Due to my prior experience as Board Certified ( Russian Federation) Physician with 10 years as a practicing physician and pediatrician.
1. Opportunity to create a New Company (CapNostics, LLC) to re-launch the FDAcleared swallowable screening device for esophageal bottle-brush cellularretrieval for use with new Genome Sequencing diagnostic tests (Biomarkers)that are expected to become mass out-patient screening tests used earlydetection of Barrett’s Esophagus, H.Pylori and other diseases.Prepared by:Martin von DyckE-mail: mvondyck@CapNostics.comhttp://www.CapNostics.comMay 30, 2013FDA ClearedReady to Launch!
2. 2Disclaimer• This “Presentation”, together with any information enclosed or accompanying it, contains restricted, privileged andconfidential information and is therefore intended solely for distribution to authorized persons. If you are not theintended recipient of this Presentation, you must not disseminate, modify, copy or take action in reliance upon it,unless expressly authorized by CapNostics, LLC This Presentation may not be used, reproduced or transmitted, inany form or by any means whatsoever, without permission from BE Holdings, LLC• Conﬁdentiality Notice: This Business Plan is conﬁdential and contains proprietary information and intellectualproperty of CapNostics, LLC Neither this Business Plan nor any of the information contained herein may bereproduced or disclosed under any circumstances without the express written permission of CapNostics, LLC ThisBusiness Plan does not constitute an offer to sell or solicitation of an offer to buy securities of CapNostics, LLC . Anysuch offers and sales will be made only to “Accredited Investors,” as defined in Regulation D under the SecuritiesAct of 1933, as amended, pursuant to separate agreements to be negotiated by the parties.• This Presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of1933, and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties, includingdiscussion of product and business plans, current asset valuations as well as financial estimates and projections.These statements are based on Ornaki’s expectations, estimates, projections and assumptions. You can identifythese statements by the fact that they do not strictly to historic or current facts. They use words such as “will”,“anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, “forecast” and similar words inconnection with any discussion of future operating or financial performance. Due to various risks anduncertainties, actual events or results may differ materially from those reflected or contemplated in such forwardlooking statements.• Neither CapNostics, LLC, nor any of its employees or representatives, make any warranty or representation,whether express or implied, or assumes any legal liability or responsibility for the accuracy and completeness ofany information disclosed in this Presentation.
3. What is Barrett’sesophagus• Gastroesophageal reflux is a normal physiologic event, which occurs in all individuals. However, when thisoccurs frequently and an individual develops recurrent symptoms and/or complications, it is consideredgastroesophageal reflux disease (GERD). It is estimated that GERD affects up to 30 million people in theU.S., with 10% of those individuals experiencing symptoms on a daily basis.• Barretts esophagus is a disorder in which the lining of the esophagus (the tube that carries food from thethroat to the stomach) is damaged by stomach acid and changed to a lining similar to that of the stomach.• Barretts esophagus occurs more often in men than women. You are more likely to have this condition ifyou have had GERD for a long time.• Patients with Barretts esophagus may develop more changes in the esophagus called dysplasia. Whendysplasia is present, the risk of getting cancer of the esophagus increases.• Early detection and treatment is highly desirable as this is a potentially lethal malignancy.• If the cancer is detected at an early stage, the 5 year survival is 83–90%, compared with a dismal 10–15% 5year survival of late stage cancers. Barrett’s esophagus is present as a pre-malignant lesion in many ormost cases of esophageal carcinoma.• Data reflect a large number of individuals with Barrett’s esophagus who remain unrecognized until theendoscopy has been performed. Moreover, a 21-fold increase in the recognition of Barrett’s (from 22.6cases per 100 000 population to 376 cases per 100 000 population) has also been reported when cases ofBarrett’s oesophagus found during autopsy were compared with those that were clinically diagnosed, thatis by endoscopy. Thus, recent data suggest that the prevalence of the Barrett’s esophagus may be muchhigher than had been originally appreciated.
