According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:

• defendants had “continuously made improvements and updates to Tablo over time since its original clearance” that required an additional 510(k) application;
• as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols;
• the Company’s inability to conduct the human factors study subjected the Company to the likelihood of the FDA imposing a “shipment hold” and marketing suspension, leaving the Company unable to sell Tablo for home use; and
• as a result, defendants’ positive statements about the Company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

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