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Vericel Corp. (VCEL)

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Last Post: 2/25/2017 1:37:19 PM - Followers: 154 - Board type: Free - Posts Today: 3

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

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


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:
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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:






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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
#5860   $VCEL 10Q lasers 02/25/17 01:37:19 PM
#5859   VCEL is expected to be profitable by the realfast95 02/25/17 08:16:29 AM
#5858   Do you know how to read a 10q MicroKing 02/25/17 12:54:40 AM
#5857   Is vcel making any money? Rubyt 02/24/17 10:51:16 PM
#5855   Many thxs for finding a $VCEL presentation on 2017/02/27. lasers 02/24/17 10:28:19 AM
#5854   Two doctors, both involved in sports medicine, are iambillytalent 02/24/17 09:41:49 AM
#5853   Vericel, among other big names, mentioned in this iambillytalent 02/24/17 09:31:52 AM
#5852   Yep, among others, I anticipate the 1st Week hurley cruppers 02/23/17 09:10:36 PM
#5851   Eastern Capital Dart has been a recent big accumulator lasers 02/23/17 09:04:28 PM
#5850   Every day it seems there is 150k on hurley cruppers 02/23/17 09:02:17 PM
#5849   For their own $VCEL accumulation of more shares. lasers 02/23/17 08:55:47 PM
#5848   Some entity is holding this stock back for hurley cruppers 02/23/17 08:53:43 PM
#5847   Absolutely HUGE, Huge Market for Ixmyelocel-T hurley cruppers 02/23/17 08:47:43 PM
#5846   The FDA knows better for $VCEL autologous stem cells. lasers 02/23/17 08:39:25 PM
#5845   VCEL and others mentioned about the DCM market: iambillytalent 02/23/17 04:27:35 PM
#5844   Has this doctor migrated to MACI ? hurley cruppers 02/22/17 11:30:50 PM
#5843   Listed are several Doctors bone specialists directly involved lasers 02/22/17 07:03:26 PM
#5842   Yeah, that video makes no sense, the doctor hurley cruppers 02/22/17 06:50:48 PM
#5841   That doctor isn't on the site search realfast95 02/22/17 06:49:28 PM
#5840   I watch the video. There was no mention lasers 02/22/17 06:43:44 PM
#5839   lasers, watch the video on this site hurley cruppers 02/22/17 05:51:01 PM
#5838   Funny, I have said ok I have enough too simple 02/22/17 04:14:00 PM
#5837   Yes most definitely! lasers 02/22/17 03:50:53 PM
#5836   And I hope they, VCEL, write the hurley cruppers 02/22/17 03:46:47 PM
#5835   All of these 114 patients were Class III/IV lasers 02/22/17 03:30:16 PM
#5834   I wonder if VCEL increased the dosage on hurley cruppers 02/22/17 03:23:53 PM
#5833   A most excellent discussion on $VCEL IxCell DCM lasers 02/22/17 03:23:36 PM
#5832   Based on the Dr. Tim Henry interview $VCEL lasers 02/22/17 03:18:57 PM
#5831   I see 147k on the Bid at 2.90 hurley cruppers 02/22/17 03:11:32 PM
#5830   Yes Indeed. Our guardian angels are working for lasers 02/22/17 03:01:56 PM
#5829   IRA is filled at 2.925, ok, it can hurley cruppers 02/22/17 03:01:50 PM
#5828   It's also possible the FDA decision was leaked realfast95 02/22/17 05:48:17 AM
#5827   They (the Shorters) could heavily short for three lasers 02/22/17 05:01:59 AM
#5826   Watch IxCell on You Tube commoncentsinvestor 02/22/17 12:43:50 AM
#5825   Shouldn't we be getting some Upgrades on DOD hurley cruppers 02/21/17 10:31:48 PM
#5824   I don't know all there is to know joemont 02/21/17 10:24:36 PM
#5823   Once a drug receives Fast Track designation, early hurley cruppers 02/21/17 10:17:23 PM
#5822   Nice find, its only going to get better. hurley cruppers 02/21/17 08:45:34 PM
#5821   MACI mentioned in Women's World magazine. Online iambillytalent 02/21/17 08:27:00 PM
#5820   Yes most likely. The tactics would be the lasers 02/21/17 05:25:39 PM
#5819   Not paying must attention to the day to too simple 02/21/17 05:16:47 PM
#5818   So it's possible that the pre market and Gremlin3a 02/21/17 04:11:12 PM
#5817   It is a tactic that Shorts use. lasers 02/21/17 04:03:45 PM
#5816   If shorts are trying to cover doesn't the Gremlin3a 02/21/17 04:00:03 PM
#5815   I hear you, the majority of shares were Gremlin3a 02/21/17 03:52:08 PM
#5814   Could be stealth accumulation or Shorts trying to cover. lasers 02/21/17 03:49:32 PM
#5813   Personally, I don't mind it going down or iambillytalent 02/21/17 03:42:30 PM
#5812   We get our next short position postings on hurley cruppers 02/21/17 03:39:36 PM
#5811   Lasers, seems backwards, lets hope there is a Gremlin3a 02/21/17 03:35:40 PM
#5810   Very possible that $VCEL would release a PR. lasers 02/21/17 03:23:51 PM