FDA's Threat of Lab-Developed Test Oversight Is Back on the Table with Proposed Rule
On October 3, 2023, the U.S. Food and Drug Administration (FDA) published aproposed ruleto regulate laboratory-developed tests (LDTs). The rule, if finalized, would amend FDA regulations to broaden the definition of “in vitro diagnostic products” (IVDs) to include laboratories that manufacture such products, thus making LDTs subject to the same medical device regulatory oversight by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Wilson Sonsini Adds Meredith Krannich to Executive Advisory Program
Wilson Sonsini Goodrich & Rosati, the premier provider of legal services to technology, life sciences, and growth enterprises worldwide, today announced that Meredith Krannich has joined the firm’s Executive Advisory Program. Based in Wilson Sonsini’s Salt Lake City, Utah, office, she will advise clients on legal, operational, and business matters in her role as an Executive Advisor. Most recently, Krannich was vice president and general counsel (North America) at bioMérieux.
Wilson Sonsini Bolsters in Boulder: Matt Dubofsky Joins as a Corporate Partner
Wilson Sonsini Goodrich & Rosati, the premier provider of legal services to technology, life sciences, and growth enterprises worldwide, today announced that Matt Dubofsky has joined the firm as a corporate partner in the Boulder, Colorado, office. His addition bolsters the firm’s transactional practice as Wilson Sonsini remains focused on representing technology and life sciences companies in the Mountain West region and the Denver-Boulder corridor. Dubofsky is the latest lateral partner to join the Boulder office since its launch in 2022.
The Life Sciences Report – June 2023
This latest issue features an article on Enliven Therapeutics’ reverse merger with Imara and concurrent financing, including an interview with Enliven co-founder and CEO Sam Kintz; a piece on trends in digital health following the end of the COVID-19 public health emergency; and an analysis of life sciences venture financings in which clients participated across the first and second halves of 2022. It also includes details on the life sciences-focused NextGen VC Forum hosted by Wilson Sonsini and LaunchBio, a preview of the U.S.-Japan Healthcare Connection’s trade mission and roadshow for healthcare companies, a recap of the firm’s inaugural 1L Life Sciences Summit, and select life sciences client highlights, among other content.
2022 Technology and Life Sciences IPO Report
In this issue of the 2022 Technology and Life Sciences IPO Report, we present analysis related to 10 initial public offerings (IPOs), valued at over $75 million, completed by U.S.-based technology and life sciences companies between January 1 and December 31, 2022.
2022 Technology and Life Sciences PIPE Report
In this inaugural issue, we present analysis related to 108 private investments in public equity (PIPEs) by U.S.-based technology and life sciences companies between January 1 and December 31, 2022, in which each company raised at least $10 million.
Wilson Sonsini Advises Caption Health in Acquisition by GE HealthCare
On February 9, 2023, GE HealthCare, a leading global precision care innovator, announced that it has signed an agreement to acquire Caption Health, Inc., a privately owned artificial intelligence (AI) healthcare leader that creates clinical applications to aid in early disease detection, using AI to assist in conducting ultrasound scans. Financial terms of the transaction are not being disclosed. Wilson Sonsini Goodrich & Rosati advised Caption Health on the acquisition.
With Caption AI applications, ultrasound examinations can be easier and faster, enabling a broader set of healthcare professionals to conduct basic echocardiogram exams. This technology can help detect signs of diseases like heart failure in at-risk patients across doctors’ offices, the home, and alternate sites of care, potentially preventing hospitalizations and supporting improved clinical outcomes.
Biden Administration's End to COVID-19 Public Health Emergency to Impact Devices Under Enforcement Discretion
On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early 2020, and gave the federal government flexibility to waive or modify certain requirements in a range of areas, including emergency use authorizations (EUAs) by the U.S. Food and Drug Administration (FDA). The FDA also reacted to the PHE by exercising enforcement discretion for premarket review and other requirements for dozens of device types, including but not limited to infusion pumps, remote monitoring devices, masks, and imaging systems. Given that the federal policies surrounding enforcement discretion are tied to the PHE, its end is expected to remove the regulatory relaxations and trigger regulatory submissions later this year.
Wilson Sonsini Advises Alleviant Medical on $75 Million Financing
On January 26, 2023, Alleviant Medical, Inc., a privately-held medical device company developing a no-implant interatrial shunt for heart failure, announced the closing of a $75 million equity financing co-led by S3 Ventures and RiverVest Venture Partners. The lead investors in this new funding round are joined by Vensana Capital, Longview Ventures, TMC Venture Fund, and a strategic investor, in addition to Gilmartin Capital, ShangBay Capital, and another undisclosed strategic investor. This financing will fund the company’s global pivotal trial, ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure). ALLAY-HF is designed to demonstrate the safety and effectiveness of the Alleviant System for the treatment of heart failure through left atrial decompression. Wilson Sonsini Goodrich & Rosati represented Alleviant Medical in the transaction.
The Life Sciences Report – January 2023
This latest issue features articles on interlocking boards in the life sciences sector, Civilization Ventures founder and general partner Shahram Seyedin-Noor, life sciences venture financings in which clients participated across 2H 2021 and 1H 2022, the FDA’s digital health policy for clinical decision software functions, and the FDA’s first pre-market consultation for lab-grown meat using animal cell culture technology. It also includes details on the launch of a life sciences representative term sheet, an article on Jon Soderstrom joining the firm as chief licensing advisor, recaps of several recent life sciences events, and select life sciences client highlights, among other content.
FDA’s Draft Guidance for Laser-Assisted In Situ Keratomileusis (LASIK) Lasers: Patient Labeling Recommendations
Firm Advises ScienTech Medical on US$83.4 Million IPO
On November 8, 2022, LEPU ScienTech Medical Technology (Shanghai) Co., Ltd. (ScienTech Medical) successfully listed on the Main Board of the Stock Exchange of Hong Kong, raising approximately HK$654.6 million (US$83.4 million) from a global offering of 22,455,000 H shares, or approximately HK$752.7 million (US$95.9 million) if the underwriters fully exercise their over-allotment option to purchase 3,368,000 additional H shares. Wilson Sonsini Goodrich & Rosati acted as U.S. and Hong Kong counsel to ScienTech Medical in the global offering and listing.