Executive Summary

The Advanced Bifurcation Solution

The ABS platform comprehensively addresses the key bifurcation disease concerns:

  • It is a truly bifurcating stent, providing complete coverage at the lesion.
  • Side-branch access is guaranteed.
  • It is not angulation-limited.
  • A single system addresses both the main and side branches.

The ABS platform addresses CAD treatment in two significant ways:

  • It simplifies the operation required, resulting in a shorter procedure time while improving outcomes.
  • It allows for interventions not previously possible.

ABS is currently developing four systems based on this concept:

  1. Total bifurcation stenting system
  2. Provisional side-branch stenting system
  3. Left main bifurcation stenting system
  4. Free-standing side-branch stenting system

While innovative in design and manufacture, the operation of these systems remains intuitive to cardiologists and encompasses the basic principles of percutaneous coronary intervention.

Market Overview

Coronary artery disease (CAD) and heart attacks are leading causes of death in the United States and worldwide. One of the many challenges of percutaneous intervention (non-surgical/ catheter-based angioplasty) is effective treatment of coronary artery disease at a bifurcation, where one artery branches into two smaller arteries. Plaque deposit at bifurcations is a major cause of poor angioplasty outcomes requiring long and repeated procedures as well as continued referral for open chest surgeries.
The coronary stent market is estimated to reach $10B by 2015. Bifurcation disease comprises about 25% of all coronary artery disease. ABS is poised to capture a significant part of this $2.5B market as the only true and complete bifurcating stents delivery platform in the market.

Current Bifurcation Techniques Using Cylindrical Stents

Heterogeneity of bifurcation disease in terms of angles, sizes, and plaque location and morphology has posed a significant challenge for interventional cardiologists. Currently most clinically significant bifurcations are only addressed by open-heart bypass surgery.
Stents presently on the market are poorly suited for the treatment of plaque deposition at bifurcations. Nevertheless, linear stents are employed at bifurcations with a variety of techniques, the most common of which are the provisional T, culotte and crush techniques. These approaches have numerous shortcomings:
Procedures are tedious and the purview of expert operators only.
Side-branch access is difficult and cannot be guaranteed.
The presence of excess metal causes tissue injury.
Recurrence rates are 4 times higher for these techniques than at linear plaque deposits.
For a number of years, many companies, from established entities to startups, have tried and are still very aggressively attempting to develop specific devices for treatment of bifurcations. They fall into three categories:

  1. Main branch stents with side-holes
  2. Dedicated side branch stents
  3. One-piece bifurcating stents

These products have had very little clinical utilization and no U.S. regulatory approval to date, with significant limitations in both design and implantation. While these devices may address parts of the bifurcation stenting issues, they all require supplemental devices to complete the procedure. Placement of a bifurcating stent has eluded the industry until now.

ABS Platform Benefits

Patients receive better care by having access to a true bifurcated stent that provides increased safety and higher patient satisfaction in a shorter procedure time.
Doctors will benefit from a platform that offers excellent placement and delivery of the stent, as well as from an intuitive system that is very similar to that of existing linear stent techniques.
Hospitals will see higher cath-lab utilization and revenue resulting from shorter times for bifurcation procedures using
the ABS system.
Insurance companies will reduce their costs due to shorter procedure times and up to a 50% reduction in materials.
Go-to-Market Strategy upon receiving the necessary CE and FDA approvals, ABS will execute an aggressive global marketing strategy that will promote rapid growth and sales.

Clinical & Short Term Efficacy Results

Field Trials

Success of initial animal studies at Cedars-Sinai in 2009 led to the pilot trial for this technology. The first human implant was
performed in November 2009 in Brazil in a 50-year-old male having a heart attack.

ABS successfully completed an international multi-center feasibility of its full bifurcation stent platform and provisional side-branch stent platform/ delivery systems in late 2010, with patients ranging from 45-71 years of age. With these implants ABS systems have covered a range of coronary bifurcations of different locations, angles, and sizes. Follow-up examinations of the patients of up to 12 month reveal excellent clinical outcomes and no complications.

ABS growing scientific advisory board consists of the world’s leading interventional cardiologists and experts in this field.

Intellectual Property

While intuitive and simple in use, the design of the ABS platform is radically different than existing technologies. Consequently, the company has been awarded 34 patents with 10 more pending. In total ABS has 300 solid claims pending in varies stages.

FIRST PATENT FILED SEP 2008 IS IN THE NATIONAL PHASE OF U.S., EU, JAPAN, CHINA, CANADA AND AUSTRALIA.
SECOND GROUP OF FIVE PATENT IN THE NATIONAL PHASE OF U.S. AND PCT (Global Patent Cooperation Treaty)
INTERNATIONALLY

THIRD GROUP OF TWO PATENTS FILED FEB 2011 ARE IN THE PROVISIONAL PHASE
Filing of additional patents and claims is anticipated.