As venture investment in medical devices stalls, companies get creative – the washington post

“We go talking to venture capitalists but unless you get one that really understands the science and market potential, there’s skepticism,” Whelan said. “The [venture capitalists] are as skeptical as everybody else.” Bioelectronics patch treats pain by transmitting radio waves deep into a person’s tissue (photo courtesy Bioelectronics Corp.) Its flagship product is a tiny sensor implanted under the skin of a patient’s shoulder, designed to continually monitor a patient’s blood sugar and communicate back to a smart-phone app that displays real-time blood

sugar levels and trends. The goal is to give diabetics a way to monitor blood sugar without the regular finger-pricking, which is a daily annoyance for some 29 million Americans. Take Senseonics, a Germantown biotech company working on an app-based blood sugar monitor that is implanted under a person’s skin. It is attempting a public offering on New York Stock Exchange by going through a rather circuitous process. To catch up, Senseonics began a clinical trial last month in patients with diabetes in the United States. By Aaron Gregg February 14 Follow @Post_AG Chief executive Andy Whelan says he has tried to raise money from venture funds with little success.

Bioelectronics Corp., a device company based in Frederick, Md., has been trading on the pink sheet market for years, and it has spent close to $30 million on research and development since its founding in 2003. In the meantime, Whelan keeps the wheels churning by raising money from individuals willing to bet on his over-the-counter stock, many of whom have tried the product themselves – housewives, doctors, mid-level business executives, he says. Total venture funding for medical device companies dropped after the 2008 recession and never recovered, even as funding has rebounded elsewhere, funding data show. That’s a potentially huge market. But the company’s dreams of profitability hinge entirely on whether it can get its products across the regulatory finish line before funding dries up. The company has spent about $150 million in investment capital on research and development, including money from specialized venture funds Delphi Ventures and Chevy Chase, Md.-based New Enterprise Associates. The company’s flagship product uses a tiny antennae on a patch to treat chronic pain by delivering electro-magnetic pulses deep into a person’s tissue.

The product still isn’t approved by the FDA but you can buy it in Walgreens in the U. K. or Canada for about $30 each. Senseonics is in the process of moving onto the New York Stock Exchange. It filed last month for an initial public offering on that exchange worth up to $52 million. Between 2008 and 2009 total U. S. venture funding for device companies dropped 27 percent to about $2.6 billion, according to a multi-year analysis of Thomson Reuters data by PricewaterhouseCoopers and the National Venture Capital Association. In the seven years since the recession, funding for device companies ticked up only slightly to $2.7 billion, and the number of deals dropped from 394 in 2008 to only 308 last year. To raise more funds, the company started trading on the so-called pink sheet market last month through a reverse merger; a type of deal through which a private company can go public by buying up a publicly traded entity and taking its spot on the listing. A pink sheet listing means a company’s stock is traded “over the counter” and not on any of the major exchanges.

Companies with such listings do not face the same filing requirements with the Securities and Exchange Commission, and tend to be regarded as riskier bets. Pushing a new device through regulatory review typically requires tens or hundreds of millions of dollars in research and development, all to prove to a panel of scientists that it is safe and effective. Investments with that level of risk are usually the domain of specialized venture funds with expertise in the medical field. And many prefer actual drug development to devices because the rewards can be bigger. In other words, what funding is still available is being captured by a smaller and smaller pool of companies. At least two other companies—U. K.-based Abbott and San Diego-based Dexcom—also have continuous blood sugar monitors.

Dexcom sprinted out ahead of the pack last year when an important component of its product won Food and Drug Administration approval and launched on iPhone. The scarcity of venture capital means that biotech companies trying to push potentially pioneering medical devices through the regulatory pipeline are engineering creative deals to sell stock to the general public in order to raise the necessary funds–no easy chore when the financial markets are in such turmoil these days. Today’s venture capital market is one where a company with less than 200 employees can rake in more than $100 million from investors. But one corner of the market has largely been left behind: companies offering new medical devices. Senseonics pulled in revenues of only $38,000 in the nine-month period ending September 30, 2015, hardly enough to fund itself through regulatory review.

Over that same period it ran an operating loss of $20.6 million, driven primarily by research and development expenses. “Even if we get 10 or 15 million [more] dollars it will still take us years,” Whelan said. “Innovation just takes a long time.” That’s not unusual for a company looking to bring a new drug or device to market.