Port-Wine Stain

Vbeam Pro will be unveiled at the 2025 Annual Meeting of American Society for Laser Medicine and Surgery (ASLMS) MARLBOROUGH, Mass., April 24, 2025 /PRNewswire/ -- Candela Corporation, a global leader in energy-based medical aesthetics, proudly announced the launch of the Vbeam Pro platform at the 2025 Annual Meeting of the American Society for Laser Medicine and Surgery (ASLMS), held in Orlando, FL. Representing the most significant advancement in Candela's four-decades of clinical leadership in pulsed dye laser (PDL) technology, the Vbeam Pro device sets a new market standard for the treatment of vascular and dermatologic conditions. Continue Reading Vbeam Pro Logo Vbeam Pro Device The Vbeam Pro device is the only vascular laser FDA-cleared for use in pediatric patients and combines an advanced 595 nm pulsed dye laser with a 1064 nm Nd:YAG wavelength to offer unmatched precision, accuracy, and treatment versatility. The platform is designed to effectively treat a broad spectrum of skin conditions, including rosacea, port-wine stains, acne, leg veins, spider veins, scars, benign pigmented lesions, wrinkles, warts, stretch marks, and photoaging. "The Vbeam Pro system is a transformative evolution in pulsed dye laser technology," says Dr. Roy Geronemus, Clinical Professor in the Department of Dermatology at NYU Grossman School of Medicine and Medical Director of the Vascular Birthmarks Foundation. "The clinical results are remarkably consistent, and patients are experiencing enhanced outcomes compared to earlier-generation systems," he adds. With its dual wavelengths and 30% tighter energy delivery control, the Vbeam Pro laser offers a new level of efficacy and efficiency for clinicians treating patients across all Fitzpatrick skin types (I–VI). The platform also features optimized dye life and an enhanced user interface, delivering a superior treatment experience for both practitioners and patients. Backed by rigorous clinical research, the Vbeam Pro laser has demonstrated: 20% improved clearance of treated lesions¹ 50% faster treatment times² 20% reduction in reported patient discomfort³ "Reinforcing Candela's commitment to scientific rigor, the Vbeam Pro system underwent extensive clinical evaluation at leading dermatology practices across the United States," says Konika Patel Schallen, MD, Senior Vice President of Clinical Operations and Medical Director at Candela. "We put the platform through stringent testing, using it in busy clinical environments on a wide variety of skin types and conditions. We are excited about the feedback from our dermatology users on enhancing patient outcomes and treatment efficiency." she concludes. "Building on Candela's longstanding clinical leadership, the introduction of the Vbeam Pro system represents a major leap forward in the treatment of vascular and other skin conditions," said Geoffrey Crouse, Chief Executive Officer of Candela. "This milestone launch reflects our unwavering commitment to continuous innovation, rooted in proven science, consistent clinical outcomes, and trusted partnerships with both healthcare providers and patients." Attendees of ASLMS 2025 are invited to experience the Vbeam Pro device by visiting Candela at