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Vericel Corp. (VCEL)

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Last Post: 1/21/2017 11:04:47 AM - Followers: 155 - Board type: Free - Posts Today: 1

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



 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.


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

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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
November 30th, 2016 The 28th Annual Piper Jaffray Healthcare Conference
December 14th, 2016 Vericel Corporation Investor Call

Investor Relations:






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#5435  Sticky Note "Maybe they will let us know if the commoncentsinvestor 01/09/17 04:26:50 PM
#4674  Sticky Note The ixCELL-DCM Trial: Transendocardial Injection of ixmyelocel-T in lasers 04/05/16 05:33:01 PM
#5568   Thomson Reuters/Verus upgrades VERICEL CORPORATION from HOLD to BUY. commoncentsinvestor 01/21/17 11:04:47 AM
#5567   Yes $VCEL DMA (50) is $2.70. Statistically Ken lasers 01/20/17 12:38:23 PM
#5566   yea im adding 2.65, 2.70 dirt cheap here. silvergun 01/20/17 12:15:54 PM
#5565   need close at 2,70 to avoid breaking 50 dma. gamesetmatch101 01/20/17 10:58:37 AM
#5564   Expecting $VCEL Commercial MACI knee procedures underway in lasers 01/20/17 09:38:38 AM
#5563   Gut feeling says we get boomer news within hurley cruppers 01/20/17 09:28:54 AM
#5562   Dart buying Aastrom and held for many years, lasers 01/20/17 09:11:32 AM
#5561   I will leave speculation about buyouts to others Sugarplum 01/20/17 08:44:26 AM
#5560   I have AMRN, PPHM and VCEL in a north40000 01/20/17 02:49:44 AM
#5559   all in mild downtrends, he can afford to gamesetmatch101 01/19/17 10:21:55 PM
#5558   Dart and his Eastern Capital hold interests in north40000 01/19/17 10:04:11 PM
#5557   what would you pay to own something that gamesetmatch101 01/19/17 09:36:22 PM
#5556   If VCEL was to get a buy out, hurley cruppers 01/19/17 07:38:48 PM
#5555   It is estimated that the 9 biggest pharma hurley cruppers 01/19/17 07:37:27 PM
#5554   SA Article on bios for 2017, you must hurley cruppers 01/19/17 06:53:43 PM
#5553   i'm in three stocks. 2 are Dart gamesetmatch101 01/19/17 05:00:30 PM
#5552   an old article from 2015 posted link by realfast95 01/19/17 05:37:45 AM
#5551   Excellent. I was going to try and find lasers 01/19/17 01:46:18 AM
#5550   According to a previous 13G/A filed on Feb. commoncentsinvestor 01/18/17 11:21:54 PM
#5549   Dart Eastern Capital was an original Institutional owner lasers 01/18/17 09:58:30 PM
#5548   My favorite site, is down for institutional realfast95 01/18/17 07:38:09 PM
#5547   EASTERN CAPITAL LIMITED has purchased 1,881,381 VCEL shares. commoncentsinvestor 01/18/17 06:48:03 PM
#5546   SCHEDULE 13G - EASTERN CAPITAL LTD realfast95 01/18/17 06:42:17 PM
#5545   sold unxl to buy this. not looking gamesetmatch101 01/18/17 04:15:31 PM
#5543   $VCEL is a "can't miss" stock to own $2.8 realfast95 01/18/17 07:09:43 AM
#5542   Hi Derek. commoncentsinvestor 01/18/17 01:19:58 AM
#5541   Is VCEL another "can't miss" stock pick like derek32smith 01/17/17 11:03:06 PM
#5540   This is not your grandma's Aastrom Biosciences. gamesetmatch101 01/17/17 09:00:46 PM
#5539   Good luck back atcha. commoncentsinvestor 01/17/17 04:33:35 PM
#5538   I'm all out -- GLT All. pgh_maulers 01/17/17 02:30:20 PM
#5537   this stock should be at least a buck higher gamesetmatch101 01/17/17 01:45:58 PM
#5536   ibox, and over 250 patents and patent applications hurley cruppers 01/17/17 12:12:21 AM
#5535   hurley cruppers Many Thxs and much appreciated. $VCEL lasers 01/16/17 08:29:07 PM
#5534   Thank you, and forgive me for beefing in hurley cruppers 01/16/17 08:26:13 PM
#5533   You are good because that is the source lasers 01/16/17 08:19:38 PM
#5532   This will be another very important area to hurley cruppers 01/16/17 08:16:35 PM
#5531   lasers, Is this still something we are waiting hurley cruppers 01/16/17 08:01:59 PM
#5530   Nah, not gonna let VCEL allow Cowen pgh_maulers 01/16/17 07:53:27 PM
#5529   Cell Therapy for Craniofacial Bone Defects lasers 01/16/17 07:50:38 PM
#5528   lasers, Did we ever hear anything on this topic hurley cruppers 01/16/17 07:38:11 PM
#5527   Suggest you wait for the 10-KSB to come hurley cruppers 01/16/17 07:33:42 PM
#5526   GLTU. I'm out tomorrow. pgh_maulers 01/16/17 07:26:29 PM
#5525   Added to ibox, or also called Intro, again hurley cruppers 01/16/17 07:25:55 PM
#5524   Thank you for posting that, I already printed hurley cruppers 01/16/17 06:42:14 PM
#5523   Not me, I am adding more shares to hurley cruppers 01/16/17 06:38:39 PM
#5522   You forget to calculate that approval came 3 Sugarplum 01/16/17 05:19:40 PM
#5521   Good advice. Probably be moving on this week. pgh_maulers 01/16/17 05:02:51 PM
#5520   If there is one thing I have learned commoncentsinvestor 01/16/17 04:52:20 PM
#5519   Would VCEL Management be so kind at to pgh_maulers 01/16/17 03:00:32 PM
#5518 Genzyme noted that MACI eneels01 01/16/17 02:10:52 PM