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Vericel Corp. (VCEL)

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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
#7929   BARDA order was discussed on the MDWD Q3 realfast95 01/08/20 01:40:26 PM
#7928   Takeaway realfast95 01/06/20 09:12:55 AM
#7927   BARDA Initiates the Procurement of NexoBrid for Emergency Response realfast95 01/06/20 06:43:16 AM
#7926   Vericel Corporation realfast95 01/06/20 06:00:18 AM
#7925   Talbott @talbottzink · 3h Very excited..I'm posting investment ideas and co realfast95 12/23/19 04:49:17 PM
#7924   No vendor is named in this article. realfast95 12/11/19 07:07:01 AM
#7923   posting the Seeking Alpha article before it gets realfast95 11/27/19 02:28:39 PM
#7922   good article on epicel sales TVDirector 11/27/19 09:23:28 AM
#7921   Texas baby born without skin on torso and realfast95 11/16/19 02:31:48 PM
#7920   Shorts taking over again, directors selling the stock julius66 11/14/19 03:39:21 PM
#7919   Thanks Real. julius66 11/13/19 05:15:17 PM
#7918   Michael Halpin Chief Operating Officer realfast95 11/13/19 07:27:18 AM
#7917   Will be interesting going into the close. Let realfast95 11/12/19 01:14:43 PM
#7916   $250m in sales in 2022 realfast95 11/08/19 08:58:24 PM
#7915   Thanks Real ! If those earnings ( Openheimer) too simple 11/08/19 05:36:57 PM
#7914   chart realfast95 11/08/19 10:41:47 AM
#7913   AnalystRatingsNetwork 07:44 AM realfast95 11/08/19 09:40:17 AM
#7912   Vericel Announces Appointment of Sean C. Flynn as realfast95 11/06/19 09:36:36 AM
#7911   Transcript now available for Q3 earnings realfast95 11/05/19 02:38:01 PM
#7910   Here since ‘16 with full position...not going anywhere. Lunacy_John Galt 11/05/19 11:07:53 AM
#7909   Like what I see, this should be marching veeets 11/05/19 10:34:08 AM
#7908   all in all, some good stuff TVDirector 11/05/19 10:21:07 AM
#7907   most of the call was about Epicel. realfast95 11/05/19 09:54:13 AM
#7906   reminder on quarterly MACI sales as a percentage realfast95 11/05/19 08:24:41 AM
#7905   Vericel Reports Record Third Quarter Revenues, Net Income realfast95 11/05/19 08:03:52 AM
#7904   Estimate for Q3 earnings Tuesday morning realfast95 11/04/19 05:02:32 PM
#7903   Allison DeAngelis realfast95 10/24/19 04:45:22 AM
#7902   What: Vericel Corporation Third-Quarter 2019 Earnings Call realfast95 10/22/19 08:45:11 AM
#7901   Vericel Corp (NASDAQ:VCEL) – Analysts at Oppenheimer raised realfast95 10/10/19 08:24:02 AM
#7900   $VCEL: H.C. Wainwright starts at Buy realfast95 10/09/19 07:14:46 AM
#7899   CAMBRIDGE, Mass. and YAVNE, Israel, Oct. 02, 2019 realfast95 10/02/19 08:21:13 AM
#7898   One Small Cap Story: Vericel realfast95 09/22/19 07:13:31 PM
#7897   thanks for the correction- TVDirector 09/10/19 12:22:34 PM
#7896   Conference is Wednesday realfast95 09/10/19 12:15:01 PM
#7895   could this really heading to 14's? TVDirector 09/10/19 10:04:36 AM
#7894   7 minutes to close. bounced off the bottom realfast95 09/04/19 03:54:14 PM
#7893   If you have the time- TVDirector 09/03/19 02:01:33 PM
#7892   Thanks, good points . I guess my $ too simple 08/31/19 01:13:49 PM
#7891   IMO it’s just a matter of time before Lunacy_John Galt 08/30/19 04:43:28 PM
#7890   I don't see any news in the short realfast95 08/30/19 04:36:29 PM
#7889   Question: are you guys holding or trading this too simple 08/30/19 04:18:26 PM
#7888   Dow Up- TVDirector 08/28/19 10:18:48 AM
#7887   Open Gaps realfast95 08/23/19 01:09:13 PM
#7886   This site doesn't show any gap ups. realfast95 08/15/19 03:53:13 PM
#7885   with 10 minutes left, this should be the realfast95 08/15/19 03:49:20 PM
#7884   sadly, I'd take that in a heart beat. TVDirector 08/15/19 01:01:04 PM
#7883   Perhaps I spoke too soon TVDirector 08/12/19 01:43:05 PM
#7882   A week to forget TVDirector 08/09/19 04:04:49 PM
#7881   Short interest up a bit TVDirector 08/08/19 08:48:31 AM
#7880   This is a very safe investment with a Lunacy_John Galt 08/06/19 01:36:28 PM
PostSubject