I Need-AL My Blood  Technology:  Jeffrey Karp, PhD, HST, BWH Alex Slocum, PhD, MIT Omid Farokhzad, MD, BWH Erik Bassett, M...
Catheter Use in Clinical Setting Insertion into the brain to drain excessive cerebrospinal fluid into the abdominal cavity...
State of the Art (start 1:04)
Catheter Insertion Steps   Step 1:  Gain access to target space by inserting needle into vein / cavity  Step 2: Insert spr...
What Can Go Wrong?
Technological Innovation: Mechanical Insight
Technological Innovation: Demonstration
Developed Market Alternatives:  Image Guided Placement
Finding Sweet Spot Faster, more accurate placement of catheter Less operator skill required Allows entry into well- define...
Criteria for Sweet Spot Image guided placement not financially viable U.S. based, Medicare funded for initial product laun...
Top Three Selections <ul><li>Fistula for Dialysis </li></ul><ul><ul><li>High frequency </li></ul></ul><ul><ul><li>High com...
Feb 2009 Pilot Trial  PoC in humans Pivotal Trial File IDE  With FDA  PoC established in porcine model, Additional $200K (...
Final Recommendation <ul><li>With increasing penetration of the US dialysis market,  Need-AL revenues approach $500 millio...
Final Recommendation <ul><li>Pursue start-up  company initially focused on US fistula-dialysis market </li></ul><ul><li>Ra...
IP <ul><li>Key Facts: </li></ul><ul><ul><li>Priority date reserved: Feb 7, 2007 </li></ul></ul><ul><ul><li>Filed Internati...
INDEX
Technological Innovation: Mechanical Insight <ul><li>1)  Sufficient compressive force along wire’s axis causes it to buckl...
Fistula  ~5.2% annual rate = 6,240 patients Total Cost $7.6 million Access dysfunction  Hospitalization  Catheter placemen...
Technological Innovation: Medical Application <ul><li>5) Once needle breaks through into a lower resistance tissue or open...
Complication Rates
Competitive Technology –  Image Guided Placement
Advantages of New Technology Improvement Optimal use Savings Faster, accurate placement of catheter Emergency situations: ...
Fistula Lee T et al.  AJKD  2006   US patients on hemodialysis therapy 300,000 patients ~40% with primary or secondary fis...
Fistula  <ul><li>Fistula provides access for hemodialysis </li></ul><ul><li>Nurse uses needles for cannulation </li></ul><...
TEAM Technology: Jeffrey Karp, PhD Tamara Isakova, MD Ridhi Tariyal, HBS/HST Dan Wolf, HBS/HST
Problem: Catheter Placement <ul><li>Multiple step process which requires time to carry out successfully </li></ul><ul><li>...
Complications <ul><li>Mechanical </li></ul><ul><ul><li>Pneumothroax – collapsed lung, requiring insertion of chest tube </...
Criteria for Evaluating Clinical Procedures <ul><li>Time it takes for the procedure to be executed </li></ul><ul><li>Compl...
Summary of Applications Considered
Summary of Applications Considered
Channel Strategy <ul><li>63% of all patients treated by one of the  four large dialysis organizations </li></ul><ul><ul><l...
Market Opportunity <ul><li>Capital needs : $0.5 - $1 million for additional proof-of-concept data </li></ul><ul><ul><li>Cu...
Startup?  <ul><li>>500K End-stage Renal Disease (ESRD) patients receiving therapy., growing at 4% </li></ul><ul><ul><li>$2...
License?  <ul><li>Potential Partners: </li></ul><ul><ul><li>Distributors and device players: Becton Dickinson, Cardinal He...
Interviews Conducted <ul><li>Dr. Tamara Isakova (Nephrologist) </li></ul><ul><li>Dr. Diane Sacco (Urologist) </li></ul><ul...
References <ul><li>Avgerinos DV et al. Management of endoscopic retrograde  </li></ul><ul><li>cholangiopancreatography: re...
