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TOPIC: Class IIII approval for Celution in Japan

Class IIII approval for Celution in Japan 03 Dec 2018 06:36 #12379

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Dec 03, 2018
Expands medical device production capabilities
SAN DIEGO and TOKYO, Dec. 03, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced that the Company has received approval for the Celution Cell Therapy System consumable bundle in Japan as a Class III medical device. The Class III designation will allow Cytori to expand its current commercial efforts in Japan and provides a clear framework for future expanded regulatory claims and reimbursement under the November 2014 PMD Act.

Furthermore, Cytori announced today that the Company has successfully outsourced an important assembly portion of the production process for its Celution Cell Therapy consumables from San Diego, CA to Viant Medical in San Antonio, Texas. The first consumable lots following this new process were shipped to customers in November 2018.

“Obtaining Class III designation follows many months of constructive interaction with the Japanese Ministry of Health, Labour and Welfare following the approval of the 2014 PMD Act,” said Marc H. Hedrick, MD, President and Chief Executive Officer of Cytori Therapeutics. “This approval coupled with the outsourced production allows Cytori to meet forecasted product demand, particularly in Japan, and better prepares us for the data read out in our Japan ADRESU pivotal trial next year.”

In Japan, Class III and Class IV medical devices require the highest levels of safety and efficacy data In Japan. These devices are also required to have special controls. Other such examples of Class III medical devices include: hemodialysis equipment, artificial bones and joints, mechanical ventilation apparatus, and balloon catheters.

Cytori currently has a fully functional logistics, sales and marketing team in Japan dedicated to commercialization of the Celution Cell Therapy System. Cytori is forecasting double digit growth in consumable utilization in Japan for 2018. Prior to the class III approval, Cytori has been selling the Celution technology mostly for aesthetic and orthopedic indications under a Class I designation.

ADRESU is an investigator-initiated, multicenter, 45 patient, open-label, single arm clinical trial of Cytori’s ECCI-50 cellular therapeutic, comprised of Celution®-prepared autologous Adipose Derived Regenerative Cells (ADRCs) and Adipose Cells for men with stress urinary incontinence as a complication of prostate intervention. A total of 45 patients, all treated in Japan, were enrolled in this potential approval trial. One-year data readout from ADRESU is anticipated in the first half of 2019.

The ADRESU trial was based on a promising pilot trial with short-term data of 11 patients published in the International Journal of Urology in 2014 and long-term data of 14 patients presented at the International Continence Society in 2017, which “demonstrated that transurethral injection of autologous ADRCs can be a safe and effective treatment modality for postprostatectomy incontinence”. Details of the ADRESU protocol and trial can be found on BMC Urology, clinicaltrials.gov and the University Hospital Medical Information Network website.

The primary endpoint for the ADRESU trial is the percentage of patients who experience greater than 50% reduction in urinary leakage volume from baseline (as measured by the weight of unintended urinary leakage over 24 hours) at 52 weeks after treatment. A number of other key secondary endpoints are also being assessed. If the primary endpoint is successfully achieved, the data may be used to seek approval of ECCI-50 for this indication.

The trial costs are substantially supported by the Japan Agency for Medical Research and Development, an independent administrative agency of the Government of Japan, with additional support from Cytori. The trial is sponsored by the lead institution, Nagoya University.

About ADRESU Investigators
The ADRESU trial is being led by Dr. Momokazu Gotoh at Nagoya University, Aichi, Japan. The other participating investigators and institutes include Dr. Kazutaka Narimoto at Kanazawa University Hospital (Ishikawa, Japan), Dr. Osamu Ishizuka at Shinshu University Hospital (Nagano, Japan) and Dr. Tomonori Yamanashi at Dokkyo Medical University (Tochigi, Japan).

About Male Stress Urinary Incontinence
Male stress urinary incontinence is a post-surgical complication of radical prostatectomy and surgeries for benign prostatic hyperplasia with limited treatment options, representing an unmet medical need. In 2016, the Ministry of Health, Labor and Welfare (MHLW) reported approximately 20,000 prostate cancer surgeries and 22,000 benign prostatic hyperplasia procedures performed at Diagnostic Procedure Combination (DPC) participating hospitals.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Class IIII approval for Celution in Japan 03 Dec 2018 07:09 #12380

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fas wrote: Dec 03, 2018
Expands medical device production capabilities
SAN DIEGO and TOKYO, Dec. 03, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced that the Company has received approval for the Celution Cell Therapy System consumable bundle in Japan as a Class III medical device. The Class III designation will allow Cytori to expand its current commercial efforts in Japan and provides a clear framework for future expanded regulatory claims and reimbursement under the November 2014 PMD Act.

Furthermore, Cytori announced today that the Company has successfully outsourced an important assembly portion of the production process for its Celution Cell Therapy consumables from San Diego, CA to Viant Medical in San Antonio, Texas. The first consumable lots following this new process were shipped to customers in November 2018.

