Lecture 2 - 10/08 Flashcards

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1
Q

Option agreement

A

An option agreement is a legally binding contract between two entities outlining each counterparty’s responsibilities to the other.

In the financial derivatives arena, the option agreement is a contract between two parties that grants one party the right, but not the obligation, to purchase an asset from, or sell an asset to, the other party. It outlines the agreed-upon price and a future date for the transaction.

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2
Q

Coronary artery stent price vs CABG

A
CABG = £40,000 - 50,000
Stent = £2000
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3
Q

Cons of coronary stent

A
  • Blood can clot on the stent
  • Scar tissue can form from the insertion of the stent
    which can then block the artery again
  • 1st blockage = stenosis
    -2nd blockage = restenosis (in mid 90s 1/3 of all pts developed restenosis)
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4
Q

Complexity of stents

A
  • floppy tube = high compliance
  • rigid tube = low compliance
  • presence of stent -> significant decreases in compliance -> abrupt compliance mismatch between arterial wall and stent -> creates flow instabilities
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5
Q

Compliance matching stent

A
  • straighter struts in middle to provide stiff support for plaque
  • parabolic struts at ends to provide compliance transition
  • leads to cleaner flow pattern
  • US patents
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6
Q

How does metal design affect restenosis rate

A
  • restenosis rates varied significantly between different stents
  • all these stents were made from the same material and used the same implantation procedure (stainless steel balloon expanded stent)
  • therefore the ONLY difference is the Design of the struts
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7
Q

Licensing the technology

A

paying rent to have rights to the invention

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8
Q

Status of compliance matching stent

A
  • 2 US patents granted (university slowed it down)
  • Option agreement (1999-2001) - Failed
  • Drug eluting stent came out (2003)
  • NIH funding (2003-2007)
  • Started company to develop CMS and related technology (Angiomechanix LLC 2002)
  • patent near expiration now
  • one potential licensee was ready to sign but found problem with 2 words in the patent ‘GENERALLY PARALLEL’ -> deal is then OFF
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9
Q

Aneurysm treatment

A
  • Surgery - invasive, traumatic and costly
  • Stent grafts of Endografts - minimally invasive, minimal trauma, costly technology, need follow up
    but has suffered component fractures and failures
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10
Q

Problem with fatigue testing

A
  • FDA only requires simple FATIGUE testing
  • PROBLEM -> Fatigue testing did not did not simulate the realities of in vivo mechanical environment
  • Additional mechanical requirement - BENDING -> 53% change in curvature in aorta when bending
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11
Q

Developing better fatigue tester

A
  • add bending and twisting
  • spinout company - Failure analysis of cardiovascular technologies (FACTS)
  • US patent issued
  • patent sold to BOSE , 2006
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12
Q

Secondary lymphoedema

A
  • 1/7 woman develop breast cancer, 20% of those develop lymphoedema (3 mil sufferers in USA)
  • USA: 10 mil suffering from lymphatic diseases overall
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13
Q

Facts about lymphoedema

A
  • 40 lymph nodes in axillary region
  • nodes are removed for diagnosis and to arrest the spread of metastasis
  • removing 1 node = 5-10% risk of oedema
  • node sparing procedures - 20% risk of oedema
  • oedema adds $11,000/year to pt care
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14
Q

Treatment for lymphoedema

A

Decongestive lymphatic therapy

- manages diseases but NO CURE

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15
Q

FaciliFlow vision

A

100,000/year node harvesting procedure

all can be done with the implant to prevent oedema

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16
Q

FaciliFlow implant

A
  • Implantable device to restore flow using parallel pathways to minimise flow resistance
  • 3-5 parallel pathways needed for implantation in humans
17
Q

FaciliFlow platform

A
  • version 1.0 : polyurethane implant with VEGFc administered
  • version 2.0 : gradual release of VEGFc, chains in series and parallel
  • version X.0 : restore and/or modulate immune function
18
Q

FaciliFlow competition

A
- autologous lymph node transfer (ALNT)
move lymph node from groin to axilla 
10 hrs under general anaesthesia 
23% complication rate 
1/4 to 1/2 develop lymphoedema in groin 
  • lymphovenous anastomoses
  • herentia pharmaceuticals
    adenovirus VEGFc for use with ALNT
  • elger biopharmaceuticals
    leukotriene b4 inhibitor
    fibralign biobridge - collagen fibres implanted subcutaneously to wick flow out of arm
19
Q

FaciliFlow pathway to the market

A
  • replace time consuming and risky node harvesting in ALNT
  • cure for early stage oedema formation
  • prophylactic use in ALL node harvesting procedures (over 100,000 in USA)
  • $1000/ implant => $100M annual market in USA
20
Q

FaciliFlow status

A
- IP filed in USA, europe, china. 
no relevant prior art identified 
- version 1.0 being tested in rats (funding secured)
- government seed grant submitted 
- company to be registered soon 
- seeking $3.7M investment
21
Q

FaciliFlow summary

A
  • incurable disease, desperate pts
  • simple, safe platform technology
  • solid IP
  • experienced team
22
Q

Lesson - Factors of success

A
  • IP protection
  • support from uni / institution
  • understand the market of similar devices (the race)
  • regulatory issues (barrier to your competition)
  • merit of the idea