Thermogenesis
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THERMOGENESIS Corp. designs, develops, manufactures, and sells products
and devices that utilize its proprietary thermodynamic technology for the
processing of biological substances including the cryopreservation, thawing, and
harvesting of blood components. The Company was incorporated July 1986 as
InstaCool, Inc. of North America, and subsequently merged with Refrigeration
Systems International, Inc. In January of 1995, the Company changed its name to
the present to better reflect the thermodynamic blood-processing segment of the
biotechnology industry that it hopes to service through development of new
products.
Historically, THERMOGENESIS` primary revenues were from sales of ultra rapid
blood plasma freezers and thawers to hospitals, blood banks and blood transfusion
centers and plasma collection centers under US Food & Drug Administration
(FDA) clearance to market in the United States. During the fiscal years 1988
through 1995, the Company focused research and development efforts on the
refinement of product design for its blood plasma freezers and thawers. During that
period, the Company also sought new applications for its technology, including the
design of micro-manufacturing systems for biopharmaceutical drugs that utilize the
Company`s thermodynamic competence in new medical therapies.
Ultra Rapid Heat Freezers and Thawers
The Company`s Ultra Rapid freezers and thawers use heat transfer liquids, rather
than gases such as air, carbon dioxide or nitrogen to transfer heat to and from a
biological substance. The Company`s patented thin flexible plastic membrane
system is automatically interposed between the heat transfer liquid and the
container housing the blood component. Tests of the technology performed by the
Hague Center of the Netherlands Red Cross reports that 300 ml bags of plasma
were core frozen in 30 minutes versus 90-120 minutes in air blast freezers that
resulted in 18 to 32% more factor VIII in the cryoprecipitate from the frozen plasma.
In late Fiscal Year 1999, MP1100 MicroCascade, the first major upgrade of the
plasma freezer line was introduced. The MicroCascade is a breakthrough new
refrigeration technology that provides radically accelerated freezing performance.
The small, lightweight (100 lbs) integrated MicroCascade compressor/condenser
utilizing compact, lightweight Schroll compressors provides refrigeration capacity
equivalent to a bulky, heavy 8hp conventional remote compressor/condenser. The
advantage of the MicroCascade technology is that expensive and inflexible remote
condenser installations are not required. This flexibility allows laboratories to
quickly start up or modify their production routing by rolling in the MP1100,
plugging it into the electrical outlet and immediately begin flash freezing plasma.
Today, the Company still maintains the premier technology position in the plasma
freezing market segment, with competitors offering primarily 30-year-old blast
freezing (forced air) technology. A direct result of this advantage was the
Company`s success in establishing a significant market position in transfusion
societies and blood banks around the globe. The Company has five models of
freezers which vary primarily by capacity and condenser type. The MP 2000 and
MP 1000/1100 are suited for large laboratories running approximately 750 bags of
plasma per day. The MP 750 and MP 500 are suited for medium sized labs running
250 to 749 bags per day. The Company has three models of thawers. They vary
primarily by capacity: The MT202 thaws two bags simultaneously, and the MT204
and the MT210 four and ten bags respectively. In North America, the four major
manufacturers of plasma freezers are the Company, Revco, Forma Scientific and
Harris.
BioArchive Platform Products
The BioArchive Stem Cell System was the first product developed under the
BioArchive System technology platform. In collaboration with The NYBC, the
Company developed a disposable blood processing bag set that provides a sterile
method for collecting, concentrating and cryopreserving stem and progenitor cells
contained in PCB. These life giving stem and progenitor cells are targeted for
therapeutic use in patients who suffer from malignancies and genetic diseases of
the blood and immune system such as leukemia, lymphomas, diverse inherited
anemias, immunodeficiencies, acquired a plastic anemia and hypoproliferative
disorders.
The BioArchive Stem Cell System features a robotic cryogenic device that
automatically freezes, archives and manages an inventory of up to 3,626 PCB units
of stem and progenitor cells for transplant. The proprietary device also controls and
records the freezing profile of each PCB donation in nitrogen vapor, after which the
PCB unit is robotically transferred to a specified indexed location in liquid nitrogen.
