Thing is JK fails to mention delay in moving along next generation cellution machine. JK already setting up for another miss. Gives him an out when he lowers target, he can say caused by unexpected delay. Whatever, read it and take it for what it's worth.
Cytori Therapeutics Inc (CYTX - NASDAQ - $0.51 )
Target Price: $6.00
Cytori Gets Final IDE Approval - Let the Trial Begin!
•Cytori announced that it has received final approval of the Investigational Device Exemption (IDE) to begin a pivotal trial for impaired hand function in scleroderma. This follows December's announcement of a conditional approval, and is good news that allows the 'STAR' trial to begin enrolling patients as expected. If the trials is successful, it should be enough for FDA approval.
•There are no changes to the plans to enroll 80 patient in up to 12 centers in the US. The 'STAR' trial is a phase II/III pivotal trial, based on phase I data (proof of concept) from an investigator-initiated trial in France that was published late this summer. (Paper Link)
•Cytori will hold two meetings in San Francisco this week. An information session with its CEO is scheduled for Monday, January 12 at 3:30 PST at the Biotech Showcase in San Francisco. An information session with the STAR trial's Principal Investigator is planned for Wednesday, January 14 at the Prescott Hotel, 545 Post Street, Room 736 from 1:30 to 4:30 PST.
•We believe that Cytori now has an accelerated pathway to ADRC approval for Scleroderma and combined with the expected release of a next generation Celution System in early 2015, is poised for a valuation inflection.
Phase I Study results. Twelve Scleroderma patients received autologous ADRCs by subcutaneous injection into each finger. Primary endpoints were safety and tolerability at 2 and 4 months, which were met and no adverse events reported. Secondary endpoints showed sustained, statistically significant improvements for hand and diabililty pain, Raynauds’s phenomenon (discoloration of extremities and pain due to lost blood flow), and quality of life at 2 and 6 months.
Key Data Points. Hand disability was reduced, as measured by a decrease from baseline in the Cochin Hand Function Scale at both two months (47.4%) and six months (56.0%); Hand pain was diminished, as measured in visual analog score at both two months (37.8%) and six months (41.7%); Raynaud’s phenomenon was reduced, as measured by a decrease from baseline in the Raynaud’s Condition Score at both two months (53.7%) and six months (67.5%); and Overall quality of life was improved, as measured by a decrease from baseline in the Scleroderma Health Assessment Questionnaire scores at both two months (45.2%) and six months (42.4%).
What is Scleroderma? Scleroderma is an autoimmune disorder that causes skin fibrosis and destructive changes in blood vessels due. Scleroderma is a systemic disease that affects the major organs but most commonly causes changes in the skin and hands, often resulting in disability, diminished mobility and pain. Care is largely palliative and is based on treatment standards for Raynauds’s phenomenon. There are 75,000 scleroderma patients in the US alone and most have hand manifestations of the disease. This represents an opportunity for Cytori to advance the ADRC franchise. The patient population is not large but the cost of care is high, likely resulting in significant market penetration quickly.
Valuation. We assume Cytori will be successful in Scleroderma and multiple other indications utilizing ADRCs (thermal burns, stress urinary incontinence, and osteoarthritis. We apply a 25% risk cut to our therapeutic model and a 30% discount to financial models for FCFF, discounted EPS, and SOP to arrive at a $6.00 price target.
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Yes, no mention of the CXT2 delay due to lack of funds but even more interesting is the failure to mention that this and all US auto-immune indication treatments are licensed from another company because Cytori failed to file for a patent !!! Can you say revenue sharing ?
Besides...JK's reports are intended for fresh lambs...not the ones already slaughtered. LOL
I wonder if there has been any discussion on a company name change ?