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Vericel Corp. (VCEL)

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Last Post: 11/21/2017 7:12:30 PM - Followers: 154 - Board type: Free - Posts Today: 0

Vericel Corporation. (VCEL) 

 

 

http://www.vericel.com/

 

 

http://epicel.com/healthcare-professionals/what-is-epicel/epicel-is-fda-approved/
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm543860.htm

vericel-map

COMPANY PRESENTATION, CLICK ON above picture AND HIT THE LEFT/RIGHT ARROWS FOR SLIDE SHOW





CLICK ON PICTURE ABOVE for GENZYME MACI Patient Information Sheet



Acquisition of Sanofi’s CTRM Business
 
On May 30, 2014, we completed the acquisition of the Cell Therapy and Regenerative Medicine (CTRM) business of Sanofi, a French  société anonyme  (Sanofi), certain assets, including all of the outstanding equity interests of Genzyme Biosurgery ApS (now known as Vericel Denmark ApS), a wholly-owned subsidiary of Sanofi, and over 250 patents and patent applications of Sanofi and certain of its subsidiaries, and assumed certain liabilities for purposes of acquiring the portion of the CTRM business, which researches, develops, manufactures, markets and sells Carticel, MACI and Epicel.
 
We believe that our acquired CTRM business has been a pioneer in the development and commercialization of autologous cell therapies. The CTRM portfolio includes three autologous cell therapy products: Carticel (autologous cultured chondrocytes), a first-generation product for autologous chondrocyte implantation (ACI) currently marketed in the U.S., Epicel (cultured epidermal autografts), a permanent skin replacement for full thickness burns in adults and pediatrics with greater than or equal to 30% of TBSA, also currently marketed in the U.S, and MACI (matrix-applied characterized autologous cultured chondrocytes), a third-generation ACI product approved in Europe and for which a Biologics License Application (BLA) is under review by the FDA. Our product candidate portfolio also includes ixmyelocel-T, a patient-specific multicellular therapy currently in development for the treatment of advanced heart failure due to ischemic DCM.
http://secfilings.nasdaq.com/filingFrameset.asp?FilingID=10025872&RcvdDate=6/2/2014&CoName=VERICEL%20CORP&FormType=8-K&View=html




 















 



 


                                                                      Click on Yellow to REVIEW FDA WEBSITE APPROVING MACI

                                                                                                                                                http://www.maci.com/

Interesting FDA Transcript discussions on MACI going forward for widened age bracket and other body joints. 
                                                                                                                                      CLICK ON THE ABOVE LINK




                   CLICK ON THE ABOVE PICTURE TO GO INTO VCEL'S CAREER'S SITE



IXMYELOCEL-T

 Our preapproval stage portfolio includes ixmyelocel-T, a unique patient-specific multicellular therapy derived from an adult patient’s own bone marrow which utilizes our proprietary, highly automated and scalable manufacturing system. Our proprietary cell manufacturing process significantly expands the mesenchymal stromal cells (MSCs) and M2-like anti-inflammatory macrophages in the patient’s bone marrow mononuclear cells while retaining many of the hematopoietic cells. These cell types are known to regulate the immune response and play a key role in tissue repair and regeneration by resolving pathologic inflammation, promoting angiogenesis, and remodeling ischemic tissue. The novelty and advantage of using ixmyelocel-T is the expansion of a unique combination of cell populations, including MSCs and M2-like macrophages, which secrete a distinct combination of angiogenic and regenerative factors, and possess the ability to remain anti-inflammatory in the face of inflammatory challenge.

 
Our lead clinical development program for ixmyelocel-T is focused on severe, chronic ischemic cardiovascular diseases. We have completed the double-blind portion of the Phase 2b ixCELL-DCM study, which is a randomized, double-blind, placebo-controlled clinical trial for patients with advanced heart failure due to ischemic DCM. Ixmyelocel-T has been granted a U.S. Orphan Drug designation by the FDA for the treatment of DCM. We also have conducted clinical studies for the treatment of critical limb ischemia and the treatment of craniofacial defects.
 
