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LBR Research
- 1. LBR Research, Inc. is a team of people with a passion about breathing. We have developed a novel therapy for COPD, which is the third leading cause of death in the United States. Annual costs exceed $30B and are rising. Our therapy reduces cost by preventing avoidable rehospitalization.
- 2. What’s the Problem? • Currently addressing obstructive lung disease, which is the 3rd leading cause of death in the US, after Cardiac diseases and Cancer • It is estimated that there may currently be 16 million people in the United States currently diagnosed with chronic obstructive lung disease (COPD) • The total estimated cost of COPD in 2002 was $32.1 billion. – $18 billion were direct costs – $14.1 billion were indirect costs
- 3. Opportunity Size (US only) • An estimated 70% of these costs are a result of approximately 10% of the patients, i.e. those with the most severe disease. From an economic burden perspective reducing hospitalization costs in this segment is the plum . % Reduction in Exacerbations Savings 5.00% $500M 10.00% $1,000M 15.00% $1,500M
- 4. The Team • Operations – Kay Gozelski – BA • Clinical Studies– Judy Smith – BSN • Medical Oversight and Insight – Toma Radut, MD • Product Development – Bob Redden – BA • Engineering – Nick Gozelski – BS – Mech. Eng – TRD • Manufacturing – George Gozelski – NASCAR • Legal Counsel – Charles Redden • Accounting – Tom Watson, CPA – www.trexlerwatson.com • Financial advisor – Tom Redden • Science Advisor – John Maddocks, PhD • Human Resources advisor – Patti Redden
- 5. Allies and Competitors • Long Term Care industry • Cultural bias toward “pill popping” health care • Pharmaceutical Industry • Hospital Bed Industry (Hill-Rom, Invacare) • Respiratory Device suppliers (OSA market)
- 6. Risk Factor and Challenges • Difficulties with regulatory agencies (FDA), • Health Care Reform legislation, • Limitations to patent (USPTO), • Patient resistance to self-care, • Dependence on key suppliers, • Difficulties with funding.
- 7. Current State • Utility patent application filed in 2011 • Four small clinical studies showimproved oxygenation and carbon dioxide elimination • SBIR grant application to be submitted by Aug 5 to support clinical trials • Low cost version of device in development • Future products concepts being developed
- 8. Exit Scenarios • Success – Patent sale in 2013 – Licensing in place in 2012 – Direct sales with contract manufacturing • Failure – Regulatory approval not available – Device turns out to be dangerous – liability losses – Patent is designed around – legal quagmire
- 9. What we need? • Clinical Evaluation Grant Funding • Research Expertise • Operations support (Ben Craig Center) • Industry Partnership Support – Medical Bed Companies – Respiratory Device Manufacturers – Long Term Care Companies
Notes de l'éditeur
- Over the next two years, we will participate in clinical evaluations of these devices and methods so that we can prove their effectiveness and realistically value our intellectual property. With 12 million sufferer s of COPD, of which 25% are acute, a mere 1% penetration with our device would yield over 30,000 units. Depending on pricing, this could yield over $100 million in revenue. We believe we have a real solution for sufferer s of COPD which will provide huge financial opportunities for the team.
- Obstructive lung disease just passed stroke as a leading cause of death No Cure - No chemotherapy or surgery or bypass or stent or angioplasty for COPD Low recogniztion compared to cancer and cardiac because there is not cure Palliative therapies are provided via inhalers Some of the therapies create their own problems Beta agonists quivering Corticosteriods pneumonia and weight gain Notice the $18 Billion in direct costs (ED and hospitalization)
- “ COPD exacerbations” is where this money goes. Patient has severe coughing and respiratory distress. Costs are for emergency care and hospitalization. Pneumonia (lung infection) is the most common form of exacerbation, and is blasted out with antibiotics. These severe patients average about two exacerbations/year and incur costs about $10K/year. Our device will improve lung function and resistance to infections, and thereby reduce frequency and severity of exacerabtions. Other opportunities Obstructive Sleep Apnea Depression Chronic Pain
- No Salaried Employees – primarily stockholders or volunteers CPA is fee-based – Intellectual Property will be fee-based Explain Gozelski duo and link to NASCAR Explain 4 Reddens Geographically distributed – wired together with Google Apps
- Biggest objection is that device takes up as much room as a sofa. Many of these severe cases are in long term care, where device can be shared. Long Term Care is motivated because exacerbations (unplanned hospitalizations) represent lost revenue. The biggest risk is a bias in our culture toward medicine as the solution, and medicine is the prevailing therapy for COPD. Pharmaceutical Industry as an ally - poor delivery is a major cause of side effects of inhalers. The more the patient needs the medicine, the harder it is to get it in. A study is planned to evaluate the WaveRider as a mechanism for improving medication delivery in addition to the primary benefits. The long-term care industry has a significant economic motivation to provide therapies that will reduce exacerbations, and appear supportive of developing approaches that cost less and keep their clients in their facilities.
- Health Care Reform is an uncertainty but it will likely support therapies that reduce costs and will support our device. SBIR grant funding is another uncertainty - will seek grants from potential licensees if SBIR becomes unabailable. Patent protection is key but isn’t always effective. Get the best IP support we can. If someone gets away with stealing the idea, we still got the therapy to the people that need it. Regulatory unknowns – hire people that know the ropes
- Revenue thru 2012 will be from various grants and investors. Limited production capability will meet the research needs. Profits are not expected during this period. When devices are well into Phase II evaluations, the efficacy of the devices will be sufficiently clear to pursue commercialization paths. Production capabilities will be expanded to meet demand until relationships develop with companies that can more effectively manufacture the devices and support the people that need them.
- We are a product development group. While making and selling the product might be more profitable, our objective is to partner with whoever can get the therapy to as many people as possible. There are many generic ways to fail, some are organizational, some are financial, and others are legal. These are the failure paths that are unique to our business model.
- The product must be proven effective and safe to receive regulatory approval. Rather than raise money from investors, our current approach focuses on getting grants thru the Small Business Innovation Research (SBIR) program. Grants from industry partners is a backup approach. cientific research .We are seeking experienced researchers to provide the scientific rigor