`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`FORM 8-K
`CURRENT REPORT
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`Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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`Date of Report (Date of earliest event reported): January 31, 2018
`RESHAPE LIFESCIENCES INC.
`(Exact name of registrant as specified in its charter)
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`Delaware
`(State or other jurisdiction of
`incorporation)
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`1-33818
`(Commission File Number)
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`48-1293684
`(I.R.S. Employer Identification
`Number)
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`1001 Calle Amanecer
`San Clemente, CA
`(Address of principal executive offices)
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`92673
`(Zip Code)
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`949-429-6680
`(Registrant’s telephone number, including area code)
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`2800 Patton Road
`St. Paul, Minnesota 55113
`(Former name or former address, if changed since last report)
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`Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
`provisions:
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`o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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`o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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`o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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`o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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`Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
`chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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`Emerging growth company o
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`If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
`new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
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`Fulfillium Exhibit 2005, Page 1
`ReShape v. Fulfillium
`Case IPR2018-00958
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`Item 7.01
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` Regulation FD Disclosure.
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`Representatives of ReShape Lifesciences Inc. (the “Company”) intend to make presentations at investor conferences and in other forums, and these
`presentations may include the information contained in Exhibit 99.1 attached to this Current Report on Form 8-K. A copy of the presentation slides
`containing such information that may be disclosed by the Company is attached as Exhibit 99.1 to this report, and the information set forth therein is
`incorporated herein by reference and constitutes a part of this report. The Company intends to disclose the information contained in Exhibit 99.1, in whole or
`in part, and with updates and possibly modifications, in connection with presentations to investors, analysts and others during 2018 or until an updated
`presentation is made available by the Company.
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`The Company is furnishing the information contained in Exhibit 99.1 pursuant to Regulation FD and Item 7.01 of Form 8-K promulgated by the Securities
`and Exchange Commission (“SEC”). This information shall not be deemed to be “filed” with the SEC for the purposes of Section 18 of the Securities
`Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by
`reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
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`The information contained in Exhibit 99.1 is summary information that is intended to be considered in the context of the Company’s SEC filings and other
`public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to
`publicly update or revise the information contained in Exhibit 99.1, although it may do so from time to time as its management believes is warranted. Any
`such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. By
`filing this report and furnishing this information, the Company makes no admission as to the materiality of any information contained in this report,
`including Exhibit 99.1.
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`Item 8.01
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` Other Events.
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`The Company is providing certain information as an update to and to supersede the information provide in the Company’s previous periodic filings with the
`SEC in order to reflect recent business developments. An updated description of the Company’s business and risk factors are attached hereto as Exhibit 99.2
`and 99.3, respectively, and are incorporated herein by reference. The information in this Item 8.01 (including Exhibits 99.2 and 99.3) should be read in
`conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, the Company’s Quarterly Reports on Form 10-Q for the
`quarters ended March 31, 2017, June 30, 2017 and September 30, 2017 and the Company’s Current Reports on Form 8-K filed with the SEC since January 1,
`2017.
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`Item 9.01
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` Financial Statements and Exhibits.
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`(d) Exhibits.
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`Exhibit No.
`99.1
`99.2
`99.3
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`Description
`Investor Presentation Slides
`Updated Business Summary
`Updated Risk Factors
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`2
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`Method of Filing
`Furnished herewith
`Filed herewith
`Filed herewith
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`Fulfillium Exhibit 2005, Page 2
`ReShape v. Fulfillium
`Case IPR2018-00958
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`Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
`behalf by the undersigned hereunto duly authorized.
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`SIGNATURES
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`Dated: January 31, 2018
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`RESHAPE LIFESCIENCES INC.
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`By:
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` /s/ Scott P. Youngstrom
`Scott P. Youngstrom
`Chief Financial Officer
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`3
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`Fulfillium Exhibit 2005, Page 3
`ReShape v. Fulfillium
`Case IPR2018-00958
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`N A S D A Q : E T R M C o m p an y P resen tatio n 2 0 1 7 N A S D A Q : R S L S C o m p an y P resen tatio n Jan u ary 2 0 1 8 C o n fid en tial in fo rm atio n . D o n o t d istrib u te.
