If you read the news reports carefully, it’s clear the management of Lexington Biosciences have no doubt they are going to get FDA approval. Of course, it would be presumptuous of them to say this. Afterall, it truly is the FDA that gives approval. But consider some key points carefully.
1 They have already tried their product on 50 patients and compared their results with the more expensive and laborious ultrasound technique. The results?
2 the Heartsentry demonstrated a strong correlation to ultrasound results in initial studies with 50 patients. More significantly, Willis said, it demonstrated 500 percent sensitivity over ultrasound, consistently higher accuracy and much lower variability.
3 Now let’s analyze this: why 50 patients? Why not only 5? With 5, it could possibly be coincidental.
4 Well, why not only 20 then? Good question but is 20 enough to be absolutely certain the Heartsentry delivers the same information as the Ultrasound? It would be a lot of work to go through with the testing at Diablo and submit to the FDA if we are not certain of our product.
5 Apparently management didn’t think 20 patients were enough to be absolutely certain.
6 Okay...how about 30? Again..are we certain?
7 So they decide to test very carefully 50 patients....FIFTY! isn’t this enought to be certain?
8 Obviously, management thought this is enough...it’s enough..we’re confident. If it wasn’t enough, they could have kept going and testing 150 if they wanted to. But not needed. Let’s move forward now.
9 Afterall, that is 1/3 of what the DIABLO clinic is testing to generate a database to submit to the FDA.
10 Now to prove they are confident consider what they are doing RIGHT NOW before they have FDA approval?
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12 Concurrent to our clinical trial execution and as we plan ahead for market entry, we believe that a key element to commercial success will come from fielding a product that meets the threshold for medical insurance coverage. Regulatory approval rarely guarantees payment coverage for new devices, so we entered into a strategic business relationship with a San Francisco based arm of Navigant Consulting known formerly as Quorum Consulting. The firm offers extensive experience in the field of medical device reimbursement and health economics alongside a proven ability to define strategic business opportunities and of influencing global coverage and payment policies. As we move ahead, we are pleased to confirm we remain on-track with our ongoing checklist of goals to bring HeartSentry to market. We continue to hold dialogue with the FDA and are preparing submissions to obtain regulatory approvals in the countries we plan to market. Accordingly, we are further developing marketing plans and materials aimed at generating sales to healthcare providers in those countries.
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14 Think about this: they have ALREADY ENTERED A STRATEGIC BUSINESS RELATIONSHIP WITH QUORUM CONSULTING. Basically, this company is gifted at INFLUENCING GLOBAL COVERAGE AND PAYMENT POLICIES. Why is this important? Well to illustrate, if you were planning on getting medical insurance to travel abroad, or even to get medical insurance in your own country but you had high blood pressure, and were on blood pressure medication, the insurance company wants to know this. And yes, you have to pay more for insurance because of this. And rightly so, since you are a higher risk. Well, the insurance companies would like to know who are higher risk and who isn’t, and price accordingly. Do you think insurance companies like to spend so much on heart attack and stroke victims, especially in a foreign country? The bills can be astronomical. So it stands to reason that if they were to come to understand that endothelial function, healthy function makes one a less risk than ones who have very poor function of their vessels, then they want to know this. Afterall, they already want to know if blood pressure is high or not. And if they made this a requirement to know a general idea of their endothelial function, then all the doctors in every medical clinic in the world needs to have some simple equipment to find out? Here is where Heartsentry comes into play. Every doctors office on the planet ALREADY HAVE BLOOD PRESSURE EQUIPMENT. And the insurance companies definitely want to know that your blood pressure and cholesterol levels are fine. But now if they can be influenced to wanting the additional key information about the functionality of their endothelial health, then it would be a complete game changer for Lexington Biosciences. But the insurance companies are not eager to put a real hardship on every doctor on the planet by requiring some brand new high tech equipment that requires a course to operate. But if Heartsentry becomes very easily accessible and available to all doctors, then it would be entirely reasonable for the Industry to now require this addition information. Why? Because the DOCTORS ARE ALREADY TAKING PATIENTS BLOOD PRESSURE all around the world. The Heartsentry would be like a new blood pressure equipment that gives all the information of their old blood pressure equipment but ALSO THAT MOST CRUCIAL addition information about the health of our endothelial lining. And That would be fantastic. That would not be a hardship to any doctor at all. No course needed to operate the equipment.
