AEMED Old News

JANUARY

2004

• AEMED publishes www.stimpad.com and www.aemed.com
• Finalizes FDA 510(k) documentation for UL® Third Party Review and commensurate FDA clearance purposes.

2005

As founder, I would like to take this opportunity at the beginning of the new year to render a status report on our company and an outline for where we are heading in 2005...

Please be sure to follow the hyper links at the bottom of each page to review the entire update, starting with a Special Thanks; and following through with November Assembly; INVIMA Certification; StimPad™ Sales; FDA Update; OutLook 2005.

Additionally, I would like to thank all of our shareholders and friends whose invaluable, continuing support and assistance have helped bring StimPad™ to market. Follow this hyper link for A personal word of appreciation to some people who have been devoted and consistently helped bring StimPad™ and its associated technologies to market.

I came to Colombia first in late October 2004 for three weeks to begin our initial manufacturing run of 10,000 StimPad™; returned to the USA to prepare for a December retail launch date. On 26 November, I returned to Colombia to review the final assembly and finalize Spanish language graphics and packaging necessary to bring StimPad™ to the Latin American market. 

Everything here takes time. Meetings are rescheduled, postponed and holidays, during which nothing gets done, are endemic to the region. From the beginning, fulfillment and Direct Response sales via Tele-Antioquia were expected in mid December --- then the inevitable delays, scheduling conflicts, etc... retail sales postponed until January. Now, rescheduled for February. 

It should be interesting to note, that the biggest problem with doing business in this region is that we speak the same language --- but do not comprehend in the same fashion. I had almost forgotten how difficult it is to work in the third world and the patience required. That being said, I can not stress enough how fortunate we are to be working with the dedicated professionals at Creatum Accesorios S.A. and Cadena Mercantil, C.I. Ltda. The final assembly and distribution folks have been great!

SPECIAL THANKS

• Clarance Quintan, our electronics engineer, and personal friend, who dedicated 13 months of time and energy to produce the FDA's 510(k) and Supporting Documents (over 320 pages of electronic data required) for US market clearance. His unparalleled attention to detail also paved the way for our INVIMA Registration (the Colombian version of the FDA) which opens the Latin America and European markets for StimPad™ sales in 2005.
• Dr. Inbody whose continuos assistance in the design and presentation of the User's Manual and clinical study requirements for the FDA clearance process has proven invaluable to the progress of the project. We are fortunate to have Dr. Inbody as an advisor and confidant in the evolution of StimPad™ and its associated technologies.
• Paul Lash whose astute vision assisted us in the initial start up of AEMED. Thanks, Paul for all of your help and support over the years.
• Raul Delgado, great corporate and personal counsel; and our associates and shareholders, Enrique Fernandez-Silva and William Hernandez, who have been stalwart supporters and truly hands on investors in raising additional capital to keep us going in a positive direction. These intrepid investors visited Creatum Accesorios, S.A., our manufacturing facility in Sabaneta, Colombia, to get a first hand look at the final assembly facility.
• Florida Circuit, and Dictaphone, our US manufacturing team. 
• Creatum Accesorios, S.A., Alfonso Velez, Cristina Muñoz, Nacho, Guillermo Gomez, Alicia Restrepo and Production Manager Fredy for their guidance in navigating the morass of bureaucracy required to do business in Latin America and in final assembly of the 10,000 StimPad™ currently being marketed in Latin America.
• Cadena Mercantil C.I., Ltda., our StimPad™ distribution arm for Colombia and MercoSur.
• Last but not least, John Burke, our resident marketing guru, and his team, Bryan Peterson (BryArt Enterprises). Friends who have gone to allot of hard work to give us the unique brand. Bryan's graphics have created a great looking international brand for StimPad™ which has helped position our product for immediate acceptance in Latin America and sales to over 42,000 retailers in the US upon FDA clearance. 

2004

• Clarance Quintan, our Chief Electronics Engineer, and Donald Ewing, Founder, completed 13 months of work generating 600+ pages of supporting documentation for the 212 page 510(k) Premarket Notification document. The 510(k) Premarket Notification was submitted to Underwriter's Laboratories® (UL®) for Third Party Review. 
• UL® is one of only a handful of companies in the world certified by the FDA to conduct Third Party Review of 510(k) Premarket Notification documents. UL®'s job is to review the 510(k) documentation, and certify to the FDA that the document and the device are substantially equivalent to existing technology. If necessary, UL® makes suggestions to clarify. UL®'s Third Party Certification positions the document for FDA Fast Track review and subsequent premarket clearance.
• UL® worked directly with Donald Ewing and Clarance Quintan during a six (6) month period to assure that the final 510(k) Premarket Notification document adequately described substantial equivalence to devices currently on the market. 
• UL® granted Third Party Certification and submitted the 510(k) Premarket Notification directly to the FDA. The FDA responded within 15 days of the UL® 510(k) submittal and indicated through UL® that our User's Manual could not contain graphics that showed the end user how to effectively utilize the device. That type of information was solely the providence of the prescribing physician.
• The User's Manual was modified according to the FDA's mandate and resubmitted first to UL® then UL® submitted the document directly to the FDA.
• On 10 September 2004, the FDA issued a finding to Will Sammons of UL® that the StimPad™ TENS "is not substantially equivalent..." They went on to say: "This decision is based on the fact that the performance data you have provided did not demonstrate your device to be as safe and effective as legally marketed devices. Specifically, your output parameters include a 7 Hz fixed frequency, a 0.245 mA peak current, and a 4 second treatment time. This is significantly different from the variable 2-160 Hz frequency / 80 mA max current (adjustable) of the predicate cited, and the treatment times on the order of 30 minutes which are currently used in marketed TENS devices. No information has been provided that would otherwise indicate that your parameters would be effective for TENS indications. You may resubmit a new 510(k) if you have data you believe can show your device to be substantially equivalent." Please review the FDA Non Substantial Equivalence letter to UL® by clicking here.

Needless to say, the finding of non-substantial equivalence came as a complete surprise to UL®, Clarance Quintan and myself. Especially when you consider that the finding does not really make sense --- logically. 