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`Exhibit 99.1
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`Fulfillium Exhibit 2005, Page 4
`ReShape v. Fulfillium
`Case IPR2018-00958
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`S afe H arb o r S tatem en t an d R isk F acto rs 2 T h is p resen tatio n co n tain s fo rw ard -lo o k in g statem en ts w ith in th e m ean in g o f th e P riv ate S ecu rities L itig atio n R efo rm A ct o f 1 9 9 5 . T h ese fo rw ard -lo o k in g statem en ts g en erally can b e id en tified b y th e u se o f w o rd s su ch as ex p ect,” “p lan ,” “an ticip ate,” “co u ld ,” “m ay ,” “in ten d ,” “w ill,” “co n tin u e,” “fu tu re,” o th er w o rd s o f sim ilar m ean in g an d th e u se o f fu tu re d ates. F o rw ard -lo o k in g statem en ts in th is p resen tatio n in clu d e statem en ts ab o u t th e co m p an y ’s to tal ad d ressab le m ark et an d an n u al p ro ced u res; co m p etitiv e co m p an ies, tech n o lo g ies an d p ro ced u res; th e co m p an y ’s ab ility to im p lem en t its b u sin ess m o d el an d strateg ic p lan , in clu d in g its co m m ercializatio n an d reim b u rsem en t strateg ies; ex p an sio n o f th e co m p an y ’s sales team ; an d im p lem en tatio n an d co m p letio n o f clin ical trials. T h ese fo rw ard -lo o k in g statem en ts are b ased o n th e cu rren t ex p ectatio n s o f o u r m an ag em en t an d in v o lv e k n o w n an d u n k n o w n risk s an d u n certain ties th at m ay cau se o u r actu al resu lts, p erfo rm an ce o r ach iev em en ts to b e m aterially d ifferen t fro m an y fu tu re resu lts, p erfo rm an ce o r ach iev em en ts ex p ressed o r im p lied b y th e fo rw ard -lo o k in g statem en ts. S u ch risk s an d u n certain ties in clu d e, am o n g o th ers: o u r lim ited h isto ry o f o p eratio n s; o u r lo sses sin ce in cep tio n an d fo r th e fo reseeab le fu tu re; o u r lim ited co m m ercial sales ex p erien ce w ith o u r v B lo c® S y stem fo r th e treatm en t o f o b esity in th e U n ited S tates o r in an y fo reig n m ark et o th er th an A u stralia an d th e E u ro p ean C o m m u n ity ; th e co m p etitiv e in d u stry in w h ich w e o p erate; o u r ab ility to m ain tain co m p lian ce w ith th e N asd aq co n tin u ed listin g req u irem en ts; o u r ab ility to co m m ercialize o u r v B lo c® S y stem ; o u r d ep en d en ce o n th ird p arties to in itiate an d p erfo rm o u r clin ical trials; th e n eed to o b tain reg u lato ry ap p ro v al fo r an y m o d ificatio n s to o u r v B lo c® S y stem ; p h y sician ad o p tio n o f o u r v B lo c® S y stem an d v B lo c® N eu ro m etab o lic T h erap y ; o u r ab ility to o b tain th ird p arty co d in g , co v erag e o r p ay m en t lev els; o n g o in g reg u lato ry co m p lian ce; o u r d ep en d en ce o n th ird p arty m an u factu rers an d su p p liers; th e su ccessfu l d ev elo p m en t o f o u r sales an d m ark etin g cap ab ilities; o u r ab ility to raise ad d itio n al cap ital w h en n eed ed ; in tern atio n al co m m ercializatio n an d o p eratio n ; o u r ab ility to attract an d retain m an ag em en t an d o th er p erso n n el an d to m an ag e o u r g ro w th effectiv ely ; p o ten tial p ro d u ct liab ility claim s; th e co st an d m an ag em en t tim e o f o p eratin g a p u b lic co m p an y ; p o ten tial h ealth care frau d an d ab u se claim s; h ealth care leg islativ e refo rm ; o u r ab ility to
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`o b tain an d m ain tain in tellectu al p ro p erty p ro tectio n fo r o u r tech n o lo g y an d p ro d u cts; o u r acq u isitio n o f B ario S u rg , In c. m ay in v o lv e u n ex p ected co sts o r liab ilities; th e ab ility to reco g n ize b en efits o f th e acq u isitio n ; an d risk s th at th e acq u isitio n d isru p ts cu rren t p lan s an d o p eratio n s. T h ese an d ad d itio n al risk s an d u n certain ties are d escrib ed m o re fu lly in th e C o m p an y 's filin g s w ith th e S ecu rities an d E x ch an g e C o m m issio n , p articu larly th o se facto rs id en tified as "risk facto rs" in th e an n u al rep o rt o n F o rm 1 0 -K filed March 8 , 2 0 1 7 an d q u arterly rep o rt o n F o rm 1 0 -Q filed May 1 5 , 2 0 1 7 . We are p ro v id in g th is in fo rm atio n as o f th e d ate o f th is p resen tatio n an d d o n o t u n d ertak e an y o b lig atio n to u p d ate an y fo rw ard -lo o k in g statem en ts co n tain ed in th is d o cu m en t as a resu lt o f n ew in fo rm atio n , fu tu re ev en ts o r o th erw ise.
