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In its Q1 2019 digital health funding report Rock Health noted that investment in digital health companies leveled off in the first quarter after a record-setting 2018. At $986 million, investment in the first three months of the year was down 21 percent from the fourth quarter of 2018, when it hit $1.2 billion

But the leveling off in funding is more likely linked to an overall decrease in venture investment than to any weakness in the fundamentals of the digital health sector.

The PwC/CB Insights MoneyTree Report Q1 2019 states that global venture funding dropped 22 percent in the first quarter over the last quarter of 2018—from $67 billion in Q4 to $52.2 billion in Q1. U.S. venture investment overall dropped even more in Q1, from $38.7 billion to $24.6, or 36 percent. As a result, digital health venture investment is either even with or outperforming the market as a whole.

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Continue Reading Digital Health Investment Levels Off and Unicorns Emerge

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With 58 U.S. biopharma IPOs in 2018, the biotech industry entered the new year with confidence. By all appearances, the longest and largest biotech IPO window in history was not going to close anytime soon. But it was biotech dealmaking that took center stage at the annual J.P. Morgan Healthcare Conference at the beginning of 2019.

On the opening day of the annual confab in San Francisco, Bristol-Myers Squibb and Eli Lilly and Company both announced blockbuster deals — strengthening the case that M&A would likely be the exit of choice. Many IPO candidates may be reluctant to pursue a public offering, given lingering political and market uncertainty in the first part of the year.

After announcing Lilly’s deal to acquire Loxo Oncology, David Ricks, the company’s chairman and CEO, assured analysts that he expects there will be an increase in M&A activity in the year to come. Lilly’s CFO and SVP Joshua Smiley, added that the company could continue doing deals throughout the year. (Fenwick represented Loxo Oncology in the $8 billion deal)

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Continue Reading Which Way to the Exits for Biotech?

Fenwick & West Digital Health Investor Summit
The Seventh Annual Fenwick & West Digital Health Investor Summit profiled a sector that continues to attract record levels in investment, further matures and consolidates, and that is leveraging the newest technologies in blockchain and artificial intelligence to improve the practice and delivery of health care. Speakers included Rock Health’s Bill Evans and Goldman Sach’s Peter van der Goes, who discussed the possibility of an investment bubble and outlook for 2019, and Ruchita Sinha of Sanofi Ventures, who talked about blockchain in digital health. Fenwick’s Kristine Di Bacco moderated a panel on machine learning and artificial intelligence in healthcare with guest speakers Brandon Ballinger, co-founder of Cardiogram; Alison Darcy, founder and CEO of Woebot Labs; and Christine Lemke, co-founder and president of Evidation Health.

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Continue Reading Takeaways from Fenwick’s 2018 Digital Health Investor Summit

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Private investment in digital health continued apace in the second quarter of 2018, based on our latest look at deal flow. As the sector has matured, growth in investment levels quarter-over-quarter and year-over-year appears sustainable for the foreseeable future.

Likewise, the closing of a handful of megadeals each quarter is becoming the rule rather than the exception. The second quarter saw seven megadeals for $100 million or more. That is right in line with the first quarter, when we also recorded seven rounds of $100 million or greater.

The top investees in the second quarter were diverse, ranging from biopharmaceuticals to artificial intelligence to primary care. This diversity may be a sign that investors are looking beyond the low-hanging fruit of infrastructure and patient engagement, or even diagnostic applications, to areas such as primary care where opportunities for digital disruption are less obvious.

It is also interesting to note that over half of the investment rounds of $100 million or more went to companies based in China. We’ve seen a steady increase in investments in Chinese digital health companies over the past few years. But this is the first time that we have seen them account for half of the top deals—including the three largest rounds for $200 million or more.

Here’s a summary of the seven largest deals of the quarter:

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Continue Reading Digital Health Investment Trends Q2 2018: Megadeals Become the Norm, China Rising

Fenwick corporate lawyer Julia Forbess discussed biotech investment and financing trends with the BIO Buzz Center at the 2017 BIO Investor Forum.

“For 2018, we’re still expecting to see investment in core areas—oncology, orphan drugs and neurology. One thing that could be new is the number of tech investors interested in diagnostics and other…

Fenwick’s Sixth Annual Digital Health Investor Summit started on an upbeat note with Rock Health’s Megan Zweig sharing the venture fund’s mid-year funding report. After the uncertainty brought by the 2016 presidential election and the political drama surrounding the future of the Affordable Care Act, it would not seem surprising to see investors take…

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the Center for Devices & Radiological Health released an action plan about its Digital Health Program and posted a notice for comment for a Software Pre-Certification Pilot Program.

The pilot program is a first step in the FDA’s reimagined digital health product oversight approach. What makes it stand out from the FDA’s prior regulatory approach is its aim "to develop a new approach toward regulating this technology – by looking first at the software developer or digital health technology developer, not the product."

Under its firm- and developer-based approach, the CDRH could "pre-certify" eligible digital health developers who "demonstrate a culture of quality and organizational excellence based on objective criteria, for example, that they can and do excel in software design, development, and validation (testing). Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review."

In his blog post, the FDA’s Scott Gottlieb announced that in August companies can submit a statement of interest that includes the qualities listed above and request participation in the pilot to FDAPre-CertPilot@fda.hhs.gov. The FDA’s Digital Health Team will evaluate submissions and select companies that reflect the broad range of software developers later in the month. “A critical component is that we will include small and large companies, traditional and non-traditional medtech companies, and products that range in risk,” Gottlieb said in his post. (Read more about how the CDRH is recruiting participants to the pilot program.)

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Continue Reading Digital Health Companies May Find a Faster Path to Market Under the FDA’s Digital Health Plan

Last September, we noted that payers and providers were expected to become increasingly active digital health strategic investors given their challenges to improve margins and outcomes.

While there were only three investments by payer/providers in the second half of 2016, we saw a notable uptick in investment activity in the first quarter of 2017, when…

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San Francisco has evolved from a J.P. Morgan private meeting for healthcare investors to a week…