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April 13 2016 is the date of the public hearing, which is of extreme importance for the future of Cytori as a Company. It will likely also determine whether Cytori is "partnerable" or not.
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TOPIC: The Draft Guidances of the FDA (CBER)

The Draft Guidances of the FDA (CBER) 06 Jul 2016 11:03 #7388

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Despite the money i.e. revenues for the next 18 months or so, should mainly come from the IDIS Managed Access program and from adoption in Japanese clinics of CCT, to me the most important event is still the new regulatory guidances on HTC/P´s (Human Cells, Tissues or Cellular or Tissue based products).

We all know about those 500+ clinics and surely they would be severe competition in the long run with "word of mouth" PR and not incurring any regulatory trial costs to conduct their business. Reason for all this, is the blind eye the FDA has been turning, bad - unclear regulations and maybe even occupance with walnuts. :grin: Whatever- this HAS to change and I believe it will.

Late in 2014 CBER issued three major guidances-

The Guidance on the meaning of Minimal Manipulation,

The Guidance on the meaning of the Same Surgical Procedure

(Both terms are important "components" of existing legislation, but badly understood or simple differently interpreted as was intended)

and last but FOR US- certainly not least ... The Guidance on the use of Adipose Tissue

As an introduction to this theme I will attach the guidances as PDF, but warn that these are really rather dull and for experts only. I admit I spent very little time on them for certain reasons..anyway- more to come later.

File Attachment:

File Name: CBER01-Guidance-DraftAdiposeTissue.pdf
File Size: 107 KB


File Attachment:

File Name: CBER02-MinimalManipulationGuidance.pdf
File Size: 65 KB


File Attachment:

File Name: CBER03-SameSurgicalProcedureGuidance.pdf
File Size: 63 KB
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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:

The Draft Guidances of the FDA (CBER) 06 Jul 2016 11:36 #7389

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As indicated in another topic related to FDA regulation of SVF, September 12 and 13 are the new dates of the Public Hearing on these drafts, which CBER themselves say that the purpose of them is the following :

The purpose of the public hearing is to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from a broad group of stakeholders, including tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers, and the public. For example, FDA would like comments on the scope of the four draft guidances, including the particular topics covered, the particular questions posed, whether there are additional issues for which guidance would be helpful, and whether FDA’s recommendations for each topic are sufficiently clear and consistent within and across documents to provide meaningful guidance to stakeholders. In addition, FDA welcomes comments that will enhance the usefulness and clarity of these documents. FDA recommends that comments exclude discussion of products that do not meet the definition of an HCT/P, such as platelet rich plasma and other blood products. FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.


The FDA according to the above is not concerned whether the guidelines are correct and not faulty, but whether they are CLEAR and NOT OPEN TO INTERPRETATION like the regulations have been for years.

However- most of the speakers at the Hearing most likely will want to do that- change the legislation- and leave adult cells - be they fresh or cultured to the practice of medicine and not be regulated at all by the FDA.

Personally I have conformed and agreed to this stance for many years- since my impression of doctors here in Europe was always, that they were doctors for a cause- the Albert Schweitzer types- and make many overtime hours for very small pay relative to their educational background. In the US that is totally different though. since the Mark Berman´s, Stanley Jones´and Marc Hedrick´s are just in it for the money. No heart period. I guess it is due to the system.
For that reason -I now also believe FDA oversight in an adapted way from what is used now- is most appropriate and good for patients, assuming similar access programs are designed as used in Europe.

Anyway- in the next post- the speakers at the meeting.... :grin: :grin:

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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:

The Draft Guidances of the FDA (CBER) 06 Jul 2016 11:58 #7391

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Limited time for all as could be expected- Cytori is not there ( :whistle: ) but Kerastem is. I know many of the individuals- we have been fighting many battles so far, without much success.

Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products
September 12-13, 2016
National Institutes of Health (NIH)
9000 Rockville Pike, Building 10, Masur Auditorium
Bethesda, MD 20892
Draft Agenda

September 12, 2016

9:00-9:10: Presiding Officer Opening Remarks and Introduction of Panel Members

9:10-10:57: Session 1

9:10-9:15: Alliqua Biomedical
9:16-9:21: Allosource
9:22-9:27: Atlanta Medical Center
9:28-9:33: Birth Tissue Recovery, LLC
9:34-9:39: INCELL Corporation LLC
9:40-9:45: Intellicell BioSciences
9:46-9:51: Johnson & Johnson
9:52-9:57: Kerastem Technologies
9:58-10:03: LifeLink Tissue Bank
10:04-10:09: LifeNet Health
10:10-10:15: MedCentris
10:16-10:21: Millennium Medical Technologies
10:22-10:27: MiMedx Group, Inc.
10:28-10:33: Musculoskeletal Transplant Foundation
10:34-10:39: Organogenesis
10:40-10:45: RTI Surgical
10:46-10:51: StemGenex Inc.
10:52-10:57: US Stem Cell Inc.
10:57-11:07: Questions from Panel
11:07-11:27: Break

11:27-11:57: FDA presentation on September 8, 2016 workshop “Scientific Evidence in Development of HCT/Ps Subject to Premarket Approval”

11:57-1:12: Lunch: Ala Carte items will be available for purchase on site

1:12-2:29: Session 2

1:12-1:17: Boston College Law School
1:18-1:23: Case Western University
1:24-1:29: Indiana University School of Medicine
1:30-1:35: NYU Langone Medical Center
1:36-1:41: Wake Forest University School of Medicine
1:42-1:47: Alston & Bird LLP
1:48-1:53: Navigant Consulting
1:54-1:59: OrthoKinetic Technologies, LLC
2:00-2:05: Parenteau BioConsultants
2:06-2:11: California Stem Cell Treatment Center and Cell Surgical Network
2:12-2:17: Celebration Stem Cell Center
2:18-2:23: Long Island Plastic Surgical Group
2:24-2:29: National Spine and Pain Centers-VA
2:29-2:39: Questions from panel
2:39-4:49: Session 3

2:39-2:47: Academy of Regenerative Practices
2:48-2:56: Alliance for Regenerative Medicine
2:57-3:05: Alliance for the Advancement of Cellular Therapies
3:06-3:14: Alliance of Wound Care Stakeholders
3:14-3:29: Break
3:29-3:37: American Association of Blood Banks
3:38-3:46: American Association of Tissue Banks
3:47-3:55: American College of Surgeons
3:56-4:04: American Society of Plastic Surgeons
4:05-4:13: Biologic Orthopedic Society
4:14-4:22: Bipartisan Policy Center
4:23-4:31: California Institute for Regenerative Medicine
4:32-4:40: California Life Sciences Association
4:41-4:49: Coalition of Wound Care Manufacturers
4:49-4:59: Questions from Panel
4:59-close: Closing remarks/adjournment

September 13, 2016

9:00-9:05: Presiding Officer Opening Remarks and Introduction of Panel Members

9:05-10:43: Session 3, Continued

9:05-9:13: Speaker Request Withdrawn
9:14-9:22: Foundation for the Accreditation of Cellular Therapy
9:23-9:31: Info Health Global
9:32-9:40: Institute for Regenerative and Cellular Medicine
9:41-9:49: International Federations for Adipose Therapeutics and Science
9:50-9:58: International Society for Cellular Therapy
9:59-10:07: International Society for Stem Cell Research
10:08-10:16: National Center for Health Research
10:17-10:25: The Cord Blood Association
10:26-10:34: The Cure Alliance
10:35-10:43: The Plastic Surgery Foundation
10:43-10:53: Questions from Panel
10:53-11:08: Break

