Participated · Series C · Jul 2020

Alydia Health is focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) and abnormal postpartum uterine bleeding. Founded in 2010 and based in Menlo Park, Calif., the company’s investigational Jada System is designed to work with normal uterine contractions to rapidly stop excessive bleeding after childbirth. Alydia completed the pivotal PEARLE IDE Study and has submitted results in a pending 510(k) to the U.S. Food and Drug Administration seeking marketing clearance. The company announced a $13.9 million Series C to support the anticipated U.S. commercial launch of the Jada System. PPH is described in the filing as one of the most common complications of birth, leading to pharmacologic treatment in up to 10% of mothers and, in some cases, emergency interventions and maternal death. Alydia positions the Jada System as a potential tool to improve outcomes for mothers and families globally. Alydia Health is a privately held, venture-backed medical device company headquartered in Menlo Park, Calif., developing an investigational device to rapidly stop postpartum hemorrhage by encouraging the uterus to contract. The device concept was developed in 2010 at Cal Poly and the company was formerly known as InPress Technologies. In a published pilot study of 10 patients in Obstetrics & Gynecology, the device controlled hemorrhage within minutes for each mother. Alydia has initiated the PEARLE Study to evaluate safety and effectiveness in 107 U.S. deliveries to support a planned 510(k) submission to the U.S. Food and Drug Administration. The company says the new funding will support the U.S. pivotal study and subsequent steps toward commercialization. Alydia is positioning its product as a physiologic, rapid-response option for managing a leading cause of maternal morbidity and mortality.

Participated · Series D · Sep 2019

Themis develops vaccines and immunomodulatory therapies using a proprietary measles vaccine vector platform. Its lead program, MV-CHIK, is Phase 3-ready and the company plans to initiate a pivotal global Phase 3 trial within months. The company is advancing other infectious-disease programs—Zika and Lassa Fever in Phase 1, and RSV, CMV, Norovirus and MERS in preclinical studies—and has an immuno-oncology portfolio launched in 2018 with the first therapeutic candidate entering clinical studies this year. Themis recently announced a collaboration with MSD to develop undisclosed vaccine candidates. The company has been funded to date by leading venture capital firms and prestigious non-dilutive grants. Themis closed a Series D financing totaling €40 million (USD 44 million) to support its clinical and pipeline expansion plans. Themis Bioscience develops vaccines and immunomodulating therapies for infectious diseases and cancer using a versatile technology platform for discovery, development and production. Its lead program, MV-CHIK, is a Chikungunya vaccine that received FDA fast track and EMA PRIME designations and produced compelling Phase 2 results published in The Lancet. The company planned a pivotal multi-center Phase 3 trial in Europe, the US and the Americas and will test a single-shot regimen, with clinical trial applications submitted in the second half of 2019 and initiation expected shortly thereafter. CEPI is providing up to US$21 million of non-dilutive capital with support from the EU’s Horizon 2020 programme to underwrite a significant portion of the Phase 3 trial and accelerate regulatory approval and access. Themis says the non-dilutive funding will extend resources for its earlier-stage vaccine and oncology programs. The company also highlights commercial manufacturing capabilities and intends to apply its platform to high-market-potential diseases both alone and with partners. Themis develops vaccines on a versatile platform, with programs targeting chikungunya, Zika, RSV, norovirus and CMV. Its most advanced candidate is a chikungunya vaccine that reported positive Phase 2 results and is being studied in 600 patients across the US, EU and South and Central America. The company presented favorable interim European study results at the ASTMH 2017 Annual Meeting. Themis intends to use recent financing to advance both clinical and pre-clinical vaccine development programs. Leadership emphasizes the platform’s potential to address major public‑health challenges and to move multiple candidates toward commercialization. The company highlights experience navigating complex clinical, regulatory and manufacturing issues as it advances its pipeline. Themis Bioscience is a Vienna, Austria-based biotechnology start-up focused on developing vaccines to prevent infectious diseases. Its lead product candidates are Dengue and Chikungunya fever vaccines built on a novel vaccine vector technology called Themaxyn™, which was initially developed at the Institut Pasteur in Paris. The company intends to use the funds from its recent financing to advance pre-clinical and clinical development activities for these candidates. Themis completed a €5m Series A financing to support these programs. Founded in 2009 and led by CEO Erich Tauber, the company previously received seed financing from the academic incubator INiTS, austria wirtschaftsservice (aws) and the Austrian Research Promotion Agency (FFG).

