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An update from Stemmed Implant Technology Inc.
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November Newsletter

Shaping the Evolution of the Dental Implant Business 

Stemmed Implant Technologies is about to undergo a significant change. In the coming months we will be moving from a small company with a great idea to a much larger company with the financing, corporate sophistication and marketing savvy to face the challenges of the commercial marketplace. While on the face of it our patented technology is simple, bringing it to market for use in the dental/medical community is not. The regulatory process is multi-faceted and obtaining the required financing in today’s climate is challenging.  The journey this far has been thrilling, but I believe the real excitement lies just ahead.  We will be challenged as we go through the approval process and refine the business case for both investors and end users, but I am confident that moving through the regulatory process will make us stronger and underscore the inherent advantage of our technology. 
Widespread acceptance of our technology is inevitable. This newsletter details some of the watershed moments on our trip to this point and time, but more importantly, points to our directions for the future.
I invite you to join us as we embark on the next steps of our incredible journey and grow with Stemmed Implant Technology Inc. as it transforms into a significant player in this important niche area of dentistry and medicine. 
Regards,
Chris Ostrovski
President
Stemmed Implant Technology Inc.

www.stemmedimplant.com

The only way to make sense out of change is to plunge into it, move with it, and join the dance.
- Alan Watts

New Members of the SIT Team

In order for SIT to grow to the point where its technology is accredited and licensed internationally, the company requires new and specialize talent. To that end, the management team has been expanded to include: 
Scott Proctor, Chief Operating Officer:  Mr. Proctor is a widely respected entrepreneur with professional experience in international accounting, finance and taxation. He has helped finance and launch numerous startup companies.  Mr. Proctor is Principal of Australia Trading LLC, a company he formed in 2002 to provide expert advice to senior managers on subjects ranging from securities policy and regulation to the international financing. He has carried on business across the globe, at times managing multi-location international offices. As SIT looks to international markets for clients and investors, Mr. Proctor’s experience and connections will be critically important. As SIT moves forward with a crowdfunding options, Mr. Proctor's strategic approach to successful offerings will position the company for success. In addition to his experience, Mr. Proctor brings the securities and legal expertise of David LeGrand of Black & Lobello.  Mr. LeGrand and Mr. Proctor have worked together on a succession of projects over the past 12 years. Black & Lobello will serve as security attorneys for SIT. The firms website is  http://blacklobellolaw.com.
Dr. Allison Komiyma,  Regulatory Coordinator:  Ms. Komiyma is a former Food and Drug Administration reviewer who has served as an expert in regulatory submissions. She will develop and manage the required regulatory process - from clinical trial administration to communication with government regulatory agencies, nationally and internationally. Her involvement will expedite the approval process by avoiding duplication of effort and ensuring procedures undertaken for one regulatory authority will be suitable to meet the standards of other jurisdictions. Ms. Komiyma is the Principal of AcKnowledge Regulatory Strategies, a consultancy for biomedical manufacturer who work with implantable and other patient-contacting medical devices.  
Dr. Geza Terezhalmy, Clinical Trial Supervisor: In order to provide appropriate evidence of the suitably of the Company’s technology, SIT will conduct clinical trials sufficient large enough to provide detailed information to accreditation authorities within the US Food and Drug Administration and Heath Canada.  SIT has been fortunate to engage Dr. Geza Terezhalmy and his team with University of Texas (San Antonio), and the US Naval Research Station (Bethesda Maryland), to carry out the clinical trial.  The number of people to be tested is unknown until the commencement of the clinical trial, but trials have commenced assuming at least 20 -25 different transplant patients will be required for treatment and post-treatment observation.  Dr. Terezhalmy is recognized globally for his clinical trial work.  He is a supporter of our technology and is currently preparing an article for submission to peer reviewed journals detailing the value of SIT technology and it use in practice. 

 

R&D Funding Update

 
Over the last few years the Company has met repeatedly with private medical funders and various venture capitalists funds.  In almost every case, the funding party wanted the majority of the Company equity and large up front fees.  After considerable time and effort, management has determined this is not an acceptable financing strategy. While other companies in the vertical may be prepared to sacrifice a majority of the equity, SIT managers believe there is another way forward.
In the last few year a promising new financial instrument has enter the marketplace. It is known as crowdfunding. It is anew, but tested alternative to fundraising in major markets. Companies such as SIT offer their shares directly to private investors through a regulated website, rather than through an exchange. The investment proposition is presented online through a crowdfunding platform, rather than thorough a stock brokerage firm.  Crowdfunding allow small investors to invest directly in companies such as SIT that are in early development stage. The type of share an investor receives is determined by mutual agreement in advance of the sale, but it is different than those available through traditional investment opportunities. The risk involved is higher than in traditional markets, but the potential returns are significantly higher.  Although this type of exchange is new, the securities laws, regulations, required disclosures, and risk to Company Directors, are identical and the same quality and completeness of information is required by law. 
Are they successful? Not always, but at a recent medical device manufacturers and developers conference held in in San Diego, a full session focused on the challenges of obtaining regulatory approval of medical devices and financing examined the Crowdfunding option. As part of the discussion, case studies were presented on several companies that successfully raised $2,000,000 to $7,000,000. SIT management is carefully reviewing those case studies

