除放射腫瘤 合富 布局 治療乾眼症 儀器

檢驗試劑業務快速成長　F-合富營收有望年增逾25%▲F-合富檢驗試劑業務持續快速穩定成長，新代理的診療設備也將於2015開始貢獻較可觀的營收。(圖／資料照片) 記者林潔玲／台北報導 F-合富(4745 ) 檢驗試劑業務持續快速穩定成長，新代理的診療設備ViewRay和TearScience也即將於2015開始貢獻較可觀的營收，並且以合資/合作方式積極擴展其業務領域，因此，法人樂觀預估，2014年的營收有機會較去年同期成長超過25%。 合富在營收分布方面，檢驗試劑的比重由1H13的72%，提升至1H14的83%，原廠代理的比重則由1H13的28%下降至1H14的17%。由於CyberKnife的原廠片面終止合約，目前還在司法仲裁階段。然而若終止CyberKnife的代理合約，法人認為，對合富營運的影響應該不大。 同時，合富以加盟方式擴大層峰計畫之規模，已有48家醫院加入臨床檢驗體外診斷試劑統一採購與物流管理的層峰計畫，目前也有一些同業公司正與合富洽談，希望能「加盟」層峰計畫，可望能進一步擴大層峰計畫的規模。預估2H14將有7~10家醫院簽約加入層峰計畫。 此外，合富新代理兩項診療設備ViewRay和TearScience，與美國ViewRay原廠簽屬放療顯像系統之台港澳代理權，目前在香港與澳門已具銷售資格，預計將於第四季取得台灣的上市許可。 也與美國TearScience原廠簽屬乾眼症檢查及治療儀TearScience System之大中華區獨家代理權，目前在香港與澳門已具銷售資格，並且已於2Q14於香港賣出一台，預計將分別於第四季和明年第三季分別取得台灣和大陸的上市許可。 由於TearScience需要大量鋪設在市場上，合富將以次級代理的方式來擴大通路規模。法人預估，今年營收可望達32.28億元，年增逾25%，稅後淨利年增超過13%。 法人分析，以目前股價計算，PER約為21倍，評價已屬合理，合富今日上漲2.65%，以116元作收，成交量達117張。權證市場中，根據權證王APP資料顯示，目前連結F-合富的相關權證標的有16，以群益Q5最熱門，成交量超過350張，VI永豐漲幅最高。

How TearScience's dry eye treatment sparked a new FDA 510(k) strategy

February 7, 2012 4:01 pm by Frank Vinluan  The dry eye treatment developed by TearScience received 510(k) clearance last week, about seven months after the company's novel medical device received its first marketing go-ahead from the U.S. Food and Drug Administration. While the speed at which regulators granted the second 510(k) clearance surprised TearScience CEO Tim Willis, he says the sequential filings were by design."If you tried to do both of these filings (at once), especially in this regulatory environment, I doubt we'd get cleared by now," he said. An estimated 100 million people worldwide have dry eyes, many of them suffering from evaporative dry eye. Evaporative dry eye is caused by insufficient supply of the oils that keep the tear film from evaporating. Dry eye symptoms can be managed with drugs or eye drops, but Morrisville, North Carolina-based TearScience has developed and commercialized a medical device to treat the condition's underlying cause. The device, LipiFlow, uses a combination of heat and pressure to clear the channels that supply oils to the tear film. According to research firm Market Scope, the dry eye market is a $2.2 billion a year business*. By comparison, Lasik eye surgery represents a $700 million market. Willis said that had TearScience been in a position to apply for FDA clearance on its technology 10 years  ago, the company would have submitted everything in one filing — all 7,000 pages of it. But Willis said that the current FDA is risk averse, which slows review of new devices. In hopes of speeding things along, the company made an initial filing for the part of LipiFlow that treats the patient — the disposable piece that is used on the patient's eye. After that part received FDA clearance, the company filed its application for what the physician uses including upgraded software and a handheld unit. It's the full unit that TearScience will be marketing in the United States. The two separate filings may have sparked what could become a new regulatory strategy for other medical device developers. Willis said that one of the firm's investors told him that he was so impressed with the relative speed of an FDA decision from the two filings that the investor will now press its other companies to pursue the same strategy. One piece of the commercialization puzzle that TearScience has yet to solve is reimbursement. Insurers do not yet pay for LipiFlow treatment and though the company has applied to instate reimbursement, Willis estimates the entire process can take anywhere from three to 10 years. For now, patients pay between $1,400 and $1,900 out of pocket for a treatment on both eyes that lasts nine to 18 months. Willis said that considering that some people with moderate to severe dry eye are already spending up to $4,000 annually on other remedies, patients are willing to pay. For a physician's practice, the entire TearScience diagnostic and treatment system costs about $100,000. The new system will become available to U.S. doctors in March. It's the same system that became available last year in Canada, Europe and Asia. The United States is the only market where TearScience made two separate LipiFlow regulatory filings for marketing clearance. Willis said in 2012 TearScience will seek clearance in as many as 20 new countries worldwide.