The BioArchive System tracks the storage address of each PCB stem cell unit and
assures that only the specifically chosen, HLA matched PCB unit is retrieved when
selected for a human transplant recipient without exposing the other archived
samples to detrimental warming effects. The PCB stem and progenitor cell
donations are collected, processed, cryopreserved and transfused utilizing three
proprietary sterile disposable bag sets developed jointly by NYBC and the
Company and licensed to Medsep Corporation, a Division of Pall Corp., for
manufacturing and distribution in North America & Europe. The Company
re-acquired the rights to distribute the bag sets under its own name throughout the
rest of the world, except Japan.
In addition, the Company manufactures and sells three additional disposables
(canisters, canister sleeve, and overwrap bag) for the protection of the PCB units
during inter-laboratory transfers and shipment to the transplant centers which the
Company believes will provide an ongoing revenue stream.
The CryoSeal Platform products provide a superior and safer approach to producing
therapeutic doses of these proteins, enzymes and growth factors. Each CryoSeal
System is a micro-manufacturing platform which harvests and concentrates these
therapeutic blood components from the patient`s own blood, or in the case of such
medical conditions as hemophilia, from a directed donor.
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Press Release Source: ThermoGenesis Corp. On Wednesday March 30, 2011, 9:00 am
RANCHO CORDOVA, Calif., March 30, 2011 /PRNewswire/ -- ThermoGenesis Corp. (Nasdaq:KOOL - News), a leading supplier of innovative products and services that process and store adult stem cells, said today that Nanshan Memorial Medical Institute (Nanshan), a leading regenerative medicine company, will be utilizing its AXP® AutoXpress™ (AXP) and BioArchive® Systems used to process and store stem cells from cord blood in its two stem cell banks in China. The Nanshan facilities are located in Biolake, Wuhan City, a Hubei provincial government supported hi-tech zone specializing in biotechnology and in Jiuzhou Biotechnology Research Park in Xian City, Shanxi Province. Nanshan expects to procure over time the necessary processing and cryopreservation storage capacity to process and store up to several hundred thousand stem cell units at each facility.
Nanshan is a progressive regenerative medicine company that distributes medical products and has operated multiple, large healthcare facilities, including hospitals, stem cell banks and research centers.
Nanshan's decision to adopt ThermoGenesis' cord blood technologies follows a four-year distribution agreement between ThermoGenesis and Nanshan signed late last year under which Nanshan will distribute in China and Hong Kong ThermoGenesis' Res-Q™ 60 BMC (Res-Q) System and MXP™ MarrowXpress™ products used to prepare cell concentrates—including stem cells—from bone marrow at the point-of-care and in the laboratory.
"We are delighted to be expanding our relationship with Nanshan as we continue to implement a key element of our growth strategy by broadening the geographic reach of our offerings into potential high growth markets," said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis.
"Dr. Lu Daopei, founder and medical director of Nanshan, is a world-renowned hematologist and expert in the field of hematopoietic stem cell transplants. He is highly regarded in the scientific and medical communities in China due to his pioneering clinical research and medical practice, including the first successful syngeneic bone marrow stem cell transplant in the People's Republic of China to treat aplastic anemia and the first allogeneic peripheral blood stem cell transplant to treat acute leukemia," Engle added.
"We are looking forward to incorporating ThermoGenesis' world-class cord blood stem cell technology into our facilities. The AXP is proven technology for the precise isolation and high yield of stem cells in a quick and efficient process, while the BioArchive represents state-of-the-art storage technology for preserving the viability of stem cells from cord blood," said Daniel Lu, President of Nanshan.
About Nanshan Memorial Medical Institute
Nanshan is a multi-platform organization engaging in the commercialization and distribution of new products, healthcare-related R&D, education and innovative therapeutics. Nanshan has a broad clinical, academic and scientific network worldwide, particularly in China and the United States. The company's web site is www.nsmmi.com.
