Industry News

Millstone Medical Adds New Equipment to Loaner Kit Processing Services

Millstone Medical Outsourcing has enhanced its loaner kit processing service by purchasing new state-of-the-art equipment for its facility in Memphis, Tenn.

The company added a washer/disinfector and an autoclave sterilizer to enhance capacity, reduce kit turn time, and cut out system redundancy. When used in conjunction with the current equipment, the new additions dramatically will increase production time and speed, Millstone executives said.

“At Millstone, we are committed to growing with our customers,” said Christopher Ramsden, Millstone’s CEO. “Our operations and distribution center in Memphis is strategically located to serve medical device manufacturers. As our Memphis operations continue to expand, we will enhance our facility, equipment, personnel, and processes to effectively serve our customers.”

The Fall River, Mass.-based company enhanced its Memphis facility earlier this year by adding more than 12,000 square feet of space to the floor plan, bringing the total square footage of the building to 43,600.Millstone expanded the facility to provide additional capacity for advanced inspection, material storage and distribution services.

Senecorp, White Systems Merge Operations

Thermoform packaging and sealing equipment supplier Sencorp Inc. of Hyannis, Mass., has merged with White Systems, a Kenilworth, N.J.-based supplier of automated carousel-type storage and retrieval technologies for processing plants and distribution centers. Terms of the deal were not disclosed.

The new company, called SWS/TEK LLC, is based in Hyannis. White’s manufacturing operation was relocated to Sencorp’s 150,000-square-foot production facility earlier this year, a move that officials said improved efficiency. White still maintains a technical support center in New Jersey.

“The teaming of White and Sencorp provide significant operational benefits and cross-selling opportunities to both companies,” said Brian Urban, president and CEO of the new firm. “Like Sencorp, White is an industry-leading brand recognized for quality and durability.”

The sales forces for both Sencorp and White have identified a number of product applications for customers with material handling and packaging problems. Machines from both firms are used by companies in the medical device, pharmaceutical and electronic sectors to package, inventory and manage parts. In the production of blood bags, for example, White’s clean room carousels provide a controlled environment for storing and transferring packaging materials used by Sencorp heat sealers.

“With over 15years of medical device packaging experience, we understand FDA requirements and the differing needs between sterile and non-sterile processes in clean room operations,” said Kent Hevenor, Sencorp’s senior product specialist. “We are encouraged that we can provide increased value to our customers with Sencorp and White products.”

Ev3 Purchases Firm Developing Aneurysm Treatment Device

Ev3 Inc. has acquired a privately held California company that is developing a new way to treat potentially deadly brain aneurysms.

The Plymouth, Minn.-based firm initially is paying $75 million in cash and stock for the firm, Chestnut Medical Technologies Inc., and will make an additional payment of up to $75 million when the company receives federal regulatory approval for its device. Ev3 is not expected to make the second payment until 2011.

Ev3 executives said the acquisition will broaden the company’s neurovascular product portfolio and provide an immediate boost to overall revenue.

“This acquisition directly supports our stated strategy of bringing breakthrough neurovascular therapies to our markets and adds an innovative new product platform to benefit the large number of patients suffering from brain aneurysms that currently are not well treated with either surgical or endovascular techniques,” said Robert Palmisano, Ev3’s prsident and CEO.“In addition, this acquisition is expected to be an immediate revenue contributor, leverage the strong global distribution capabilities of Ev3’s neurovascular sales organization and provide another growth engine for delivering enhanced value to our shareholders.”

Chestnut Medical is developing a minimally invasive technology called Pipeline to treat aneurysms. The device works by diverting blood away from an aneurysm during surgery.

Aneurysms are bulges that develop in an artery. When these arteries rupture, they cause internal bleeding, which in the brain, can lead to a stroke or sudden death.

Industry sources estimate that one in 15 people in the United States will develop a brain aneurysm this year, and 10 percent to 15 percent of those patients will die before reaching a hospital. Ev3 executives believe the global market for diversion devices such as the Pipeline will reach $350 million by 2013.

The Pipeline has been approved for sale in Europe. The Menlo Park, Calif.-based firm is conducting two clinical trials to gain U.S. Food and Drug Administraton approval for use of the device in the United States. Ev3 said the acquisition is expected to close by the end of the third quarter.

GE Opens New MammographyMachine Factory in N.Y.

GE Healthcare has opened a new $165 million factory in upstate New York to build state-of-the-art digital mammography machines. 

The 230,000-square-foot plant opened June 5 at the Rensselaer Technology Park outside Albany. The new facility is expected to bring 150 high-paying manufacturing jobs to the area. The expansion is GE Healthcare’s first for high-tech medical equipment manufacturing in New York. The digital X-ray technology used in mammography was developed at GE Global Research in Niskayuna, a town of about 20,000 people that is 12 miles northwest of Albany.

