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Welcome!

Stan Van Gent, Gynesonics

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Housekeeping

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Introductions

Physician Educators and Gynesonics Faculty

David Toub, MD

David Levine, MD, Director of MIGS, Mercy – St. Louis Harry Kwan, Director of Clinical Applications

Shane Raine & Frank Constantino, Health Economics & Market Access

Stan Van Gent, Senior Director, Global Marketing

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Course Objectives

Provide SONATA Clinical Data

Provide detailed information for patient counseling and consent about patient indications and contraindications, and clinical study outcomes

Reimbursement Overview and Updates

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Course Materials

Course materials in your packet include:

Agenda

FIGO Card

Post Meeting

Link to all presentations, Clinical Compendium of all Sonata Clinical Studies, Sonata Procedure Training Booklet, Sonata Procedure Video

Certificate of completion of Clinical Data, Patient Selection portion of training

When possible, make arrangements for Sonata Procedure Hands On portion of training

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Gynesonics Remote Activities

To meet the increasing demand for training and practice support, two major programs are being pioneered utilizing remote/virtual technology

1. Virtual training for all didactic, patient selection and case discussion modules of the Sonata training

2. Acceleration of patient education webinars. These will be tightly geofenced around trained physician’s locations

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Agenda for Today

Welcome Stan Van Gent

Dr. Chudnoff Sonata® Procedure Video

Sonata® System Overview Harry Kwan

Clinical Trial Results David Toub, MD

Patient Selection, Expectations, and Experience, Case Discussion David Levine, MD

Reimbursement and Market Access Shane Raine / Frank Constantino

Wrap-Up Stan Van Gent

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Dr. Chudnoff Sonata® Procedure Video

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Sonata Procedure Didactic TrainingSonography-Guided Transcervical Fibroid Ablation

Harry Kwan, Gynesonics

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Intended Use

The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

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Treatable Fibroid Types

Submucous

Intramural

Transmural

Subserous

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Contraindications and

Cautions for Certain Patients

Contraindications:

Current pregnancy

Intratubal implants

Active pelvic infection

Suspected gynecologic malignancy/premalignancy

Intrauterine device (IUD) that can’t be removed prior to procedure

Refer to the Sonata System Operator Manual for complete operating instructions.

Use caution in patients with:

o Nickel allergy

o Coagulopathy

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Treatment Not Intended for Use If:

Unusually shortened endometrial cavity (< 4.5 cm fundus-to-external os)

Endometrial cavity is abnormal preventing sufficient access

Dispersive Electrodes overlap (very small thighs)

Piercings can’t be removed (abdominal/genital) Implants in lower extremities

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System Components

SMART

Tablet

RF

Generator

System

Cart

RFA Handpiece (single use)

Two (2) Dispersive

Electrodes

IUUS Probe (reusable)

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Radiofrequency (RF) Generator

RF Generator

▪ Energy delivered through RFA Handpiece

▪ Dispersive electrodes complete circuit

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Radiofrequency Ablation

Energy is dispersed through Needle Electrodes

Ablation temperature is 221°F (105°C) Heat is dispersed for tissue treatment in Ablation

Zone

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SMART Tablet

Ultrasound imaging capabilities

Compatible with Intrauterine Ultrasound Imaging Probe

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SMART Guide “Setting Margins for Ablation in Real Time”

SMART Guide is a graphical overlay used for:

Planning ablation

Deploying Needles

Preparing to activate RF energy

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Radiofrequency Ablation

Fibroids were treated transcervically with the Sonata System prior to elective hysterectomy two weeks later.

The treating gynecologist utilized the SMART Guide to target fibroids.

Uteri were sectioned and ablations assessed.

Pathologists found that ablations were located and sized as predicted.

Fibroid B:

4.1 x 3.7 x 3.8 cm

Fibroid A:

2.8 x 2.5 x 2.1 cm

Viable, non-ablated fibroid tissue. Ablated fibroid tissue.

Full Reference: Garza-Leal, JG, Toub, D, León, IH, et al. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation

results in a closed abdomen setting. Gynecol Surg (2011) 8: 327.

90% fibroid volume ablated 100% fibroid volume ablated

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Intrauterine Ultrasound (IUUS) Imaging

Imaging from within the uterus

IUUS Tip is within the endometrial cavity

The ALARA principle (exposure of the patient to

ultrasound energy at a level that is As Low As

Reasonably Achievable) should be practiced.

