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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:


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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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#5647  Sticky Note $VCEL Daily and Weekly Charts http://www.stock $Pistol Pete$ 02/01/17 12:40:12 PM
#4674  Sticky Note The ixCELL-DCM Trial: Transendocardial Injection of ixmyelocel-T in lasers 04/05/16 05:33:01 PM
#6141   Proxy cover letter realfast95 04/23/17 10:10:33 AM
#6140   Great articles. I'm excited that the military iambillytalent 04/20/17 11:23:51 PM
#6139   "New surgery debuts at MAHC" commoncentsinvestor 04/20/17 10:54:38 PM
#6138   Nicholas DiNubile, MD, Contributor commoncentsinvestor 04/20/17 10:50:56 PM
#6137   Vericel to Present at the 5th Annual Cell lasers 04/20/17 12:31:21 PM
#6136   $VCEL remains in contact with those treated patients lasers 04/20/17 11:34:09 AM
#6135   your too fast. I updated that message realfast95 04/20/17 11:32:22 AM
#6134   The FDA can approve $VCEL Ixmyelocel-T based lasers 04/20/17 11:30:51 AM
#6133   CardiAMP this is a phase 3 trial though. realfast95 04/20/17 11:25:04 AM
#6132   Vericel Corporation (Nasdaq:VCEL), a leading developer of expanded realfast95 04/20/17 11:08:33 AM
#6131   $VCEL Ixmyelocel-T results have been fantastic as a lasers 04/20/17 04:12:56 AM
#6130   This article looks strikingly similar to Vericel's trial realfast95 04/19/17 09:48:12 PM
#6129   There are no references from the FDA that lasers 04/19/17 09:09:40 AM
#6128   Looks like India stole the ACI idea realfast95 04/18/17 11:52:13 AM
#6127   Blue Cross: 4/2017 Policy statements clarified to include commoncentsinvestor 04/17/17 12:53:53 AM
#6126   Someone name dropped Hitachi Chemical on stockwits as realfast95 04/14/17 04:00:08 PM
#6125   As any reasonably informed investor knows, VCEL is commoncentsinvestor 04/14/17 03:21:17 PM
#6124   New technique effective for repairing isolated cartilage damage realfast95 04/13/17 04:33:54 PM
#6123   So as a follow-up to my post yesterday. realfast95 04/13/17 02:15:48 PM
#6122   I don't understand your post. realfast95 04/13/17 01:27:57 PM
#6121   manisero66 do you have a link that you lasers 04/13/17 10:26:50 AM
#6120   On Friday the 21st of Abril is FDA manisero66 04/13/17 09:24:46 AM
#6119   More MACI in military: commoncentsinvestor 04/12/17 12:19:28 PM
#6118   These were listed in the MACI zip code realfast95 04/12/17 09:12:26 AM
#6117   New surgical technique performed at Munson realfast95 04/12/17 09:04:21 AM
#6116   I was being sarcastic. me33 04/12/17 08:46:55 AM
#6115   Not ,and they are not even going after scubastevemd 04/12/17 08:40:59 AM
#6114   Thanks to Obama it's illegal to be uninsured me33 04/12/17 06:54:52 AM
#6113   In an attempt to get from point A realfast95 04/12/17 06:53:49 AM
#6112   Short sales for 3/31/2017 1,808,420 won't want to be shorty........ Gremlin3a 04/11/17 04:12:50 PM
#6111   If you look at the presentation on their realfast95 04/11/17 02:40:45 PM
#6110   Seems for an uninsured person that is well scubastevemd 04/11/17 02:02:28 PM
#6109   $44,000 is the list price VCEL charges. The realfast95 04/11/17 09:37:55 AM
#6108   What some here fail to account for is scubastevemd 04/11/17 08:19:26 AM
#6107   First-In-Connecticut: Innovative Outpatient Knee Repair Surgery Utilizing MACI® realfast95 04/10/17 07:41:43 PM
#6106   So the first thought on this new hire, realfast95 04/10/17 12:54:50 PM
#6105   According to the 10K in regards to the realfast95 04/10/17 09:52:49 AM
#6104   Vericel Corporation (Nasdaq:VCEL), a leading developer of expanded realfast95 04/10/17 09:28:40 AM
#6103   Hope it is your 10 bagger. scubastevemd 04/10/17 08:20:26 AM
#6102   There are 636 ACI specialists within 50000 miles realfast95 04/08/17 08:42:45 AM
#6101   Question for the board. What is the product realfast95 04/05/17 04:05:52 PM
#6100   I'M NOT SELLING.......... joemont 04/05/17 02:10:29 PM
#6099   Now only 15 days away from FDA´s IXMYELOCEL-T manisero66 04/05/17 07:22:47 AM
#6098   "Yes, timing is everything" commoncentsinvestor 04/04/17 11:45:35 AM
#6097   With a down market and a unfriendly chart. realfast95 04/04/17 08:51:59 AM
#6096   Yes, timing is everything along with limiting risk. scubastevemd 04/04/17 08:08:12 AM
#6095   "It is new and private pay" commoncentsinvestor 04/03/17 06:48:03 PM
#6094   It is new and private pay so no scubastevemd 04/03/17 04:19:55 PM
#6093   Will just be my 5th. Late bloomer and scubastevemd 04/03/17 01:33:03 PM
#6092   The one time I checked my area a too simple 04/02/17 10:38:33 AM