References <ul><li>Myers RP et al. Utilization rates, complications and costs of percutaneous liver  </li></ul><ul><li>bio...
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  • PMA Process is Expensive and Lengthy
  • [ ] I Need AL My Blood.pp

    1. 1. I Need-AL My Blood Technology: Jeffrey Karp, PhD, HST, BWH Alex Slocum, PhD, MIT Omid Farokhzad, MD, BWH Erik Bassett, MIT Commercialization: Dan Wolf, HBS/HST Ridhi Tariyal, HBS/HST Tamara Isakova, MD, HMS, MGH
    2. 2. Catheter Use in Clinical Setting Insertion into the brain to drain excessive cerebrospinal fluid into the abdominal cavity <ul><ul><li>Insertion into peritoneal cavity to drain excess fluid associated with ascites </li></ul></ul><ul><ul><li>Insertion into pericardium to drain blood in sac surrounding heart </li></ul></ul>
    3. 3. State of the Art (start 1:04)
    4. 4. Catheter Insertion Steps Step 1: Gain access to target space by inserting needle into vein / cavity Step 2: Insert spring wire into needle and pass into target space Step 3: Remove needle from space Step 4: Catheter is threaded down the guide wire into target space Step 5: Remove guide wire Where in this process we can make an impact
    5. 5. What Can Go Wrong?
    6. 6. Technological Innovation: Mechanical Insight
    7. 7. Technological Innovation: Demonstration
    8. 8. Developed Market Alternatives: Image Guided Placement
    9. 9. Finding Sweet Spot Faster, more accurate placement of catheter Less operator skill required Allows entry into well- defined spaces without advanced imaging tech Benefits Limitations Most procedures in the U.S. now guided with imaging technology Most central lines, A-lines and other percutaneous procedures are done by trained and ultra-sound armed physicians Unknown regulatory process for clearance in battlefield, developing world markets
    10. 10. Criteria for Sweet Spot Image guided placement not financially viable U.S. based, Medicare funded for initial product launch Procedure conducted by less skilled operators (more error prone) Complications significant and costly High throughput
    11. 11. Top Three Selections <ul><li>Fistula for Dialysis </li></ul><ul><ul><li>High frequency </li></ul></ul><ul><ul><li>High complication rate </li></ul></ul><ul><ul><li>High complication cost </li></ul></ul><ul><ul><li>Large market </li></ul></ul><ul><ul><li>Medicare </li></ul></ul><ul><li>“ Centesis” procedures </li></ul><ul><li>Vascular access </li></ul>
    12. 12. Feb 2009 Pilot Trial PoC in humans Pivotal Trial File IDE With FDA PoC established in porcine model, Additional $200K (NIH) for AV fistula in animals $2-3 million 2 years Submit 510(k) Application FDA Approval: Jan 2011 Patient Monitoring and Data Collection Request Coverage Decision from CMS Clinical Development and Regulatory Timeline Pre-Clinical Bench Testing Animal Testing Timeline June 2008 $1 million Series A Round $1-2 million Series B Round
    13. 13. Final Recommendation <ul><li>With increasing penetration of the US dialysis market, Need-AL revenues approach $500 million by 2020 </li></ul>
    14. 14. Final Recommendation <ul><li>Pursue start-up company initially focused on US fistula-dialysis market </li></ul><ul><li>Raise $1 million on $3M pre-money to fund pilot PoC trial in humans </li></ul><ul><ul><li>PoC established in 1 porcine model </li></ul></ul><ul><li>Outsource manufacturing needs to China </li></ul><ul><ul><li>Need economies of scale to achieve manufacturing cost efficiencies </li></ul></ul><ul><ul><li>Easily manufactured technology </li></ul></ul><ul><ul><li>Medicare is payor – big players afraid of price war </li></ul></ul><ul><ul><li>Customers heavily concentrated in large organizations </li></ul></ul><ul><ul><ul><li>Ability to complete in