Medical Device Development

Why You Should Help

Children who need RVOT1 reconstruction are suffering from repeated surgeries and interventions that are unavoidable with current devices.

Apart from PECA, no effort is being made to provide a better commercial option due to the high average cost of bringing a Class III device to market ($70M) compared with the small population affected by this procedure.

PECA's surgeon-created, clinically-validated design and HUD2 status has provided a unique opportunity to reduce costs to the point of quick profitability in this niche market.

Now we need surgeon support to help bring us through FDA approval and into the operating room to start improving children's lives.

Towards the Future

Heart

For Children

PECA is developing a valved RV-PA shunt for the treatment of hypoplastic left heart syndrome (HLHS). This device is expected to decrease the high mortality and morbidity rates associated with the Norwood Procedure.

For Researchers

PECA is developing a heart valve mock loop capable of performing both hydrodynamic and accelerated wear testing on valves and valved conduits in virtually any orientation. PECA's mock loop will provide far more flexibility for testing new cardiovascular devices, especially for abnormal conditions. Additionally, the price will be around 1/3 of the current cost of hydrodynamic testing for standard anatomies, allowing more labs to conduct better research and development.

  1. Right Ventricular Outflow Tract

  2. Humanitarian Use Device designated by the FDA

Medical Device Development

RVOT Reconstruction

A reconstructed pediatric RVOT poses very unique design challenges:

GENERAL PEDIATRIC PROBLEMS
Quick calcium cycling (leads to stenosis)
Rapid somatic growth

SPECIFIC RVOT RECONSTRUCTION PROBLEMS
Low pressure
High curvature (~70°)

RVOT reconstruction can be mandated by a variety of cardiovascular conditions. This procedure normally involves establishing a new RV-PA3 connection.

The native RVOT is not curved, however the reconstructed RVOT now lies along a ~70° curvature. This has drastic effects on the flow profile of the RVOT, and concordantly on valve function.

Simulation, Validation,
Optimization

CFD5 studies were performed to gain a detailed understanding of the flow profile through a conduit at the curvature of a reconstructed RVOT with varying parameters.

Velocity

Solid mechanics simulations were used in conjunction with CFD studies to create optimal leaflet designs to minimize regurgitation.

Color Graph

These studies were combined with mock heart loop studies to compare the functionality and regurgitation with different leaflet designs. Dr. Yoshida's design, based on his surgical knowledge and intuition, had resulted in valve leaflets which were nearly optimal based on the simulated flow, and showed great valve motion.

PECA has now translated our design to a manufacturing process that allows us to provide our conduits pre-packaged and sterile. Our new manufacturing process allows us to use resources and put in place quality controls that would not be possible with intra-operative construction.

The pre-packaged MASA Valve is currently undergoing its final biocompatibility validations before submitting for FDA marketing approval through an HDE6.

Clinical Validation
freedom from reintervention in human implantations

Patients Implanted at
<1 yr of age

54.2%
Improvement after 3 years

Freedom from...

Contegra7

Homograft8

MASA Valve8

Severe Stenosis @ 1yr

47%

85%9

100%

Reintervention @ 1yr

63%

42%

91%

Reintervention @ 3yrs

43%

0%

41%

Patients Implanted at
>1 yr of age

13.6%
Improvement after 3 years

Freedom from...

Contegra7

Homograft8

MASA Valve8

Severe Stenosis @ 3yr

85%

87%9

100%

Reintervention @ 1yr

96%

95%

100%

Reintervention @ 3yrs

81%

90%

100%

  1. Right Ventricle to Pulmonary Artery

  2. Yokota, T, et al. ''In situ tissue regeneration using a novel tissue-engineered, small-caliber vascular graft without cell seeding'' Journal Thoracic and Cardiovascular Surgery 136 (2008):900-907

  3. Computational Fluid Dynamics

  4. Humanitarian Device Exemption

  5. Meyns, B, et al. ''The Contegra conduit in the right ventricular outflow tract induces supravalvular stenosis'' Journal Tho- racic and Cardiovascular Surgery 128 (2004): 834-840
    Rastan, A, et al. ''Bovine Jugular Vein Conduit for Right Ventricular Outflow Tract Reconstruction: Evaluation of Risk Factors for Mid-Term Outcome'' The Annals of Thoracic Surgery. 82:4 (2006): 1308-1315

  6. Both Homograft and MASA Valve (with intra-operative construction) were implanted at Children's Hospital of Pittsburgh of UPMC. Data shown is more recent than in cited publication.
    Yoshida, M, et al. ''Right ventricular outflow tract reconstruction with bicuspid valved polytetrafluoroethylene conduit'' Annals of Thoracic Surgery. 91:4 (2011):1235-1238

  7. Brown, J, et. al. ''Right Ventricular Outflow Tract Reconstruction With an Allograft Conduit in Non-Ross Patients: Risk Factors for Allograft Dysfunction and Failure'' The Annals of Thoracic Surgery, 80:2 (2005): 655-664 (includes regurgitation)

