== Thermogenesis (KOOL) - fliegt hier der Deckel? == - 500 Beiträge pro Seite
eröffnet am 05.01.12 14:45:53 von
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Beiträge: 51
ID: 1.171.468
ID: 1.171.468
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Gesamt: 4.591
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ISIN: US88362L2097 · WKN: A3D3XX · Symbol: THMO
0,6390
USD
+10,36 %
+0,0600 USD
Letzter Kurs 02:00:00 Nasdaq
Werte aus der Branche Sonstige Technologie
Wertpapier | Kurs | Perf. % |
---|---|---|
2,0000 | +81,82 | |
2,0000 | +33,33 | |
0,7000 | +25,00 | |
0,6160 | +17,56 | |
0,5900 | +11,32 |
Wertpapier | Kurs | Perf. % |
---|---|---|
0,5120 | -10,61 | |
3,6600 | -11,49 | |
10,130 | -11,60 | |
0,7000 | -12,50 | |
1,8400 | -15,21 |
Tach allerseits.
Es gibt sehr interessante News bezüglich Thermogenesis!
THERMOGENESIS ANNOUNCES APPROVAL OF AXP® BY INDIA MINISTRY OF HEALTH
(RANCHO CORDOVA, CA), January 4, 2012 —ThermoGenesis Corp. (NASDAQ: KOOL),
a leading supplier of innovative products and services that process and store adult stem cells, said today that India’s Ministry of Health has approved the AutoXpress® System (AXP), enabling the Company to initiate commercial sales of the product in India. The AXP is used for the
processing of stem cells from cord blood.
“We are pleased to have achieved registration for the AXP in India and will be working closely with Fenwal, Inc., our AXP distributor in the market, to begin the commercial launch of the device,” said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis.
“The AXP represents advanced stem cell technology and India is one of the largest and fastestgrowing markets in the world,” said Vikram Karnani, vice president, Therapeutics, for Fenwal.
We look forward to working with ThermoGenesis to introduce this important technology to physicians in India.”
Engle noted that the AXP approval in India comes as the Company awaits approval of the product in China. “As we announced in October, the submission has been accepted by the Chinese Food & Drug Administration (SFDA), which represents successful completion of product testing and the administrative acceptance of the submission. The final professional
review is now in process and we are hopeful that the AXP will receive regulatory approval in China in early 2012.”
Es gibt sehr interessante News bezüglich Thermogenesis!
THERMOGENESIS ANNOUNCES APPROVAL OF AXP® BY INDIA MINISTRY OF HEALTH
(RANCHO CORDOVA, CA), January 4, 2012 —ThermoGenesis Corp. (NASDAQ: KOOL),
a leading supplier of innovative products and services that process and store adult stem cells, said today that India’s Ministry of Health has approved the AutoXpress® System (AXP), enabling the Company to initiate commercial sales of the product in India. The AXP is used for the
processing of stem cells from cord blood.
“We are pleased to have achieved registration for the AXP in India and will be working closely with Fenwal, Inc., our AXP distributor in the market, to begin the commercial launch of the device,” said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis.
“The AXP represents advanced stem cell technology and India is one of the largest and fastestgrowing markets in the world,” said Vikram Karnani, vice president, Therapeutics, for Fenwal.
We look forward to working with ThermoGenesis to introduce this important technology to physicians in India.”
Engle noted that the AXP approval in India comes as the Company awaits approval of the product in China. “As we announced in October, the submission has been accepted by the Chinese Food & Drug Administration (SFDA), which represents successful completion of product testing and the administrative acceptance of the submission. The final professional
review is now in process and we are hopeful that the AXP will receive regulatory approval in China in early 2012.”
1. Widerstand durchgebrochen.
Man, ich bin ein Alleinunterhalter hier. Schläft ihr alle?
Thermogenesis Signs Worldwide Res-Q System Distribution Agreement With Arthrex for Sports Medicine Applications
RANCHO CORDOVA, Calif., Jan. 10, 2012 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store human cell concentrates, said today it has entered into a five year collaboration with Arthrex, Inc., under which Arthrex will market ThermoGenesis' Res-Q® 60 (Res-Q) System technology for use in the preparation of autologous Platelet Rich Plasma (PRP) and Bone Marrow Concentrate (BMC).
Based in Naples, Florida, Arthrex is a worldwide leader in sports medicine product development and educational services for orthopaedic surgeons. The company has developed more than 5,000 products for arthroscopic and minimally invasive orthopaedic surgical procedures used worldwide.
The Res-Q technology is a point-of-care platform designed for the preparation of cell concentrates. In June, 2011, the Company received FDA clearance of its 510(k) submission for use of Res-Q technology for the safe and rapid preparation of autologous PRP from a small sample of blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
About Arthrex
Arthrex, headquartered in Naples, FL, is a worldwide leader in sports medicine product development and educational services for orthopaedic surgeons. More than 5,000 products for arthroscopic and minimally invasive orthopaedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.arthrex.com.
About ThermoGenesis Corp.
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products.
