Ropes & Gray Digital Health Initiative

1 TO HELP YOU STAY ABREAST OF KEY DEVELOPMENTS, we are pleased to share the Fall 2021 issue of the Digital Health Download, a series curating the latest business and regulatory news impacting the industry. According to Rock Health, digital health funding in the first half of 2021 reached $14.7B, already surpassing 2020’s funding of $14.6B. Rock Health named mental health as one of the top three funded clinical indications this year as shown by LifeStance Health’s $720M IPO and Amwell’s acquisition of SilverCloud Health. Additionally, breaking down silos in health care has been the focus of multiple mergers in the last year, exemplified by the $7B merger of Datavant, a health IT entity which develops and maintains a digital ecosystem for the exchange of health care data, and Ciox, a health information management company that is creating the nation’s largest health data ecosystem. This summer and fall were packed with exciting digital health activity. Ropes & Gray’s inaugural episode of Decoding Digital Health was released in May, discussing digital health emerging trends and hot topics in 2021. In July, Kellie Combs continued the discussion of digital health trends, including impactful tech deals, regulatory developments and the legal concerns within cybersecurity of health care data at the Women Leaders in Life Sciences Law Conference. Christine Moundas continued to share insights in September at the inaugural Financial Times’ Future of American Healthcare Conference and our event with Mass Insights exploring how health data sharing and analytics is fueling innovation in the industry. In our latest podcast episode we discussed artificial intelligence in life sciences and health care with partner Regina Sam Penti. Additionally, we’ve summarized the recent digital health updates that have captured our interest. If you have questions about digital health, please contact us or your usual Ropes & Gray advisor. Check out the Ropes & Gray Digital Health page for the latest insights, upcoming events and useful tools. Best, Co-Chairs of the Ropes & Gray Digital Health Initiative Megan Baca Partner, Silicon Valley Kellie Combs Partner, Washington, D.C. Christine Moundas Partner, New York DIGITAL HEALTH DOWNLOAD FALL 2021 IN THIS ISSUE n RECENT EVENTS ..................2 n ROPES & GRAY INSIGHTS .....2 n ROPES & GRAY IN THE NEWS ......................3 n FUNDING & INVESTMENTS ....4 n IPOS AND SPACS ..................5 n PARTNERSHIPS AND TRANSACTIONS ...................6 n FDA CLEARANCES AND PRODUCT/SOFTWARE LAUNCHES ..........................8 n INTERNATIONAL ..................9 FALL 2021 DIGITAL HEALTH DOWNLOAD DIGITAL HEALTH DOWNLOAD FALL 2021 DIGITAL HEALTH DOWNLOAD 2 RECENT EVENTS n Ropes & Gray health care partner Christine Moundas was joined by Thomas Schinecker, CEO of Roche Diagnostics, and David Jaffray, Chief Technology and Digital Officer of the MD Anderson Cancer Center at the University of Texas, on the panel “Driving the Digital Health Revolution” at the inaugural Financial Times’ Future of American Healthcare Conference on September 14. n Ropes & Gray hosted a session with Mass Insights on September 23 on “How an Explosion of Health and Genomic Data Sharing and Analytics is Fueling Innovation.” During the panel, Christine Moundas and David Peloquin were joined by Dr. Todd R. Golub, Director of Broad Institute of MIT and Harvard, Dr. Brian Alexander, Chief Executive Officer of Foundation Medicine, Andy Beck, MD PhD, Co-Founder & CEO of PathAI and Rebecca Li, PhD, Executive Director of Vivli, to discuss their involvement in various health and genomic data sharing and secondary use endeavors, including discussion of the challenges and opportunities in this evolving field, as well as some of the key legal implications of such activities. n Life sciences regulatory & compliance partner Kellie Combs presented on July 28 on the panel on “Assessing the Recent Explosion of Digital Health and Health Tech: An Industry Discussion of the Latest Deals, Increasing Regulations and the Top Legal Issues to Have on Your Radar.” The session focused on the latest digital health advancements impacting and disrupting the health care market, the most