Abcam plc closed out a three-month whirlwind of activity this morning with an agreement to sell the medical equipment and consumables company to Danaher Corp. for $5.7 billion. The transaction represents a cash purchase price of $24 per share, a 2.7% premium over the closing price on Friday, and assumption of approximately $200 million in debt. Since founder Jonathan Milner, who owns about 6.3% of the company, ignited a boardroom battle by asking to be named executive chairman May 30 and calling an extraordinary general meeting of shareholders in June, the company has evaluated offers from 30 potential acquirors and seen its stock price rise 20%.
China issues draft rules to enhance device classification and ensure quality and safety
Two new sets of draft guidelines in China aim to strengthen and streamline registration systems while clearly spelling out additional rules for device makers to ensure quality management and controls, including strengthening controls over any outsourced manufacturing and calling of makers of implantable devices to manufacture in house. In a set of opinions issued for comments on July 28, the NMPA outlined proposed rules for companies that register medical devices to “ensure the quality and safety of medical devices, prevent and control the risks and potential hazards of commissioned production of medical devices, as well as strengthen the supervision of commissioned production of medical devices,” the NMPA said. The new draft guidelines call on device makers to establish a quality management system that covers the entire lifecycle of medical devices.
Aquedeon gets FDA nod for pivotal trial of vascular graft system
The U.S. FDA has given Aquedeon Medical Inc. the green light to conduct an IDE clinical trial of its Duett vascular graft system. The device is designed to improve outcomes in surgical thoracic aortic procedures by simplifying treatment of target vessels and reducing overall procedure time. According to the Sunnyvale, Calif.-based startup, the Duett system aims to standardize open thoracic aortic procedures by eliminating the need to circumferentially suture each anastomosis and connecting native aortic arch branch vessels directly to the surgical graft.
Cochlear, Sensorion merge drug and implant to enhance patient hearing
Cochlear Ltd. and Sensorion SA have published encouraging results on the combination of a molecule with a cochlear implant. Their proof-of-concept phase 2a study involved the combination of an orphan drug recognized in both Europe and the U.S. with cutting edge hearing aid implants to enhance the auditory capabilities of hearing aid users. Positive preliminary data unveiled this summer reveals that the small molecule developed by Sensorion has a clinically significant effect on the preservation of residual hearing after cochlear implant surgery. “The level of residual preservation increases the probability of better distinguishing speech in noise and enjoying more natural sound quality with both speech and sound for patients with moderate to severe hearing disorders,” Nawal Ouren, CEO of Sensorion, told BioWorld.
Damaged lungs can be renewed by engrafting stem cells
One of the key advances in regenerative medicine has been the engraftment of external epithelial stem cells to supplement or replace damaged native cells. However, the difficulty in engrafting internal tissues has hindered the long-term rescue of diseased internal epithelia, such as those in the respiratory airways. Recently, researchers from the Center for Regenerative Medicine, a joint venture of Boston University and Boston Medical Center, have discovered a novel approach for engrafting engineered cells into injured lung tissue. In two separate publications appearing in the Aug. 23, 2023, online edition of Cell Stem Cell, researchers led by Darell Kotton described the methodologies for engineering lung stem cells and transplanting them into two different compartments of the injured experimental lungs without immunosuppression. These findings may lead to novel therapeutic approaches for management of lung diseases, such as emphysema, pulmonary fibrosis and COVID-19.
Also in the news:
Bioamerica, Dexcom, Glucotrack, Icecure Medical, 3B Scientific, Danaher, Abcam, Nanovibronix, Oncyocyte, Reprise Biomedical, Heartflow, Bioprotect.