• StimPad™ has already been classified by UL® as safe, medical equipment. See, June 2003 UL® Listing; 
• Moreover, it is unequivocal that the StimPad™ 7 Hz frequency falls within the 2-160 Hz frequency of the predicate;
• And, 0.245 mA peak output is far less, i.e., safer, than 80 mA max of the predicate device. 
• We received the FDA findings from UL® on 24 September 2004. I immediately contacted Will Sammons at UL®, who put me directly in touch with the FDA Examiner, Jeff Rongero. Mr. Rongero was very pleasant and indicated that it was not a question of safety, per se, but that the FDA did not have any "data indicating" that the 0.245 mA peak StimPad™ produced was effective as TENS.
• Moreover, by mandate UL® would be unable to review clinical data and therefore suggested that we file another 510(k), reclassifying StimPad™ as an Electro-Acupuncture device, and/or submit a PRE IDE Submission of the 510(K) along with clinical data (and our clinical protocol) directly to Mr. Rongero's attention. Mr. Rongero indicated that a PRE IDE Submission was a method in which we could obtain the FDA's assistance in classifying and fine tuning our submission without cost. They would assign a physician that would liaise with AEMED to ascertain the best method to proceed.
• After review of the FDA's suggestions and Electro-Accupuncture alternative classification to TENS and consulting with UL® and Clarance Quintan, I contacted Dr. Steven Inbody, AEMED Medical Advisor, and explained the parameters of concern. Specifically of the 0.245 mA effectiveness issue.
• Dr. Inbody immediately began an extensive and ongoing review of published empirical clinical trial data that corresponds to the FDA's reclassification suggestion to Electro-Accupuncture device.
• Early on, even though StimPad™ is based on existing technology, John Burke realized the necessity of clinical trials for the retail US market. John worked closely with Dr. Inbody, Rudy Ide & Associates and the Florida Pain Medicine Association to create and engage in an ongoing thirty (30) day clinical trial to determine StimPad's ™ efficacy and ease of use. The previous year's trials have shown that StimPad™ has proven to generate a marked diminution in pain over a thirty day period. (See, collected StimPad™ Clinical Trial Data).
• Fortunately, our ongoing clinical trial has given us substantial data of efficacy and ease of use for a minor level of concern device. Therefore, once Dr. Inbody completes his review, I shall collate all data and resubmit via the PRE IDE Submission process suggested by Mr. Rongero. This places us in the unique position of having the FDA actually assist us in positioning StimPad™ and review our protocols to suggest the optimal method to proceed for an expedient market clearance. In essence, what they require to give us OTC market clearance.
• The difficulty is that we now must go through another 4-to-6 month process to receive the FDA Clearance.
• The really bright spot is the we have received INVIMA Certification (the Colombian counterpart to the US FDA) to import/export/sell StimPad™ which allows us to begin generating revenue while we finish with the FDA clearance process. 

FDA, This is where we stand:

• The FDA has requested a reclassification of StimPad™ from a TENS to an Electronic Acupuncture device. And/or clinical trial data. Dr. Inbody, AEMED Medical Advisor, is preparing a paper --- based upon published, independent clinical trials --- that supports the results of the continuing clinicals being conducted by Rudy Ide & Associates and the Florida Pain Medicine Associates. The Florida Pain Medicine Associates --- a state-of-the-art pain facility specializing in Arthritis, Osteoarthritis, Neuropathy, Nerve entrapment, Postlaminectomy Pain, RSD, Sciatica and Joint Pain --- joined us in Phase II of the StimPad™ clinical trials. This facility was chosen to broaden the scope of study subjects, in both age, psycho graphic and need for pain relief. The combined resume's of study sponsors Dr. Steven Inbody, Dr. Albert Rodriguez, Dr. Alexis Renta, and Rudy Ide & Associates bring an entirely new dynamic to the StimPad™ research. As per the FDA's suggestion, we are collating Dr. Inbody's information with our clinical trial data for a Pre IDE Submission of the revised 510(k) Premarket Notification. We are in constant communication with the FDA and things are progressing. Please review US FDA 510(K) Update for complete information.
• An independent valuation of the company was commenced at the end of 2004 by Silver Glade L.L.C. Once our first cycle of offshore sales have been completed, audited financial statements shall be submitted to complete the valuation and we shall distribute the data to all shareholders. An independent valuation --- supported by offshore sales and revenue --- shall substantially improve shareholder value and also help facilitate manufacturing and marketing avenues required to expand product inventory and global sales.
• We have completed final assembly on the first 10,000 unit production run of StimPad™. See, Final Assembly for more information. Packaging components, clam shells, master cartons, etc..., for domestic and international sales have been completed. 3000 units are destined to the USA for ongoing clinical trials and global marketing purposes.
• Cadena Mercantil has purchased 7,000 units and taken possession of the first 3,000, which shall be distributed to the retail public at approximately 50,000 pesos retail (i.e., +/- $20.00 USD). Discounts for wholesalers and Direct Response Television campaigns are anticipated and taken into consideration for final product sales. Take a look at our associate to get a preview of how we are preparing to use the internet for penetration of the Latin America market at www.cadenamercantil.com. The remaining 4000 units must be exported to Panama for latter reintroduction to Colombia. There is less tax exposure (under Colombian tax law) by exporting and reintroducing the product than by nationalization direct from Creatum Accesorios S.A., our final assembly facility.
• We are eight (8) weeks behind on product roll out due to printing and final packaging fulfillment issues. Getting the graphics adjusted and master plates finished have been a lengthy process. Adjusting the printing and the Recycle Return Form and mailing labels while waiting for the Colombian postal service to issue the return mail number (required for prepaid correspondence) has been a bit of an ordeal. Ordeal in the sense that these folks do not operate like we do. The quality of work is extremely high and the process is clarifying, just takes a little longer to accomplish our goals.
• Our Latin American packaging not only looks fabulous, but we are utilizing the packaging as the Recycle/Return Envelope. It allows the end user to keep StimPad™ and the User's Manual in one place. When the device has been used to battery expiration or there is a technical malfunction, the end user places StimPad™ into the original package and completes the StimPad™ Recycle/Return Form, which is designed to acquire additional data reference efficacy, ease of use, customer contact criteria, etc...;  StimPad™ and the completed StimPad™ Recycle/Return Form is placed into the package, where the end user removes the Prepaid Mailing Label, attaches it to the package and drops it at any postal facility in Colombia for which the customer shall receive a coupon good for a 10% discount on their next StimPad™ purchase.
• The Manual Usuario --- Spanglish for User's Manual --- was faithfully translated by Clarance Quintan, following the contextual verbiage, layout and graphics created by Dr. Inbody, Bryan Peterson & John Burke. Simply stated, the Manual Usuario is awesome! Shareholders shall be receiving samples once we have everything sealed in the finished package.
• More slowly than anticipated, the logistics of manufacturing, fulfillment and marketing are coming together. 
• This initial production run of 10,000 StimPad™ has accomplished precisely what was intended... We have identified the production and fulfillment bottlenecks and are already working to correct problem areas.