interesting and impactful health tech deals in the last year and the latest and emerging regulatory landscape governing these new technologies. ROPES & GRAY INSIGHTS n ALERT: Proposed Rule on CY 2022 Physician Fee Schedule Addresses Telehealth (Especially Mental Health), Drug Pricing and Reimbursement, Provider Enrollment, Vaccines, and Physician-Owned Distributor Transparency – August 13, 2021 n ARTICLE: Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings – June 23, 2021 n PODCAST: Decoding Digital Health: 2021 Developing Trends and Hot Topics in Digital Health – May 19, 2021 n ARTICLE: Mutual Recognition of Physician Licensure By States Would Provide For Better Patient Care – May 10, 2021 FEATURED The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. Check out our latest episode, in which the co-leads of the Ropes & Gray Digital Health Initiative, Megan Baca, Kellie Combs and Christine Moundas, as well as Intellectual Property Transactions partner Regina Sam Penti, explored the latest developments and legal issues relating to artificial intelligence in life sciences and health care. DIGITAL HEALTH DOWNLOAD FALL 2021 DIGITAL HEALTH DOWNLOAD 3 Continued on page 4 n EQRx, a company committed to developing and delivering important new medicines to patients at radically lower prices, and Absci announced a strategic drug discovery and development partnership to use Absci’s artificial intelligence and synthetic biology platform to create more affordable protein-based therapies for patients. – October 8, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to EQRx with a team led by Abigail Gregor and James McLeod. n Aquiline Capital Partners has acquired Avera Health, the Sioux Falls-based telemedicine services provider. As part of the acquisition, Aquiline will execute the carve-out of Avera eCare and rename the company Avel eCare. – August 6, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to Aquiline Capital Partners with a team led by Carolyn Vardi, that included Christina Bergeron, Andrea Hwang, Loretta Richard, Alyssa Kollmeyer, Violetta Kokolus, Kevin Angle, Steven Kaye and Samuel Levitt. n Amwell, a national telehealth company, announced that it has signed definitive agreements to acquire SilverCloud Health, a digital mental health platform, and Conversa Health, an automated virtual health care company. – July 28, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to Amwell with a team led by Michael Beauvais, Bryan Lowrance, Joe Muller, Chris Celentano, Debbie Wang, Justin Yee, Taylor Solomon and Brittany Pifer, that included Pam Glazier, Josh Lichenstein, Violetta Kokolus, Zach Blume, Kellie Combs, Tim McCrystal, Michael Jurasic, Steve Kaye, Deidre Johnson, Dave Mandel, Will Dunham, Clare Sellars and Kevin Angle. n WellSky Corporation, a portfolio company of TPG Capital and Leonard Green & Partners, has agreed to sell WellSky International to System C Healthcare, a provider of information technology implementation software and services to the health sector – and portfolio company of CVC Capital Partners. – July 28, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to WellSky Corporation with a team led by Matthew Martindale, Ashleigh Morton, Victoria McGrath, and John Newton, that included Rohan Massey, Clare Sellars, Andrew Howard, Danna Kivell, Nick Steynberg, Sean Seelinger and Brendan Kearney. n Sandbridge Acquisition Corporation, a SPAC co-sponsored by affiliates of Sandbridge Capital and PIMCO private funds, completed its business combination with Owlet Baby Care, a company building a connected and accessible nursery ecosystem that brings technology and vital data to modern parenting. The business combination and concurrent private placement value Owlet at approximately $1.07 billion and provide over $135 million to accelerate Owlet’s expansive product pipeline, product penetration and global expansion. – July 20, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to Sandbridge Acquisition Corporation with a team led by Emily Oldshue, Christopher Comeau, Brittany Pifer, Kasey McNamara and Sarah Smith. n HeartFlow Holding, the leader in revolutionizing precision heart care, and Longview Acquisition Corp. II, a SPAC sponsored by affiliates of Glenview