Vc Presentation Full 02152010
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![An unmet clinical need…Low Back Pain, Degenerative Disc Disease, Spinal Instability ,[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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Vc Presentation Full 02152010
- 1. Intralink-Spine, Inc. Introducing a Chemically-Made Class III Medical Device for the treatment of Degenerative Disc Disease Eric Hauck – CEO & President Dr. Tom Hedman – Founder, CSO & Associate Professor
- 3. 9.4% of US population (diabetes 5.9%, heart disease 8.1%, cancer 0.5%)
- 4. Most costly ailment for working age adults
- 5. >15 million/year in US receiving treatment
- 6. For every surgical patient there is >20 back pain sufferers receiving treatment for back pain
- 7. Majority of back pain cases (~90%), termed “Mechanical Back Pain”, involve muscle strains and inflammation, resolve in weeks
- 8. Due largely to mechanical insufficiency (instability) of the passive joint tissues (the disc)
- 12. Cost effectiveCrosslinking Collagen Chains in the Native Tissue
- 14. 30% reduction in disc bulge under compressive load – Pain reduction
- 15. Doubled nutritional flow to center of disc – Long term viability
- 16. 50% increase in tear resistance – Prevent disc herniation
- 17. 93% restabilization post-discectomy – Ideal adjunct to discectomy
- 18. 2-3 fold improvement in fatigue resistance – Durability
- 19. 2-fold increase in tensile strength - Strength
- 20. 25% reduction in intradiscal pressure, 50% less depressurization during loading – Pain
- 21. 3-8 fold reduction in annular tensile stress – Elimination of tensile failure
- 22. No inflammatory or adverse biological response – In vivo validation
- 23. Prevented/counteracted mechanical degradation in animal model
- 24. No concerns after in vitro and subcutaneous in vivo biocompatibility studies
- 25. Formulations optimized for reaction kineticsHedman 2003, 2006, Elliott 2005, Iatridis 2007, Hedman 2009, Hedman 2007, Cochrane 1997, Hunter 2005, Hedman 2007, Hedman 2003, Hedman 2006, Hedman 2009, Hedman 2008, Slusarewicz 2010a, 2010b, Hedman 2010
- 26. Research Grants Grants Received Grants Anticipated
- 27. NEXT™ – Competitive Advantage 7
- 28. NEXT™ – Competitive Advantage
- 30. Management Team
- 32. Intellectual Property Issued Patents Selected Patents Pending
- 34. BioGlue’s primary mode of operation is to chemically crosslink the BSA to the patient’s own vascular tissue to approximate and reinforce weak tissues.
- 35. BioGlue was approved as medical device in the US and OUS.
- 36. TruFill Liquid Embolic (Cordis JNJ) is comprised of n-Butyl Cyanoacrylate (n-BCA) which is mixed with tantalum powder and a commercially available contrast agent, Ethoiodol (for radiopacification).
- 37. TrueFill polymerizes (crosslinks) into a cast when it comes in contact with the blood.
- 38. TruFill is intended to occlude (embolize) brain AVMS (presurgically).
- 40. “And the best way for us to do that is to reduce health care costs. That's not just my opinion. That's the opinion of almost every single person who has looked at our long-term fiscal situation.” President Obama, national press conference March 24th 2009 “It is companies like Intralink Spine that will provide solutions to the current financial crisis our healthcare system is experiencing without sacrificing the highest standards of care Americans deserve and expect.” – Congressman John Carter
- 41. Non-surgical modification of spinal discs Non-surgical solutionfor spinal deformity Non-surgical prevention of knee meniscus degradation Regenerative therapy including immediate stabilization & nutritional support
- 42. Non-surgical modification of spinal discs for the treatment of Degenerative Disc Disease
- 45. >1 million spine surgeries annually
- 46. worldwide market > $17 billion, growing 16%/year+
- 47. DDD Degenerative Pathway |←~10 years->| Early Stage Disease Advanced DDD NEXT as a primary treatment NEXT as a surgical substitute or an adjunct to surgery
- 50. “Falling off” (kyphotic deformity) – above
- 52. External braces
- 53. Noncompliance
- 55. Grade I&II
- 57. Can Cell-Based Treatments Work in the Intervertebral Disc? Harsh, nutritionally deficient environment of the disc led to DDD in the first place – Buckwalter 1995 Cell environmental conditions limit cell/cytokine viability & prevent cells from producing matrix proteins Waste accumulationpH productivity “Degenerative discs may not be able to support the added nutrient demands resulting from an increase in cellular activity or cell number… the treatment will fail [growth factors, gene therapy, tissue engineered constructs, stem cells] ” – Urban 2006 Increasing nutritional demand without improving nutritional conditions of nutritionally deficient tissues doesn’t make sense! Biological treatments offer no near-term effect! Not appropriate as a stand-alone treatment.
