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Published: 2021-05-04 21:55:05 ET
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1 In sp ir e M e d ic a l S y st e m s, I n c . M a y 2 0 2 1 N Y S E : IN S P


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L D is c la im e r T h is p re s e n ta ti o n c o n ta in s f o rw a rd -l o o k in g s ta te m e n ts w ith in t h e m e a n in g o f th e P ri v a te S e c u ri tie s L iti g a tio n R e fo rm A c t o f 1 9 9 5 . A ll st a te m e n ts o th e r th a n s ta te m e n ts o f h is to ri c a l fa ct s a re f o rw a rd - lo o k in g s ta te m e n ts . In s o m e c a s e s , yo u c a n id e n tif y fo rw a rd -l o o k in g s ta te m e n ts b y te rm s s u ch a s ‘‘ m a y, ’’ ‘‘w ill ,’ ’ ‘‘s h o u ld ,’’ ‘ ‘e xp e c t, ’’ ‘‘p la n ,’’ ‘‘a n tic ip a te ,’’ ‘ ‘c o u ld ,’’ “ fu tu re ,” “ o u tlo o k ,” ‘‘ in te n d ,’’ ‘ ‘t a rg e t, ’’ ‘‘p ro je c t, ’’ ‘‘c o n te m p la te ,’’ ‘ ‘b e lie ve ,’’ ‘ ‘e st im a te ,’’ ‘ ‘p re d ic t, ’’ ‘‘p o te n tia l,’ ’ ‘‘c o n tin u e ,’’ o r th e n e g a tiv e o f th e s e t e rm s o r o th e r si m ila r e xp re s si o n s , a lth o u g h n o t a ll fo rw a rd -l o o k in g s ta te m e n ts c o n ta in t h e s e w o rd s. T h e f o rw a rd -l o o k in g s ta te m e n ts in t h is p re s e n ta tio n r e la te t o , a m o n g o th e r th in g s , st a te m e n ts r e g a rd in g t h e im p a ct o f th e C O V ID -1 9 p a n d e m ic o n o u r b u si n e s s o p e ra tio n s , fin a n c ia l r e s u lts a n d fi n a n c ia l c o n d iti o n , in ve s tm e n ts in o u r b u si n e s s , o u r g ro w th s tr a te g ie s , o u r e xp e c ta tio n t h a t a s u b s ta n tia l p o rt io n o f p o st p o n e d In s p ir e t h e ra p y p ro c e d u re s w ill b e r e sc h e d u le d , th e a ct iv it y o f o u r c o m m e rc ia l t e a m o n c e c ir c u m s ta n c e s a llo w , fu ll ye a r 2 0 2 1 f in a n ci a l a n d o p e ra tio n a l o u tlo o k , a n d p o s iti ve i n su ra n c e c o ve ra g e o f In s p ir e t h e ra p y a n d im p ro ve m e n ts in m a rk e t a cc e ss , c lin ic a l d a ta g ro w th , p ro d u c t d e ve lo p m e n t, in d ic a tio n e xp a n s io n , m a rk e t d e v e lo p m e n t, a n d p ri o r a u th o ri za ti o n a p p ro va ls . T h e se f o rw a rd -l o o k in g s ta te m e n ts a re b a se d o n m a n a g e m e n t’s c u rr e n t e xp e c ta tio n s a n d in vo lv e k n o w n a n d u n k n o w n r is k s a n d u n ce rt a in tie s th a t m a y ca u s e o u r a c tu a l r e s u lts , p e rf o rm a n ce o r a c h ie ve m e n ts t o b e m a te ri a lly d iff e re n t fr o m a n y fu tu re r e s u lts , p e rf o rm a n ce o r a c h ie ve m e n ts e xp re s s e d o r im p lie d b y th e f o rw a rd -l o o k in g s ta te m e n ts . S u c h r is k s a n d u n c e rt a in tie s in c lu d e , a m o n g o th e rs , e st im a te s r e g a rd in g t h e a n n u a l t o ta l a d d re s sa b le m a rk e t fo r o u r In s p ir e t h e ra p y in t h e U .S . a n d o u r m a rk e t o p p o rt u n it y o u ts id e t h e U .S .; f u tu re r e s u lts o f o p e ra tio n s, f in a n ci a l p o s iti o n , re s e a rc h a n d d e v e lo p m e n t c o s ts , c a p ita l re q u ir e m e n ts a n d o u r n e e d s fo r a d d iti o n a l f in a n c in g ; c o m m e rc ia l s u c c e s s a n d m a rk e t a c c e p ta n c e o f o u r In s p ir e t h e ra p y; t h e im p a c t o f th e o n g o in g a n d g lo b a l C O V ID - 1 9 p a n d e m ic ; g e n e ra l a n d in te rn a tio n a l e c o n o m ic , p o lit ic a l, a n d o th e r ri s k s , in c lu d in g c u rr e n cy a n d s to ck m a rk e t fl u c tu a tio n s a n d t h e u n ce rt a in e c o n o m ic e n vi ro n m e n t; o u r a b ili ty t o a ch ie v e a n d m a in ta in a d e q u a te le ve ls o f co v e ra g e o r re im b u rs e m e n t fo r o u r In sp ir e s ys te m o r a n y fu tu re p ro d u c ts w e m a y se e k t o c o m m e rc ia liz e ; co m p e ti tiv e c o m p a n ie s a n d t e ch n o lo g ie s in o u r in d u st ry ; o u r a b ili ty t o e n h a n c e o u r In s p ir e s ys te m , e x p a n d o u r in d ic a tio n s a n d d e ve lo p a n d c o m m e rc ia liz e a d d iti o n a l p ro d u c ts ; o u r b u s in e s s m o d e l a n d s tr a te g ic p la n s fo r o u r p ro d u c ts , te c h n o lo g ie s a n d b u s in e s s , in cl u d in g o u r im p le m e n ta tio n t h e re o f; o u r a b ili ty t o a cc u ra te ly f o re c a st c u s to m e r d e m a n d f o r o u r In s p ir e s ys te m a n d m a n a g e o u r in ve n to ry ; o u r d e p e n d e n ce o n t h ir d -p a rt y su p p lie rs , c o n tr a c t m a n u fa c tu re rs a n d s h ip p in g c a rr ie rs ; c o n so lid a tio n in t h e h e a lth ca re in d u s tr y; o u r a b ili ty t o e x p a n d , m a n a g e a n d m a in ta in o u r d ir e c t sa le s a n d m a rk e tin g o rg a n iz a tio n , a n d t o m a rk e t a n d s e ll o u r In s p ir e s ys te m in m a rk e ts o u ts id e o f th e U .S .; r is k s a ss o c ia te d w ith i n te rn a tio n a l o p e ra tio n s ; o u r a b ili ty t o m a n a g e o u r g ro w th ; o u r a b ili ty t o in c re a s e t h e n u m b e r o f a c tiv e m e d ic a l c e n te rs im p la n tin g In s p ir e t h e ra p y; o u r a b ili ty t o h ir e a n d r e ta in o u r s e n io r m a n a g e m e n t a n d o th e r h ig h ly q u a lif ie d p e rs o n n e l; ri sk o f p ro d u ct li a b ili ty c la im s ; ri s k s r e la te d t o in fo rm a ti o n t e ch n o lo g y a n d c yb e rs e c u ri ty ; ri s k o f d a m a g e t o o r in te rr u p tio n s a t o u r fa c ili ti e s ; o u r a b ili ty t o c o m m e rc ia liz e o r o b ta in r e g u la to ry a p p ro va ls f o r o u r In s p ir e t h e ra p y a n d s ys te m , o r th e e ff e ct o f d e la ys i n c o m m e rc ia liz in g o r o b ta in in g re g u la to ry a p p ro va ls ; F D A o r o th e r U .S . o r fo re ig n r e g u la to ry a ct io n s a ff e c ti n g u s o r th e h e a lth c a re in d u st ry g e n e ra lly , in c lu d in g h e a lth c a re r e fo rm m e a s u re s in t h e U .S . a n d in te rn a tio n a l m a rk e ts ; t h e tim in g o r lik e lih o o d o f re g u la to ry f ili n g s a n d a p p ro v a ls ; ri s k s re la te d t o o u r d e b t a n d c a p ita l s tr u c tu re ; o u r a b ili ty t o e s ta b lis h a n d m a in ta in in te lle ct u a l p ro p e rt y p ro te c tio n f o r o u r In sp ir e t h e ra p y a n d s ys te m o r a vo id c la im s o f in fr in g e m e n t; t a x ri s k s ; ri s k s t h a t w e m a y b e d e e m e d a n in ve s tm e n t c o m p a n y u n d e r th e I n ve st m e n t C o m p a n y A c t o f 1 9 4 0 ; re g u la to ry r is k s ; th e v o la til it y o f th e t ra d in g p ri c e o f o u r c o m m o n s to ck ; a n d o u r e x p e c ta tio n s a b o u t m a rk e t tr e n d s . O th e r im p o rt a n t fa c to rs t h a t c o u ld c a u se a ct u a l r e s u lts , p e rf o rm a n c e o r a c h ie ve m e n ts t o d if fe r m a te ri a lly f ro m t h o s e c o n te m p la te d in t h is p re s e n ta tio n c a n b e f o u n d u n d e r th e c a p ti o n s “ R is k F a c to rs ” a n d “ M a n a g e m e n t’s D is c u ss io n a n d A n a ly si s o f F in a n c ia l C o n d iti o n a n d R e s u lts o f O p e ra tio n s” in o u r A n n u a l R e p o rt o n F o rm 1 0 -K f o r th e ye a r e n d e d D e c e m b e r 3 1 , 2 0 2 0 , a s u p d a te d in o u r Q u a rt e rl y R e p o rt o n F o rm 1 0 -Q f o r th e q u a rt e r e n d e d M a rc h 3 1 , 2 0 2 1 , a n d a s s u c h f a ct o rs m a y b e u p d a te d f ro m t im e t o t im e in o u r o th e r fi lin g s w it h th e S E C , w h ic h a re a cc e s si b le o n t h e S E C ’s w e b si te a t w w w .s e c .g o v a n d t h e I n ve st o rs p a g e o f o u r w e b s it e a t w w w .in s p ir e sl e e p .c o m . T h e se a n d o th e r im p o rt a n t fa c to rs c o u ld c a u s e a c tu a l r e s u lts t o d if fe r m a te ri a lly f ro m t h o s e in d ic a te d b y th e f o rw a rd -l o o k in g s ta te m e n ts m a d e in t h is p re s e n ta ti o n . A n y s u ch f o rw a rd -l o o k in g s ta te m e n ts r e p re s e n t m a n a g e m e n t’s e st im a te s a s o f th e d a te o f th is p re s e n ta tio n . W h ile w e m a y e le c t to u p d a te s u c h f o rw a rd -l o o k in g s ta te m e n ts a t s o m e p o in t in t h e f u tu re , u n le s s re q u ir e d b y a p p lic a b le l a w , w e d is c la im a n y o b lig a ti o n t o d o s o , e ve n if s u b se q u e n t e ve n ts c a u se o u r vi e w s t o c h a n g e . T h u s , o n e s h o u ld n o t a s su m e t h a t o u r s ile n c e o v e r tim e m e a n s t h a t a c tu a l e ve n ts a re b e a ri n g o u t a s e xp re s s e d o r im p lie d in s u ch f o rw a rd -l o o k in g s ta te m e n ts . T h e se f o rw a rd -l o o k in g s ta te m e n ts s h o u ld n o t b e r e lie d u p o n a s r e p re s e n tin g o u r vi e w s a s o f a n y d a te s u b se q u e n t to th e d a te o f th is p re s e n ta tio n . T h is p re s e n ta ti o n c o n ta in s t ra d e m a rk s, t ra d e n a m e s a n d s e rv ic e m a rk s o f o th e r c o m p a n ie s, w h ic h a re t h e p ro p e rt y o f th e ir r e sp e c ti ve o w n e rs . W e d o n o t in te n d o u r u s e o r d is p la y o f o th e r p a rt ie s ' tr a d e m a rk s , t ra d e n a m e s o r s e rv ic e m a rk s t o im p ly , a n d s u ch u se o r d is p la y s h o u ld n o t b e c o n st ru e d t o im p ly , a r e la tio n sh ip w ith , o r e n d o rs e m e n t o r s p o n s o rs h ip o f u s b y, t h e se o th e r p a rt ie s . 2


