Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Approval of final cohorts was received and we can expect news of phase 1 completion for all trials.
NEJM still a waiting game.
No mention of Reverse Split.
Actively searching financing.
Always good to hear Lanza.
Did I miss anything??
Casually waiting on the update. Progress is all I'm looking for. IMO any step(s) forward toward the direction of our ultimate goal would make this call worth it, no matter the size of the steps. This will be the first corporate update in a long time where we actually have a CEO in place. Hopefully he sees it paramount to flex his worth and boast of the progress he has initiated or set in motion... Then we'd really be in for an interesting call. IMO. Either way I'm in it for the long run so it's no different for me what is released later today as I'm in it for the bigger picture that I truly believe this staff can make come to fruition. GLTA
ONLY THING ANYONE NEEDS TO KNOW IMO, PROGRESS. from the last 10Q
We are focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. In our pipeline, we have multiple product candidates for the treatment of heart damage, including MyoCell, Myocell SDF-1 and AdipoCell. MyoCell and MyoCell SDF-1 are clinical muscle-derived cell therapies designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.
MyoCell SDF-1 is intended to be an improvement to MyoCell. MyoCell SDF-1 is similar to MyoCell except that the myoblast cells to be injected for use in MyoCell SDF-1 will be modified prior to injection by an adenovirus vector or non-viral vector so that they will release extra quantities of the SDF-1 protein, which expresses angiogenic factors. AdipoCell is a patient-derived cell therapy proposed for the treatment of acute myocardial infarction, chronic heart ischemia, and lower limb ischemia. We hope to demonstrate that these product candidates are safe and effective complements to existing therapies for chronic and acute heart damage.
Our most recent completed clinical trials of MyoCell are the SEISMIC Trial, a 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe and the MYOHEART Trial, a 20-patient, multicenter, Phase I dose-escalation trial conducted in the United States. We were approved by the FDA, to proceed with a 330-patient, multicenter Phase II/III trial of MyoCell in North America and Europe, or the MARVEL Trial. We completed the MyoCell implantation procedure on the first patient in the MARVEL Trial on October 24, 2007. Thus far, 20 patients, including 6 control patients, have been treated. Initial results for the 20 patients were released at the Heart Failure Society of American meeting in September, 2009, showing a significant (35%) improvement in the 6 minute walk for those patients who were treated, and no improvement for those who received a placebo. On the basis of these results, we have applied for and received approval from the FDA to reduce the number of additional patients in the trial to 134, for a total of 154 patients. The SEISMIC, MYOHEART and MARVEL Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue in the United States from the sale of MyoCell cell-culturing services for treatment of patients by qualified physicians.
We received approval from the FDA in July of 2009 to conduct a Phase I safety study on 15 patients of a combined therapy (Myocell with SDF-1), which we believe was the first approval of a study combining gene and cell therapies. We initially commenced work on this study, called the REGEN Trial, during the first quarter of 2010. We suspended activity on the trial in 2010 while seeking additional funding necessary to conduct the trial.
We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds.
We have completed the Phase 1 Angel Trial for AdipoCell (adipose derived stem cells). Five patients were enrolled and treated in the second quarter of 2013.
We have also initiated several Institutional Review Board studies in 2013 using adipose derived stem cells for various indications including dry macular degeneration, degenerative disc disease, erectile dysfunction and chronic obstructive pulmonary disease.
In Q2, 2014, the company announced the treatment of a patient in Honduras with congestive heart failure using AdipoCell and MyoCell. This was the first patient treated in the world using a combination of stem cells.
We have begun two clinical trials in India. The first cardiac patient has successfully been enrolled and treated in India using AdipoCellâ„¢ or adipose derived stem cells. The second trial will involve the combination of AdipoCell and MyoCell® or muscle derived stem cells for congestive heart failure patients. These trials are active and ongoing
MyoCath Product Candidate
The MyoCath is a deflecting tip needle injection catheter that has a larger (25 gauge) needle to allow for better flow rates and less leakage than systems that are 27 gauge. This larger needle allows for thicker compositions to be injected, which helps with cell retention in the heart. Also, the MyoCath needle has more fluoroscopic brightness than the normally used nitinol needle, enabling superior visualization during the procedure. Seeing the needle well during injections enables the physician who is operating the catheter to pinpoint targeted areas more precisely. The MyoCath is used to inject cells into cardiac tissue in therapeutic procedures to treat chronic heart ischemia and congestive heart failure. Investigators in our MARVEL Trial may use either our MyoCath catheters or Biosense Webster’s (a Johnson & Johnson company) NOGA® Cardiac Navigation System along with the MyoStarâ„¢ injection catheter for the delivery of MyoCell to patients enrolled in the trial. We are currently producing Myocath catheters with a contract manufacturer on an as needed basis.
We conduct operations in one business segment. We may organize our business into more discrete business units when and if we generate significant revenue from the sale of our product candidates. Our revenue since inception has been generated inside and outside the United States, and the majority of our long-lived assets are located in the United States.