Moving Forward: Our Crowdfunding Plan:  To generate the financing required to take SIT from its current position, through the regulatory process and into international markets, the Company will need to present a series of crowdfunding offerings. One alternative under consideration is holding one round of crowdfunding for each step in the complex process of product certification and related clinical trials. In order to protect the value of the equity in the Company,  it is management's intention to raise only the amount of capital required for each major step.  As one goal is achieved, the Company will offer the required number of shares to fund the next step.  As each step is completed, risk decreases and the price of shares being offered will be increased.  Management believes this is the best approach to ensure that those who support the company receive the largest return on investment.
To make SIT shares as attractive as possible, the Company will open a US parent company that will acquire the shares of SIT Canada. The shares of all current shareholders will be exchanged automatically, and there are no income tax implications.  In essence, nothing changes, except that the parent company will be registered in Nevada. This move will allow SIT to attract a wider and larger investor group and raise funds in US dollars. As most of the R&D costs and contracts are already in US dollars, management believes the geographic transition serves the best interest of the company and shareholders.   Some investors will be pleased that the value of their investment has effectively been converted to US currency with no exchange cost.

Promissory Note Financing Ending : Over the past several years the Company has accepted investor funds in various forms.  Most recently the Company had offered Promissory Notes with interest bearing terms and convertible features.  In order to conform with securities regulations, the Company will stop offering these notes prior to the crowdfunding documents being finalized and released.  Management cannot accept any further notes after  November 30, 2015. If you have a registered note commitment, this is the last day the Company can accept your funds.

Please understand the information available to investors is limited to newsletters and material found on the corporate website.  All information to be released as part of the Crowdfunding offering is confidential and subject to securities laws that ensure all investors obtain the same information at the same time.

Our regulatory approval plan

Our customers are worldwide, so our focus must be on identifying and working through the regulatory approval process that will lead to greatest international acceptance of our technology by the entities that license our technology. This will not be easy. The government product approval process is expensive and includes administrative measures, laboratory measures, animal testing and clinical trials.  While the approval board in every country has the same safety objectives, their procedures and requirements often differ. Established standards often do not exist and applicants must deal with guidelines that can be open for interpretation.
At SIT, our strategy will consider the big picture first. Rather than focus on meeting the unique demands of a single regulator, we will proceed with the development of a high-level blend of  of professional protocols that meet the requirements of Health Canada, the United States FDA and the major European approval bodies. Through careful management, and continual consultation with the regulators, we believe SIT will be able to carry out most tasks or test in a way that satisfies each of the relevant bodies, maximizing the use of resources while minimizing costs. 
There is not always a clear path or route from the beginning to the end of the regulatory process, but by being flexible, and being prepared to make modifications based on the results of clinical trials, we can navigate this process successfully.
We have the greatest technology. Now we need to build the organization that can push for the required approvals and create the infrastructure that will make it available to professionals and the public. We also need to create a situation that makes it attractive to investors. 

Clinical Trials: The Gateway to Licensing 

 Licensing the Company’s technology remains a key focus of the Company’s business plan. The level of interest in licensing this technology, and the amount a customers is willing to pay, rise dramatically following regulatory approval of the Company’s product, as well as with positive results of clinical trials.  The pursuit of clinical trials is essential to regulatory approval and the Company is finalizing the arrangement with respect to its first clinical trial with Dr. Terezhalmy  of the University of Texas.  The trial will include the selection of patients, the placement of implants and monitoring of results. The process  is scheduled to take 24 months to complete.  We expect compelling data  within the first year of the trials. The Regulatory approval process has already commenced with the engagement of Dr. Komiyma as Regulatory Coordinator. The company is ready do negotiate with serious licensing interests during latter stages of regulatory approval, and as clinical trial results are reported.

Medical Testing at McMaster University

Clinical testing involves using the Company’s dental implants on a group of people who need this procedure and agree to have their results monitored as part of the clinical trial process.  In addition to clinical testing of people using dental implants, regulators require that the Company’s technology is used in other forms of experimental medical testing.  A comparative (SIT implant vs. conventional implant ) animal study over time was conducted. The preliminary results show the bone tissue is bonding to the dental implant far better than the technology used in current dental practice. In the short term this is good for our regulatory approval of dental implant technology. In the long run it shows our technology may have a role in orthopedic surgery in the future.

Hip replacement implant?

In cooperation with McMaster University a prototype of a hip replacement implant has been developed where the steel from an artificial hip that is joined to the bone has been modified using the Company’s patented technology More work needs to be done, but current animal test results at the university indicate SIT’s technology encourages earlier bone growth than traditional technology. 

MAJOR MILESTONES 

As the management of SIT we are focused on tomorrow and the next phases of growth. For the benefit of investors, and other interested parties,  a detailed listing our our important milestones is available on the SIT website. 
Copyright © 2015 Stemmed Implant Technology Inc, All rights reserved.


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