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L 3


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Fo c u s o n a S tr o n g S ta rt t o 2 0 2 1 !! ! U pd at ed F Y 20 21 G ui da nc e: Re ve nu e: $ 19 2M - $1 96 M , r ep re se nt in g 66 % - 70 % g ro w th fr om F Y 20 20 re ve nu e of $ 11 5. 4M G ro ss m ar gi n: 8 4% - 85 % Te rr ito ri es : 8 to 9 te rr ito ri es p er q ua rt er N ew U .S . c en te rs : 3 6 to 4 0 ce nt er s pe r qu ar te r In 2 02 1, o ur fo cu s w ill b e to c on ti nu e ex pa ns io n by im pr ov in g ca pa ci ty an d co nv er si on : 1. H ig hl ig ht in g ex pa ns io n of tr ai ni ng n ew c en te rs w it h fo cu s on A m bu la to ry S ur gi ca l C en te rs (A SC s) 2. Ca de nc e of r ec ru it in g Te rr ito ry M an ag er s in -li ne w it h ce nt er e xp an si on , a lo ng w it h su pp or t st af f ( FC Rs ) 3. N ew D ir ec t- to -C on su m er c am pa ig ns to b ri ng m or e pe op le to th e w eb si te 4. Ex pa ns io n of A dv is or C ar e Pr og ra m (c al l c en te r) to c ap tu re m os t in -b ou nd c al ls t he re by d ri vi ng im pr ov em en ts in p at ie nt c on ne ct io ns to h ea lt hc ar e pr ov id er s 5. G ro w c ap ac it y at e xi st in g ce nt er s N ew C at eg or y I C PT c od es a pp ro ve d an d in t he R U C su rv ey p ro ce ss N ew fo rm al D RG c od e in G er m an y be ca m e ef fe ct iv e Ja n 1, 2 02 1 (p re vi ou s 5 ye ar s w er e un de r N U B sy st em ) 4


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L W e co nt in ue to c lo se ly m on it or C O V ID -1 9 in cl ud in g: W e ex pe ri en ce d ca nc el at io ns o r de la ys in c as es in e ar ly 2 02 1 in s el ec t st at es (N or th ea st a nd So ut he as t) , b ut d o no t c ur re nt ly s ee s ig ni fic an t im pa ct b ey on d no rm al Q 1 se as on al it y W it h A SC s, w e ha ve s om e fle xi bi lit y to m ov e ca se s, b ut d o no t e nv is io n th e lo ca liz ed lo ck -d ow ns to b e su st ai ne d Ce nt er o pe ni ng s an d ne w T er ri to ry M an ag er h ir in g re m ai n st ro ng Co nt in ui ng w it h an a ct iv e pr io r au th or iz at io n pi pe lin e an d hi gh a pp ro va l r at es En ga gi ng a nd e du ca ti ng p hy si ci an s an d pa ti en ts t hr ou gh o ur o nl in e pl at fo rm u si ng v ir tu al h ea lt h ta lk s, on lin e to ol s an d th e ne w In sp ir e Sl ee p ap p Re fo cu si ng a nd e xp an di ng d ir ec t- to -c on su m er m ar ke ti ng s tr at eg ie s be tw ee n ra di o an d TV , a s w el l a s ex pa nd in g ca ll ce nt er c ov er ag e an d im pr ov in g co nv er si on ra te s Fo cu s re m ai ns o n en su ri ng s tr on g pa ti en t ou tc om es a nd fo llo w -u p U p d a te o n I n sp ir e O p e ra tio n s: I m p a c t o f C O V ID -1 9 5


