SUMMARY OF BUSINESS AND SCALE-UP PLAN
Medventions Technologies, LLC
Regarding investment and the private sale of $5,000,000 of
Convertible Promissory Notes
Medventions Technologies, LLC
5528 Force Four Parkway
Orlando, FL 34135
medventionstech.com
For more information, call Michael Rawers, Chief Strategy Officer & VP of Sales, 239-207-9880 or email
[email protected].© 2023 Medventions Technologies, LLC. All rights reserved. The Medventions Technologies, LLC company name, including the name MED Techand the company's logo, swirl angel image, product names including UroCycler and all other brand or product names included in this and attached or embedded communications and media are trademarks owned by Medventions Technologies, LLC.
Medventions Technologies, LLC has developed proprietary technology and novel next-generation medical devices for critical care patient management with indwelling urinary catheters: the most notable is the UroCycler®. Called “the most important advancement in catheter care since WWII” by US KOL Dr. Sanjay Saint, MD, the UroCycler is projected to become standard practice for all patients requiring catheter use, either short or long-term. The UroCycler® adaptive technology is first-in-class FDA-approved, introducing automatic bladder cycling and acting as a device replacement for required antibiotic use during catheter placement. Longtime Harvard-MGH Surgeon-Scientist, Dr. Brian Awbrey, MD, FACS, has seized a bid from Company Founders to join and lead Medventions Technologies as Chief Medical Officer to launch the UroCycler® life-saving bladder cycling device based upon this unique and peerless scientific breakthrough. UroCycler®technology includes 46 patents, full FDA approval, EU CE and outstanding unpublished clinical trials which document a decreased risk of UTI by 96% w/o ATBx, by a unique and novel medical device analyzed to be used by 100M catheter users saving $40B per year, standing alone in a $9B market. UroCycler® defines a completely new methodology and class of medical treatment by use of a medical device to resolve the infamous modern medical scourge of a 10% patient mortality rate and 7% daily infection rate.
This medical device is life-changing for the patient and the caregiver, alike. Clinical trials demonstrate major improvement over the current standard of care for patients requiring catheters, including: 96% reduction in urinary tract infection, reduced catheter care nursing time, decreased pain, allows normal bladder retraining, decreased post-void residual, normalized urine pH, prevented retrograde bacterial infection and provided significant potential cost savings for patients, payers, hospitals and providers. Simply stated, catheter use carries a 3-10% daily infection rate, comprising more than 40% of institutionally acquired infections, which manifest as 12 major catheter problems. Urinary catheters are used in 20% of all hospital patients, where 80% of all hospital acquired UTI's are catheter use (CAUTI). CAUTl's have been shown to prolong the mean length of hospital stay by 2.4 to 4.5 days, while in 2023 the average cost of that first day of hospital admission is $12,000.00. The UroCycler® uniquely addresses all 12 of these problems and is predicted to substantially reduce hospitalizations and costs.
Medventions Technologies commissioned industry leading business consultant Frost and Sullivan for expert analysis of the device, clinical trials and an extensive review of industry data and to provide growth advisory. For 60 years, Frost & Sullivan has guided the world's top companies toward transformational growth and led the way in international business and financial growth advisory & analytics, helping companies identify, plan, and capture growth opportunities around the world. Frost and Sullivan conducted extensive specific market research and insights, while analyzing Medventions Technologies’ Start-Up position in the US and Global medical device technology space, which was published in a 205-page report. That in-depth market research reveals a $9 billion dollar opportunity globally across multiple healthcare market segments, with decades of growth ahead, and is available upon request.
The Company Founders have assembled an excellent team of executives, leading medical doctors and scientist-engineers with extensive industry experience. They now bring the Medventions UroCycler® technology to market with full US manufacturing ability protected by multiple US Patents, full Regulatory Affairs approval, many years of proprietary device research and development and remarkable clinical trials. The Founders Leadership team includes two serial entrepreneurs; a Chief Technology Officer of international fame awarded numerous international prizes as a physicist-engineer-inventor leading R&D, and Chief Strategy Officer past elite national corporate success. Under their strong team leadership Medventions Technologies has prepared a $5M initial private offering for 2024, to be followed by planned Series A Funding. In its second year of operations, Medventions Technologies, LLC remains 100% owned by the Founding and Executive Members, who have funded the Company to date without debt.