The Phase 2b ixCELL-DCM clinical study treated 114 patients at 28 sites in the U.S. and Canada. We completed enrolling and treating patients in February, 2015. Patients were followed for 12 months for the primary efficacy endpoint of major adverse cardiovascular events, defined as all-cause deaths, all-cause hospitalizations, and unplanned outpatient or emergency department visits for IV treatment of acute worsening heart failure. Secondary endpoints include clinical, functional, structural, symptomatic, quality of life, and biomarker measures at 3, 6 and 9 months. On March 10, 2016, we announced the trial had met its primary endpoint of reduction in clinical cardiac events, and that the full data results from the ixCELL-DCM trial were presented at the Late-Breaking Clinical Trial Sessions of the American College of Cardiology 65 th Annual Scientific Session & Expo on April 4, 2016. On April 4, 2016, we announced that incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable to or lower than patients in the placebo group.  With respect to the secondary endpoints of the trial, the components of the primary endpoint were also analyzed using the Win ratio in a hierarchical manner to incorporate both the incidence and timing of the endpoint components.  The Win ratio result of 1.56 showed that more often ixmyelocel-T was the "winner" in that the time to death, left ventricular assist device placement, heart transplantation or time to cardiovascular hospitalization was shorter for placebo-treated patients, but this difference did not reach statistical significance.  The time to first
 
16

Table of Contents
 
event was longer in the ixmyelocel-T group compared to placebo, but was not statistically significant.  There were no significant structural changes in left ventricle cavity size or left ventricular ejection fraction as measured by echocardiogram in either the ixmyelocel-T or placebo groups.  Both treatment groups had an improvement in the New York Heart Association class and six-minute walk test, with no statistical difference between the groups after 12 months using the last observation carried forward. Because the trial met the primary endpoint, patients who had been assigned to the placebo group or randomized to ixmyelocel-T in the double blind portion of the trial but did not receive ixmyelocel-T will be offered the option to receive treatment.
 
Future development plans for ixmyelocel-T are dependent upon input from our regulatory interactions and the availability of financing. We are focused on determining the most appropriate manner to fund future development of ixmyelocel-T, balancing risk to the overall business, dilution to current shareholders, and retaining a significant portion of the upside potential of the program for the company and our shareholders.


Ixmyelocel-T for Craniofacial Tissue Engineering
http://stemcellstm.alphamedpress.org/content/3/12/1495.full
https://www.findmecure.com/ClinicalTrials/Show/NCT00755911


                           Click on above picture to enter another talk/idea zone






 
 

About Vericel Corporation:

Vericel develops, manufactures, and markets autologous cell-based therapies for patients with serious diseases and conditions. The company markets two cell therapy products in the United States. Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant intended to treat cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  Vericel is also developing 2 additional cell products. MACI is a third generation autologous chondrocyte implant intended to treat cartilage defects in the knee. Ixmyelocel-T is a multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy (DCM).

Developing autologous (patient’s own) cell therapies—with integrity
Vericel uses rigorous scientific methods to develop novel therapies for the treatment of patients with autologous (patient’s own) cells.  In addition, personal integrity, team work, collaboration, and innovative technology are the foundations of our work.  We seek to practice transparency in our clinical trials and research, and in our relationships with each other, our patients, and the investors who support us.