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Si g n ifi c a n t B u si n e ss P ro g re ss S in c e I P O : St ro n g Fo u n d a tio n in P la c e t o D ri v e G re a te r P e n e tr a tio n C li n ic a l P h a s e R e g u la to ry P h a s e R e im b u rs e m e n t P h a s e 1 B ro a d e r C o m m e rc ia l E x p a n s io n P h a s e P M A a p p ro v a l fr o m t h e F D A i n 2 0 1 4 C li n ic a l e v id e n c e i n a p p ro x im a te ly 2 ,5 0 0 p a ti e n ts a n d 1 5 0 + p a p e rs E ff e c ti v e n e s s d e m o n s tr a te d i n a r e a l- w o rl d s e tt in g ( A D H E R E ) M o re t h a n 1 4 ,0 0 0 p a ti e n ts t re a te d w it h I n s p ir e t h e ra p y t o d a te M e d ic a re c o v e ra g e i n a ll 5 0 s ta te s w it h i n c re a s e i n s u rg e o n f e e s R ap id In cr ea se in C ov er ed L iv es (m m ) E x p a n d in g c o m m e rc ia l e ff o rt s t o d ri v e c o n ti n u e d g ro w th i n t h e ra p y a d o p ti o n C o n ti n u e t o I n c re a s e V o lu m e b y T ra in in g a n d O p e n in g N e w C e n te rs D ri v e I n c re a s e d U ti li za ti o n a t E x is ti n g C e n te rs C o n ti n u e t o M a in ta in H ig h q u a li ty P a ti e n t O u tc o m e s 2 25 16 5 22 0 IP O (M ay '1 8) D ec '1 8 D ec '1 9 D ec '2 0 6


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Q ua lif yi ng In te re st D ri vi ng C on ve rs io n G en er at in g In te re st Se le ct iv el y Ex pa nd in g D TC A dv er ti si ng C o m m e rc ia l E x e c u ti o n : O p p o rt u n ity t o A c c e le ra te In te re st a n d C o n v e rs io n s O ur D ir ec t- to -P at ie nt S tr at eg y H as P ro ve n to B e Su cc es sf ul in R ea ch in g an d Ed uc at in g Pa ti en ts A bo ut In sp ir e Th er ap y… In sp ir e W eb si te V is it or s (m m ) … A nd W e A re N ow F oc us ed o n B ot h B ro ad en in g Th es e Ef fo rt s an d In cr ea si ng O ur O ve ra ll Co nv er si on R at e an d U ti liz at io n at E xi st in g Ce nt er s 1 M at ch in g th e R ig ht P at ie nt w it h th e R ig ht P hy si ci an fo r th e R ig ht T he ra py Co nv er si on o f < 1 0% o f In co m in g Ca lls 2 3 • 23 7k D oc to r Se ar ch es • 62 k D oc to r Co nt ac ts • La un ch ed A dv is or C ar e Pr og ra m 2 0 2 0 2 0 2 1 Ex pa nd in g A dv is er Ca re P ro gr am ~4 k U .S . I m pl an ts 2 0 2 0 2 0 2 1 St ri ve fo r Co nt in uo us Im pr ov em en t of Co nv er si on R at es 2. 3 4. 5 4. 8 20 18 20 19 20 20 7


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L In sp ir e is a n I n n o v a tiv e N e u ro st im u la tio n S o lu tio n f o r M o d e ra te t o S e v e re O b st ru c tiv e S le e p A p n e a ( O SA ) F ir st a n d o n ly F D A -a p p ro ve d n e u ro st im u la tio n t e ch n o lo g y fo r O S A M o re t h a n 1 4 ,0 0 0 p a tie n ts t re a te d w ith I n sp ir e t h e ra p y T h e ra p y fo r th e e st im a te d 3 5 – 6 5 % o f n o n -C P A P c o m p lia n t p a tie n ts ~ $ 1 0 b n a n n u a l U .S . m a rk e t o p p o rt u n ity In n o va tiv e , cl o se d -l o o p , m in im a lly i n va si ve s o lu tio n S a fe , co m fo rt a b le , a n d c o n ve n ie n t th e ra p y S ig n ifi c a n t b o d y o f cl in ic a l e vi d e n ce i n vo lv in g o ve r 2 ,5 0 0 p a tie n ts a cr o ss 2 3 s tu d ie s S tr o n g c u st o m e r b a se a n d g ro w in g s a le s te a m G ro w in g r e im b u rs e m e n t w ith 2 2 0 m ill io n U .S . co ve re d l iv e s P ro ve n m a n a g e m e n t te a m le a d in g 3 7 5 + e m p lo ye e s O u r H is to ry & K e y M il e s to n e s 1 9 9 0 s: M e d tr o n ic ( M D T ) b e g in s e a rl y w o rk o n t h e d e ve lo p m e n t o f In s p ir e 2 0 0 1 : In iti a l c lin ic a l re s u lts p u b lis h e d b y M D T 2 0 0 7 : In s p ir e is f o u n d e d a ft e r b e in g s p u n -o u t o f M D T 2 0 1 1 : In iti a te d P h a s e I II p iv o ta l S T A R t ri a l; C E m a rk r e c e iv e d in E u ro p e 2 0 1 4 : S T A R r e s u lts p u b lis h e d i n t h e N e w E n g la n d J o u rn a l o f M e d ic in e in J a n u a ry ; re c e iv e d P M A a p p ro v a l fr o m t h e F D A 2 0 1 5 : 1 8 -m o n th S T A R d a ta p u b lis h e d ; re ve n u e s o f $ 8 .0 M 2 0 1 6 : 1 ,0 0 0 th im p la n t m ile s to n e ; re ve n u e s o f $ 1 6 .4 M 2 0 1 7 : L a u n ch e d I n s p ir e I V n e u ro s tim u la to r in U .S .; a n n o u n c e d 5 -y e a r S T A R r e s u lts ; 2 ,0 0 0 th im p la n t; r e v e n u e s o f $ 2 8 .6 M 2 0 1 8 : In s p ir e I V C E m a rk ; 5 -y e a r S T A R r e s u lts p u b lic a ti o n ; in iti a l p u b lic o ff e ri n g o n N Y S E ; A e tn a b e g in s c o ve ri n g t h e I n s p ir e t h e ra p y; re ve n u e s o f $ 5 0 .6 M 2 0 1 9 : 7 ,5 0 0 th p a tie n t re ce iv e s In s p ir e t h e ra p y; M a n y B C B S p la n s a n d o th e r la rg e in s u re rs w ri te p o s iti ve c o ve ra g e ; s ix M e d ic a re L C D d ra ft s; re ve n u e s o f $ 8 2 .1 M 2 0 2 0 : M e d ic a re c o ve ra g e in a ll 5 0 s ta te s ; F D A a p p ro ve d e x p a n d e d a g e r a n g e t o in cl u d e 1 8 t o 2 1 -y e a r- o ld p a tie n ts ; In s p ir e S le e p a p p re le a se d ; 1 0 ,0 0 0 th p a tie n t re ce iv e s In s p ir e t h e ra p y; r e ve n u e s o f $ 1 1 5 .4 M 8


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L St ro n g M a n a g e m e n t Te a m T im H e rb e rt P re s id e n t, C E O & F o u n d e r 3 0 + Y e a rs o f E x p e ri e n c e R ic k B u c h h o lz C h ie f F in a n c ia l O ff ic e r 2 5 + Y e a rs o f E x p e ri e n c e R a n d y B a n C h ie f C o m m e rc ia l O ff ic e r 2 5 + Y e a rs o f E x p e ri e n c e P h il E b e li n g C h ie f O p e ra ti n g O ff ic e r 2 0 + Y e a rs o f E x p e ri e n ce 9 B ry a n P h il li p s S V P , G e n e ra l C o u n s e l & C h ie f C o m p li a n c e O ff ic e r 2 0 + Y e a rs o f E x p e ri e n ce


