Lumicell, Inc.

作者｜momo 截止目前，FDA已经批准35款新药上市，其中多款药物具有里程碑意义。    01   2024年FDA已批准药物 1.1.Zelsuvmi (berdazimer) 适应症：局部传染性软疣 批准日期：2024年1月5日 企业：Novan Inc. 1.2.Exblifep (cefepime and enmetazobactam) 适应症：尿路感染 靶点：LACTB、PBP 批准日期：2024年2月22日 企业：Orchid Chemicals & Pharmaceuticals Ltd. 1.3.Letybo (letibotulinumtoxin a-WLBG) 适应症：中度至重度眉间纹的外观改善 靶点：BoNT/A 批准日期：2024年2月29日 企业：Hugel Inc. 1.4.Tevimbra (tislelizumab-JSGR) 适应症：不可切除、局部晚期或转移性食管鳞状细胞癌 靶点：PD-1 批准日期：2024年3月13日 企业：百济神州 1.5.Rezdiffra (resmetirom) 适应症：中晚期非肝硬化性非酒精性脂肪性肝炎 靶点：THR-β 批准日期：2024年3月14日 企业：罗氏 1.6.Tryvio 适应症：高血压 靶点：ET-A、ET-B 批准日期：2024年3月19日 企业：Idorsia. 1.7.Duvyzat 适应症：杜氏肌营养不良症 靶点：HDAC 批准日期：2024年3月21日 企业：Italfarmaco Spa. 1.8.Winrevair (sotatercept-CSRK) 适应症：肺动脉高压 靶点：INHBA 批准日期：2024年3月26日 企业：Acceleron Pharma Inc. 1.9.Vafseo 适应症：成人慢性肾脏疾病引起的贫血 靶点：HIF 批准日期：2024年3月27日 企业：宝洁 1.10.Voydeya 适应症：阵发性夜间血红蛋白尿治疗血管外溶血 靶点：CFD 批准日期：2024年3月29日 企业：Achillion Pharmaceuticals Inc. 1.11.Zevtera (ceftobiprole medocaril sodium) 适应症：血液感染、细菌性皮肤和相关组织感染、社区获得性细菌性肺炎 靶点：PBP 批准日期：2024年4月3日 企业：Roche 1.12.Lumisight 适应症：乳腺癌荧光成像 批准日期：2024年4月17日 企业：Lumicell Inc., 杜克大学 1.13.Anktiva (nogapendekin alfa inbakicept-pmln) 适应症：膀胱癌 靶点：IL-15R 批准日期：2024年4月22日 企业：Altor Bioscience Corp. 1.14.Ojemda (tovorafenib) 适应症：复发或难治性儿童低级别胶质瘤 靶点:RAF 批准日期：2024年4月23日 企业：Viracta Therapeutics Inc. 1.15.Xolremdi (mavorixafor) 适应症：治疗12岁及以上患有WHIM综合征的患者 靶点：CXCR4 批准日期：2024年4月26日 企业：赛诺菲 1.16.Imdelltra (tarlatamab-dlle) 适应症：广泛期小细胞肺癌 靶点：CD3E、DLL3 批准日期：2024年5月16日 企业：Amgen Inc. 1.17.Rytelo (imetelstat) 适应症：低危骨髓增生异常综合征伴输血依赖性贫血 靶点：Telomerase 批准日期：2024年6月6日 企业：Geron Corp. 1.18.Iqirvo (elafibranor) 适应症：原发性胆汁性胆管炎 靶点：PPARɑ/γ 批准日期：2024年6月10日 企业：Genfit SA 1.19.Sofdra (sofpironium) 适应症：原发性腋窝多汗症 靶点：AChR 批准日期：2024年6月18日 企业：Bodor Laboratories Inc. 1.20.Piasky (crovalimab-akkz) 适应症：阵发性睡眠性血红蛋白尿症 靶点：C5 批准日期：2024年6月20日 企业：Sino-Foreign Pharmaceutical Co., Ltd. 1.21.Ohtuvayre（Ensifentrine） 适应症：治疗慢性阻塞性肺病 靶点：PDE3/4 批准日期：2024年6月26日 企业：Verona Pharma. 1.22.Kisunla（Donanemab-azbt） 适应症：阿尔兹海默病 靶点：pGlu3Aβ 批准日期：2024年7月2日 企业：lilly 1.23.Leqselvi（Deuruxolitinib） 适应症：严重斑秃 靶点：JAK 批准日期：2024年7月25日 企业：Sun Pharmaceuticals 1.24.Voranigo（vorasidenib） 适应症：IDH1或IDH2易感突变的2级星形细胞瘤或少突胶质细胞瘤。 靶点：IDH1、IDH2 批准日期：2024年8月6日 企业：Servier Pharmaceuticals 1.25.Yorvipath（palopegteriparatide） 适应症：甲状旁腺功能亢进 批准日期：2024年8月9日 企业：ascendis Pharma. 