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`Fulfillium Exhibit 2005, Page 5
`ReShape v. Fulfillium
`Case IPR2018-00958
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`A d d ressin g $ 1 .5 b illio n /y ear su rg ical d ev ice m ark et¹ S afe, m in im ally in v asiv e, an ato m y p reserv in g so lu tio n s w ith d u rab le o u tco m es P ro v id in g a co m p reh en siv e to o lb o x o f so lu tio n s fo r o b esity co n tin u u m o f care 1 . G lo b al B ariatric S u rg ery D ev ices Mark et A n aly sis an d T ren d s, In d u stry F o recast to 2 0 2 5 , A ccu ray R esearch 3 A m ed ical tech n o lo g y co m p an y serv in g th e g ro w in g o b esity ep id em ic
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`Fulfillium Exhibit 2005, Page 6
`ReShape v. Fulfillium
`Case IPR2018-00958
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`O b esity : E p id em ic, C o stly an d U n d erserv ed 4 1 T h e S tate o f O b esity : B etter P o licies fo r a H ealth ier A m erica, 2 0 1 6 . 2 McK in sey G lo b al In stitu te, O v erco m in g O b esity : A n In itial E co n o m ic A n aly sis, p g . 1 , N o v em b er 2 0 1 4 . 3 A ccu ray R esearch , B ariatric S u rg ery D ev ices Mark et R ep o rt. 2 0 1 7 . 4 A n terb u rn D E , Maciejew sk i ML , T sev at J. Im p act o f Mo rb id O b esity o n Med ical E x p en d itu res in A d u lts. 2 0 0 5 . 5 A m erican S o ciety fo r Metab o lic an d B ariatric S u rg ery . 2 0 1 4 . 1 in 3 ad u lts in th e U .S . are o b ese1 6 0 0 m illio n p eo p le are o v erw eig h t an d o b ese w o rld w id e2 9 % C A G R ex p ected th ro u g h 2 0 2 5 fo r th e g lo b al b ariatric su rg ery d ev ice m ark et3 U .S . h ealth care co sts o f m o re th an $ 1 4 9 b illio n /y ear fo r o b esity 1 In d irect co sts estim ated as h ig h as $ 6 .4 b illio n 1 H ealth care co sts fo r sev erely o r m o rb id ly o b ese ad u lts are 8 1 % h ig h er th an fo r h ealth y w eig h t ad u lts4 O n ly 1 % o f o b ese p atien ts w h o q u alify h av e su rg ery 5 H u g e o p p o rtu n ity fo r effectiv e, p atien t-frien d ly su rg ical so lu tio n s B ariatric S u rg ery P en etratio n 1 % G astric b y p ass an d sleev e su rg ery , th e cu rren t stan d ard o f care, are in v asiv e, an ato m y ch an g in g , an d lifesty le alterin g .
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`Fulfillium Exhibit 2005, Page 7
`ReShape v. Fulfillium
`Case IPR2018-00958
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`T o d ay 's O b esity C o n tin u u m (U .S . P o p u latio n s* ) 1 4 0 Millio n O v erw eig h t o r O b ese 6 5 Millio n O v erw eig h t 6 0 Millio n O b ese an d S ev erely O b ese 1 5 Millio n Mo rb id ly O b ese Weig h t Man ag em en t S u rg ical Weig h t L o ss O n ly 1 % o f p atien ts w h o q u alify receiv e o b esity su rg ery to d ay A esth etic Weig h t L o ss * S o u rce: N IH 5
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`Fulfillium Exhibit 2005, Page 8
`ReShape v. Fulfillium
`Case IPR2018-00958
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`2 0 1 5 – 2 0 2 5 G ro w th D riv ers Mo re in terv en tio n s w ith n ew p ro ced u res A n ato m y -frien d ly O u t-p atien t Im p ro v ed co v erag e b y p ay ers T h erap ies p ro v en to ad d ress co m o rb id ities D ata su p p o rtin g h ealth eco n o m ic sav in g s C o st efficien cies v s. d ru g s 6 G ro w th o f U .S . O b esity an d B ariatric P ro ced u res (2 0 1 1 – 2 0 2 5 E ) h ttp s://w w w .cd c.g o v /n ch s/d ata/d atab riefs/d b 2 8 8 _ tab le.p d f h ttp s://asm b s.o rg /reso u rces/estim ate-o f-b ariatric-su rg ery -n u m b ers G lo b al B ariatric S u rg ery D ev ices Mark et A n aly sis an d T ren d s, In d u stry F o recast to 2 0 2 5 , A ccu ray R esearch C an acco rd G en u ity E q u ity R esearch 2 0 1 4 0 2 0 0 4 0 0 6 0 0 8 0 0 1 ,0 0 0 1 5 % 2 0 % 2 5 % 3 0 % 3 5 % 4 0 % 4 5 % 2 0 1 1 - 2 0 1 2 2 0 1 3 - 2 0 1 4 2 0 1 5 - 2 0 1 6 2 0 1 6 - 2 0 1 7 2 0 2 0 E 2 0 2 5 E O b ese U .S . A d u lts 3 4 .9 0 % 3 7 .7 0 % 3 9 .6 0 % 4 1 .8 8 % 4 4 .1 5 % O b ese U .S . Y o u th 1 6 .9 0 % 1 7 .2 0 % 1 8 .5 0 % 2 0 .2 1 % 2 2 .4 9 % S u rg ical P ro ced u res 1 5 8 ,0 0 0 1 7 9 ,0 0 0 1 9 6 ,0 0 0 2 1 6 ,0 0 0 8 0 0 ,0 0 0 B ariatric P ro ced u res (T h o u san d s) % o f P o p u latio n w ith O b esity