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Sacramento Business Journal - by Kathy Robertson, Staff writer
Date: Thursday, April 14, 2011, 9:44am PDT
ThermoGenesis Corp. announced Wednesday that its device used to process stem cells from bone marrow got commercial approval in India, sending its shares up as much as 8 percent before closing at $2.25.
The Rancho Cordova-based company will launch the Res-Q system in India with its South Asian partner TotipotentSC in the quarter ending June 30.
ThermoGenesis (Nasdaq: KOOL) provides technology to hospitals and blood banks that help in stem cell separation and preservation.
“This is a major regulatory milestone for the company and our market expansion strategy,” chairman and chief executive officer J. Melville Engle said in a statement.
The company expects to record initial revenues from the launch during the current quarter, supported by existing clinical trail programs managed through Totipotent’s clinical division.
“New stem cell technologies such as Res-Q are being adopted at a gradual but growing rate in India — a macro market which has enjoyed double-digit growth despite a challenging economic environment,” Kenneth Harris, chairman of Totipotent parent company MK Alliance Inc., said in a statement. “We believe in cellular medicine and that this device can have an important impact on the clinical cell therapy platform we make available to the medical community.”
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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.”
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
Mr. Ken Harris, Study Director and Chief Executive Officer of TotipotentRX, presented a case study and physician feedback confirming that the Company's Acute Myocardial Infarction Rapid Stem Cell Therapy ("AMIRST") protocol utilizing autologous bone marrow derived stem cells achieved its primary safety and secondary efficacy endpoints by improving the patient's Left Ventricular Ejection Fraction ("LVEF") from 35% to 60.3% in 24 months while preventing further infarct scarring and undesirable remodeling. Low LVEF and heart remodeling are two key contributors in AMI patients advancing to heart failure.
Dr. Ashok Seth, Chairman - Cardiac Sciences, and Dr. Vinay Sanghi, both of Fortis Healthcare, conducted the clinical case study which shows the AMIRST treatment safely delivered to a single male patient an effective dose of autologous selected stem cells in a single intracoronary heart catheterization procedure. The Company believes this is the first integrated combination product treatment, consisting of a combination of devices and biologics, to be evaluated in a larger follow-up study.
The combination product and procedure developed by TotipotentRX (patent pending) incorporating ThermoGenesis' cell processing technology, is known as the AMIRST protocol. The AMIRST protocol is performed by a cardiac interventional physician in less than 60 minutes to treat acute ST-elevated myocardial infarction in patients having an LVEF below 40%. This fully integrated treatment includes:
•a stem cell friendly process for harvesting bone marrow derived stem cells
•an optimized stem cell dose preparation process (device & biological)
•a rapid bedside cell analysis system (dose verification)
•and a proprietary intracoronary catheter delivery method (device + method)
Dr. Vinay Sanghi, Clinical Investigator and treating physician on this case, said "conducting a fully-integrated point-of-care treatment on a patient with an acute ST-elevated myocardial infarction using the AMIRST protocol was straightforward and very exciting as a practicing interventional cardiologist. The safety and positive clinical benefits demonstrated in this single patient case study are very encouraging as we begin the double-blinded AMIRST study which should provide statistically significant insights".
Mr. Harris noted, "this case study affirmed that our integrated combination product has appropriately considered the essential devices, diagnostics, cell formulation, and directions for use ensuring the AMIRST treatment meets the objectives of providing a safe, effective, rapid, bedside therapy for treating low ejection fraction after a primary myocardial infarction." He continued, "we are enthusiastically looking forward to the randomized placebo controlled Phase Ib study in the coming few months. We envision this product, if approved, will improve the quality of life and mortality rates of low LVEF patients."
"We are very pleased with the initial results of this study using our combination product," said Mr. Matthew Plavan, Chief Executive Officer of ThermoGenesis. "In addition to the positive safety and efficacy data, we are particularly encouraged by the potential durability of the treatment, given this patient's LVEF exceeded 60% two years post treatment. Based upon the AMI population and those that meet the criteria for an approved AMIRST therapy, we estimate the addressable U.S. market for our combination product to exceed $500 million per year."