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L O SA is a S e ri o u s a n d C h ro n ic D is e a se O S A i s C a u s e d b y a B lo c k e d o r P a rt ia ll y B lo c k e d A ir w a y • B lo ck a g e p re v e n ts a ir fl o w t o t h e lu n g s • R e su lts in r e p e a te d a ro u sa ls a n d o xy g e n d e -s a tu ra tio n s • S e ve ri ty o f sl e e p a p n e a is m e a su re d b y fr e q u e n cy o f a p n e a o r h yp o p n e a e ve n ts p e r h o u r, w h ic h i s re fe rr e d t o a s th e A p n e a -H yp o p n e a I n d e x (A H I) A ir w a y o b s tr u c ti o n d u ri n g b re a th in g N o rm a l ra n g e : A H I < 5 e ve n ts p e r h o u r M il d s le e p a p n e a : M od er at e sl ee p ap ne a: Se ve re s le ep a pn ea : In sp ir e’ s Fo cu s M os t Pa ti en ts A re U na w ar e of T he ir C on di ti on … … an d U nt re at ed O SA M ul ti pl ie s Se ri ou s H ea lt h R is ks • H ig h ri sk p at ie nt s: o be se , m al e or o f a dv an ce d ag e • Co m m on fi rs t i nd ic at or : h ea vy s no ri ng • O th er in di ca to rs : • La ck o f e ne rg y • H ea da ch es • D ep re ss io n • N ig ht ti m e ga sp in g • D ry m ou th • M em or y or c on ce nt ra ti on pr ob le m s • Ex ce ss iv e da yt im e sl ee pi ne ss So ur ce : C om pa ny W eb si te 1. Re dl in e et a l, Th e Sl ee p H ea rt H ea lt h St ud y. A m J R es a nd C ri t Ca re M ed 2 01 0. 2. G am i e t al , J A m C ol l C ar di ol 2 01 3. 3. Yo un g et a l, J S le ep 2 00 8. 2 x T h e r is k fo r s tr o k e 1 2 x T h e r is k fo r s u d d e n c a rd ia c d e a th 2 5 7 % In cr e a s e d r is k fo r re cu rr e n ce o f A tr ia l F ib ri lla ti o n a ft e r a b la tio n 4 Ye ar s of F ol lo w -u p % Surviving In cr ea se d R is k of M or ta lit y 5 4. Li e t al , E ur op ac e 20 14 . 5. Pr os pe ct iv e St ud y of O bs tr uc ti ve S le ep A pn ea a nd In ci de nt C or on ar y H ea rt D is ea se a nd H ea rt F ai lu re f ro m S H H S an d W is co ns in S le ep C oh or t St ud y. 5 x T h e r is k fo r c a rd io va sc u la r m o rt a lit y 3 1 0


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L C u rr e n t Tr e a tm e n t O p tio n s, S u c h a s C P A P a n d I n v a si v e Su rg e ry , H a v e S ig n ifi c a n t Li m ita tio n s In a U vu lo pa la to ph ar yn go pl as ty (U PP P) M ax ill om an di bu la r A dv an ce m en t (M M A ) • Se ve ra l v ar ia ti on s of s le ep s ur ge ry • Su cc es s ra te s va ry w id el y (3 0% - 60 % )1 • Ir re ve rs ib le a na to m y al te ra ti on • In -p at ie nt s ur ge ry w it h ex te nd ed re co ve ry In va si ve S ur ge ry In a Co nt in uo us P os iti ve A ir w ay P re ss ur e (C PA P) is t he L ea di ng T he ra py fo r O SA 1. Sh ah , J an ki , e t al ; A m er ic an J ou rn al o f O to la ry ng ol og y (2 01 8) . U vu lo pa la to ph ar yn go pl as ty v s. C N X II st im ul at io n fo r tr ea tm en t of ob st ru ct iv e sl ee p ap ne a: A s in gl e in st itu tio n ex pe ri en ce . D ri ve rs o f N on -C om pl ia nc e M as k D is co m fo rt M as k Le ak ag e Pr es su re In to le ra nc e Sk in Ir ri ta ti on N as al C on ge st io n N as al D ry in g N os eb le ed s Cl au st ro ph ob ia La ck o f I nt im ac y • D el iv er ed th ro ug h a m as k th at c on ne ct s th ro ug h a ho se to a b ed si de a ir p um p • D em on st ra te d im pr ov em en ts in p at ie nt -r ep or te d sl ee p qu al it y an d re du ct io ns in d ay ti m e sl ee pi ne ss • Lo ng -t er m li m it at io ns a s a th er ap eu ti c op ti on , pr im ar ily d ue t o lo w p at ie nt c om pl ia nc e (a pp ro xi m at el y 35 % – 65 % ) • Lo w p at ie nt c om pl ia nc e as m an y pa ti en ts fi nd th e m as k or t re at m en t c um be rs om e, u nc om fo rt ab le a nd lo ud 11


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L A S tr o n g M a rk e t O p p o rt u n it y E x is ts f o r a n A lt e rn a tiv e t o C P A P t h a t is E ff e c tiv e a n d M in im a lly I n v a si v e Sl ee p ap ne a af fe ct s +1 00 m ill io n pe op le w or ld w id e1 A pp ro xi m at el y 17 m ill io n in di vi du al s in t he U .S . w it h m od er at e to s ev er e O SA • A nn ua lly , ~ 2 m ill io n ad ul t p at ie nt s ar e pr es cr ib ed a CP A P de vi ce 2 A nn ua l U .S . e co no m ic c os ts o f u nt re at ed m od er at e to se ve re O SA a re b et w ee n $6 5 -$ 16 5 bi lli on 3 O SA e co no m ic c os ts a re p ot en ti al ly g re at er t ha n as th m a, he ar t fa ilu re , s tr ok e, a nd h yp er te ns iv e di se as e O SA is a ss oc ia te d w it h an in cr ea se in : • Ra te & s ev er it y of v eh ic le a cc id en ts • In cr ea se d he al th ca re u ti liz at io n • Re du ct io n of w or k pe rf or m an ce • O cc up at io na l i nj ur ie s Pr ev al en ce & E co no m ic C os ts N ot e: A SP c on st itu te s ab br ev ia ti on f or a ve ra ge s el lin g pr ic e. 1. So ur ce : W or ld H ea lth O rg an iz at io n. 2. Co m pa ny e st im at es . 3. Re pr es en ts m od er at e to s ev er e O SA . S ou rc e: M cK in se y & C om pa ny , 2 01 0. A du lts w ith M od er at e to S ev er e O SA Pr es cr ib ed C PA P2 = ~2 m ill io n •L es s: 6 5% C PA P Co m pl ia nt 35 % o f C PA P N on - Co m pl ia nt A du lt s = ~7 00 ,0 00 •L es s: 3 0% A na to m y Ch al le ng es 70 % In sp ir e A na to m y El ig ib le = ~ 50 0, 00 0 •M ul ti pl ie d by o ur A SP In sp ir e U .S . M ar ke t = ~$ 10 b ill io n Pu bl is he d lit er at ur e es ti m at es C PA P no n- co m pl ia nc e ra te s of 35 % - 65 % 1 2


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L In sp ir e T h e ra p y is a P ro v e n S o lu tio n fo r P a tie n ts w ith O SA In sp ir e Sy st em 1 2 3 In sp ir e Pr oc ed ur e A pp ro xi m at el y a tw o- ho ur o ut pa ti en t p ro ce du re Re qu ir es th re e sm al l i nc is io ns Pa ti en ts t yp ic al ly r ec ov er q ui ck ly a nd r es um e no rm al ac ti vi ti es in ju st a fe w d ay s Sy st em a ct iv at io n oc cu rs 3 0 da ys a ft er im pl an ta ti on Pa ti en t co nt ro ls s ys te m b y tu rn in g on t he d ev ic e ea ch ni gh t w it h th e re m ot e co nt ro l b ef or e go in g to s le ep 2 1 H yp og lo ss al N er ve N eu ro st im ul at or St im ul at io n Le ad Pr es su re Se ns in g Le ad 23 Re m ot e co nt ro l a nd t hr ee im pl an ta bl e co m po ne nt s: Pr es su re s en si ng le ad : d et ec ts w he n th e pa ti en t i s at te m pt in g to b re at he N eu ro st im ul at or : h ou se s th e el ec tr on ic s an d ba tt er y po w er fo r th e de vi ce St im ul at io n le ad : d el iv er s el ec tr ic al s ti m ul at io n to t he hy po gl os sa l n er ve 1 3


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L In sp ir e T h e ra p y is a S a fe a n d E ff e c tiv e S o lu tio n M ild S ti m ul at io n is a C le ar M ec ha ni sm o f A ct io n St ro ng s af et y pr of ile Ef fe ct iv e an d du ra bl e tr ea tm en t Cl os ed -lo op s ys te m St ro ng p at ie nt c om pl ia nc e H ig h pa ti en t sa ti sf ac tio n M in im al ly in va si ve o ut pa ti en t pr oc ed ur e ~1 1- ye ar b at te ry li fe (w it ho ut r ec ha rg in g) U ti liz es p at ie nt ’s n at ur al p hy si ol og y Sh or t re co ve ry ti m es p os t su rg er y Pa ti en t co nt ro lle d th er ap y In sp ir e Th er ap y O ff er s Si gn if ic an t B en ef it s Lo ng -t er m o ut co m es d em on st ra te th at In sp ir e th er ap y ad dr es se s th e sh or tf al ls o f c ur re nt tr ea tm en ts 1 4