Results of Operations Overview
Three and Six Months Ended June 30, 2014 as compared to the Three and Six Months Ended June 30, 2014
Revenues
We have not generated any material revenues from our MyoCell product candidate. The revenues we have recognized to date are related to (i) sales of MyoCath, (iii) revenues generated from patient paid studies, (iv) revenues from the sale of our AdipoCell system and related supplies and (v) revenues generated for providing cell culturing and banking services. We did not generate significant revenues in 2013. Our revenue may vary substantially from quarter to quarter and from year to year. We expect to have steady growth of revenue as the above programs grow and expand.
We recognized revenues of $497,034 and $819,606 for the three and six months ended June 30, 2014, respectively, compared to revenues of $20,129 and $24,321 for the three and six months ended June 30, 2013, respectively. Our revenue in 2014 was generated from the sale of MyoCath catheters, AdipoCell, physician training, patient studies and laboratory services. Our revenues for 2013 were generated from the sale of MyoCath Catheters and laboratory services.
Haha wrong stock! Either way same rules apply only here were waiting on Monday conference call!!
Wrong. This stock isn't traded because most are holding for the big news of phase 1 Adipocell results and financing for phase 3 Myocell!!!
Lol... "That makes all the sense in the world" to me. IMO
"It makes all the sense in the world"?
That is a strong statement... What is your source? How is your sentence validated? "All the sense in the world" does that mean that there is no "sense" for anything else since "all the sense in the world" was taken by your statement.
How about a PR of increased revenues of around 200K from last quarter.
Or how about a PR about Adipocell phase 1 completion and results.
Or maybe a PR about Myocell financing and continued enrollment for phase 3.
Would any of those PRs do anything for the volume hop?
IMO these PRs are definitely coming and will skyrocket the pps... It's just a matter of how much patience one has and whether or not one can see the big picture of what's going on in the biotech stem cell sector. IMO this stock will be in the dollars soon
You nailed it. Excellent post.
We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds.
We have completed the Phase 1 Angel Trial for AdipoCell (adipose derived stem cells). Five patients were enrolled and treated in the second quarter of 2013.
We have also initiated several Institutional Review Board studies in 2013 using adipose derived stem cells for various indications including dry macular degeneration, degenerative disc disease, erectile dysfunction and chronic obstructive pulmonary disease.
In Q2, 2014, the company announced the treatment of a patient in Honduras with congestive heart failure using AdipoCell and MyoCell. This was the first patient treated in the world using a combination of stem cells.
We have begun two clinical trials in India. The first cardiac patient has successfully been enrolled and treated in India using AdipoCellâ„¢ or adipose derived stem cells. The second trial will involve the combination of AdipoCell and MyoCell® or muscle derived stem cells for congestive heart failure patients. These trials are active and ongoing
Our most recent completed clinical trials of MyoCell are the SEISMIC Trial, a 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe and the MYOHEART Trial, a 20-patient, multicenter, Phase I dose-escalation trial conducted in the United States. We were approved by the FDA, to proceed with a 330-patient, multicenter Phase II/III trial of MyoCell in North America and Europe, or the MARVEL Trial. We completed the MyoCell implantation procedure on the first patient in the MARVEL Trial on October 24, 2007. Thus far, 20 patients, including 6 control patients, have been treated. Initial results for the 20 patients were released at the Heart Failure Society of American meeting in September, 2009, showing a significant (35%) improvement in the 6 minute walk for those patients who were treated, and no improvement for those who received a placebo. On the basis of these results, we have applied for and received approval from the FDA to reduce the number of additional patients in the trial to 134, for a total of 154 patients. The SEISMIC, MYOHEART and MARVEL Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue in the United States from the sale of MyoCell cell-culturing services for treatment of patients by qualified physicians.
We received approval from the FDA in July of 2009 to conduct a Phase I safety study on 15 patients of a combined therapy (Myocell with SDF-1), which we believe was the first approval of a study combining gene and cell therapies. We initially commenced work on this study, called the REGEN Trial, during the first quarter of 2010. We suspended activity on the trial in 2010 while seeking additional funding necessary to conduct the trial.
We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds.
We have completed the Phase 1 Angel Trial for AdipoCell (adipose derived stem cells). Five patients were enrolled and treated in the second quarter of 2013.
27
We have also initiated several Institutional Review Board studies in 2013 using adipose derived stem cells for various indications including dry macular degeneration, degenerative disc disease, erectile dysfunction and chronic obstructive pulmonary disease.
In Q2, 2014, the company announced the treatment of a patient in Honduras with congestive heart failure using AdipoCell and MyoCell. This was the first patient treated in the world using a combination of stem cells.
We have begun two clinical trials in India. The first cardiac patient has successfully been enrolled and treated in India using AdipoCellâ„¢ or adipose derived stem cells. The second trial will involve the combination of AdipoCell and MyoCell® or muscle derived stem cells for congestive heart failure patients. These trials are active and ongoing
For an R&D (company) not for R&D... They're product pipeline is Presley much set for now IMO. No need to spend much on new R&D. NOW WHAT IF SOME OF THAT MONEY WAS USED TO FURTHER ALONG MYOCELL MIRROR ENROLLMENT??
