Valvublator SWOT Analysis

by | Dec 11, 2020 | Uncategorized

Valvublator II Video

Valvublator Core Pitches >
1.  Helping patients keep their own heart valve instead of getting a cow, pig, steel or plastic implant.
2.  Intervening early to de-calcify and regenerate heart valves BEFORE they are so degraded that a foreign implant is needed.  You should start taking care of your heart valves like you do your teeth and gums and prevent the need for implants.
Core obstacle = Others have successfully decalcified heart valves but the problem was that the re-calcified very quickly or they had aortic regurgitation (see attached paper and https://www.onlinejacc.org/content/16/3/623).
Core solution = We more gently decalcify the heart valve and use patented bioelectric signaling controlled stem cell homing, differentiation and regenerative protein expressions as well as calcification prevention protein expressions to prevent decalcification.
Journal of the American College of Cardiology

Volume 16, Issue 3, September 1990DOI: 10.1016/0735-1097(90)90352-P 

 PDF Article
Ultrasonic aortic valve decalcification: Serial Doppler echocardiographic follow-up
William K. Freeman, Hartzell V. Schaff, Thomas A. Orszulak and A.Jamil Tajik

Author + information

Abstract

Serial two-dimensional and Doppler echocardiography was performed on 61 patients who had surgical ultrasonic aortic valve decalcification for calcific aortic stenosis. The mean patient age at the time of operation was 77.4 ± 7.0 years; 93% had moderate to severe preoperative symptomatic limitation.
Compared with preoperative studies, Doppler echocardsographic evaluation before hospital discharge revealed a significant reduction in the mean aortic valve pressure gradient (45.3 ± 16.2 to 14.4 ± 6.5 mm Hg, p < 0.0001) and improvement in aortic valve area (0.62 ± 0.17 to 1.33 ± 0.33 cm2, p < 0.0001). There was no initial change in aortic regnrgitation grade.
Follow-up Doppler echocardiographic evaluation was passible in 43 patients alive at 9.3 ± 3.9 months.
A small but statistically significant trend toward aortic restenosis was found; only one patient had severe restenosis. Severe aortic regurgitation had developed in 26% of patients and moderate aortic regurgitation in 37%. Aortic valve replacement was performed in six patients (14%) wiyh severe symptomatic aortic regurgitation. Significant deficiency in central coaptation as a result of cusp scarification and retraction appeared to be the mechanism of postdecalcification regurgitate.
Attempted salvage of the native aortic valve in severe calcific stenosis by ultrasonic decalcification adequately relieves stenosis but leads to an unacceptable incidence of significant aortic regurgitation at follow-up study.
 
Strengths 
  • Patented technology for regenerating heart valves via SDF1, PDGF, Klotho, Follistatin and more.
  • Patent pending technology for preventing re-calcification.
  • Patent pending technology for gentle de-calcification of heart valves.
  • Percutaneous 14FR delivery for catheter based device.
  • Simple to use.
  • Takes under 1 hour.
  • Supplemented with at home Klotho stimulation of thigh muscle to prevent recalcification.
  • May open new market of early intervention and prevention.
  • Proven management team in cardiovascular sector.
  • World opinion leaders on advisory board.
  • Both catheter based and surgical models available.

 

Weaknesses 
  • Un-proven > need more supporting pre-clinical and clinical data.
  • Will be challenge to overcome obstacle of re-calcification.
  • Percutaneous heart valves are working reasonably well .
  • Limited resources cash and staff.

 

Opportunities 
  • $10 billion+ market
  • Market growing at up to 20% annually.
  • Early intervention market could broaden market by 5X.
  • Could be a 510K product > short duration use catheter.
Threats 

TAVR Risks

All medical procedures come with some type of risk. Risks of transcatheter aortic valve replacement (TAVR) may include:
  • Bleeding
  • Blood vessel complications
  • Problems with the replacement valve, such as the valve slipping out of place or leaking
  • Stroke
  • Heart rhythm problems (arrhythmias) and the need for pacemaker implantation
  • Kidney disease
  • Heart attack
  • Infection

Mechanical Decalcification of the Aortic Valve – Click Here