Organon wins FDA clearance for Jada system technological updates

Organon today said it has received FDA 510(k) clearance for technological updates to its Jada system.

Jersey City, N.J.-based Organon designed the Jada system to control and treat abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. The new product updates in the clearance include a new kit configuration with updated packaging and a streamlined designed to help improve the device’s ease of use.

“More options in the area of maternal health for healthcare providers and women are urgently needed, which was what motivated Organon’s early acquisition of Jada,” CEO Kevin Ali said in a news release. “Postpartum hemorrhage continues to be one of the most common complications of childbirth and this recent FDA clearance supports our ability to continue providing healthcare providers this important option for treating women with abnormal postpartum bleeding.”

The Jada system applies a low-level vacuum to encourag…

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Merck results miss in Q2

Merck (NYSE: MRK) posted second-quarter results today that missed the consensus forecast on Wall Street, though the company expects up to 14% sales growth this year.

The Kenilworth, N.J.–based pharmaceutical giant reported profits of $1.213 billion, or 48¢, off $11.402 billion in sales, nearly halving its bottom line while boosting sales 19% from Q2 2020. Merck adjusted earnings and revenue to take into account its June 2021 spinoff of Organon, which brought Merck a $9 billion windfall.

Adjusted to exclude one-time items, earnings per share were $1.31, 13¢ behind The Street, where analysts looked for EPS of $1.44 on sales of $11.54 billion.

Related: FDA approves Merck’s Keytruda to treat certain types of breast cancer

“We are encouraged by the strong momentum of our underlying business led by our key growth drivers as the impact of the pandemic on our performance lessens,” said Merck CEO Rob Davis said in a news release. “We are confident that we …

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MedTech 100 roundup: Industry climbs again

The medtech industry built off a strong performance two weeks ago with another uptick in the midst of an up-and-down year.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 18) at 110.64 points, producing a 0.9% rise from the 109.63-point mark set one week prior (June 11). In all, the industry has risen 3.4% over the past two weeks.

The recent upswing provides a welcome sight after the industry’s progress came to a halt with a -1.4% dip earlier this month. The index looks poised to pick up again as it nears the high points registered when April brought the industry’s all-time best performance.

Even with some recent setbacks, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered an 19.8% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 78.1% increase from the …

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Merck spinoff Organon completes Alydia Health acquisition

Merck (NYSE: MRK) spinoff Organon (NYSE:OGN) today announced the completion of its acquisition of Alydia Health for up to $240 million.

Alydia Health develops treatments centered around preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding. The company designed its Jada system to control and treat abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Jersey City, N.J.-based Organon announced an agreement for the acquisition in March. Total consideration amounts to $240 million, including a $215 million cash payment, of which Merck paid $50 million upon signing. Organon paid the remaining $165 million at closing and the final $25 million will potentially arrive as a contingent milestone payment.

“Organon’s acquisition of Alydia Health expands our portfolio into the medical device category and underscores our commitment to identify options for women’…

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