This Year's Highlights

• To determine the effects of force reduction using vibrations, a pre-Alpha prototype was tested at low frequencies. The prototype consisted of a rotary solenoid to generate vibrations and a 14-gauge hollow, bevel-tip needle to pierce and core the sample.
• An experiment conducted at the University of Virginia using an anesthetized rabbit and a controlled insertion testing mechanism verified histologic equivalence of energy-assisted biopsy procedures.
• An independent marketing study demonstrated that 84% of bone marrow biopsy practitioners expressed interested in the idea of the EANeedle technology. The same study indicated that the product would be very readily accepted in the marketplace.

Anticipated Highlights

• Systems will be optimized based on performance, cost, complexity and availability of components. Different needle designs will be assessed for effectiveness. A testing protocol will be developed and the test apparatus modified to accommodate the device.
• Utilizing specifications of the Alpha Prototype, and concept feedback obtained from focus groups, several (3+) manufacturing firms will be asked to provide an estimate of manufacturing costs for mass production.
• Prior communication with the FDA will be assessed and current research results will be utilized to identify potential predicate devices. The pathway to 510(k) clearance will be developed along with a comprehensive needs assessment for payer requirements.

Corporate Mission

Alarmed by an estimated 600,000 to 800,000 needlestick injuries each year, Congress passed the Needlestick Safety and Prevention Act (HR 5178) in 2000, mandating that healthcare facilities eliminate the use of "sharp" devices when possible. Reacting to this critical demand, a $693 million annual market was created, boasting safety needles, syringes, and needleless devices. Growing at 21.7% each year, this new market segment is also helping address the annual $2.8 billion of treatment costs, lost productivity, and legal liability resulting from needlestick injuries. Despite design improvements that retrofit sharp devices with safety sheaths or spring-loaded retractable mechanisms, no technology has offered a solution for completely eliminating sharp needles from healthcare.

Many needle insertion procedures require sharper tips to assist tissue penetration. Two examples are bone and bone marrow biopsy, where the cortical (outer) layer of bone represents a hard, highly resistant layer that must be penetrated early in the biopsy procedure. If the needle is too sharp, it will be bent by the required manual force of entry. If too blunt, then it will not penetrate the bone under manual conditions and is difficult for the physician to guide. Broad user acceptance could result if a platform technology could address major problems with existing methods of bone entry: difficulty of needle insertion, control of movement, and reduction of physical and psychological trauma for the patient. Furthermore, hospitals would reap significant cost benefits if such a device was compliant with safety needle legislation.

While it is likely that the EANeedle's unique combination of safety and control will ultimately lead to its use across all needle biopsy markets, the initial goal is to produce a high-powered needle for penetrating bone, where competition is low and present biopsy approaches have known deficiencies (operator control and fatigue, and patient anxiety and pain).