With investment The Company is now prepared to manufacture and fulfill orders for the UroCycler®, with an estimated immediate potential of $9-17 million dollars in annual recurring revenue with exponential growth based upon adoption in the U.S. medical market alone. Use of this new device is reimbursed by Medicare, Federal Agencies and most private insurers. The product has received enthusiastic response by patients and clinicians, as well as adoption and endorsement from numerous leading international physicians from some of the largest and most respected healthcare organizations in the world. These include evaluation by National Rehabilitation Hospital, Massachusetts General Hospital, Horizon Specialty Hospital and Generations Medical Center (NV), Royal Adelaide Hospital, Bayfront Medical Center (FL), Veterans Administration Hospitals (x5), SW FL Urologic Association, Kettering Medical Center and Good Samaritan Hospital (OH), Baylor Rehabilitation Hospital (TX) and many more.
In 2023 only 10% of US Hospitals and doctors received the top CMS 5 Star Hospital Quality Rating. That means that Medicare and Federal Overseers now rate 90% of US Hospitals, Doctors and Risk Managers to be practicing medicine at a level that is below that of Best Medical Practice excellence. The UroCycler® can improve 3 of 5 of the important quality measures to improve patient care quality by CMS: those of Mortality, Safety of Care, Readmission, Patient Experience, and Timely & Effective Care. One of the highest quality factors, affecting all 5 criteria is Catheter-Associated Urinary Tract Infection (CAUTI). It is specifically named by Medicare-CMS as a measured Safety of Care issue, leading to increased rates of readmission, sepsis and septic shock. All of these CMS Quality Star issues can be addressed and reversed by one simple and inexpensive efficacious solution: the UroCycler®.
Medventions Technologies’ Pre-Order Program has shown strong market demand which is consistent with early physician adopter and patient testimonials. Pre-orders evidenced via Intent to Purchase records indicate an immediate demand by early adopters for over 6,000 units, and climbing. These pre-orders are expected to generate a minimum of $9-17 million dollars in annual recurring revenue. The Company is active in negotiations with Sofwerx (Special Forces), Department of Defense and the Veterans Administration for immediate application. The Company is optimizing deployment, service, sales, manufacturing and improving upon present Medicare billing infrastructure, especially important are new HCPCs Code application for this new class of medical care, as the Company prepares to scale up to fulfill the expected market demand. The cost of manufacture supports a MSRP of $399.00 for the UroCycler® packaged with drainage bag as a sterile disposable unit recommended for 30 days of use per device.
The Company has just completed a series of randomized prospective clinical trial scientific studies which document, both, the extraordinary clinical efficacy of the product resolving 12 major problems and complications of catheter use, and the cost savings of our product to hospitals, caregivers and patients.1,2,3Preparations are being finalized for immediate publication in medical journals worldwide, plus further clinical trials with major US Healthcare Partners.
With proof of superior clinical efficacy for patients, proven cost savings for payers and providers, endorsements by a large number of highly-respected physicians, and strong demand for our product (evidenced by a growing volume of orders), The Company is advancing quickly toward rapid widespread adoption of our next-generation technology in the Medical, Urological, Nursing, Rehabilitation, Long-Term Care, Critical Care, and Infection Control-Risk Management Officers of hospitals and health insurers.
Pilot clinical trial studies of use for over 2,500 patient days1, 2, 3 has revealed positive clinical results and FDA Award of 510(k) approval as an anti-reflux valve with CE mark for marketing by the European Union. The latest miniature next-generation device has received 10 industry awards for design and functionality. The clinical trial results, together with our market research, indicate further strong product demand, additional vast markets, and steep growth opportunity, with multi-billion dollar revenue potential.
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1. Use Of A New Sterile Urinary Catheter Artificial Sphincter To Improve Bladder Function And Reduce Infection In 82 Patients. Dr. Gale Curtis, MBBS, FRACS. Royal Adelaide Hospital, Johanna Briggs Institute, University of Adelaide, South Australia. Abstract reprinted 2023 from Medventions Technologies and UroSolutions FDA submission.
2. Reduced Rate of Urinary Tract Infection in Catheterized Patients Treated with an Advanced Bladder Management System Medical Device. Alan Arnold, RN, MS, CRRN and K E Pedersen, MD. Bayfront Medical Center, St. Petersburg, FL. Abstract reprinted 2023 from and Medventions Technologies and UroSolutions FDA submission.
3. Performance Analysis of the Novel Urinary Catheter Anti-Reflux Synthetic Automated Sphincter Device (UroCycler®). Dr. Cesar Monteverde Gheter, MD, Facultad de Medicina de la National Autonomous University of Mexico (UNAM), Mexico City, Mexico. Abstract reprinted 2023 from Medventions Technologies and UroSolutions FDA submission.