15 This would be an ABSOLUTE GAME CHANGER.... for now that Heartsentry is patent protected then no one else can use their patented software that has been developed over 15 years. And once a significant number of doctors start using this equipment and your endothelial function starts becoming a household term much like blood pressure, then every doctor will start following in step. Even though the product is so simple, it would be a complete game changer. Lexington Biosciences will go right through the roof....
16 Let’s do some crude mathematics. Google says their are approximately 10 million doctors on the planet,,not counting specialists. 10 million doctors serving 8 billion people. Suffice it to say that almost 100 percent have blood pressure equipment and it is a standard procedure to take a patients blood pressure when they come in to see a doctor. Obviously the manufacturers of blood pressure equipment have a pretty big market here. But imagine if the doctors of the world could be influenced to wanting this key additional information of your endothelial function. Again, it would be unreasonable to expect every doctor in the world to buy an expensive ultrasound equipment and take a course to operate it. But something so simple as the HeartSentry device could truly make it so that a huge number of doctors want this device.
17 It would take only ONE medical convention to ILLUSTRATE and make know the product and every doctor on the planet would be now aware of it. WHY? Because, since the medical community is actually a very tight knit community in constant communication of all the latest techniques to improve health care, It would spread like wild fire. So of the 10 million doctors,,,let’s say initially only 2 million want the device.
18 And the device costs 1500. That is actually cheap. For very good blood pressure equipment that is used in medical offices can cost upwards of a 500. So of the 1500, let’s say manufacturing costs and everything else is 1000 , and 500 is profit for Lexington. So that would mean the
19 Profit for Lexington is 500 x 2 million or 1 BILLION dollars. And that’s not counting all the other doctors that would eventually want to upgrade and be able to diagnose the health of their patients endothelial function. The other 8 million doctors would represent another 4 BILLION dollars profit to tap into. And here’s the best part....the 15 years of research and patented technology is already done. The share count is not 300 million as so many companies that are finally ready for production have finally gotten to because of private placement after private placement to get to production. We are HERE...WE HAVE ARRIVED. And the share count is only about 35 million.
20 We are about to submit to FDA for approval after the end of MAY. We could literally be going to the manufacturer at the beginning of 2019. And we could be looking for which most strategic medical conventions on the planet would be the best to educate about our device. This is such a game changer...it could be huge.
21 Think also about the quote earlier...I will restate it here.
We continue to hold dialogue with the FDA and are preparing submissions to obtain regulatory approvals in the countries we plan to market. Accordingly, we are further developing marketing plans and materials aimed at generating sales to healthcare providers in those countries.
Management is holding dialogue with the FDA and are preparing submission to obtain regulatory approvals in the countries we PLAN to MARKET. Also they are ALREADY DEVELOPING MARKETING PLANS AIMED AT GENERATING SALES TO HEALTHCARE PROVIDERS IN THOSE COUNTRIES.
Imagine...they are ALREADY developing marketing plans to healthcare providers in those countries. This will be huge... for those countries also have to respect Lexington’s patent on it’s incredible simple device.
Think carefully about this. Do you think they would be preparing submissions to obtain regulatory approvals in other countries if they were not certain their going to get FDA approval? No...they already tested it with 50 people and the results correlated to the industry standard and expensive ultrasound equipment with a very trained technician. And get this....it wouldn’t matter if it wasn’t perfectly accurate. To illustrate: If a blood pressure equipement is only 90% accurate...is it worthless? No. For if your blood pressure is 170 over 140....that is very serious. But how would you know.? Well if you used a blood pressure device that was only 90% accurate, it would still tell you either it was 185 over 155 or it was 155 over 130.....that is still accurate enough to make the device very useful and let’s a physician know their is a concern with the patients blood pressure. They don’t throw away blood pressure equipment just because it isn’t 100% accurate. Well the same holds true for Heartsentry. It doesn’t matter if it isn’t 100% accurate. Doesn’t matter at all. It gives some vital information about the health of the endothelial functionality of the vessels. And this is crucial. How do we know? Because 1000’s of peer reviewed studies and reports have all testified to how crucial endothelial function is. Many have said it is as important as blood pressure information and as cholesterol information. A case could be made that it is actually the most important of the 3 pieces of information mentioned.
Never have I been so convinced that you we want to be patient another year more with this company and we will get to see some serious growth. Hang on...it’s going to get exciting.
AI
