Rotation's Bioinductive Shoulder Implant Succeeds In Australian Trial
The device has 510(k) clearance for a broad tendon-repair indication, but the company is sponsoring clinical trials to further validate the technology, which induces new tissue growth around partially torn rotator cuffs rather than simply mechanically reattaching it.
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Rotation Medical Inc.’s implantable collagen scaffold induces formation of new tendon-like tissue, and in some cases eliminates the need for suture anchors in surgical repair. This new technique has the potential to prevent rotator cuff disease progression and significantly reduce the incidence of re-tears.
An internal investigation found that the company’s leadership may have directed employees to improperly account for sales-incentive payments. As a result, the company has been unable to file its quarterly report for the first quarter of 2022 with the SEC.
Analysts believe the company’s arrythmia mapping technology could potentially disrupt the electrophysiology mapping market, but are disappointed with Acutus’ growth so far.