Consult Operator’s Manual for more information.

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Intrauterine Ultrasound Imaging

IUUS

Probe Tip

Myometrium Fibroid

Serosa

Fluid in

Endometrial

Cavity

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Intrauterine Ultrasound Imaging

Serosa

Bladder

Fibroid

IUUS Probe Tip

Endometrial

Cavity

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IUUS Imaging – Introducer and Needle Electrodes

Introducer and Needle Electrode visualization

Introducer in tissue

Needle Electrodes in tissue

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Ablation Targeting

Ablation Zone Red inner ellipse

Encompass as much fibroid as possible

Thermal Safety Border Green outer ellipse

Must always be inside the uterine serosa

▪ Thermal Safety Border can be positioned up to the serosa▪ It should never cross the serosa

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Treatment Device Controls

Articulation Lever

NeedleElectrode

Sliders

AblationGuideKnob

Introducer Sliders

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Treatment Device Controls

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Essential Safety Steps

1

2

3 Perform Safety Rotations

Thermal Safety Border within the serosa

Align Introducer Tip “Click to Tip”

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Start Ablation

To start ablation:

Operator steps once on Footswitch (Do not rest foot on it to prevent unintended stop)

OR

Support Staff presses ON/OFF button on RF Generator (not sterile)

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RF Status - Active

RF is

RF energy is delivered

Temperature is displayed

Energy heats to 221°F (105°C) Ablation Time is displayed

Status bar indicates ablation progress

Ablation size is displayed

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Treatment Complete: Retract Controls 4-3-2-1

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Support Staff Responsibilities

Set up Sterile draped table Sonata System set-up

Power ON Cable Connections

Patient preparation Apply Dispersive Electrodes

Procedure Click on Tip Freeze and Store image Press “Ready” after Final Safety

Check

Post-procedure

Disconnect cables Remove Dispersive Electrodes from

patient and inspect skin

Preclean IUUS Probe for reprocessing Dispose of RFA Handpiece Power OFF Sonata System

Wipe down system including Footswitch and Mouse

Wrap and store power cord Store Footswitch Lower System Cart completely

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Review

▪ Intended use

▪ Contraindications

▪ Sonata System Components

▪ Treatment Device controls

▪ SMART Guide

▪ Support Staff role

▪ 3 Essential Safety Steps

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Essential Safety Steps

1

2

3 Perform Safety Rotations

Thermal Safety Border within the serosa

Align Introducer Tip “Click to Tip”

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Thank You

Learn more or contact us at www.sonatatreatment.com

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Sonography-Guided

Transcervical Fibroid Ablation (TFA): Clinical Data

David Toub, MD, MBA, FACOGMedical Director, Gynesonics

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Transcervical Fibroid Ablation (TFA)

Volumetric, image-guided radiofrequency ablation

Enables optimized ablated volume of targeted fibroid

Avoids multiple passes of energized needles through the serosa

Not a global therapy; can treat the fibroids that are likely to be symptomatic

Incites thermal fixation and coagulative necrosis

Not associated with infarction-related post-embolization syndrome.

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Intended UseThe Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment

of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

Contraindications

Current pregnancy; active pelvic infection; known or suspected gynecologic malignancy or premalignant disorders such as atypical endometrial hyperplasia;

presence of one or more intratubal implants for sterilization; and presence of an intrauterine device (IUD), unless removed prior to the introduction of the

Sonata Treatment Device.

Patient Selection Considerations

Safety and effectiveness with regard to fertility and fecundity after the use of the Sonata System have not been established, and effectiveness in women with

clinically significant adenomyosis has not been established.

Anticipated Postoperative Events and Potential Risks

Anticipated postoperative events include abdominopelvic pain/cramping; back pain; constipation; dizziness/fatigue; headache; fever; malaise;

nausea/vomiting; sloughing and, less commonly, intact expulsion of ablated fibroid tissue per vaginam (particularly after ablation of submucous fibroids),

and vaginal spotting/bleeding/dysmenorrhea. Potential risks associated with fibroid ablation using the Sonata System include: allergic reactions (including

rash) to device materials; bowel or bladder perforation; cervical/vaginal laceration or tear; dysmenorrhea; electrical shock; hematometrium; hemorrhage;

infections: major and minor local and systemic infections, including intrauterine infection; retention of device fragment; skin burn from the dispersion of RF

energy; thrombotic events; unintended injury to the uterus, cervix or vaginal vault, adjacent organs or tissue; unknown risk to future pregnancies; and

complications including death.