Capital Management, announced that they have entered into a definitive business combination agreement that will support HeartFlow’s vision of revolutionizing precision heart care. – July 15, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to Longview Capital Management with a team led by Carl Marcellino and Paul Tropp. ROPES & GRAY IN THE NEWS DIGITAL HEALTH DOWNLOAD FALL 2021 4 Continued from page 3 Continued on page 5 DIGITAL HEALTH DOWNLOAD n EQRx and Exscientia, an AI-driven pharmatech company, announced a strategic research and development collaboration agreement to accelerate the delivery of new medicines to more patients at lower prices. – June 24, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to EQRx with a team led by Abigail Gregor and Katherine Kim. n LifeStance Health, one of the nation’s largest providers of outpatient mental health care, announced the closing of its $720 million initial public offering. In the offering, LifeStance sold 32.8 million shares and existing investors, TPG Capital, Summit Partners and Silversmith Capital Partners sold 7.2 million shares, each at a public offering price of $18 per share. – June 14, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to LifeStance Health with a team led by Tom Fraser and Dayna Mudge, that included Renata Ferrari, Adam Greenwood, Tim McCrystal, Christina Bergeron, Ed McNicholas, Morey Ward and Claire Rosa. n New Mountain Capital and its portfolio company Ciox Health have entered into a definitive agreement to merge Ciox Health with Datavant. The transaction is valued at $7 billion, and the combined company will be named Datavant. – June 9, 2021 (Ropes & Gray) n ROPES & GRAY acted as legal advisor to New Mountain Capital and Ciox Health with a team led by John Sorkin, Andrew Silver, Danna Kivell, Rachel Phillips, Adam Greenwood, Garrett Charon and Jennifer Romig. n One Medical, a leading technology-powered primary care organization, entered into a definitive agreement to acquire Iora Health in an all-stock transaction valued at approximately $2.1 billion. – June 7, 2021 (Ropes & Gray) n ROPES & GRAY acted as health care counsel to One Medical with a team led by Jennifer Romig, that included Sam Perrone, Grace Kim, Eliza Pan, Emma Kaufman and Ryan Marcus. n Pager announced $70 million in newly raised equity and debt financing. The series C round was headed by Susquehanna Private Equity Investments. – September 22, 2021 (FierceHealthcare) n WHOOP announced that it has raised $200 million in a Series F funding round at a $3.6 billion valuation led by SoftBank Vision Fund 2. – August 30, 2021 (WHOOP) n Accenture has made a strategic investment in ixlayer, a provider of technology-based solutions for diagnostic testing. – August 24, 2021 (Accenture) n Morgan Health announced a $50 million investment in Vera Whole Health. – August 5, 2021 (VeraWholeHealth) n Cadence has raised $41 million in funding from rounds led by General Catalyst and Thrive Capital. In conjunction with its launch, Cadence has forged a founding partnership with national healthcare company LifePoint Health. – August 5, 2021 (LifePointHealth) n InnovAge Holding Corp. announced it has made an equity investment in Jetdoc, a telehealth and virtual urgent care app. – August 4, 2021 (Innovage) n VisiQuate announced a new $50 million equity investment from Sixth Street Growth. – July 13, 2021 (SixthStreetGrowth) n Linus Health has raised $55 million in funding for screening tools to diagnose dementia and Alzheimer’s disease. Morningside Ventures led the round. – July 8, 2021 (VentureBeat) FUNDING AND INVESTMENTS DIGITAL HEALTH DOWNLOAD FALL 2021 5 Continued from page 4 DIGITAL HEALTH DOWNLOAD n Novo Holdings announced a strategic minority investment in Availity. – July 8, 2021 (Availity) n 4G Clinical, a randomization and trial supply management (RTSM) company, raised $230 million in funding led by Goldman Sachs Asset Management. – July 1, 2021 (CBInsights) n LetsGetChecked completed a $150 million Series D round of financing led by Casdin Capital. – June 8, 2021 (MobiHealthNews) n Akili Interactive announced $160 million in combined equity and debt financing. The $110M Series D equity financing was led by Neuberger Berman Funds. – May 