2021 CARMAT Ladenburg Thalmann Oct 20

This is my transcription of this conference call presented by investment banking firm Ladenburg Thalmann.  If you're a prospective patient, cardiothoracic surgeon, or potential investor in Carmat, this is a must watch.  Conference took place on October 20, 2021.

Destiny Hance=DH from Ladenburg Thalmann = LT cues up this video presentation.
DH is VP of Equity Research, Healthcare and Med Tech at LT.  She is
Dbuch@Ladenburg.com

Host is Jeffrey Cohen, Managing Director of Equity Research, Healthcare and Medical Tech,
at LT Co.  He is Jcohen@Ladenburg.com

Speakers are 
Stephane Piat CEO  of Carmat  (=SP)
Dr Piet Jansen is Chief Med Officer at Carmat

Dr. Carmel Milano is Prof of Surgery and Chief   =(CM)
Section  of Adult Cardiac Surgery and
Surgical Direc for the LVAD Program in
Div of Cardiothoracic Surgery at
DUKE Univ Med Center

Dr. Mark Slaughter is
Lead Cardiothoracic Surgeon at
Univ of Louisville/ Jewish Hospital and
Prof and Chair of Dept of CV and CT Surgery.

Stephane Piet =  SP begins at Minute two.

Presents vision of Company and Mission;

Key Dates of the company:  (SP continues)

2008  Creation of company
2013  1st implant
2020  CE Mark  bridge to transplant indication
2021  1st Euro sales and
initiation of EFS = early feasibility study in the US

Carmat has 200 highly skilled people;
SOTA (state of art)  manufac facility near Paris
capable of making 20 devices per month
and planning for a larger manufac site.

Company is listed on Euronext Growth (paris)  Ticker is  ALCAR.
Market cap is now >  Euro  420M .

Commerical rollout in Europe: in 2021
6 pts rx in 2 months in 4 hospitals  Italy and Germany

Early Feasibility Study = EFS;   
3 pts rx in 2 centers in US:  Louisville and Duke.  waiting to start  cohort B
(waiting to start cohort B after 60 days)

AESON is the trademark name of their TAH = total artificial heart;

Chief Med Officer  Piet Jansen:

treatments for advanced heart failure

6.2M  total cases of heart failure in US  of which 300k to 600k  advanced
(End state on inotropes
abt 100k could benefit from heart replacement rx
but only  5,500 ht transplants were done in combined  US and Europe in 2017.

end stage: rx can be treated with LVAD and then TAH.

Big market opportunity:

shows cardiac devices:  from  stents thru pacemakers, etc to valves,  LVADs, etc.

he shows  Syncardia  and Abbott  as the existing solution.

shows a chart:  progressively increasing  HF  starting with

inotrope dependent;  exertion intolerant;  limited exertion;  (NYHA class III
then to  class NYHA Class IV:  limited exertion; exertion intol;
thru resting sxs;
then  stable inotrope depend;  then to progressive decline then to
critical cardiogenic shock... with hours to survive.

the AESON has a portable bag with   4 batteries and a monitor; 
provides for  autonomy for > 4 hours at a blood flow of 6 liters per min.

3 unique features:  hemocompatibility:  bio membranes;
no sheer stress;  

pulsatile flow:  clinically you cannot see difference externally;
 it  mimics  normal heart; 

autoregulation:  based on pressure sensors;

if pressure increases in one of the chambers  then device must incr flow;

Bllod Flow Autoregulation...

min 13 of talk: compare CARMAT to  Syncarida  TAH  vs  BVAD (biventric assist device)
vs  LVAD +  pRVAD  vs  LVAD only
poor level of biocompat =>  high level of  anticoagulation;

from  TAH to physio heart replac therapy;

PIVOTAL Study... 15 pts  as of  Sept 15 2021  (goal is 20 pts)

EFICAS  in France:  samle size  52 pts;  enroll starting in Q4 2021.

to support French reimbursement

then  do  PMCF  post-market  clinical follow up

6 pts to date  goal is 95 pts;

*****
US  EFS   sample size  10
2 step  3 pts then  7 pts

cohort 1  (3 pts done already);
then do 7 more pts.

PIVOTAL study:  15 pts to date

avg age was 58 pts  (30 to 70 yrs)
1/3  had  ischemic ht dis other had dilated cardiomyopthay;

survival rate 73%
and  78%  sucess

NO stroke, no GI bledds no driveline infection   vs others;

AESON   asa  75 to 100 mg  and prophy  low molec wt heparin

vs  Coumadin , ASA in others.

shows  circadian cycle in pts;

100%  procedure  success;

total  :  29 patients have been done;

no tissue adhesion  (so easy to remove/ repalce;

he shows  pt on exercie machine;

35 yo  lifting weights:  3-4 weeks late;

treadmill  2 weeks after xplant;

v cool  videos of pts!!!  exercising;

potential pt population is v large  up to 90k in US alone;

with LVADs you still have a sick heart to take care of.

*************************

DUKE:  Dr Milano:

Prof Surgery; and head of adult cardiac surgery...

DUKE has implanted 1500 pts with durable LVAD.

durable LVADs,,,

also over 100 ht transplants...

pts live abt 5-6 years and some  have lived 13 years.

most are not eligible for ht transplant.