This press release contains forward-looking statements. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors including timing of FDA and foreign regulatory approvals, changes in customer forecasts, our failure to meet customers' purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers' products, introduction timing and acceptance of our new products scheduled for fiscal year 2012, and introduction of competitive products and other factors beyond our control could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2012. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption "Risk Factors" in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
ThermoGenesis Corp.
Web site: http://www.thermogenesis.com
Contact: Investor Relations
+1-916-858-5107, or
ir@thermogenesis.com
SOURCE ThermoGenesis Corp.
© 2012 PR Newswire
RANCHO CORDOVA, Calif., Jan. 10, 2012 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store human cell concentrates, said today it has entered into a five year collaboration with Arthrex, Inc., under which Arthrex will market ThermoGenesis' Res-Q® 60 (Res-Q) System technology for use in the preparation of autologous Platelet Rich Plasma (PRP) and Bone Marrow Concentrate (BMC).
Based in Naples, Florida, Arthrex is a worldwide leader in sports medicine product development and educational services for orthopaedic surgeons. The company has developed more than 5,000 products for arthroscopic and minimally invasive orthopaedic surgical procedures used worldwide.
The Res-Q technology is a point-of-care platform designed for the preparation of cell concentrates. In June, 2011, the Company received FDA clearance of its 510(k) submission for use of Res-Q technology for the safe and rapid preparation of autologous PRP from a small sample of blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
About Arthrex
Arthrex, headquartered in Naples, FL, is a worldwide leader in sports medicine product development and educational services for orthopaedic surgeons. More than 5,000 products for arthroscopic and minimally invasive orthopaedic surgical procedures have been developed by Arthrex and are currently marketed worldwide. For more information, visit www.arthrex.com.
About ThermoGenesis Corp.
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products.
This press release contains forward-looking statements. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors including timing of FDA and foreign regulatory approvals, changes in customer forecasts, our failure to meet customers' purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers' products, introduction timing and acceptance of our new products scheduled for fiscal year 2012, and introduction of competitive products and other factors beyond our control could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2012. A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption "Risk Factors" in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
ThermoGenesis Corp.
Web site: http://www.thermogenesis.com
Contact: Investor Relations
+1-916-858-5107, or
ir@thermogenesis.com
SOURCE ThermoGenesis Corp.
© 2012 PR Newswire
ich bin hier schon 10 jahre dabei x-mal nachgekauft und immer noch DICKE im minus.
sollte mal DER biotech-titel für den bereich "stammzellen" werden....tja defakto sind die eine firma mit so gut wie keinem umsatz geschweige denn gewinnen.
sollte mal DER biotech-titel für den bereich "stammzellen" werden....tja defakto sind die eine firma mit so gut wie keinem umsatz geschweige denn gewinnen.
Und wie sieht es aus mit axp und res-q? Das lässt sich doch beides bald verkaufen?
Und mit 23millionen cash und 2.3 Millionen schulden in 2011 haben die noch mehr als genug um neue Produkte in 2012 zu entwickeln. Siehe Präsentation http://www.thermogenesis.com/CMSFiles/Pdf/Corporate/investor…
meiner Meinung machen ist deren Potenzial noch nicht annähernd ausgeschöpft.
meiner Meinung machen ist deren Potenzial noch nicht annähernd ausgeschöpft.
der kurs hätte angeblich potentiel bis 400 EUR / je Aktie
sofern man unterstellt, dass kool die entsprechende nachfrage auch bedienen kann.
defakto wechselt dort ständig das management und es geht umsatzmäßig nichts vorwärts. die vorschusslorbeeren sind vorbei, der kurs dümpelt seit JAHREN vor sich hin, der nächste RE_Split ist wohl nicht mehr fern.
was fehlt ist der durchbruch, eine hammermeldung und dann kommt auch wieder leben in den wert.
sofern man unterstellt, dass kool die entsprechende nachfrage auch bedienen kann.
defakto wechselt dort ständig das management und es geht umsatzmäßig nichts vorwärts. die vorschusslorbeeren sind vorbei, der kurs dümpelt seit JAHREN vor sich hin, der nächste RE_Split ist wohl nicht mehr fern.
was fehlt ist der durchbruch, eine hammermeldung und dann kommt auch wieder leben in den wert.
und...läuft doch prima hier ;-)
ThermoGenesis Announces Registration Approval for BioArchive in China
Submitted by alex.folkenflik on 12 April 2012 - 5:47pm
ThermoGenesis Corp. (NASDAQ: KOOL), a supplier of innovative products and services that process and store adult stem cells, said that China's State Food and Drug Administration (SFDA) has approved the registration of the Company's BioArchive System (BioArchive), enabling its direct commercial sale by the Company into the People's Republic of China. ThermoGenesis Corp. is a company in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These include: The BioArchive System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant. AXP AutoXpress Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP MarrowXpress and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood. The MXP is used for the preparation of cell concentrates, including stem cells, from bone marrow aspirates in the laboratory setting. The Res-Q 60 BMC/PRP (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
Submitted by alex.folkenflik on 12 April 2012 - 5:47pm
ThermoGenesis Corp. (NASDAQ: KOOL), a supplier of innovative products and services that process and store adult stem cells, said that China's State Food and Drug Administration (SFDA) has approved the registration of the Company's BioArchive System (BioArchive), enabling its direct commercial sale by the Company into the People's Republic of China. ThermoGenesis Corp. is a company in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These include: The BioArchive System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant. AXP AutoXpress Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP MarrowXpress and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood. The MXP is used for the preparation of cell concentrates, including stem cells, from bone marrow aspirates in the laboratory setting. The Res-Q 60 BMC/PRP (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
Antwort auf Beitrag Nr.: 43.047.095 von DR.ZEISSLER am 17.04.12 07:08:56Was ist los, Dr.Zeissler ? Immer noch dabei ? Kommt hier bald eine fusion mit totipotenRX ? Das wäre doch der Hammer !
