Electric Medicine

At the Mann Biomedical Park in Valencia, Jeff Greiner is working on a treatment for urinary incontinence that doesn’t involve medication or surgery. Instead, it’s a tiny implanted device that works a bit like a pacemaker, but for the part of the nervous system that controls bladder function. “We think we can affect change in a positive way and possibly replace drugs,” Greiner told the Business Journal. His company, Valencia Technologies Inc., is part of a cluster of biotech firms that is turning the Santa Clarita Valley into a hotspot for neuromodulation, a type of therapy that has been heralded as a probable solution to conditions ranging from rheumatoid arthritis to depression. Most of the companies are in some way linked to the legacy of the late serial entrepreneur and billionaire Alfred Mann, who died in 2016. “(Mann) was a legend in our field,” Greiner said. Mann’s company PaceSetter Systems, which later became St. Jude Medical before it was acquired by Abbott, provided the basis for implantable bioelectronics through the first cardiac pacemaker. A second Mann firm, Minimed – acquired by Medtronic in 2001 – dramatically changed the treatment of diabetes with the first insulin pumps and continuous glucose monitors. It was through a third company, Advanced Bionics, that Mann shaped the foundation of neuromodulation with implantable devices for treating deafness and lower back pain. Though the technology was sold off to Sonova International and Boston Scientific Corp. around 2010, much of the talent behind its development has remained in Santa Clarita, where Advanced Bionics was founded. “We’re seeing former researchers and execs from some of (Mann’s) companies developing their own companies to pursue additional technologies,” Holly Schroeder, chief executive of the Santa Clarita Economic Development Corp., said. “That’s a really good sign for the growth of this cluster.” Devices galore Neuromodulation technology works through implanted devices that act directly on the nervous system. The U.S. Food and Drug Administration has approved a handful of such products for sale, including Boston Scientific’s spinal cord stimulation system that was built using the technology the company acquired with the Advanced Bionics purchase for $2.5 billion in 2002. “Advanced Bionics is the most successful company in neuromodulation that started from scratch,” Greiner said. “It was something quite extraordinary from the start.” Greiner himself worked with Mann for more than 20 years as the driving force that established Advanced Bionics as an industry leader. From the time he came on board with the company as its chief operating officer in 1992 until the sale of its cochlear hearing aid implant technology in 2010, at which time he was serving as chief executive, Greiner grew Advanced Bionics from a team of seven scientists and engineers to more than 2,500 employees and $300 million in annual revenue. After the sale of the cochlear implant technology – which was purchased by Swiss biopharma Sonova International for $500 million – many members of the Advanced Bionics talent pool went off to form their own firms, as Greiner did, or to work for other neuromodulation companies. Company alum populate the leadership team of SetPoint Medical Corp., a biotech located in the Mann Biomedical Park that has built a device for treating rheumatoid arthritis and Crohn’s disease by way of the nervous system’s “inflammatory reflex.” Ex-Advanced Bionics employees can be found beyond Santa Clarita as well, from startups like Nevro Corp. in Redwood City to the neuromodulation initiatives of major firms the likes of GlaxoSmithKline and Alphabet Inc., according to Greiner. “A lot of these people worked for me at one time or another,” Greiner said. “Advanced Bionics was the leading startup in this field for many years until it was sold off by Al.” Trial to market The neuromodulation industry began more than three decades ago, when researchers set out to understand how nerve-stimulation technology impacted the various pain-relief pathways, according to Nancy Patterson, chief executive of L.A.-based medical device valuation and market analysis firm Strategy Inc. “The last five to six years have been dedicated to understanding the nervous system in expanded detail and how to communicate with it in more effective methods,” she said. The technology is approved for use in the treatment of Parkinson’s disease, epilepsy, pain, deafness and overactive bladder. The small firms within the Santa Clarita cluster are either working on new indications or improving the technology that treats established ones. Valencia Technologies’ eCoin, for instance, offers a “simpler” approach to treating overactive bladder by stimulating the appropriate nerve for 30 minutes every other day – a significantly shorter period than other devices on the market. “Most of neuromodulation today has one principal assumption … you need constant stimulation of a particular nerve with a particular paradigm,” Greiner said. “But there’s underlying scientific work suggesting that you don’t need constant stimulation for the brain to react.” Valencia Technologies is waiting to hear back from the FDA on its application to start the next round of clinical trials. A much smaller neuromodulation firm built by Mann, Bioness Inc., has three devices on the market for treatment of weakness and mild paralysis caused by neurological syndromes such as multiple sclerosis. In early December, SetPoint Medical received FDA approval to run a second clinical trial on its proprietary device as a treatment for rheumatoid arthritis, a follow-up to a proof-of-concept study the company completed in 2016. Like Valencia Technologies, SetPoint Medical describes its product as a more efficient answer to the “traditional” neuromodulation devices currently on the market, as it works through brief electrical impulses rather than continuous stimulation. “(We are) targeting inflammatory diseases with a tiny, proprietary bioelectronic medicine device custom built for the diseases we treat,” SetPoint Chief Executive Anthony Arnold said in an e-mail. “(This) creates a lasting effect and stimulate(s) the body’s natural mechanisms to treat a disease.” SetPoint Medical has begun enrolling patients in its clinical trial, which is slated to begin later this year. Scaling up The global market value for neuromodulation devices is expected to reach $5.2 billion by 2021, including $2.5 billion in the U.S., according to Patterson’s firm. That’s good news for the Santa Clarita Valley, which stands to gain from an influx of talent as the startups expand. “I think that we’re seeing companies – especially the younger companies – grow,” she said. “We anticipate that once (their devices) are approved there will be a marked increase in hiring as they ramp up into larger-scale production.” Fortunately, they have plenty of room to grow in Santa Clarita. Long-term success was factored into the development of the Mann Biomedical Park, which was designed to accommodate the entry of new companies or the expansion of those currently housed there, Schroeder said. “It creates a very good cluster for attracting talent,” Schroeder said. “That’s paramount for these types of research and development operations.”