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Vericel Corp. (VCEL)

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Last Post: 12/15/2017 9:15:44 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
#7362   *** LT that buy ( fat finger problems CoastalTrader83 12/15/17 09:15:44 PM
#7361   Whoever painted the tape , thx you ! Makes CoastalTrader83 12/15/17 09:14:11 PM
#7360   Heard you sold all yours at $2.65, is hurley cruppers 12/15/17 08:34:34 PM
#7359   manisero, you have been so wrong about this commoncentsinvestor 12/15/17 04:54:07 PM
#7358   no bad news reported. aka no insider selling. realfast95 12/15/17 10:05:03 AM
#7357   Touched now 4,45 I m still 20 cents manisero66 12/15/17 09:54:08 AM
#7356   bought some more, at 4.6, fricking 5 cent realfast95 12/14/17 04:22:12 PM
#7355   You sound like you don’t know anything . CoastalTrader83 12/13/17 08:49:25 PM
#7354   Shares behaviour is like human behaviour: When you manisero66 12/13/17 09:56:56 AM
#7353   Nice. lasers 12/12/17 04:03:45 PM
#7352   https://questex-lifesciences2017.secure-platform.com/a/ CoastalTrader83 12/12/17 03:53:31 PM
#7351   Do they call that a staircase formation on hurley cruppers 12/12/17 10:57:02 AM
#7350   VCEL it's about to happen! Wow1234 12/12/17 10:30:32 AM
#7349   Nice find on the "in the news" on hurley cruppers 12/10/17 11:54:23 AM
#7348   Hurley it was on ST, but that’s why CoastalTrader83 12/10/17 11:33:33 AM
#7347   I was trolling the PowerPoint presentation looking for CoastalTrader83 12/10/17 11:17:49 AM
#7346   Wow, when this this page come up on hurley cruppers 12/10/17 10:11:43 AM
#7345   VCEL on national syndication radio. Nice exposure to say CoastalTrader83 12/10/17 10:02:57 AM
#7344   Yep. At the Mesa conference, Colangelo also mentioned CoastalTrader83 12/09/17 09:17:09 PM
#7343   It’s a bullish sign that they could even CoastalTrader83 12/09/17 08:30:37 PM
#7342   yes JOhn Galt. This arrangement with this bank Cat Whisperer 12/09/17 08:02:26 PM
#7341   And .. Trader83 ... I haven't seen a Cat Whisperer 12/09/17 07:51:11 PM
#7340   I love hearing folks nit pick. Maci wasn't CoastalTrader83 12/09/17 07:41:07 PM
#7339   Coastal I'm with ya. I'll take pills. should Cat Whisperer 12/09/17 07:38:55 PM
#7336   If that’s the case it’s still very insignificant. Lunacy aka John Galt 12/09/17 04:17:36 PM
#7335   I think it's double. $115k by both. 54-59k realfast95 12/09/17 03:43:01 PM
#7334   27k shares, I hope you don’t consider that Lunacy aka John Galt 12/09/17 03:41:28 PM
#7333   2023... I’m losing sleep tonight lol CoastalTrader83 12/09/17 01:53:19 PM
#7332   Warrant! that wasn't in the press release realfast95 12/09/17 12:58:58 PM
#7331   $4.90 currently (formerly $3.05 ) lasers 12/09/17 05:35:55 AM
#7330   I got a kick out the good news Cat Whisperer 12/08/17 09:15:01 PM
#7329   Well, that is the highlight of the week. :))))) hurley cruppers 12/08/17 08:16:14 PM
#7328   Good luck and safe driving! lasers 12/08/17 08:13:39 PM
#7327   We know from the PJ webcast, it's coming, hurley cruppers 12/08/17 08:11:20 PM
#7326   IMO yes. The $4.90 PPS is the updated lasers 12/08/17 07:55:13 PM
#7325   Wondering if the deal is going to be hurley cruppers 12/08/17 07:52:41 PM
#7324   Not a problem for me. Dominick Colangelo President lasers 12/08/17 07:19:04 PM
#7323   Lasers - don't sweat that guy Mans whatshisname Cat Whisperer 12/08/17 04:49:54 PM
#7322   Not missing anything. ICT will be finalized before lasers 12/08/17 02:28:56 PM
#7321   Say manisero, you really need to relax. commoncentsinvestor 12/08/17 01:26:27 PM
#7320   For better or for worse. Here's a compilation. Cat Whisperer 12/08/17 01:18:11 PM
#7319   Is it a surprise to you that a Lunacy aka John Galt 12/08/17 10:26:09 AM
#7318   Vericel´s google´s intelligence dpto.(Lasers, Cat talker etc). seems manisero66 12/08/17 10:15:54 AM
#7317   Both Massachusetts lasers 12/08/17 09:21:06 AM
#7316   Here's a pointless fact. Bob Kraft is Cat Whisperer 12/08/17 08:48:59 AM
#7315   Saw this analysis. Thoughts? Eblair84 12/08/17 07:42:22 AM
#7314   Good link. Thxs lasers 12/08/17 06:41:21 AM
#7313   Excellent reference. Thxs lasers 12/08/17 06:39:42 AM
#7312   Orthopedic Summit going on now in Las Vegas. commoncentsinvestor 12/08/17 01:03:30 AM
#7311   Yup. These guys do some serious DD. Cat Whisperer 12/07/17 07:48:58 PM
PostSubject