funny..I JUST HAD to get my shares before the close...come hell or high water I decided to buy...I refused to wait till tomorrow...In all honesty i would have paid 4 cents today...because I had that terrible feeling this would open up at like 4 cents..and I would be ultra miserable tomorrow..Now if that happens I will be ultra happy
The Japanese and Stem Cells $120 BILLION world market by 2030
In the second half of the 20th century, Japan emerged as a world leader in automobiles and consumer electronics. In the first half of this century, the country plans to do the same with stem cells and regenerative medicine.
Japanese government officials and foreign companies working in Japan outlined that vision Wednesday at the annual Stem Cell Meeting on the Mesa. This annual gathering on Torrey Pines Mesa has attracted more than 800 attendees seeking to learn how to bring regenerative therapies to patients -- and make a profit.
With a declining population, more than 25 percent of which are over 65, Japan faces a demographic imperative to extend the healthy lives of its citizens. That vision encompasses repairing damaged organs, replacing worn-out tissues with replacements grown from stem cells, and developing better drugs and biomedical devices.
The United States, with its own aging Baby Boomer population, may see its own future in Japan's struggles to bring advanced biomedical research to patients who need it. And Japan is inviting the U.S. and other nations working in the field to join it, by collaborating with companies and even helping them set up operation in Japan.
Fast track in JAPAN
Under this law, accelerated marketing approval of cell-based regenerative medicine products is possible after demonstration of safety and some signs of efficacy (Phase 1/2 trials). In September of this year, the first two products were approved in Japan under new law. ______________________________________________________________________________ This is Heart Sheet. A "Cellular and Tissue Based Stem Cell Product" which is a Heart Failure Therapy similar to what US Stem Cell Inc. has with MYOCELL SDF-1.
June 6 ,2016 Terumo Launches HeartSheet®: A Global First Cellular and Tissue-based Product Designed for the Treatment of Heart Failure.
Terumo Corporation (Headquarters: Tokyo, Japan; President and CEO: Yutaro Shintaku) announced today that in late May it commenced sales of HeartSheet - a global first cellular and tissue-based product designed for the treatment of heart failure.
HeartSheet is designed for treating severe heart failure caused by chronic ischemic heart disease. The treatment involves producing skeletal myoblast sheets by culturing skeletal myoblasts contained in muscle tissue that has been taken from the patient’s own thigh, and then transplanting the sheets onto the surface of the patient’s heart.
HeartSheet is a product comprised of two kits: Kit A for collecting the patient’s cells, and Kit B with cultured skeletal myoblasts and tools for producing sheets from cells. Kit A has already been sold to one medical institution, leading to the first case of patient cell collection covered by health insurance. Terumo estimates that the product will be used 20 to 30 cases per year for treatment.
HeartSheet is expected to become a new alternative for the treatment of severe heart failure caused by chronic ischemic heart disease, for which conventional treatments, such as drug therapy and coronary artery bypass surgery,* lack efficacy.
* (artery bypass being..) A surgical procedure for transplanting blood vessels from the legs or other body area to a blocked coronary artery to create an alternative path for blood to flow
In addition, HeartSheet was the first product to be designated as a conditional approval, a system put in place for the purpose of facilitating practical applications of regenerative medicine by the Ministry of Health, Labour and Welfare of Japan. The system is attracting attention among corporations and researchers involved in cellular and tissue-based products, and the utilization of the system is expected to promote advancements in regenerative medicine going forward.
HeartSheet (produced by Terumo) is priced ~$120k. Depending on insurance plans, Japanese patients will still have to pay anything between 5% to 30% of this price out of pocket.
THATS RIGHT. I SAID IT. 120,000 DOLLARS. Now I am not making this up. Check out the Seeking Alpha Article if you don't believe me...
Terumo has been promoting joint research with Osaka University, where clinical research on skeletal myoblast sheets is being carried out by Professor Yoshiki Sawa as part of a project sponsored by the New Energy and Industrial Technology Development Organization (NEDO). Terumo has also participated in a research project on regenerative medicine using cell sheets. It is led by Professor Teruo Okano of Tokyo Women’s Medical University, which is part of a special consortia involved in developing advanced medical care in Japan.