these channels </li></ul></ul></ul><ul><li>Pursue additional markets in developing countries, battle medicine, and veterinary procedures where image-guided placement is absent </li></ul><ul><li>Immediate licensing deal would not unlock value potential or immediately “move the Need-AL” for big players or attract VC investment </li></ul><ul><ul><li>~$5-10M upfront plus single-digit royalty on sales </li></ul></ul><ul><ul><li>Implies 1.3-2.5x return on invested capital of $1 million </li></ul></ul><ul><ul><li>Licensing would result in shelved and undeveloped technology for fear of product cannibalization </li></ul></ul>
    15. 15. IP <ul><li>Key Facts: </li></ul><ul><ul><li>Priority date reserved: Feb 7, 2007 </li></ul></ul><ul><ul><li>Filed International application Feb 7, 2008 </li></ul></ul><ul><ul><li>International search report pending </li></ul></ul><ul><li>Coverage </li></ul><ul><ul><li>Broad claims which encompass vessels, organs, and body cavities </li></ul></ul><ul><ul><li>Both product and method claims which describe the steps in operating prototype device </li></ul></ul><ul><li>Validity </li></ul><ul><ul><li>Inventor does not know of any prior art that invalidates claims </li></ul></ul><ul><ul><li>No opinions yet from patent office </li></ul></ul><ul><li>Freedom to Operate </li></ul><ul><ul><li>Search of Google patents and WIPO database for broad claims in cannulation, percutaneous intervention, catheterization did not reveal any major findings </li></ul></ul><ul><ul><li>Possibility of combining our product with other technologies that will need to be licensed </li></ul></ul>
    16. 16. INDEX
    17. 17. Technological Innovation: Mechanical Insight <ul><li>1) Sufficient compressive force along wire’s axis causes it to buckle and lock inside needle </li></ul><ul><li>2) But compressive force required for locking must be less than compressive force required for advancement of wire through the tissue </li></ul><ul><li>3) S-shape that causes wire to buckle at a lower compressive force and wedges and locks wire in place </li></ul><ul><li>4) Once locked, an increase in compressive force applied to wire is transferred to needle, causing needle and wire to advance together as one </li></ul>
    18. 18. Fistula ~5.2% annual rate = 6,240 patients Total Cost $7.6 million Access dysfunction Hospitalization Catheter placement Fistula Infiltration Catheter Related Infection
    19. 19. Technological Innovation: Medical Application <ul><li>5) Once needle breaks through into a lower resistance tissue or open cavity, opposing force of tissue on tip of wire rapidly drops and wire unbuckles </li></ul><ul><li>6) When wire unbuckles, it can not transmit force to needle so needle stops advancing </li></ul><ul><li>7) Wire advances into target space alone </li></ul>
    20. 20. Complication Rates
    21. 21. Competitive Technology – Image Guided Placement
    22. 22. Advantages of New Technology Improvement Optimal use Savings Faster, accurate placement of catheter Emergency situations: OR / Ambulatory services Reduced watch time Less operator skill required In clinics with a low doctor to patient ratio Transfer entire skill set to a less trained professional, allow doctors to reduce time with patient and increase overall throughput in clinic Allows entry into well-defined spaces without advanced imaging technology Battle field, rural hospitals, developing nations with smaller healthcare budget Interventional radiologist may not be needed and turf war eliminated