MFG
Chali
MFG
Chali
ich bin schon seit mehr als 10 Jahren mit Dauerverlusten dabei.
(/) 2,20 EUR habe ich bezahlt. Resplit's gab es wegen der 1 EUR
Nasdaq-Regel usw.
Die kurzzeitige Erholung wurde doch schon wieder massiv abverkauft.
So wird das nix.
Der Langfristchart spricht Bände. Ich verkaufe nicht mit Verlust.
(/) 2,20 EUR habe ich bezahlt. Resplit's gab es wegen der 1 EUR
Nasdaq-Regel usw.
Die kurzzeitige Erholung wurde doch schon wieder massiv abverkauft.
So wird das nix.
Der Langfristchart spricht Bände. Ich verkaufe nicht mit Verlust.
Hallo allerseits,
nach der Restrukturierung geht doch endlich was: Heute knallt es zumindest gewaltig.
nach der Restrukturierung geht doch endlich was: Heute knallt es zumindest gewaltig.
Welches Potential siehst hier noch? Nach dem heutigen Anstieg?
Vor 1-2 Jahres hieß es mal, dass die Aktie "theoretisch" ein Potential bis 400 USD hat.
Was man da Zugrunde gelegt hat, weis ich leider nicht mehr. Mir würden schon 4 USD
reichen.
Was man da Zugrunde gelegt hat, weis ich leider nicht mehr. Mir würden schon 4 USD
reichen.
http://www.nasdaq.com/press-release/totipotentrx-corporation…
Das ist natürlich sensationell...
Wenn von 19 Personen, die an CLI (Critical Limb Iscemia= Raucherbein)leiden, und nur nur die Wahl zwischen der Amputation und einer Stammzellentherapie und sich für letztere entschieden hatten und 80% ihren Unterschenkel behalten konnten- bedeutet dass ein riesiges Potentzial im ganzen cardiovascular Bereich. Der merger zwischen thermogenesis und totipotent(bis jetzt privately held) zur neuen Fa.
Cesca Therapeutics soll am 10. Feb. vollzogen werden.
Mit dann 30Mio. shares outstanding ist die Bewertung bei 60 Mio market cap immer noch ein Witz..
Das ist natürlich sensationell...
Wenn von 19 Personen, die an CLI (Critical Limb Iscemia= Raucherbein)leiden, und nur nur die Wahl zwischen der Amputation und einer Stammzellentherapie und sich für letztere entschieden hatten und 80% ihren Unterschenkel behalten konnten- bedeutet dass ein riesiges Potentzial im ganzen cardiovascular Bereich. Der merger zwischen thermogenesis und totipotent(bis jetzt privately held) zur neuen Fa.
Cesca Therapeutics soll am 10. Feb. vollzogen werden.
Mit dann 30Mio. shares outstanding ist die Bewertung bei 60 Mio market cap immer noch ein Witz..
Antwort auf Beitrag Nr.: 46.272.125 von sm74 am 21.01.14 20:05:40die geht leicht über 10 $
bescheidene >Gewinnmitnahmen am Freitag
ich habe mit weit mehr gerechnet
die neue Woche wird dunkelgrün
ich habe mit weit mehr gerechnet
die neue Woche wird dunkelgrün
Der gestrige conference call war sehr professionell, die slide presentation auf der KOOL website gibt noch mehr Aufschluss über die Erfolge bei CLI (critical limb ischimia)und dem kommerziellen Potential!
Phase 2/3 soll in q2 beantragt werden und in q 4 gestarted werden. KOOL geht davon aus, dass die Studie eine Laufzeit von 2 Jahren haben wird.
Einziger Wermutstropfen: im Anschluss an die Präsentation waren nue 2 Fragen zu beantworten, also gilt es noch eine Menge non-believers zu überzeugen...
Phase 2/3 soll in q2 beantragt werden und in q 4 gestarted werden. KOOL geht davon aus, dass die Studie eine Laufzeit von 2 Jahren haben wird.
Einziger Wermutstropfen: im Anschluss an die Präsentation waren nue 2 Fragen zu beantworten, also gilt es noch eine Menge non-believers zu überzeugen...
jetzt wird der dampf wieder abgebaut..fällt seit tagen wie ein stein.
jeden Tag im fetten Minus
down down down...
