The amount of money raised by medical technology companies in 2021 has dropped by about 26% in comparison with the same timeframe last year, although amounts from IPOs and venture capital rounds have more than doubled. By this point in 2020, $31.48 billion was raised through 282 transactions, while 2021 has so far brought in $23.3 billion through 311 financings, a 10% higher volume.
LONDON – The U.K. health technology assessment agency, NICE, has called for a halt to the use of transvaginal laser therapy in the treatment of urinary stress incontinence and vaginal atrophy, saying there is not enough evidence of long-term safety, or proof that the procedures are effective.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agendia, Caredx, Cergentis, Guard Medical, Histosonics, Medtronic, Nyxoah, Prelude, Renovacare.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta Group, Medtronic, Opgen, Orasure Technologies.
The European Commission unveiled its third alternative to providing global access to COVID-19 vaccines and treatments just ahead of the June 8 meeting of the World Trade Organization’s Council for Trade Related Aspects of Intellectual Property Rights and the start of the G7 summit.
Grail Inc. reported on June 4 the first results of its Pathfinder study evaluating its assay for the early detection of 50 cancers, showing a positive predictive value of 44.6%. With a total of 6,629 study participants across more than 140 clinical study sites, the blood test is supported by what the health care company believes to be the “largest clinical study program in genomic medicine.”
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.