In November 2004 Creatum Accesorios, S.A. our final assembly facility in Sabaneta, Colombia, completed final assembly of our first production run of 10,000 StimPad™. Let's walk through a brief synopsis of the process...

• Step 1: Rotary silk screen machine produces 300 StimPad™ PVC housings per hour. 
• Step 2: Two layers of UL 94V rated PVC cover an upper and lower foam insulation layer with the electronic Printed Circuit Board (PCB) in the center. Precise alignment of the casing and electronics components are required to avoid electronic component meltdown.
• Step 3: High Frequency Final Assembly occurs when the 4 layers, which enveloping the PCB, are sealed together utilizing a hydraulic press which emits adjustable high frequency ultrasound waves that virtually weld all of the components into a water resistant StimPad™.
• Step 4: GelPad placement on the finished StimPad™ and product bagged for fulfillment.
• Step 5: Finished product (bags of 300) are sent to fulfillment centers in Bogota, Cali & Medellin prior to distribution.

26 November 2004, StimPad™ receives Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Certification #2004024214 --- the Colombian counterpart to the US FDA --- clearance to import, export and market StimPad™ products. INVIMA standards are the highest in Latin America and pave the way for our initial product roll out with an interview on Noticias TeleAntioquia.

• The INVIMA clearance also lays the foundation for expedient introduction of our products throughout the rest of Latin America. Specific target countries are Argentina, Brazil, Chile, Mexico, and Peru.               
• Based upon our US Marketing Plan, we have created a plan to penetrate Latin America with Direct Response Commercials and wholesale / retail sales --- first in Colombia --- and over the next 6 months of operations, the rest of Latin America. Although Latin America has a population of approximately 300,000,000 (basically the same population as the US), financial demographics do not make it as lucrative a market. However a minimum of 20% (60,000,000) potential customers exist that can afford StimPad™ and we have structured our plan to effectively target that demographic.
• Since my arrival in Colombia, I have personally invested another $50,000 dollars to complete the product roll out and maintain momentum as we launch StimPad™ in Latin America. And although we begin sales, we continue to vigorously pursue all avenues of loans/investment (both stateside and offshore) to increase manufacturing and marketing by several orders of magnitude. Large scale production runs allow us to take advantage of the component price breaks to increase profits. 
• As offshore sales begin to multiply, I feel confident that we shall achieve our goals either through an influx of offshore capital or revenue generated by sales. Naturally, an influx of capital would help immensely in reducing the time in going forward --- more product and marketing exposure equals larger volume sales. However, we are moving forward nonetheless, and shall generate revenue.
• We are dedicated to working directly with the FDA through the PRE IDE Submission process to finalize StimPad™ OTC clearance to market; and, upon Dr. Inbody's completion of the clinical data review, we shall immediately file the revised documentation and finish with the FDA clearance process. We are shooting for November 2005 as the StimPad™ US OTC product debut. In the interim...
• We are creating the global StimPad™ brand! It is our solemn obligation to the shareholders, friends and family, without whose support this venture would not have taken place, to bring StimPad™ to market and increase shareholder value by generating revenue through global sales. 
• At this juncture I do not anticipate returning to the USA until we have positive cash flow from sales. We are not in a position to let the ball drop at the last instance and suffer a defeat do to fulfillment inefficiencies.
• In March 2005, AEMED has invited 200 of the top physicians from Medellin, Colombia to attend the formal introduction of StimPad™ at the Dan Carlton Hotel; We are also coordinating attendance at numerous regional trade shows that will give StimPad™ much needed exposure within the Latin America medical community. John Burke has been invited to return to the ECRM conference where he will be meeting with the major US retailers to give them an update on StimPad™. In August of 2003, StimPad™ was the most scanned item by all the major retailers of the conference. See, August 2003 News for more information.
• August 2005, our plan is to have penetrated our next targets of distribution: Argentina, Chile, Panama and Peru (Brazil to follow last quarter 2005, when we anticipate beginning sales of Feminine StimPad™ for Menstrual Pain Relief.
• Thank you for your support and patience. Best wishes to all. We look forward to bringing you more exiting news as we move forward in international market penetration and the FDA clearance process. In the interim, if anyone needs to reach me, my US cell phone (305) 790 4768 operates (sporadically) in the region. If you can not get through, please do not leave a message as I have no way to retrieve... keep trying until you connect directly. Or, try my e-mail at dewing@aemed.com or my Colombian cell phone can be reached by dialing 011 57 315 767 0996. 
• In our September 2004 Newsletter we announced joining forces with Cadena Mercantil C.I. LTD., US Innovations Corp., S.A., and Veryan International, S.A., in initial marketing roll out of StimPad™ and Feminine StimPad™ for Menstrual Relief to Latin America.
• 12 January 2005, a principle of TeleAntioquia News --- one of the most watched news stations in Colombia --- arranges a 2 minute news spot featuring StimPad™ with Founder, Donald Ewing.
• StimPad™ renders immediate relief to the interviewer and camera crew's muscle tension, arm, shoulder & back pain. The camera guys were especially taken with the device. They did not want to let go of the StimPad™ and were adamant about purchasing. We left several samples for them to continue spreading the news.
• 13 January... the 90 second TeleAntioquia news spot aires at 1330 local time. As a news spot, direct response contact information is not permitted. However, by 1340, 9 phone calls were received at the news station with people requesting either more information or where to purchase our product. These calls were initiated by people having to look up the number for the news station and inquire. The news team directed the callers to www.cadenamercantil.com web site, which experienced an exciting increase in sight traffic (see Green Oval, below).
• 25 January... The interest generated by the StimPad™ news spot has created forward momentum with investors in the region who have demonstrated an interest in helping market StimPad™. Finalizing negotiations, commencing with Colombia, we launch a multi-phase sales campaign to penetrate the Latin American markets.