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L O b je c tiv e M e a su re s Sh o w t h e I m p a c t o f In sp ir e Th e ra p y o n O SA In sp ir e sy st em tu rn ed o n A ir fl ow B re at hi ng O xy ge n Sa tu ra ti on N o O SA e ve nt s O SA e ve nt s Po ly so m no gr am B ef or e an d A ft er A ct iv at io n of In sp ir e Sy st em A ft er a ct iv at in g th e In sp ire sy st em , t he p at ie nt ex hi bi te d a m or e re gu la r br ea th in g pa tt er n, h ig he r an d m or e co ns is te nt b lo od ox yg en le ve ls , a nd fe w er o r no t ra ns ie nt a ro us al s. 1 5


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L C lin ic a l E v id e n c e 1 6


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Si g n ifi c a n t B o d y o f C lin ic a l E v id e n c e E v a lu a ti n g I n sp ir e in m o re t h a n 2 ,5 0 0 P a tie n ts , in 1 5 0 + p a p e rs 1. D ue to t he in cl us io n of c er ta in p at ie nt s in m ul ti pl e st ud ie s, s om e st ud ie s ar e no t sh ow n in t he t ab le b ec au se t he y do n ot a dd an y in cr em en ta l p at ie nt s to th e ov er al l t ot al . 2. In cl ud es T ho m as Je ff er so n U ni ve rs it y H os pi ta l ( TJ U H ) & U ni ve rs ity o f P it ts bu rg h M ed ic al C en te r (U PM C) ; U ni ve rs ity H os pi ta ls – Cl ev el an d; N on -A ca de m ic H os pi ta l i n Sa n D ie go ; a nd U ni ve rs ity of P en ns yl va ni a. Cl in ic al S tu di es Pa ti en ts Ev al ua te d Company Sponsored St im ul at io n Th er ap y fo r A pn ea R ed uc ti on (S TA R) 12 6 G er m an P os t- M ar ke t S tu dy 60 A D H ER E Pa ti en t R eg is tr y 1, 01 7 Pe di at ri c / D ow n Sy nd ro m e 26 Independent In sp ir e vs . t ra di ti on al s le ep s ur ge ry (C le ve la nd C lin ic , T ho m as Je ff er so n, U Pe nn ) 24 8 In de pe nd en t S tu di es in S in gl e Ce nt er s2 15 0 In de pe nd en t S tu di es o f S pe ci fic P op ul at io ns 41 8 G er m an a nd F re nc h Ex pe ri en ce (M un ic h, L ub ec k, B or de au x) 14 3 To ta l P at ie nt s Ev al ua te d A bo ve 2, 18 8 1 7


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L ST A R T ri a l M e t B o th P ri m a ry E n d p o in ts & S h o w e d S ta tis tic a lly Si g n ifi c a n t R e d u c tio n s in A H I & O D I Si gn if ic an t R ed uc ti on in S ev er it y of O SA A pn ea -H yp op n ea In de x (M ed ia n) 29 .3 9. 0 9. 7 6. 0 6. 2 Ba se lin e N =1 26 12 M on th N =1 24 18 M on th N =1 23 3 Ye ar N =9 8 5 Ye ar N =7 1 re su lt s in m ed ia n Events per Hour M ea ni ng fu l L ev el s of C om pl ia nc e Po st -I m pl an ta ti on O xy ge n D es at ur at io n In de x (O D I) (M ed ia n) 25 .4 7. 4 8. 6 4. 8 4. 6 Ba se lin e N =1 26 12 M on th N =1 24 18 M on th N =1 23 3 Ye ar N =9 8 5 Ye ar N =7 1 re su lt s in m ed ia n Events per Hour W it hd ra w al o f I ns pi re T he ra py R es ul te d in R ev er sa l o f T he ra pe ut ic B en ef it , F ur th er D em on st ra ti ng In sp ir e’ s Ef fe ct iv en es s 31 .3 7. 2 8. 9 30 .1 7. 6 25 .8 Ba se lin e 1 Ye ar Ra nd om iz ed , T he ra py - w ith dr aw al T ri al Th er ap y- m ai nt en an ce G ro up (N =2 3) Th er ap y- w it hd ra w al G ro up (N =2 3) Score (Events/hr) 26 .7 6. 3 8. 0 26 .8 6. 0 23 .0 Ba se lin e 1 Ye ar Ra nd om iz ed , T he ra py - w ith dr aw al T ri al Th er ap y- m ai nt en an ce G ro up (N =2 3) Th er ap y- w it hd ra w al G ro up (N =2 3) Score (Events/hr) A pn ea -H yp op ne a In de x (M ea n) O xy ge n D es at ur at io n In de x (M ea n) 1 8


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L 30 % 5% 4% 3% 1% Ba se lin e N =1 08 12 M o. N =1 03 18 M o. N =1 03 3 Yr . N =1 00 5 Yr . N =8 0 17 % 86 % 87 % 81 % 90 % Ba se lin e N =1 08 12 M o. N =1 03 18 M o. N =1 03 3 Yr . N =1 00 5 Yr . N =8 0 A d d iti o n a l S TA R F in d in g s Sh o w e d M e a n in g fu l Im p ro v e m e n t in Q u a lit y o f Li fe M e tr ic s Fu nc tio na l O ut co m es o f S le ep Q ue st io nn ai re (M ed ia n) 14 .6 18 .2 18 .4 18 .8 18 .7 Ba se lin e N =1 26 12 M o. N =1 24 18 M o. N =1 23 3 Yr . N =9 8 5 Yr . N =9 2 11 .0 6. 0 6. 0 6. 0 6. 0 Ba se lin e N =1 26 12 M o. N =1 24 18 M o. N =1 23 3 Yr . N =9 8 5 Yr . N =9 2 Ep w or th S le ep in es s Sc al e (M ed ia n) N or m al iz ed d ay ti m e sl ee pi ne ss = 1 0. 0 N or m al iz ed d ay ti m e fu nc ti on in g = 17 .9 N o or S of t Sn or in g (M ed ia n) B ed P ar tn er L ea ve s R oo m (M ed ia n) 1 9


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Su m m a ry o f In sp ir e C lin ic a l S tu d ie s ST A R Tr ia l1 G er m an P os t- M ar ke t St ud y1 A D H ER E Pa ti en t Re gi st ry 1 TJ U H a nd U PM C Ev al ua ti on 2 # of In sp ir e Pa ti en ts 12 4 97 56 1, 01 7 97 Ti m e Fo llo w in g Im pl an ta ti on 12 M on th s 5 Ye ar s 12 M on th s 12 M on th s 3 M on th s A H I – B as el in e 29 .3 29 .3 28 .6 32 .8 35 .6 A H I – Th er ap y 9. 0 6. 2 9. 5 9. 5 6. 3 ES S – B as el in e 11 11 13 11 11 ES S – Th er ap y 6 6 7 6 6 FO SQ – B as el in e 14 .6 14 .6 13 .7 * * FO SQ – Th er ap y 18 .2 18 .7 18 .6 * * Th er ap y Co m pl ia nc e 86 % d ai ly ; 93 % 5+ d ay s w ee kl y 80 % d ai ly A ve ra ge 3 9 ho ur s pe r pe r w ee k A ve ra ge 5 .6 h ou rs p er ni gh t A ve ra ge > 45 h ou rs p er w ee k 1. Re pr es en ts m ed ia n re su lt s. 2. Re pr es en ts m ea n re su lt s. * N ot m ea su re d 2 0