1.26.Nemluvio（nemolizumab-ilto） 适应症：结节性痒疹 靶点:IL-31 批准日期：2024年8月12日 企业：Galderma Pharma. 1.27. Livdelzi（seladelpar） 适应症：原发性胆汁性胆管炎 靶点：PPAR-δ 批准日期：2024年8月14日 企业：Gilead Sciences 1.28.Niktimvo（axatilimab-csfr） 适应症：慢性移植物抗宿主病 靶点CSF-1R 批准日期：2024年8月14日 企业：Incyte/Syndax制药 1.29.Lazcluze（lazertinib） 适应症：非小细胞肺癌 靶点：EGFRm 批准日期：2024年8月19日 企业：强生 1.30.Ebglyss（lebrikizumab-lbkz） 适应症：中度至重度特应性皮炎 靶点：IL-13 批准日期：2024年9月13日 企业：lilly 1.31.Miplyffa（arimoclomol） 适应症：C型尼曼-匹克病 靶点：HSP 批准日期：2024年9月20日 企业：Zevra Therapeutics 1.32.Aqneursa （levacetylleucine） 适应症：儿童和成人C型尼曼匹克病 批准日期：2024年9月24日 企业：IntraBio. 1.33.Cobenfy（xanomeline and trospium chloride） 适应症：成人精神分裂症 靶点：M1-和M4-选择性毒蕈碱受体 批准日期：2024年9月26日 企业：百时美施贵宝 1.34.Flyrcado（flurpiridaz F 18） 适应症：评估心脏血流阻塞（心肌缺血）和心脏病发作（心肌梗塞） 批准日期：2024年9月27日 企业：GE HealthCare 1.35.Tevimbra（Tislelizumab） 适应症：不可切除或转移性食管鳞状细胞癌 靶点：PD-1 批准日期：2024年10月4日 企业：百济神州   02   2024年FDA批准的突出药物 Voranigo（vorasidenib）这种双重IDH1/IDH2抑制剂处理导致癌细胞代谢变化的突变。它被批准用于2级星形细胞瘤或少突胶质细胞瘤，这是一种生长缓慢的脑肿瘤，具有显著的风险。这是一个突破，因为它直接针对驱动肿瘤生长的突变，提供了一种更有效的治疗选择，可以延缓疾病进展，减少对辐射等侵入性治疗的依赖。 Niktimvo（Axatilimab）是一种CSF-1R单克隆抗体，通过限制巨噬细胞活性来治疗cGVHD，巨噬细胞在免疫应答中起着至关重要的作用。这种疗法对患有cGVHD的患者至关重要，这是干细胞移植后的一种严重并发症，通常对现有治疗无效。它提供了一种更有针对性的策略来改善患者的生活质量。 Cobenfy作为Xanomeline和Trospium Chloride这种联合治疗方法，通过调节毒蕈碱受体，为治疗精神分裂症带来了新的途径。通过平衡大脑中的神经递质活动，它解决了这种疾病的阳性和阴性症状，这使得它对那些用其他药物都没有成功的患者特别有价值。它的双重机制提供了更全面的症状管理，改善了那些受这种具有挑战性的精神健康状况影响的结果。 Rezdiffra（resmetirom）是一款甲状腺激素受体（THR）-β口服选择性激动剂，THR-β在肝脏中高度表达，能够调节脂代谢，降低LDL-C、甘油三酯和致动脉粥样硬化性脂蛋白。此外，THR-β还能通过促进脂肪酸的分解和刺激线粒体的生物发生来减少脂肪毒性并改善肝功能，从而减少肝脏脂肪。Rezdiffra用于治疗患有中重度肝纤维化（F2至F3期）的非肝硬化非酒精性脂肪性肝炎（NASH）患者，成为FDA批准的首款NASH疗法，具有里程碑意义。 Anktiva是一款IL-15超级激动剂。IL-15通过影响自然杀伤（NK）细胞和免疫T细胞的发育、维持和功能，在免疫系统中发挥着至关重要的作用。Anktiva由与IL-15受体α/IgG1 Fc融合蛋白结合的IL-15突变体（IL-15N72D）组成。它与βγ T细胞受体结合，直接特异性刺激CD8阳性T细胞和NK细胞，同时避免刺激调节性T细胞（Treg）。与天然、非复合IL-15相比，Anktiva在患者体内具有更优的药代动力学特性，且能在淋巴组织中存在更长时间，表现出增强的抗肿瘤活性。Anktiva在2019年获FDA授予突破性疗法认定，用于与BCG联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。 参考资料 [1]Novel Drug Approvals for 2024 | FDA [2]百济神州官网 BiG近期会议 10月26日，第三届生物计算大会保留栏目-第二届吐槽大会即将再度来袭！本届吐槽大会将围绕投融资、行业心态、年轻人，及AI等热门话题展开策划，通过移幕换景，大咖带新秀，让更多80-00后的行业亲历者来到聚光灯下，邀与会嘉宾一同探讨AI+Biomed的融合之道！ 共建Biomedical创新生态圈！ 如何加入BiG会员？

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 >>

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