A Medical Device Daily

Medifacts International (Rockville, Maryland), a cardiovascular core lab, reported the acquisition of the Clinical Trials Services (CTS) division of Spacelabs Healthcare (Issaquah, Washington). Financial terms were not disclosed.

The combination of Medifacts and CTS, a provider of integrated, centralized cardiovascular safety and diagnostic services to the pharmaceutical and biotechnology industries, brings together Medifacts' scientific and regulatory expertise, global logistics and support infrastructure with CTS' "demonstrated commitment" to technology, service excellence and client-focused solutions, according to the companies.

"This combination brings together two highly motivated teams that share a passion for delivering the highest quality service, and creates the broadest product offering of cardiac safety and efficacy services for Phase I through IV clinical trials to pharmaceutical, biotech and medical device manufacturers worldwide," said Michael Woehler, PhD, president/CEO of Medifacts. "We are delighted to welcome the CTS team into the Medifacts organization."

"Through the combination with Medifacts, we will be able to provide existing and future clients with a wide array of ECG, Holter, and Blood Pressure technologies supported by the industry's most experienced technologists and scientific experts," said John Carpentier, general manager of CTS. "I am excited to be joining the Medifacts group and look forward to serving all of our clients as a part of this world-class team."

In other dealmaking activity, OmniComm Systems (Fort Lauderdale, Florida) and eResearchTechnology (ERT; Philadelphia), a provider of technology and services that enable the pharmaceutical, biotechnology, and medical device industries worldwide to collect, interpret, and distribute cardiac safety and clinical data, reported that OmniComm has acquired the EDC business of ERT.

"We believe strongly in the long-term growth of the EDC and eClinical markets. We have positioned ourselves to be a leading provider of EDC solutions and expect this transaction to allow us to grow more rapidly. By combining the two EDC businesses, OmniComm extends and deepens its roster of EDC customers and gains several key technologies that can be added to the TrialMaster eClinical suite of applications," said Cornelis Wit, CEO of OmniComm. "We believe that we will be able to leverage our existing EDC infrastructure and expertise to further penetrate the combined portfolio of customers."

Wit added, "the eClinical industry is going through a period of consolidation and we believe that only those firms that can combine superior products and services along with a demonstrated ability to deliver a broad array of solutions will be able to effectively compete. We are dedicated to broadening the products and services we offer and developing as diverse a client base as possible. Our expansion into Europe during 2007-2008 was the first prong of executing on this strategy. ERT has served several markets, including the governmental sector and Fortune 500 sponsors, that complement our focus on biotech and medical device clinical trial sponsors."

Revenues of the ERT EDC business were $5.9 million in the year ended Dec. 31, 2008 and $1.4 million in the three months ended March 31, 2009. ERT said it anticipates that the sale, excluding any impact of one-time charges related to the sale, will not affect the company's 2009 fiscal year guidance.

OmniComm issued 8.1 million shares of common stock and assumed certain liabilities including deferred revenue relating to ERT's EDC business in exchange for the EDC assets of ERT, which primarily include its EDC software, applications and fixed assets and $1.15 million in cash paid by ERT.

OmniComm said it would open a new branch office in the New Jersey area and will be transitioning the majority of the ERT eClinical support team to this new office to provide on-going support and maintenance to the ERT customers it acquires.