Market Overview and Quantified Opportunity
Aortic Aneurysms- of which Abdominal Aortic Aneurysms (AAAs) are the most common - are segmental dilatations of the aortic wall that cause the vessel's diameter to become larger than normal. These enlargements often continue to expand and rupture spontaneously, causing massive blood loss, resulting in death.
Patients diagnosed with AAA are followed and surgery is indicated when aneurysms reach a size that warrants the risk of intervention. Roughly 25% of AAA patients are judged to be in sufficiently good health to undergo surgery.
In Open AAA surgery (OSR) a graft is inserted inside the dilated segment to reinforce the aorta from within. OSR is considered risky, with approximately a 5% mortality and 17% morbidity rate during and at 30 days post surgery. Risk is correlated to post-suture bleeding which necessitates re-clamping, and/or the length of time the aorta needs to be clamped during surgery to enable the grafting ("clamping time"). Thus, the quality of the graft anastomosis and the time needed to achieve it ("clamping time" and "clamping/re-clamping cycles") constitute two major risk factors of this operation.
Endovascular aortic repair (EVAR) was introduced 15 years ago as a minimally invasive alternative to OSR aimed at reducing many of the risks associated with open surgery which is a major advantage for high-risk patients. Unfortunately, although aortic endo-grafts did demonstrate a benefit in AAA of 5.5 cm in diameter (equivalent mortality to actively surveilled patients with delayed OSR; lesser morbidity and operative costs), they did not demonstrate benefits in many cases:
- though peri-operative outcomes are improved for AAA 5.5 cm and more, EVAR has not been shown to improve long-term survival and health status in comparison to OSR
- EVAR does not improve survival in patients who are medically unfit for OSR; and
- EVAR is associated with more complications, need for re-intervention and monitoring.
Open Surgical AAA Market Overview
The Company's immediate addressable market for the Aortic Staplers includes over 120,000 patients undergoing open AAA repairs annually worldwide. An eventual extension of this product through a modified laparoscopic variation of the same device will allow the Company to gain additional access to 315,000 patients (in the EU and the US together) undergoing aorto-bifemoral/biiliac bypass surgery and balloon angioplasty (PTA).
An open AAA surgical operation typically costs $50,000-$60,000 while the patient is reimbursed by CMS for $20,000-$30,000; the procedure involves at least one week of hospital stay of which 2-3 days in ICU.
The Endovascular Surgical Market Overview
Approximately 100,000 EVAR procedures were performed in the EU and US together in 2004. The US endovascular AAA device market reached close to $500 million in value in the year 2004, as the percentage of patients treated with endovascular procedure has grown steadily since the introduction of stent-grafts to the US market in 1999.
A typical AAA endovascular procedure costs $5,000 more than an open procedure. Current commercial stent-graft kits (graft with anchoring device) are priced at $10,000-$15,000, with some new devices costing up to $25,000, which would be in addition to the cost of the stapler.
According to several reports (Deutsche Bank Report, 2002, American Heart Association, MedTech Insight, 2005), it is projected that in near future at least 50% of all AAA surgeries will eventually be performed through an endovascular procedure.
The CLI Surgical Market Overview
In the US and EU 1.9 million surgical interventions (out of 2.7 million PAOD procedures) are performed for patients suffering from Critical Limb Ischemia (CLI). Approx. 80% of these are above knee procedures, divided between Femoral-Popliteal Bypass Surgery (70%, evenly split between vein-graft bypasses and PTFE-graft bypasses) and minimally invasive balloon angioplasty and stenting procedures (30%). Like in AAA surgery, these procedures have not gained the lion's share of CLI procedures in spite of their low invasiveness because of relatively poor clinical outcome.
The total addressable market for the CLI device in the US and EU, based on above knee procedures including synthetic revascularizations with synthetic grafts, atherectomies and half the number of amputations (200,000 a year in the US) is estimated at 1 million procedures annually.
CLI Market Needs
Peripheral Arterial Occlusive Disease (PAOD) affects 8-12 million people in the US and approximately 17 million in the EU. It is mostly caused by atherosclerosis affecting peripheral arteries, commonly manifest as occlusive or stenotic lesions of the iliac, superficial femoral-popliteal and calf arteries. Critical Limb Ischemia (CLI), ischemic leg ulcerations and gangrene can develop and amputation is eventually required in more than one third of affected patients. Mortality is around 30% within 5 years, 50% within 10 years and an overwhelming 75% within 15 years
Revascularization procedures in above-knee CLI patients (representing the majority of PAOD interventions) include PTA and/or Stenting and mostly synthetic (i.e. PTFE, Dacron) bypass surgery (Fem-Pop bypass - FPB) - the intervention of choice in the majority of patients, when the arterial occlusions are longer than 7cm, ruling out PTA. Unfortunately bypass surgery's patency rate (in the case of synthetic grafts) is quite low: various studies showed patency rates of only 70% within 12 months post-surgery and quite often requiring re-operation.
FPB surgery is still carried out as an open, highly invasive procedure: it usually lasts at least 2 hours, with suturing taking up a significant part of the operation. Seven to ten days of hospitalization is the regular stay. Obviously, a less invasive procedure with better clinical outcome is highly desired.