    23. 23. Fistula Lee T et al. AJKD 2006 US patients on hemodialysis therapy 300,000 patients ~40% with primary or secondary fistulae 120,000 patients ~5.2% annual major infiltration rate 6,240 patients Average prolongation per patient of catheter-dependence = 97 days 605,000 catheter-days Assume 3.0 episodes of CRB/1,000 catheter-days 1,815 CRBs/y 15% of CRBs require inpatient care at $14,448/episode $3.9 million 85% of CRBs require outpatient care at $2,414/episode $3.7 million Total cost of CRBs arising from fistula infiltration $7.6 million
    24. 24. Fistula <ul><li>Fistula provides access for hemodialysis </li></ul><ul><li>Nurse uses needles for cannulation </li></ul><ul><li>Needle overshooting  bleeding and hematoma  infiltration  access dysfunction  hospitalization for catheter placement  catheter related infection </li></ul><ul><li>Overshooting depends on quality of dialysis staff </li></ul>Dember LM et al. JAMA 2008 and Lacson E et al. AJKD 2007
    25. 25. TEAM Technology: Jeffrey Karp, PhD Tamara Isakova, MD Ridhi Tariyal, HBS/HST Dan Wolf, HBS/HST
    26. 26. Problem: Catheter Placement <ul><li>Multiple step process which requires time to carry out successfully </li></ul><ul><li>Operator expertise dependent </li></ul><ul><li>Small part of entire clinical experience but can lead to complications which extend hospital stay and increase healthcare burden </li></ul>
    27. 27. Complications <ul><li>Mechanical </li></ul><ul><ul><li>Pneumothroax – collapsed lung, requiring insertion of chest tube </li></ul></ul><ul><ul><li>Hemothorax – blood in pleural cavity </li></ul></ul><ul><ul><li>Hematoma - collection of blood outside the blood vessels, could require blood transfusion or surgery </li></ul></ul><ul><ul><li>Arterial puncture </li></ul></ul>
    28. 28. Criteria for Evaluating Clinical Procedures <ul><li>Time it takes for the procedure to be executed </li></ul><ul><li>Complication rates involved in procedure </li></ul><ul><li>Frequency of procedures </li></ul><ul><li>Current standard of care for procedure </li></ul><ul><li>Reimbursement landscape </li></ul><ul><li>Other relevant factors </li></ul>
    29. 29. Summary of Applications Considered
    30. 30. Summary of Applications Considered
    31. 31. Channel Strategy <ul><li>63% of all patients treated by one of the four large dialysis organizations </li></ul><ul><ul><li>Per year: DaVita (94K patients), Dialysis Clinics Inc. (13K patients), Fresenius (111K patients ) </li></ul></ul><ul><li>Hospital-based clinics treated 40K patients in 2006, a drop of 6% despite a 1.3% growth in the number of hospital-based units </li></ul><ul><li>Independent clinics treated 65K patients in 2006 and saw an 9% increase in unit and patient counts </li></ul><ul><li>Small dialysis organizations (20-29 clinics) accounted for 24K patients in 2006 </li></ul><ul><ul><li>Renal Advantage, Satellite Healthcare, Renal Research Institute, Dialysis Corp. of America, National Renal Institutes, National Renal Alliance and American Renal Associates </li></ul></ul>
    32. 32. Market Opportunity <ul><li>Capital needs : $0.5 - $1 million for additional proof-of-concept data </li></ul><ul><ul><li>Current data: 1 porcine model, PoC established </li></ul></ul><ul><ul><li>Need small trial in humans: safety and PoC data </li></ul></ul><ul><li>Premarket notification 510(k) , not PMA </li></ul><ul><ul><li>Only substantial equivalence needed </li></ul></ul><ul><ul><li>Shorter and cheaper development timeline </li></ul></ul><ul><li>Injection device market of ~$2B in US and $4B worldwide </li></ul><ul><ul><li>Includes renal, coronary, and infusion </li></ul></ul><ul><ul><li>US syringes and needles ~ $1B market opportunity </li></ul></ul>
