中国国际医疗器械设计与制造技术展览会(Medtec China)2021

专注于为医疗器械研发与生产服务

2022年8月31-9月2日 | 上海世博展览馆1&2号馆

Another Defining Moment for Minimally Invasive Glaucoma Surgery

2021-11-22

iStar Medical just left its mark on the fast-growing market for minimally invasive glaucoma surgery (MIGS).

The Wavre, Belgium-based company now has CE mark to launch its MINIject glaucoma implant in Europe. iStar said MINIject is now the only commercially available minimally invasive supraciliary device for glaucoma, meaning it is the only approved MIGS device designed to target the supraciliary space as a natural outflow pathway for the reduction of intra-ocular pressure (IOP).

Glaucoma continues to be the leading cause of irreversible blindness, and is estimated to affect about 100 million people worldwide. With all types of glaucoma, the nerve connecting the eye to the brain is damaged, usually due to high eye pressure. According to the Mayo Clinic, the most common type of glaucoma (open-angle glaucoma) often has no symptoms other than slow vision loss. Angle-closure glaucoma, although rare, is a medical emergency and its symptoms include eye pain with nausea and sudden visual disturbance.

The diagram below shows the development of glaucoma.


According to iStar, MIGS represents the most promising and fastest-growing glaucoma therapy, due to its enhanced safety profile compared to traditional surgery. Right now, the MIGS market is estimated to reach about $786 million by 2026, according to report from MarketWatch.

Data reported to date by iStar across four trials in more than 150 patients consistently show that MINIject demonstrates a balance of powerful and sustained IOP reduction with a positive safety profile. The company also touts that MINIject's efficacy and safety profile make the implant optimal for treatment in a broader glaucoma population.

The company is already rolling out the device in select European regions, and the first commercial implantations have already taken place in Germany.

"I'm very pleased that I'm now able to offer the MINIject supraciliary device as a treatment option to my mild-to-moderate glaucoma patients, the first of which was treated successfully today," said Burkhard Dick, head of the ophthalmology department at the University Eye Hospital in Bochum, Germany. "Based on results so far, MINIject may open up new treatment paradigms for patients with glaucoma across Europe."


As MD+DI reported last year, strong one-year results from the company's STAR-II European trial were presented at the 2020 meeting of the American Academy of Ophthalmology (AAO). More recently, positive two-year results from the trial were presented at this year's AAO meeting, demonstrating a sustained powerful efficacy and safety outcome in patients with open-angle glaucoma.

MINIject is currently being investigated in STAR-V, a pivotal study, which FDA gave its blessing for in July. The study is expected to enroll more than 350 patients with primary open-angle glaucoma.

"The launch of our first product in Europe sets iStar Medical on a very promising trajectory for future value generation," said David Stocker, vice president of sales and marketing at iStar. "With its unique product characteristics, MINIject has the potential to gain a significant share of the growing wider market for glaucoma treatments, and amongst its peers in the MIGS segment. Our ambition is to make this novel MIGS solution available to a broad patient community and grow the organization, our network, and our international footprint to meet the size of the opportunity."

Moments that defined the minimally invasive glaucoma surgery market

The MIGS market has undergone many significant changes in recent history, and there are more changes on the horizon that will further define the space. At one point, six stand-alone companies were competing in MIGS, but many of those original players have either been acquired or dropped out of the race due to product failures.

• One MIGS OG that continues to dominate the space is Glaukos. The San Clemente, CA-based company has been at the forefront of the MIGS market for several years now, and was the first to gain FDA approval in the space. Glaukos was also the first MIGS company to go public back in 2015, raising $140 million in its initial public offering.
Another leading contender in the space is Ivantis. The Irvine, CA-based received FDA approval for its Hydrus Microstent in August 2018, marking another defining moment for MIGS. The Hydrus Microstent is used to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. Glaukos and Ivantis recently settled a patent lawsuit, which will have Ivantis paying Glaukos $60 million, plus a 10% ongoing royalty through April 26, 2025.
• The original six stand-alone MIGS players became a group of five after Dublin, Ireland-based Allergan bought AqueSys in 2015 for $300 million plus milestone payments. That deal was the first time a large public company made a move in the space, but it certainly wouldn't be the last. In 2016, Osaka, Japan-based Santen Pharmaceuticals acquired Innfocus for $225 million. That was the third such merger in the space, which left Glaukos, Ivantis and iStar as the only three stand-alone MIGS players.
• Alcon pulled its Cypass Micro-Stent off the global market in 2018 due to patients experiencing statistically significant endothelial cell loss compared to patients who underwent cataract surgery alone. Alcon, which was part of Novartis at the time, acquired the CyPass Micro-Stent when it bought Transcend Medical in 2016. The CyPass product removal caused shares to skyrocket for Glaukos, and created distance between the other MIGS firms. It looks as though Alcon will be getting back into MIGS soon though. The Geneva, Switzerland-based company recently announced its inentions to acquire Ivantis for $475 million.
• We'd be remiss not to mention Sight Sciences, which is also eyeing a strong position in the stand-alone MIGS market, and has the data to back that up. A study, showing two-year outcomes of the Menlo Park, CA-based company’s Omni Surgical System, was published in Clinical Ophthalmology earlier this year.