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`Fulfillium Exhibit 2005, Page 9
`ReShape v. Fulfillium
`Case IPR2018-00958
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`7 R eS h ap e: Min im ally In v asiv e O fferin g s fo r th e F u ll C o n tin u u m o f C are * R eS h ap e V est is fo r in v estig atio n al u se o n ly an d n o t ap p ro v ed fo r u se. V ag al n erv e stim u latio n b lo ck s h u n g er sig n als T ak es u p ro o m in th e sto m ach so th ere is less sp ace fo r fo o d * R estrictio n creates feelin g s o f fu lln ess
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`Fulfillium Exhibit 2005, Page 10
`ReShape v. Fulfillium
`Case IPR2018-00958
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`R eS h ap e P ro d u cts Meet P atien t R eq u irem en ts 8 MIN IMA L L Y IN V A S IV E L IF E S T Y L E E N H A N C IN G D U R A B L E WE IG H T L O S S R eS h ap e p ro d u cts h elp p atien ts lo se w eig h t an d liv e a m o re co m fo rtab le life, w h ile also red u cin g co -m o rb id ities asso ciated w ith ex cess w eig h t R eS h ap e p ro d u cts d o n o t ch an g e an ato m y an d are rem o v ab le o r rev ersib le R eS h ap e o ffers su stain ab le so lu tio n s th at h elp p atien ts ach iev e lo n g term su ccess C u rren t su rg ical o p tio n s d o n o t satisfy p atien t n eed s; R eS h ap e p ro d u cts w ill d riv e m ark et p en etratio n
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`Fulfillium Exhibit 2005, Page 11
`ReShape v. Fulfillium
`Case IPR2018-00958
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`9 2 0 1 5 2 0 2 5 E ~ 1 9 8 ,0 0 0 P ro ced u res $ 1 .5 B illio n ~ 8 0 0 ,0 0 0 P ro ced u res $ 3 .8 B illio n * G lo b al B ariatric S u rg ery D ev ices Mark et A n aly sis an d T ren d s, In d u stry F o recast to 2 0 2 5 , A ccu ray R esearch ; C an acco rd G en u ity E q u ity R esearch 2 0 1 4 U .S . O b esity P ro ced u re Mix (2 0 1 5 – 2 0 2 5 E )* 9 % C A G R G astric B y p ass 2 2 % B allo o n , v B lo c 1 % R ev isio n s 1 4 % L ap - B an d 6 % S leev e 5 3 % O th er 4 % A n ato m y A lterin g S u rg ery 2 5 % A n ato m y F rien d ly P ro ced u res 6 0 % R ev isio n s 1 5 %
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`Fulfillium Exhibit 2005, Page 12
`ReShape v. Fulfillium
`Case IPR2018-00958
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`R eS h ap e In trag astric D u al B allo o n T ech n o lo g y 1 0 3 0 – 4 0 > 4 ,0 0 0 P atien ts Im p lan ted 1 0 .5 % 2 0 0 + P h y sician s Im p lan tin g 6 0 % Main tain ed o r co n tin u ed to lo se w eig h t (1 y ear) A cq u ired in O cto b er 2 0 1 7 F D A ap p ro v ed E n d o sco p ic p ro ced u re th ro u g h th e m o u th N o t an ato m y alterin g S ix Mo n th B allo o n Im p lan t fills v o lu m e in sto m ach to m ak e p atien t feel fu ll P atien t B MI R an g e* T o tal Weig h t L o ss (6 m o n th s)* * * T h e R eS h ap e D u al B allo o n is ap p ro v ed fo r p atien ts w ith a B MI o f 3 0 -4 0 w ith o n e o r m o re h ealth -related co m o rb id ities. * * S h aw n G arb er, S p en cer H o lo v er, Jo h n A n g stad t, E ric S o m m er, N ik ilesh S ek h ar, Jeffrey C h iao ,” In trag astric B allo o n : 3 4 2 P atien ts T reated at a Mu lticen ter B ariatric P ractice” 3 0 -4 0 3 0 - 4 0
