St. Jude Medical plans to acquire Spinal Modulation and add several new therapies to its chronic pain treatment portfolio, the company said. The buyout will give St. Jude access to the CE Mark-approved Axium neurostimulator system for relief from dorsal root ganglion pain. The FDA is reviewing a PMA on the product. A deal was made possible by St. Jude’s $40 million equity investment in Spinal Modulation, which granted the devicemaker an exclusive option to distribute the Axium system worldwide as well as buyout options. Upon the closing of the deal, St. Jude will pay $175 million, with additional payments due upon FDA approval of the Axium system and other sales-based milestones. St. Jude expects to finalize the acquisition in the second quarter of 2015.Boston Sci Seeks China Alliance
Boston Scientific has entered into a strategic alliance with Frankenman Medical Equipment Co. to develop and manufacture endoscopic products in China, the Marlborough, Mass., devicemaker said. The alliance lets Boston Scientific take advantage of Frankenman’s entrenchment in the China surgical devices market. The two companies plan to accelerate medical training and implement less invasive procedures in China. The agreement stipulates that Boston Scientific will become a Frankenman shareholder and provide services and expertise to the company. Frankenman was established in 2003 and is based in Suzhou, China, serving more than 100 hospitals in the country.
Roche Buys Cancer Screening Startup
Roche has acquired CAPP Medical, a genomics research startup focused on cancer screening and monitoring, the Switzerland-based company said. CAPP Medical’s disruptive liquid noninvasive technology works by isolating and quantifying small amounts of circulating tumor DNA in the bloodstream. Through a blood draw, health professionals have the potential to monitor tumor response and resistance to cancer therapy. The Palo Alto, Calif., company’s next-generation sequencing assays could significantly speed up cancer diagnosis and prove to be more cost effective than the current standard of care, says Roland Diggelmann, COO Roche Diagnostics.CAPP Medical’s technology has been designated for Research Use Only by the FDA.
Heartware IDE Study Finds Success
Heartware’s first destination therapy clinical trial has achieved its primary endpoint, the devicemaker says. The investigational device exemption study tested the HVAD Pump as long-term therapy for patients with end-stage heart failure ineligible for a heart transplant. The HVAD system treatment yielded a higher stroke rate, but device malfunction was evidenced more frequently in the control arm, says Dr. Joseph Rogers, a co-principal investigator. Of the 200 patients who were implanted with the device with a sintered inflow cannula — a 2011 FDA-approved modification that enables better tissue adhesion — 57.5 percent of patients reached the primary endpoint.