26, 2021 (Akili) n Cue Health has closed a $235 million private financing round. Investments were made by new backers Perceptive Advisors, MSD Capital and Koch Strategic Platforms. – May 14, 2021 (CueHealth) n DrFirst received a $50 million equity investment from Sixth Street Growth. – May 13, 2021 (SixthStreetGrowth) n Caris Life Sciences announced an $830 million growth equity round. The round was led by Sixth Street Growth. – May 11, 2021 (SixthStreetGrowth) n Oura raised $100 million in funding. New investors that participated in the funding round include Temasek, JAZZ Venture Partners, Eisai and Elysian Park Ventures. – May 6, 2021 (TechCrunch) n Collective Health closed a $280 million Series F financing round led by Health Care Service Corp. – May 4, 2021 (CollectiveHealth) n EQRx and SPAC CM Life Sciences III sponsored by affiliates of Casdin Capital and Corvex Management, announced that they have entered into a definitive business combination agreement. – August 6, 2021 (EQRx) n LifeSpeak announced the successful closing of its previously announced initial public offering and secondary offering. – July 6, 2021 (LifeSpeak) n SOPHiA GENETICS filed for a $100 million initial public offering. – July 2, 2021 (SOPHiAGENETICS) n Pear Therapeutics and SPAC Thimble Point Acquisition Corp. announced their definitive business combination agreement. – June 22, 2021 (PearTherapeutics) n Doximity announced that it has launched the roadshow for its initial public offering. – June 15, 2021 (Doximity) n Babylon Health and SPAC Alkuri Global Acquisition Corp. have entered into a definitive merger agreement. – June 3, 2021 (Babylon) n Bright Health Group is officially going public; it is seeking to raise up to $100 million. – May 20, 2021 (MobiHealthNews) n Roivant Sciences is going public, merging with SPAC Montes Archimedes Acquisition Corp. at a $7.3 billion valuation. – May 3, 2021 (Forbes) IPOs and SPACs Continued on page 6 DIGITAL HEALTH DOWNLOAD FALL 2021 6 Continued from page 5 DIGITAL HEALTH DOWNLOAD n GE has entered into an agreement to acquire BK Medical, a leader in advanced surgical visualization, from Altaris Capital Partners for a cash purchase price of $1.45 billion. – September 23, 2021 (GE) n Unite Us has announced the acquisition of NowPow, the Chicago-based referral platform. – September 21, 2021 (UniteUs) n symplr announced that it has agreed to acquire Halo Health, a provider of clinical communication and collaboration software. – September 14, 2021 (HaloHealth) n One Medical (1Life Healthcare) announced it has completed the acquisition of Iora Health, a humancentered, value-based primary care organization with built-for-purpose technology. – September 1, 2021 (OneMedical) n Mayo Clinic and Verily announced a strategic two-year collaboration which focuses on the development of a digital point-of-care resource of vetted knowledge to support an individualized approach to patient care. – August 26, 2021 (Verily) n AppliedVR will test its virtual-reality-based digital therapeutics across five studies using the decentralized clinical trials software from Curebase. – August 26, 2021 (Curebase) n Foundation Medicine announced a partnership to integrate its comprehensive genomic profiling and other testing services with Epic’s electronic medical record system. – August 26, 2021 (FoundationMedicine) PARTNERSHIPS AND TRANSACTIONS n AccessDX Holdings has acquired 2bPrecise™ from Allscripts Healthcare Solutions. – August 25, 2021 (2bPrecise) n Headspace and Ginger are merging to form a $3 billion entity called Headspace Health. – August 25, 2021 (MedCityNews) n Optellum has entered a strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson. Through the collaboration, Optellum will apply its AI-powered clinical decision support platform with the goal of increasing lung cancer survival rates through early intervention and prevention. – August 18, 2021 (Optellum) n Verily, an Alphabet company, and SignalPath announced that they have entered into an agreement in which Verily will acquire SignalPath. – August 17, 2021 (Verily) n Unite Us has announced the acquisition of the health analytics company, Carrot Health. – August 17, 2021 (UniteUs) n LabCorp announced that it has