A Medical Device Daily

BIT Analytical Instruments (Schwalbach, Germany) has acquired a 50% equity investment in contract manufacturing services (CMS) firm Source Scientific (Irvine, California).

BIT is described as the European market leader in providing complete CMS, as well as product development and after-sales services to medical and industrial instrument original equipment manufacturer clients.

As part of the investment, BIT has acquired the 30% equity ownership position in Source Scientific held by Pressure BioSciences (Bridgewater, Massachusetts) since 2004. Source Scientific will continue to provide engineering, manufacturing and other related services for Pressure BioSciences.

“BIT’s strategic investment in our company will help to fuel our growth globally and capitalize on the surge in demand for outsourced medical devices and clinical instruments manufacturing,” said Richard Henson, president and CEO of Source Scientific. “We anticipate that Source Scientific will grow 10-fold over the next five years. This is a time of rapid expansion for our industry sector, and we’re poised to capitalize on industry trends.”

“Clients like Atherotech [Birmingham, Alabama], Hitachi Chemical Diagnostics [Mountain View, California] and Mettler Electronics [Anaheim, California] rely on outsourced partners to do what we do best — prototyping, manufacturing, shipping and customer support — so that they can focus on their core competencies of product development and marketing,” Henson said.

He said BIT, which also has U.S. facilities in the Boston area, complements Source Scientific’s business model because of its strength in manufacturing complex medical instruments and its global market share position

“The arrangement between BIT and Source Scientific creates a perfect partnership,” said Marius Balger, CEO and president of BIT. “Source Scientific’s strength is in engineering and partnering with clients to bring ideas to market, while BIT excels in manufacturing. As a result, the client can take advantage of a single relationship to reduce its manufacturing costs and supply-chain expenses while driving innovation and time to market. Together, we’re delivering a global solution combining our more than 30 years of complex instrument manufacturing with Source Scientific’s nearly three decades of product development knowledge, experience and success.”

U.S. firm eyes Slovak, Belgian ventures

Integrated Endoscopy (Rancho Santa Margarita, California) reported receiving a first draft of a letter of intent from EDM (Nizna, Slovak Republic), committing EDM to build a new facility in Slovakia to produce the U.S. company’s disposable arthroscopes and laparoscopes.

EDM is a new company formed by Stephan Pirard, formerly president and statutory director of Punch Technix, a company traded on the Euronext Amsterdam Exchange. Its commitment will entail an investment worth nearly 14.6 million.

In addition, Integrated Endoscopy reported forming a joint venture with A-Medica (Brussels, Belgium) known as Integrated Endoscopy Europe. Together, the companies plan to build and market disposable, high-definition arthroscopes and laparoscopes throughout Europe and the U.S., where the combined market is estimated at more than 11.5 billion.

George Wright, president/CEO, said Integrated Endoscopy’s new disposable scopes are the result of years of development of the company’s patented technology, “which improves the resolution of the scopes as well as the color intensity.”

The U.S. firm said the disposable scopes will be marketed at a price which is lower than the per-use cost of conventional, reusable scopes. Reusable arthroscopes and laparoscopes sell for $3,000 to $6,000 each, while resterilization and repair fees add up to more than $150 per use, according to the company.

“Because the new scopes are a single-use product, they eliminate the potential for cross-contamination from patient to patient and provide surgeons with a new scope for each surgical procedure,” Integrated Endoscopy said. “A new scope for each procedure insures the highest available resolution and color intensity, a tremendous improvement over reusable scopes which are degraded over time, potentially impeding a surgeon’s performance.”

Integrated Endoscopy said it is soliciting an additional capital investment of up to $6.5 million for the expansion of sales and marketing of its products worldwide.

New Scottish facility for Quintiles

Quintiles Transnational (Research Triangle Park, North Carolina) said it plans to build a new office near Edinburgh that will be the Scotland home for its Product Development business, including Quintiles Laboratories , and its NovaQuest group.

The company said it will add 150 jobs in Scotland over the next four years.

The new 112,000-square-foot structure — which Quintiles could expand to 132,000 square feet — will be built in Livingston, West Lothian, near the firm’s present 36,500-square-foot laboratory. The new building will provide about 80,000 square feet of space for the laboratory business.

Quintiles’ Product Development and NovaQuest personnel occupy about 25,000 square feet in a Bathgate office, and those units also will move into the new building. Quintiles has 390 employees in the two locations.

“Our lab business is expanding — globally and in Europe — because of our proximity to clinical trial sites and our tight quality control,” said Thomas Wollman, senior vice president, global central laboratories. “This new facility will enhance our level of customer service in the UK and Europe, just as our new central lab in Mumbai has improved service in India. We will continue to look for opportunities to strengthen our global central lab network.”

SACS Medical gets FDA 510(k) clearance

LinkMed ’s (Stockholm, Sweden) portfolio company, SACS Medical , has been granted 510(k) clearance by the FDA for sales of its medical signal handling systems in the U.S.

“FDA clearance is a stamp of quality that will facilitate us in our search for an industrial partner for SACS Medical,” says Ingemar Lagerl f, CEO of LinkMed.

SACS Medical’s system for medical signal handling can handle EEG and EMG signals, among others. The system is used by specialist clinics to diagnose, monitor and treat patients spread over a large geographical area from one centralized location.

LinkMed, whose ownership stake in SACS Medical is 43%, has created a portfolio of 11 companies, six in biotechnology and five in medical technology.

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