                                                                                               CLICK ON ABOVE PICTURE TO SEE NASDAQ.COM SHORT INTEREST
 
 

Management:
http://vcel.com/about-vericel/#Management
 
Clinical Research: 

http://vcel.com/research-and-development/#cardioMyopathy
 
Recent News: 

http://investors.aastrom.com/releases.cfm
http://www.4-traders.com/VERICEL-CORP-18635051/
http://finance.yahoo.com/q/h?s=VCEL+Headlines

Events and Presentations:
http://investors.aastrom.com/events.cfm

Analyst Coverage:
http://investors.aastrom.com/analysts.cfm
http://www.streetinsider.com/Analyst+Comments/Vericel+(VCEL)+MACI+Approval+Puts+Profitability+Within+Reach+-+Needham+%26+Company/12343070.html
https://www.thecerbatgem.com/2016/12/19/needham-company-llc-analysts-give-vericel-corp-vcel-a-9-00-price-target.html
https://sportsperspectives.com/2016/12/22/piper-jaffray-cos-begins-coverage-on-vericel-corp-vcel.html
http://www.4-traders.com/VERICEL-CORP-18635051/consensus/
http://seekingalpha.com/symbol/VCEL
http://seekingalpha.com/article/1228921-is-takeda-interested-in-aastrom-bio

Filings:
http://www.sec.gov/cgi-bin/browse-edgar?company=&match=&CIK=0000887359&filenum=&State=&Country=&SIC=&owner=exclude&Find=Find+Companies&action=getcompany

Share Structure:
See Filings
http://data.cnbc.com/quotes/vcel
http://finance.yahoo.com/quote/VCEL/?p=VCEL

YOU TUBE VIDEOS, and the fourth video down, you will NOW appreciate the meaning of less invasive on the new FDA approved MACI procedure and why MACI is anticipated to be 20x the procedures of Carticel
https://www.youtube.com/watch?v=y3S1kFfT0Qk
https://www.youtube.com/watch?v=dP5TgnS3Vr4
https://www.youtube.com/watch?v=gCbpFoY6ZUM
https://www.youtube.com/watch?v=3MFL10O-avE  MUST WATCH
http://wnyt.com/health/maci-new-procedure-to-repair-damaged-knee-cartilage/4369510/
https://www.dvidshub.net/news/223965/wbamc-employs-state-art-knee-implant-first-time-dod

Conference Calls
September 27, 2016 Ladenburg Thalmann
October 24, 2016 Meeting on the Mesa
November 30th, 2016 The 28th Annual Piper Jaffray Healthcare Conference
December 14th, 2016 Vericel Corporation Investor Call

Investor Relations:
http://investors.aastrom.com/index.cfm


 

 


 

 Yummy Land, click on Above Picture

 

