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Innovasis Reaches Settlement with Government After Voluntary Self-Disclosure

May 28, 2024 – OrthoSpineNews – Innovasis, Inc. announces resolution of a five-year investigation by the U.S. government. In April of 2019, in conjunction with a business acquisition, Innovasis’ Board of Directors commenced an internal compliance audit. The audit revealed certain compliance issues including that a high level employee of the company had placed himself over the Compliance Committee and was also negotiating and executing physician agreements using his own discretion and incentives. At various Compliance Committee meetings, other members of the Compliance Committee were excluded from attending the meeting and only the high level employee and his assistant were present.

Following review of the internal audit findings, Innovasis’ Board of Directors determined that Innovasis would engage Hooper Lundy & Bookman, P.C., a healthcare law firm, and made the decision to fully self-disclose the noncompliance, uncovered as a result of the internal audit, to the U.S. government in May of 2019. Also, with the help of external counsel, the company revamped its entire compliance program and procedures.

During the time of the internal audit, the high level employee resigned.

While the company was already in the process of resolving the identified compliance issues with the OIG through its reporting program, in October 2019, a former employee filed a whistleblower lawsuit in federal court. The filing of the suit came after the company had already fully self-disclosed, been accepted into the self-reporting program, and was seeking to remedy any outstanding compliance issues completely. Of note, the company’s former high level employee was not named as a defendant in the whistleblower lawsuit, even though he executed most of the agreements which had been deemed to have compliance issues and were included in the company’s self-disclosure.

Since October of 2019, the company has worked cooperatively with the government to resolve any compliance concerns. ”Even though Innovasis self-reported in May 2019 and does not understand why a whistleblower should be rewarded after a company self-reports, it is in the company’s best interest to resolve this matter. As per the company’s mission, it is time to put full focus on advancing spine care.”

Innovasis has contracted with a third-party to collect outcome data on over 3,800 patients. This data shows excellent outcomes with their bioactive implants made of PEEK, infused with hydroxyapatite. “Innovasis is excited with these results. In continuing to advance the technology, Innovasis has launched HA Cancellous PEEK implants. These implants are chemically bioactive through the addition of HA in the material, and structurally bioactive by the addition of bimodal pores in the implant.” Innovasis is the only company to offer products of this kind backed by clinical data. Innovasis has been and remains fully committed to advancing spine care. For further information, see

Tim Allen

Medtech leader with 19+ years of experience in medical device product development, manufacturing, and project management.

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