Booth #321. For more information, please visit: candelamedical.com 1. Compared to Vbeam Perfecta; Vbeam 595 nm output Accuracy and Precision data on file 2. Supported by early LCR participant treatment feedback 3. Data from LCR sites relative to Perfecta 4. Based on patient reports from LCR sites relative to prior Vbeam systems Media Contact: Lindsey Hans, [email protected] SOURCE CANDELA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The gala raised hundreds of thousands of dollars that will go directly toward vital medical care for children with physical and cosmetic deformities SAN DIEGO, Nov. 11, 2024 /PRNewswire/ -- Continuing their incredible mission to transform the lives of underprivileged children through no-cost reconstructive medical care, global nonprofit Fresh Start Surgical Gifts hosted its 33rd Annual Butterfly Ball in San Diego, California, sponsored by Axos Bank and Salvatore J. Pacella Plastic Surgery. With hundreds in attendance, this year's Butterfly Ball celebrated the extraordinary, life-changing work of the nonprofit and the generous support of its donors, while also raising funds to provide reconstructive surgeries for disadvantaged children around the world. Continue Reading All money raised by the nonprofit goes directly toward medical care, ensuring no patient will be left uncared for. Post this Fresh Start Surgical Gifts hosted their 33rd Annual Butterfly Ball. The 33rd Annual Butterfly Ball raised hundreds of thousands of dollars, which will go directly toward helping dozens of children receive the life-altering medical care they desperately need. Children from across the United States and around the world seek Fresh Start's medical services and attend the nonprofit's Surgery Weekends, where experts in reconstructive surgery donate their time and skills to transform the lives of children. Fresh Start's volunteer medical team provides world-class care for children and adolescents with a wide range of medical conditions, such as microtia, hemangioma, neurofibromatosis, hairy nevus, Apert syndrome, cleft lip and palate, Treacher Collins syndrome, port-wine stains and hemifacial microsomia. The nonprofit also treats children and adolescents suffering from deformities caused by abuse, disease and accidents who are unable to afford medical care. The money raised from Fresh Start's Annual Butterfly Ball not only goes toward reconstructive surgeries for these patients but also helps fund speech therapy sessions, minor treatments, postoperative appointments, evaluations for ongoing patients and consultations with new patients. Fresh Start has been providing comprehensive medical care to children around the world since 1991, having transformed the lives of over 9,000 children and teens through more than 23,000 reconstructive surgeries. With care from world-class surgeons and medical staff, Fresh Start's annual gala ensures that no family will ever receive a bill for the medical services their child receives and that each patient undergoes thorough postoperative care so they can grow up to lead healthy, productive lives. Beyond medical transformations, the impact on these children's lives extends even further. Patients experience a profound increase in self-esteem and