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Hologic Returns to Form with Acessa Health Acquisition

Hologic is strengthening its GYN Surgical portfolio with the acquisition of Acessa Health. The Marlborough, MA-based company picked up Acessa, a specialist in the minimally invasive treatment of fibroids, for $80 million in cash.


There’s also an option for contingent payments based on future revenue growth.


Austin, TX-based Acessa has developed the Acessa ProVu system, a fully integrated laparoscopic system that combines radiofrequency ablation with advanced intra-abdominal ultrasound visualization and guidance mapping, enabling physicians to effectively and safely treat women with symptomatic, benign uterine fibroids.


Clinical studies have shown that the Acessa ProVu system is a safe and minimally invasive alternative to hysterectomy and myomectomy. The system is indicated for the treatment of benign uterine fibroids and is designed to detect more fibroids as compared to current imaging modalities.


Hologic estimates that Acessa Health will generate approximately $13 million of revenue in fiscal 2021. The acquisition is expected to be slightly dilutive to Hologic’s non-GAAP earnings per share in fiscal 2021, break-even in 2022, and accretive thereafter.


“Acessa Health provides best-in-class technology that improves patient outcomes and is an excellent fit with our GYN Surgical business,” Steve MacMillan, Hologic’s Chairman, President and CEO, said in a release. “This exciting tuck-in acquisition is consistent with our capital deployment goals, will be accretive to our revenue growth rate, and provides an attractive return on invested capital.”


The acquisition represents a return to form for Hologic. In 2017, the company shocked investors with its plan to acquire leading aesthetics player Cynosure for $1.65 billion.


The Cynosure deal placed Hologic in the fast-growing cash-pay segment. However, Cynosure repeatedly underperformed, so much so that it was divested to an affiliate of investment funds managed by Clayton, Dubilier & Rice for $205 million.


During a presentation at the 38th annual J.P. Morgan Healthcare Conference, Hologic said it was finished with big medtech acquisitions for the near future and would in turn return to tuck-in deals to drive growth.

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Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation

AbstractBackground

Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)–related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown.

Objectives

This study sought to compare DOACs with LAAC in high-risk patients with AF.

Methods

Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat.

Results

A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients.

Conclusions

Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944)

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