10 Events in Medtech That We Didn’t See Coming This Year
OK, so 2019 is a little more than halfway finished at this point and it’s safe to say this has been a blockbuster year for medtech so far. From high-powered acquisitions to shakeups at FDA, 2019 has had its share of controversial and shocking moments. Here are 10 explosive events that have occurred in the industry.
Edwards and Boston Scientific Bury the Hatchet
Well, 2019 started off with the resolution to a patent war between two of the biggest players in the transcatheter aortic valve replacement space – Edwards Lifesciences and Boston Scientific. The two had been in a series of TAVR lawsuits for years and there was even concern on how the lawsuits might impact Boston Scientific bringing the Lotus Edge to the U.S. That was until Edwards agreed to dole out a one-time payment of $180 million to Boston Scientific. It was shocking because initially, it looked like there was no end in sight between the two TAVR rivals.
Thrive Brings in Record Series A Round
Ah, the Series A round. In medtech the Series A round usually ranges anywhere between $2 million and $15 million (could be a little higher, not usually). But Thrive Earlier Detection Corp., a specialist in the liquid biopsy space, made everyone do a double-take when it announced it raised $110 million in its initial round. The Cambridge, MA-based company’s round was $10 million more than the amount Grail raised for its series A in 2016.
Obalon Changes Course
Restructuring. You hate to see it. So when Obalon announced it was eliminating its direct sales force and explore strategic and financial alternatives, many were pondering about the direction the company. However, the San Diego-based company revealed its plan was to transition to a new sales model. This would have the company own and operatea network of retail centers throughout the U.S. to focus on patients who want to lose weight using the Obalon Balloon System.
Alcon Takes Off Out of the Gate!
OK, so it wasn’t exactly a shock in 2019 that Alcon was going to separate from Novartis. After all, it was revealed in June of 2018 that Novartis would spin-off Alcon as a separate company. Now what was a bit shocking was how well Alcon would do out of the gate. In April, soon after the split was complete, Alcon was performing extremely well on the market. Alcon’s American Depositary Receipts were trading at $57.81 leaving the company to be valued at nearly $29 billion.
Abbott’s Astronomical Success with Freestyle Libre
It’s true, FDA’s approval of Abbott’s FreeStyle Libre Flash glucose monitoring system in 2017 was considered a major win for American adults with diabetes because the device eliminated the need for routine finger sticks, which had been the standard of glucose testing for more than 40 years. Abbott recorded sales of $430 million for Libre just in 2Q19. Analysts expect it to approach $2 billion for the year, based on consensus, according to Matthew Taylor, an analyst for UBS. Libre is a unicorn in the medical device world because of its mass-market potential and unprecedented growth. Abbott’s CEO Miles White estimated that there are more than 80 million people around the world who would benefit from the device, including both Type 1 and Type 2 diabetes patients. That translates into a massive market opportunity. “It’s unlike anything seen before in device or diagnostics businesses,” White said. “To be honest, traditional medical device companies aren’t used to having to deal with that kind of scale.”
The Theranos Documentary
The fall of Theranos wasn’t exactly ‘new’ news. However, HBO’s documentary, The Inventor Out for Blood in Silicon Valley, managed to piece together Theranos’ fall and give us new insight into the company and its founder Elizabeth Holmes. And yes, it’s much worse than we originally thought. Editor’s viewing the documentary, which aired in March, was blown away. The one hour and 59 minute-opus was filled with alleged fraud, betrayal, lawsuits, a secret romance – and MC Hammer’s pop hit You Can’t Touch This. You know this almost could be a movie.
Johnson & Johnson Improves Surgical Robotics Prowess
Johnson & Johnson made some serious noise in February when it announced it would acquire robotics specialist Auris Health for $3.4 billion. The deal would take J&J from being a contender into the surgical robotics to being a major force in the space. The New Brunswick, NJ-based company said the acquisition would go hand-in-hand with Verb, a surgical robotics joint venture it has with Verily Lifesciences.
Lutonix Rejected by FDA
Paclitaxel-coated balloons have been heavily scrutinized this year by FDA. But it was actually kind of a shock when Becton, Dickinson, and Company disclosed during its quarterly earnings call that FDA rejected the company’s application to approve the Lutonix drug-coated balloon to treat patients with below-the-knee peripheral artery disease. “We didn’t expect the DCB situation,” BD CEO Vince Forlenza said during the call, as transcribed by Seeking Alpha.The next steps for the technology also depend on what action FDA ultimately decides to take regarding the paclitaxel device concerns and what labeling changes the agency might decide on.
The Sterilization Shutdown
Earlier this year, FDA was in the position of carefully monitoring the medical device supply chain amid a shutdown of facilities that use a gas called ethylene oxide to sterilize medical devices. The shutdowns raised concern about potential shortages in the medtech industry because this is such a popular sterilization method for medical devices. However, according to the EPA, long-term exposure to EtO can irritate the eyes, skin, nose, throat, and lungs, and harm the brain and nervous system (causing headaches, memory loss, and numbness). Studies show that breathing air containing elevated EtO levels over many years increases the risk of some types of cancers, including cancers of the white blood cells (such as non-Hodgkin’s lymphoma, myeloma, and lymphomatic leukemia). It also has been found to cause breast cancer in women.
FDA Commissioner Scott Gottlieb Steps Down
The industry was stunned when FDA Commissioner Scott Gottlieb announced he was stepping down. After all, he had only served in the position for about two years and was well liked-by the medtech industry. In his short tenure, Gottlieb took a tough stance on tobacco, underaged vaping, and has been very aggressive in combatting the opioid epidemic. Gottlieb helped guide FDA through a grueling government shut down.
Original Article: (https://www.mddionline.com/10-events-medtech-year-we-didn%E2%80%99t-see-coming)