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Vericel Corp. (VCEL)

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Vericel Corporation. (VCEL)




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.




                                                                      Click on Yellow to REVIEW FDA WEBSITE APPROVING MACI


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



 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

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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

                           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

Clinical Research:
Recent News:

Events and Presentations:

Analyst Coverage:


Share Structure:
See Filings

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  MUST WATCH

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:




 Yummy Land, click on Above Picture


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News News Alert: Vericel to Present at Multiple Upcoming Conferences 09/21/2018 08:30:00 AM
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#7685   VCEL appears undervalued when compared to UBX, a north40000 09/13/18 10:39:19 PM
#7684   wouldn't doubt if we see low 11's again TVDirector 09/13/18 11:00:23 AM
#7683   It seems your moving average of $12,40 has manisero66 09/12/18 03:44:03 PM
#7682   Yea 200% is tough to make now in silvergun 09/12/18 07:46:42 AM
#7681 I hope this helps everyone! Due dili Jsteezy 09/11/18 08:13:01 PM
#7679   I think that VCEL. is catching up with manisero66 09/11/18 10:36:14 AM
#7678   yes no doubt, HC Wainwright analyst Swayampakula Ramakanth Giovinco 09/06/18 09:24:34 AM
#7677   Companies are devastated by sub-optimal trial designs all Lunacy aka John Galt 09/06/18 09:00:01 AM
#7676   no, HSGX would have even met primary endpoint Giovinco 09/06/18 08:37:58 AM
#7675   I haven't completely reviewed the data, but didn't Lunacy aka John Galt 09/06/18 08:29:00 AM
#7674   VCEL vs HSGX You should read this Giovinco 09/06/18 07:25:14 AM
#7673   HSGX missed because micro procedure did better than expected. realfast95 09/05/18 10:18:08 AM
#7672   Much seem to be the only person north40000 09/05/18 09:28:48 AM
#7671   HGSX failed their Ph3 trial, which was looked Lunacy aka John Galt 09/05/18 09:17:17 AM
#7670   Up big pre market to 13.55 new 52 silvergun 09/05/18 09:13:14 AM
#7669   SEC acceptance of S3 - Notice of Effectiveness (effect) realfast95 08/29/18 06:19:08 AM
#7668   Back at 12.5 looking strong. If we can silvergun 08/25/18 01:36:19 PM
#7667   Dilution is virtually assured for investors in small MaineMan5 08/20/18 03:06:10 PM
#7666   Knee braces, that's where the money is. Every realfast95 08/20/18 10:58:20 AM
#7665   Vericel Announces Appointment of Jonathan Hopper as Chief realfast95 08/20/18 08:28:05 AM
#7664   Yes, it is disappointing to see rounds of San Onofre 08/17/18 03:57:31 PM
#7663   it's a crying shame that the PPS fall TVDirector 08/17/18 11:10:32 AM
#7662   Yes, I'm thinking along your lines..... San Onofre 08/17/18 09:45:28 AM
#7661   or it's simply a plan to dilute now TVDirector 08/17/18 09:33:30 AM
#7660   They would probably say that it's just available realfast95 08/17/18 07:50:42 AM
#7659   Odd. They raised 75 mil which they have silvergun 08/17/18 07:25:54 AM
#7658   S-3 filing realfast95 08/16/18 05:40:51 PM
#7657   Hope so !! That would be crazy. Holding silvergun 08/14/18 05:45:44 PM
#7656   VCEL will be $100/share this time next year! San Onofre 08/11/18 06:37:06 PM
#7655   Vericel Corp (NASDAQ:VCEL) – Research analysts at Leerink realfast95 08/10/18 07:52:17 AM
#7654   VCEL: ~ $11.75 AH on this report north40000 08/06/18 04:43:36 PM
#7653   Nice AH rise! TVDirector 08/06/18 04:30:48 PM
#7652   We disagree. BCDA is almost done with the realfast95 07/28/18 12:39:16 PM
#7651   Realfast:I see without purpose spending $100 million in manisero66 07/28/18 11:04:56 AM
#7650   My case on what to do with the money. realfast95 07/21/18 08:32:45 AM
#7649   Yes I agree ! Plus it’s hard to silvergun 07/18/18 09:02:44 PM
#7648   I think it depends on your investment horizon. MaineMan5 07/16/18 08:34:14 PM
#7647   or perhaps the Shorts didn't want to cover realfast95 07/16/18 04:27:17 PM
#7646   Certainly underwhelming the investment community. TVDirector 07/16/18 11:18:51 AM
#7645   Vericel $VCEL Raised to Buy at LADENBURG THALM $13 realfast95 07/16/18 07:58:26 AM
#7644   Q2 is seasonally, the WEAKEST Q of the SwingEquityTrader 06/28/18 12:41:38 PM
#7643   Yea long term should be fine. Anyone good silvergun 06/27/18 06:49:53 PM
#7642   gotta hope so TVDirector 06/27/18 03:08:48 PM
#7641   Silvergun—- Yes so cheap right now! Hope it bigstocksnbonds 06/25/18 05:38:34 PM
#7640   So cheap. Should bounce and go up soon silvergun 06/25/18 05:22:06 PM
#7639   Silvergun— Good for you in from $2!! Excellent!! bigstocksnbonds 06/21/18 07:39:40 PM
#7638   I’m in from $2. Did take some profits silvergun 06/21/18 07:00:54 PM
#7637   Silvergun—- $20 by winter or early 2019 sounds bigstocksnbonds 06/21/18 05:04:03 PM
#7636   Yea hopefully the bleeding stops here in the silvergun 06/21/18 04:45:35 PM
#7635   Tv Director— Yes lots of paper value gone bigstocksnbonds 06/21/18 04:11:22 PM