Minerva Surgical seeks retraction of Hologic-backed NovaSure study

Minerva Surgical is seeking the retraction of a study backed by rival Hologic (NSDQ:HOLX) comparing its NovaSure endometrial ablation system to Minerva’s competing device, alleging “material misleading statements” that violate ethics guidelines.

Results from the 189-patient study, published in the International Journal of Women’s Health, found a higher one-year rate of amenorrhea and higher quality of life for women treated with the NovaSure, despite a higher rate of perioperative adverse events.

But Minerva alleged last month that the study’s claim that it enrolled all 92 subjects treated with the Minerva system is demonstrably false, citing evidence that 256 patients were treated with its system at the study sites, “including 169 patients at the lead author’s clinical site alone.”

“Also troubling is Minerva’s understanding, as supported by one of the study site investigator’s, that Hologic personnel were on-site, and conducted the patient selection process. The same Hologic personnel had access to the patient charts (electronic medical records) at the clinics, and selected which Minerva patients and which NovaSure patients were enrolled in the study. This obviously biased patient selection process is not fully disclosed in the paper,” Minerva alleged.

The IJWH-published study also said that post-procedure bleeding was not reviewed or known at enrollment, despite the inclusion of such data in an earlier draft that was rejected by the Journal of Minimally Invasive Gynecology and the Journal of Gynecological Surgery, according to Minerva.

“Hologic’s access to the patient’s early post-procedure bleeding status, when combined with the study sponsor’s full control over the patient selection process, data collection, and analysis, resulted in a study population that was clearly biased in favor of the NovaSure arm of the study,” the company said. “Minerva believes that failure to disclose the actual methodology of a study constitutes a clear violation of the [Committee of Publication Ethics] guidelines, hides potentially significant selection bias, and distorts any study conclusions.”

The Redwood City, Calif.-based company said it lodged a formal complaint and retraction request with Dove Medical Press, which publishes the IJWH, with copies sent to Hologic and the FDA.

“We trust that Hologic will live up to its Code of Ethics published on their website that commits them to ethical conduct, to honesty, and to being truthful and upfront with customers and shareholders. We also trust that the International Journal of Women’s Health will live up to its commitment to abide by the COPE guidelines. Minerva looks forward to the timely announcement that the Int’l Journal of Women’s Health has retracted this publication,” Minerva president & CEO David Clapper said April 26 in prepared remarks.

Asked about the allegations during Hologic’s fiscal second-quarter earnings call, CEO Steve MacMillan said the IJWH study “will not be retracted.

“We feel very good about the underlying way that that study was done, so feel really, really good about that,” MacMillan said.

“Not only the clinical results that have come out and were published, but also some of the surveys, I think we’ve given our sales organization more tools to be able to be much more competitive in the marketplace,” added CFO Robert McMahon.

Hologic “strongly disputes” Minerva’s accusations, spokeswoman Jane Mazur told Stat.

“We stand by the integrity of the investigators’ data and appreciate the [IJWH‘s] rigorous standards,” Mazur told the website.

Minerva and Hologic are embroiled in an intellectual property spat over endometrial ablation technology that dates back to November 2015, when Hologic sued in the U.S. District Court for Delaware over the alleged infringement of a trio of patents (Hologic later asserted unfair competition, deceptive trade practices and tortious interference and infringement of a fourth patent). Minerva’s counter-claim contained its own allegations of unfair competition, deceptive trade practices and interference, plus breach of contract and trade libel; a trial is slated for July.

Minerva in April 2017 leveled another suit against Hologic and its Cytyc Surgical Products subsidiary, alleging that its NovaSure Advanced device infringes a Minerva patent; a trial in that case is scheduled for July 2020.

Meanwhile, the battle played out at the U.S. Patent & Trademark Office, where Minerva sought inter partes review of two of the Hologic patents and sought a post-grant review of a third. Although review was denied for one of the patents, the Patent Trial & Appeals Board in December 2017 invalidated all claims of the other; Hologic appealed in February, according to a regulatory filing. The post-grant review is still under way, according to the filing.

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