To learn more about the Sonata System, visit us at gynesonics.com/sonata-system or sonatatreatment.com

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Designed to Treat a Wide Range of Fibroid Types (ablates or partially ablates all non-pedunculated fibroids)

The Sonata System is designed to ablate or

partially ablate the target fibroids in GREEN

FIGO Leiomyoma Subclassification System

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The FAST-EU trial:

12-month clinical outcomes of women

after intrauterine sonography-guided

transcervical radiofrequency ablation

of uterine fibroids.

Brölmann H, Bongers M, Garza-Leal JG et al.

Gynecol Surg. 2016; 13: 27-35.

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Brölmann H, Bongers M, Garza-Leal JG

et al. The FAST-EU trial: 12-month

clinical outcomes of women after

intrauterine sonography-guided

transcervical radiofrequency ablation

of uterine fibroids. Gynecol Surg. 2016;

13: 27-35.

Baseline 3-months 12-months

Time course series on MR, courtesy of Jose Gerardo Garza-Leal, MD

FAST-EU

Clinical Trial

Objective To establish the safety and effectiveness of the Sonata

System in the treatment of symptomatic uterine fibroids

Study Design ▪ 50 patients treated at 7 centers in Europe and Mexico

3-months ▪ 90% of patients had a reduction in menstrual bleeding

12-months

▪ 92% of patients were free from surgical reintervention for heavy menstrual bleeding

▪ 54% mean reduction in menstrual bleeding

▪ 67% mean reduction in fibroid volume

▪ 88% overall patient satisfaction

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The SONATA Pivotal IDE Trial:

Ultrasound-Guided Transcervical Ablation of

Uterine Leiomyomas

12-Month Results

Chudnoff S, Guido R, Roy K, Levine D, Mihalov L,

Garza-Leal JG. Obstetrics & Gynecology. 2019; 133: 13-22.

Transcervical Radiofrequency Ablation of

Symptomatic Uterine Fibroids:

2-Year Results

Miller CE, Osman KM, J Gynecol Surg

2019; 35:345-349

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Treatment Summary, Procedure Time, and Length of Stay

Total Fibroids Ablated 442

Mean # Ablated Fibroids per Patient 3.0 (range:1-9)

Mean # Ablations per Fibroid 1.1 ± 0.4

Procedure Time (minutes)(time elapsed from insertion of device to removal of device)

Median

40.0 min Mean

46.9 ± 29.7minLength of Stay (hours)(time elapsed from insertion of device to time of discharge)

Median

2.3 hours

Mean

2.5 ± 1.2 hours

Return to Normal Activity (days)Median

1 day

Mean

2.2 ± 2.2 days

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Significant Reduction in Menstrual Bleeding

through 12 Months

303.6

175.9159.5

143.8

0

50

100

150

200

250

300

350

Baseline 3M 6M 12M

Mean Pictorial Blood Loss Assessment Chart (PBAC)

All p < 0.001

-39% -48% -51%

▪ 86% of patients reported a reduction in menstrual bleeding at 3 months

post-procedure.

▪ 95% of patients reported a reduction in menstrual bleeding at 12 months

▪ 65% of women reported >50% reduction in menstrual bleeding.

▪ Sonata was effective in patients where their only qualifying fibroid

was one or more intramural type 3.

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TimepointCumulative Surgical

Reinterventions

Cumulative Surgical

Reintervention Rate

(Kaplan-Meier)

1 Year 1 0.7%

2 Year 7 5.0%

3 Year 11 8.2%

Low Rate of Surgical Reintervention for HMB through 3 Years

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Significant Improvements in Symptom Severity and

Quality of Life Persist Through 3 Years

All p-values < 0.001

compared to baseline

54.9

26.922.7 22.6 23.7 22.2

40.3

77.9

84.0 84.2 82.7 83.1

0.0

20.0

40.0

60.0

80.0

100.0

Baseline 3M 6M 12M 24M 36M

SSS HR-QoL

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Safety Profile

▪ No device-related adverse events

▪ 2 procedure-related SAEs; both resolved with no sequelae

▪ DVT 15 days post-procedure

▪ Vaginal discharge with low-grade fever and cramping 28 days post-procedure▪ Overnight hospital stay for antibiotic administration per hospital policy

▪ Cultures negative for infection

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Long-Term (5-year) Clinical Outcomes of

Transcervical Radiofrequency Ablation

of Uterine Fibroids: The VITALITY Study.