confidence, with many reporting feeling empowered to pursue their dreams—90% are even inspired to enter medical fields themselves. Additionally, the majority engage more actively in healthy habits, resulting in an overall improvement in their well-being, happiness and quality of life. Over 98% are currently enrolled in school or employed, highlighting how this care contributes to both their immediate and long-term success. Through funds raised from its annual Butterfly Ball and general donations sent in through Fresh Start's website, the nonprofit has been able to make a lasting impact on the lives of hundreds of children from around the world. All money raised by the nonprofit goes directly toward providing comprehensive medical care with a team of world-class volunteer surgeons, ensuring no patient will be left uncared for. For more information on Fresh Start Surgical Gifts or to make a donation, visit FreshStart.org. For media inquiries, please contact [email protected]. For photos from the 33rd Annual Butterfly Ball, click here. Esta información y el comunicado de prensa están disponibles en español para los medios de comunicación que así lo requieran. About Fresh Start Surgical Gifts Since 1991, Fresh Start Surgical Gifts has been transforming the lives of underprivileged infants, children and adolescents from all over the world through the gift of reconstructive surgery. With medical care offered in California, Texas, Illinois, Massachusetts and Costa Rica, Fresh Start Surgical Gifts' team of world-class surgeons and medical professionals volunteer their time to treat children with physical deformities caused by birth, accidents, abuse or disease. Ensuring every patient receives the highest quality treatment, Fresh Start's commitment goes beyond medical care, empowering children to leave feeling more confident and self-assured. All monetary contributions to Fresh Start go directly to funding patient's medical procedures, making sure all care comes at no cost to the patient or their families. To learn more and donate, visit FreshStart.org. Contact: Karla Nafarrate Vice President of Public Relations InnoVision Marketing Group [email protected] SOURCE Fresh Start Surgical Gifts WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

欢迎关注凯莱英药闻 复旦张江生物于1996年创立，知名企业上海医药集团等担任其公司股东，目前已成长为一家“H+A”双资本平台上市的科创公司。 公司成立之初，依靠TPA、TNF受体等一系列生物医药技术转让和医疗诊断产品销售，为公司的创新研发提供资金支持；经过多年的不懈努力，公司在基因技术药物、光动力技术药物、纳米技术药物及口服固体制剂技术药物等领域不断推出新技术及产品，形成了明显的竞争优势。 截至2023年度，复旦张江在ADC药物相关研究领域的投资金额已达到3.5亿元，规模在四大平台中居首位；一起来看复旦张江有哪些优势平台及值得关注的产品。 一 技术平台 1、光动力技术平台  公司针对目前无法治疗或干预的一些癌前病变及非肿瘤疾病的治疗，早在1999年即开始从事光动力新药的研究开发，逐步构建了光动力药物研发平台；已建立了包括光敏剂合成、筛选，适应症及作用机理研究，工艺开发，临床研究，配套激光设备及医疗器械开发的完整研发体系。其中，盐酸氨酮戊酸（艾拉）、海姆泊芬（复美达）是其代表性产品。 2、纳米技术平台 该平台主要由两部分组成，一是基于脂质的药物传输系统；二是基于白蛋白的药物传输系统。公司分别选择了体内生物相容性好，安全性高的磷脂和HSA（人血清白蛋白）作为药物的载体，构建化疗小分子药物、多肽、蛋白类药物新的给药系统，用于提高系统给药后的组织分布，选择性的输送药物到病理部位，以及避免在正常组织中聚集。 其中，盐酸多柔比星脂质体（里葆多）是一种采用先进的隐形脂质体技术包封，具有被动靶向特性的多柔比星新剂型。除此以外，治疗恶性肿瘤的纳米药物硫酸长春新碱脂质体已经完成I期临床研究。治疗肿瘤的紫杉醇白蛋白纳米粒项目正开展临床前相关研究。 3、基因工程技术平台 利用该平台，公司在原核细胞表达系统的高密度发酵与表达、哺乳动物细胞表达系统的发酵表达与糖基化工程控制、蛋白质大规模纯化以及抗体与小分子偶联技术上有突出创新研究。 其中，治疗关节炎的高活性重组人肿瘤坏死因子受体突变体-Fc融合蛋白(rhTNFR(m):Fc) 已经完成临床I期研究；治疗肿瘤的注射用重组人鼠嵌合抗CD30单克隆抗体-MCC-DM1偶联剂(CD30-DM1)已取得了国家药品监督管理局颁发的药物临床试验批件； 另两项针对乳腺癌、胃癌的抗体偶联药物正进行临床前概念验证研究。