Alcon AG reported its plans to acquire Ivantis Inc., adding the Hydrus microstent for glaucoma to its ophthalmology portfolio. Ivantis will receive $475 million at closing, with additional unspecified contingent payments dependent on achievement of certain milestones. The transaction is expected to close in the first quarter of 2022.

Rewalk Robotics wins FDA breakthrough device designation for Reboot exo-suit

Shares in Rewalk Robotics Ltd. are on the up after the FDA awarded its Reboot exoskeleton device breakthrough device designation status. The wearable, battery-powered device is designed to assist individuals with lower limb disability due to stroke. With this designation, Rewalk said it will now pursue the FDA approval pathway. The Marlborough, Mass.-based company was trading 51.94% higher following the announcement. "Breakthrough device designation from the FDA is a critical milestone for the Reboot, as it provides a more streamlined review pathway that can get this uniquely innovative device to market faster," said Rewalk Robotics CEO, Larry Jasinski. "The Reboot will give stroke survivors a device customizable for each individual user, giving them the opportunity for regular assistance at home and in the community."

Geninus endures rocky start in Korean Stock Exchange debut, but raises $34M

Geninus Inc. endured a difficult debut on Korea Exchange’s KOSDAQ board, but still raised ₩40 billion (US$33.83 million) through its listing. The two million shares on offer tumbled 25.56% at ₩13,400 (US$11.33) at the close of trading on Nov. 8, after Geninus priced them at ₩20,000. This was below a ₩24,700 to ₩32,200 range, which is where the company initially expected the stocks to price at. “We plan to use a significant portion of the IPO funds to invest in our facilities. This includes the construction of good manufacturing process facilities and purchasing sequencing equipment,” a Geninus spokesperson told BioWorld. Geninus develops clinical genome analysis solutions and big data that are used in precision cancer care. It was spun off from the Samsung Genome Institute in April 2018.

Transcatheter mitral valve replacement devices gaining ground in clinical studies

Catheter-based delivery of replacement valves is established practice for patients with aortic regurgitation, but the mitral valve has only repair devices to address this condition. However, transcatheter mitral valve replacement devices by Medtronic plc and Edwards Lifesciences Inc. made some noise at this year’s edition of Transcatheter Cardiovascular Therapeutics, suggesting that these patients might soon have a wider range of options than just the Mitraclip by Abbott Vascular.

Quantumdx receives $20M equity investment to build on its pandemic-driven product line

LONDON – PCR point of care testing specialist Quantumdx Group Ltd. is poised to accelerate its commercial development in China, after the Hong Kong venture capital fund Vita Spring made a £15 million (US$20.3 million) equity investment. The money will enable Quantumdx to build on its pandemic-driven breakthrough to market, adding further tests to the SARS-CoV-2 assay currently available on its hand-held, battery-operated PCR device. The device processes tests in 30 minutes. Newcastle-based Quantumdx also noted it is in discussions with the in vitro diagnostics company, Sansure Biotech Inc., of Changsha, China, over a marketing tie-up in China. The two also plan to work together on manufacturing of the Q-POC device and test cassettes.

In head-to-head trial, it’s Watchman by a nose

Two studies presented at the 33rd Transcatheter Cardiovascular Therapeutics conference directly compared Boston Scientific Corp.’s Watchman 2.5 and Watchman Flx to Abbott Laboratories’ Amplatzer Amulet device. Both showed Amulet had less than half as many leaks, but the clinical impact of the lower rate remained unclear. On the downside, Amulet had more than three times the rate of procedure-related complications in the Swiss-Apero trial and both deaths in that study occurred with Abbott’s device.

BSX scores win with Enduralife battery tech for cardiac resynchronization devices

The U.K. National Institute for Health and Care Excellence (NICE) said in a new health technology assessment that cardiac resynchronization devices using the Enduralife battery by Boston Scientific Corp., are ready for prime time in the U.K. national health system. NICE said the extended battery life offered by the Enduralife could shave £6 million (US$8.13 million) off the nation’s tab for heart failure over five years, giving BSX the upper hand against its rivals in the cardiac electrophysiology space.

Also in the news

Ancora, Angel Medical, Baxter, Becton Dickinson, Cardiologs, Docgo, EBR, Edwards, Flume, Genecentric, Gilero, I-Mab, Koru, Mainz, Masimo, Medtronic, Motion, Nanox, Orasure, Qiagen, Philips, Roche, Seastar, Spinal Elements, Zebra Medical Vision