4. What is Barrett’sesophagus• How Is Barretts Esophagus Diagnosed?• Because there are often no specific symptoms associated with Barretts esophagus, it can only be diagnosed withan upper endoscopy and biopsy. In general, doctors recommend that people over the age of 40 who have a long-term history of GERD be screened for Barretts esophagus.• To perform an endoscopy, a doctor called a gastroenterologist inserts a long flexible tube with a camera attacheddown the throat into the esophagus after giving the patient a sedative. This is expensive with the Nationalaverage being $2700 per procedure. (http://www.newchoicehealth.com/Directory/Procedure/126/Upper%20GI%20Endoscopy)• Biomarkers (This what CapNostics,LLC will partner with)• Several new biomarkers that have recently been evaluated can potentially also help to identify a group of patientswith a high risk of developing HGD and cancer. Recent studies have found that in individuals who progressed fromBarrett’s esophagus to esophageal carcinoma, one of two normal p53 alleles was inactivated by mutation and thesecond was lost by a mechanism termed as loss of heterozygosity (LOH). Reid and colleagues followed 256patients with Barrett’s esophagus and p53 LOH data at baseline for up to 5 years and found p53 LOH to be astrong predictor of progression to esophageal carcinoma (relative risk 16; 95% CI 6.2 to 39; p<0.001).• In another study, biopsy specimens from 11 of 12 patients with esophageal carcinoma stained positive for cyclinD1 and a statistically significant risk for progression to carcinoma (OR 6.85; 95% CI 1.57 to 29.91, p 0.0106) wasfound in the patients who stained positively for this biomarker. Systematic flow cytometry can identify patientswith increased 4N or aneuploidy and has also been used in recent studies. A 28% 5 years cumulative esophagealcancer incidence was found in those Barrett’s patients with either aneuploidy or increased 4N compared to a 0% 5year cumulative esophageal cancer incidence in patients with neither aneuploidy nor increased 4N fractions. Asyet, none of the molecular markers has shown to be a better predictor or more cost effective than the finding ofdysplasia on biopsy. Prospective multicenter validated studies need to be performed to provide more informationregarding these predictors and their exact role in surveillance of Barrett’s esophagus patients.
5. Current method of diagnosis vsCapNostics swallowable device$2700 on average and quite unpleasant.VSLess than $100 and in Doctors office.
6. Introduced in 1993the device was on themarket for 1.5 yearsand was withdrawndue the lack offunctional Biomarkertest kits.20 years later, withthe recent break-through BiomarkerTechnology, theworld is ready for thisnon-endoscopicoption!
7. CapNostics, LLCMISSION STATEMENT: To form company that will capitalize on the existing IP, FDA 510k cleared status&Technical File. While remaining a virtual holding company, have the vital Cellular RetrievalDevice manufacturing outsourced and sell the FDA Approved Cellular RetrievalDevice to genome sequencing (Biomarker) diagnostic testing companies to sellalong with their Biomarker Kits. Several Biomarker companies are eager to place orders for the CellularRetrieval devices once they become available.7Est. Sales Price$20 each
8. Device isFDA Cleared !On January 20, 2000:All Biosearch MedicalProducts, Inc.’s rights tothis product and it’s FDA510K were formallytransferred toMartin von Dyck.
9. Publishedin 1992
10. Instructionsfor use.INSTRUCTIONS:No scope, swallow method1) Give the patient a drink of water at room temperature, exceptwhen medically contraindicated.2) Allow the patient to swallow the capsule. Gently advance thestylus to follow the capsule, as with a nasogastric feedingtube. (The atraumatic distal deflector tip is radiopaque,placement confirmation can be achieved via fluoroscopy or X-ray.)3) Allow time for the gelatin capsule to dissolve and the foamsphere to be completely exposed. This will normally occurafter 2 - 4 minutes at normal body temperature. Five (5)minutes should assure uniform withdrawal in all patients.(Swallowing some warm water will accelerate this process.)4) CAUTION : Withdraw the foam sphere at once if substernalpressure or dysphagia develops during passage of thedevice.5) After confirmation of position, gently and slowly withdraw thefoam sphere from the patient by pulling the stylus.6) Amputate the foam sphere from the stylus assembly.7) Transfer the collected cells from the foam sphere byimprinting the foam onto slides. Or swirl the foam sphere insaline (for immediate transport to pathology) or appropriatesolution for Cytology, Cytometry.WARNING : Contraindicated for documented esophagealdysfunction that could preclude safe passage of endoscopeor capsule.