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L W e I n te n d t o C o n ti n u e t o B u ild t h e D e p th o f O u r C lin ic a l D a ta w ith O u r A D H ER E P a ti e n t R e g is tr y Re gi st ry R es ul ts f ro m 1 ,0 17 P at ie nt s Re gi st ry s tu dy d es ig ne d to b e re tr os pe ct iv e an d pr os pe ct iv e 54 c en te rs a re in vo lv ed in r eg is tr y to d at e Re gi st ry e nr ol le d >2 ,7 00 p at ie nt s si nc e O ct ob er 2 01 6 Fi ve p ee r- re vi ew ed m an us cr ip ts Pa ti en ts w ou ld Ch oo se In sp ir e A ga in A pn ea H yp op ne a In de x (M ed ia n) P< 0. 00 01 32 .8 9. 5 Ba se lin e N =9 84 12 M on th s N =3 82 71 % R ed uc ti on 45 % R ed uc ti on P< 0. 00 01 Re su lt s fr om t he A D H ER E re gi st ry s ho w In sp ir e th er ap y is a n ef fe ct iv e tr ea tm en t f or O SA in a r ea l- w or ld s et ti ng . A D H ER E Pa ti en t Re gi st ry : O ur p os t- im pl an ta ti on s tu dy w it h th e go al o f c ol le ct in g da ta o n a gr ou p in e xc es s of 5 ,0 00 p at ie nt s O ve ra ll Pa ti en t S at is fa ct io n W ou ld R ec om m en d to Fr ie nd s / Fa m ily A dh er en ce M on ito ri ng : A ve ra ge h om e de vi ce us e: 5 .6 h ou rs / n ig ht Ep w or th S le ep in es s Sc al e (M ed ia n) 11 6 Ba se lin e N =8 81 12 M on th s N =4 39 N or m al iz ed d ay ti m e sl ee pi ne ss = 1 0. 0 N ot e: E nr ol lm en ts a s of A pr il 20 21 . R es ul ts a re fr om T ha le r, L ar yn go sc op e 20 19 In sp ir e is B et te r Ex pe ri en ce th an C PA P 95 % 96 % 93 % 94 % 2 1


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L R e im b u rs e m e n t 2 2


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L A M A G ra n ts A p p ro v a l f o r N e w , C a te g o ry I P ro c e d u re C o d e s • H yp og lo ss al N er ve S ti m w ill n o lo ng er s ha re P ro ce du re C od es w it h Va gu s N er ve S ti m fo r Ep ile ps y • N o m or e ‘N ew T ec hn ol og y’ C at II I c od es fo r In sp ir e (T -C od es ) e ff ec ti ve J an ua ry 1 , 2 02 2 • H ig h po te nt ia l t ha t Ph ys ic ia n pa ym en t fo r In sp ir e’ s pr oc ed ur e w ill in cr ea se w it h ne w c od es • ‘R U C ’ s ur ve y w ill b e pe rf or m ed t o ev al ua te p hy si ci an ‘w or k’ a nd e xp en se s fo r ou r co de s • M ed ic ar e m ak es th e ca ll on h ow m an y ‘R V U s’ w ill b e as si gn ed : RV U (R el at iv e Va lu e U ni ts ) p ro po sa l f ro m M ed ic ar e pu bl is he s in m id -y ea r 20 21 • H os pi ta l p ay m en t fo r In sp ir e w ill n ot c ha ng e: N ew c od e m ap s to s am e Fa ci lit y pa ym en t bu ck et (A PC ) a s ol d co de s fo r bo th h os pi ta l a nd a m bu la to ry s ur gi ca l c en te rs (A SC ) • • Th e A A O -H N S ph ys ic ia n so ci et y ap pl ie d fo r a c om pr eh en si ve , d ed ic at ed n ew C PT C od e se t fo r th e hy po gl os sa l n er ve s ti m ul at io n im pl an t. T he se n ew co de s w ill h av e pa ym en t ra te s m ea su re d on ly fo r In sp ir e an d no t b le nd ed , b ec om in g ef fe ct iv e Ja nu ar y 1, 2 02 2 2 3


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L C o v e re d L iv e s Su m m a ry La rg e In su ra nc e Pl an s • U ni te d H ea lt hc ar e: 4 1M • A et na : 22 M • H um an a: 1 7M • Ci gn a: 1 6M • A nt he m : 40 M – co nt in ue to o bt ai n in di vi du al p ri or a ut h ap pr ov al s Po si ti ve B CB S Pl an s: 8 2M T ot al C ov er ed L iv es • W el lm ar k • H or iz on • N or th C ar ol in a • Pr em er a • Re ge nc e • Ka ns as • M is si ss ip pi • Lo ui si an a • Ka ns as C it y • In de pe nd en ce • M in ne so ta • Fl or id a • So ut h Ca ro lin a • Id ah o • H ea lt hN ow N Y • Fe de ra l E m pl oy ee P la n • A la ba m a • H ig hm ar k • M as sa ch us et ts • Ex ce llu s • Ca lif or ni a • M ic hi ga n • N eb ra sk a • Te nn es se e • H CS C (IL , T X, e tc .) • Ca re Fi rs t (D C) • Ca pi ta l B lu e • N or th D ak ot a • A rk an sa s • A ri zo na • Rh od e Is la nd Co ve re d Li ve s Su m m ar y To ta l P la ns G ai ne d in 2 02 0: 13 To ta l L iv es G ai ne d in 2 02 0: 48 m ill io n To ta l P os it iv e Pl an s at 1 2/ 31 /2 0: 6 3 To ta l U .S . C ov er ed L iv es a t 12 /3 1/ 20 : 22 0 m ill io n Sm al l P la ns – Po si ti ve C ov er ag e • Tr iC ar e • Em bl em H ea lt h • M ed ic a • M ed ic al M ut ua l • H A P of M I • A sc en si on • Q ua rt z H ea lt h • Ca pi ta l D is tr ic t Ph ys ic ia ns H ea lt h Pl an (N Y) • Ke ys to ne F ir st V IP Ch oi ce • A V M ed • Cl ev el an d Cl in ic • Pr ef er re d O ne • O hi o St at e U ni ve rs it y • W EA T ru st (W I) • Pr io ri ty H ea lt h (M I) • H ea lt h N ew E ng la nd • Se le ct H ea lt h (U ta h) • H ea lt hP ar tn er s (M N ) • G ei si ng er • Se cu ri ty H ea lt h Pl an • U PM C H ea lt h Pl an • Fa llo n H ea lt h of M as sa ch us et ts • Ce nt en e Co rp . • G EH A (G ov ’t Em pl oy ee s H ea lt h A ss oc .) • Pr ov id en ce H ea lt h Pl an • A llW ay s H ea lt h Pa rt ne rs • H ar va rd P ilg ri m • Tu ft s H ea lt h Pl an 2 4


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L M e d ic a re L o c a l C o v e ra g e D e te rm in a tio n ( LC D ) C o m p le te d a n d I n -P la c e - A ll c o v e ra g e c ri te ri a c o n si st e n t in a ll 5 0 s ta te s M A C Fi na l L CD Pu bl ic at io n D at e N or id ia n M ar ch 1 5, 2 02 0 N ov ita s M ar ch 1 5, 2 02 0 Fi rs t Co as t (F lo ri da ) M ar ch 1 5, 2 02 0 N at io na l G ov er nm en t Se rv ic es (N G S) A pr il 1, 2 02 0 Pa lm et to Ju ne 2 1, 2 02 0 CG S A pr il 1, 2 02 0 W is co ns in P hy si ci an s Se rv ic e (W PS ) Ju ne 1 4, 2 02 0 • BM I c ri te ri on = B el ow 3 5 • A H I c ri te ri on = 1 5 to 6 5 ev en ts p er h ou r • O th er c ri te ri a m ir ro rs F D A In di ca ti on s • Re pr es en ts 4 0 m ill io n co ve re d liv es • M ed ic ar e A dv an ta ge is a n ad di ti on al 2 0 m ill io n co ve re d liv es 2 5


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L P ro d u c t D e v e lo p m e n t a n d D ig ita l H e a lth 2 6


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L In sp ir e D ig it a l H e a lt h D e fin iti o n Co nn ec te d to ol s fo r Sl ee p D oc s, S ur ge on s, a nd P at ie nt s th at im pr ov e ou tc om es a nd r ed uc e w or k. • Co lla bo ra ti ve p at ie nt s cr ee ni ng • Se am le ss , p er so na liz ed c ar e • Ef fi ci en t th er ap y m an ag em en t 2 7


