About 17 years ago, James Muller's vision of developing an intravascular imaging device to advance the diagnosis and management of coronary artery disease hit a turning point. Muller, a former professor of medicine at Harvard Medical School (Boston) founded Infraredx (Burlington, Mass.) to get the imaging device to market. Since that time, the company has gone through a great deal – from getting an FDA-cleared device on the market, to withdrawing a $56 million initial public offering. Last week, Infraredx hit another huge milestone as Nipro (Osaka, Japan) revealed it would acquire the company.
"I'm deeply grateful for the vision of Dr. Muller to create this company and then the persistence he's shown in remaining seriously focused on the detection of the conditions that cause heart attacks," Jonathan Isenburg, Infraredx CFO, told Medical Device Daily. "This isn't an ending but a new beginning."
He added, "Dr. Muller will absolutely remain involved in continuing to pursue a successful outcome from [clinical trials] evaluating the system]." One of the studies the company is involved in is PROSPECT II. It's a multi-center, prospective study of 900 patients designed to assess the intravascular imaging system.
Financial details of the pending acquisition were not disclosed. The two companies have worked together in the past. Infraredx had an exclusive 5-year distribution deal with Nipro to sell the private company's technology.
The pending acquisition is expected to help introduce Nipro's cardiovascular product line into the U.S., and continue Infraredx's mission to empower interventional cardiologists with the advanced imaging tools required to predict heart attacks and prevent them–catalyzing a global shift from reactive treatment to proactive care of coronary artery disease.
"The Nipro group has deep significant experience in the marketing of intravascular imaging systems," he said. "It is their knowledge and expertise with respect to intravascular imaging that attracted Nipro to Infraredx."
Infraredx already has FDA clearance and a CE mark for its TVC System. The system gained approval in Japan last year. It is based on near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). The LipiScan IVUS system's design provides physicians with a grayscale IVUS image of the coronary artery along with a complete and co-registered chemogram – a map of lipid core plaque within the imaged vessel. The company is gathering additional data through clinical trials that could support the imaging system in the use of predicting heart attacks.
"Company founder James Muller, MD, and the Infraredx management team have empowered interventional cardiologists with the NIRS-IVUS imaging system, which is approved to detect the lipid-core plaques that cause most heart attacks," said Yoshihiko Sano, president, Nipro. "Nipro and Infraredx share a strong patient-centered focus and the combination of the companies' global portfolio and cardiovascular expertise will help us deliver the most comprehensive imaging solution available to change how cardiovascular disease is managed. We look forward to bringing together the two companies to deliver the best of medicine and innovation."
Nipro, which could not be reached for additional comments, has a substantial presence in the health care sector. The company offers products and technologies that meet the needs of patients and medical professionals in a wide range of fields, such as artificial organs, circulatory devices, test/diagnostic agents, injection/infusion solutions, ethical pharmaceuticals and medical glass products.
The acquisition is expected to close in October. Shares of Nipro (TYO:8086) opened at $1,3160 closing at $1,340 up 1.13%
Backing out of IPO
In January, the company set the terms for its public offering. Infraredx said it planned to offer about four million shares between $13 to $15 and hoped to raise about $56 million. However, in February, the company delayed the action and ultimately, withdrew plans for an IPO citing "unfavorable market conditions." Isenburg said the company's withdrawal of the IPO wasn't connected to pending merger plans.
"For numerous reasons, the company withdrew its IPO," Isenburg said. "However this transaction is focused on broadening the reach of our technology and making sure we continue to pursue our mission of detecting and ultimately preventing heart attacks." //