A Medical Device Daily

Volcano (Rancho Cordova, California), a provider of IVUS, FM and OCT products designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said it has acquired Novelis (Methuen, Massachusetts), a privately held company with ultrasonic visualization and therapy technology for minimally invasive diagnostic and therapeutic devices.

Volcano paid about $12 million in cash at closing. It may make an additional cash payment of $3 million based on the achievement of a specific regulatory milestone.

Volcano said that Novelis' proprietary IVUS technology platform is expected to build upon its existing suite of products and further enhance Volcano's position as an imaging technology leader in the field of interventional medicine by enabling forward-looking IVUS (FLIVUS) and associated therapies in the interventional cardiology market.

It said it expects to add the Novelis products and capability onto its s5i multi-modality integrated platform/hub.

Novelis' core product line is based on FLIVUS technology. The line includes an image-guided crossing catheter that combines visualization, steerability and RF tissue ablation, which is designed to permit interventional cardiologists to safely cross chronic total occlusions (CTOs) in the coronary and peripheral arteries, and a FLIVUS catheter (imaging-only version) to facilitate current guidewire-based CTO crossing techniques, as well as other potential product offerings with possible applications outside of vascular medicine.

The companies said they believe this platform technology may have applications for numerous minimally invasive procedures, including plaque modification in the coronary or peripheral arteries, guidance in structural heart procedures, including cardiac ablation guidance and therapy, breast biopsy guidance and therapy, and orthopedic (spine) guidance and therapy.

"Novelis' technology has potential applications for a number of minimally invasive diagnostic and therapeutic applications in the coronary and peripheral arteries, including the treatment of CTOs," said Scott Huennekens, president/CEO of Volcano. "It is estimated there are over 200,000 CTOs performed in the U.S., Europe and Japan each year. The products under development by Novelis have the potential to shorten procedure times and minimize complications plus dramatically add to the total number of procedures being performed — enabling patients with CTOs to be treated in the cath lab rather than in the surgery suite. "

Huennekens estimated that the total market potential for Novelis' CTO products is more than $500 million.

Volcano said it expects to file for appropriate U.S. and international approvals on the first of several devices during 2009 and begin commercialization of a stand-alone imaging console in the second half of 2009 in the U.S. and Europe. It said it expects a majority of the purchase price to be written off immediately as in process research and development and to incur ongoing development costs in the range of $300,000 to $400,000 per quarter.

Covidien (Hamilton, Bermuda) reported that it has acquired 100% ownership of Tissue Science Laboratories (TSL; Aldershot, UK), a company developing tissue-implant products for surgical and wound care therapies.

Covidien launched a public tender offer in the UK for all of TSL's outstanding shares held by UK residents on March 12.

Covidien, which paid 103.5 pence (about $2.10, a share, or about $80 million) in cash for the company, makes product lines in four segments: medical devices, imaging solutions, pharmaceuticals and medical supplies.

Covidien also reported completing the sale of its European incontinence business in Lille, France, to a private French company that will rename the business Lille Healthcare. Terms of the agreement were not disclosed.

The business was part of Covidien's Medical Supplies segment and had sales of $109 million in fiscal 2007.

In other dealmaking news:

• Accelr8 Technology (Denver) reported that it has signed an agreement with BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey) with respect to Accelr8's BACcel rapid pathogen diagnostics platform.

BD will fund a research program at Accelr8 through Sept. 30, 2009. The research program includes mutually agreed milestones to support BD's product development planning. BD has the option, during or at the conclusion of the research program, to exclusively license Accelr8's intellectual property in the field of infectious diseases diagnostics.

Accelr8 retains the right to commercialize its technology for other applications.

The option, if exercised by BD, requires BD to pay an initial fee, as well as running royalties on covered products. The license further contains certain diligence requirements for BD to develop and commercialize such products. Under the license, BD will fund and conduct all product development, manufacturing, and marketing.

This agreement follows a standstill agreement signed in December 2007. Since signing that agreement, Accelr8 has placed research systems into two research institutions, Denver Health Medical Center and Washington University (St. Louis).