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Fo u n d a tio n a l C u st o m e r N e e d s O p p o rt u n it ie s to C re a te B ra n d P re fe re n c e 2 8 EN T Su rg eo n • St ro ng , P re di ct ab le Pa ti en t O ut co m es • Sp ee d an d Ea se o f Im pl an t Pr oc ed ur e • St ro ng , P re di ct ab le Pa ti en t O ut co m es • Sp ee d an d Ea se o f Pa ti en t M an ag em en t • O ut co m es – Fe el B et te r / Re du ce R is k • Co m fo rt • Co nv en ie nt / E as y to u se Sl ee p M D Sl ee p A pn ea P at ie nt s


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Th e re a re 6 ,0 0 0 B o a rd C e rt ifi e d S le e p M D s in t h e U S O v e r 9 0 % a re a w a re o f In sp ire Le ss t h a n 4 0 % a re c u rr e n tl y re fe rr in g f o r In sp ire Tr ai ni ng A ge Pr ac ti ce M an ag em en t & M in ds et 63 % In te rn al M ed ic in e / Pu lm on ar y 25 % P sy ch ol og y / N eu ro lo gy 4% O to la ry ng ol og y 8% O th er 39 % u nd er 50 yr s ol d 30 % 50 -6 0 31 % >6 0 27 % A ca de m ic 33 % P ri va te Pr ac ti ce 27 % E m pl oy ed (c om m un it y sy st em ) 14 % O th er (m ili ta ry , e tc .) • G ro w th o ri en te d • In te rn al D M E vs . Ex te rn al D M E • H yp er fo cu se d on A H I v s. B al an ce d pe rs pe ct iv e • Q oL • Lo ng te rm r is k (A H I) • Pa ti en t Sa ti sf ac ti on 2 9


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L W ha t th ey t hi nk a bo ut C PA P W ha t th ey t hi nk a bo ut In sp ir e Pa ti en t Tr ea te d O SA Pe rc ei ve d to b e: • In va si ve • Co st ly • Co m pl ex Sl ee p M D s N ee d Fa m ili ar ity /C on fid en ce in th e Th er ap y Pa th w ay In su ra nc e Pr oc ed ur e Pr og ra m m in g Et c. 3 0


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L C P A P H is to ry : A p ro v e n m o d e l CP A P In ve nt ed G am e ch an gi ng n ew t he ra py In cr ea se d Co m fo rt Fi rs t n as al p ill ow Ea se o f U se In te gr at ed h um id ifi er A ut o A dj us ti ng Fi rs t A ut o PA P Sm ar t, c on ne ct ed C PA P A ny ti m e ad he re nc e & e ff ic ac y Re m ot e ad ju st m en t of s et ti ng s 2 0 0 7 2 0 1 4 1 9 9 5 1 9 9 4 1 9 8 0 In sp ir e H is to ry : A s im ila r p a th FD A A pp ro va l G am e ch an gi ng t he ra py 40 % S iz e Re du ct io n In cr ea se d co m fo rt N ew P at ie nt R em ot e In cr ea se d ea se o f u se In sp ir e Cl ou d Tr ac k ad he re nc e & e ff ic ac y 2 0 1 8 2 0 2 1 + 2 0 1 6 2 0 1 7 2 0 1 4 Sm ar t, c on ne ct ed In sp ir e A ny ti m e ad he re nc e & e ff ic ac y Re m ot e ad ju st m en t of s et ti ng s 3 1


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L 2 0 2 1 I n sp ir e S y st e m B lu e to o th ® U S B : fl a sh d ri ve H os pi ta l P C or W eb B ro w se r In d u ct iv e T e le m e tr y B lu e to o th ® In sp ir e Cl ou d In te rn e t M ob ile A pp Sl ee p D ia gn os ti c Cl ou d Sl ee p D ia gn os ti c D ev ic es 3 2 B lu e to o th ® a n d t h e B lu e to o th lo g o a re r e g is te re d t ra d e m a rk s o f B lu e to o th S IG , In c.


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L 20 20 Q 2 Q 3 Q 4 20 21 Q 2 Q 3 D ig ita l P ip e lin e 2 0 2 0 /2 0 2 1 20 20 /2 02 1 • Pa ti en t ed uc at io n tr ac ki ng • Co lla bo ra tiv e pa ti en t sc re en in g • V ir tu al p at ie nt c he ck -in 20 21 • D ig ita l m on ito ri ng o f u sa ge • Br ow se r- ba se in te rf ac e • Po ss ib le in te gr at io n of A H I m on it or A pp • Pa ti en t ed uc at io n • Fi nd a d oc to r • Cl in ic al E SS s ur ve y Cl ou d • Cl in ic ia n co lla bo ra ti on • U sa ge m on it or in g 3 3


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L M ar ke t D ev el op m en t D ir ec t- to -P at ie nt C ha nn el s / Se lf -R ef er re d In sp ir e Pr og ra m Co re T ea m Sl ee p Pr ac ti ce R ef er a nd M an ag e Sl ee p Pr ac ti ce R ef er ra ls D en ta l P ra ct ic e R ef er ra ls Ca rd ia c Pr ac ti ce / EP 1 R ef er ra ls D ir ec t- to -P at ie nt O ut re ac h M ac hi ne In sp ir e ha s bu ilt a re fe rr al n et w or k w it h ph ys ic ia ns a cr os s th e tr ea tm en t co nt in uu m D iff er en ti at ed m ar ke tin g en gi ne c ap ab le o f g en er at in g de m an d th ro ug h pa ti en t ch an ne ls __ __ __ __ __ __ __ __ __ __ 1. El ec tr op hy si ol og is ts (E P) W e h a v e a T a rg e te d A p p ro a c h t o M a rk e t D e v e lo p m e n t a n d P a tie n t O u tr e a c h 89 K D oc to r Se ar ch es (+ 9% Y oY ) 27 K D oc to r Co nt ac ts (+ 10 2% Y oY ) 1. 7M W eb V is ito rs (+ 7% Y oY )Q 1 20 21 W eb si te R es ul ts Ph ys ic ia n to Ph ys ic ia n Pa ti en t W or d of M ou th Co m pa ny S po ns or ed Pu bl ic R el at io ns Lo ca l R ad io Lo ca l T V 3 4


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L D TC P ro g ra m : St ra te g ic P ill a rs # 3 : C o n v e rt t o A p p o in tm e n t # 1 : D ri v e E ff ic ie n t A w a re n e s s # 2 : E d u c a te & S e g m e n t IS .c o m # 4 : C o n v e rt A p p o in tm e n t to I m p la n t P a id M e d ia • B re a k th ro u g h C o n te n t • P la y b o o k T e s ti n g C u s to m iz e d j o u rn e y s “G e t S ta rt e d ” A d v is o r C a re P ro g ra m (A C P ) M a rk e tin g A u to m a ti o n In s p ir e A p p , T a b le t, P a ti e n t T ra c k in g 3 5


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L A d v is o r C a re P ro g ra m ( A C P ) C o n n e c tin g Q u a lif ie d P a tie n ts D ir e c tly t o o u r C e n te rs 3 6 P a ti e n t c a ll s n u m b e r o n M D L is ti n g C a ll c o n n e c te d t o In s p ir e A d v is o r In s p ir e A d v is o r c a ll s c li n ic ; C o n n e c ts p a ti e n t w it h L IV E s c h e d u le r T u rn in g P a ti e n t In te re s t in to A c ti o n a b le S te p s T o w a rd a n In s p ir e I m p la n t


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L H ol is ti c A pp ro ac h to E ng ag em en t A cr os s Ke y St ak eh ol de rs in t he O SA T re at m en t Pa ra di gm U .S . S al es O rg an iz at io n 11 7 Te rr ito ri es in U .S . a nd 9 in E ur op e M an ag ed b y 4 A re a V ic e- Pr es id en ts a nd 20 R eg io na l S al es M an ag er s Su pp or te d by T he ra py A w ar en es s M an ag er s an d Fi el d Cl in ic al R ep s Fi el d Tr ai ni ng S ta ff Ta rg et fo r ea ch r ep to m an ag e 5 – 7 ac ti ve ce nt er s pe r te rr it or y Co nt in ue to b ui ld c ap ac it y to t re at p at ie nt s by a dd in g ce nt er s, h ir in g Te rr it or y M an ag er s, a nd a dd in g tr ai ni ng an d su pp or t st ru ct ur e, in cl ud in g Re gi on al M an ag er s an d st af f t o co ve r im pl an t ca se s an d ac ti va ti on s O u r Sa le s St ra te g y E n g a g e s A ll K e y S ta k e h o ld e rs A c ro ss th e O SA T re a tm e n t P a ra d ig m Pa ti en ts EN T Ph ys ic ia ns Sl ee p Ce nt er s 3 7


