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Cytori Receives U.S. FDA Approval for Burn Clinical Trial Related to BARDA Contract
46 minutes ago - DJNF
Cytori Receives U.S. FDA Approval for Burn Clinical Trial Related to BARDA Contract
SAN DIEGO, April 10, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for a pilot clinical trial to evaluate Cytori Cell Therapy(TM) in patients with thermal burn injury. This trial, named the RELIEF trial, is a continuation of Cytori's ongoing research and development efforts under its contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
The RELIEF trial will assess safety and feasibility of intravenous delivery of Cytori Cell Therapy(TM) as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. The trial is approved to enroll up to 30 patients in up to 10 U.S. sites. Initiation of RELIEF is dependent upon execution of a contract option by BARDA to provide the necessary funds.
"This announcement is yet another milestone achieved as BARDA and Cytori continue to move this technology forward through the development process, from preclinical to clinical implementation," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "Approval of RELIEF is a major step towards the ultimate goal of making this technology available to our citizens as a national countermeasure against burn injuries potentially including those complicated by radiation exposure."
The current healthcare system is ill-prepared for large numbers of patients requiring simultaneous treatment for thermal burns, particularly those complicated by radiation exposure. Current standard of care consists of dressings, skin grafts and skin substitutes. Despite these treatments, patients with severe burns commonly suffer from prolonged pain, aggressive scarring, skin contracture and reduced range of motion. Cellular therapeutics such as those offered by Cytori may have the potential not only to improve the quality and rate of wound healing and reduce scarring but also to be deployable in a cost effective manner, even in mass casualty situations.
According to the American Burn Association, there were approximately 450,000 burn injuries in 2013 that required medical treatment in the United States, with approximately 40,000 requiring hospitalization. According to a report from the Government Accountability Office, as many as 10,000 patients could require thermal burn care in a mass casualty event. The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event.
The RELIEF Trial is designed as a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wound that is to be autografted with a meshed split thickness skin graft (STSG). Subjects randomized to Cytori Cell Therapy will undergo small volume fat harvest (100 to 150 mL) during scheduled burn surgery followed by intravenous delivery of Cytori Cell Therapy. Subjects randomized to usual care will not undergo a fat harvesting procedure.
About Cytori Therapeutics, Inc.
Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy(TM) acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy(TM) may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products. Cytori Nanomedicine(TM) is developing encapsulated therapies for regenerative medicine and oncologic indications. For more information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, statements regarding: potential BARDA funding of the pilot clinical trial, conduct of the RELIEF clinical trial, and potential benefits of Cytori Cell Therapy (including its cost and clinical benefits, and its future availability as a national countermeasure against radiation and thermal burn exposure), are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include: a possible adverse decision by BARDA to delay, suspend or reduce funding of Cytori's proposed RELIEF clinical trial or other development efforts under its contract with BARDA or other changes in BARDA's funding and procurement priorities that may adversely affect our thermal burn injury program; BARDA's sole discretion in determining funding timing and amounts; BARDA's ability to reduce, modify or terminate its contract (and contract options) with us if it determines it is in the government's best interests to do so; the risk that Cytori is unable to complete development work necessary to receive BARDA funding; the risks that quality of data supporting IDE approval and execution of BARDA contract options is deemed insufficient; risks in the collection and results of clinical data; risks associated with final clinical outcomes; regulatory risks and uncertainties; risks related to dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" section in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.
CYTORI THERAPEUTICS
Tiago Girao, 1.858.458.0900
ir@cytori.com
(MORE TO FOLLOW) Dow Jones Newswires
April 10, 2017 07:00 ET (11:00 GMT)
Cytori Receives U.S. FDA Approval for Burn Clinical Trial Related to BARDA Contract
46 minutes ago - DJNF
Cytori Receives U.S. FDA Approval for Burn Clinical Trial Related to BARDA Contract
SAN DIEGO, April 10, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for a pilot clinical trial to evaluate Cytori Cell Therapy(TM) in patients with thermal burn injury. This trial, named the RELIEF trial, is a continuation of Cytori's ongoing research and development efforts under its contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
The RELIEF trial will assess safety and feasibility of intravenous delivery of Cytori Cell Therapy(TM) as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. The trial is approved to enroll up to 30 patients in up to 10 U.S. sites. Initiation of RELIEF is dependent upon execution of a contract option by BARDA to provide the necessary funds.
"This announcement is yet another milestone achieved as BARDA and Cytori continue to move this technology forward through the development process, from preclinical to clinical implementation," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "Approval of RELIEF is a major step towards the ultimate goal of making this technology available to our citizens as a national countermeasure against burn injuries potentially including those complicated by radiation exposure."
The current healthcare system is ill-prepared for large numbers of patients requiring simultaneous treatment for thermal burns, particularly those complicated by radiation exposure. Current standard of care consists of dressings, skin grafts and skin substitutes. Despite these treatments, patients with severe burns commonly suffer from prolonged pain, aggressive scarring, skin contracture and reduced range of motion. Cellular therapeutics such as those offered by Cytori may have the potential not only to improve the quality and rate of wound healing and reduce scarring but also to be deployable in a cost effective manner, even in mass casualty situations.
According to the American Burn Association, there were approximately 450,000 burn injuries in 2013 that required medical treatment in the United States, with approximately 40,000 requiring hospitalization. According to a report from the Government Accountability Office, as many as 10,000 patients could require thermal burn care in a mass casualty event. The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event.
The RELIEF Trial is designed as a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wound that is to be autografted with a meshed split thickness skin graft (STSG). Subjects randomized to Cytori Cell Therapy will undergo small volume fat harvest (100 to 150 mL) during scheduled burn surgery followed by intravenous delivery of Cytori Cell Therapy. Subjects randomized to usual care will not undergo a fat harvesting procedure.
About Cytori Therapeutics, Inc.
Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy(TM) acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy(TM) may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products. Cytori Nanomedicine(TM) is developing encapsulated therapies for regenerative medicine and oncologic indications. For more information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, statements regarding: potential BARDA funding of the pilot clinical trial, conduct of the RELIEF clinical trial, and potential benefits of Cytori Cell Therapy (including its cost and clinical benefits, and its future availability as a national countermeasure against radiation and thermal burn exposure), are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include: a possible adverse decision by BARDA to delay, suspend or reduce funding of Cytori's proposed RELIEF clinical trial or other development efforts under its contract with BARDA or other changes in BARDA's funding and procurement priorities that may adversely affect our thermal burn injury program; BARDA's sole discretion in determining funding timing and amounts; BARDA's ability to reduce, modify or terminate its contract (and contract options) with us if it determines it is in the government's best interests to do so; the risk that Cytori is unable to complete development work necessary to receive BARDA funding; the risks that quality of data supporting IDE approval and execution of BARDA contract options is deemed insufficient; risks in the collection and results of clinical data; risks associated with final clinical outcomes; regulatory risks and uncertainties; risks related to dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" section in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.
CYTORI THERAPEUTICS
Tiago Girao, 1.858.458.0900
ir@cytori.com
(MORE TO FOLLOW) Dow Jones Newswires
April 10, 2017 07:00 ET (11:00 GMT)
I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