This study will be advanced to a double blinded placebo-controlled randomized Phase Ib clinical trial of 30 patients (NCT01536106) in the first quarter of 2014.
About Acute Myocardial Infarction
Cardiovascular disease ("CVD") is the number one cause of morbidity and mortality worldwide. An estimated 17.3 million people died from CVDs in 2008, representing 30% of all global deaths. Of these deaths 7.3 million were due to coronary heart disease and 6.2 million from stroke. In the progression of CVDs, plaque lesions develop in arteries that result in a narrowing of vessels, and in severe cases the vulnerable plaque breaks open and creates a blockage of blood flow to vital organs in the heart or brain. In the case of the heart, this is classified as a myocardial infarction. LVEF is one of the key indications of mortality rates post myocardial infarction with a reduced LVEF being a risk factor for both sudden and non-sudden death, with the odds ratio for 1 year mortality after myocardial infarction at 9.48 (High Rate) for patients with an LVEF 30% compared to patients with LVEF > 50%, 2.94% (Moderate Rate) for patients with LVEF 30-40%, whereas the risk is not significantly increased (low rate) in patients with LVEF 40-50%. The specific patient highlighted in this announcement was in the moderate risk category.
About TotipotentRX Corporation
TotipotentRX Corporation is engaged in the research, development, and commercialization of cell-based therapeutics for use in regenerative medicine. We provide products and services to patients, physicians and partners including cell therapeutics, contract services, cell manufacturing and banking, and medical devices for cell therapies.
The Company's lead therapeutic technology platform, TotiCell(TM) (an intraoperative rapid system for harvesting, preparing, testing, and delivering a therapeutic dose of autologous bone marrow derived or peripheral blood derived cells and proteins), is currently in varying stages of Phase 1b trials as a potential treatment for acute myocardial infarction, critical limb ischemia, non-healing ulcers and avascular necrosis.
Our patented therapies are designed for rapid (under 60 minute) use at the bedside and per U.S. regulations include all integrated equipment, diagnostics, devices, and software to produce the specified autologous therapeutic cell dose.
About ThermoGenesis Corp.
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood and bone marrow processing systems and companion disposable products that enable the separation, processing and preservation of cell and tissue therapy products. These include:
•The BioArchive(R) 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(R) AutoXpress(R) Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP(R) MarrowXpress(R) 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-QTM 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).
In July 2013, TotipotentRX and ThermoGenesis Corp. announced their entry into a merger agreement which will operate under the name Cesca Therapeutics. The merger is subject to TotipotentRx and ThermoGenesis stockholder approval, among other conditions.
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As a result of eliminating a total of eleven positions in connection with the reorganization, coupled with other targeted savings in operating costs, the Company expects to realize approximately $1.5 million in annual expense savings. One-time severance costs of approximately $210,000 are expected over the next two quarters.
About ThermoGenesis Corp.
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood and bone marrow processing systems and companion disposable products that enable the separation, processing and preservation of cell and tissue therapy products. These include:
•AXP(R) AutoXpress(R) Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP(R) MarrowXpress(R) 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 BioArchive(R) 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.
•The Res-QTM 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).
In July 2013, TotipotentRX and ThermoGenesis Corp. announced their entry into a merger agreement which will operate under the name Cesca Therapeutics. The merger is subject to TotipotentRX and ThermoGenesis stockholder approval, among other conditions
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http://totipotentrx.com/
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.RANCHO CORDOVA, Calif., Nov. 14, 2013 (GLOBE NEWSWIRE) -- ThermoGenesis Corp. (KOOL) ("ThermoGenesis"), a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, today reported financial results for the first quarter of fiscal 2014.
For the quarter ended September 30, 2013, revenues were $3.6 million, compared to $4.1 million for the same period in 2012. The decrease in year-over-year revenues of $478,000 was primarily attributable to an anticipated temporary decrease in AXP disposable revenues due to the termination of the GE distribution agreement and the related wind-down of their inventory. This decrease was partially offset by increases in AXP sales in the Asian market.