11:08-4:46: Session 4

11:08-11:13: Waldo Acebo
11:14-11:19: Rebecca Baergen
11:20-11:25: Harold Brem
11:26-11:31: Julie Cerrone
11:32-11:37: Kara Couch
11:38-11:43: Charles Cox Jr.
11:44-11:49: Georgianna Crocker
11:50-11:55: Fiona Cunningham
11:56-12:01: Roxana Daftarian
12:02-12:07: Rahul Desai
12:08-12:13: Yoelma Eid Sandoval
12:14-12:19: Ryan Fitzgerald
12:19-1:34: Lunch: Ala Carte items will be available for purchase on site
1:34-1:39: Timothy Freeman
1:40-1:45: Brian Gates
1:46-1:51: Marie Gehling
1:52-1:57: Ted Gradel
1:58-2:03: R. Scott Graham
2:04-2:09: Sarah Hughes
2:10-2:15: Scott James
2:16-2:21: Kristen King
2:22-2:27: John Klimkiewicz
2:28-2:33: Speaker Request Withdrawn
2:34-2:39: Jeanne Loring
2:40-2:45: Norman Marcus
2:46-2:51: Brian Marr
2:52-2:57: Kristen Marr
2:58-3:03: Carl Nicastro
3:04-3:09: Michael Sabolinski
3:10-3:15: Sheila Sabon DeCastro
3:16-3:21: Carolyn Salafia
3:21-3:41: Break
3:41-3:46: John Samies
3:47-3:52: George Sauter
3:53-3:58: Rosemary Tambouret
3:59-4:04: Tracy Thompson
4:05-4:10: Amy Tucker
4:11-4:16: Leigh Turner
4:17-4:22: Eliza Tyler
4:23-4:28: Newton Vaughn
4:29-4:34: Samantha Wilkinson
4:35-4:40: Joan Woodward
4:41-4:46: Jennifer Ziegler
4:46-4:56: Questions from Panel
4:56-close: Closing remarks/adjournment

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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:

The Draft Guidances of the FDA (CBER) 06 Jul 2016 13:44 #7393

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Revenues still a big ? for the next 18 months.
I can agree on that and IDIS and Japan will be the biggest source no matter how large or small.
Regulation only for Cytori...maybe suing the FDA wasn't so smart after all but perhaps there is also a whisper from certain players in the medical community who just want enough stalling until the patents run out.
Either way, the latest raise has NOT eliminated the danger presented by the balance sheet. :bang: :really:

3 analyst have a $2.5 million average est. for Jun/2016...we will know in about a month how close they get.

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The Draft Guidances of the FDA (CBER) 07 Jul 2016 08:55 #7394

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Since those 3 guidelines have so many words in them, which could create minor headaches, it is good to be able (for a change) to leave it to Cytori i.e. Ken Kleinhenz - the VP Regulatory, to explain and interpret the stuff-

I understand that many may not want to read this all- but I advise, you make yourself familiar with the last bit in bold- that is the relevant part and crystal clear...

Investor Note: Cytori Updates Investors on Recent FDA Draft Guidance on Cell Therapy and Adipose Tissue

Feb 02, 2015

Dear Investors:
In Fall 2014, the Center for Biologics, Evaluation and Research (CBER), a branch of the United States Food and Drug Administration (FDA), issued three draft guidance documents clarifying regulatory issues pertaining to adipose tissue, the manipulation of cells and tissues, and exemptions regarding the use of cell and tissue products in the same surgical procedure.
In 2009, in response to a formal request for designation or ‘RFD’ from the Office of Combination Products at FDA, Cytori received notification that Cytori Cell Therapy would be regulated as a Class III device through CBER (RFD# 090013). The three new guidance documents from FDA relate to the cell therapy field and adipose therapeutics in general, and provide insight into the thinking behind that important designation decision rendered to Cytori.
“We are pleased to see the new FDA draft guidance documents and appreciate the clarity they provide to both physicians and companies developing and using adipose derived therapeutics,” said Dr. Marc Hedrick, President and CEO of Cytori. “The guidelines provide a clear and unambigous path to market for us, which is fully consistent with our current regulatory approach in bringing Cytori Cell Therapy to market here in the US via the PMA (premarket approval) device pathway.”
The draft guidelines contain several points worthy of highlight:
· The clinical use of cells isolated from human tissue, no matter the isolation process, and including cells derived from adipose tissue, will require FDA oversight.
· The process of extracting any cell population or cellular subset from adipose tissue will be considered beyond the technical process of ‘minimum manipulation’. Minimal manipulation means a process that does not change the relevant biological characteristics of a cell or tissue.
· The clinical use of an isolated cell population will not be considered exempt under the technical definition of ‘same surgical procedure’. The same surgical procedure exemption is important because it was the legal mechanism that allowed physicians to legally utilize cell isolates from tissue on the same patient. This exemption has now been redefined to require ‘minimum manipulation’ as a new requirement for the exemption.
· Adipose derived cellular products may be regulated through the investigational drug pathway (as a drug or biological product) or as a PMA device at the discretion of the FDA.
· Any party, in the US, extracting cells from adipose tissue for use as a therapeutic will be required to obtain a biologics license from FDA to commercialize the product or obtain approval for an IND or IDE to pursue a clinical investigation. Products with formal device designation from FDA are eligible to proceed to market through a PMA device pathway where device regulations are applied versus the very different pharmaceutical regulations.
· Physicians can no longer make their own cell therapies from adipose tissue without FDA oversight.
Kenneth Kleinhenz, Cytori’s Vice President, Global Regulatory Affairs offers the following detailed comments on the guidelines.
Same Surgical Procedure Draft Guidance
In the FDA draft guidance document titled, ‘Same Surgical Procedure Exemption under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exemption’, the FDA indicates that it will be applying the scope of the same surgical procedure exemption, listed in 21 CFR 1271.15(b), in a very limited way. Specifically, the guidance document states, ‘FDA’s view is that autologous cells or tissues that are removed from an individual and implanted into the same individual without intervening processing steps beyond rinsing, cleansing, or sizing, or certain manufacturing steps, raises no additional risks of contamination and communicable disease transmission beyond that typically associated with surgery. FDA considers the same surgical procedure exemption to be a narrow exception to regulation under Part 1271.’ Based on the above statement from FDA, it is clear that FDA only considers washing, cutting, and rinsing of tissues to be within the meaning of same surgical procedure. “The guidance document clearly indicates that minimum manipulation will now be an additional criterion, along with existing autologous and same surgical procedure criteria, for physicians to operate outside of FDA oversight,” stated Kenneth Kleinhenz, Vice President of Global Regulatory Affairs.
The draft guidance document can be found at: www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm419911.htm