GE Electric Co. is based in Fairfield, Conn.

The factory opening occurred as the company continued to announce layoffs at its facilities in Vermont and Wisconsin. Just two weeks after the grand opening of the mammography facility, the Milwaukee Journal Sentinel reported an “undetermined” number of workers were laid off from the company’s facility in Waukesha, Wis.

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ISO Certifications

• Biomerix Corporation, a developer and manufacturer of implantable medical devices for soft tissue repair, neurovascular embolization, spine annular repair, cardiovascular repair and women’s health, has received ISO 13485:2003 certification. The Fremont, Calif.-based firm developed a biointegrative synthetic tissue scaffold five years ago called Biomerix Biomaterial. The certification applies to the firm’s Fremont location, which designs, manufactures and distributes finished devices, and a Somerset, N.J., facility that makes the biomaterial.

• Biomerix Corporation, a developer and manufacturer of implantable medical devices for soft tissue repair, neurovascular embolization, spine annular repair, cardiovascular repair and women’s health, has received ISO 13485:2003 certification. The Fremont, Calif.-based firm developed a biointegrative synthetic tissue scaffold five years ago called Biomerix Biomaterial. The certification applies to the firm’s Fremont location, which designs, manufactures and distributes finished devices, and a Somerset, N.J., facility that makes the biomaterial.

• Boston Endo-Surgical Technologies, a company that develops, manufactures and markets reusable and disposable devices for use in arthroscopic, spinal, sports medicine, and general orthopaedic surgery, has received ISO 13485:2003 certification. The firm is based in Hampton, N.H.

• Eagle Stainless Tube & Fabrication Inc., a supplier of ultra high-precision, cut-to-length stainless steel tubing and bar, has received ISO 13485:2003 certification. The 27-year-old company is headquartered in Franklin, Mass., and serves the medical, electronic, semi-conductor, industrial and aerospace markets.

• ISO 13485:2003 certification has been awarded to Mack Prototype Inc., a division of Arlington, Vt.-based Mack Molding Co., a custom plastics molder and contract manufacturer. The certification allows Mack Prototype to partner with its parent company to provide a wider range of services to OEMs. “Achieving this quality hallmark uniquely positions us as a prototype house and low-volume manufacturer,” Mack Prototype’s President Ric Perry said. “Many manufacturers our size are not certified to this medical standard. It will put us at the table with major medical OEMs.”

• Sonora Medical Systems Inc., a Longmont, Colo.-based supplier of after-market products, training, depot-level repair and support services, and test equipment to the medical imaging market, has achieved ISO 17025:2005 certification for its Acoustic Power Testing Laboratory. The ISO 17025 standard specifies the general requirements for competence of testing and calibration laboratories.
“Accreditation allows customers to make informed decisions when selecting a test laboratory,” said G. Wayne Moore, Sonora Medical’s president and CEO. “It demonstrates competence, impartiality, capability, and substantiates the credibility of test results.” Sonora’s parent company, Misonix Inc., develops minimally invasive ultrasonic device technology. The company is based in Farmingdale, N.Y.

• Contract manufacturer TRICOR Systems Inc. has received ISO 13485:2003 certification. The Elgin, Ill.-based firm is a contract manufacturer of various products, including image photometers, automated force, wiring board assemblies and life cycle testers.

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Biotech in Brief

Arizona technology and business leaders have established a $20 million venture capital fund that will target early stage bioscience firms looking for a financial boost to develop their ideas. Dubbed the Translational Accelerator LLC, the new fund was created to bridge a money gap that Arizona officials believe has slowed the flow of successful startups in the state…The Kansas Bioscience Authority has approved more than $11 million in new investments as part of a $581 million initiative to help researchers and biotechnology businesses thrive. The money will create bioscience centers of innovation in biomaterials and plant biology, expand cancer drug development efforts, and create a strong bioenergy research partnership between the University of Kansas and the Archer Daniels Midland Company…One out of every six jobs in the Greater Philadelphia region is connected to the life science industry, according to a study conducted by the Milken Institute. The study also concluded that 15 percent of all economic activity in the region is triggered by the life sciences…A new regional angel fund called Mass Medical Angels (MA2) is looking for early stage device firms that want to raise between $250,000 and $3 million. MA2 will fund all or part of the first round, depending on the exact amount needed. The fund is looking to get its investment back 10 times over within five years, according to its Web site, www.massmedangels.com…Next year’s BIO International Convention will take place in Chicago, Ill., from May 3-6. Representatives from more than 60 countries and 2,100 companies are expected to attend. The event was last hosted in the Windy City in 2006.