FEBRUARY

2004

• A new, comprehensive patent application combining our innovative treatment protocol with the self contained musculo-skeletal stimulation apparatus and wireless data transfer system has been completed to further protect our proprietary system approach to electrotherapy devices.  The wireless data transfer system holds far reaching potential beyond the current application and we anticipate filing five additional patents on products under development.
• StimPad™ and AEMED are listed with the FDA Device and Establishment Registration Listing Databases...

MARCH

APRIL

2004

• We are very proud to announce that we have officially filed an FDA 510(k) Premarket Notification with UL® - Underwriters Laboratories® - as a third party reviewer of the StimPad™ TENS.     UL® 's recommendation and third party certification with the FDA will give our 510(k) Premarket Notification FAST TRACK status -  and we expect to receive a fast approval. In fact, they have already called us and we have begun working with UL® to finalize the FDA documentation. We anticipate UL®'s recommendation will be a tremendous assistance with the FDA in finding the StimPad™ to be substantially equivalent to the predicate device and look forward to working closely with UL® over the next few weeks to expedite the FDA process.
• For his exhaustive efforts and assistance in preparing the supporting documentation for the 510(K) Premarket Notification, we'd like to take this opportunity to issue a special word of thanks to our Vice President of Product Development & Electronics Engineer, Clarance Quintan.  He has been invaluable towards the compilation of the 400+ pages of Software Documents supporting the 510(K) Premarket Notification and additional work on our new, patent pending StimPad™ that augments our device with wireless data transfer systems. 
• A special thanks to Raul Delgado, our corporate counsel for his invaluable assistance and patience while dealing with our offshore sales negotiations; and, Dr. Steve Inbody, for his outstanding work on The User's Manual. As a result of Dr. Inbody's dedication and unique understanding of the protocol, our User's Manual is so innovative that we have included it in our patent application on the StimPad™ device.
• In other news... Creatum,S.A., our assembly facility in Sabaneta, Colombia, shall begin final assembly and packaging of 10,000 units for sale to the Latin American Market.
• AND, AEMED, Inc., has entered into an agreement to begin marketing StimPad™ in Panama.

2005

In our January NewsLetter, StimPad_Sales & OutLook 2005, we outlined a Marketing Plan to penetrate Latin America in wholesale / retail sales augmented with Direct Response Commercials. As per the plan, we have initiated the introduction of StimPad™ in the three major cities of Colombia and Panama. The largest retail outlets in both countries have been targeted and local distributors have been enlisted to position StimPad™ in regional and smaller retail channels of distribution.

This issue delineates the process and results from:

• The initial Product Introduction of StimPad™;
• The 5-7 April Health and Beauty Expo at FUMC (Fundacion Universitaria Maria Cano);
• StimPad™ — for more than musculoskeletal pain... Alternative uses as an Electro Acupuncture device;
• An Overview of the countries in which we are commencing operations, Colombia and Panama; 
• April FDA PRE-IDE Submission Update.

Summation:

• We are achieving primary goals of market penetration — slowly!
• Additional Funding must be secured to implement the Television Advertising Campaign estimated to attain forecast unit sales! (See, 6,7 below).
• There is nothing currently on the market that offers "Push Button Pain Relief".
• The vagaries of the Latin American sociological and economic systems have made it impossible to maintain projected timelines.
• There have been unanticipated delays in research, compilation and analysis of clinical data related to FDA PRE-IDE Submission documentation — which are now resolved.
• The Marketing Plan has been adjusted to account for the next phase of market penetration, i.e., mass product awareness… Educating the consumer to the concept of "Push Button Pain Relief."
• Now, we must implement the Marketing Plan's Television Advertising Campaign to educate the retail consumer in order to attain forecast unit sales and market penetration. The potential revenue is very favorable. E.g., analysis indicates that during popular programs and viewing times a direct call to action on a commercial equates to conservative numbers of 1%-3% of viewers will purchase StimPad™ during the show. The numbers are easy, 1% of 2,000,000 viewers = 20,000 unit sales. 
• Define, Identify and Research the Clinical Protocols for the expanded utilization of StimPad™ as an Electro Acupuncture device.
• Global sales through Vertical Market Penetration of multinational customers conducting business in Colombia and Panama.
• A soft release of StimPad™ is currently underway in the three major cities of Colombia — Bogota, Cali & Medellin...

Purpose:

To test a broad demographic of customers and set an initial retail price for the product.

Methodology: We first researched and identified a select group of medical, pharmacy wholesale and retail customers. From those we selected the largest multinational entities and the smaller, regional pharmacy outlets, physicians and general public to participate in the product release. Different prices for StimPad™ were set in different parts of the country; In Bogota and Medellin, StimPad™ is on sale to the retail public at $33.00 USD per unit; Cali is testing the market at $25.50.

Our objectives:

1. Determine Product Acceptance (international).
2. Determine Packaging Acceptance (international).
3. Identify Retail Price (initial).
4. Research Regional, National, Multinational Distribution Channels.
5. Identify Regional, National, Multinational Distribution Channels.
6. Target Identified Regional, National, Multinational Distribution Channels.
7. Penetrate and Present StimPad™ to identified Regional, National, Multinational Distribution Channels.
8. Collate Data.
9. Analyze Data.
10. Analyze Marketing Plan.
11. Adjust, Enhance Marketing Plan based upon analyzed data (if required).
12. Present vertical StimPad™ Marketing Plan (and line extensions) to world markets via multinational distribution channels recruited in Latin America.
13. Collate Data.
14. Analyze Data.
15. Adjust, Enhance Marketing Plan to more effectively penetrate multinational vertical markets.