I'm just a poor boy
KOOL -One More Hurdle, to Complete the Transition
https://maxim.bluematrix.com/sellside/EmailDocViewer?encrypt…
https://maxim.bluematrix.com/sellside/EmailDocViewer?encrypt…
Cesca Therapeutics Receives Notice of NON-Compliance, with NASDAQ Listening Rule - Feb 27, 2015
http://cescatherapeutics.com/wp-content/uploads/2015/02/0227…
"Rancho Cordova, CA, February 27, 2015 -- Cesca Therapeutics Inc. (Nasdaq: KOOL), an autologous cell-based regenerative medicine company, announced today that the Company received a letter from Nasdaq indicating that the Company had become non-compliant with the Nasdaq Listing Rule 5250(c)(1) requiring the Company to timely file its December 31, 2014 quarterly report with the Securities and Exchange Commission.
Under Nasdaq listing rules the Company has 60 calendar days to submit a plan to regain compliance and has until August 24, 2015 to regain compliance if its plan is accepted by NASDAQ. Failure to meet these conditions may subject the Company’s common stock to delisting. The Company is currently working on its plan to regain compliance and to file its quarterly report for the quarter ended December 31, 2014..
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
- SurgWerks(TM); proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
Cell harvesting
Cell processing and selection
Cell diagnostics
Cell delivery
- CellWerks(TM); a proprietary stem cell laboratory kit for the processing of target cells used in the treatment of oncological and hematological disorders.
- The AutoXpress(R) (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
- The MarrowXpress(R) (MXP); a derivative product of the AXP and its accompanying disposable bag set, for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood (RBC's and plasma) from bone marrow (stem cells) to a user defined volume in 30 minutes while retaining over 90% of mononuclear cells (MNCs).
- The Res-Q(TM) 60 (Res-Q); a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
- The BioArchive(R) System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant. "
http://cescatherapeutics.com/wp-content/uploads/2015/02/0227…
"Rancho Cordova, CA, February 27, 2015 -- Cesca Therapeutics Inc. (Nasdaq: KOOL), an autologous cell-based regenerative medicine company, announced today that the Company received a letter from Nasdaq indicating that the Company had become non-compliant with the Nasdaq Listing Rule 5250(c)(1) requiring the Company to timely file its December 31, 2014 quarterly report with the Securities and Exchange Commission.
Under Nasdaq listing rules the Company has 60 calendar days to submit a plan to regain compliance and has until August 24, 2015 to regain compliance if its plan is accepted by NASDAQ. Failure to meet these conditions may subject the Company’s common stock to delisting. The Company is currently working on its plan to regain compliance and to file its quarterly report for the quarter ended December 31, 2014..
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
- SurgWerks(TM); proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
Cell harvesting
Cell processing and selection
Cell diagnostics
Cell delivery
- CellWerks(TM); a proprietary stem cell laboratory kit for the processing of target cells used in the treatment of oncological and hematological disorders.
- The AutoXpress(R) (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
- The MarrowXpress(R) (MXP); a derivative product of the AXP and its accompanying disposable bag set, for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood (RBC's and plasma) from bone marrow (stem cells) to a user defined volume in 30 minutes while retaining over 90% of mononuclear cells (MNCs).
- The Res-Q(TM) 60 (Res-Q); a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
- The BioArchive(R) System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant. "
H.C.Wainwright / KOOL: FY2Q'15 Update—Pivotal CLI Trial Strengthened, by FDA Feedback - H.C.W. - Mar 4, 2015
- Reni Benjamin, Ph.D. -
- Investment opinion. We are reiterating our Buy rating for Cesca Therapeutics, but lowering our 12-month target price target, to $3(previously was $5), based on a discounted earnings/revenues analysis. As one of the only fully integrated regenerative medicine companies, Cesca has expanded beyond devices +tools, to develop therapies for patients with critical limb ischemia(CLI), acute myocardial infarctions(AMI), +patients who require hematopoietic stem cell transplants. Baaased on recent FDA feedback, the company plans to initiate a pivotal CLI trial, in 2Q'15, following final approval of a revised IDE protocol. With a solid portfolio of diverse assets, +a cash position of $8,400,000, weee believe Cesca represents an undervalued player, with upside for the long-term investor.
FY2Q'15 financial results, +outlook. On Feb 12, Cesca reported FY2Q'15 service-related revenues of $4,600,000, higher our estimate, of $3,700,000. The company also reported a net loss of ($4,400,000), or ($0.11)/share. Total R&D expenses were $1,500,000, comparable to our estimate, of $1,900,000, for the quarter. G&A expenditures were $3,600,000, higher than our estimate, of $2,200,000, +S&M expenditures of $720,000 were less than our estimate, of $816,000. We believe the company has sufficient resources, to fund operations, until mid-'15.