Article source: Qmed and MD+DI

 

伴随着人工智能兴起,起步较晚的国产医疗机器人正在加快发展,逐步扩大应用场景。5月26日,第十一届中国生物产业大会在武汉光谷发布本土健康企业的7项最新成果,首先推介的便是武汉兰丁公司的宫颈癌检测智能机器人。

 

《每日经济新闻》记者在大会现场了解到,多家企业正在推广医疗机器人,应用范围涵盖胃镜检查、腹腔手术、美容抗衰等,并且已有成熟产品进入国内医院,打破进口机器人在医院应用的垄断局面。

 

 

据主办方介绍,“LANDING”机器人通过筛查样本拨片进行自动化诊断,每月有108万例的样本检测能力,效率远远超过人工。目前,武汉兰丁公司与阿里巴巴的合作,使“LANDING”机器人在中国各地基层终端收集的大量细胞特征参数及数据,在云平台上完成分析诊断工作。

 

 

科技颠覆想象力,机器人在医疗领域的应用范围更加广泛。《每日经济新闻》记者注意到,多家企业在生物产业大会上重点推介医疗机器人产品。

 

患者吞下一粒胶囊,在胃里变成机器人进行螺旋式扫描,将检查图像实时传输至医生电脑,这便是安翰光电技术(武汉)有限公司研制的磁控胶囊胃镜机器人。该公司展位负责人程先生介绍,目前全国已有1000多家医疗机构应用了胶囊胃镜机器人,包括三甲医院、大型体检中心等,涵盖专业医疗和常规健康体检领域,年消耗量达50万粒。

 

据了解,这粒胶囊仅重5G,但包含了80多项科技创新专利,集成400多个精密元器件。上述负责人表示,在检查方面,胃镜机器人可以替代传统的电子胃镜,不过电子胃镜可以做小型的腔镜手术、切片等,胶囊机器人还不具备这些功能,但在进一步研发中。

 

苏州康多机器人有限公司则在大会上重点推介腹腔镜手术机器人系统,该公司展位负责人张辉介绍,这款手术机器人由医生控制台、支撑臂、手术器械三部分组成,通过机器人操作可以起到防止手抖、放大病灶视野等精确治疗的效果。

 

其实,在“机器换人”升级过程中,国产医疗机器人起步虽晚,但发展很快,不少上市公司将其作为下一风口进行布局。

 

2015年,制造装备公司楚天科技(行情300358,诊股)(300358,SZ)表示正在研发医药机器人和医疗机器人,一年后,首台医药无菌生产智能机器人下线,步入医药装备4.0时代;2017年11月,科大讯飞(行情002230,诊股)(002230,SZ)研发的医疗机器人“智医助理”通过临床执业医师综合笔试,目前已进入合肥基层卫生中心,辅助全科医生进行诊疗;2017年,埃斯顿(行情002747,诊股)(002747,SZ)收购美国Barrett 30%股权,全面进军康复医疗机器人市场,并计划与Barrett共同出资在中国境内成立一家新的合公司。

 

国产机器人拥有成本优势 在多家企业布局的背后,是医疗机器人巨大的市场潜力。普华永道中国发布的《医疗机器人宏观应用趋势与研究方向》显示,2014年,全球医疗机器人的市场价值是26亿美元,到2020年预计会达到76亿美元。

 

人均可支配收入的增加会促使高质量医疗需求的增长,而医疗机器人正好有出血少、精准度更高,恢复快的优势。整个发展趋势显示医疗机器人市场潜力巨大。

 

目前,国内医院的医疗机器人仍依赖进口,最为广泛应用的就是美国直觉外科公司制造的达芬奇手术机器人,2016年国内手术量突破1.5万台。

 

但是,进口医疗机器人价格昂贵,使得医疗费用也居高不下,如一台达芬奇机器人在国内售价2000万元左右,附带长期的耗材费用。

 

“进口机器人就算不用,一年的保养费都得80~100万元,每天开机费用就达1万元左右。”张辉表示,国外的机器人设备,主要包括维修费、保养费、耗材费等费用,所以价格居高不下。

 

随着国产医疗机器人发力,这一局面有望打破。此前,楚天科技研发的医药无菌生产机器人定价500万~600万元,而国际同类机器人定价800万~1000万元左右。

 

张辉告诉《每日经济新闻》记者,国产医疗机器人的优势是小型化、便捷化,还有国内的服务体系,针对三甲医院、县级医院等机构,可以实现分级应用,因此价格应该会比进口设备低一半左右,降低医疗成本。

 

来源:每日经济新闻

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