BUT unmet need;

common:  biventric failure;  persistent  V TACH;
end stage  CHF;

also high incid.  of RV failure  even after LV  has decompressed;

shows indications for TAH;

also   restricted cariomyopathy  (constrained; limited ability to expand)
and rhythm disturbance:  eg  VT;
and end-stage  congential heart conditions.

he has attempted LVAD support  but  its poor;

challenges to TAH]]shows Bill Devries and he aboth trained at DUKE.

shows him with Barney Clark.

Milano has used  difft potential TAHs

durability is crucial  (don't have  natl heart as backup;

stroke is an issue;

balancing  R and L heart are crucial...

and livable...  needed giant  pneumatic console.

cropped out of picture;

we HOPE that pericardial membrane =>  low  thrombus;

and want to avoid  overcirc of lungs;  and must be durable;

he says PETE  for Piet.

v difft than  rotary flow LVAD;
vsmooth  pumping  as distinct from rotary flow LVAD

our LVADs use : motor boat propeller  5k to 10k  revolutions per min
great sheer force =>  von Willebr   and platelet activation; incr bleeding risk;

this is much gentler on blood;  hopefully fewer complications;

impalnte don July 12 2021...

39 yo from SC  with hx of  MI and CHF

needed  Ventric assist and ECMO and then Impella; and
recurrent VT;

have tried  LVADs on cases like this in the past.

must FIT into pts;   overlay of devie on CT images;  must FIT!!!

need proper fit;

Carmat provided intesnive training for the cardiac nurses;
v impressed with corporate support.

shows intraoper  ECHO after   AESON is in situ.

with LVADs   do NOT get normal flow dynamics...

he needs 6 yo 7 L/min

with just an LVAD would NOT have gotten this flow rate;

we really have tru restoration of hemodynamics;

after 4 months on support;  discharge;
he is to b elisted with heart transplant.

wanted to do a heart transplant.
shows him in acar high 5ing  child.

*****************************

Mark Slaughter at  U of L

he did two pts;

he knew Milano in college!!  known him for decades;

he agreed with everything that Milano said...

his lifelong interest has been on  mechanical support for HF.

eg Abiocor  device was done  here (at U of L/ Jewish)

U of L/Jewish

58 you man and 57 yo woman  gots  AESON hts.

similar to heart transplant tempo on OR>

woman:  2 week stay in ICU and then in Stepdown.
could have left 4 days sooner;

woman:  prev  CABG and valve repair;
had  IHD;  small statue  155 cm but good anatomic fit;

we reduced time in OR by 90 minutes... 2nd one much quicker;

fit into her chest cavity;  well predicted;

uneventful  procedure;

great software program to predict the fit of the devie: shows table.

rx with ASA 81 mg and LMW heparin.

she comes up to 6 to 7 liters/min.
walking laps in hospital  after a few weeks.

pre-op Creat was 1.28;
post op up to 1.86 and now  28 days postop wa at 0.73 !!!

LDH  a measure of blood trauma:  post op her LDH was at 527  due to heeart lung bypass;

now dropped to 281;

so no blood trauma;

man:  on Aristra and ASA;

cummary:

female:  no szie issue;
despite redo sternotomy with prev valve srugey;
good meocompa.

with BiVADs  need to manually adjust them;

device is easier to manage than typical VADs.

they manage devie by themselves  despite limited educaiton.

will prob. fit in many pts including women;

******************************

one hour : start of QA;

Jeff Cohen is in the moderator;

Q:  comparison of  anticoag regimens with LVADS:
during same time we did 4 VAD implants:

not as routine:  need blood drawn daily:
have ongoing renal issues and pulmon congestion;

markedly improved pt satisfaction and easier management of anticoag.

many LVAD pts get  GI bleeding or nose bleed or delayed surgical bleeding;
have descturc of vonWillebarand monomers  due to pump.

Q:  Circadian regulation:

Q:    candidates for Aeson:  how abt pt on LVADs that develop bad RV function;

yes  prob. would be a candidate for Aeson.

Q:  could you see this as destination rx???

Slaughter:  A is YES!  (largest # of VADs are put in for destination rx... they have a contraindication to xplant)  assumning device itself  are DURABLE then why not
be used as destination device.

Milano:  cardiologists might be concerned with LVADs abt bleeding, stroke or  RV failure...
This could def be a destination rx.  

Slaughter:  operative mortality for LVAD is less than for CAD;  hesitancy is abt adverse events
that occur later;    if reduced strokes, GI bleeding and no RV failure, then will get
additional referrals.

Q:  hwo do you measure success of this product and suggestions for future:

we are focused on destination rx  (says Milano)  but must walk before we can run.

this wise and appropriate.  lots of learning to be done:  in OR and pre-op planning;
bridge to tranplant is great place to start;  

Three US patients were v v sick:  needed to get better before transplant.

Slaughter: our first (male) pt was in hospital every month for a year before this operation.

6 monthsor 12 months for these pts would be a huge win.

these pts are no option.

transplant is a winderful option  but requires huge hospital infrasturcture;
immune suppression;  best option; but efficeint TAH would be a huge reduciton in
resources requried to support.

company formed in 2008;  and now in 2021  starting 2nd clinical trial: testimony
to their persistence;    

Jeff Cohen is from Ladenburg Thalmann R&D Showcase; host.