- 59. NEXT provides long term nutritional support
- 60. Retention of GAGs Swelling Pressure , Hydration , Diurnal Flow , Waste Products & Nutritional Exchange
- 61. Hydraulic & Macromolecular Permeability Diurnal Flow , Waste Products & Nutritional Exchange Intervertebral Disc (largely avascular) Vertebral Body (well vascularized)
- 63. Primary Treatment – Meniscal Repair High-prevalence, parallel application: knee meniscus Meniscus damage is the most common knee injury 850,000 surgeries/year in US Most tears cannot be repaired Meniscal degeneration leads to knee osteoarthritis.
- 64. In Summary
Notas do Editor
- Please let me introduce to you to a revolutionary approach for the treatment of Degenerative Disc Disease the leading cause of Lower Back Pain. <next Slide 2>
- NEXT has three areas one could consider disruptive, the first is that NEXT is the only non-surgical solution which immediately stabilizes the degraded spinal disc. Patients will be treated on an out-patient basis and the procedure should last less than 1 hour. Other therapies simply treat the pain and inflammation resulting from the failure of the disc. NEXT improves tissue strength, durability, and joint stability resulting in less pain episodes and halting the progression of DDD in the patient. Secondly, the NEXT treatment is a long term fix in that it permanently creates collagen crosslinks that stabilize and strengthen the spinal disc resulting in long term relief from pain. This is unlike all other non-surgical treatments which address the pain but do nothing for the root problem of the spine- the degeneration of the disc material itself. And lastly NEXT is patient friendly in that it avoids the risks associated with spinal surgery, reduces costs and lost work. <slide 8>
- Our management team and consultants have over 200 years of experience in the Medical Device industry! <slide 15>
- Our approach to crosslinking collagen has been approved by the FDA for other pathologies including the treatment of aortic dissections and cerebral hemorrhages.
- A quick time line showing our Regulatory Plan <slide 18>
- “Medicare, which is facing soaring costs and an aging population, is trying to save money by taking a hard look at the $87 billion-a-year spent on medical-devices, requiring companies to prove that new products have greater benefits and are worth higher payments than older ones.” (Bloomberg.com) Our NEXT device meets the current cost savings need for the Heath Care system. This is the conclusion of out short presentation. If you are further interested please contact us via the web at www.intralink-spine.com. Thank you!
- Intralink-Spine Inc. (ILS) is a company formed to develop, manufacture, and sell a tissue revitalization reagent that can be injected into the spinal disc to increase stabilization of the joint and decompress the surrounding neural tissues without the high expense and risks associated with spinal surgery. This injected reagent reduces disc bulge under load and significantly strengthens disc tissue, increasing durability and tear resistance for immediate and long-term treatment of Degenerative Disc Disease (DDD) and it’s associated pathologies including Spinal Stenosis, Herniated Disks, Post-Surgical Syndromes and Back Pain, affecting over 15 million people each year in the US alone.
- Intrabrace LLC (IB) is a company formed to develop, manufacture, and sell a tissue revitalization reagent that can be injected into the spinal disc to treat spinal deformity diseases including scoliosis and spondylolisthesis (slipped disc) without the high expense and risks associated with spinal surgery.
- Biosupport is a company formed to work in conjunction with other biological treatments of spinal disc diseases as it increases nutritional flow into the avascular regions of the spinal disc thereby increasing the efficacy of the biological treatment itself.
- Is a company formed to commercialize our NEXT technology applied to the avascular areas of the knee including meniscal repair.