MILESTONES
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| Augusti |
Microarray systems developer Affymetrix Inc. (Santa Clara, CA) has opened a new manufacturing facility in Singapore. The company reports that the new location—its first manufacturing facility outside of the United States—will enable the company to better serve and support its growing international business. The Singapore facility, designed to look and operate like Affymetrix's main manufacturing facility in Sacramento, CA, has been operational since the end of 2006 and employs 120 staff members. By the end of 2007, Affymetrix plans to shift about 40% of its total microarray production to Singapore.
Baxa Ltd., a subsidiary of Baxa Corp. (Englewood, CO), has moved to a direct sales and marketing presence in Switzerland. Baxa products in the Swiss market were previously sold primarily through an exclusive distributor, with customer and technical support provided by Baxa Ltd. from its European headquarters. "Following implementation of direct sales in other European countries, we are building on the successes of our distributor partner in Switzerland to continue to improve our service and our products through a greater understanding of customer needs," said Terry Aston, managing director of Baxa Ltd. The move to direct sales in Switzerland took effect this past May.
CoreValve (Irvine, CA) has received CE mark approval of its CoreValve percutaneous revalving system for treatment of high-risk patients. However, the company will not immediately begin marketing the system, which is intended to provide an alternative to open-heart surgery. Rather, CoreValve reports that it will proceed with an expanded clinical evaluation at select international centers to help ensure that interventional cardiologists are well trained, that patients are appropriately selected for treatment, and that appropriate clinical feedback is obtained. CoreValve has established a mandatory expanded clinical evaluation patient registry to gather additional clinical data for submission to FDA in support of clinical trials and regulatory approval in the United States.
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Hammes |
The orthopedic trauma and clinical therapies business unit of Smith & Nephew (London) has entered into an agreement with Teknimed SA (Vic-en-Bigorre, France) to distribute, market, and sell Teknimed's Spine Fix product in North America, Europe, and Australia. Spine Fix is a self-hardening bone cement used to treat compression fractures in the spine. "As a market leader in bone substitutes and surgical cements, Teknimed's Spine Fix product complements Smith & Nephew's outpatient spine portfolio and enhances our presence in this market," said Mark Augusti, president of Smith & Nephew's orthopedic trauma and clinical therapies unit. Spine Fix was approved for use in Europe in 2003 and in the United States in 2006. It has already been launched in Europe, and Smith & Nephew will roll out the product to the U.S. market in the third quarter of 2007.
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| Kersey |
Apnex Medical Inc. has completed a $16.1 million series A private equity financing. The funds are intended to enable the company to complete development and initiate clinical studies of Apnex's implantable technology to treat obstructive sleep apnea. Participants in the financing include Domain Associates, New Enterprise Associates, Polaris Venture Partners, and Michael Berman. Apnex Medical is the second spin-off company of Prospex Medical Inc. (Minneapolis), a medical device incubator founded in 2005.
In May, Sunrise Medical (Carlsbad, CA) announced plans to split into two separate organizations—a mobility-focused business under the name Sunrise Mobility and a respiratory-focused business under the name DeVilbiss Healthcare. "Ultimately, the creation of the two separate organizations will improve focus and create long-term value for customers," said Michael N. Hammes, chairman and CEO of Sunrise Medical. "A truly focused approach can make all the difference in the world, and we just couldn't provide the necessary focus as one organization." At press time, Sunrise Mobility and DeVilbiss Healthcare were finalizing their global operational and commercial plans. However, they reported that each organization would have a dedicated sales force.
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Powell |
Analogic Corp. (Peabody, MA) and CAS Medical Systems Inc. (Branford, CT) have signed an agreement granting worldwide exclusive rights to CAS Medical to market and sell Analogic's Lifegard family of noninvasive patient monitors. The monitors will be cobranded with the CAS Medical and Analogic names, and both companies plan to work together to develop additional monitors for the Lifegard family and for other specialty niche markets. "We are pleased to be adding the Lifegard family of patient monitors to complement our existing vital signs monitors," said Andrew Kersey, president and CEO of CAS Medical. "Leveraging CAS Medical's global strengths in marketing, sales, and distribution, and its proprietary motion artifact extraction technology, together with Analogic's expertise in engineering and product design, the companies will be able to more successfully address the changing needs of the subacute care and specialty patient-monitoring markets."
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| Ogier |
Timm Medical Technologies Inc. (Eden Prairie, MN), a subsidiary of Plethora Solutions Holdings PLC (London), has acquired marketing rights to two new products: the Acticuf device for the management of light to moderate male urinary incontinence and the Midstream Cleancatch device for the collection of midstream urine samples. "The Timm operation has made substantial progress with the marketing of its ErecAid and Rigiscan products for the treatment and management of erectile dysfunction," said Steven Powell, CEO of Plethora. "We believe that the time is right to begin to implement the next phase of our growth strategy for Timm, which is to utilize its sales and marketing capability to market a broader portfolio of urology products and, in so doing, accelerate revenue growth."
Arbios Systems Inc. (Los Angeles), a biomedical device and cell therapy company developing liver-assist products for the treatment of liver failure, has closed a private placement financing round of $4.8 million led by MicroCapital Funds. "We anticipate that these funds will enable us to move forward aggressively with our plans for product registration of our Sepet liver-assist device in Europe under the medical device CE mark, as well as initiation of a pivotal clinical trial of Sepet in support of future commercialization of the product in the United States," said Walter Ogier, president and CEO of Arbios.