Results:

• StimPad™ receives praise from medical and retail customers, alike. The idea of Drug Free Pain Relief to a society accustomed to alternative remedies enhances our standing. 
• Virtually all surveyed and sold StimPad™ liked the Reusable/Recyclable package concept; User's Manual; Quick Reference Guide; Return Mail Label; Recycle/Return From.
• Complete sales data have not been correlated for Bogota and Cali. However, preliminary analysis indicates that the identified distribution channels in Medellin were satisfied with the perceived value of $33.00. $1.10 per day for drug free, temporary relief from musculoskeletal pain was not considered exorbitant. There is room to lower the price if necessary to stimulate sales. However, if the trend continues, a higher retail sales price equates to higher profits for AEMED.
• Researched, Identified, Targeted, Penetrated & Presented StimPad™ to select Physical Therapist, Chiropractors, Physicians, BELCORP/EBEL; CARREFOUR; COPIDROGAS; DROGUERIDA HUMANITARIA; FARMACIAS AROCHA; FUMC; INNER BEAUTY & HEALTH INSTITUTE; LA 14; SANOFI AVENTIS; SUPERMERCADOS EL REY. (5,6,7)
• We are continuing to gather data on National, Multinational Distribution Channels (8) and are in process of Analysis of Regional and Medical, Retail customers data (9,10).
• Initial analysis indicates: (a) There is nothing like StimPad™ on the market (Novelty); (b) The billboard size of StimPad™ single unit packaging and the presentation of StimPad™ #305001 - 3 Unit Display generates interest wherever it is placed; (c) A brief explanation / demonstration of utilization = consummated Sales; (d) No explanation / demonstration = light Sales, much interest.
• In adjusting Marketing Plan to analyzed data (10,11): (a) In order to achieve forecast market penetration, it is imperative we do more to educate the medical professional and consumer; (b) To drive retail OTC international sales and educate the consumer we must expediate, finish development, and implement our television marketing campaign --- sooner, rather than later!
• (12,13,14,15) await multinational vertical market penetration and subsequent data analysis.

For more information on our channels of distribution click Colombian Product Introduction or continue scrolling here.

FDA UPDATE:

• As previously indicated in the FDA Update of the January 2005 AEMED NewsLetter, at our request Dr. Inbody initiated a study into the clinical aspects of the StimPad™ device for the purposes of the FDA 510(k) and PRE-IDE Submission. Due to the sheer volume of data researched to accomplish his tasks, Dr. Inbody's clinical paper on efficacy at the miliampres StimPad™ uses has taken considerably longer than anticipated. However, the voluminous research, compilation and analysis — critical to our presentation — have determined the following:
• StimPad™ (as per the FDA's suggestion) falls within the parameters of an Electro Acupuncture Device. Moreover, the research indicates that Electro Acupuncture is one of the most effective electrotherapy protocols in use today.
• On 15 April, Donald Ewing, Founder, spoke with the FDA examiner working with AEMED to secure the StimPad™ 510(k) Premarket Clearance. The FDA examiner instructed us to: (a) furnish the FDA with two (2) copies of the PRE-IDE Submission and 510(k) to their facility in Maryland; (b) one (1) copy directed to the examiner; (c) a phone call when the documents arrived so that the examiner would personally take our submission and supporting documents to the physician(s) assigned to review the PRE-IDE Submission.
• On 18 April, Donald Ewing, Founder, and John Burke, VP Marketing, spoke with Dr. Inbody who has completed the documentation required to proceed; He is in the process of digitizing and forwarding the information to AEMED.  (A computer malfunction (probably a virus) has caused a slight delay in Dr. Inbody's data download to AEMED corporate, however he is done and we shall be collating the information for the amended filing). 
• Upon receipt of the clinical data review from Dr. Inbody, we shall be filing the PRE-IDE Submission and amended 510(k) Premarket Clearance documentation as per the examiner's instructions.
• Thank you for taking the time to read the April 2005 AEMED NewsLetter. We look forward to bringing you more exciting news as the year progresses and we accomplish our goals to achieve greater market penetration, increase profits and reduce manufacturing costs.

MAY

2002

• After 4 years of research and development of the Self Contained Electronic Musculoskeletal Stimulation Systems, Donald Ewing, founder incorporates AEMED, Inc., as a State of Florida C Corporation to commence final product development and manufacturing and marketing of the StimPad™ TENS System.

2003

• AEMED contracts the services of Talent & Energy to design and implement a cohesive marketing strategy for the StimPad™ TENS .

2004

• Innovative Remedies, an Online Pharmacy outlet located in Doral, Fl., has agreed to market StimPad™ upon FDA clearance to its customer base. Innovative Remedies prescribes over a thousand prescriptions per day to 44 of the United States.
• We would like to take this opportunity to thank and congratulate our associate Teresita Martinez for opening the door to Innovative Remedies and creating another avenue of distribution for StimPad™ and our associated products to come.  

JUNE

2003

• Underwriters Laboratories Listing of the StimPad™ TENS (EMSS Patch).
• Click on the hyper link to review our product listing http://database.ul.com/cgi-bin/XYV/template/LISEXT/1FRAME/showpage.html?name=PIDF.E230575&ccnshorttitle=Medical+Equipment&objid=1076400917&cfgid=1073741824&version=versionless&parent_id=1073991179&sequ ence=1

2004

• Last week, our founder, Donald Ewing, received the rare opportunity to actually meet in person and discuss StimPad™ with the Underwriter's Laboratories third party certification reviewers. A more clear direction for the requirements and labeling was resolved, and we discussed other products currently under development, specifically the StimPad™  for feminine menstrual relief and the UL's and FDA's role in the safety testing and certification of additional new products.
• In other news... We have a major distributor in the USA. Upon FDA clearance, ANDA Pharmaceutical has agreed to warehouse and act as a StimPad™ distributor to over 10,000 independent pharmacies and utilizing their extensive telemarketing capabilities to begin penetration of over 40,000 doctors of chiropractic medicine.

2006

AEMED Newsletter Volume 8 - June 2006

Hi Everyone,

Many of our investors have written to us asking for updates, so we have decided to create a SECURE AREA within our www.aemed.com web site STRICTLY for our investors - including confidential information on our FDA Process, our USPTO Patent status, our GLOBAL roll-outand our latest PROTOTYPES for the USA Market.

At any time, you can visit the site and receive the latest information. Our goal is to keep you well informed - because things are happening each and every day.

Here's how it works...

• Start by going to the site at: www.aemed.com;
• Then proceed to the My Account section by clicking on the My Account tab on the page menu in the upper left hand corner;
• Click on the area that states, "Click here to sign-up" ; You must fill in the sign-up page; Once you have filled in the cells, then you will be redirected to the…
• My Account page - where you will sign in using the information you created at the sign-up page.
• After sign-in, you are redirected to our secure pages

Once in the secure area, you'll be able to view animations and see drawings of our new ergonomically designed device. But - here's a quick preview:

• We are in the process of rewriting the USER MANUAL - as per the FDA. There will be fewer words, more pictures and at their request -- the ability for anyone with a 5th grade reading level to understand and comprehend the material.
• We have concluded the statistical analysis criteria for the 2nd USER STUDY - as requested by the FDA. This new study will comply with all FDA requirements.
• We have appointed John K. Burke, who has been directing the sales, marketing and product development of the StimPad™ to President of AEMED Inc. John will add operations to his already full schedule. Founder, Don Ewing, will focus his efforts on the finalization of the engineering, CAD-CAM work and development of the new prototypes while overseeing manufacturing.

