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Henry McCusker
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Analyst, Journalist and Publisher ... Henry enters his tenth (10) year at Scimitar Equity -Regenerative Medicine Investors which aggregates, curates and creates bottom-line content weeding of regenerative medicine and cell therapy news to provide a customized, vetted selection of relevant and... More
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  • Stem Cell Heart Attack Trial in EU, Cytori Therapeutics (CYTX) 1 comment
    Jan 20, 2011 6:18 PM
    First ADVANCE trial site to begin enrollment in the Netherlands

    CYTX received approval from The Netherlands to initiate a pivotal European trial, named ADVANCE, to investigate adipose-derived stem and regenerative cells (ADRCs) processed by the Celution® One System, in the treatment of patients with acute heart attacks.

    • This is the 1st country and trial center approval for ADVANCE;
    • Additional country and trial center approvals are anticipated throughout Europe during the first half of 2011;
    • One of the goals of the trial is to expand the Celution® System CE Mark to include acute heart attack claims and to provide economic data to justify its implementation and reimbursement.

    ADVANCE is a randomized, placebo controlled, double-blind trial that will enroll up to 360 patients with ST-elevation myocardial infarction in up to 35 centers, predominately in Europe.

    • The primary endpoint of the trial is reduction in infarct size as measured by cardiac magnetic resonance imaging (MRI);
    • ADVANCE will use the Celution® One, its next generation device manufactured by Olympus-Cytori Joint Venture;
    • The Celution® One System is an investigational device that is not yet commercially available.

    In 2010, Cytori reported results from the APOLLO trial, a pilot study for acute heart attack patients who underwent ADRC therapy.

    • The study showed that the harvest and injection of ADRCs were safe and well-tolerated in this patient population;
    • At 6 months, the procedure was associated with an improvement in infarct size in ADRC-treated patients, as well as in other measures.
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    wonder why cytx kept on skirting the USFDA trial and did all those trials in other places if they truly believe ADSC has any value at all.

    the way i see it, a third grade medical device company with a third grade device looking for a new drug status - a lot of smoke and they actually fooled a lot of stupid money but they can't fool the USFDA, thank GOD....
    22 Jan 2011, 12:43 PM Reply Like
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Financial considerations of the agreement include development and commercial milestone payments to Opexa of up to $195 M and a tiered royalty rate from the high single digits to the mid-teens based on net sales payable to Opexa. The potential payments to, Financings seem to always set a downward motion to the share pricing – expect a 5-10 depreciation., I have maintained a “BUY” in this market and at this pricing because of the late stage trial status even with a dwindling RegMed universe pricing and visibility. As the BOD … fulfills its responsibility … they will make this appointment permanent in the , If this isn't a SELL – what is , Is there more to come … , VSTM just “trugs” along in the preliminary stages of clinical development with twists and turns but nothing that upsets the apple cart – but great cash position!, $0.01 is dribble. A little early for an “Atta boy.” But, $190 M contingent payments of another $190 M…or $12.97 with terms of: $1.50 in cash up front and 0.2482 of a WMGI share (for total $6.47); 1 contingent value right (CVR) for additional $6.50 cash payable upon FDA approval of BMTI’s Augment Bone Graft an, $4.5 M in restricted common stock and $6 M through the issuance of an 8 amortizing redeemable convertible debenture that matures 6/1, 1/18/13 at $0.62. It is probably an appreciable release but, 10 M shares and warrant Offering at $2.10, A challenge to FDA’s Medical Device Authority … , a lot off issues – trials, A “good to great” clean-up year to … position NBS for the future and specifically that Suzhou Erye is gone replaced by cash, A “Strong BUY” and a price target of $3.00 for end of year FY12. , ACT will pay $12.5 M to the investors, ACTC – the “whirling dervish” of RegMed companies.Can anyone take responsibility to make ACTC a real company – that has good science, Advances in Autologous Whole Blood and Bone Marrow Separation , ALD-401 Safety Data presented at the World Stroke Congress in Brazil, An actionable release – based on increased revenue capacity. CMXI closed at $0.60 and could add $0.05 to $0.10 to their share price with this CE Mark., An overnight deal in a negative surprise – the after-market has been selling off the share to the tune of $2.88 … from the close of $3.32., and their owners are willing to spend “unlimited” amounts of money on their health care, Another significant milestone. The Erye divestiture brings non-dilutive capital that bolsters cash position, anticipated IND filing and clinical data., As usual $0.04 or -3.05 to $1.27. So hold on … still a “Speculative BUY” … but, ASTM, ASTM has “spit the chew” of investor sentiment with investors having NO choice but to allow the new coach to yank the failing seasoned veteran with a rookie reliever . Tough and painful but not surprising with the RegMed, ATHX, ATHX does have a 17 M share offering coming … and the stock has been trading $0.01 to $1.22., Bio-preservation Technology Recognized by 50 Client usage, BioTime (NYSE MKT: BTX) proposes stem cell assets acquisition deal – Issues Open Letter to Shareholders of Geron (GERN), BLFS, BLFS closed on Friday at $0.32 up $0.04 from $0.028 on 1/31/13., Breakdown of Q3/12 Achievements and Highlights and Results -NBS can break the $1.00 trend line by Q1/13. NBS is up $0.03 or 4.61 to $0.669., Breaking down Q3/12 Results and a "BUY" on no legal fanfare on Prochymal worldwide rights, BTX closed at $3.97 on 4/6/13 and is DOWN -$0.01 or -0.25 to $3.96. BTX has been flip-flopping since the 26 of April on small to moderate volumes undermining the 52 week high of $5.07. A HOLD., cancellation of options, Cardiovascular and Chronic Liver Disease Cell Therapy Clinical Studies approved in Japan …, cash, CEO retires, CMXI closed at $0.47 on 5/9/13. The 50 day moving average is $0.50 compared with the 200 day of $0.63 – the needle needs to be pushed! Investors should compare CMXI to Cytori (CYTX) who is trading at $2.59 as a good hybrid comparable. Let’s watch the stat, collaboration and reverse split , Collaboration as HypoThermosol® Media Demonstrates Improved Storage with Exclusive Distribution Rights for Cellenergy™ Hair Graft Storage Additive, Collaboration with Genzyme/Sanofi Ended , comprised of $2 M in cash, Contract by BARDA to Develop Cell Therapies for Thermal Burns Combined with Radiation Injury – Strong BUY – Stock UP $0.54 or 13.99 to $4.40, CYTX, CYTX closed at $2.52 and is UP $0.04 or 1.599 – expect small volume but a penny or two on a fastly closing Holy week., CYTX closed at $2.93 up $0.08 or $2.63 . A “BUY” with expectation of a $0.10 to $0.20 pop in the next week.CYTX Q4 EPS of -$0.06 beats by $0.10. Revenue of $4.3 M beats by $0.2 M. CYTX made substantial progress in 2012 ., CYTX closed on 11/9 at $3.83 and should be up $0.05-$0.10 in a higher market as shorts has been covering in the recent upward spiral since the earnings release.,
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