Theradaptive Inc. has received an FDA breakthrough medical device (BMD) designation for its Osteo-Adapt SP spinal fusion implant for transforaminal lumbar interbody fusion to treat degenerative disc disease, spondylolisthesis, or retrolisthesis. Under the program Theradaptive will enjoy priority review for its spinal bone growth implant and interactive advice for continued development as well as clinical trial protocols during premarket review.
PARIS – Orixha SAS raised $2.25 million to bolster development of its Vent2cool medical device, pulmonary ventilation technology used in critical care settings. Investment company Erganeo SAS, the Angels Santé business angels group and three French industrial partners – Infiplast SAS, OEM Development SAS and Activation SAS – all participated in the round.
LONDON – Lifelight Ltd. is preparing for a new funding round in the first quarter of 2022 after making significant headway with its contactless technology for monitoring vital signs, as push came to shove during the pandemic and remote patient monitoring became a necessity.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cooler Heads, Longeviti.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cambridge Orthopaedic, Eurofins, Exthera, Leica, Predicate HPG, Surgicalone, Tianrong, Wilton Management.
Becton, Dickinson and Co. (BD) reported it acquired Tissuemed Ltd., maker of the self-adhesive Tissuepatch surgical sealant. The terms of the deal were not disclosed. The transaction is not expected to have a material impact on BD’s fiscal 2022 financial results. Tissuemed reported 2020 revenues of £2.6 million (US$3.44 million) up from £1.7 million (US$1.32 million) in 2019 in a filing made in November 2020. Net profit was £1.06 million (US$1.40 million) up from £851,000 (US$1.124 million). BD has been on a purchasing binge in recent years with more than a dozen tuck-ins since the start of 2020.
The European Investment Bank (EIB) is continuing a streak of investments in the med-tech space, signing a €20 million (US$22 million) loan agreement with Midiagnostics NV, to scale-up a new rapid COVID-19 PCR test. Leuven, Belgium-based Midiagnostics is developing a rapid PCR test for SARS-CoV-2, which can achieve an accuracy speed 20 times faster than classic PCR machines. A nasopharyngeal swab sample is transferred on a PCR testcard, from which the results are read by a compact reader. Pilot programs for the test began at Brussels Airport this month, with a market launch pegged for Spring 2022.
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