11. In-Vivo Endoscopic view of theCapnostics SwallowableSpecimen retrieval device.Video still shots show the Capsule dissolving in thestomach and then collecting cells through the LowerEsophageal sphincter and throughout the Esophagus.Sample shown is a 25mm, 40ppi foam version.
12. Foam collector expanding as gelatincapsule dissolvesVery flexiblepolyestermonofilament forstrength andcomfort.
13. Foam collector expanding as gelatincapsule dissolves
17. Fully deployed! White material iscellular material being collected
18. Fully deployed! White material iscellular material being collected
19. Copy Cat Product (CytoSponge)verifies that our version has meritSponge on string trial launched to try and prevent deadly oesophageal cancer25 Jul 2011Cancer Research UK has launched a large multi-centre trial to test a new device for detecting Barretts oesophagus – a condition that puts sufferers at increasedrisk of developing cancer of the oesophagus, one of the most deadly cancers.In the last thirty years oesophageal cancer rates have risen dramatically in the UK compared with many other Western countries, particularly for a certain typecalled adenocarcinoma, which is linked to Barretts oesophagus.The trial will examine whether a promising new test called cytosponge could provide an improved method of identifying patients with Barretts oesophagus, sothey can be offered treatment to reduce their risk of oesophageal cancer.The test involves patients swallowing a small capsule with a string attached, which dissolves in the stomach and expands to form a 3cm sponge.The sponge is gently drawn back out using the string, removing a small sample of the cells lining the oesophagus as it passes, which can be tested in the lab forearly signs of cancer.Each test should cost just £25, compared with £400 for a traditional endoscopy, and the procedure is far less invasive.Chief Investigator Dr Rebecca Fitzgerald, who led the Cambridge-based team that developed the cytosponge test, said: "If this trial is successful it will provide acheap, safe and highly effective method of identifying people with Barretts oesophagus, so they can take steps to reduce their risk of developing cancer."This would open the doors for a national screening programme, much like those offered for breast, cervical and bowel cancers, to help prevent oesophagealcancer among the one to two people in every 100 with Barretts oesophagus who go on to develop the disease."Oesophageal cancer is the sixth most common cause of death from cancer in the UK, with around 7,500 people dying from the disease each year. It is oftendiagnosed at a late stage, making it difficult to treat, and this largely accounts for the poor survival rates.Persistent heartburn or indigestion, caused by stomach acid coming back up the gullet, is a major risk factor for cancer of the oesophagus. Over time this cancause the cells lining the lower oesophagus to start to resemble those found in the small and large intestines, a condition known as Barretts oesophagus.But if the condition can be diagnosed before cancer develops, patients can be offered closer monitoring and treatment to help remove abnormal cells.At present the condition can only be detected by endoscopy – a relatively expensive procedure which involves putting a camera down the throat to collect asample of the cells the lining the oesophagus for analysis under the microscope.Most patients with heartburn symptoms take medication without ever having an endoscopy, meaning cases of Barretts oesophagus often go undiagnosed.Dudley Hedge, 71, from Cambridge, has been involved with the cytosponge trial. He said: "It is important to get a diagnosis quickly and I was happy to be on thetrial. Having the cytosponge was a relatively straightforward procedure and I would definitely encourage others to take part."Earlier pilot studies, funded by the Medical Research Council, found that patients significantly preferred cytosponge compared to endoscopy. This latest studywill look more closely at the accuracy of the test and identify new biomarkers for diagnosing the different grades of Barretts oesophagus more reliably.Kate Law, director of clinical trials at Cancer Research UK, said: "Oesophageal cancer is one of the most difficult cancers to detect and treat, with only eight percent of people with the disease surviving over five years. Hopefully this trial will provide a simple means of screening people for Barretts oesophagus on a muchlarger scale, so those at high risk can be offered closer monitoring and measures to help prevent them developing this devastating form of cancer."Barretts Esophagus