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Te rr it or y M an ag er S tr at eg y K e y s To D ri v in g a S tr o n g T e rr ito ry H ow T M s Sp en d th ei r Ti m e Fi nd T he Ri gh t Ce nt er s At te nd D IS E, Ca se s & Fo llo w u p D ri ve Pa ti en t F lo w & P ra ct ic e Re ad in es s N ew C en te rs a nd T er ri to ry F ra m in g Le ad in g w it h 4 A re a V ic e Pr es id en ts A re a Bu si ne ss M an ag er s fo cu s so le ly o n ne w c en te rs Bu ild in g Re gi on al M an ag er T ea m , 2 0 in Q 1 20 21 A dd in g Fi el d Cl in ic al R ep s (F CR s) t o su pp or t im pl an ts Co nt in ue a dd in g Te rr it or ie s En de d Q 1 20 21 w it h 11 7 U .S . T er ri to ri es (1 0 ad de d in Q 1 20 21 ) Sa le s Tr ai ni ng In sp ir e U ni ve rs it y co nd uc te d qu ar te rl y fo r ne w e m pl oy ee s Fr ee u p se lli ng t im e fo r te nu re d re ps t o fo cu s on d ri vi ng p at ie nt fl ow In ve st in F CR s to c ov er c as es a nd a ct iv at io ns F in d T h e R ig h t C e n te rs A tt e n d D IS E , C a s e s & F o llo w u p M a n a g e P ri o r A u th o ri za ti o n , C o d in g & P a ym e n t D ri v e P a ti e n t F lo w & P ra ct ic e R e a d in e ss FC Rs t o Su pp or t 3 8


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L KE EP IN G C O N TR O L W H IL E G RO W IN G F A ST Fo cu s on t he ra pi d sc al in g of c om m er ci al iz at io n w hi le e ns ur in g pr op er t ra in in g to m ai nt ai n co nt ro l o f h ig h- qu al it y th er ap y ou tc om es Th e G re a t B a la n c in g A c t 3 9


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L Fi n a n c ia ls 4 0


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L $3 .0 $3 .6 $4 .7 $5 .2 $5 .3 $6 .0 $7 .3 $1 0. 0 $1 0. 0 $1 0. 9 $1 3. 1 $1 6. 6 $1 6. 3 $1 8. 0 $2 0. 9 $2 6. 9 $2 1. 3 $1 2. 2 $3 5. 8 $4 6. 0 $4 0. 4 1Q 16 2Q 16 3Q 16 4Q 16 1Q 17 2Q 17 3Q 17 4Q 17 1Q 18 2Q 18 3Q 18 4Q 18 1Q 19 2Q 19 3Q 19 4Q 19 1Q 20 2Q 20 3Q 20 4Q 20 1Q 21 __ __ __ __ __ __ __ __ __ __ Q ua rt er ly a m ou nt s ar e un au di te d Q u a rt e rl y R e v e n u e ( $ in M ill io n s) 4 1 % Yo Y Re ve nu e G ro w th 79 % 69 % 56 % 91 % 90 % 81 % 80 % 66 % 62 % 65 % 60 % 62 % 31 % -3 2% 72 % 71 % 89 %


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L $2 1. 3 $4 0. 4 Q 1 20 20 Q 1 20 21 Yo Y Re ve nu e ($ in m ill io ns ) Yo Y In cr ea se : 8 9% Yo Y G ro ss M ar gi n Yo Y In cr ea se : 6 0b ps Q 1 2 0 2 1 P e rf o rm a n c e 84 .6 % 85 .2 % Q 1 20 20 Q 1 20 21 Te rr it or ie s EQ 1 20 21 : 1 17 EQ 1 20 20 : 8 2 90 % 10 %Q 1 20 20 R ev en ue M ix U S O U S 94 % 6%Q 1 20 21 R ev en ue M ix U S O U S 4 2


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L $1 6. 4 $2 8. 6 $5 0. 6 $8 2. 1 $1 15 .4 G ui da nc e $1 92 -1 96 20 16 20 17 20 18 20 19 20 20 20 21 20 16 – 20 20 C A G R : 6 2. 9% A n n u a l R e v e n u e a n d G ro ss M a rg in ($ in m ill io n s) A nn ua l G ro ss M ar gi n 76 .2 % 78 .9 % 80 .1 % 83 .4 % 84 .7 % G ui da nc e 84 - 85 % U pd at ed 2 02 1 G ui da nc e: • FY 20 21 r ev en ue r an ge o f $ 19 2M - $1 96 M , r ep re se nt in g 66 % - 70 % g ro w th fr om F Y2 02 0 • FY 20 21 g ro ss m ar gi n be tw ee n 84 % - 85 % 4 3


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L O u r G ro w th S tr a te g ie s En su re s tr on g an d co ns is te nt p at ie nt o ut co m es g lo ba lly t hr ou gh p la nn ed a nd co nt ro lle d ex pa ns io n an d ro bu st p hy si ci an t ra in in g Pr om ot e aw ar en es s am on g pa ti en ts , E N T ph ys ic ia ns , s le ep c en te rs , a nd r ef er ri ng ph ys ic ia ns Ex pa nd U .S . s al es a nd m ar ke ti ng o rg an iz at io n to d ri ve a do pt io n of o ur In sp ir e th er ap y Le ve ra ge fi na l M ed ic ar e LC D s an d 22 0 m ill io n co ve re d liv es w hi le c on ti nu in g w it h pr io r au th or iz at io n m od el In ve st in r es ea rc h an d de ve lo pm en t t o dr iv e in no va ti on a nd e xp an d in di ca ti on s Fu rt he r pe ne tr at e ex is ti ng a nd e xp an d in to n ew in te rn at io na l m ar ke ts 4 4


 
© I n s p ir e M e d ic a l S y s te m s , In c . A ll R ig h ts R e s e rv e d IN S P IR E C O N F ID E N T IA L La rg e an d gr ow in g pr ev al en ce o f O SA Si gn if ic an t ec on om ic c os t of u nt re at ed O SA U rg en t cl in ic al n ee d fo r an ef fe ct iv e al te rn at iv e to CP A P ~$ 10 bn a nn ua l m ar ke t op po rt un it y in t he U .S . Co m pe lli ng M ar ke t O pp or tu ni ty O u r In n o v a tiv e I n sp ir e S o lu tio n h a s a Si g n ifi c a n t Fi rs t M o v e r A d v a n ta g e FD A P M A a pp ro va l s in ce 2 01 4 M or e th an 1 4, 00 0 pa ti en ts tr ea te d at o ve r 54 0 m ed ic al ce nt er s ac ro ss t he U .S . a nd E ur op e Si gn if ic an t pa yo r ex pe ri en ce 22 0 m ill io n co ve re d liv es in t he U .S . Le ve ra ge h ig hl y ef fe ct iv e pr io r au th or iz at io n m od el Ev id en ce o f s af et y an d 5- ye ar lo ng -t er m s us ta in ed e ff ic ac y Co ns is te nt r es ul ts a cr os s fo ur s po ns or ed a nd 1 9 in de pe nd en t cl in ic al s tu di es e va lu at in g ~2 ,5 00 p at ie nt s O ng oi ng e nr ol lm en t o f 5 ,0 00 p at ie nt A D H ER E re gi st ry (> 2, 70 0 pa ti en ts e nr ol le d th ru A pr il 20 21 ) D if fe re nt ia te d pr od uc ts b ui lt o n ye ar s of d ev el op m en t Cl os ed lo op s ys te m t ha t l ev er ag es o ur p re ss ur e se ns in g le ad an d pr op ri et ar y al go ri th m Cu rr en t d ev ic e re pr es en ts th e 4t h ge ne ra ti on o f o ur In sp ir e sy st em , w hi ch h as a n ~1 1- ye ar b at te ry li fe a nd a llo w s fo r M RI of h ea d an d ex tr em it ie s In sp ir e Th er ap y is S tr on gl y Po si ti on ed 4 5