We aspire to be the "Intel inside" for wearable glucose sensing systems.
Founded in 2013, Glucovation has developed a continuous glucose monitoring system (CGM)
for the diabetic patient. CGM is the new technology replacing the old
technology of blood glucose (BG) meters. The BG meter market is $40B and
the CGM market is $1B with 30% CAGR.
Our CGM sensor is based on new sensing technology that is highly accurate, factory calibrated, and very low cost to manufacture, (high margins).
Glucovation has developed a novel CGM that addresses the deficiencies of the existing CGM systems. The main players currently in this market are Medtronic, Dexcom and Abbott. All three are chasing the triad of (1) high accuracy, (2) ease of use (factory calibration which equals no fingersticks), and (3) low cost to the patient, (which requires low manufacturing cost).
Our CGM system has been designed from the beginning to be highly accurate, factory calibrated and low cost to manufacture. We have (3) patents on our current technology and have obtained very good pre-clinical results. The market is very large, (greater than $1B), and growing fast, (CAGR ~ 30%). There are 20+ companies, large and small, that are trying to enter this market. These potential strategic partners are insulin drug companies, insulin pump companies, blood glucose meter companies, medical device companies seeking entrance into this large and fast growing market, and other glucose sensing companies that desire a better sensor than their current products.
Our technology is developed and ready for confirmatory clinical trials.
Our strategy is to obtain ISO certification, conduct clinical trials and
file for regulatory approval. At the same time, we are cultivating
relationships with potential strategic partners. Obtaining the right
strategic partner(s), will allow us to leverage their existing
infrastructure and go to market quickly.
Glucovation achieves consistently solid in-vivo results with high accuracyOctober, 2018
Glucovation achieves consistently solid in-vitro resultsSeptember, 2018
Glucovation significantly improves sensor-build yieldsAugust, 2018
Glucovation develops Fused Membrane Technology™ (FMT) and files patentJuly, 2018
Glucovation halts clinical trials and refocuses on improving foundational sensor chemistry and sensor-build processDecember, 2017
Glucose sensor accuracy good but not good enoughNovember, 2017
Glucovation conducts a series of clinical trials in ChinaOctober, 2017
Glucovation obtains investment at a $20M valuationMarch, 2017
China Sun enters into Development AgreementMarch, 2016
China Sun invests in Glucovation at a $10M valuationSeptember, 2015
Glucovation files three patentsApril, 2014
Founders form Glucovation to develop novel and superior CGM technologyMay, 2013
Currently the majority of diabetics use blood glucose meters, also known as fingersticks or BG meters, to obtain their glucose levels throughout the day. Using multiple fingersticks, usually prior to meals, the diabetics can then determine how much insulin to inject or dose into their bodies. Replacing fingersticks, GV is developing a wearable glucose sensor for diabetics, also known as a continuous glucose monitor or CGM. A CGM is worn on the body and gives the patient their glucose levels every 5 minutes for 10 days. The CGM device is coupled with a smart device so the patient can see their trends and also obtain alarms when their blood sugar or glucose levels go too high or too low.
The strategy involves strategic partnerships. Rather than compete directly, GV will leverage its superior technology and low cost of goods to supply other large players that already have the existing infrastructure to compete with M, D and A.
GV technology works. It works on the bench, in vitro. It works in the body, in vivo. We did clinical testing in people in 2017 in China and achieved decent but not great results. We then put a pause on clinicals and spent the last year upgrading the (a) sensor chemistry, (b) sensor-build process and (c) the applicator design. After these changes we achieved significant improvements in vitro and in vivo. Our recent in-house clinical trials have yielded industry leading accuracy with the system in a pre-commercial state. Our next step is to conduct a second round of clinicals to confirm our in-house results.
We have connected with several strategic targets. We are speaking with one company specifically about a partnership to produce the first low cost disposable artificial pancreas pairing our glucose sensor with their insulin patch pump. Another has indicated that they would be extremely interested if we could provide them a small sample of clinical data that met a certain threshold. Our in-house clinical data meets that threshold, however we need to conduct an out of house clinical for the next step with them. Speaking with these strategics, it became evident that as a small company our negotiating position is weaker if we are only courting one strategic partner versus multiple ones. Therefore, our strategy is to achieve as much progress, clinical trials and regulatory filings, as possible under our own capital before engaging all the way. This strategy seeks to maximize the benefits to GV and its investors of any long-term deal.
We have a large and already established market as the CGM market was pioneered by Medtronic and Dexcom and is known to be very large and growing very fast especially when considering that it is taking over the BG meter market.
We have established our patented technology that we developed over the last five plus years. Our technology was confirmed through due diligence by an established company as they were targeting our glucose sensing technology for their in-hospital liver therapy system. In addition, we have seen consistently good in-vivo results with our latest technology, but it requires confirmatory clinical trials.
Our manufacturing process is simple as the technology was designed for low cost manufacturing. We have targeted price points that should allow us to open new low cost markets and offer a lower cost, highly accurate sensor to the existing market.
The regulatory path is established and well known. In fact, the regulatory path was recently made simpler and faster as Dexcom has obtained a Class II 510(k) FDA regulatory approval for their latest iCGM device which we can follow.
Execution risk depends on the competence of the management and employees. The GV management have worked in this space for many years and know the landscape. In addition, we have overcome amazing obstacles and have proven that we can create and innovate under pressure and can navigate difficult challenges.
Obtaining investment capital to finance the plan execution is the biggest risk at this time.
DISCLAIMER: THIS PRESENTATION IS FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSTITUTE AN OFFER TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, ANY SECURITIES OF, OR INTEREST IN, GLUCOVATION, INC. (THE “COMPANY” OR “WE”) OR ANY OTHER SECURITIES. INTERESTS IN, OR SECURITIES OF, THE COMPANY WILL BE OFFERED ON A PRIVATE PLACEMENT BASIS (I.E., PURSUANT TO EXEMPTIONS FROM PROSPECTUS AND REGISTRATION REQUIREMENTS UNDER APPLICABLE SECURITIES LEGISLATION) ONLY TO THOSE PERSONS WHERE AND TO WHOM THEY MAY BE LAWFULLY SOLD AND ONLY BY PERSONS LAWFULLY PERMITTED TO SELL SUCH INTERESTS OR SECURITIES PURSUANT TO DEFINITIVE DOCUMENTS PROVIDED THEREFOR.INVESTORS SHOULD CONDUCT THEIR OWN DILIGENCE PRIOR TO PURCHASING ANY SECURITIES FROM THE COMPANY.
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