acquired the femtech startup Ovia Health. – August 12, 2021 (LabCorp) n Sharecare entered home health market with acquisition of CareLinx. – August 11, 2021 (Sharecare) n GoodRx struck a partnership with medication data company Surescripts that would let health care providers access cash price information on medications. – August 5, 2021 (MedCityNews) n Relatient, a SaaS-based, patient engagement platform, announced the signing of a definitive agreement to merge with Radix Health while also raising $100+ million of additional growth equity capital from its existing investor, Brighton Park Capital and its affiliates. – August 5, 2021 (RadixHealth) Continued on page 7 DIGITAL HEALTH DOWNLOAD FALL 2021 7 Continued from page 6 DIGITAL HEALTH DOWNLOAD n Teladoc announced a collaboration with Microsoft in which Teladoc Health’s Solo platform for hospitals and health systems will be integrated into the Microsoft Teams environment to strengthen physician and patient access to best-in-class virtual healthcare. – July 14, 2021 (Teladoc) n Francisco Partners has signed a definitive agreement to acquire Starlims from Abbott. – July 8, 2021 (MiddleMarket) n Intelerad Medical Systems, a medical image management solutions company backed by Hg, has acquired Heart Imaging Technologies. – July 8, 2021 (Intelerad) n Hims & Hers Health announced its acquisition of teledermatology specialist Apostrophe. – July 7, 2021 (Hims&Hers) n GE Healthcare and SOPHiA GENETICS announced that they have signed a letter of intent to collaborate on advancing cancer care. – July 6, 2021 (SOPHiAGENETICS) n Health Catalyst announced that it has entered into a definitive agreement to acquire Twistle. – June 24, 2021 (HealthCatalyst) n Ada has signed new partnerships with key global players across life sciences, insurance and health systems, including Alnylam, Pfizer, Sanofi, Takeda and Novartis. – June 14, 2021 (Ada) n Ensemble Health Partners announced it has acquired Odeza. – June 2, 2021 (EnsembleHP) n Quest Diagnostics has partnered with Paige to develop AI-enabled products and services. – May 25, 2021 (QuestDiagnostics) n PicnicHealth and Komodo Health announced a partnership to support real-world evidence research programs for complex illnesses like multiple sclerosis and hemophilia. – May 24, 2021 (PicnicHealth) n Ro announced the acquisition of Modern Fertility. – May 19, 2021 (Ro) n KKR closed its acquisition of a majority interest in Therapy Brands. – May 18, 2021 (TherapyBrands) n Cedar acquired another billing startup, OODA Health, for $425 million. – May 13, 2021 (Cedar) n CellCarta announced the acquisition of Reveal Biosciences. – May 11, 2021 (CellCarta) n Walmart Health has entered into an agreement to acquire MeMD. – May 6, 2021 (Walmart) n GoodRx is launching a new health information tool designed to give in-depth information to some of the most common health questions and conditions. – September 23, 2021 (MobiHealthNews) n Welldoc announced the receipt of its ninth 510(k) clearance from the FDA for its award-winning diabetes platform, BlueStar. – September 22, 2021 (WellDoc) n Paige announced that the FDA has granted de novo marketing authorization for Paige Prostate, a clinicalgrade AI solution for prostate cancer detection. – September 22, 2021 (Paige) Continued on page 8 FDA CLEARANCES AND PRODUCT/ SOFTWARE LAUNCHES DIGITAL HEALTH DOWNLOAD FALL 2021 8 Continued from page 7 DIGITAL HEALTH DOWNLOAD n Johns Hopkins Medicine has developed a tool aimed at automatically identifying patients likely to need telehealth technical assistance. – August 10, 2021 (HarvardBusinessReview) n CVS Health’s Aetna unveils nationwide primary care telehealth service Aetna Virtual Primary Care. Aetna Virtual Primary Care provides virtual primary care to self-funded employers nationwide. – August 10, 2021 (CVSHealth) n Abbott received FDA clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon Software. – August 3, 2021 (Abbott) n After the FDA loosened guidelines last year for digital health products treating some behavioral health conditions, startup Happify Health is making an appbased treatment for anxiety and depression available to patients. The company’s new digital therapeutic, called Ensemble, uses app-based