美国Microline PENTAX Inc
美国Microline PENTAX 内窥镜
Founded in 1987, Microline is a wholly owned subsidiary of HOYA Corporation in Tokyo, Japan, a $4.5 billion company with approximately half of its revenue in medical business, including endoscopy and eye care. The Company, acquired in 2004, designs, develops, manufactures, and markets worldwide a broad range of minimally invasive reposable instruments for surgery.

Founded in 1997, Starion Instruments ™ Corp. is a wholly-owned subsidiary of Microline. The Company, acquired in April 2009, develops advanced surgical devices that enhance performance, minimize risk and improve patient outcome.

Products Microline‘s product portfolio comprises cutting, dissecting, grasping, cauterizing and ligating instruments used in all laparoscopic surgical disciplines, including General Surgery, Ob-Gyn, Urology, and Bariatric Surgical procedures. All products are FDA cleared and CE marked.

The Company’s flagship products are:

• The ReNew™ reposable laparoscopic surgical instruments associating various single-patient use, disposable tips with a universal reusable handpiece,

• The M/L-10 and Gemini™ laparoscopic Clip Appliers combining single-patient use disposable clip cartridges with a reusable handpiece, and

• The Visu-Loc® laparoscopic 5mm single-patient use disposable Clip Applier using an innovative self-ligating clip technology.

• The Mi-Flex™ reposable laparoscopic deflectable instruments with single-patient use disposable tips dedicated to Single Port Access (SPA) surgical procedures.

Starion’s instruments employ a patented Tissue Welding technology that seals and divides soft tissue with only direct focused heat and pressure. Known for their effectiveness, reliability and versatility, Starion’s products are used worldwide for open and endoscopic Cardiac, Gynecology, General Surgery, Otolaryngology and Urology procedures.

Markets

The Microline Group products address a primary market opportunity estimated at $900 million in a global minimally invasive surgery market estimated at about $4 billion. The Group’s products are distributed worldwide through a network of over 70 independent distributors in the U.S., Europe, Japan, the Middle-East and Asia. The Group leverages its relationship with its parent company HOYA, by using its sales offices in select Asian territories. In the U.S., Microline is the recipient of 3 contracts with leading Group Purchase Organizations.

Research & Development

The Microline Group invests over 8% of its revenue into Research and Development. Its highly skilled engineers design and develop products in the Company’s newly expanded, state-of-the-art, proprietary research facility. The Company has a strong patent portfolio around laparoscopic surgical instruments and is consistently building upon its comprehensive Intellectual Property base.

Manufacturing Facilities

The Company employs 170 collaborators and occupies 50,000 sq ft at its worldwide headquarters located in Beverly, Massachusetts, USA. Based in Sunnyvale, California, the Starion Instruments subsidiary employs 10 collaborators. Microline’s vertical integration enables complete control of its supply chain and quality process, while leveraging its low-cost supply base in Shenzhen, China, as a strategic element of its competitiveness.

Regulatory Affairs and Quality Assurance

Microline and its subsidiary are ISO 13485: 2003 certified companies registered with the U.S. Food and Drug Administration (FDA). The facilities are periodically audited by FDA, SGS and KEMA, the European Notified Bodies which allow for CE marking of products marketed in the European Union. Every single part, sub-assembly, and finished product of the Company is subjected to multiple quality control inspections at each manufacturing step.