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Vericel Corp. (VCEL)

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Last Post: 8/14/2017 1:59:47 PM - Followers: 150 - 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
#6308   Most likely $VCEL PPS is reacting to FIRST lasers 08/14/17 01:59:47 PM
#6307   Form CT ORDER Vericel Corp lasers 08/14/17 12:23:45 PM
#6306   SEC 13F filed 8-10-2017 showing 2B$ Tute FIRST hurley cruppers 08/14/17 12:10:13 PM
#6305   Is there something about First Washington CORP? lasers 08/14/17 09:27:52 AM
#6304   $VCEL mosr recent info on ICT from the lasers 08/14/17 08:34:31 AM
#6303   Wouldn't this be an 8-K material event? If hurley cruppers 08/13/17 09:16:10 PM
#6302   Vericel burned only $2.4mil in Q2. The company me33 08/13/17 08:19:37 PM
#6301   This is a different time and Vericel is commoncentsinvestor 08/13/17 03:55:50 PM
#6300   I would expect to see proof that the realfast95 08/13/17 02:31:59 PM
#6299   Actually realfast it is possible that the ICT commoncentsinvestor 08/13/17 01:34:31 PM
#6298   Recent news indicates China is cutting back on realfast95 08/13/17 12:39:59 PM
#6297   Global banking with China isn't difficult. I Zeke3960 08/13/17 11:52:17 AM
#6296   they missed the deadline. As of the Q2 realfast95 08/13/17 09:41:48 AM
#6295   Any trade war will be focused on the Zeke3960 08/13/17 08:31:57 AM
#6294   60 days from effective date of agreement. Zeke3960 08/13/17 08:29:10 AM
#6293   how do you know it's already in the bank? realfast95 08/13/17 08:22:50 AM
#6292   ICT 6 mil is already in the bank Zeke3960 08/13/17 07:50:19 AM
#6291   after the 10Q, the new risk is cash. realfast95 08/13/17 07:29:46 AM
#6290   $VCEL looking good, will soon be net profitable lasers 08/13/17 04:08:35 AM
#6289   http://www.twcnews.com/nys/rochester/news/2017/08/12/new-knee-cartilage-growth-p me33 08/12/17 11:25:43 PM
#6288   $vcel UPGRADES COMING ANYONE ? hurley cruppers 08/12/17 09:39:12 PM
#6287   $vcel Look at the holdings in this, Microsoft, hurley cruppers 08/12/17 09:38:10 PM
#6286   In two to three years, we are going hurley cruppers 08/12/17 07:56:47 PM
#6285   $VCEL lasers, do you realize what this means, hurley cruppers 08/12/17 07:53:13 PM
#6284   $VCEL Thank you rani9990 from another board https://fintel.io/so/us/vcel hurley cruppers 08/12/17 04:53:50 PM
#6283   Form CT ORDER Vericel Corp lasers 08/10/17 11:27:46 AM
#6282   Excellent info on $VCEL lasers 08/10/17 09:59:35 AM
#6281   Piper Jaffray analyst Edward Tenthoff reiterated a Buy realfast95 08/10/17 08:56:04 AM
#6280   Yes most definitely! lasers 08/10/17 08:28:59 AM
#6279   I will look into your question today. lasers 08/10/17 07:14:11 AM
#6278   BTIG stayed at $6 realfast95 08/10/17 07:05:05 AM
#6277   They had said in the past, that Q4 realfast95 08/10/17 06:58:53 AM
#6276   Very happy that it beat my expectations. Restocked commoncentsinvestor 08/09/17 10:57:43 PM
#6275   Hoping shorty about to get knee capped........ Gremlin3a 08/09/17 04:14:56 PM
#6274   $VCEL very impressive Qtr earnings that beat all lasers 08/09/17 04:04:05 PM
#6273   Form 10-Q Vericel Corp For: Jun 30 lasers 08/09/17 04:02:00 PM
#6272   They just proved to wallstreet today VCEL is hurley cruppers 08/09/17 02:23:57 PM
#6271   $VCEL new HOD $3.50. Transcript is a must lasers 08/09/17 02:10:23 PM
#6270   transcript available realfast95 08/09/17 02:02:52 PM
#6269   non-cash loss detail figures were incorrect, no big deal realfast95 08/09/17 01:54:21 PM
#6268   FORM 8-K Aug 9, 2017 lasers 08/09/17 01:53:22 PM
#6267   Form 8-K/A Vericel Corp For: Aug 09 lasers 08/09/17 01:50:13 PM
#6266   Vericel beats by $0.13, beats on revenue lasers 08/09/17 09:06:51 AM
#6265   $VCEL preMkt responding to better than analysts expected earnings! lasers 08/09/17 08:18:27 AM
#6264   Vericel Reports Second-Quarter 2017 Financial Results lasers 08/09/17 07:24:58 AM
#6263   Earnings (0.07 ), on revenue of 17 million realfast95 08/09/17 07:14:14 AM
#6262   The competitor $HSGX completed enrollment June 27th, so realfast95 08/07/17 08:42:39 AM
#6261   You need to wait for July numbers. me33 08/07/17 08:24:27 AM
#6260   I don't see much change in institutional ownership realfast95 08/07/17 08:23:13 AM
#6259   The stock went up because institutions have me33 08/07/17 07:43:29 AM
PostSubject