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`Fulfillium Exhibit 2005, Page 13
`ReShape v. Fulfillium
`Case IPR2018-00958
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`P A T IE N T R E S U L T S A T 4 8 MO N T H S P atien ts d em o n strated im p ro v em en ts in o u tco m es an d co m o rb id ities H b A 1 c (% ) red u ctio n o f 0 .2 p o in ts S y sto lic b lo o d p ressu re d ecreased 6 .6 m m H g D iasto lic b lo o d p ressu re d ecreased 4 .4 m m H g Im p ro v em en ts in co -m o rb id ities y ield sig n ifican t sav in g s to th e h ealth care sy stem R eS h ap e R esu lts* 1 1 Waist circu m feren ce red u ced b y 2 .2 " 3 0 - 4 0 * S h aw n G arb er, S p en cer H o lo v er, Jo h n A n g stad t, E ric S o m m er, N ik ilesh S ek h ar, Jeffrey C h iao ,” In trag astric B allo o n : 3 4 2 P atien ts T reated at a Mu lticen ter B ariatric P ractice” D ecrease in L D L o f 4 .6 u n its
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`Fulfillium Exhibit 2005, Page 14
`ReShape v. Fulfillium
`Case IPR2018-00958
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`v B lo c® B io electro n ic N eu ro b lo ck in g T ech n o lo g y 1 2 3 5 - 4 5 In term itten tly b lo ck s sig n als o f h u n g er o n th e v ag u s n erv e > 7 0 0 P atien ts Im p lan ted 4 .3 ” 1 6 C en ters Im p lan tin g 2 5 % Im p lan ted su b cu tan eo u sly R ev ersib le o r rem o v ab le N o t an ato m y alterin g F D A A p p ro v ed E WL at 1 Y ear* * P atien t B MI R an g e* * v B lo c T h erap y is ap p ro v ed fo r u se in p atien ts w ith a B MI o f 3 5 – 4 0 alo n g w ith o n e related co m o rb id co n d itio n an d fo r u se in p atien ts w ith a B MI o f 4 0 – 4 5 . * * S h ik o ra, S co tt, et al. “V ag al B lo ck in g Im p ro v es G ly cem ic C o n tro l an d E lev ated B lo o d P ressu re in O b ese S u b jects w ith T y p e 2 D iab etes Mellitu s.” Jo u rn al o f O b esity , (2 0 1 3 ) A rticle ID 2 4 5 6 8 3 . D O I: 1 0 .1 1 5 5 /2 0 1 3 /2 4 5 6 8 3 . Waist R ed u ctio n at 1 Y ear* * 3 5 - 4 5
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`Fulfillium Exhibit 2005, Page 15
`ReShape v. Fulfillium
`Case IPR2018-00958
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`5 0 % rem ittan ce o f m etab o lic sy n d ro m e S y sto lic b lo o d p ressu re red u ced b y 1 2 m m H g in p atien ts w ith elev ated B P R ed u ctio n in L D L “b ad ” ch o lestero l o f 6 .2 m g /d L H b A 1 c (% ) red u ctio n o f 1 .0 p o in t H ig h ly co m p etitiv e w ith lead in g d iab etes d ru g s 1 3 v B lo c C lin ical E v id en ce C L IN IC A L S T U D Y P A T IE N T S A T 1 Y E A R v B lo c T h erap y p atien ts ach iev ed m ean in g fu l an d su stain ab le w eig h t lo ss an d ex p erien ced a red u ctio n in co m o rb id ities an d im p ro v em en ts in o v erall card io v ascu lar h ealth C L IN IC A L S T U D Y P A T IE N T S A T 2 Y E A R S R ed u ctio n s in co -m o rb id ities y ield sig n ifican t sav in g s to th e h ealth care sy stem 5 0 % rem ittan ce o f p re-d iab etes 1 1 . S h ik o ra, S co tt, et al. “V ag al B lo ck in g Im p ro v es G ly cem ic C o n tro l an d E lev ated B lo o d P ressu re in O b ese S u b jects w ith T y p e 2 D iab etes Mellitu s.” Jo u rn al o f O b esity , (2 0 1 3 ) A rticle ID 2 4 5 6 8 3 . D O I: 1 0 .1 1 5 5 /2 0 1 3 /2 4 5 6 8 3 . 7 .9 % to tal b o d y w eig h t 3 5 - 4 5
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`Fulfillium Exhibit 2005, Page 16
`ReShape v. Fulfillium
`Case IPR2018-00958