Operating expenses for the quarter ended September 30, 2013 were $3.7 million, compared to $634,000 for the same period in 2012. The increase in operating expenses of $3.1 million was primarily attributable to a gain on the sale of the CryoSeal product line of $2.0 million in 2012, reflected as a reduction in operating expenses. Excluding the impact of this gain, operating expenses increased by $1.1 million due to professional fees associated with the proposed merger with TotipotentRX, legal diligence associated with patent litigation, and costs associated with establishing sales and distribution channels in Asia.
Adjusted EBITDA loss was $2.0 million for the quarter ended September 30, 2013 compared to $0.7 million for the same period in 2012. Adjusted EBITDA loss increased by $1.2 million compared with the same period in 2012 due to the decline in revenues associated with the decline in AXP sales and an increase in legal and professional fees associated with the proposed merger with TotipotentRX and legal diligence associated with patent defense litigation.
Net loss for the quarter ended September 30, 2013 was $2.3 million or $0.14 per share, compared to net income of $1.0 million or $0.06 per share for the same prior year period. The increase in the net loss of $3.3 million was primarily due to the gain of $2.0 million on the sale of a product line in 2012.
ThermoGenesis ended the first quarter with $5.3 million in cash compared to $6.9 million at the end of fiscal 2013. The Company's product backlog at the end of the first quarter was $300 thousand.
"The beginning of fiscal '14 has been marked by significant developments in our transformation into a regenerative medicine company focused on large and growing markets", said Matthew T. Plavan, Chief Executive Officer of ThermoGenesis. "These developments include the definitive agreement to merge with TotipotentRX, further repurposing of our resources towards high value clinical capabilities, publishing interim clinical trial results and the identification of new clinical applications having significant revenue potential." He continued.
In July 2013, ThermoGenesis announced the signing of a definitive merger agreement with TotipotentRX further outlined on Form S-4, filed with the SEC November 8, 2013.
In October 2013, TotipotentRX and ThermoGenesis released the results of their clinical pilot study confirming TotipotentRX's acute myocardial infarction ("AMI") combination product utilizing ThermoGenesis' point-of-care cell processing technology for an autologous bone marrow derived stem cell therapy can be delivered safely in 60 minutes. This ground-breaking combination product and procedure developed by TotipotentRX incorporating ThermoGenesis' cell processing technology is known as the AMIRST protocol. The AMIRST protocol is performed by a cardiac interventional physician in less than 60 minutes to treat acute ST-elevated myocardial infarction in patients having an LVEF below 40%.
"This case study affirmed that our integrated combination product has appropriately considered the essential devices, diagnostics, cell formulation, and directions for use ensuring the AMIRST treatment meets the objectives of providing a safe, effective, rapid, bedside therapy for treating low ejection fraction patients after a primary myocardial infarction." said Mr. Ken Harris, CEO of TotipotentRX, "we are enthusiastically awaiting the randomized placebo controlled Phase Ib study in the coming few months. We envision this product, if approved, will improve the quality of life and rehospitalization rates of low LVEF patients and represent a significant new revenue opportunity for our companies." The companies intend for this study to be advanced to a double blinded placebo-controlled randomized Phase Ib clinical trial of 30 patients (NCT01536106) in the first quarter of 2014.
In August 2013, ThermoGenesis and TotipotentRX announced the successful launch of their pediatric bone marrow transplant program at the Fortis-TotiRx Centre for Cellular Medicine in New Delhi, India. The new program recently achieved its first 100-day survival milestone following an allogeneic bone marrow engraftment in a pediatric patient with aplastic anemia using a donor with ABO-incompatible bone marrow. The successful transplant was performed using ThermoGenesis' MXP(R) MarrowXpress(R) System ("MXP").
ThermoGenesis also announced in October, a strategic reorganization initiative designed to better align resources with our expected cord blood revenue streams, provide additional funding to enhance our internal clinical resource capabilities and provide greater focus on new application development to improve the Company's market competitiveness. The net result of our reorganization is the elimination of a total of eleven positions. Coupled with other targeted savings in operating costs, the Company expects to realize a net savings of approximately $1.5 million from this reorganization.
