Management is beaming with delight at Heartbeam Inc. as the company's appeal strategy paid off with U.S. FDA clearance for its synthetic 12-lead electrocardiogram software for the assessment of arrhythmias. In November, the Santa Clara, Calif.-based company received a Not Substantially Equivalent determination from the agency on its 510(k) application, which could have substantially delayed commercialization. Following a plan disclosed Nov. 28, the company resolved the agency's issues through an appeal process and active engagement and obtained clearance much more quickly than expected.
Daewoong Pharmaceutical Co. Ltd. and Daewoong Therapeutics Inc. reported that their self-developed microneedle patch loaded with semaglutide demonstrated 80% relative bioavailability compared to an injectable subcutaneous formulation of semaglutide in a pilot human pharmacokinetic study. That far exceeds rates seen in other patches or oral formulations.
Daewoong Pharmaceutical Co. Ltd. and Daewoong Therapeutics Inc. reported that their self-developed microneedle patch loaded with semaglutide demonstrated 80% relative bioavailability compared to an injectable subcutaneous formulation of semaglutide in a pilot human pharmacokinetic study. That far exceeds rates seen in other patches or oral formulations.
The €10.2 million (US$11 million) that Bedal International NV recently closed in a funding round is “crucial” for the company’s continued growth and development, co-CEO Alexander Van Damme, told BioWorld. “The financing provides the necessary resources to scale up operations, enhance product development, and expand market reach, particularly in the competitive U.S. market,” he said.
My Life Technologies Corp. has raised $4 million from investors to fund production and clinical trials for its microneedle technology. Based in Leiden, Netherlands, the company is developing a ceramic patch that can deliver vaccines or drugs through the skin. The technology could prove to be an attractive alternative to standard vaccine injections due to what the company says is its simple and painless delivery.
PARIS – Grapheal SAS, of Grenoble, France, is developing a new generation of dressings integrating an embedded electronic biosensor. The Grapheal device consists of monolayer graphene on a polymer layer 0.3 nanometers thick. “This noninvasive embedded device collects data from the wound. The wireless e-health wound monitoring system, or smart patch, remotely reports the status of chronic wounds to the care team,” Vincent Bouchiat, co-founder and CEO at Grapheal, told BioWorld MedTech.
HONG KONG – South Korea's major pharmaceutical company GC Pharma Corp., based in Yong-in, Gyeonggi-do, and the Cambridge, Mass.-based U.S. biotech Vaxess Technologies Inc., have partnered to globally commercialize a flu vaccine patch based on Vaxess' Mimix Smart Release Patch technology. The patch is designed to deliver medicines and vaccines through silk microneedles that dissolve at a precise rate.
Netanya, Israel-based Theranica Bioelectronics Ltd., which is focusing on the development of advanced electroceuticals for migraine and other pain disorders, scored a win at the U.S. FDA, with the agency granting its de novo request for the smartphone-controlled Nerivio Migra.
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