“Obtaining Class III designation follows many months of constructive interaction with the Japanese Ministry of Health, Labour and Welfare following the approval of the 2014 PMD Act,” said Marc H. Hedrick, MD, President and Chief Executive Officer of Cytori Therapeutics. “This approval coupled with the outsourced production allows Cytori to meet forecasted product demand, particularly in Japan, and better prepares us for the data read out in our Japan ADRESU pivotal trial next year.”

In Japan, Class III and Class IV medical devices require the highest levels of safety and efficacy data In Japan. These devices are also required to have special controls. Other such examples of Class III medical devices include: hemodialysis equipment, artificial bones and joints, mechanical ventilation apparatus, and balloon catheters.

Cytori currently has a fully functional logistics, sales and marketing team in Japan dedicated to commercialization of the Celution Cell Therapy System. Cytori is forecasting double digit growth in consumable utilization in Japan for 2018. Prior to the class III approval, Cytori has been selling the Celution technology mostly for aesthetic and orthopedic indications under a Class I designation.

ADRESU is an investigator-initiated, multicenter, 45 patient, open-label, single arm clinical trial of Cytori’s ECCI-50 cellular therapeutic, comprised of Celution®-prepared autologous Adipose Derived Regenerative Cells (ADRCs) and Adipose Cells for men with stress urinary incontinence as a complication of prostate intervention. A total of 45 patients, all treated in Japan, were enrolled in this potential approval trial. One-year data readout from ADRESU is anticipated in the first half of 2019.

The ADRESU trial was based on a promising pilot trial with short-term data of 11 patients published in the International Journal of Urology in 2014 and long-term data of 14 patients presented at the International Continence Society in 2017, which “demonstrated that transurethral injection of autologous ADRCs can be a safe and effective treatment modality for postprostatectomy incontinence”. Details of the ADRESU protocol and trial can be found on BMC Urology, clinicaltrials.gov and the University Hospital Medical Information Network website.

The primary endpoint for the ADRESU trial is the percentage of patients who experience greater than 50% reduction in urinary leakage volume from baseline (as measured by the weight of unintended urinary leakage over 24 hours) at 52 weeks after treatment. A number of other key secondary endpoints are also being assessed. If the primary endpoint is successfully achieved, the data may be used to seek approval of ECCI-50 for this indication.

The trial costs are substantially supported by the Japan Agency for Medical Research and Development, an independent administrative agency of the Government of Japan, with additional support from Cytori. The trial is sponsored by the lead institution, Nagoya University.

About ADRESU Investigators
The ADRESU trial is being led by Dr. Momokazu Gotoh at Nagoya University, Aichi, Japan. The other participating investigators and institutes include Dr. Kazutaka Narimoto at Kanazawa University Hospital (Ishikawa, Japan), Dr. Osamu Ishizuka at Shinshu University Hospital (Nagano, Japan) and Dr. Tomonori Yamanashi at Dokkyo Medical University (Tochigi, Japan).

About Male Stress Urinary Incontinence
Male stress urinary incontinence is a post-surgical complication of radical prostatectomy and surgeries for benign prostatic hyperplasia with limited treatment options, representing an unmet medical need. In 2016, the Ministry of Health, Labor and Welfare (MHLW) reported approximately 20,000 prostate cancer surgeries and 22,000 benign prostatic hyperplasia procedures performed at Diagnostic Procedure Combination (DPC) participating hospitals.

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Good news - now they need to solve the imminent cash issue.

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Class IIII approval for Celution in Japan 03 Dec 2018 08:52 #12381

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My guess is that the cash issue gets resolved in some fashion particularly given the good news from Japan - therefore, the current SP s/b considerably higher than the current 50-day moving avg. of.38. JMHO.

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Class IIII approval for Celution in Japan 03 Dec 2018 14:25 #12382

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From the slide below we had a few (3) announcements- the main one, with hopefully some cash upfront is still outstanding i.e. the ATI-0918 partner.


We will see- from this

Cytori announced today that the Company has successfully outsourced an important assembly portion of the production process for its Celution Cell Therapy consumables from San Diego, CA to Viant Medical in San Antonio, Texas. The first consumable lots following this new process were shipped to customers in November 2018.

one can reasonably assume that they were looking in the area of their new HQ i.e. San Antonio. The callan Road lease expires at year-end. :whistle:
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Class IIII approval for Celution in Japan 03 Dec 2018 15:00 #12383

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fas wrote: From the slide below we had a few (3) announcements- the main one, with hopefully some cash upfront is still outstanding i.e. the ATI-0918 partner.



We will see- from this

Cytori announced today that the Company has successfully outsourced an important assembly portion of the production process for its Celution Cell Therapy consumables from San Diego, CA to Viant Medical in San Antonio, Texas. The first consumable lots following this new process were shipped to customers in November 2018.

one can reasonably assume that they were looking in the area of their new HQ i.e. San Antonio. The callan Road lease expires at year-end. :whistle:

/

Fas, I would doubt that today's release would have been issued without a fair amount of certainty that the cash issue will be resolved in some way - of course, "some way" is the big question.

PS - interesting close on CYTXZ at .0148!

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