What changed in this filing

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Item 3. Legal Proceedings

2024-03-28 compared with 2023-03-30 · 2 added, 42 removed, 3 unchanged (94% of the section changed)

Legal Proceedings.

previously disclosed, on April 14, 2017, representatives for the estate of an individual plaintiff filed a wrongful death complaint with

the Suffolk Superior Court, in the County of Suffolk, Massachusetts, against us and other defendants, including Harvard Bioscience, Inc.,

or HBIO, the former parent of the Company that spun off the Company in 2013, as well as another third party.

The complaint sought payment

for an unspecified amount of damages and alleged that the plaintiff sustained terminal injuries allegedly caused by products provided

by certain of the named defendants and utilized in connection with surgeries performed by third parties in Europe in 2012 and 2013.

lawsuit relates to our first-generation trachea scaffold technology for which we discontinued development in 2014, and not to our current

esophageal implant.

April 27, 2022, the Company and HBIO executed a settlement with the plaintiffs (the “Settlement”), which resolves all claims

relating to the litigation.

The Settlement resulted in the dismissal with prejudice of the wrongful death claim, and neither we nor HBIO

admitted any fault or liability in connection with the claim.

The Settlement also resolved any and all claims by and between the parties

and our products liability insurance carriers, which resulted in the dismissal with prejudice of all claims asserted by or against those

carriers, the Company and HBIO.

However, based on review of the circumstances surrounding the Settlement, we recorded an accrual for

this matter of approximately $3.3 million in general and administrative expenses during the year ended December 31, 2021.

relation to the litigation, we have incurred approximately $5.9 million of aggregate costs, all of which has been paid as of

December 31, 2022.

This aggregate amount includes the cost of both the accrual for contingency matter of approximately $3.3 million

and approximately $2.6 million of legal and related costs incurred by us which consist of attorney’s fees and advisor and

specialist costs as part of our defense in this matter.

For the year ended December 31, 2022, we incurred legal and related costs of

approximately $1.3 million recorded in general and administrative expenses.

On March 3, 2022, we received a cash payment of

approximately $0.1 million from Medmarc, our insurance carrier.

This amount represented a reimbursement of previously incurred legal

costs and was recorded as a reduction to general and administrative expenses during the year ended December 31, 2022.

respect to such $5.9 million of costs described above, we were required to either pay such costs directly or indemnify HBIO as to such

amounts it incurs.

With respect to the indemnification obligation of the Company to HBIO pertaining to such costs, we and HBIO entered into a Preferred

Issuance Agreement dated as of April 27, 2022, or the PIA.

In connection with the PIA, we and HBIO agreed that once HBIO

had paid at least $4.0 million in such costs, to satisfy our indemnification obligations with respect thereto, in lieu of paying cash,

we would issue senior convertible preferred stock to HBIO that will contain terms as described in the PIA, including the term sheet attached

On June 10, 2022, following the execution of a subscription agreement and HBIO providing evidence of payment of the requisite

$4.0 million amount, we issued HBIO 4,000 shares of Series E Preferred Stock at a price of $1,000 per share to satisfy our related indemnification

obligations aggregating $4.0 million, which included the accrual for contingency of approximately $3.3 million and approximately $0.8

million of legal and related costs paid on behalf of the Company by HBIO.

time to time, we may be involved in various claims and legal proceedings arising in the ordinary course of business.

Other than the above

matter, there are no such matters pending that we expect to be material in relation to its business, financial condition, and results

of operations or cash flows.

such matters pending that we expect to be material in relation to our business, financial condition, and results of operations

or cash flows.

Mine Safety Disclosures.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 3. Legal Proceedings