Minimum Manipulation Draft Guidance
The FDA draft guidance document titled, ‘Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance,’ indicates that cells isolated from adipose tissue are considered drug products. Example number 10 of the guidance document describes a scenario where cells are isolated from structural tissue to produce a cellular therapy product. The guidance document describes manipulations to adipose tissue that would be beyond minimum manipulation due to changes in the ‘original relevant characteristics’ of a structural tissue (adipose) regardless of the mechanisms leading to such changes. Specifically, the draft guidance document indicates that, ‘original relevant characteristics of adipose tissue, a structural tissue, to pad and cushion against shocks generally include its bulk and lipid storage capacity. A manufacturer recovers adipose tissue by tumescent liposuction and processes the adipose tissue to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells. The HCT/P generally is considered more than minimally manipulated because the processing breaks down and eliminates the structural components that provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement.’ Therefore, manufacturing processes that isolate a cellular component from adipose tissue are now considered to be beyond minimum manipulation and will require FDA oversight for clinical use in humans. Furthermore, the guidance document specifically addresses a scenario in which an autologous tissue is processed at the point of care within the same surgical procedure. A scenario is outlined in which, ‘adipose tissue is recovered by tumescent liposuction. Stem cells from the lipoaspirate are then isolated. Cell isolation would typically cause the adipose tissue to no longer be such HCT/P. Thus, even if the processed HCT/P from adipose tissue is injected into the same patient from whom it was removed during the same surgical procedure, the establishment would generally not be considered to qualify for the exception under 21 CFR 1271.15(b).’ FDA has clarified that cell isolation from adipose tissue will now be considered a drug and the ‘establishment’ performing these actions (physician or hospital) will not be exempt from FDA oversight. Practically speaking, physicians and hospitals isolating cells from adipose tissue will be manufacturing a drug product and such activities will require an FDA approval (NDA or BLA) if cells are separated from adipose tissue and used clinically. “Now it is clear that the isolation of cells from adipose tissue will not be viewed as minimum manipulation. This view by FDA affects physicians and industry alike as the physicians will no longer be exempt from FDA oversight through the same surgical procedure exemption because minimum manipulation is a new criteria for such exemptions. Furthermore, the device-based point-of–care industry will require FDA oversight as their devices will be now be producing an FDA regulated drug or biologic that will be regulated no differently than cultured cells. Both cultured cells and isolated cells, at the point-of-care, will have the same regulatory burdens due to the manipulation criteria, which now applies to simple cell isolating techniques from adipose tissue,” stated Kenneth Kleinhenz, Vice President of Global Regulatory Affairs.
The FDA guidance document on minimum manipulation is located at:
www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm427692.htm