20. MANAGEMENT TEAM, FOUNDERS & DIRECTORSMartin von Dyck Co-Founder and CEO/President of CapNostics• Martin von Dyck with over 25 years of Medical Device experience is Presidentfunctioning as special start-up and launch advisor to CapNostics.• Presently, he is also the Executive Vice President – Operations with Hydromer, Inc. and isthe President of Biosearch Medical Products, Inc. (a wholly owned subsidiary) . Hydromeris Publically Traded Bio-chemical company specializing in various market sectors andacquired all outstanding shares of the publically trade Biosearch Medical Products, Inc. in2000. Martin was the President and Board Member of Biosearch Medical Products whoinitiated and consummated the merger.• He has personally designed, filed FDA 510k submissions and successfully launchednumerous medical devices such as Nasogastic Feeding Catheters, PercutaneousGastrostomy catheters, Mass Cellular Retrieval and Biopsy devices, Bi-polarelectrocoagulation devices for Intestinal lesions and others for treatment ofhemorrhoids, Laparoscopically placed Jejunostomy catheters, UrologicalCatheters, Laparoscopic Instruments, Electronic Biofeedback Devices for incontinence andconstipation and many others.• Simultaneously managed multiply medical device manufacturing facilities while understrict US FDA and ISO quality guidelines.• Identified and successfully negotiated numerous medical company acquisitions anddivestitures maintaining SEC compliance and improving shareholder value.• In addition to negotiating domestic OEM and Private Label manufacturing anddistribution agreements with such companies as C.R.Bard, Baxter, Olympus, Conmed, Wilson-Cook, U.S. Endoscopy, TycoMedical, Medinol, Boston Scientific, Johnson & Johnson, etc. , Martin has negotiatedcomplex multiple two and three party Cross-Border Technology License Agreements withRoyalty Components. USA, EU, China, Japan.
21. MANAGEMENT TEAM, FOUNDERS & DIRECTORSElena McGuire, M.D.; Vice President of Sales and Marketing and Business Development• Currently with Hydromer, Inc. and it’s Biosearch Medical Products, Inc. subsidiary, she manages the highlyprofitable and innovative Medical Coatings strategic business units which services the domestic and internationalmedical device industries.• Responsible for managing product development from a customer request, through the R&D process, themanufacturing, to the delivery to the end user.• Develop marketing strategies, organizing, and attending trade shows in the US, China and Europe.• Negotiating the Coating Services and Supply Support Agreements with transfer the Coating Technology to thecustomers facility.• Developed distribution network in Asia and Europe.• Manage a team of 10 people of R&D bio-chemists, engineers, coating specialists, and 12 production operators.“Due to her prior experience as a Physician, Pediatrician (Russian Federation)as well as a Project, Sales, Marketing Manager, Business Development in theMedical Device Industry, Elena has solid knowledge and clear vision of theHealthcare, the Global Market, its major tendencies, and Medical Deviceneeds and applications. I enjoyed be involved in developing novel approachesor new projects for improving Medical Device capabilities and features forincreasing and growing commercial opportunities.”
22. 2nd Marketing Opportunity:Helicobacter pylori• Helicobacter pylori ; H. pylori, previously named Campylobacterpyloridis, is a Gram-negative, microaerophilic bacterium found inthe stomach. It was identified in 1982 by Barry Marshall and RobinWarren, who found that it was present in patients with chronicgastritis and gastric ulcers, conditions that were not previouslybelieved to have a microbial cause. It is also linked to thedevelopment of duodenal ulcers and stomach cancer. However,over 80 percent of individuals infected with the bacterium areasymptomatic and it has been postulated that it may play animportant role in the natural stomach ecology.• More than 50% of the worlds population harbor H. pylori in theirupper gastrointestinal tract.• Infection is more prevalent in developing countries, and incidence isdecreasing in Western countries.
