Cytori和Lorem Vascular获中国监管部门批准上市 作者:美国商业资讯中文版 发表:2015-04-07 Cytori通过授权人获得中国开业首笔产品采购订单 圣迭戈和北京 -- (美国商业资讯) -- Cytori Therapeutics, Inc. (NASDAQ: CYTX)今天宣布，中华人民共和国国家食品药品监督管理局(CFDA)已核准了该公司的Cytori Celution®系统，并向其独家授权人Lorem Vascular签发了法规批复函。该法规批复函正式宣告Cytori的Celution系统在世界上最大的医疗保健市场上市，由此Cytori通过Lorem Vascular获得一份巨额的2015年度产品采购订单。 在去年准备CFDA报批和策划Celution产品家族在中国上市期间，Cytori在该地区的独家授权人Lorem Vascular与Cytori密切合作。今天的新闻标志着Cytori的Celution系统首次获得全面进军中国大陆市场的许可。Lorem Vascular 将即刻在中国主要医院启动Celution的产品上市。 Lorem Vascular首席执行官David C. Oxley说："我们的联合团队去年花了一年时间来研究中国的医疗保健体制，结果表明，西方国家的流行病对中国数百万公民造成的负担在迅速加重，并且已经对医疗保健体制造成了大量的资源流失。取得CFDA批准后，Lorem Vascular 现在将开始与全中国主要医院缔结伙伴关系，采用患者自身的脂肪组织衍生的再生细胞，来应对特定的血管和非血管应用，该疗法已在全球多项研究中显示了临床前景。" 2013年11月，Cytori Therapeutics与Lorem Vascular 就Cytori Celution系统在中国大陆、香港、马来西亚、新加坡和澳大利亚的商业化签署了一份为期30年的独家授权协议。按照该协议的部分条款，Lorem Vascular同意按特定销售额里程碑向Cytori支付最高达 5亿美元，以获得在授权地区除脱发以外的所有适应证中的30年独家授权，Lorem Vascular还将支付一笔专利费，金额是Lorem 在中国大陆、马来西亚和香港的营业毛利的30%。此外，在今天的新闻发布后，Lorem Vascular签下一份开业首笔订单，包括23台Celution器械和1,100套Celution 耗材，该订单预计将在2015年期间交付。在这份开业首笔订单之后，Lorem Vascular 已同意，自CFDA批复起三年内，每年至少采购五十(50)台Celution 器械，以及与每台Celution器械配套的五十(50)套Celution 耗材。 Cytori Therapeutics财务副总裁兼首席财务官Tiago Girao说："Lorem Vascular对中国市场的承诺，加上今天的CFDA 批复和Lorem Vascular签下的开业首笔订单，是我们2015年计划的重要组成部分，也是今年的关键里程碑。随着今后数年Lorem Vascular在该地区进行商业扩张，我们打算继续全力支持Lorem Vascular。"
关于Cytori Therapeutics, Inc. Cytori Therapeutics是一家晚期细胞疗法公司，开发实验室设备和源自脂肪组织的自体细胞疗法，用于治疗各类内科疾病。临床前研究和临床试验数据显示， Cytori Cell Therapy™ 的作用机制主要是通过改善血流、调控免疫系统以及促进伤口修复。因此，Cytori Cell Therapy™可在多个疾病阶段提供益处，通过Cytori的专利技术和产品，医生和患者可在治疗现场实施该疗法。进一步信息，请访问www.cytori.com。
关于Lorem Vascular Lorem Vascular Pte. Ltd.是再生医学这一新领域的领军企业。公司总部设于新加坡，在澳大利亚、中国大陆、香港和马来西亚设有办事处，通过使医院和医生能够应用患者自身的细胞应对各类重大的血管和非血管疾病，公司正在变革患者治疗的品质。 免责声明：本公告之原文版本乃官方授权版本。译文仅供方便了解之用，烦请参照原文，原文版本乃唯一具法律效力之版本。 联系方式： Cytori Therapeutics, Inc. Shawn Richardson, 1.858.875.5279 ir@cytori.com 或 Lorem Vascular Pte Ltd David Oxley, +61.488.303.060 doxley@loremvascular.com
Cytori and Lorem Vascular Receive Regulatory Clearance in China
04/06/2015 Cytori Receives China Opening Product Purchase Order from Licensee SAN DIEGO & BEIJING--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that its exclusive licensee, Lorem Vascular, has been granted regulatory clearance for the Cytori Celution® System by the State Food and Drug Administration of the People's Republic of China (CFDA). This regulatory clearance officially makes Cytori's Celution System available in the largest healthcare market in the world and triggers a substantial 2015 product purchase order for Cytori from Lorem Vascular. Cytori's exclusive licensee in the region, Lorem Vascular, has worked closely with Cytori during the last year preparing for CFDA clearance and planning for commercial introduction of the Celution family of products in China. Today's news marks the first time that Cytori's Celution System has gained any level of access to the mainland Chinese healthcare market. Lorem Vascular will begin product launch of Celution in key hospitals in China immediately. "Our combined teams have spent the past year examining the delivery of healthcare in China and it is clear that diseases endemic is western countries are a rapidly growing burden on millions of citizens and already represent a heavy drain on resources of the healthcare system," said David C. Oxley, Chief Executive Officer of Lorem Vascular. "With CFDA clearance, Lorem Vascular will now begin to consummate partnerships with key hospitals throughout China to address specific vascular and non-vascular applications using patients' own adipose derived regenerative cells, which have demonstrated clinical promise in studies around the world." In November 2013, Cytori Therapeutics and Lorem Vascular entered into a 30-year