Doug Sipp letter Stemedica

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Doug Sipp letter Stemedica Powered By Docstoc
					                                                                      Stemedica Cell Technologies, Inc.
                                                                       5375 Mira Sorrento Place, Ste. 100
                                                                                   San Diego, CA 92121
                                                                                   858 | 658-0910 phone
                                                                                      858 | 658-0986 fax
                                                                                     www.stemedica.com



                                      Memorandum
November 12, 2009
To:   Douglas Sipp               PRIVATE & CONFIDENTIAL
From: Dr. Maynard Howe           cc: Dave McGuigan
Re:   Your Comments About Stemedica In Science Magazine
As a follow-up to your correspondence with Dave McGuigan, please accept this response to your
article in the March 20, 2009 issue of Science. There were several allegations in the article we
believe inaccurate and potentially damaging to the image of Stemedica within the regulatory,
medical and investment communities. We believe that you and Sorapop Kiatpongsan neglected to
do proper research on Stemedica, and instead relied on old, third party opinion and outdated web
research. Additionally, neither you nor Sorapop Kiatpongsan ever called Stemedica as part of
your due diligence process which should have been a primary step in any effort to make sure your
information was factual and accurate.
Doug…here are the facts:
       Stemedica is not in the treatment business and never has been. We are in the business of
       developing allogeneically-based adult stem cell products. We will manufacture these
       products under cGMP compliance as called for by the manufacturing license we’ve been
       granted by the State of California’s Food & Drug Branch.
       Early in our incorporation, Stemedica underwrote the treatment for several individuals
       who received treatment by Dr. Nikolay Mironov, a leading Russian neurologist who is
       licensed to administer allogeneically-based adult stem cells. These patients were
       properly qualified for treatment and agreed to comprehensive Informed Consent
       documentation. These patients were ‘No Option Patients’ and agreed to treatment as part
       of Stemedica’s due diligence process. Our personnel did not conduct these treatments
       and all of these treatments were conducted under clinical protocol.
       Our business model has always called for the licensing of treatment facilities that can
       meet Internationally-recognized regulatory standards prior to Stemedica selling its
       products to those facilities. While we did promote two of those licensed partners prior to
       August 2008 on the older version of the Stemedica Web site, we: (A) made it clear on
       that older version of our web site that we were not in the treatment business; and, (B) we
       never sold either of the facilities promoted on that site - in Mexico and in Bermuda -
       product because they had yet to meet those Internationally-recognized standards.
       Prior to Stemedica selling product to any medical facility for clinical application, they
       must meet the following basic requirements: (A) Agree to conduct a formal Clinical
       Trial that includes proper Informed Consent documentation; reporting of all adverse
       events; and, adheres to a formal Treatment Protocol. (B) Secure formal approval of the
       Clinical Trial and Treatment Protocol by the facility’s Ethics Committee. (C)
       Acknowledge that their government allows for the transplantation of allogeneically-based
       adult stem cells. (D) Secure national regulatory approval for the importation of
       Stemedica’s products.
                                                                        Stemedica Cell Technologies, Inc.
                                                                         5375 Mira Sorrento Place, Ste. 100
                                                                                     San Diego, CA 92121
                                                                                     858 | 658-0910 phone
                                                                                        858 | 658-0986 fax
                                                                                       www.stemedica.com



    Doug Sipp Memorandum                 PRIVATE & CONFIDENTIAL
    November 12, 2009
    Page Two

        Since August of 2008, all of our marketing communications, including our corporate
        Web site, has made it clear about who we are and what we do. There have been no
        patient testimonials, no promotion of licensed treatment facilities, no promotion of
        “treatment for treatment sake.” There can be no confusion about who we are or what we
        do when you review our materials or talk to any of our personnel.
        In countries like Bermuda and Mexico, we have been working closely with leaders within
        those countries to help develop Regulatory Guidelines that can help advance the stem cell
        industry in a safe manner with all of the necessary oversight to protect interested patients
        as well as the future of the entire stem cell movement. We can provide numerous
        contacts around the world that can validate that we’re investing significant amounts of
        the company’s resources to help with the education and regulatory development process.
        Upon close inspection, you will find that few companies have made as significant an
        investment in this education and development process as Stemedica.
While Stemedica lauds your attempt at disclosing misuses of stem cells in the treatment of
unproven applications, we regret that you used inaccurate information about our company in that
article. We welcome honest, tough and direct questions about our company in which we’re given
a fair and open chance to answer those questions completely. We have worked hard to evolve
into a company that takes its leadership role in advancing this emerging industry seriously and
hope that those writing about the evolution of the stem cell industry will take the time, and be
genuine and sincere in their efforts as well.
It is for that reason that I respectfully ask for a written or phone response as to how you and
Sorapop Kiatpongsan came to the conclusion that, “Companies such as Stemedica have taken
advantage of the resulting confusion and have occupied the current international regulatory
vacuum”, which is a paraphrase (minus the mention of the other companies you called out) from
your recent Science article. Specifically, what advantage did we take of whom? Finally, we
request that you join us for a phone conversation – or a visit to our facilities in San Diego – in
order to take the time to find out who we really are and what we’re really doing to bring
advancement and credibility to this emerging industry.
Upon close inspection, you’ll find that Stemedica has dedicated itself to being a leader within the
stem cell movement. We recognize, and respect the roles that basic bench research and properly
approved clinical trials have in the advancement of this industry. We strive to do what is right
and responsible and wish to work with you to help clear up this current confusion on a priority
basis.

With regard,

 Maynard
Maynard A. Howe, PhD
Vice Chairman & CEO

				
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