PARIS – Defymed SAS reported the formation of the Decapes consortium, which brings together the Institute of Chemistry and Processes for Energy, Environment and Health (ICPEES) and the specialist microtechnology and biomaterials service provider for med-tech companies, Statice. This French consortium is working on a minimally invasive version of Defymed's Mailpan device, which will extend the application range for this artificial pancreas to include other chronic pathologies besides type 1 diabetes.
3D Systems Inc. acquired Volumetric Biotechnologies Inc. as part of its plan to expand its organ bioprinting program. The deal entails a $45 million upfront payment with an additional $355 million linked to meeting milestones “planned between now and 2035, and aligned with key points in the development process,” Volumetric President and CEO Jeffrey Graves told BioWorld. Houston-based Volumetric has focused on building replacement organs through bioprinting and created an approach that produces complex vasculature using light-based bioprinting.
PARIS – Carmat SA has just completed a capital increase of $66.4 million to boost development of its total artificial heart. The Aeson system was awarded CE marking four months ago, as a total bridge to transplantation for patients suffering with end-stage biventricular heart failure who are not eligible for maximal medical therapy or a left ventricular assist device (LVAD), and who are likely to undergo a heart transplant within 180 days of the implantation.
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.
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.
Spanish researchers developed a new artificial pancreas system that maintained blood glucose levels in individuals with type 1 diabetes mellitus (T1D) during and following heavy physical exercise. Results of the small study were published in the Endocrine Society’s Journal of Endocrinology & Metabolism.