A Medical Device Daily

BioClinica (Newtown, Pennsylvania), a provider of clinical trial services, said it has acquired the CardioNow (Newtown, Pennsylvania) unit of Agfa HealthCare (Mortsel, Belgium). With this addition, BioClinica now offers streamlined electronic transport solutions to facilitate the blinding, sharing, tracking and archiving of medical images for multi-center clinical trials as part of its suite of imaging services. Imaging information will also be integrated with BioClinica Express electronic data capture to further simplify and enhance the clinical trial process for life science companies, BioClinica said.

According to the company, CardioNow has provided core labs, investigator sites, and medical device and pharmaceutical companies with an established and proven web-based system for the secure, regulatory compliant transmission and analysis of medical images that are integral components of clinical trials since 1999. The solution is also extensively utilized by remote independent reviewers for online case review and quantitative analysis, clinical event adjudication, and data safety monitoring, BioClinica said. Over the past 10 years, CardioNow has managed more than 8.8 million DICOM (Digital Imaging and Communications in Medicine) images for clinical studies worldwide.

With the integration of CardioNow, BioClinica says it will be able to manage every step of the process that begins once a medical image is acquired at a clinical site through the delivery of evaluated results to the sponsor. This end-to-end control will ensure that the process is as efficient and expedient as possible, the company said.

"CardioNow fits perfectly into BioClinica's strategy of adding components that are both complimentary to our current products and services and that help to create a more efficient clinical trial process. We will continue to build on the superior technology and high level of customer service offered by Agfa Healthcare's CardioNow unit," said Mark Weinstein, president/CEO of BioClinica. "An additional benefit is that once CardioNow is integrated with our current processes – approximately 45 days – we can offer our clients an immediate cost savings on each of the more than 200 clinical trials that we are currently supporting."

"A leading solution like CardioNow is well suited to support the ongoing expansion of BioClinica's extensive global clinical trial services portfolio," said Eric Maurincomme, chief strategy & marketing officer of Agfa. "We are convinced that the CardioNow business will continue to flourish within BioClinica, and are working closely together to enable a smooth transition."

Agfa provides IT-enabled clinical workflow and diagnostic image management solutions, and systems for capturing and processing images in hospitals and healthcare facilities.

In other dealmaking activity:

• Edwards Lifesciences (Irvine, California) said it has completed the sale of certain assets related to its hemofiltration product line to Baxter International (Deerfield, Illinois), consistent with its previously disclosed agreement (Medical Device Daily, June 24, 2009).

• Cavit Sciences (Paterson, New Jersey) reported that it has been negotiating with Randall McCoy and Joe Connell, principle owners of McCoy Enterprises (Little Falls, New Jersey), to merge the two companies.

"We all feel very good about this so we have added a breakup clause to show our commitment to each other," said Maggie Smyth, CEO of Cavit.

According to the company, McCoy has been working on getting FDA approval for its cultured skin substitute (CSS), PermaDerm. Its CSS has already been given orphan drug status by the FDA and will be indicated for children under 12 years of age with 50% or more body surface burned, Cavit said.

Along with the merger agreement Cavit and McCoy are working together to secure a $16 million loan to facilitate and get final FDA approval for the first indication of PermaDerm. This should be accomplished in the next few days, according to Cavit.

"We have taken all serious efforts to see that PermaDerm gets to market as fast as possible for the people that need it," said Connell, COO of McCoy. "As we grow and develop new indications for our CSS we see our merged companies as a leader in skin cell regeneration. We expect to have PermaDerm available in 2010 for its first indication."