St. Jude has entered into an agreement to pick up heart-rhythm device specialist Nanostim for $123.5 million. Earlier this year, we reported that Nanostim's leadless technology may represent the future of heart-rhythm technology. Nanostim's core technology, a small implantable wireless pacemaker recently obtained European Union approval. By the end of the year, the company could pay an additional $65 million if regulatory and sales milestones are hit.
|The leadless Nanostim device is small enough to fit within the heart.|
In related news, the company's CEO, Daniel Starks stressed at a conference that innovation in the medical device industry is still alive despite regulatory and political headwinds. Speaking to an audience of 350 investors and entrepreneurs at the Minnesota Venture and Finance Conference, the CEO stated that there's still plenty of room for new technologies that can improve patient health and cut costs.
In his speech, Starks offered harsh criticism of the FDA. He stated that regulations often swing back and forth like a pendulum, making it difficult for manufacturers to forecast the success or failure of a PMA or 510(k) clearance application. He also noted that the current administration had pursued policies that were harsher than that of the previous administration.
In one part of his presentation, Starks discussed a new algorithm-driven pacemaker. While this technology has already been commercialized in other parts of the world, the United States remains a no-go for the novel tech. To gain access to the U.S. market, the company must complete a trial comprising 5,000 patients. This trial could take years and could delay a life-saving treatment for a significant number of patients.
"That's always been the sweet spot for medical device technology," noted Starks. "There are significant challenges, and it has gotten more expensive, and the timelines are more uncertain, but the payoff for a well-targeted technology, going after the right disease state, can be just huge."