Garza-Leal JG. Long-Term Clinical Outcomes of Transcervical

Radiofrequency Ablation of Uterine Fibroids: The VITALITY

Study. J Gynecol Surg. 2019; 35:19-23.

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Low Rate of Surgical Reintervention Over 5 Years

17 subjects with mean follow-up of 5.4 years

No surgical reinterventions for HMB in the first 3.5 years

11.8% cumulative surgical reintervention rate over 5 years

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Bongers M, Quinn SD, Mueller MD,

et al. Evaluation of Uterine Patency

following Sonography-Guided

Transcervical Ablation of Fibroids.

Eur J Obstet Gynecol Reprod Biol.

2019;242:122-125.

OPEN Trial

Objective Characterize incidence of new intrauterine adhesions following

Sonata treatment

Study Design Post-market, prospective, multicenter, single-arm, observational

study in Europe. Indenting fibroid required for inclusion.

• Hysteroscopic assessment at baseline and 6-weeks

Endpoint Incidence of new adhesions at 6 weeks per European Society of

Hysteroscopy adhesion scoring by independent readers

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OPEN Trial Results:

No Adhesiogenesis After Treatment

37 patients enrolled at 6 sites

Mean patient age: 42.4 ± 7.2 years (range 29-55)

Mean ablated fibroid diameter: 3.2 ± 1.6 cm (range 1-8 cm)

2 patients withdrew prior to follow-up

35 pairs of baseline and follow-up hysteroscopies were evaluated by independent readers.

1 patient video was unevaluable (no agreement in evaluation by any of the 3 independent readers)

34 showed no sign of adhesions after Sonata per agreement in evaluation by 2 independent readers

6 out of 34 patients had apposing submucous fibroids ablated with no resulting adhesions

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Systematic Review and Meta-analysis of Studies

Radiofrequency Ablation of Uterine Fibroids

Bradley LD, Pasic RP, Miller LE. Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis

of Prospective Studies. J Laparoendosc Adv Surg Tech A. 2019;1507-1517.

OBJECTIVETo examine the evidence regarding typical patient outcomes

with radiofrequency ablation (RFA)

OUTCOMES

FOR ANALYSIS

• Procedure time and patient recovery metrics

• Change in fibroid volume

• Symptom Severity Scores and Health-Related QOL Scores

• Reinterventions

N=32 articles

1283 unique patients

CONCLUSIONS

Radiofrequency ablation (RFA) of uterine fibroids significantly

reduces fibroid volume, provides significant durable improve-

ments in fibroid-related quality of life and is associated with

favorable reintervention rates.

REPORTED KEY

OUTCOMES

LAPAROSCOPIC

APPROACH

TRANSCERVICAL

APPROACH

Mean procedure

time73 min 44 min

Mean time to

discharge10.7 hours 2.5 hours

Mean return to

normal activities9.0 days 3.3 days

Mean time to

return to work6.5 days 3.6 days

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Summary of Key Outcomes

Outcomes associated with sonography-guided transcervical fibroid ablation

(TFA) to treat symptomatic uterine fibroids:

A significant reduction in mean menstrual bleeding

Low surgical reintervention for HMB through 3 years

No device-related adverse events

Well tolerated by patients with rapid return to normal activity

Significant and durable improvements in fibroid symptoms and health-related

quality of life

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Patient selection & ExpectationsDIPAK DELVADIA, DO

VIRTUA OB/GYNVOORHEES, NJ

David Levine, MD

St. Louis, MO

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Sonata Contraindications

Active pelvic infection

Presence of one or more intra-tubal (intrauterine) implants for sterilization

Presence of an intrauterine device (IUD), unless removed prior to the introduction of the Sonata treatment device.

Known or suspected gynecologic malignancy or premalignant disorders such as EIN - endometrial intraepithelial neoplasia (atypical endometrial hyperplasia)

Current pregnancy

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Patient Selection Considerations

Fibroid size Published experience includes fibroids 7-8 cm Fibroids ≥ 6 cm require multiple ablations to optimize volume reduction

Number of fibroids - up to 10 fibroids were ablated/patient during SONATA Trial

Safety and effectiveness regarding fertility and fecundity after the use of the Sonata System have not been established

Effectiveness in women with clinically significant adenomyosis has not been established

