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

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;17:1646-1655. 2. Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990–1997. Obstet Gynecol. 2002;99: 229–234. 3. 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.

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).

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

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)

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

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

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

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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576022/ 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. http://www.jmig.org/article/S1553- 4650(12)00945-4/fulltext “Among women who underwent hysterectomy for benign indications, black women were less likely to receive minimally invasive hysterectomy compared to white women .”http://www.jmig.org/article/S1553-4650(17)30784-7/fulltext “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.” http://www.jmig.org/article/S1553-4650(17)31015-4/fulltext “Non-white women and those without private insurance are less likely to undergo minimally invasive hysterectomy.”  http://www.jmig.org/action/doSearch?searchType=quick&searchText=fibroids%2C+racial&occurrences=all&journalCode=jmig&searchScop 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 http://www.jmig.org/article/S1553-4650(17)30226-1/fulltext  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. http://www.jmig.org/article/S1553-4650(14)00720-1/fulltext Fibroid recurrence is associated with increasing fibroid weight. This would play a role in preoperative counseling those patients with large or multiple uterine fibroids. http://www.jmig.org/article/S1553-4650(16)30226-6/fulltext 

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