IDE protocol addresses FDA feedback. In December, Cesca received feedback from the FDA, on its Investigational Device Exemption(IDE) application, for the planned pivotal CLI trial. Speciiifically, the FDA requested additional characterization steps, for the SurgWerks-CLI process, including: (1) cell quality +potency data, for each step of the process, +(2) rapid, intraoperative testing of product quality, prior to injection into patients, to ensuuure the treatment clears a defined minimum therapeutic cell dose level, +product sterility. Baaased on our discussions with management, we believe these additional characterization steps are achievable, in a relatively short timeframe, +weee expect a modified IDE application to be submitted, within the next two or three months. Pending FDA authorization, we believe the pivotal CLI trial could initiate in 2Q'15, enroll 224 Rutherford 5 CLI patients @60 sties,
+take ~12 months to complete enrollment. Assuuuming trial initiation in 2Q'15, we anticipate primary endpoint readout, in 1H'17, which we believe could be a 'key value driver', for shareholders.
Powered for success. The CLI trial is powered to reeesolve a 20% difference in amputation free survival rate(AFSR), between treatment +placebo arms with 80% statistical power, with a built-in interim analysis that allows for repowering. We believe that by assuming a high(60%) AFSR in the placebo arm, the company may avoid biases, that have plagued other late-stage CLI trials, in which control arm amputation rates were significantly lower, than expected.
Valuation. We value Cesca using a risk adjusted discounted earnings/share, +revenue multiples, analysis. Applying an 8x multiple to our risk adjusted '22 revenues, of $240,000,000, we obtain a $3.68 valuation. Applying a 28x multiple to our probability adjusted '22 earnings/share, of $0.67, we obtain a valuation of $2.98. By averaging the two valuation methodologies, we obtain a 12-month price target of $3. ...-
rbenjamin@hcwresearch.com
212-356-0542
https://hcwco.bluematrix.com/sellside/EmailDocViewer?encrypt…
- Reni Benjamin, Ph.D. -
- Investment opinion. We are reiterating our Buy rating for Cesca Therapeutics, but lowering our 12-month target price target, to $3(previously was $5), based on a discounted earnings/revenues analysis. As one of the only fully integrated regenerative medicine companies, Cesca has expanded beyond devices +tools, to develop therapies for patients with critical limb ischemia(CLI), acute myocardial infarctions(AMI), +patients who require hematopoietic stem cell transplants. Baaased on recent FDA feedback, the company plans to initiate a pivotal CLI trial, in 2Q'15, following final approval of a revised IDE protocol. With a solid portfolio of diverse assets, +a cash position of $8,400,000, weee believe Cesca represents an undervalued player, with upside for the long-term investor.
FY2Q'15 financial results, +outlook. On Feb 12, Cesca reported FY2Q'15 service-related revenues of $4,600,000, higher our estimate, of $3,700,000. The company also reported a net loss of ($4,400,000), or ($0.11)/share. Total R&D expenses were $1,500,000, comparable to our estimate, of $1,900,000, for the quarter. G&A expenditures were $3,600,000, higher than our estimate, of $2,200,000, +S&M expenditures of $720,000 were less than our estimate, of $816,000. We believe the company has sufficient resources, to fund operations, until mid-'15.
IDE protocol addresses FDA feedback. In December, Cesca received feedback from the FDA, on its Investigational Device Exemption(IDE) application, for the planned pivotal CLI trial. Speciiifically, the FDA requested additional characterization steps, for the SurgWerks-CLI process, including: (1) cell quality +potency data, for each step of the process, +(2) rapid, intraoperative testing of product quality, prior to injection into patients, to ensuuure the treatment clears a defined minimum therapeutic cell dose level, +product sterility. Baaased on our discussions with management, we believe these additional characterization steps are achievable, in a relatively short timeframe, +weee expect a modified IDE application to be submitted, within the next two or three months. Pending FDA authorization, we believe the pivotal CLI trial could initiate in 2Q'15, enroll 224 Rutherford 5 CLI patients @60 sties,
+take ~12 months to complete enrollment. Assuuuming trial initiation in 2Q'15, we anticipate primary endpoint readout, in 1H'17, which we believe could be a 'key value driver', for shareholders.
Powered for success. The CLI trial is powered to reeesolve a 20% difference in amputation free survival rate(AFSR), between treatment +placebo arms with 80% statistical power, with a built-in interim analysis that allows for repowering. We believe that by assuming a high(60%) AFSR in the placebo arm, the company may avoid biases, that have plagued other late-stage CLI trials, in which control arm amputation rates were significantly lower, than expected.
Valuation. We value Cesca using a risk adjusted discounted earnings/share, +revenue multiples, analysis. Applying an 8x multiple to our risk adjusted '22 revenues, of $240,000,000, we obtain a $3.68 valuation. Applying a 28x multiple to our probability adjusted '22 earnings/share, of $0.67, we obtain a valuation of $2.98. By averaging the two valuation methodologies, we obtain a 12-month price target of $3. ...-
rbenjamin@hcwresearch.com
212-356-0542
https://hcwco.bluematrix.com/sellside/EmailDocViewer?encrypt…
Antwort auf Beitrag Nr.: 49.270.685 von Popeye82 am 08.03.15 05:35:27
Cesca Therapeutics Announces Approval of Its MarrowXpress(TM) System, in India - Feb 11, 2015
http://cescatherapeutics.com/wp-content/uploads/2015/02/MXPA…
"RANCHO CORDOVA, Calif., Feb. 11, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (KOOL), an autologous cell-based regenerative medicine company, today announced that the Company has received approval from the India Drug Controller General ("DCGI") for the import and commercialization of its MarrowXpressTM ("MXPTM") System in India.
