The study is part of Virtual Incision’s broader efforts to expand MIRA’s applications. Following its first clinical evaluation, which supported FDA authorization for colectomy procedures, the company continues to develop new versions of MIRA for general surgery, urology, and other specialties. about the procedure and the robot >> FDA clears new cervical cytology AI tech from Hologic Hologic won FDA 510(k) clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm in February. The company said it is the first FDA-cleared digital cytology system that combines AI with volumetric imaging to detect pre-cancerous lesions and cervical cancer cells. It digitally images glass slides of cervical cells and applies AI to highlight areas of concern for cytologists and pathologists. Hologic’s new process improves sensitivity without sacrificing specificity, reducing false negatives for high-grade squamous intraepithelial lesions by 28% compared to traditional microscopic review. The system enables faster, more effective treatment decisions and supports remote collaboration across healthcare settings. Get more about the technology >> Moon Surgical expands surgical robot indications to gynecological laparoscopy Moon Surgical announced in April its Maestro surgical robot is being used clinically in gynecological laparoscopic procedures. The recent gynecological use was for hysterectomy, cystectomy, adnexectomy and ovariectomy procedures. Moon Surgical designed Maestro to provide an accessible, enhanced version of traditional laparoscopy. Maestro acts as a robotic surgical assistant to augment the precision and control of laparoscopic surgery. The small, adaptable system can integrate into existing clinical workflows. It features capabilities that bolster operating room efficiency and allow for alternative labor models. about the procedures >> FDA approves Lumicell’s breast cancer visualization system Lumicell announced in April it received FDA approval for its LumiSystem direct visualization system for breast cancer removal. According to the company, the LumiSystem allows surgeons to scan the breast cavity post-lumpectomy in real time to detect and resect residual cancer that could have been missed with 84% diagnostic accuracy. The LumiSystem with the company’s LumiSight optical imaging agent is indicated for fluorescence imaging in adults with breast cancer as a supplement for the intraoperative detection of cancerous tissues within the resection cavity after removing primary specimens during lumpectomy surgery. Lumicell used data from more than 700 breast cancer patients across five clinical studies to assess the safety of the system. The most common side effects of LumiSight are hypersensitivity and an abnormal color in urine. Get the full story >>

Clinical Result

05 Sep 2024

·www.businesswire.com

CMS Grants Transitional Pass-Through Payment for LUMISIGHT™ (pegulicianine) and Increases Access for Patients with Breast Cancer

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) MKT00267rA

Drug Approval

15 Jul 2024

·www.businesswire.com

Lumicell Announces New Category III CPT® Code for Intraoperative Fluorescence Imaging Margin Assessment in Support of Market Launch

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 the American Medical Association has granted a Category III, Current Procedural Terminology (CPT) add-on code 0945T specifically for intraoperative fluorescence imaging margin assessment following breast cancer lumpectomy. 3 The new CPT code is expected to become effective on Jan. 1, 2025. The purpose of CPT coding is to provide a uniform language that accurately describes medical, diagnostic, and testing services for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties such as payors. The granting of this add-on code will allow physicians to report their usage of LUMISIGHT™ and Lumicell™ DVS, together referred to as LumiSystem™, to help payors collect claims data for improved access. “This is an important milestone for providers who offer this new adjunctive treatment option to their patients with breast cancer undergoing lumpectomy,” said Howard Hechler, President and Chief Operating Officer, Lumicell. “The Category III code will enable wider commercial access to LumiSystem by facilitating future reimbursement from US government payors and commercial health insurance companies.” Clinical studies have shown that up to 36% of patients have re-excisions due to positive margins and 14% of patients with negative margins after lumpectomy have cancer remaining. 1 With 84% diagnostic accuracy, LumiSystem is the first and only system that enables surgeons to scan inside the breast cavity, in real-time, to detect and resect residual cancer that may have otherwise been left behind. 2 “This new CPT code demonstrates positive momentum towards improving patient access to LumiSystem, which will have significant impact on breast cancer surgical outcomes for patients,” said Peter Blumencranz, MD, Medical Director, BayCare Oncology Service Line and The Comprehensive Breast Care Center of Tampa Bay. LumiSystem will be commercially available in Q4 of this year. Please visit www.LumiSystem.com to learn more about LUMISIGHT and 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 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 the most important information I should know about LUMISIGHT? 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 other safety information should I know about LUMISIGHT? 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 using dyes before imaging with LUMISIGHT. 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 is the most important information I should know about 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 using dyes before imaging with LUMISIGHT. Tissue perforation or damage : During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage. Infection risk : To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover. Eye discomfort : Avoid direct eye exposure to 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 . © 2024 Lumicell Inc. All Rights Reserved. MKT00246 1 Dupont, et al., Ann Surg 2021; 273(5): 876-881 2 Smith, et al., NEJM Evidence 2023; 2(7) 3 https://www-ama-assn-org.libproxy1.nus.edu.sg/system/files/cpt-category3-codes-long-descriptors.pdf

100 Deals associated with Lumicell, Inc.

100 Translational Medicine associated with Lumicell, Inc.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 05 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Pegulicianine ( Cathepsin )	Breast Cancer More	Approved

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis