fda-approved
(12)
Neurotech Pharmaceuticals, Inc.
Neurotech Pharmaceuticals is a Cumberland, Rhode Island biotechnology company that develops long-acting therapies for chronic retinal diseases using its Encapsulated Cell Technology (ECT) platform - a tiny implant of genetically engineered cells that continuously secretes a therapeutic protein inside the eye. In March 2025 its lead product ENCELTO (revakinagene taroretcel-lwey, formerly NT-501/Renexus) became the first and only FDA-approved treatment for macular telangiectasia type 2 (MacTel), delivering ciliary neurotrophic factor (CNTF) to slow the loss of photoreceptors.
Shorla Oncology
Shorla Oncology is a specialty pharmaceutical company based in Clonmel, Ireland, with a U.S. base in Cambridge, Massachusetts, that develops and commercializes innovative oncology drugs for orphan and pediatric cancers. Founded in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla focuses on indications where existing treatments are limited, in shortage, or poorly suited to patients - reformulating and reinventing cancer therapies into easier-to-administer forms such as oral liquids and ready-to-dilute vials. The company markets four FDA-approved products in the U.S. and is advancing an early-stage pipeline addressing rare cancers.
EBR Systems, Inc.
EBR Systems is a Sunnyvale, California medical device company that developed the WiSE System, the world's first and only leadless left ventricular endocardial pacing device for cardiac resynchronization therapy. About the size of a grain of rice, the ultrasound-powered electrode paces the inside of the heart's left ventricle without wires, working alongside a patient's existing pacemaker or defibrillator. After its pivotal SOLVE-CRT trial was halted early for success, the WiSE System won U.S. FDA approval in April 2025 and began its commercial launch for heart failure patients who have run out of conventional options.
Zenflow, Inc.
Zenflow is a South San Francisco medical device company that built the Spring, a small nitinol coil implanted through a flexible cystoscope to prop open the urethra and relieve the symptoms of an enlarged prostate (benign prostatic hyperplasia). Spun out of Stanford's Biodesign program in 2014, the company won FDA approval in December 2025 for a first-line interventional therapy that requires no catheter afterward, preserves sexual function, and can be reversed. It has raised roughly $85 million across multiple rounds and ran the multinational BREEZE pivotal trial to get there.
Theravance Biopharma US, LLC
Theravance Biopharma is a South San Francisco biopharmaceutical company built around a focused respiratory franchise. Its flagship product, YUPELRI (revefenacin), is the first and only once-daily nebulized long-acting muscarinic antagonist approved in the U.S. for COPD maintenance, commercialized with partner Viatris. Spun out of Innoviva in 2014 and trading on Nasdaq as TBPH, the company combines a profitable marketed product with high-value royalty assets - including a now-monetized stake in GSK's TRELEGY - and runs a lean, capital-disciplined model rather than chasing scale.
Geneoscopy
Geneoscopy is a St. Louis life-sciences company building noninvasive diagnostics that read RNA biomarkers in stool to prevent, detect, and treat gastrointestinal disease. Its flagship product, ColoSense, is the first FDA-approved multi-target stool RNA (mt-sRNA) test for colorectal cancer screening in adults 45 and older, designed to lift screening compliance by replacing the colonoscopy prep and the clinic visit with a kit that arrives in the mail. Founded by siblings Andrew and Erica Barnell, the company is extending its RNA platform from cancer screening into inflammatory bowel disease.
Alloy Health
Alloy Health is a direct-to-consumer women's telehealth company built to fix how medicine treats menopause. Founded by Anne Fulenwider and Monica Molenaar, Alloy connects women in perimenopause and menopause with menopause-trained doctors and a full menu of FDA-approved, science-backed treatments - hormone replacement therapy, vaginal estrogen, plus hair, skin, sexual-wellness, gut and weight solutions - delivered to the door via an asynchronous platform with a flat $50 annual membership. The company raised a $16M Series A in November 2024 and reached profitability while serving women historically dismissed by the healthcare system.
Element Science, Inc.
Element Science is a San Francisco medical device and digital health company building the Jewel - a patch-based wearable cardioverter defibrillator that continuously monitors high-risk cardiac patients and delivers a life-saving shock when a lethal rhythm is detected. Founded in 2011 by Dr. Uday Kumar, the company combines clinical-grade wearables, machine learning, and human-centered design to protect patients with elevated, temporary risk of sudden cardiac arrest.
Wildtype
Wildtype is a San Francisco-based cultivated seafood company that grows real salmon from fish cells in stainless steel bioreactors - no fishing, no farming, no ocean required. Founded in 2016 by a cardiologist-turned-food-scientist and a former U.S. Foreign Service officer, the company received FDA clearance in May 2025, making it the first cultivated seafood product approved for sale in the United States. With $123.5M raised and backing from Jeff Bezos, Leonardo DiCaprio, and Cargill, Wildtype is betting that the future of seafood is grown, not caught.
Michael Bigham
Michael F. Bigham is a veteran biopharmaceutical executive and investor who spent nearly a decade as Chairman and CEO of Paratek Pharmaceuticals, guiding the company through the FDA approval and commercial launch of NUZYRA (omadacycline) - a novel tetracycline-class antibiotic tackling drug-resistant bacterial infections. A Stanford MBA and CPA with roots in Gilead Sciences' early days, he has built, funded, and led companies across the full arc of drug development. He now operates as founder and managing director of Firebrand River Capital.
Rick Winningham
Rick Winningham is the CEO of Theravance Biopharma, a biopharmaceutical company focused on organ-selective medicines for serious diseases including COPD, rare neurological conditions, and inflammatory diseases. With over 40 years in the pharmaceutical industry - including 13 years as CEO of Innoviva and 15 years at Bristol-Myers Squibb - Winningham has built a career defined by transformative drug development, strategic company leadership, and a widely recognized commitment to mentoring the next generation of biopharma executives, particularly women in leadership. He was named the 2026 HBA Honorable Mentor by the Healthcare Businesswomen's Association.
Valeska Schroeder
Valeska Schroeder, Ph.D., is CEO and Chairman of the Board at Cerapedics Inc., the Colorado-based orthobiologics company behind i-FACTOR and PearlMatrix - two of only three FDA PMA-approved bone grafts on the U.S. spine market. A materials scientist by training (BS, MS, PhD from UC Berkeley), she spent the first part of her career in medtech product development before transitioning to venture investing at KCK MedTech, where she led deals and sat on boards of companies including Sight Sciences, Aerin Medical, Intuity Medical, and Lungpacer. She joined Cerapedics' board in 2018, deepened her involvement in 2021, and took the helm as CEO in November 2022, steering the company through PearlMatrix's landmark FDA approval in June 2025 - making Cerapedics the only company with two PMA-approved spinal biologics.