此外，治疗肿瘤的Avastin生物类似药已获得临床批件并转让给第三方。 4、口服固体制剂技术平台 公司联合了第三方机构逐步建立了该平台的技术体系，正在开发多个具有独特临床治疗价值的新药和仿制药。 目前，治疗肝脏疾病的奥贝胆酸已正式启动临床一致性评价研究并计划尽快申请药品注册；此外，公司开展了小分子靶向药物JAK1选择性抑制剂项目的临床前研究，已确认对自身免疫疾病具有巨大治疗价值。 二 财务情况 近期，公司发布了2024年上半年报告，H1实现营业收入4.08亿元，同比下降21.94%，这一下降主要归因于公司与推广服务商上海辉正终止合作，导致主要产品之一里葆多的销售下降；归属于上市公司股东的净利润为7047.31万元，同比增长2.97%。尽管营收有所下滑，公司在研发投入方面显著增加，研发费用达到1.55亿元，占营收比例达到38.06%，较上年同期增加15.38%。 其中，2024年第二季度实现营收2.60亿元，较一季度环比增长76.42%，归母净利润6812.57万元，较一季度环比增长2802.18%。 截至2024年6月30日，公司总资产为28.49亿元。 三 创新药管线介绍 （一）光动力产品 1、盐酸氨酮戊酸（艾拉） 盐酸氨酮戊酸（5-ALA）是第2代光敏剂，是一种体内血红蛋白合成过程的前体物，用于尖锐湿疣的治疗。该药物能够选择性地在尖锐湿疣细胞中分布和累积，加以特定波长和能量的光波照射，可以选择性地杀死尖锐湿疣细胞，而不损害周围正常组织细胞。尤其对亚临床感染和潜伏感染也能清除，从而降低复发率。 2、海姆泊芬（复美达） 海姆泊芬一种卟啉类光动力治疗药物，用于鲜红斑痣的治疗。经静脉注射后，该药物立即在血液中形成浓度高峰，其迅速向组织扩散并特异性分布于血管内皮细胞；此时给予特定波长的激光或LED光照射，将激发海姆泊芬的光动力反应，选择性破坏富含光敏剂的血管内皮组织。患部病灶部位扩张畸形的毛细血管网将在光动力作用和后续的体内凝血系统作用下被清除。由于海姆泊芬的选择性分布，病灶部位的正常表皮层将不受光动力反应的损伤。 作为第二代光敏剂，海姆泊芬具有明显的技术优势：（1）海姆泊芬为单体化合物，结构明确，质量可控；（2）海姆泊芬对正常组织的光毒作用很低，因此相对更安全、不良反应更少；（3）海姆泊芬代谢迅速，可迅速从组织中清除，因此具有治疗后避光期短和可在短期内重复治疗的优势。 临床试验结果表明，复美达光动力治疗用于鲜红斑痣，2次治疗后有效率97.4%，基愈率高达28.10%。 （二）纳米技术产品 盐酸多柔比星脂质体是将盐酸多柔比星包封于表面结合有甲氧基聚乙二醇(MPEG化)的脂质体中，通过脂质体表面的PEG水化层阻止了脂质体与血浆调理素的结合，从而保护脂质体免受单核巨噬细胞系统（MPS）识别，延长其在血液循环中的时间。因此，本品具有与盐酸多柔比星完全不同的药代动力学特点。经静脉给药后，包封在PEG化脂质体内的盐酸多柔比星在体内的循环时间明显被延长，同时利用肿瘤部位EPR效应，使盐酸多柔比星在肿瘤部位实现靶向富集，减少了药物原有的心脏、骨髓以及脱发等毒副反应。 本品可用作一线化疗药物，或者用作治疗病情有进展的AIDS-KS病人的二线化疗药物，也可用于不能耐受下列两种以上药物联合化疗的病人：长春新碱、博莱霉素和多柔比星（或其他蒽环类抗生素）。 （三）ADC药物 1、FDA018 FDA018 是新一代针对 TROP2 靶点的抗肿瘤 ADC 药物，通过可水解的 pH 敏感型连接子将抗 TROP2 人源化单克隆抗体与小分子细胞毒药物（拓扑异构酶 I 抑制剂）SN-38 偶联，定向杀伤肿瘤细胞。2024年5月，公司披露其用于治疗晚期实体瘤的剂量递增研究和三阴性乳腺癌（TNBC）队列扩展之I期临床研究的数据结果，主要终点包括最大耐受剂量（MTD）、安全性以及耐受性；次要终点包括疗效、药代动力学以及抗药抗体发生率，结果显示：在接受了10.0 mg/kg剂量治疗且疗效可评估的29例TNBC患者中，11 名部分缓解，客观缓解率（ORR）和疾病控制率（DCR）分别为37.9%和79.3%。最常见的 3 级 TRAE 是中性粒细胞减少症 (45.2%)、白细胞减少症 (33.9%)、发热性中性粒细胞减少症 (4.8%)、贫血 (4.8%) 和斑丘疹 (4.8%)。 2、FDA022 FDA022 由针对人表皮生长因子受体2 （HER2）靶点的单克隆抗体与BB05 偶联组成；可通过与HER2 表达的肿瘤细胞结合并内吞，在溶酶体内通过蛋白酶剪切定向释放小分子细胞毒药物（拓扑异构酶I 抑制剂），杀伤肿瘤细胞。该药物拟用于治疗HER2 表达阳性的晚期实体瘤，如乳腺癌、胃癌、肺癌、结直肠癌等。 3、F0002-ADC F0002-ADC（CD30-MCC-DM1）结合了抗有丝分裂剂 DM1 和稳定的 SMCC 连接子，拟用于治疗CD30 阳性血液系统恶性肿瘤。在体内实验中，抗 CD30-MCC-DM1 被发现能够诱导皮下接种 Karpas 299（间变性大细胞淋巴瘤）、HH（皮肤 T 细胞淋巴瘤）和 L428（霍奇金病）细胞模型的肿瘤消退。4 mg/kg 和 12 mg/kg 抗CD30-MCC-DM1 在食蟹猴中的半衰期约为 5 天，非人类灵长类动物的耐受剂量为 30 mg/kg，支持抗 CD30-MCC-DM1 在人体内中使用。 4、FZ-AD004 FZ-AD004由针对人滋养层细胞表面糖蛋白抗原（TROP-2）靶点的单克隆抗体与 BB05 偶联组成，通过与 TROP-2 表达的肿瘤细胞结合并内吞，在溶酶体内通过蛋白酶剪切定向释放小分子细胞毒药物（拓扑异构酶 I 抑制剂），杀伤肿瘤细胞。该药物拟用于治疗晚期实体瘤，包括但不限于肺癌、乳腺癌、胃癌、食管癌、结直肠癌、尿路上皮癌、膀胱癌和子宫内膜癌等。 5、FZ-AD005 FZ-AD005是一款靶向DLL-3的ADC，由新型抗 DLL3 抗体FZ-A038 和缬氨酸-丙氨酸 (Val-Ala) 二肽接头与 DXd 结合而生成的，利用具有强细胞毒性和相对较好安全性的 DXd 来最大化治疗指数。此外，FZ-AD005引入了Fc沉默技术，避免了FcγR介导的脱靶毒性，并且在体外表现出可忽略不计的Fc介导的效应功能。 在临床前评估中，FZ-AD005表现出DLL3特异性结合，在细胞系衍生的异种移植（CDX）和患者衍生的异种移植（PDX）模型中表现出高效的内化、旁观者杀伤和出色的体内抗肿瘤活性。在食蟹猴中，FZ-AD005循环稳定，药代动力学特征可接受。在大鼠和猴子中，FZ-AD005耐受性良好。此外，FZ-AD005的安全性良好，在食蟹猴中最高无严重毒性剂量为30mg / kg。 （四）小分子药物 FZJ-003 是一种对丝氨酸蛋白酶抑制剂进行结构改造的选择性 Janus 激酶 1 (JAK1) 抑制剂，用于治疗类风湿性关节炎 (RA)。体内和体外实验显示，清醒大鼠经等摩尔剂量静脉或灌胃给药后，FZJ-003的全身暴露量比filgotinib高2倍以上，清除率较低。在不同给药方式的麻醉大鼠中，FZJ-003具有较高的肠道生物利用度(98.47 vs 34.54%)，但具有较低的肝脏生物利用度(61.45 vs 92.07%)。Caco-2细胞渗透性试验表明，FZJ-003可能是被动扩散转运，其渗透性略高。代谢研究表明，FZJ-003经历了更多的NADPH依赖性代谢，特别是在肝微粒体部分。与filgotinib不同，FZJ-003在全身前代谢位点，未检测到明显的酰胺水解代谢物。 参考资料 1、公司官网 2、偶联天夏、有连云、第一财经、财联社、医药魔方 感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下