We encourage each of you to visit the site as often as you like. As milestones are met, we will continue to update the SECURE SITE. We hope you like the format and look forward to finishing the new device and getting a sample off to you soon.

On behalf of the entire team working on StimPad™, we thank you for your confidence in us and your continued support.

JULY

2003

• AEMED begins initial prototype manufacturing of the StimPad™ with Dictaphone USA & Creatum, S.A.

2004

• Great news.... UL® has requested original hard copies of the 510(k) Premarket Notification and Software Documents for submittal to the FDA. UL® then prepares a report of substantial equivalency and submits their report and our hard copies to the FDA for fast track clearance of the StimPad™ TENS.

2005 NEWSLETTER

This issue delineates the exciting news and the results from:

• The 27 June - 4 July 2005 Health & Beauty Trade Show at COFERIAS, Bogota, Colombia.
• StimPad™ Canadian device Class 2 classification
• World class soccer league Atletico Nacional uses StimPad™ for physical therapy.
• July FDA PRE-IDE Submission Update.
• Our January NewsLetter, StimPad_Sales & OutLook 2005, outlined a Marketing Plan to penetrate Latin America in wholesale / retail sales augmented with Direct Response Commercials. The April NewsLetter delineated the results from the FUMC Health & Beauty Show and our initial Product Introduction to Colombia & Panama following the marketing plan's initial rollout. 
• Now, the July NewsLetter updates the progress we have made and where we need to continue to focus our efforts to achieve target market penetration. 

Summation:

• The Health & Beauty Trade Show, 27 June - 4 July, was an outstanding success! StimPad™ was displayed to an audience of over 25,000 people and we were relieving pain throughout the show! 
• Over 200 people contacted our reps with interest in distributing StimPad™ throughout Latin America and the Caribbean, follow up is in process..
• There were no other products available that offer "Push Button Pain Relief".
• Previously Identified Channels of Distribution have been penetrated and we continue to position product in regional and national chains with more distribution avenues commencing as a result of the trade show.
• We have successfully penetrated a multinational ColSanitas — part of the Sanitas Health Care Group which specializes in health care and prepaid medicine in Latin America and Europe — in order to pursue Vertical Market Penetration throughout the company's sphere of influence in the rest of Latin America and Europe.
• Canada has listed StimPad™ as a class two medical device. John Burke, our VP of Marketing, has distribution lined up with our northern neighbors.
• Free Press, Founder is scheduled to appear on five television stations and 4 different television programs.
• To achieve target market penetration, educating the consumer on our unique approach for Push Button Pain Relief remains a top priority on our list of things to do. Production of one (1) minute television spots and call centers have been identified and are ready to implement upon funding.
• Additional Funding must be secured to implement the Television Advertising Campaign estimated to attain forecast unit sales! Manufacturing must be commenced to successfully fulfill anticipated demands generated by our Latin American and Canadian marketing endeavors.

Dr. Steven Inbody, who performed a masterpiece of comprehension and ease of use with our User's Manual, is in the final stages of completing 500+ pages of supporting documentation for inclusion in the Pre-IDE Submission for the FDA clearance to market. Final cross referencing to assure scientific integrity and collating is in the works and upon receipt we shall submit the corroborating documentation to the FDA for final clearance to market.

We are starting down the road to generating revenue. Our independant valuation is almost complete, which we plan to utilize as a tool to capitalize the manufacturing and advertising necessary to reach our target market penetration. 

• Atletico Nacional --- the world class soccer league --- utilizes StimPad™ for physical therapy both on and off the field. StimPad™ has demonstrated to be of considerable practical use to highly trained athletes and sports medicine peesonnel.
• Cadena Mercantil has presented StimPad™ to these select national and multinational channels of distribution. For more information on identified channels of distribution, click on any of the logos in this NewsLetter to hyperlink to the respective web sites. 
• The national supermarket chain Carulla, celebrating their 100th Anniversary in business, was thoroghly impressed with the presentation and concept of StimPad™ and are presently codifying and setting plannograms for product placement.
• La 14, Operating 14 retail department stores in the Valle del Cauca (Cali) region is in process of planogram and codifying Cadena Mercantil into their system for product rollout.
• Carrefour, a French multinational corporation operating 17 retail outlets (Hypermarkets) in the WalMart® Superstore concept are in committe and expected to begin planogram and product codification process within next 30 days.
• ColSanitas, part of the Sanitas International Health Organization, purchasing director took the initiative of contacting our representative Cadena Mercantil after having seen StimPad™ in use at the trade show. They are not only interested in purchasing StimPad™ for its pre-paid medicine group, but for its affiliates Farmacity phamacy outlets and Locatel, the Drug Store Supermarket concept, with multiple outlets in Venezuela and Colombia.
• Cadena Mercantil C.I. Ltda., has also engaged into distribution agreements with Natural Light of Colombia, a natural health and nutrition store distributing products to 137 locations throughout the country, and has been accepted as a product with the employees unions for the banking, medical and military industries. This liaison places StimPad™ before 3,000,000+ employees of Colombia.
• We are currently awaiting Dr. Inbody's final review of the 500+ pages of supporting clinical and independant documentation that he has generated in support of our 510(k) Premarket Notification documentation required for final FDA clearance to market.

AUGUST

2003

• In August of 2003, AEMED was invited to the ECRM Conference in Orlando, Fl.,  where 100 manufacturers — presenting 843 new products — met with 60 of the top retailers and wholesalers — representing over 60,000 outlets — in the United States.  We presented StimPad™ to companies such as Wal-Mart, Target, Rite-Aid, Eckerd's, CVS Pharmacies, AARP, ANDA, Burgen-Brunswig, McKesson Pharmaceuticals, etc..…. 
• To begin the purchasing process, the buyers use hand held scanners.  Once an item is scanned, a new item form is automatically generated, product shipping details are sent to the receiving / shipping department and the advertising department is given the color photographs of the product to arrange a promotional slot in their ad plan. Plan-o-grams are implemented, and what would normally take months to accomplish — not to mention the days of travel by the salesperson — is accomplished over a three-day period.  
• Of the 843 products featured at the ECRM Conference, StimPad™ was the most scanned item of the show.  Virtually every major United States retail chain has given commitments to purchase StimPad™.   Actual purchases are awaiting FDA OTC clearance, which is currently in process.

