Medifocus, Inc.
OTC: MDFZF  TSXV: MFS
www.medifocusinc.com

Feb. 2020

Public Nomination to Comments to 59452 
Federal Register/ Vol. 83, No. 226 as Potentially Misvalued




Prolieve®Transurethral Thermodilatation™ System  

.FDA approved for the treatment of Benign Prostatic Hyperplasia (BPH), a medical term for benign enlargement of prostate  

.50% of men over age 50 and 90% over age 70 will develop symptoms of BPH

.BPH symptoms may include urgency, nocturia, hesitancy, weak stream, dysuria, retention and intermittency

.The quality of life of BPH sufferers is severely compromised

.Most other treatment options are either less effective, or have unacceptable risks of significant side effects. 




BPH800 Masked BSC Colors




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Patent Prostatic Urethra
AfterProlieve®
(With a Natural Biological Stent)

BPH with Obstruction
BeforeProlieve® Treatment


Rectal Temp. Monitor

ThermotherapyCombined with Balloon Dilatation

Anchoring Balloon at Bladder Neck




A Safe & Effective Alternative to BPH Medications & Surgery
.Minimal/No Sexual Side Effects (E.D. & Retrograde Ejaculation)

.Proven Long-Term Safety, Efficacy & Durability

.No Foreign Bodies/Clips/Anchors embedded within the Urinary Tract

.No Perforation of Prostatic Urethra to minimize Pain & Hemorrhage

.Improved Patient Comfort & Rare Requirement of Post-Treatment Catheterization



“Prevention of BPH Progression”
12-Year FDA Post Market Study 
of Prolieve®-Treated Patients with 5-Year Follow-ups
Now Completed and Accepted 
.85% Post-Treatment Catheter-Free Rate

.Minimal/No Sexual Side Effects 

•Erectile Dysfunction: 0.3 per 100 person-years

•Retrograde Ejaculation: 0.3 per 100 person-years



.Improvement of Mean AUA Symptom Score

•Baseline = 20.1  vs.  Year 5 = 12.8 



.Improvement of Peak Flow Rate (Qmax)

•Baseline = 8.6 mL/sec   vs.   Year 5 = 12.8 mL/sec



.Improvement of Quality of Life (QoL) Score

•Baseline = 22.0   vs.  Year 5 = 16.5



.Stabilization of BPH Symptoms

•83% reported No Progression at Year 5



.Stabilization of Serum PSA and Prostate Size



Prolieve®Transurethral Thermodilatation™ Advantages 
The Only TUTD™



.The Only TransUrethral ThermoDilatation™ (TUTD) with a Patented Dilating Balloon

.A 45-minute In-Office Procedure Performed Under Local Anesthesia

.Proven Safety and Efficacy Records -Over 100,000 Cases Performed in the U.S.



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TheRUCcommittee,inJanuaryof2018,didnothavethelatestFDAPMSSupplementofProlievewhichwasapprovedon11/21/18(seebelow).




FDA’s Approval


*Our letter to CMS of 11-11-19 outlines this in detail.

1st& 2ndGeneration vs. 3rdGeneration



A.Current CPT Code 53850 is for traditional microwave single modality TUMT.

B.ProlieveTransurethral Thermodilatationis currently lumped under CPT 53850.

C.Prolieve is NOT a 1st and 2ndgeneration TUMT treatment device. We agree with the RUC committee as based upon the 1stand 2ndgeneration TUMT falling under 53850 as they require lesstreatment time than the 3rdgeneration.  This justifies the reduction in reimbursement of the CPT code by 24%.

D.However, that does not take into account ProlieveSystem also provides the demonstrated clinical benefits of the Prostatic Urethral Dilation Balloon. 

E.The proven immediate and long-term benefits of our office-based treatment, as accepted by the FDA, is attributed to the thermotherapy AND the Prostatic Urethral Dilation Balloon.

F.The ProlieveTUTD 3rd generation TUMT requires an increase of 50% treatment procedural time over the 1st and 2nd Generation TUMT to provide the added clinical and safety benefits of our TUTD treatment modality.



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The Only Transurethral ThermoDilatation™ (TUTD ™) 
with a Patented 46 Fr. Dilating Balloon

How is Prolieve® Different?