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`1 4 1 1 . S h ik o ra, S co tt, et al. “V ag al B lo ck in g Im p ro v es G ly cem ic C o n tro l an d E lev ated B lo o d P ressu re in O b ese S u b jects w ith T y p e 2 D iab etes Mellitu s.” Jo u rn al o f O b esity , (2 0 1 3 ) A rticle ID 2 4 5 6 8 3 . D O I: 1 0 .1 1 5 5 /2 0 1 3 /2 4 5 6 8 3 . S tu d y D esig n S tatu s K aiser P erm an en te D iab etes S tu d y v B lo c N o w P atien t R eg istry v B lo c R eN E W P o st A p p ro v al S tu d y P rio r A u th o rizatio n s S u b m itted C o v ered V eteran s w ith O b esity ? ? B allo o n P o st A p p ro v al S tu d y R eal w o rld o u tco m es fo r reim b u rsem en t 1 2 5 p atien ts w / co m o rb id ity d ata 3 y ear, 6 0 p atien ts D em o n strate v B lo c ad v an tag e v s m ed s fo r d iab etes 5 y ears, 1 5 sites, 2 0 0 p atien ts S afety an d efficacy w eek s, 1 5 sites, 2 5 0 p atien ts S afety an d efficacy In itiated Ju n e 2 0 1 7 6 6 p atien ts en ro lled S tu d y p ro to co l co m p leted E n ro llm en t in itiatio n Q 1 2 0 1 8 4 S ites activ ated 1 E n ro lled w ith 4 sch ed u led 1 5 activ e sites 1 2 4 su b jects en ro lled S trateg y to C o llect O u tco m es D ata fo r R eim b u rsem en t
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`Fulfillium Exhibit 2005, Page 17
`ReShape v. Fulfillium
`Case IPR2018-00958
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`P ro v id e A C o m p ellin g , D ifferen tiated O fferin g E q u ip P ractices F o r S u ccess R each & C o n v ert Mo tiv ated & Q u alified C o n su m ers 1 5 T h e R eS h ap e sales team is co m p rised o f 1 3 d irect rep s, g ro w in g to 1 6 in 2 0 1 8 A ll team m em b ers rep all p ro d u cts T h ree d ed icated team s fo cu s o n V A , In tern atio n al an d U .S ./n o n -V A O n ly co m p an y to o ffer a co m p lete to o lb o x o f m in im ally in v asiv e, p atien t-frien d ly d ev ices fo r b ariatric su rg ery F ield -b ased m ark etin g p erso n n el p artn er w ith p ractices to d riv e R eS h ap e B allo o n an d R eS h ap e v B lo c p atien t acq u isitio n an d in teg ratio n A g reem en t w ith V A en ab les n atio n al R eS h ap e v B lo c co v erag e fo r v eteran s C areP lu s co v erag e o f R eS h ap e B allo o n sets p reced en t fo r co rp o rate co v erag e p o licies S ales S trateg y fo r v B lo c an d R eS h ap e
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`Fulfillium Exhibit 2005, Page 18
`ReShape v. Fulfillium
`Case IPR2018-00958
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`1 6 R eS h ap e V est Wrap s aro u n d sto m ach to restrict am o u n t o f fo o d eaten ; em u lates co n v en tio n al w eig h t lo ss su rg ery 8 5 .5 % 1 5 ” C E Mark S tu d y 1 H / 2 0 1 8 ID E P lan n ed 2 H / 2 0 1 8 P atien ts Im p lan ted E x cess Weig h t L o ss (1 Y ear)* A cq u ired May 2 0 1 7 N o t an ato m y alterin g In ten d ed fo r m o rb id ly o b ese n eed in g rap id w eig h t lo ss C u rren tly in v estig atio n al u se > 4 0 P atien t B MI R an g e * Ju an L ó p ez-C o rv alá MD , F ern an d o G u zm án -C o rd ero MD , C ley sa H erm o sillo -V ald ez MD , Jan in e R o sales-L an d g rav e MD , “G astric V est S y stem : In itial R esu lts o f a N o v el R estrictiv e B ariatric P ro ced u re” Waist R ed u ctio n * * > 4 0
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`Fulfillium Exhibit 2005, Page 19
`ReShape v. Fulfillium
`Case IPR2018-00958
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`1 7 G astric V est S y stem P ilo t S tu d y O u tco m es E fficacio u s P ilo t stu d y p atien ts ach iev ed g o ld stan d ard o f w eig h t lo ss at 1 2 m o n th s Min im ally In v asiv e V est is lap aro sco p ic an d a rem o v ab le, an ato m y frien d ly p ro ced u re T ran sfo rm ativ e T ech n o lo g y N o o th er d ev ice h as T B WL n ear th e stan d ard o f b ariatric su rg ery 3 0 .2 % 1 2 . S ch au er et al. N .E .J.M. 3 6 6 : 1 5 6 7 , 2 0 1 2 . * Ju an L ó p ez-C o rv alá MD , F ern an d o G u zm án -C o rd ero MD , C ley sa H erm o sillo -V ald ez MD , Jan in e R o sales-L an d g rav e MD , “G astric V est S y stem : In itial R esu lts o f a N o v el R estrictiv e B ariatric P ro ced u re” 2 7 .6 2 4 .9 0 5 1 0 1 5 2 0 2 5 3 0 3 5 Mo n th 1 Mo n th 3 Mo n th 6 Mo n th 9 Mo n th 1 2 P ercen t T o tal B o d y Weig h t L o ss (% T B WL ) G astric B y p ass S leev e G astrecto m y G astric V est S y stem ™
