Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second quarter of 2021. The artificial heart offers a bridge to transplant in patients with end-stage biventricular heart failure. It provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated.

PARIS – Carmat SA has closed an $11.8 million loan in the form of a government-backed loan from a French banking syndicate. In an environment made uncertain by the COVID-19 crisis, Carmat will be able to continue its clinical development program on its total artificial heart, undisturbed. “This financing facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021,” Stéphane Piat, CEO of Carmat, told BioWorld.

Wellcome Leap has launched its first program, dedicating $50 million to help develop human tissues, organoids and full organs. The Human Organs, Physiology and Engineering (HOPE) program is looking to bring biologists and engineers together to develop both therapeutic organs as well as organs that can be used in vitro to help discover and develop new medications.

HONG KONG – Kangstem Biotech Co. Ltd. has completed research on South Korea’s first artificial liver and is taking the next steps towards the device’s clinical trials. The research outcome was published in a paper authored by Kyung-Sun Kang, CEO at Kangstem, and his team titled ‘Development of highly functional bioengineered human liver with perfusable vasculature’ in Biomaterials.

HONG KONG – Kangstem Biotech Co. Ltd. has completed research on South Korea’s first artificial liver and is taking the next steps towards the device’s clinical trials.

The U.S. Centers for Medicare & Medicaid Services (CMS) recently proposed some changes to national coverage policies for left ventricular assist devices (LVADs) and artificial hearts, the latter of which would no longer be covered under a national coverage determination. The proposal to allow Medicare administrative contractors (MAC) to make coverage decisions for artificial hearts on a case-by-case basis clanged across both industry and medical societies, which cited data collection problems and inequalities in access as reasons the existing coverage policy should remain in place.

In a single draft coverage memo, the U.S. Centers for Medicare and Medicaid Services (CMS) proposed to eliminate national coverage for artificial hearts and to provide coverage of ventricular assist devices (VADs) coverage for those in need of short-term ventricular support. Coverage of artificial hearts would thus revert to Medicare administrative contractors, while the change in VAD coverage would resolve a long-running dispute between cardiologists and the agency.

PARIS – Carmat SA, which is based in Vélizy Villacoublay, France, reported the first implantation of its bioprosthetic artificial heart at the Heart Center of the Rigshospitalet in Copenhagen, Denmark.

Farmington, Conn.-based biotech startup Lambdavision Inc. is preparing to test the benefits of microgravity in producing its protein-based artificial retina, thanks to a $5 million, three-year award from the National Aeronautics and Space Administration (NASA). The first-of-a-kind treatment aims to restore vision to people who have lost all or much of their sight due to advanced retinitis pigmentosa (RP).