"We are very pleased to receive approval from the DCGI for our MXP System for bone marrow stem cell processing specifically for the preparation of intra-operative at the point-of-care or clinical laboratory preparation of bone marrow concentrate," said Ken Harris, President and leader of Cesca's clinical programs. "In collaboration with Fortis Healthcare, India is a major focus in our bone marrow transplant initiative. Cesca is uniquely positioned to provide proprietary services and technology that will positively impact the lives of a growing number of patients in the region. With a current bone marrow market of approximately 30,000 to 40,000 patients per year and only 1,000 bone marrow transplants conducted annually in India, our reach and technology give us a first mover advantage that will benefit patients with hematological and oncological disorders across South Asia," continued Harris.
Cesca provides in-house GMP cell laboratory services, scientific support, and medical technology to Fortis' cutting edge program at the Fortis Memorial Research Institute, including use of Cesca's proprietary "CellWerks" approach that employs the MXP Platform. Cesca's technology and services expand both pediatric and adult patient access to life saving cellular treatments by enabling a number of transplants that might otherwise not be an option for the patient. These include:
- ABO Major Mismatched Transplants: The MXP System effectively removes the undesired red blood cells from a mismatched donor bone marrow unit without compromising the quantity and viability of targeted stem cells. This is especially important in pediatric transplants.
- Matched Unrelated Donor Programs: Volume debulking of undesired red blood cells and plasma of matched unrelated donor cells.
- Haploidentical Program: Enabling mismatched transplants by simultaneously reducing or eliminating the unwanted red blood cells, donor plasma containing harmful antibodies, and improving the efficiency for depleting harmful T-cells from the haploidentical (half-matched donor's) cells.
- Cord Blood Transplant Program: Cord blood processing and storage for the cutting edge double cord blood transplant.
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
- SurgWerks(TM); proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
- Cell harvesting
- Cell processing and selection
- Cell diagnostics
- Cell delivery
- CellWerks(TM); a proprietary stem cell laboratory kit for the processing of target cells used in the treatment of oncological and hematological disorders.
- The AutoXpress(R) (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
- The MarrowXpress(R) (MXP); a derivative product of the AXP and its accompanying disposable bag set, for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood (RBC's and plasma) from bone marrow (stem cells) to a user defined volume in 30 minutes while retaining over 90% of mononuclear cells (MNCs).
- The Res-Q(TM) 60 (Res-Q); a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
- The BioArchive(R) System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant. "
Cesca Therapeutics Announces Approval of Its MarrowXpress(TM) System, in India - Feb 11, 2015
http://cescatherapeutics.com/wp-content/uploads/2015/02/MXPA…
"RANCHO CORDOVA, Calif., Feb. 11, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (KOOL), an autologous cell-based regenerative medicine company, today announced that the Company has received approval from the India Drug Controller General ("DCGI") for the import and commercialization of its MarrowXpressTM ("MXPTM") System in India.
"We are very pleased to receive approval from the DCGI for our MXP System for bone marrow stem cell processing specifically for the preparation of intra-operative at the point-of-care or clinical laboratory preparation of bone marrow concentrate," said Ken Harris, President and leader of Cesca's clinical programs. "In collaboration with Fortis Healthcare, India is a major focus in our bone marrow transplant initiative. Cesca is uniquely positioned to provide proprietary services and technology that will positively impact the lives of a growing number of patients in the region. With a current bone marrow market of approximately 30,000 to 40,000 patients per year and only 1,000 bone marrow transplants conducted annually in India, our reach and technology give us a first mover advantage that will benefit patients with hematological and oncological disorders across South Asia," continued Harris.
Cesca provides in-house GMP cell laboratory services, scientific support, and medical technology to Fortis' cutting edge program at the Fortis Memorial Research Institute, including use of Cesca's proprietary "CellWerks" approach that employs the MXP Platform. Cesca's technology and services expand both pediatric and adult patient access to life saving cellular treatments by enabling a number of transplants that might otherwise not be an option for the patient. These include:
- ABO Major Mismatched Transplants: The MXP System effectively removes the undesired red blood cells from a mismatched donor bone marrow unit without compromising the quantity and viability of targeted stem cells. This is especially important in pediatric transplants.
- Matched Unrelated Donor Programs: Volume debulking of undesired red blood cells and plasma of matched unrelated donor cells.
- Haploidentical Program: Enabling mismatched transplants by simultaneously reducing or eliminating the unwanted red blood cells, donor plasma containing harmful antibodies, and improving the efficiency for depleting harmful T-cells from the haploidentical (half-matched donor's) cells.
- Cord Blood Transplant Program: Cord blood processing and storage for the cutting edge double cord blood transplant.
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
- SurgWerks(TM); proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
- Cell harvesting
- Cell processing and selection
- Cell diagnostics
- Cell delivery
- CellWerks(TM); a proprietary stem cell laboratory kit for the processing of target cells used in the treatment of oncological and hematological disorders.