Lefkowitz_ProlieveMD

46 Fr. Dilatation Balloon

Rectal Temp 
Monitor


Anchoring Balloon


*A 1.2 cm built-in Microwave Antenna is Positioned At the Base of the Prostate Gland




*

*

*



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We believe CPT Code 53850 for Prolieve is misvaluedas evidenced by our latest FDA approved 5 year study, which demonstrated durable, lasting results.
ProlieveTimeRequirements:
•Additionalpre-treatmentpreptime.Thisincludesaminimumof15-20minutestopressurizethesystem,pre-heattheheatexchanger,testtherectaltemperaturemonitorandtoensurenoleakageoftheanchoringandespeciallythedilatationballoon.

•10-minutestoadministerlocalintraurethralanesthesiaandtoassessadequacyofanesthesia.

•45-minutetreatment(asopposedto1st&2ndgenerationof28.5minutes);withaddedcomplexityrequiredinmonitoringofthehighlypressurizedsystemandconstantassessmentofthepositioningoftheanchoringballoonandrectaltemperatureprobe.

•5-minutecool-downperiodtoeffectabiologicalstent.

•15minutestode-pressurizethesystem,fill/irrigatethebladderwithsalineandremovalofthetreatmentcatheterandrectalmonitoringprobe.

•20-25minutesofimmediatepost-treatmentvoidingtrialwithassessmentofvoidingpatternandofanybleeding/clots,sincealmostallpatientsaresenthomewithoutanindwellingcatheterasopposedtootherTUMTorminimally-invasivetreatments.


ProlieveTreatmentDevice/Equipment:
•ThesophisticateddesignoftheProlievecatheterwiththeembeddedmicrowaveantennaandProstaticUrethralDilationBalloonincreasesthemanufacturingcostsofProlievecatheterseveraltimesoverthatofthecathetersusedinthe1stand2ndgenerationTUMTtreatmentdevice.

•Costoftreatmentconsoleishigherthanthe1st&2ndgenerationTUMTduetoitsabilitytocontrol/monitorandinflate/pressurizethetransurethralprostaticdilationballoonusedinthetreatment.

•IncreasedcostduetopressurizedHeatExchangertoensureoptimumtreatmenttemperatureandpressure.ThisisuniquetoProlieve®ThermodilatationSystem.





Prolieve®Costs


Healthcare Savings of BPH Management

•Prolieve® is a savings to the overall health care cost for the management of BPH as compared to other treatment modalities such as ie: TURP, Lasers, Uroliftand medications. 


•We are an office-based treatment so it eliminates the higher costs of hospital or surgery centers.

•It’s a safe and effective, patient friendly treatment and only local anesthesia is required.

•The majority of patients donotrequirepost-treatment catheterization which can be from 1 week to over 1 month with these other treatments.

•It improves the quality of life and does not have side effects like the other treatment options.






BPH Options from least invasive to most invasive




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Our Proposed Recommendations

•IncreaseCPTreimbursementof53850tocompensateforthesignificantincreaseinexpertise,equipmentcostandtimerequiredtoperformtheProlievetreatment.

•AllowthebundlingofCPTCode74485whichisforthedilationofureter(s)orurethra,radiologicalsupervisionandinterpretation.ThedilationfeatureofProlieveTransurethralThermodilatation™issimilarinscopeandapplicationtotheproceduresunderCPTCode74485.Therefore,additionalCPTCode74485shouldapplytoProlieveTransurethralThermodilatation™procedure.

•NewmodifiedCPTcodetoincorporatetheFDAsupplementalapprovalforProlieveaswearetheonlyThermodilatationtreatmentplatform.






Conclusion

•Inconclusion,withoutconsiderationforthemisvaluationoftheProlievereimbursement,itiseconomicallynotfeasibleforMedifocus,Inc.toprovideourProlievetreatmenttothemarketplace.


•ThephysiciansusingProlievewillnotbeabletoprovidetheProlievetreatmentbecausetheyarenotfullycompensatedforthecostoftheequipmentandtheirtime.

•Itwillreducethetreatmentoptionsofthe3rdgenerationmicrowavetothepatientswhocangreatlybenefitbyitsuse.Todate,Prolievehasalreadybenefitedover100,000patients.


•Finally,webelievethecorrectionofthemisvaluationwillfallinlinewithCMS’sagendainkeepingnewtechnologiesonthemarketforthebenefitofthepatients.