And for the record, the NEW revenue is a substantial increase from las quarters revenue, imagine what the 10K will look like at this pace!! IMO 2 million
Wow! Half a million in a quarter for an R&D!! That's awesome!!! Here we go!!! GLTA
Yeah definitely... I mean, it's still new today. IMO
"New" is an opinion. April is pretty new to me... IMO
Lol!!
Couldn't have said it better myself pijoe, and the upcoming 10Q will solidify your statements.
The asking price should be raised to .027 now that .026 sold IMO
I don't worry about why it would matter to the share price all I know and care about is that it does matter. Why do I know this? Because of how the stock reacted when the 6 month results for phase 1 Adipocell were released. Will the announcement of phase 3 Myocell matter? Yes, way more IMO therefore IMO they both matter.
Phase 1, 12 month results coming soon... 12 months marks the phase 1 end point which ended this past June. Full 12 month phase 1 results coming soon. IMO this stock is going to make a much higher jump compared to the last one... And much higher since we have sustained some gains since then.
Phase 1, 6 month results.
Comella is in that shot.
From a financial stand point, who wouldn't want to be part of one of if not the first FDA approved stem cell therapies? GLTA IMO
Most definitely.
Wotton is living proof of the direction we are heading in. He is proven and jump on board IMO to be part of our success.
Absolutely not IMO. When the dam breaks and the water comes rushing you have no choice but to let the waters run or be swept away in them trying to rebuild in that moment. No one can hold back white waters rushing.
Excellent post chuck. The great thing about this road trip is we've got 4 stops to make that will be a breath of fresh air to us passengers as we get off on rest stops phase1, 2, and 3 completions to have a stretch. The final stop and destination is market approval. But I'm only focused on the next time I can get off and stretch my legs for now... Considering I'm 6'2". and it looks to me like we got a new driver just in time as we've been going in what would seem like circles being so close to the first rest stop? I'm confident that we will reach it now with our new driver... and just in time as i am beginning to cramp but doing my best to stretch it out while keeping my buckle locked in. GLTA IMO
IMO that target is going to be something we pass by and waive it... My reasoning is that with the quarterly report that is about to be released next month and with the phase 1 adipocell results being released... I see BHRT going beyond .10 cents but below .20 cents (not reaching the .40 cent target). Now when financing and phase 3 enrollment are announced... BHRT IMO will skyrocket beyond the 1$ pps because of the obvious. At that point we will become an active phase 3 stem cell leader that will soon after apply for FDA approval. IMO
I think the numbers are in out favor Gs. It is definitely financing that us available. There are so many millions being poured into the stem cell biotech sector because of it's capability and future worth to the medical industry health and dollar wise. IMO
Awesome! Thanks for posting the update and great news here in ihub. Go BHRT!
I guess this makes it official.
http://ih.advfn.com/p.php?pid=nmona&article=63024157&xref=newsalert
IMO the 10Q due in august will tell the true story of the direction of this company. Substantial revenue increases are 100% guaranteed IMO.
Wow!! "Bioheart Announces WORLD'S FIRST COMBINATION STEM CELL TREATMENT" that's amazing stuff!!! GO BHRT!!
And this is the link to the PR?
http://www.marketwatch.com/story/bioheart-announces-worlds-first-combination-stem-cell-treatment-2014-07-24
Wow and BioHeart is doing another very informative webinar?
ADIPOSE VS. BONE MARROW STEM CELLS
Partake in a discussion with the industry expert, Kristin Comella, to discuss the differences between Bone Marrow
Stem Cells and Adipose Derived Stem Cells. Register Today.
Wednesday, July 30, 2014 3:00pm - 4:00pm EDT
IMO the 10Q due in august will tell the true story of the direction of this company. Substantial revenue increases are 100% guaranteed IMO.
Wow!! "Bioheart Announces WORLD'S FIRST COMBINATION STEM CELL TREATMENT" that's amazing stuff!!! GO BHRT!!
And this is the link to the PR?
http://www.marketwatch.com/story/bioheart-announces-worlds-first-combination-stem-cell-treatment-2014-07-24
Wow and BioHeart is doing another very informative webinar?
ADIPOSE VS. BONE MARROW STEM CELLS
Partake in a discussion with the industry expert, Kristin Comella, to discuss the differences between Bone Marrow
Stem Cells and Adipose Derived Stem Cells. Register Today.
Wednesday, July 30, 2014 3:00pm - 4:00pm EDT
Wow!! "Bioheart Announces WORLD'S FIRST COMBINATION STEM CELL TREATMENT" that's amazing stuff!!! GO BHRT!!
And if I type in BioHeart in to a google search it will confirm this PR?! That's great news!!
Wow!! "Bioheart Announces WORLD'S FIRST COMBINATION STEM CELL TREATMENT" that's amazing stuff!!! GO BHRT!!
Wow, worlds first combination stem cell therapy. That's awesome. What an incredible feat.
The India PR is stating that they have begun the first ever combination TRIAL.
The Honduras PR is stating they have TREATED the first patient with combination therapy.
Read carefully...