23. Current tests for Helicobacter pylori• According to the NIH, There are several different methods to test for H. pylori infection.• Breath test (called the carbon isotope-urea breath test or UBT):• Up to 2 weeks before the test, the patient must stop taking any antibiotics, bismuth-containingmedications such as Pepto-Bismol, and proton pump inhibitors (PPIs).• The patient swallows a special substance containing urea (a waste product the body produces as it breaksdown protein) that has been made harmlessly radioactive.• If H. pylori are present, the bacteria convert the urea into carbon dioxide, which is detected and recordedin the patients exhaled breath after 10 minutes.• This test can identify almost all people who have H. pylori and confirm that the H. pylori infection has beenfully treated.• Blood tests:• Blood tests are used to measure antibodies to H. pylori, and the results are reported in minutes.• This test is not quite as accurate as the other tests.• These blood tests can be used to diagnose whether an H. pylori infection is present. However, the testcannot determine whether you have an infection at the time of the test or how long you have had itbecause the test remains positive for years even if the infection is cured. As a result, it cannot be used tosee if the infection has been eradicated.
24. Current tests for Helicobacter pylori• According to the NIH, There are several different methods to test for H. pylori infection.• Stool test:• A test to detect the genetic traces of H. pylori in the feces appears to be as accurate as thebreath test for initially detecting the bacteria, and for detecting recurrences after antibiotictherapy.• This test can also be used to diagnose the infection and confirm that the H. pylori infectionhas been eradicated.• Biopsy:• The most accurate way to identify the presence of H. pylori is by taking a tissue biopsy fromthe lining of the stomach. The only way to do this is with endoscopy, which is an invasive butsafe procedure.• A biopsy will be done if endoscopy was needed for other reasons. This includes diagnosingthe ulcer, treating any bleeding, or making sure cancer is not present. Otherwise, manypatients are treated for H. pylori based on one of the three noninvasive tests listed above.
25. Copy Cat Product (CytoSponge)verifies that our version has meritINTRODUCTION/OBJECTIVES:Benign conditions of the esophagus are common and are either treated empirically with acid-suppressants or investigated by endoscopy whensymptoms are significant and a definitive diagnosis is warranted. The Cytosponge (Lao-Sirieix Gut 2009) has the potential to diagnose a range ofconditions (oesophagitis, eosinophilic oesophagitis, lymphocytic gastritis, candidiasis and H.pylori infection) from a single sample and would havesignificant benefits for patients (less invasive and more acceptable than endoscopy) and health care providers (cost-effective, rapid diagnosticinformation without referral to secondary care).AIMS & METHODS:We aimed to determine if benign esophageal and gastric pathologies can be diagnosed using the Cytosponge and associated assays. Samples froma prospective multicentre primary care cohort comprising 504 males and females aged 50 to 70 with a history of reflux symptoms (Kadri BMJ2010) were used. All individuals had a Cytosponge test followed by upper GI endoscopy within 6 weeks at which any pathology was notedaccording to standard criteria and biopsies were taken from any abnormal areas and for CLO test when clinically indicated. Cytosponge sampleswere analysed for inflammatory cells, yeast and bacteria using haematoxylin and eosin stained sections and immunostaining for H. pylori.Inflammation was scored according to predefined criteria.RESULTS:Full data set was available for 464 individuals including 263 patients with no findings by either endoscopy or Cytosponge and 103 cases withnegative endoscopies and findings on the Cytosponge (table 1). Of particular note, 1 cardia cancer case, missed by endoscopy, was identified onthe Cytosponge sample. Overall, inflammatory conditions were diagnosed more readily on the Cytosponge with 95 extra patients being diagnosedwith significant inflammation either by lymphocytic, neutrophil or eosinophilic infiltrate or by the presence of ulcer slough. Similarly, 7 furtherpatients were diagnosed with candidiasis by the Cytosponge alone. 20 CLO tests were performed and 7 out of the 7 positive tests were confirmedby the Cytosponge.CONCLUSION:The Cytosponge and associated tests have the potential to diagnose benign oesophageal pathologies and H.pylori infection. A larger clinical studyis warranted to confirm the utility of the Cytosponge in this setting.NON-ENDOSCOPIC DIAGNOSTIC TESTS FOR ESOPHAGEAL DISEASES AND H.PYLORI USING THE CYTOSPONGEPierre Lao-Sirieix (October 22, 2012)H.PYLORI