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`Fulfillium Exhibit 2005, Page 20
`ReShape v. Fulfillium
`Case IPR2018-00958
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`P IL O T S T U D Y P A T IE N T S A T 1 Y E A R P atien ts in th e G astric V est p ilo t stu d y d em o n strated sig n ifican t im p ro v em en ts in co m o rb id ities H b A 1 c (% ) red u ctio n o f 2 .1 p o in ts S y sto lic b lo o d p ressu re d ecreased 1 3 m m H g In crease in H D L “g o o d ch o lestero l” o f 2 9 m g /d L Im p ro v em en ts in co -m o rb id ities y ield sig n ifican t sav in g s to th e h ealth care sy stem 1 8 G astric V est C lin ical E v id en ce: R ed u ctio n in C o m o rb id ities Waist circu m feren ce red u ced b y 1 5 " > 4 0 * Ju an L ó p ez-C o rv alá MD , F ern an d o G u zm án -C o rd ero MD , C ley sa H erm o sillo -V ald ez MD , Jan in e R o sales-L an d g rav e MD , “G astric V est S y stem : In itial R esu lts o f a N o v el R estrictiv e B ariatric P ro ced u re”
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`Fulfillium Exhibit 2005, Page 21
`ReShape v. Fulfillium
`Case IPR2018-00958
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`C E Mark trial N o n , ran d o m ized trial en ro llin g 6 5 p atien ts 1 2 m o n th p rim ary en d p o in t (w eig h t lo ss an d safety ) 2 4 m o n th lo n g -term fo llo w -u p 1 9 G astric V est C lin ical an d R eg u lato ry P ath U S P iv o tal T rial (P ro p o sed ) N o n -ran d o m ized trial en ro llin g u p to 2 5 0 p atien ts 1 2 m o n th p rim ary en d p o in t (w eig h t lo ss an d safety ) 2 4 -3 6 m o n th lo n g -term fo llo w -u p B o th stu d ies w ill in clu d e m etrics req u ested b y p ay ers (e.g . safety , efficacy , h ealth eco n o m ics, co -m o rb id ity red u ctio n s) 1 H 2 H 1 H 2 H 1 H 2 H 1 H 2 H C E Mark T rial In itiatio n P MA T rial In itiatio n C E Mark A p p ro v al P MA A p p ro v al F Y 2 0 1 8 F Y 2 0 1 9 F Y 2 0 2 0 F Y 2 0 2 1
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`Fulfillium Exhibit 2005, Page 22
`ReShape v. Fulfillium
`Case IPR2018-00958
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`2 0 In tellectu al P ro p erty B io electro n ic Med icin e U tilizin g V ag u s N erv e B ro ad co v erag e fo r n eu ro reg u latio n o f v ag u s n erv e/ b io electro n ic sy stem s an d m eth o d s related to n eu ro b lo ck in g , n eu ro m o d u latio n , an d n eu ro stim u latio n tech n o lo g y C o v erag e o f v ag u s n erv e ap p licatio n s in clu d in g o b esity , b u lim ia, p an creatitis, h eart rate reg u latio n , g lu co se reg u latio n 4 5 g ran ted U .S . p aten ts, ad d itio n al p en d in g 4 5 g ran ted fo reig n p aten ts in A u stralia, E u ro p e, C h in a an d Jap an , ad d itio n al p en d in g G astric V est In tellectu al p ro p erty fo r g astric restrictio n d ev ice to treat o b esity 4 g ran ted U .S . p aten ts 4 g ran ted fo reig n p aten ts in C h in a, Israel, C an ad a an d A u stralia In traG astric B allo o n R o b u st co v erag e fo r m u lti-b allo o n g astric im p lan ts an d m eth o d s fo r its p lacem en t an d retriev al. C o v erag e related to m eth o d s o f m an u factu rin g an d ad d itio n al th erap y ap p licatio n s. 3 5 p aten ts g ran ted in th e U S , E u ro p e, C an ad a, an d Jap an . A d d itio n al p en d in g .