2004

• A company milestone... Underwriters Laboratories® (UL®) has Third Party Certified the StimPad™ 510(k) Premarket Notification and supporting documents to the FDA for final premarket clearance of the StimPad™ TENS; UL®'s certification places our premarket notification in Fast Track Status with the the FDA reviewers. 
• We anticipate UL®'s recommendation will be of tremendous assistance with the FDA in finding the StimPad™ to be suitable for OTC, Physician offices, Chiropractic clinics and Sports Medicine facilities in the domestic market and that we should receive clearance to market in the next 30-to-45 days.

SEPTEMBER

2004

• Creatum, S.A. our final assembly facility in Sabaneta, Colombia, begins final assembly of the StimPad™ TENS and Feminine StimPad™ for Menstrual Relief, See, StimPad™ Final Assembly
• Underwriter's Laboratories® (UL®) representatives to certify Creatum Accesorios, S.A., Quality Systems and Good Manufacturing Systems requirements of ISO (International Standards Organization) during final assembly process of StimPad™ TENS and StimPad™ Menstrual Relief products.

2007

An update from the Founder…

In this issue:

FDA Clarification Status

• Our Response to the FDA: 

In the July 1^st Newsletter, the FDA had responded to our April 510(k) submission and requested additional information and clarification. Quality First International, Limited, (QFI, http://www.qualityfirstint.com/), our partners and consultants on regulatory issues and technical analysis, met with us and submitted a seventeen page meeting summary with additional information guiding us through the final clarification issues. We are pleased to say that we are now in the final stages of testing and data acquisition so that we can formulate and submit our response:

• The modifications suggested by the FDA have been implemented; 
• Material selections have been addressed and modified;
• Polycarbonate vs. Polypropylene;
• 2^nd Generation Device modifications to accommodate material selection issues have been resolved;
• User's Manual editions are completed; 
• Final review and clarifications with QFI are nearing completion.

A special thanks to Haroon Atiche and the QFI team of Allen Barker and Ralph Jugo for their superlative efforts and assistance as we continue to work through the process to bring StimPad™ to market. For his unwavering friendship, ongoing support of the project, accolades are also in order for Clarance Quintan, our Software/Hardware Electronics Engineer.

Thanks for your patience and continued support throughout the years of R&D, product development and regulatory issues. We are now in the final stages of the approval process — with an excellent team of professionals that shall bring this project to fruition. After submittal of our clarifications to the FDA, the FDA will then have ninety (90) days to respond. We are diligently aligning banking and further investment capital for product launch upon final clearance to market. Standby for more news from your company…

OCTOBER

2002:

• AEMED, Inc., is proud to introduce Dr. Steven Inbody, M.D., as one of our Medical Advisors. Dr. Inbody is a renowned Neurologist who founded Consultative & Therapeutic Neurology in September of 1994, following his eight-year tenure on the academic faculty of Baylor's Department of Neurology. This transition from academic neurology, to the private clinical setting, was motivated by his desire to develop a neurology clinic devoted to the comprehensive evaluation and treatment of patients in the ambulatory clinical setting.
• The basic clinical goals underlying the development of Consultative & Therapeutic Neurology include:
• Restoring and protecting the quality time and communication necessary during each physician-patient encounter, which has often been sacrificed in the current health care environment.
• Preserving the comprehensive and intensive diagnostic techniques, including Electromyography (EMG), necessary for complex neurologic problems.
• Maintaining a state of the art, clinic-based infusion center, capable of providing the full spectrum of intravenous therapies currently indicated for neurologic disease.
• Implementation of a collaborative onsite physical therapy program offering comprehensive and intensive manual therapy techniques and neuromuscular massage.
• Developing and integrating an aquatic therapy program utilizing an advanced, current-based pool design.
• Facilitating the transition of indicated patients through a reconditioning program with neuromuscular reeducation, supervised by an exercise physiologist.
• Consultative and Therapeutic Neurology represents a collaboration in patient care, which has expanded Dr. Inbody's consultative practice to include a spectrum of therapies provided by onsite and full time healthcare professionals including: RNs with extensive ICU experience, pharmacist with clinic dedicated pharmacy, physical and aquatic therapists, and an exercise physiologist. Dr. Inbody's clinical approach to patients with neurologic disease has developed from his 8 years as a physician-scientist while at Baylor, and more than 14 years in clinical practice. As an author of 23 scientific journal publications and book chapters, and a nationally recognized lecturer at medical conferences throughout the United States. Dr. Inbody currently treats patients from throughout the country and internationally. It is from this scientific platform that Dr. Inbody has utilized his clinical experience and academic background to guide his patient management decisions. His research interests include neuroimmunological diseases such as Inflammatory Neuropathies (i.e., CIDP) & Myopathies, Multiple Sclerosis, Vasculitis, and Connective Tissue Disease. Other special interests include chronic pain and pain generating mechanisms, for which Dr. Inbody was honored with a CO-appointment to the faculty of Baylors Department of Anesthesiology.
• The accompanying curriculum vitae, lists Dr. Inbody's numerous publications in both peer-reviewed journals and chapters in authoritative neurology reference textbooks.

2005

• Outstanding news for investors… our goals for developing StimPad™ and its associated technologies into the brand associated with "Push Button Pain Releif" are closer to becoming a reality.
• With sales commencing in Latin America, the need to educate the consumer and medical community to the benefits of StimPad™ has become a requirement. Our VP of Marketing and his production team have completed the layout and script for our 60 second television commercial. We are in the process of updating web sites and StimPad™ in order to make it more user friendly, cheaper to manufacture and reduce manufacturing lead times.
• Thanks to the team of Raul Delgado, Corporate Counsel, John Burke, VP Marketing and Jose Luis Castro, American Merchant Banking Group, we have negotiated bridge financing with TBeck Capital that affords us the ability to aggressively market StimPad™ and position product throughout Latin America. TBeck Capital has financed and helped take public MEDirect Latino (OTC:MLTO); Interlink Global Corp. (OTC: ILKG); Orion Technologies; Pet Ecology - (OTC:PECB); Trans Global - (OTC: TLGI) and is coming aboard as an active investor to help structure the continued roll out of StimPad™ and its associated technologies. 
• With the advent of initial funding, December 2005 marks the commencement of our formal launch of product via the television media. 
• We are excited to announce that we anticipate going public with AEMED during the first quarter of 2006. Our new associates have assured us that the public venue is the best vehicle to secure the additional funding to effectively open the worldwide market for StimPad™ and its associated technologies.

