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Cytori´s Technology- Celution, IP etc etc
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TOPIC: The Worthington Celase Distributor Deal

The Worthington Celase Distributor Deal 01 Dec 2015 08:26 #5542

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Just to make sure that we report ALL Cytori news in the Lodge... :whistle:

12/01/2015
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the signing of a non-exclusive, 3 year distribution agreement with Worthington Biochemical Corporation for Celase® GMP enzyme for research markets in the U.S. and select international countries.

Celase® GMP is a proprietary enzyme containing a unique blend of collagenase, neutral protease and buffer salts that are produced using avian and mammalian tissue-free raw materials, aseptically processed, sterile filtered and highly purified under cGMP guidelines. Integrating Celase® GMP into cell isolation study protocols can facilitate a smooth transition from bench and animal research to downstream clinical applications.

“The addition of Cytori’s Celase® GMP product to Worthington’s Collagenase and STEMxyme® portfolio provides our customers with more options to support their unique research needs than ever before,” said Von Worthington, President and CEO at Worthington Biochemical Corporation. “We plan to offer Celase® GMP through Worthington’s catalog, direct sales force, distributor network and e-commerce website. Also, we intend to showcase the product at upcoming scientific meetings and trade shows."

“We are very excited and pleased to initiate a partnership for Celase® GMP. The goal of the partnership is to facilitate translational research in regenerative medicine using Celase® GMP and potentially broaden the number of clinical applications for Cytori Cell Therapy,” said Russ Havranek, Director of Marketing at Cytori Therapeutics.

Researchers may subscribe to celase.com to learn of product updates or send inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it..


At least we learn also, that cytori has a new Director of Marketing- Russ Havranek...., who has been at Cytori since April 2014. :whistle:

His background at LinkedIn states the following:

Driven biotechnology and medical device professional with 18 years of marketing, general management, and biomedical engineering experience in successfully developing and globally commercializing novel diagnostic and therapeutic solutions for a diverse set of clinical indications that maximize company financial performance, improve customer satisfaction, and enhance brand equity. Strong track record in completing dynamic projects on-budget and on-time that determine and fulfill business strategies as a cross-functional team leader within international matrix organizations, collaborator with key opinion leaders, and trusted advisor to external partners.

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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 Worthington Celase Distributor Deal 01 Dec 2015 08:39 #5543

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You would think that if they are starting distribution deals with third parties on Celase, than the introduction of CTX2 is not too far away???

:whistle: :really:

If the goal is. The goal of the partnership is to facilitate translational research in regenerative medicine using Celase® GMP and potentially broaden the number of clinical applications for Cytori Cell Therapy

thanthat research has to be done with a Cytori device , one would think :yep:

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The Worthington Celase Distributor Deal 01 Dec 2015 10:13 #5544

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Fas,

I really don't understand what this is about. If it is related to the CTX2, as you speculate, than why would you need a separate distributer for Celase as it would make sense to sell it with the new machine? They do go hand in hand. Pure speculation but I'm wondering if this is an attempt to enter the large existing stem cell clinic market in the U.S. Since the FDA continues to allow these clinics to operate illegally could these clinics incorporate Celase into their practices now? The press clearly states that this is for "research purposes" but don't many of these clinics call their operations "patient funded clinical trials"?

Here is an interesting link to a company product sheet .

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The Worthington Celase Distributor Deal 01 Dec 2015 12:00 #5545

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WST-

I think, all we can do is speculate. On the one side, I do not think Celase is "tied" to Celution/CTX2. You can surely use it with a manual procedure like Coleman´s too. On the other side- if it should promote Cytori Cell Therapy apps, than of course the link between cartridge and device has to be made.

I think your idea of them wanting to enter the "unregulated" market could be correct. Back in 2008/9 the same happened with GE selling Celution´s as laboratory devices in the US - Todd Malan in Arizona being one of the first recipients. (By the way- he seems disappeared from the Okyanos site :whistle: ) , so they might want to use distributors who are knowledgeable on the equipment and on the enzymes. At least Worthington´s competence appears to be the disassociation of tissue- so Celase is perfectly placed there.

What Company will market the devices might be an open question. Since Cytori surely does not want to antagonize the FDA, they might seek a new type of "GE" solution... :whistle:

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The Worthington Celase Distributor Deal 01 Dec 2015 21:23 #5552

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I think your idea of them wanting to enter the "unregulated" market could be correct

.

Just for the record its an unenforced, regulated market in the U.S.

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The Worthington Celase Distributor Deal 02 Dec 2015 06:01 #5553

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Just for the record its an unenforced, regulated market in the U.S.


:grin: One could identify the presently existing regulatory rules on HCT/P´s as "regulated". To me they are not so, since the borderline´s between a "361" or "351" are simply too vague and badly worded and a lot is simply interpretation.

The new guidelines will be better, but still need some clarity too.

The major part of the "unregulated" market to me is the education of the medical doctors participating. A two days course in Las Vegas and you are a qualified "Stem Cell Doctor" - that is where the state boards probably have to do some work. :whistle: . Preferable in concert with the FDA enforcing their forthcoming rules.

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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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