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`Fulfillium Exhibit 2005, Page 23
`ReShape v. Fulfillium
`Case IPR2018-00958
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`2 1 S trateg ic P artn ersh ip fo r N eu ro reg u lato rs an d th e V ag u s N erv e C o llab o ratio n A g reem en t (fo r p re-clin ical research ) F u n d ed co -d ev elo p m en t o f n ew m o d ified R eS h ap e L ifescien ces‘ p ro d u cts F u tu re o p p o rtu n ities (co n tin u ed IP + tech n o lo g y p latfo rm co -d ev elo p m en t) In tellectu al p ro p erty licen sin g R eS h ap e L ifescien ces w ill receiv e p ay m en ts fo r its d ev elo p m en t w o rk an d su p p ly u n d er th is ag reem en t
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`Fulfillium Exhibit 2005, Page 24
`ReShape v. Fulfillium
`Case IPR2018-00958
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`2 2 R eS h ap e L ifescien ces Milesto n es an d O b jectiv es R eim b u rsem en t G ro w P ip elin e D riv e R ev en u e an d C lin ical O u tco m es B allo o n / v B lo c co m m ercial co v erag e C o m m ercial d ata th ro u g h clin ical u se P u b lish real-w o rld o u tco m es an d co -m o rb id ity d ata C o m p lete C E Mark trial fo r G astric V est C o m p lete U S P MA trial fo r G astric V est C o n tin u e to ad v an ce n ex t g en eratio n tech n o lo g ies U n ified sales o rg an izatio n ad d ressin g en tire m ark et F o cu sed o n m ark et ex p an sio n C o -m o rb id ity an d clin ical su p p o rt 3 1 2
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`Fulfillium Exhibit 2005, Page 25
`ReShape v. Fulfillium
`Case IPR2018-00958
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`2 3 Man ag em en t T eam D an w . G lad n ey – C h ief E x ecu tiv e o fficer H ealth care ex ecu tiv e w ith o v er 2 5 y ears o f ex p erien ce lead in g a v ariety o f m ed ical d ev ice co m p an ies L an x , H eart L eaflet T ech n o lo g ies, A C IS T Med ical, C o m p ex T ech n o lo g ies; N o rw est E q u ity P artn ers S co tt P . Y o u n g stro m – C h ief fin an cial o fficer F in an cial ex ecu tiv e fo cu sed o n creatin g sh areh o ld er v alu e w ith 2 5 y ears o f strateg ic fin an cial an d o p eratio n al ex p erien ce in a v ariety o f m ed ical d ev ice co m p an ies G alil Med ical, A n u lex , E n p ath Med ical, C o m p ex T ech n o lo g ies R aj N ih alam i, MD – C H IE F T ech n o lo g y o fficer an d b u sin ess d ev lo p m en t Med ical d ev ice ex ecu tiv e an d p h y sician en trep ren eu r w ith 2 0 + y ears o f ex p erien ce in sm all an d larg e m ed tech co m p an ies F o u n d er an d C E O o f B ario S u rg ; O n cio m ed , Med tro n ic, E n d o lo g ix , A cu fo cu s, R o x Med ical, Md n o o k D E B O R A H S C H MA L Z – V IC E P R E S ID E N T , C L IN IC A L A N D R E G U L A T O R Y O v er 2 5 y ears o f ex ecu tiv e lead ersh ip ex p erien ce in m ed ical d ev ice reg u lato ry affairs, clin ical research , co m p lian ce an d reim b u rsem en t Med p ace, V en iti, E n tellu s Med ical, V ascu lar S o lu tio n s, E m p i B O B H A G G E R T Y – V IC E P R E S ID E N T , S A L E S P ro v en b ack g ro u n d in creatin g d istrib u tio n , lau n ch in g n ew tech n o lo g ies, an d d ev elo p in g lo n g -term relatio n sh ip s w ith cu sto m ers C eterix O rth o p aed ics, C o v id en /G I S o lu tio n s, B A R R X Med ical, G y ru s/ A C MI, B o sto n S cien tific A m y S co tt – v ice p resid en t, m ark etin g O v er 2 0 y ears o f m ark etin g an d co m m ercializatio n ex p erien ce w ith m ed ical tech n o lo g ies E d w ard s L ifescien ces, Wav eT ec V isio n S y stem s, D JO G lo b al S h aro n Wh alen – v ice p resid en t, R E IMB U R S E ME N T L ead er in m ed ical d ev ice an d m an ag ed care. E v id en ce d ev elo p m en t, h ealth tech n o lo g y rev iew s, n ew p ro d u ct reim b u rsem en t, an d ad v o cacy ex p ertise. A celity , E d w ard s L ifescien ces, Wo rld H eart, E n d o care, P acticC are.
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`Fulfillium Exhibit 2005, Page 26
`ReShape v. Fulfillium
`Case IPR2018-00958
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`R eS h ap e L ifescien ces In c. (N A S D A Q :R S L S ) 1 0 0 1 C alle A m an ecer S an C lem en te, C A 9 2 6 7 3 D an G lad n ey P resid en t, C h ief E x ecu tiv e O fficer & C h airm an o f th e B o ard 6 5 1 -6 3 4 -3 0 8 9 d w g lad n ey @resh ap elifesci.co m
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`Fulfillium Exhibit 2005, Page 27
`ReShape v. Fulfillium
`Case IPR2018-00958
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`APPEN