Participated · Series B · Jul 2018

Univercells is a B2B bioprocessing company that develops compact, cost-efficient manufacturing technologies including the NevoLine biomanufacturing platform and the scale-X bioreactor portfolio. The company designs its solutions to reduce footprint, capital and operational expenditures for producing biologics and viral products. With support from stakeholders such as the Bill & Melinda Gates Foundation, the Global Health Investment Fund and the European Investment Bank, Univercells aims to increase global access to affordable vaccines, biosimilars and advanced therapies. The new financing will be used to industrialize and commercialize its manufacturing technologies and to drive product and application development. Univercells plans to expand further into the gene therapy segment, enabling best-in-class solutions for viral manufacturing. The company is headquartered in Gosselies, Belgium. Univercells develops compact biomanufacturing platforms aimed at increasing the availability and affordability of biologics, including recombinant proteins and vaccines. Founded in 2013 by Hugues Bultot (CEO) and José Castillo (CTO) and based in Gosselies, Belgium, the company builds technology solutions for vaccines, monoclonal antibodies and enzyme replacement therapies. It intends to commercialize a diversified portfolio of technologies with first products available for human use as soon as 2019. Univercells is concluding technology transfer negotiations with established biologics manufacturers and healthcare providers in China, India and Latin America. The company has received regional support from the Walloon region and prior financing including a €3m seed from Takeda in 2015 and a $16m grant from the Bill & Melinda Gates Foundation at the end of 2016. Univercells is a Gosselies, Belgium-based technology company that develops innovative and cost-effective biomanufacturing solutions. The company designs novel production processes for biologics, including recombinant proteins and vaccines, to significantly decrease the size of required equipment and facilities and lower capital and operational costs. It was founded in 2013 by Hugues Bultot (CEO) and José Castillo (CTO). Univercells will use a €2.4M grant from the Walloon Region to develop its antibody production platform. The program focuses on designing next-generation production technologies to drastically reduce manufacturing costs while producing large quantities. The resulting low-footprint, high-capacity production units are intended to be more affordable to build and operate, improving worldwide access to high-quality biologics. Univercells, founded in 2013 and based in Gosselies, Belgium, develops novel biomanufacturing platforms for recombinant proteins and vaccines. Its core products include a viral micro-facility and an innovative recombinant production platform. The company aims to increase the availability and affordability of biologics through these technologies. Univercells closed a €3m Series A equity round to fund commercial and development activities. Proceeds will support the commercial roll-out of its viral micro-facility and the completion of its recombinant platform. A first technology transfer for the viral micro-facility is anticipated in Q4 2018 within a Bill & Melinda Gates Foundation-supported program. Univercells is a Gosselies, Belgium-based developer of a vaccine manufacturing platform that leverages manufacturing sciences to design biomanufacturing solutions for viral vaccines and recombinant proteins. The company focuses on process intensification and integration technologies to enable local bioproduction facilities. It will use a $12M grant from the Bill & Melinda Gates Foundation to develop a vaccine manufacturing platform aimed at lowering costs and increasing vaccine availability and affordability in developing countries. The development will be performed by a consortium including Batavia Biosciences and Natrix Separations, combining Univercells' process intensification and integration capabilities, Natrix's single-use chromatography membrane platform, and Batavia's vaccine development and manufacturing capabilities. The initial target is a micro-facility for inactivated polio vaccine (sIPV) capable of producing 40 million trivalent doses per year at a manufacturing cost below $0.15 per dose. The company is led by CEO and co-founder Hugues Bultot and CTO and co-founder José Castillo.

Participated · Equity · Feb 2017

Path is an international nonprofit organization headquartered in Seattle that invents and advances vaccines, therapeutics, diagnostics, medical devices, and health-system innovations aimed at solving pressing public-health challenges in low-income regions, primarily across Africa and Asia. Its portfolio spans research, development, and deployment of solutions targeting diseases such as intestinal worms, malaria, and other neglected tropical illnesses. The organization collaborates closely with governments, academic institutions, and commercial partners to take scientific discoveries from laboratory to large-scale implementation. A current strategic priority is securing U.S. Food and Drug Administration approval for tribendimidine (TrBD) to treat hookworm infections, the first step toward mass deworming campaigns via the Tribendimidine Consortium it leads. Partners in this consortium include the Chinese CDC’s National Institute of Parasitic Diseases, manufacturer Shandong Xinhua Pharmaceutical Company, and the Swiss Tropical and Public Health Institute. Path plans to channel its newly raised capital into accelerating this work on soil-transmitted helminth infections. No revenue or user metrics were disclosed in the article, reflecting the nonprofit nature of the organization.

Led · Equity · Aug 2016

Atomo Diagnostics designs and manufactures user-centric rapid diagnostic test (RDT) devices that use capillary blood and integrate multiple test components into a single all-in-one device. The company focuses on simple, safe, low-cost RDT solutions aimed at reducing user error and misdiagnosis in field and home settings. Its AtomoRapid™ HIV 1&2 professional-use test won ‘Best in Show’ at the 2014 Medical Design Excellence Awards, reflecting the firm’s emphasis on usability and design. Atomo’s products target screening for infectious and chronic conditions, with particular attention to low- and middle-income country needs. The company plans to develop a next-generation HIV self-test for global health markets and to engage public and private partners, researchers, health workers and end users to support commercial launches in high-burden countries. Financially, Atomo has received a US$2.6 million grant from the Bill & Melinda Gates Foundation and recent equity funding from the Global Health Investment Fund to support development and commercialization efforts. Atomo Diagnostics develops a platform of innovative, user-friendly rapid diagnostic devices and services for point-of-care and consumer testing. The company emphasizes quick, accurate and affordable diagnostics intended to deliver clinical and economic value to healthcare consumers and providers. Its devices are positioned for infectious-disease detection, including HIV, with potential application in Africa and other global markets. Management says the platform improves convenience, simplicity and user experience for testing. Atomo recently received further capital support as it seeks to expand its presence in the global health market. GHIF involvement on the board is expected to support the company’s commercial expansion. Atomo Diagnostics is a point-of-care diagnostics company that develops the AtomoRapid™ platform—an integrated, single‑device rapid diagnostic test intended to replace multi‑component lateral flow kits. The platform is designed to improve usability, reduce user error, and enable professional and consumer self-testing for infectious diseases. Atomo supplies its platform as both finished products and OEM solutions for diagnostic partners, and its AtomoRapid HIV professional test launched in early 2014 and has won industry awards. The company is commercializing self-test solutions for HIV and other infectious diseases and is finalizing a Hepatitis C test, working on combination tests as well as digital readers and e-health capabilities. Financially, Atomo received a $6 million loan from the Global Health Investment Fund to scale production and expand commercial activities. Atomo is based in Sydney, Australia.