_______________________________________________________________________________ Now In Japan:
Clinical trials can be started with just a demonstration of "probable benefit," and products can be approved by successfully conducting a relatively small number of trials, he said.
Already, two cell-based therapies have been approved under the new system, he said. One consists of sheets of muscle cells grown from the patient's own cells, and grafted into the heart to improve function. The other is a treatment of graft vs. host disease, a potentially fatal complication of a bone marrow transplant. That treatment is made from mesenchymal stem cells, which modulate the immune response.
To keep costs down, academic medical centers can outsource cell production to manufacturing centers that can bring economies of scale. And a whole host of well-known Japanese companies such as Nikon, Fujifilm, Panasonic and Olympus are partnering with companies in America and elsewhere.
Predicting a $120-billion market, Japan targets stem cells to recharge economy
Japan believes regenerative medicine will grow from a $950-million domestic industry in 2020 to a $10 billion one by 2030, according to a report by Bloomberg News.
And the Japanese expect to tap into a $120-billion global market over the same time span if regenerative medicine fulfills its potential to set off “a medical and industrial revolution.”
...predicts the overall market for stem cells will reach $12bn in 2018, achieving high revenue growth from 2015 to 2025.
"Therapies in myocardial infarction, heart failure and other prominent diseases have reached phase III trials, suggesting the stem cells market will achieve rapid growth during the middle of our forecast period.
Ocata Therapeutics of Marlborough, which researches treatments for eye diseases, has agreed to be sold to Astellas Pharma Inc. of Japan for $379 million, the two companies announced late Monday.
Cellular Dynamics International, an up-and-coming player in the stem cell field and one of Wisconsin’s more promising biotech companies, is being acquired by Fujifilm for $307 million in cash.
Takeda Pharmaceutical, Japan's largest drugmaker, is scouting for potential multibillion-dollar acquisitions in the United States and other overseas markets
...he declined to confirm a report in the Financial Times that the company had set aside $10 billion to $15 billion for acquisitions.
Positive results with USRM and Myocardial infarction (Heart Attack) could lead to a possible situation where the Japanese would maybe want to be involved with Myocell ...
Promising Results Company’s MARVEL Trials on MyoCell
The company recently announced positive clinical results for MyoCell following the first part of its Phase II/III, double-blinded, placebo-controlled clinical trial called MARVEL. Over the 6-month observation period in this trial, the most pronounced changes were seen in the cell-treated groups. The six minute walk distance (6MWD), an established parameter of efficacy utilized in heart failure studies, one of the primary end points in the trial, increased on average by more than 91 meters, or 35%, in cell-treated patients, whereas in the placebo-treated group a decrease of nearly 4 meters was seen. This suggests that patients with heart failure could return to a more active lifestyle after receiving Bioheart’s treatment. No stem cell related safety issues such as arrhythmias, or irregular heartbeat, were observed. An arrhythmia event is disturbing but not serious. In the MARVEL trial pre-treatment with amiodarone enabled patients to avoid arrhythmias.
Cleveland Clinic in Licensing Agreement with Bioheart for SDF-1 In February 2006, Bioheart signed a patent licensing agreement with the Cleveland Clinic of Cleveland, Ohio which gave the company exclusive license rights to pending patent applications in connection with SDF-1. Dr. Marc Penn, the Medical Director of the Cardiac Intensive Care Unit at the Cleveland Clinic and a staff cardiologist in the Departments of Cardiovascular Medicine and Cell Biology, joined Bioheart’s Scientific Advisory Board. The license for SDF-1 was passed on to a Cleveland Clinic affiliate, Juventas, in July of 2009. Bioheart has a memorandum of understanding with Juventas pursuant to which the license with Bioheart will be reinstated upon completion of certain milestones.
from filing:
Bioheart Has Opportunity to Commercialize SDF-1 from Ono Pharmaceutical In 2007, Bioheart signed a Letter of Intent with Ono Pharmaceutical which provided rights to conduct clinical development and testing of SDF-1 to determine the effectiveness of SDF-1 for the treatment of damaged myocardium and tissues following acute myocardial infarction
Testing Acute Myocardial Infarction:
Before Bioheart Went Public: Research with Yoshiki Sawa
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