REVA Medical Inc. (REVA), a medical-device manufacturer, previously specialized in blood-vessel stents. The San Diego-based company produced these products for heart patients in European clinical trials. Unlike metal stents, REVA’s polymer-based stents gradually dissolved in the body, reducing inflammation and lowering risks of long-term complications once blood vessels healed.
Despite the advantages of such products, some research studies questioned the effectiveness of absorbable stents in heart procedures. At the same time, REVA was complying with numerous rules and regulations related to international medical trials which put a strain on the company’s resources. Exacerbating the company’s operational difficulties, REVA was negatively impacted by guidelines published by the European Society of Cardiology. Subsequently, REVA faced disappointing sales of its dissolvable stents. With $5.9 million in assets and $104.5 million in liabilities, REVA, as a single debtor, filed Chapter 11 bankruptcy on January 14, 2019 in the District of Delaware as part of a pre-packaged effort to restructure its heavy debt load.
Stretto worked closely with REVA’s turnaround advisors, including DLA Piper, to streamline case administration. The noticing aspects of this matter were particularly challenging due to the accelerated timeline and geographic location of potential claimants. The United States Trustee had concerns foreign creditors would not be aware of the Chapter 11 bankruptcy process – especially a shortened process – and worried about confirming the plan without proper notification. As REVA didn’t have a list of patients participating in the clinical trials, Stretto collaborated with publication providers to identify appropriate international financial and mainstream publications for broader notification across nearly 15 European countries. While DLA Piper hired translators to create messaging and develop the ads, Stretto worked to get the ads published, often complying with constantly changing publishing requirements and strict, local regulations.
In certain countries including Germany, Australia, and Switzerland, Stretto had to navigate diplomatic channels and engage the US embassy to get ads published. These herculean efforts were necessary as REVA’s new lenders and the United States Trustee stipulated they wanted wide-reaching notification to prevent future claims since the company’s products dissolved in the body. Stretto disseminated and processed ballots based on plan specifications, provided instant tabulation results and its case-management team created and maintained a customized REVA website. The pre-packaged plan was confirmed and looking ahead, REVA will concentrate on non-heart vascular product lines. The company is also pursuing regulatory approval for its X-ray visible embolic microbeads for cancer treatment. This original regimen involves placing the beads inside blood vessels, in effect feeding a tumor to starve it of nutrients. Stretto played a critical role as a trusted service partner in ensuring REVA remains a viable company on the cutting-edge of medical-device innovation.