1. Acessa Health Kim Rodriguez
Confidential and Proprietary to Acessa Health Inc.

2. Uterine Fibroids
Uterine fibroids (leiomyoma) are very common among women of reproductive age
The lifetime prevalence is between 70% and 80%, with black women having a higher risk.1 25% can experience heavy menstrual bleeding, dysmenorrhea, pelvic pressure, increased urinary frequency, and painful intercourse.
Fibroids are the primary indication for hysterectomy in the United States2
Symptoms associated with uterine fibroids can be quantified using the well-validated Uterine Fibroid Symptom and Quality of Life (QoL) questionnaire (UFS-QoL).3
Management of fibroids is rapidly evolving. Patients are seeking less- invasive methods of managing symptoms associated with what is almost always a benign gynecologic condition
1. Stewart EA. Uterine Fibroids. Engl J Med. 2015;372;17: Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990–1997. Obstet Gynecol. 2002;99: 229– Spies JB, Coyne K, Guaou Guaou N, et al….UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002;99(2):290–300.

3. Challenges with Uterine Fibroids
Symptomatic uterine fibroids are a significant societal and healthcare burden
No clear consensus among medical professionals as to which procedural treatment is most appropriate for each symptomatic patient1
There is no “one size fits all” approach to treating symptomatic patients
Non-manufacturer driven procedures, such as hysterectomy and myomectomy are driving datasets
Conducting RCTs with the standard of care today is difficult, especially when trying to make clinically relevant comparisons
Insurance carriers do not widely cover all available options for patients
1 Havryliuk Y, Setton R, Carlow JJ, Shaktman BD. Symptomatic Fibroid Management: Systematic Review of the Literature. JSLS. 2017;21(3).

4. Confidential and Proprietary to Acessa Health Inc.
EXECUTIVE SUMMARY
Acessa System™ is indicated for laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic fibroids under laparoscopic ultrasound guidance
Acessa System™ is a minimally invasive, outpatient, uterine-sparing alternative to hysterectomy and myomectomy
Using laparoscopic ultrasound, the uterus is mapped for fibroids
Under both laparoscopic ultrasound, the Handpiece is inserted in to the fibroid
The electrode array is deployed and ablation is activated
Once ablation is complete, electrode array is retracted, Handpiece removed 2. 1. 3. 4.
Performed by laparoscopic gynecologists in an outpatient setting using two ports and one percutaneous treatment device
Laparoscope placed through a 5mm umbilical port
Laparoscopic ultrasound transducer placed through a 10mm supra-pubic port
RF Handpiece placed percutaneously; treats a volume of tissue depending on the deployment of the electrode array
Fibroid
Confidential and Proprietary to Acessa Health Inc.
Uterus

5. Key Questions
How can core minimum datasets and future registries help manufacturers with current issues and in conducting studies that they need?
How would manufacturers feel about a universe in which data is shared about specific devices and interventions? Has this historically been a challenge?
What will the manufacturers’ role be in improving the quality of data in the registry? (e.g., contributing to UDI database)

6. How can core minimum datasets and future registries help manufacturers with current issues and in conducting studies that they need?
Core minimum datasets and national registries are needed; a standardized/national reporting mechanism to access outcomes
There is substantial variability across treatment options from drugs to surgery to devices
We are lacking a national picture on utilization, volume tied to outcomes, cost and alternative comparators
We must benchmark well-established registries in other therapies such as cardiovascular
Patient outcomes are measurably improving
Cost of care is improving
Inappropriate utilization of services is reducing

7. How would manufacturers feel about a universe in which data is shared about specific devices and interventions? Has this historically been a challenge?
Acessa Health believes this is a great idea!
Over time, it would greatly benefit women suffering from symptomatic fibroids
If you look at coronary stents, pacemakers or defibrillators – the information is shared
The industry is constantly innovating and driving better outcomes as a result
Companies are implementing corrective actions more quickly

8. What will the manufacturers’ role be in improving the quality of data in the registry? (e.g., contributing to UDI database)
Promoting and leading Real-World Evidence (RWE) generation
Use datasets to drive meaningful medical device innovation
Improve detection of safety signals
Education and best practices across key centers of excellence
Often times, registries are not mandatory – It would be important to set standards to drive compliance

9. Challenges with Uterine Fibroids (cont…)
Utilization of minimally invasive surgery varies considerably in the U.S., representing one of the greatest disparities in health care.
Fibroids negatively impact women's careers. Women want to avoid surgery and preserve fertility. Noninvasive treatment options are not widely discussed. While there are several noninvasive treatments for uterine fibroids, women report they are not adequately informed about noninvasive alternatives, such as focused ultrasound, and may not have access to the treatments that they believe best meet their needs (12) /fulltext
“Among women who underwent hysterectomy for benign indications, black women were less likely to receive minimally invasive hysterectomy compared to white women .”
“There may be multiple significant factors associated with increased complications in patients undergoing myomectomy, including patient race, surgical modality, uterine volume, and number of fibroids. African-American women had a larger burden of these potential risk factors when compared to other races.”
“Non-white women and those without private insurance are less likely to undergo minimally invasive hysterectomy.”  e=fullSite
We demonstrate that racial minority patients are less likely to receive a minimally invasive surgical approach compared with an open abdominal approach despite universal insurance coverage. Further work is warranted to better understand factors other than insurance access that may contribute to racial differences in surgical approach to hysterectomies
 The adoption of newer minimally invasive technologies for benign hysterectomy has shown racial and socioeconomic discrepancies at the national level. However, some disparities may be partially attributed to racial differences in fibroid burden. 
Fibroid recurrence is associated with increasing fibroid weight. This would play a role in preoperative counseling those patients with large or multiple uterine fibroids.

10. Thank you!