ERT has snatched up iCardiac Technologies, a company known for its cardiac safety services for clinical studies, just three months after it bought Biomedical Systems, which started shop in 1975 with clinical cardiac solutions.
“iCardiac has introduced several breakthrough innovations over the past decade, including High Precision QT and Early Precision QT methodologies,” said iCardiac president and CEO Alex Zapesochny, who will join ERT’s executive team to lead the cardiac safety business.
Back in 2015, the International Council for Harmonisation updated its E14 Q&A guideline, adopting an alternative path that allows data from early-stage clinical trials be used to demonstrate a noncardiac drug’s QT effect. The previous guideline, adopted in 2005, required such drugs to undergo a dedicated clinical study to ensure that the drugs don’t cause unusual QT interval prolongation, which could lead to cardiac arrhythmia.
That revision was based on a study (PDF) conducted by iCardiac with the Cardiac Safety Research Consortium. It confirms that combining ECGs and pharmacokinetic samples—the basic components of iCardiac’s High Precision QT approach—with exposure response analysis can achieve much higher precision in gauging drug candidates’ cardiac safety profiles in phase 1 trials.
Besides, iCardiac touts that its method of performing QT assessment as part of routine early-phase in-human studies only costs $150,000 to $300,000, saving developers millions of dollars as compared to $2 million to $5 million when conducting the usual stand-alone Thorough QT (TQT). So far, eight of the top 10 pharma companies, along with several mid- and small-sized biopharma firms, have signed up for its services.
Philadelphia-headquartered ERT has existing offerings in cardiac safety, so, to ERT president and CEO James Corrigan, the deal is “a natural fit.”
The company just expanded the sector three months ago with the purchase of Biomedical Systems. ERT at that time pictured the acquisition mainly as a move for Biomedical Systems’ 30-year-plus experience in imaging technology, as a further expansion from a May purchase of Cleveland Clinic’s cloud-based imaging technology to meet the industry’s growing demand for imaging data submissions per requests from regulators.
But it’s worth noting now that the Missouri-based company’s origin is actually in cardiac services. Biomedical started offering cardiac services when founded in 1975 and ran its first centralized ECG in 1979. By time of the ERT deal, it has managed more than 8,000 cardiac safety trials across the globe and offers cardiac event monitoring, blood pressure monitoring, echocardiography and TQT studies.
Both iCardiac and Biomedical provide respiratory/pulmonary solutions that accelerate clinical research and are now all part of ERT’s portfolio.