    33. 33. Startup? <ul><li>>500K End-stage Renal Disease (ESRD) patients receiving therapy., growing at 4% </li></ul><ul><ul><li>$23 billion spend by Medicare p.a., over $33 billion total </li></ul></ul><ul><ul><li>Large market opportunity, but large gorilla payor </li></ul></ul><ul><li>Low margins in Dialysis procedures, because Medicare supported </li></ul><ul><ul><li>No premium pricing on devices, no room to undercut competition </li></ul></ul><ul><li>Customers heavily concentrated in large organizations </li></ul><ul><ul><li>Difficult to compete with large players in these channels </li></ul></ul><ul><li>Product not as valuable alone in a salesforce’s bag </li></ul><ul><ul><li>Could gain pricing power by combining with other devices on a sales call </li></ul></ul><ul><li>$1 million investment on $3 million pre-money </li></ul>
    34. 34. License? <ul><li>Potential Partners: </li></ul><ul><ul><li>Distributors and device players: Becton Dickinson, Cardinal Health, Tyco, other needle companies </li></ul></ul><ul><ul><li>Customers: Davita, Dialysis Clinics Inc. Fresenius </li></ul></ul><ul><li>Need easy math for corporate partners: how does this contribute to net income? </li></ul><ul><li>Licensing deal: </li></ul><ul><ul><li>~$5-10M upfront plus single-digit royalty on sales </li></ul></ul><ul><ul><li>Implies 1.3-2.5x return on invested capital of $1 million </li></ul></ul>
    35. 35. Interviews Conducted <ul><li>Dr. Tamara Isakova (Nephrologist) </li></ul><ul><li>Dr. Diane Sacco (Urologist) </li></ul><ul><li>Dr. Steven Wu (Interventional Nephrologist) </li></ul><ul><li>Dr. Raul Uppot (Abdominal Interventional Radiologist) </li></ul><ul><li>Dr. Benjamin Medoff (Pulmonary Medicine and Intensive Care) </li></ul><ul><li>Dr. Kathleen Corey (Gastroenterologist) </li></ul><ul><li>Dr. Stephan Wicky (Interventional Radiologist) </li></ul><ul><li>Dr. Faisal Merchant (Interventional Cardiologist) </li></ul><ul><li>Dr. Thomas Wolf (Neuro-Ophthalmologist) </li></ul><ul><li>Dr. Kiran Reddy (Neurologist) </li></ul><ul><li>Dr. Ugwuji Maduekwe </li></ul><ul><li>Dr. Mark Conrad </li></ul>
    36. 36. References <ul><li>Avgerinos DV et al. Management of endoscopic retrograde </li></ul><ul><li>cholangiopancreatography: related duodenal perforations. Surg Endosc 2008. </li></ul><ul><li>Holzmann M et al. Complication rate of right ventricular endomyocardial biopsy </li></ul><ul><li>via the femoral approach: a retrospective and prospective study analyzing 3048 </li></ul><ul><li>diagnostic procedures over an 11-year period. Circulation 2008;118:1722-8 </li></ul><ul><li>Liang SJ et al. Application of ultrasound-guided pigtail catheter for drainage of </li></ul><ul><li>pleural effusions in the ICU. Intensive Care Med 2008. </li></ul><ul><li>Klein SV et al. CT directed diagnostic and therapeutic pericardiocentesis: 8- </li></ul><ul><li>year experience at a single institution. Emergency Radiology 2005; 11: 353 – </li></ul><ul><li>363 </li></ul><ul><li>McGee DC, Gould MK. Preventing complications of central venous </li></ul><ul><li>catheterization. NEJM 2003 </li></ul>
    37. 37. References <ul><li>Myers RP et al. Utilization rates, complications and costs of percutaneous liver </li></ul><ul><li>biopsy: a population-based study including 4275 biopsies. Liver Int 2008 </li></ul><ul><li>28:705-12. </li></ul><ul><li>Skolarikos A et al. Ultrasound-guided percutaneous nephrostomy performed by </li></ul><ul><li>urologists: 10 year experience. Urology 2006 </li></ul><ul><li>Raad II and Bodey GP. Infectious complications of indwelling vascular </li></ul><ul><li>Catheters. Clin Infec Dis 1992; 15: 197-210 </li></ul><ul><li>Weber A et al. Complications of percutaneous transhepatic biliary drainage in </li></ul><ul><li>patients with dilated and nondilated intrahepatic bile ducts. Eur J Radiol 2008 </li></ul><ul><li>Wu Y et al. Ventriculoperitoneal shunt complications in California: 1990 to </li></ul><ul><li>2000. Neurosurgery 2007;61:557-62 </li></ul>

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