exercises to help people change negative thinking patterns and develop healthy habits. – July 23, 2021 (MedCityNews) n Rockley Photonics revealed its complete full-stack, “clinic-on-the-wrist” digital health sensor system. Rockley’s sensor module enables wearable devices to monitor multiple biomarkers. – July 14, 2021 (RockleyPhotonics) n Carrot announced that its Pivot Carbon Monoxide Breath Sensor has received expanded indications for use in a new 510(k) clearance by the FDA based on published clinical trial data. – July 12, 2021 (MedCityNews) n Nuvo Group announced the FDA has granted supplemental 510(k) clearance to add a new uterine activity module to its INVU system, a physicianprescribed, wearable pregnancy monitoring system. – June 10, 2021 (MobiHealthNews) n Amazon Halo is adding a new feature designed to help users understand their functional fitness, dubbed Movement Health. – June 3, 2021 (MobiHealthNews) n Cognoa has received FDA De Novo classification for its autism spectrum disorder (ASD) software diagnostic aid, Canvas Dx. – June 3, 2021 (Cognoa) n Becton Dickinson announced the U.S. launch of a Urine Culture Application for use with the BD Kiestra™ lab automation incubation and imaging system using artificial intelligence to transform the way microbiology labs approach urine culture analysis. – May 26, 2021 (BectonDickinson) n Apple announced new software features designed for people with mobility, vision, hearing and cognitive disabilities. The first of the new features, SignTime, allows users to communicate with AppleCare and Retail Customer Care using sign language. – May 19, 2021 (Apple) n Google revealed a preview of its dermatology assistant that runs on a web-based application and uses artificial intelligence to help patients using their personal cameras. – May 18, 2021 (Google) n Medtronic is rolling out Careguidepro, its first patientfocused digital tool for spinal cord stimulation. It enables providers to better manage patients’ pain relief with realtime feedback and data. – May 5, 2021 (Medtronic) Continued on page 9 DIGITAL HEALTH DOWNLOAD FALL 2021 9 Continued from page 8 DIGITAL HEALTH DOWNLOAD n King’s College London and global pharmaceutical company GlaxoSmithKline have formed a new five-year partnership to use AI to provide insight into why and how some patients respond to certain cancer treatments. – September 23, 2021 (MobiHealthNews) n Aurora Mobile, a leading mobile developer service provider in China, announced that it has entered into a partnership agreement with Health Headline Technology. Leveraging the Company’s Video-as-a-Service solutions, Aurora Mobile helps Health Headline to deliver comprehensive health care information to users in China. – August 24, 2021 (AuroraMobile) n China-backed MediTrust Health, an online pharmacy platform, raised $308 million in a Series C funding round. The round drew participation from Boyu Capital, Janchor Partners, Lilly Asia Ventures and Sinovation Ventures, among others. – August 13, 2021 (CBInsights) n Everest Medicines, a biopharmaceutical company focused on developing and commercializing pharmaceutical products for patients in Greater China and Asia, announced that it has entered into a strategic collaboration with Medbanks Health Technology. – July 13 2021 (Everest) n Eli Lilly announced a strategic collaboration with Chinese internet giant Tencent. The deal will see both parties empower medical services with cloud technology, big data analysis and artificial intelligence, and build a patientcentric, smart medical ecological system. – July 12, 2021 (ChinaDaily) n Carlyle and Inova announced a long-term funding partnership to accelerate growth, fund product innovation and M&A initiatives. – July 1, 2021 (Carlyle) n JD Health and Pfizer China announced plans to initiate a health-management program for children’s vaccinations in Beijing. – June 2, 2021 (JDCorporateBlog) n Genetron, a leading precision oncology platform company in China, announced a strategic partnership with Siemens Healthineers. – May 13, 2021 (Genetron) INTERNATIONAL Check out the Ropes & Gray Digital Health page for the latest insights, upcoming events and useful tools. 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