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PostSubject
#4674  Sticky Note The ixCELL-DCM Trial: Transendocardial Injection of ixmyelocel-T in lasers 04/05/16 05:33:01 PM
#7121   That is good Cat Whisperer. When $VCEL's CEO lasers 11/21/17 07:12:30 PM
#7120   Lasers - I never thought it to be Cat Whisperer 11/21/17 07:06:40 PM
#7119   Working with lawyers on Patents is a completely lasers 11/21/17 06:57:51 PM
#7118   I'm pretty sure there will be no news Eblair84 11/21/17 06:41:38 PM
#7117   I would say Eblair is saying "hope" is Cat Whisperer 11/21/17 06:35:25 PM
#7116   I find hope unfortunately That statement fights itself. hurley cruppers 11/21/17 06:29:19 PM
#7115   Cat Whisperer, when we do International licensing contracts lasers 11/21/17 06:28:30 PM
#7114   I know no one really put in the Cat Whisperer 11/21/17 06:02:22 PM
#7113   It is the formal approval by the Chinese lasers 11/21/17 05:54:07 PM
#7112   So, the "conclusion" that nick spoke of.. Is Eblair84 11/21/17 05:30:43 PM
#7111   Yes it is much more than licensing. ICT lasers 11/21/17 05:16:03 PM
#7110   Fair enough! I find hope unfortunately creeping into Eblair84 11/21/17 05:11:56 PM
#7109   For those of us in the Pharma Industry, lasers 11/21/17 05:09:17 PM
#7108   Right, that's the licensing deal.. Not a partnership.. Eblair84 11/21/17 04:15:46 PM
#7107   Augmenting this additional cash flow will be the lasers 11/21/17 04:14:42 PM
#7106   Which cc comments? Can you screen shot the Eblair84 11/21/17 04:07:48 PM
#7105   LOL, looks like the mm's will park us hurley cruppers 11/21/17 03:29:12 PM
#7104   Next Time leaving the computer, give us a pbor 11/21/17 03:23:51 PM
#7103   I leave my computer for 3 hours and hurley cruppers 11/21/17 03:20:41 PM
#7102   PR or Filing coming today/tomorrow? pbor 11/21/17 03:08:49 PM
#7101   It is all the signs IMO of Institutions lasers 11/21/17 03:02:17 PM
#7100   It seemed like today there were no shares hurley cruppers 11/21/17 02:56:29 PM
#7099   $VCEL HOD = $4.40 lasers 11/21/17 02:35:26 PM
#7098   https://www.prnewswire.com/news-releases/complete-remission-rate-of-90-china-bas CoastalTrader83 11/21/17 12:36:30 PM
#7097   You too, you put in countless hours of hurley cruppers 11/21/17 11:14:19 AM
#7096   Can you find out what biotechs are in lasers 11/21/17 11:11:21 AM
#7095   VCEL ... MACD crossover in the chart, RSI hurley cruppers 11/21/17 11:07:10 AM
#7094   Thanks to laser, Hurley, whisper, and common for CoastalTrader83 11/21/17 10:47:00 AM
#7093   If this chart is correct, the average PE commoncentsinvestor 11/21/17 10:44:19 AM
#7092   Yes most definitely the Pharma industry accepts a lasers 11/21/17 10:27:44 AM
#7091   It looked like different industries have different tolerance Cat Whisperer 11/21/17 10:23:15 AM
#7090   Indeed yes. With expected growth the MKT will lasers 11/21/17 09:59:58 AM
#7089   Right . That’s my only concern is that CoastalTrader83 11/21/17 09:08:52 AM
#7088   60/39.5/0.5 With 1, 2, and 3 in your Cat Whisperer 11/21/17 08:52:29 AM
#7087   If VCEL was to hurley cruppers 11/21/17 08:35:41 AM
#7086   If we look at NFLX at $1.96 per lasers 11/21/17 07:06:36 AM
#7085   BREAKING DOWN 'Multiple Compression' Remember, the multiple is based CoastalTrader83 11/21/17 01:18:44 AM
#7084   Thanks Donald. I appreciate the detailed response . CoastalTrader83 11/21/17 12:22:22 AM
#7083   P = Price per share commoncentsinvestor 11/21/17 12:05:57 AM
#7082   P = Price per share commoncentsinvestor 11/21/17 12:05:48 AM
#7081   Just checking on my technical cheat sheet. $4.07 CoastalTrader83 11/20/17 11:57:34 PM
#7080   Donald , I love your stuff. I catch CoastalTrader83 11/20/17 10:38:59 PM
#7079   How easy will it be to get to commoncentsinvestor 11/20/17 09:07:52 PM
#7078   Most definitely IMO also. $VCEL double digits coming. lasers 11/20/17 08:09:10 PM
#7077   I have the same gut feeling going on, hurley cruppers 11/20/17 07:24:41 PM
#7076   I woke up. Since earnings report added another commoncentsinvestor 11/20/17 05:39:54 PM
#7075   $VCEL B/A $3.90/$3.95 Wake up retail investors Institutionals lasers 11/20/17 02:16:05 PM
#7074   Gremlin3a This is what we have been lasers 11/20/17 12:13:59 PM
#7073   IMO ICT is that partner in $VCEL MACI lasers 11/20/17 11:58:12 AM
#7072   lasers, agreed, sets us up strategical strong going hurley cruppers 11/20/17 11:55:29 AM
PostSubject