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"Bebevida is a leading cord blood bank that offers cryopreservation services of both umbilical cord blood stem cells and umbilical cord tissue of newborns for family purposes in Portugal," said Matthew Plavan, Chief Executive Officer of ThermoGenesis. "This is an important win for us, having replaced yet another competitor's automated cell processing system installation, further increasing our footprint in Europe. We expect to begin the AXP conversion in February 2014," he continued.
"We have conducted an extensive evaluation of the AXP which verified that ThermoGenesis' platform yields higher stem cell recoveries and lower and more desirable hematocrit levels than our existing product platform. We are pleased to partner with ThermoGenesis and look forward to implementing the AXP System," said Silvia Martins, Chief Executive Officer of Bebevida. "We have invested more than three million Euros in a new state-of-the art laboratory to establish a leading position in Portugal's cord blood market and believe the performance of the AXP will enable us to further our growth objectives," she added.
Plavan also said, "We are committed to expanding our presence in Europe, so it is important to have valued partners like Bebevida committed to the AXP System. We believe this is a testament not just to our technology, but to our customer-centric approach incorporating marketing, service and support for our cord blood products."
Wednesday, 8 Jan 2014 09:00am EST
ThermoGenesis Corp:Says the signing of a five-year agreement to supply Cord Blood Registry (CBR), with ThermoGenesis' AutoXpress System (AXP) cord blood processing system and disposables.
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http://www.bizjournals.com/sacramento/news/2014/...out-of-danger.html
The trial achieved both its primary safety and secondary efficacy endpoints at 12 months, achieving statistical significance in five key areas including, major amputation free survival rates (82.4%), both resting and walking pain reduction, improved walking distance, open wound healing and vasculogenesis (generation of new blood vessels) in the treated leg. Furthermore, there were no serious adverse events determined to be related to the therapy. The open label single center study enrolled 17 patients and was completed at Fortis Escorts Heart Institute in New Delhi with Dr. Suhail Bukari, Senior Consultant and Vascular Surgeon serving as the primary investigator. Fortis Escorts Heart Institute and Dr. Bukari previously served as clinical investigator for the Juventas Therapeutics critical limb ischemia trial.
Dr. Bukari noted, "This is a significant breakthrough for medicine as all the patients enrolled were scheduled for amputation of their afflicted limb prior to consenting to the stem cell intervention." He further noted, "The simple kit process will enable any surgeon treating peripheral vascular disease to have a readily available safe and autologous therapeutic to reverse this debilitating disease."
CLIRST is a proprietary bedside technology platform and method which uses the patients own bone marrow stem cells to promote tissue repair through activation of natural stem-cell repair pathways, promotion of new blood vessel formation and prevention of on-going cell death. The integrated combination device-biological product called SURGWERKS(TM) - CLI, contains optimized stem cell harvesting, selection, and delivery disposables in a single kit, and the procedure can be completed on a patient in less than 60 minutes in the operating room with mild sedation as an alternative to major limb amputation. The SURGWERKS-CLI product delivered a mean cell dose of BMCePC (bone marrow concentrate enriched progenitor cells) of 8.04 x 108 +/- 3.65 cells in a 20ml final product which was injected intramuscularly in the lower afflicted leg.
"We are extremely excited to demonstrate that our integrated cell therapy SURGWERKS kit has removed the variability that has plagued most stem cell treatments developed to date, especially in treating CLI. This study demonstrated that our SURGWERKS' amputation free survival rate of 82% is almost 25% higher than alternative therapeutic approaches to date, which we believe is a testament to the quality of our autologous cell formulation and the repeatability of our proprietary process," said Ken Harris, Chief Executive Officer of TotipotentRX. "The goal of the stem cell therapy is to prevent major limb amputation, and improve quality of life, decrease morbidity and mortality rates, and ultimately reduce total healthcare spend on these patients. We anticipate offering this treatment at a significantly lower cost than non-bedside treatments, and will stay focused on the large U.S., European and Indian markets," he continued.
