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NEW YORK, Nov. 11, 2022 (GLOBE NEWSWIRE) — Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Establishment Labs Holdings Inc. ESTA, Accelerate Diagnostics, Inc. AXDX, Instil Bio, Inc. TIL, and Unisys Corporation UIS. Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices. Additional information about each case can be found at the link provided.

Establishment Labs Holdings Inc. ESTA

On October 19, 2022, market analyst Hindenburg Research published a report entitled “Establishment Labs: A Financially Stretched Silicone Safety Charade” which alleged, among other things, that “[d]espite claims of superior safety, we found that almost all key safety studies touted by the company have conflicts of interest, with many undisclosed or under-disclosed.” Further, the report alleged that “Establishment claims to have successfully piloted a ‘revolutionary’ technique to place implants through the armpit using local anesthesia (instead of general), claiming the technique will greatly expand its Total Addressable Market (TAM). This type of insertion has been reported since the 1970s and has been widely available for almost 20 years. It has failed to gain traction due to safety risks.”

The report also alleged that “[b]eyond undisclosed safety questions, we have also identified financial risks. Import/export records show that Establishment ships product to entities formerly owned by the CEO and his family, raising questions of conflicts of interest.”

On this news, share price fell by 17% when the market opened on October 19, 2022.

For more information on the Establishment investigation go to: https://bespc.com/cases/ESTA

Accelerate Diagnostics, Inc. AXDX

After the market closed on October 21, 2022, Accelerate Diagnostics disclosed receiving a request from the U.S. Food and Drug Administration for the company to immediately discontinue marketing and distribution of its Accelerate Arc system and related BC Kit for a particular diagnostic use.

Previously, Accelerate Diagnostics had been marketing the Accelerate Arc products as Class I devices, exempting them from 510(k) clearance requirements. Recently, the FDA informed the company that marketing the products in the U.S. requires 510(k) clearance.

Shares of Accelerate Diagnostics stock dropped approximately 9% in premarket trading and were down more than 40% in intraday trading on October 24, 2022.

For more information on the Accelerate Diagnostics investigation go to: https://bespc.com/cases/AXDX 

Instil Bio, Inc. TIL

The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Instil Bio disclosed on October 31, 2022, that it had informed the FDA that it had voluntarily paused enrollment in a clinical trial due to problems in manufacturing one of its therapies. The manufacturing trouble resulted in an inability to properly dose patients in a clinical trial of ITIL-168 for advanced melanoma.

On this news, shares of Instil Bio fell by more than 33% in intraday trading.

For more information on the Instil investigation go to: https://bespc.com/cases/TIL

Unisys Corporation UIS

On November 8, 2022, Unisys disclosed that it would not be able to timely file its third quarter 2022 financial results due to an internal investigation regarding “certain disclosure controls and procedures matters, including, but not limited to, the dissemination and communication of information within certain parts of the organization.” The Company stated that it expects that the results of the investigation may determine that there are “one or more material weaknesses” in its internal control over financial reporting.

On this news, the Company’s stock fell as much as 49% during intraday trading on November 8, 2022, thereby injuring investors.

For more information on the Unisys investigation go to: https://bespc.com/cases/UIS

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:

Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Melissa Fortunato, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com



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