Medical Device Development

Overview

MARKET

  • 3200 patients per year @ $15K/unit (based on reimbursement)
  • Two competitors; both acknowledged to be insufficient in the field
  • ~100 customers in US
  • $48M US Market ($120M Worldwide)
  • $30M projected 2018 revenue ($65M with 2 additional indications)

PRODUCT

  • Intra-operative device has shown improved clinical results in 49 children after 4 years
  • Translation to pre-packaged version should save thousands of children from 1-2 open heart surgeries
  • FDA-designated Humanitarian Use Device (HUD)
  • >90% margins with current price point

PECA Labs is a CMU and UPMC spin-off, and an Innovation Works portfolio company

Market Strategy

Although PECA Labs plans to bring the MASA Valve to market by selling the technology to a larger company, excitement and support in the field of pediatric cardiothoracic surgery is very important to ensure the best possible deal made. Early results of the MASA Valve have already been published in "The Annals of Thoracic Surgery". PECA received a great reception at the Society of Thoracic Surgeons Annual Conference in January of 2013.

The support of key opinion leaders is also extremely important for the acceptance of uptake of the MASA Valve. PECA will be working with such leaders to expose them to the technology and to have them act as independent evaluators of the MASA Valve. The clinical data that have been accumulated so far will undoubtedly gain support from those surgeons who are looking for new, promising answers to a currently unsolved problem.

Regulatory Strategy

PECA Labs is currently seeking regulatory approval of the MASA Valve in the US through the Humanitarian Device Exemption (HDE) pathway. This pathway involves two separate steps: becoming designated as a Humanitarian Use Device (HUD) and proving safety and probable benefit in an HDE application.

The MASA Valve has already been designated by the FDA as an HUD. We are currently finishing up the last of our in vitro analysis on the MASA Valve's performance before having the necessary data for the full HDE application. HDEs in the past have been approved with clinical data from as few as two patients. In addition, previous conduits for RVOT reconstruction have been approved through this pathway with data showing safety only up to two years. PECA will be submitting published data on the implantations in 49 patients over more than three years to show the MASA Valve's safety and probable benefit. This clinical data can be seen at the end of this document; it shows a clear improvement over the existing technologies available for this procedure.

In addition, PECA is continuing to perform a wide array of experimental and computational in vitro analysis to further support the MASA Valve's performance. Simulation and hydrodynamic testing are planned to be performed in-house, while biocompatibility, structural, and sterilization testing will be outsourced to FDA-registered contractors.

Insurance Reimbursement

In order to gain revenue from a medical device, a successful insurance reimbursement strategy must be put into place. There are three different ways a device such as the MASA Valve can attempt to be reimbursed: a new code, a miscellaneous code, or becoming part of an existing code. All three options have been evaluated in order to determine the best strategy for the MASA Valve. PECA has consulted with insurance reimbursement experts to refine our strategy, and will be utilizing the procedural code already in place for RVOT reconstruction, the reasoning for which is explained below:

Obtaining a new reimbursement code for a medical device is an extremely long and difficult process, however the benefit is that a new price can be determined for the device. Normally obtaining a new code takes over two years from the time of market entry, and there is no guarantee of ever successfully obtaining one. Support from physicians in all 50 states is often required to show the necessary uptake for a new code to be written, the difficulty of which is compounded by the small market for the MASA Valve. Precedence for this difficulty has been shown by Medtronic's Contegra® Conduit, which was released in 2003 has still not been given its own code. During the process of obtaining a new code it is often difficult to gain any revenue from products, if any can be gained at all. These issues have led PECA to determine that aiming for a new code for the MASA Valve is not the best route.

New devices can also be placed under a miscellaneous code while there is no specific code available. Categorization under a miscellaneous code normally involves the initial rejection of all reimbursement charges; obtaining payment for a sold device then involves a fight with the insurance company involved; this process is expensive and draining for a small company. However without an existing code, a device must initially be placed under a miscellaneous code.

Alternatively, Homografts currently obtain reimbursement through an existing procedural code for RVOT reconstruction; this means that when an RVOT reconstruction is performed a code is used which reimburses the entire procedure and allows for the payment of the conduit involved as part of that procedure. The code reimburses $33-82K for an RVOT reconstruction procedure, not including surgeon pay. The current price paid for a homograft as part of an RVOT reconstruction can be above $13,000, which is paid for through this code. The MASA Valve is used as part of the same procedure, but will be sold at a reasonable premium based on our advanced materials and improved results.

Take Part

Contact Us via

peca@PECALabs.com

340 Butler Street
Pittsburgh, PA 15223

Tel: 412 589 9847
Fax: 412 228 5868

Request Info
Choose one
  • Investor
  • Surgeon
  • I'm both an Investor & Surgeon!
Medical Device Development

Contact Us

Contact Us via

peca@PECALabs.com

340 Butler Street
Pittsburgh, PA 15223

Tel: 412 589 9847
Fax: 412 228 5868

Request Info
Choose one
  • Investor
  • Surgeon
  • I'm both an Investor & Surgeon!