"One of the benefits of our long-standing partnership with TotipotentRX, is the successful integration of our cell processing systems into the SURGWERKS-CLI therapy kit," said Matthew Plavan, Chief Executive Officer of ThermoGenesis, Corp. "Based upon the statistical significance of these Phase Ib trial results, we are highly encouraged with the potential for this therapy to perform well in the next phase of the clinical trial process and to ultimately lead to a curative treatment for CLI and a very large market opportunity for our two companies," he continued.
Dr. Venkatesh Ponemone, PhD, Executive Director of Clinical Affairs for TotipotentRX and scientific investigator for the study commented that this is the first known study to provide statistically significant angiographic quantitative and qualitative evidence of limb revascularization as independently verified by a core radiology lab.
The statistical significance reached in the phase Ib trial includes:
Major limb Amputation free survival rates - 82.4%
Pain reduction - mean VAS score pre-therapy 7.8 +/- 0.97 and 12 month follow-up 0.2 +/- 0.58 on a scale of 0-10, p=0.0005
6-minute walking distance - mean distance pre-therapy of 14.5 meters +/- 37.57 and 12 month follow-up of 157 meters +/- 100.92, p=0.0039
Open wound healing - 11 patients had gangrene with or without ulceration pre-treatment and all patients had neither gangrene nor ulceration at 12 month follow-up
Vasculogenesis in the treated leg - both collateral vessel numbers improved, p=0.0156 in distal thigh, p=0.0313 in proximal leg, and vessel size improvements in the distal thigh, p=0.0156 and proximal leg, p=0.0625, and TcPO2 levels (mean pre-therapy of 14.66 +/- 6.93 improved to 35.75 +/- 17.04, p=0.0032)
Critical limb ischemia afflicts an estimated 2 million people combined in the United States, European Union and Indian sub-continent, and results in approximately 500,000 amputations each year. The overall prevalence (0.23%) and incidence (0.20%) in the United States increases with age and diabetes status, and 5 year mortality rate post limb amputation reaches nearly 50%.
The companies will host a joint conference call to review the study results in detail on Monday, January 27, 2014 at 2:00pm Pacific (5:00pm Eastern).
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was meint ihr, geht noch weiter nach oben ?
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Chali
P.S. Hast du unsere Partie vergessen ? Wo bleibt dein Zug ??
Wir hatten ja im Cardiome-Thread darüber gesprochen und bis heute hatte ich gedacht, dass sie ein reiner Zulieferer wären, bis ich die news heute gelesen hab:
Schaut mal bei yahoo!
(wie kopiert man hier einen link rein?)
Statistisch signifikante Verbesserung einer Gliedischämie sowie Verbesserung der Laufstrecke, wenn ich die Meldung heute richtig verstanden habe.
Denke, dass bei aktueller MK sogar weit mehr als ein Verdoppler drin sein dürfte!!! 100 Mio MK dürften sie schon in den nächsten Wochen erreichen!
Schade, dass ich kein Geld mehr habe, hat nur für 2k gereicht.
Hammer-Volumen heute!!!
Da sind definitiv keine Kleinanleger gewesen!
Hatte am WE leider keine Zeit um mir die Firma genauer anzugucken, hatte wirklich gedacht, die würden nur zuliefern. Bin mal auf die Kurse der nächsten Wochen gespannt.
Und Chali, nur für Dich und off-topic: Hab bin China Mina Yang (wiesst Du noch, die chinesische Nordex, heute nachgeladen)
Gruss an Alle, und Leute, nicht vor 5$$$ verkaufen!!! (Ihr kennt ja die Amis, das ist der Kurs spätestens Ende Februar!)
Dann denke ich, dass wenn die Masse noch aufmerksam wird, wir diese Woche noch bei > 5$ stehen dürften.
Aber ganz locker. Sollte ich morgen welche für <2,50 bekommen, werden ich die Hälfte meiner geliebten Cardiome verkaufen Chali und hier nachkaufen.
Wie ist Deine Meinung?
Signifikante Verbesserung einer kritischen Minderversorgung (mit Blut) einer Gliedmaße. Wisst ihr, dass damit nichts anderes gemeint ist, als man Amputationen vermeiden könnte??? !!!!!