exclusive licensing agreement to commercialize Cytori Celution System in China, Hong Kong, Malaysia, Singapore, and Australia. As part of that agreement, Lorem Vascular agreed to pay up to $500 million in fees to Cytori for a 30-year exclusive license for all indications, excluding alopecia, in the licensed territories following specific revenue milestones, as well as royalties of 30% on gross profits from Lorem's operations in China, Malaysia and Hong Kong. Furthermore, following today's news, Lorem Vascular placed an opening order of 23 Celution Devices and 1,100 Celution Consumable Sets, which is anticipated to be fulfilled throughout 2015. Following this opening order, Lorem Vascular has agreed to purchase annually a minimum of fifty (50) Celution Devices and fifty (50) Celution Consumable Sets for each of the Celution Devices for the next three years from CFDA clearance. "Lorem Vascular's commitment to the Chinese market, along with today's CFDA clearance and receipt of the opening order from Lorem Vascular is an important part of our 2015 plan and a key milestone for the year," said Tiago Girao, Vice President of Finance and CFO of Cytori Therapeutics. "We intend to continue our full support of Lorem Vascular as it expands its commercial efforts throughout its territories in the years ahead."
About Cytori Therapeutics, Inc. Cytori Therapeutics is a late stage cell therapy company developing laboratory equipment and autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products. For more information: visit www.cytori.com.
About Lorem Vascular Lorem Vascular Pte. Ltd. is a leader in the new field of regenerative medicine. Headquartered in Singapore, with offices in Australia, China, Hong Kong, and Malaysia, Lorem Vascular is transforming the quality of patient care by enabling hospitals and doctors to address a variety of major vascular and non-vascular diseases using patients' own cells.
The Celution® System: Automated Processing of Adipose-Derived Regenerative Cells in a Functionally Closed System Adv Wound Care (New Rochelle). 2014 Jan 1; 3(1): 38–45.
Objective: To develop a closed, automated system that standardizes the processing of human adipose tissue to obtain and concentrate regenerative cells suitable for clinical treatment of thermal and radioactive burn wounds.
Approach: A medical device was designed to automate processing of adipose tissue to obtain a clinical-grade cell output of stromal vascular cells that may be used immediately as a therapy for a number of conditions, including nonhealing wounds resulting from radiation damage.
Results: The Celution® System reliably and reproducibly generated adipose-derived regenerative cells (ADRCs) from tissue collected manually and from three commercial power-assisted liposuction devices. The entire process of introducing tissue into the system, tissue washing and proteolytic digestion, isolation and concentration of the nonadipocyte nucleated cell fraction, and return to the patient as a wound therapeutic, can be achieved in approximately 1.5 h. An alternative approach that applies ultrasound energy in place of enzymatic digestion demonstrates extremely poor efficiency cell extraction.
Innovation: The Celution System is the first medical device validated and approved by multiple international regulatory authorities to generate autologous stromal vascular cells from adipose tissue that can be used in a real-time bedside manner.
Conclusion: Initial preclinical and clinical studies using ADRCs obtained using the automated tissue processing Celution device described herein validate a safe and effective manner to obtain a promising novel cell-based treatment for wound healing.
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