Other conditions as stated in the Sonata System Operator’s Manual

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Fibroid Size and Volume

RF ablation is volumetric

Assume sphere where V = 4/3 πr3

An 8-cm myoma = 268.1 cc but a 9-cm myoma = 381.7 cc (42.4% increase)

5 cm x 4 cm Sonata ablation (largest size) = 41.9 cc

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Diameter vs. Volume

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Patient Selection: Considerations for New Users

Ideal patient selection for new Sonata users:

Primary target of Type 1, 2 or 3 myoma ≤6 cm in diameter• Higher likelihood of success/symptom improvement• Fibroid associated with HMB,

• Ability to target

• Treat fibroid with single ablation

• Associated with increased safety margin between fibroid and serosa

Limited number of fibroids to treat, preferably no more than 3 fibroids

Avoid patients presenting with isolated subserous fibroids

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Patient Expectations

Setting appropriate expectations is critical to avoiding patient regret and need for potentially-avoided surgical reintervention

Most patients will see improvement in HMB within 3 months

The goal is meaningful improvement in symptoms

This may or may not meet the definition of eumenorrhea (≤ 80 cc MBL)

Important for patients to not expect

Amenorrhea (this is not endometrial ablation)

Immediate results

Patients should be counselled about potential fibroid sloughing

It can result in intermenstrual spotting

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Perioperative Care

Bladder drainage not mandatory for imaging but helpful for patient comfort Always best for patient to void on her own just before TFA

Antibiotics? As with operative hysteroscopy, no clear need except for other indications (eg, SBE)

In SONATA, 0.7% of patients received prophylaxis

General Anesthesia not required but may be indicated for specific patients Better to have proper airway control if deep sedation is needed for pain control

Postop Patients typically on NSAIDs

Similar expected events to operative hysteroscopy (leukorrhea x days, spotting, cramping)

Postop visit or call as per your customary practice

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Some Potential Challenges

Small lower uterine segment myoma

Need 2.3 cm of space for minimum ablation size

Large / firm (calcified) myoma

Tight cervix/cervical stenosis

Take extra care to verify intrauterine entry!

Marked anteflexion/retroflexion

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Lower Uterine Segment Ablations

• Minimum of 2.3 cm distance between endometrial surface and uterine serosa• Smallest ablation size is 2.2 cm x 1.5 cm

Need ≥ 2.3 cm

Serosa

Serosa

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7 Women, 7 Sonata Stories

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REIMBURSEMENT FOUNDATIONS

HEALTH ECONOMICS AND MARKET ACCESS

Frank Constantino: Director, Reimbursement and Payer Relations

Shane Raine: HEMA- Sr. Manager Value Based Offers and Payer Relations

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Sonata US Covered Lives

Market Opportunity

Top Plan Types

300M

LIVES

Commercial182,023,569 (58%)

Medicaid / CHIP 72,438,965 (23%)

Medicare 58,266,514 (19%)

250MCommercial and Medicaid

Total Market 312.7M

Sonata 254.4M

Uninsured: 27M

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Authorizations – Coding – Payment

SUCCESS

Proper Coding

Policy Review

Claim Submission

Appeal, if Necessary

Peer-to-Peer Review

Patient Charting

Treatment(s) to Date

Pre-Auth Approval

Establish Medical Necessity

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CODING AND PAYMENT

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Coding – Physician and Facility

APC 5416 – Level 6 –Gynecologic Procedures

($6,702.85)

0404T Transcervical uterine fibroid(s) ablation with ultrasound guidance,

radiofrequency

Medicare OPS Facility Payment CPT Coding

Transcervical fibroid ablation is typically performed in the hospital outpatient department

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Charge Letter – Cross Walk

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Need Assistance?

PRIA

Preauthorization's Claims Submission & Appeals

Patient eligibilityand benefits verification

Precertification/preauthorization assistance

Preauthorization appeal denial assistance

Coding guidance

Claim submission guidance

Claim appeal assistance

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Disclaimer

The information provided contains general reimbursement information only and is not legal

advice nor is it advice about how to code, complete, or submit any particular claim for payment.

Information provided is not intended to increase or maximize reimbursement by any payer. The

information provided represents Gynesonics’ understanding of current coding and reimbursement policies. Gynesonics disclaims all responsibility related to provider billing. It is

the provider’s responsibility to determine appropriate codes, charges, and modifiers, and submit claims for the services consistent with the payer requirements. Third-party payer policies and

coding requirements vary and are updated and change over time. Providers should check and

verify

current policies and requirements with the payer for any particular patient.

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