- The AutoXpress(R) (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
- The MarrowXpress(R) (MXP); a derivative product of the AXP and its accompanying disposable bag set, for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood (RBC's and plasma) from bone marrow (stem cells) to a user defined volume in 30 minutes while retaining over 90% of mononuclear cells (MNCs).
- The Res-Q(TM) 60 (Res-Q); a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
- The BioArchive(R) System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant. "
Antwort auf Beitrag Nr.: 49.271.876 von Popeye82 am 08.03.15 12:59:55
mi sieht die Firma schon ausgesprochen interessant aus, halte aber, bis dato, keinerlei Anteile hier
KOOL -'Steady Progress' - MG - Mar 2, 2015
- Jason Kolbert -
Summary:
+ Cell Therapy Manufacturing: It's NOT Easy. Understanding what qualifies as an autologous cell therapy, and what represents product characterization, release characteristics, and sterility testing for a point-of-care process are critical issues. Resolution of these is positive and we believe eminent. In fact, we recently spoke with management and believe the proves is progressing well.
+ We believe that Cesca will meet the FDA requests and that the initiation of the pivotal phase III trial in no-option CLI for SurgWerks cell therapy should begin in 1H15. This should mark the beginning of Cesca's transition from low-margin device manufacturer to a high-margin, full therapeutics company.
+ As of the last reported quarter, the company had $8M in cash, sufficient to cover expenses over the next year.
+ Last, we are aware of the notice that management received regarding its 60-day notice to be in compliance with NASDAQ requirements. Management is confident that this will be resolved quickly, and we do not believe that "it's a big deal."
Details:
CLI Trial Represents the Future, and Adjudicated Amputations Are Novel. Cesca disclosed that, in prior CLI trials in the landscape, placebo rates have been hard to predict. Placebo patients in CLI trials tend to believe that their limb was improving from therapy and refused amputation. However, in the post-analysis, the patients learned that they did not receive therapy and that the limb/digit would have been amputated already if they were not in the trial. As a result, the placebo arm's amputation-free survival often is higher in trial; in the one we reviewed, it rose to >60%, vs. cell-treated patients' 82%. Our understanding is that the FDA will accept adjudicated amputations, meaning that the statement, "We would have amputated in any other circumstance," is enough to count a placebo patient’s limb as having been amputated. We believe this gives a strategic advantage to Cesca for their trial's design probability.
Conclusion: Stay Focused. We believe the issues cited by regulators are not insurmountable by the company. It may take a few months to resolve, but, in doing so, it paves the way for the trial to begin and validates the process, which, in turn, validates the platform. All Cesca then needs to do is demonstrate that the end product is potent and efficacious at doing what we believe these cells can do (promoting blood vessel formation and flow, reducing inflammation, and transitioning the body from scarring to healing). As such, we see a silver lining in this process, and we are encouraged, as it's clear that the company will marshal the resources to move forward into the first pivotal program. ...
jkolbert@maximgrp.com
(212) 895-3516
https://maxim.bluematrix.com/sellside/EmailDocViewer?encrypt…
mi sieht die Firma schon ausgesprochen interessant aus, halte aber, bis dato, keinerlei Anteile hier
KOOL -'Steady Progress' - MG - Mar 2, 2015
- Jason Kolbert -
Summary:
+ Cell Therapy Manufacturing: It's NOT Easy. Understanding what qualifies as an autologous cell therapy, and what represents product characterization, release characteristics, and sterility testing for a point-of-care process are critical issues. Resolution of these is positive and we believe eminent. In fact, we recently spoke with management and believe the proves is progressing well.
+ We believe that Cesca will meet the FDA requests and that the initiation of the pivotal phase III trial in no-option CLI for SurgWerks cell therapy should begin in 1H15. This should mark the beginning of Cesca's transition from low-margin device manufacturer to a high-margin, full therapeutics company.
+ As of the last reported quarter, the company had $8M in cash, sufficient to cover expenses over the next year.
+ Last, we are aware of the notice that management received regarding its 60-day notice to be in compliance with NASDAQ requirements. Management is confident that this will be resolved quickly, and we do not believe that "it's a big deal."
Details:
CLI Trial Represents the Future, and Adjudicated Amputations Are Novel. Cesca disclosed that, in prior CLI trials in the landscape, placebo rates have been hard to predict. Placebo patients in CLI trials tend to believe that their limb was improving from therapy and refused amputation. However, in the post-analysis, the patients learned that they did not receive therapy and that the limb/digit would have been amputated already if they were not in the trial. As a result, the placebo arm's amputation-free survival often is higher in trial; in the one we reviewed, it rose to >60%, vs. cell-treated patients' 82%. Our understanding is that the FDA will accept adjudicated amputations, meaning that the statement, "We would have amputated in any other circumstance," is enough to count a placebo patient’s limb as having been amputated. We believe this gives a strategic advantage to Cesca for their trial's design probability.