Adipose Tissue Processing Draft Guidance
The FDA draft guidance document titled, ‘Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance’ indicates that stromal vascular cells (SVF) isolated from adipose tissue are considered to be drugs. The guidance document identifies the process of recovering SVF from adipose tissue as being a regulated drug product. The guidance document identifies SVF as a drug product, under any scenario, when it outlines the example of, ‘adipose tissue is recovered by tumescent liposuction. The adipose tissue undergoes processing or manipulation (e.g., enzymatic digestion, mechanical disruption, etc.) to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells for clinical therapeutic uses. This processing breaks down and eliminates the structural components that function to provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement. Therefore, based on the definition of minimal manipulation for structural tissue, this processing would generally be considered more than minimal manipulation.’ Therefore, it is clear that the process of isolating SVF from adipose tissue creates a drug product that will be regulated by FDA, regardless of how the SVF is obtained. “If there was any doubt about the processing of SVF from adipose tissue being beyond minimum manipulation and such SVF products being regulated as a drug, this guidance documents makes it abundantly clear, regardless of the mechanisms to obtain such SVF. This guidance document makes it clear that it is the SVF that is the drug product, and the focus of this determination is based on the SVF product and not the mechanisms by which the SVF was obtained or processed. This view by FDA removes any ambiguity around the question of SVF being a drug and now directs industry and clinicians alike to obtain FDA approval prior to using all and any forms of SVF on humans,” stated Kenneth Kleinhenz, Vice President of Global Regulatory Affairs
.

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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:

The Draft Guidances of the FDA (CBER) 07 Jul 2016 20:18 #7395

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>>>This view by FDA removes any ambiguity around the question of SVF being a drug and now directs industry and clinicians alike to obtain FDA approval prior to using all and any forms of SVF on humans,” stated Kenneth Kleinhenz, Vice President of Global Regulatory Affairs<<<

This and $2 gets you a share of Cytori but no one is stopping their "illegal" usage ! :bash:

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The Draft Guidances of the FDA (CBER) 08 Jul 2016 06:13 #7396

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myownhedgefund wrote: >>>This view by FDA removes any ambiguity around the question of SVF being a drug and now directs industry and clinicians alike to obtain FDA approval prior to using all and any forms of SVF on humans,” stated Kenneth Kleinhenz, Vice President of Global Regulatory Affairs<<<

This and $2 gets you a share of Cytori but no one is stopping their "illegal" usage ! :bash:


I know...I wish I was stupid enough to not know.. :whistle:

Tells you - as first mover in a brand new technology you have to cope with regulatory folks- all across the globe- who have been known to "do things a certain way" and were confronted with heaps of different issues, which obviously they were un-able to cope with "in that same old fashion".

The Japanese get the best marks from me- they pulled the strings heavily in 2009, when suddenly no publicity was allowed to be made of anecdotal SC treatments (the ones I will have on my sites, as proof of history), but after their key Think Tanks in Japan in 2012 published their plans with support of Abe politics, all in all it took 3+ years only to set up what they have now. Extremely good job. :yep:

In Europe they started in earnest already in 2009, but the EMA guidelines published for ATMP´s in 2011 are to me still a work-in-progress. Europe has the disadvantage of a missing centralized device agency, dealing with Human Cells and Tissues and that makes it a bit of a mess

The US and the FDA took by far the longest..although they had CBER already from the early century I believe. Anyway- the birth pains of legislation were slow and full of conflict, but conflicts (including Cytori) were always won since the legislature is always supported in the trias-politica system and always will, for which reason those illegal clinics, I believe will not stand a chance and a time will come that enforcement will be applied.

So from the RFD which Cytori put in in early 2007- response late 2009- issuance of new guidances - late 2013 early 2014, we are approaching late 2016, to early 2017 for finalization. ALMOST 10 YEARS. Fits all with the plan that is on the table at Cytori right now. I bet Calhoun learned also- he learned that the way he did business with devices of the spine did not apply to HTC/P´s. :grin: :grin:

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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:
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