Costa Rica

• On 13 September 2005, StimPad™ received the approval for sales and importation from the Costa Rica Minister of Health. Immediately thereafter, AVON of Costa Rica, which has been in business for four decades and has a network of over 16,000 sales representatives, submitted a formal proposal to market StimPad™ through their extensive channels of distribution that include most of Central America. 
• Weekend of 8-9 October 2005, Managua, Nicaragua, AVON Costa Rica is presenting StimPad™ at a conference of the regional managers for AVON Central America. 

Colombia

• The Colombian companies listed below have begun selling StimPad™. They are looking forward to our December television marketing campaign to boost awareness and sales of our novel method of "Drug Free Pain Relief". There will be additional Colombian retail channels of distribution selling StimPad™ by the launch of the campaign. See our July 2005 AEMED Newsletter for information on additional Colombian channels of distribution.
• Hector Garces, the star of the very popular women's variety show EnLace, aired on TeleAntioquia TV, Medellin, Colombia, has invited StimPad™ Founder to appear on the show in November 2005.

Mexico

• We are presently in contact with HBC out of Texas, which markets to Wal-Mart Mexico. Samples and information have been forwarded. We are vigorously pursuing the appropriate documentation from the Mexican government and hope to begin StimPad™ sales to Wal-Mart Mexico in December 2005.
• Prior to the end of the year, we look forward to holding a formal shareholder's meeting in Miami to bring everyone up-to-date on the latest developments of AEMED. If you any questions, please feel free to contact me at the below numbers or email founder@aemed.com. 

2006

AEMED October 2006 Newsletter, Volume 9

NOVEMBER

• 26 November 2004, StimPad™ receives Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) Certification #2004024214 --- the Colombian counterpart to the US FDA --- clearance to import, export and market StimPad™ products. INVIMA standards are the highest in Latin America and pave the way for our initial product roll out with an interview on Noticias TeleAntioquia.
• The INVIMA clearance also lays the foundation for expedient introduction of our products throughout the rest of Latin America. Specific target countries are Argentina, Brazil, Chile, Mexico, and Peru. 

DECEMBER

2003

• AEMED is featured on ABC program, "Boomers and Seniors", showcasing a 4 minute documercial about the StimPad™ Push Button Pain Relief System. Stand by for additional updates on the continued development of AEMED.

2004

• Cadena Mercantil takes delivery of the first StimPad™ units for final fulfillment and retail sales in January 2005.

2007

AEMED, INC. December 3, 2007 Newsletter Volume 15  Seasons Greetings, an update from the Founder…   In this issue:  ·       FDA Response Submission ·       2nd Generation Device Housing Validation ·       AEMED Taxes 2003-2007 Our Response to the FDA:  Great news! We are another step closer to achieving the goal of worldwide market clearance and product launch.  As you are aware, our partners and consultants on regulatory issues and technical analysis, Quality First International, Limited, (QFI, http://www.qualityfirstint.com/), team of Haroon Atchia, Ralph Jugo, Alan Barker, et al, have been working in conjunction with AEMED, Inc.'s, team of Clarance Quintan and myself to complete the responses to the FDA's request for clarification of the StimPad™ 510(k).  We have undergone hundreds of hours of a concerted team effort by engineers and device/regulatory consultants, working on both sides of the Atlantic, unanticipated financial outlays, along with additional FDA mandated bench testing on conductive media degradation issues, in order to complete this phase of the project. An incredible amount of effort has gone into the sculpting of the response language and data clarification issues in order to demonstrate substantial equivalence.Table of Contents, New Graphs and Exhibits are complete; and after almost six months,our responses shall be submitted next week.   The FDA has 90 days to respond to our response.  They responded in 58 days to 757 pages  As all we are doing is clarifying the 23 points of interest, the response to another 100+ pages should be considerably less. Worse case scenario, the question is not "IF" we will receive clearance, but "WHEN." In order to receive final validation of the product, we may still be required to conduct a one (1) month usage trial by the FDA. Manufacturing of the devices for usage trial must be through an ISO 13485 Manufacturing facility and shall take approximately 60-to-90 days; An additional 60 days shall then be utilized to test, compile and delineate our response to the usage trial data to the FDA. Manufacturing + Usage Trial + Response = 150-to-180 days from FDA Usage Trial mandate. 2nd Generation Device Housing Validation: We are engaged in the final steps of taking the product to market. In order to complete validation of the 2nd Generation StimPad™ TENS Housing and Graphical User Interface,the first of three housings is being "grown" to exact dimensional specifications.  This model is Opaque, affords the opportunity to Validate the visual aspects of the interior graphical user interface, and simulates the final production tolerances for the fit and function of all components.Once final design concept is Validated, Soft Molds shall then be created, which are good for an initial production of up to 200 Housings.  This process is expensive, with each housing costing $200.  However, once we begin full scale production, costs shall go down according to scale.  AEMED Taxes 2003-2007: AEMED Income Taxes from 2003-2007 are filed and can be viewed as a PDF on our MyAccount Secure Web Site at http://www.aemed.com/AEMED_Taxes.php. Sign in to sift through the 30+ pages for more information.    Standby while we continue the process of taking StimPad™ and its associated technologies to market and align further investment capital for product launch upon USA / European clearance.  Thanks for your patience and continued support throughout the years. We shall keep you abreast of the developments as we remain steadfast in our process and complete our goals.  Seasons Greetings and Happy Holidays to all…, Donald Ewing Founder AEMED, Inc. 1100 N. Royal Poinciana Blvd., Miami Springs, Fla.33166 (Off) +1 (305) 433 3064 * (Cell) +1 (305) 359 5745 (Toll Free) +1 (888) 666-3123 E-mail: founder@aemed.com http://www.aemed.com * http://www.stimpad.com * Any review, retransmission, dissemination or other use of or taking action in reliance upon this information by person or entities other than the intended recipient is prohibited. If you have received this email in error, please contact the sender and delete the material from any computer. ***