Conclusion: Stay Focused. We believe the issues cited by regulators are not insurmountable by the company. It may take a few months to resolve, but, in doing so, it paves the way for the trial to begin and validates the process, which, in turn, validates the platform. All Cesca then needs to do is demonstrate that the end product is potent and efficacious at doing what we believe these cells can do (promoting blood vessel formation and flow, reducing inflammation, and transitioning the body from scarring to healing). As such, we see a silver lining in this process, and we are encouraged, as it's clear that the company will marshal the resources to move forward into the first pivotal program. ...
jkolbert@maximgrp.com
(212) 895-3516
https://maxim.bluematrix.com/sellside/EmailDocViewer?encrypt…
Antwort auf Beitrag Nr.: 49.726.989 von Popeye82 am 07.05.15 00:18:48
https://hcwco.bluematrix.com/sellside/EmailDocViewer?encrypt…
https://hcwco.bluematrix.com/sellside/EmailDocViewer?encrypt…
St. Jude Children's Research Hospital +Cesca Therapeutics Enter Into Collaboration Agreement, Targeting Bone Marrow Transplantation - Oct 1, 2015
http://app.quotemedia.com/quotetools/newsStoryPopup.go?story…
"RANCHO CORDOVA, Calif., Oct. 1, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that it has entered into a collaboration agreement with St. Jude Children's Research Hospital, Memphis, Tennessee.
Under the terms of the agreement, St. Jude Children's Research Hospital will evaluate a prototype for a new CellWerksTM device under Cesca's "Early Technology Access Program". The new device will specifically address the need for reduced red blood cell content in stem cell preparation for patients at risk of major blood-type mismatches. Commercial launch of the new device is expected in late 2016.
Mitchel Sivilotti, Senior Vice President and Chief Biologist at Cesca Therapeutics stated, "This exciting collaboration with St. Jude Children's Research Hospital, one of the world's leading pediatric treatment and research facilities focused on children's catastrophic diseases, is a strategic next-step to Cesca's recent announcements addressing life-saving areas of need in hematology/oncology. We are in a unique position to develop and commercialize rapid cell isolation technology for multiple clinical applications and view major blood-type mismatch as one of the cornerstones of our growing CellWerks portfolio. This project, in addition to recent developments in our Haplo-identical Transplant program in India, represents a robust approach to addressing this growing, high value space."
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
SurgWerks™; proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
Cell harvesting
Cell processing and selection
Cell diagnostics
Cell delivery
CellWerksTM; an integrated system which includes a protocol, disposables and equipment for intra-laboratory use in treatment of oncological and hematological disorders.
The AutoXpress® (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
The MarrowXpress™ (MXP); a device and disposable system based on the AutoXpress platform for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control and optical sensors and concentrates white blood cells from bone marrow to a user- defined volume in 40 minutes while retaining over 90% of mononuclear cells (MNCs).
The BioArchive® System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant. "
http://app.quotemedia.com/quotetools/newsStoryPopup.go?story…
"RANCHO CORDOVA, Calif., Oct. 1, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that it has entered into a collaboration agreement with St. Jude Children's Research Hospital, Memphis, Tennessee.
Under the terms of the agreement, St. Jude Children's Research Hospital will evaluate a prototype for a new CellWerksTM device under Cesca's "Early Technology Access Program". The new device will specifically address the need for reduced red blood cell content in stem cell preparation for patients at risk of major blood-type mismatches. Commercial launch of the new device is expected in late 2016.
Mitchel Sivilotti, Senior Vice President and Chief Biologist at Cesca Therapeutics stated, "This exciting collaboration with St. Jude Children's Research Hospital, one of the world's leading pediatric treatment and research facilities focused on children's catastrophic diseases, is a strategic next-step to Cesca's recent announcements addressing life-saving areas of need in hematology/oncology. We are in a unique position to develop and commercialize rapid cell isolation technology for multiple clinical applications and view major blood-type mismatch as one of the cornerstones of our growing CellWerks portfolio. This project, in addition to recent developments in our Haplo-identical Transplant program in India, represents a robust approach to addressing this growing, high value space."
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
SurgWerks™; proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
Cell harvesting
Cell processing and selection
Cell diagnostics
Cell delivery
CellWerksTM; an integrated system which includes a protocol, disposables and equipment for intra-laboratory use in treatment of oncological and hematological disorders.
The AutoXpress® (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
The MarrowXpress™ (MXP); a device and disposable system based on the AutoXpress platform for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control and optical sensors and concentrates white blood cells from bone marrow to a user- defined volume in 40 minutes while retaining over 90% of mononuclear cells (MNCs).
The BioArchive® System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant. "
Der Versuch auf Ihub das Ding zu heben!
Kommt von 6,4$,nächsten Tage beobachten! Angeblich sollen News kommen!Alles ohne Gewähr!
kommen immer neue aktien und keine news...schon zigmal nachgekauft und schon wieder völlig unterwasser. bin seit 2000! dabei!
Heute kamen News,aber alles wieder verpufft!
und wie soll es jetzt weitergehen? Neuer Versuch mit "brandheißen News" oder doch der klassische und schon zigmal durchgeführte Re-Spilt?
ist das bitter, schlägt quasi ungebremst auf!
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