PocketSonics, Inc... point of care ultrasound in your pocket

Because it is low cost, easy to use and extremely portable, the Sonic Window™ will play an important role in the more than one billion vascular access procedures performed in the U.S. each year. Below is a look at the current Hand-Carried Ultrasound and Vascular Access markets.

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Current Vascular Access Standard of Care

• 1 in 3 first attempts at IV insertion fail in normal adults
• 1 in 5 first attempts at venipuncture fail
• 1 in 2 first attempts at IV insertion fail in pediatrics
• 1 in 3 pediatric IV insertions require three or more insertion attempts
• 1 in 8 IV attempts in cancer patients fail outright 
 

Hand-Carried Ultrasound (HCU)

 

Harvey Klein of Klein Biomedical:
“Now we are seeing new emerging HCU markets, like emergency medicine and anesthesiology, expanding their use of this imaging modality. This is why we believe the HCU market will continue to grow in double digits and reach over one billion dollars in five years.”

 

The Hand-Carried Ultrasound market is growing at 22% CAGR, with 2007 global sales of $565 Million and projected sales of $1.2 Billion in 2012, according a 2008 Klein Biomedical report. In 2007, domestic HCU sales were $239M; growing at 33%. Clearly, the demand for HCU is huge, but existing solutions are simply ‘miniaturized’ versions of traditional ‘hard to use’ systems. The Sonic Window™ technology allows an entirely new approach that will bring HCU to the mass market.

Vascular Access

Almost everyone has required a vascular access procedure for one reason or another – most likely to administer fluids, drugs, or solutions, to obtain and monitor vital signs, to place a long term access device or simply to draw blood (venipuncture). This is why vascular access is the most commonly performed invasive medical procedure in the U.S. – with over 1.4 Billion procedures annually. The majority of these procedures, however, are performed without the ability to visualize the vessel of interest – relying instead on the clinicians’ ability to locate the vessel based on anatomical landmarks. In the medical literature, failure rates with landmark techniques are reported to be anywhere from 20% to 45% depending on the procedure, patient type and clinician’s experience. In many cases the clinician is unable to obtain access even after multiple attempts. These multiple attempts and outright failures lead not only to a high incidence of patient discomfort and complaint, but also increase heath care costs. This is because they delay patient treatment, require additional clinicians to become involved and ultimately can lead to more invasive procedures with an increased chance of complications.

There is evidence, however, that ultrasound guidance can reduce the failure rate to as low as 2% and also reduce the number of attempts and overall time to achieve access in “difficult” patients. Despite the clear need for improvement in vascular access procedures, the high cost and substantial training requirements of existing imaging solutions have greatly limited acceptance. In the venipuncture market in particular, focus groups and interviews by the company have indicated that even with 20 to 25% first-strike failures, most phlebotomists do not use devices to reduce the failure rate, primarily because of the high cost. Phlebotomist groups have told us that they would eagerly purchase an ultrasound guidance device if it was easy to use and the cost was in the several thousand dollar range.

Our initial focus targets guidance of vascular access procedures and potential military & first responder needs. By easing use and lowering cost, the Sonic Window™ will play an important role in the more than one billion vascular access procedures performed in the U.S. each year. Because the Sonic Window™ product will be very low cost, compact in size, and specifically designed to be used by non-ultrasound users at the point of care, it will open up entirely new segments within the medical device market. In effect, it represents the packaging of a sophisticated technology as a commodity medical instrument, not unlike stethoscopes and otoscopes.

Some numbers from the medical literature related to the targeted vascular access procedures are included in the table below. 

Table 1. Summary of potential market for peripheral IV insertion, central venous access, and venipuncture procedures

In addition to saving time and supplies costs, the Sonic Window™ will generate positive revenue by allowing customers to utilize existing Medicare billing codes.

Other Markets

While the Sonic Window™’s initial use will be specifically as a guidance tool for peripheral IV line insertion and routine blood draws (venipuncture), the technology can be used in a variety of other related ways including: guidance of central line insertion; guidance of needle biopsy and cyst aspiration; emergency medicine; veterinary applications; health sciences instruction; nursing education; diagnostic monitoring for cardiology and obstetrics procedures; and many more applications.

References

1. Rosenthal, K., Get a hold on costs and safety with securement devices. Nursing Management, May 2005. 36(5): p. 52-54.
2. Rothschild, J.M., Ultrasound Guidance of Central Vein Catheterization (Chapter 21), in Evidence Report/Technology Assessment, No. 43. Making Health Care Safer, A Critical Analysis of Patient Safety Practices. 2001, Agency for Healthcare Research and Quality. p. 245-253.
3. Mansfield, P.F., et al., Complications and failures of subclavian-vein catheterization. N Engl J Med, 1994. 331(26): p. 1735-8.
4. Ogden-Grable, H. and G.W. Gill, Phlebotomy Puncture Juncture: Preventing Phlebotomy Errors - Potential For Harming Your Patients. Lab Med (American Society for Clinical Pathology), 2005. 36(7): p. 430-433.
5. Reeves, A.R., R. Seshadri, and S.O. Trerotola, Recent Trends in Central Venous Catheter Placement: A Comparison of Interventional Radiology with Other Specialties. J Vasc Interv Radiol, 2001. 12(10): p. 1211-1214.
6. Jacobson, A.F. and E.H. Winslow, Variables influencing intravenous catheter insertion difficulty and failure: An analysis of 339 intravenous catheter insertions. Heart Lung, 2005. 34(5): p. 345-59.
7. Brown, P., An I.V. specialty team can mean savings for hospital and patient. Nita, 1984. 7(5): p. 387-8.
8. Costantino, T.G., et al., Ultrasonography-guided peripheral intravenous access versus traditional approaches in patients with difficult intravenous access. Ann Emerg Med, 2005. 46(5): p. 456-61.
9. Lininger, R.A., Pediatric peripheral i.v. insertion success rates. Pediatr Nurs, 2003. 29(5): p. 351-4.
10. Calvert, N., et al., The effectiveness and cost-effectiveness of ultrasound locating devices for central venous access: a systematic review and economic evaluation. Health Technol Assess, 2003. 7(12): p. 1-84.
11. Brannam, L., et al., Emergency nurses' utilization of ultrasound guidance for placement of peripheral intravenous lines in difficult-access patients. Acad Emerg Med, 2004. 11(12): p. 1361-3.
12. Costantino, T.G. and J.P. Fojtik, Success Rate of Peripheral IV Catheter Insertion by Emergency Physicians Using Ultrasound Guidance. Acad Emerg Med, 2003. 10(5): p. 487-a-.
13. Parikh, A.K., et al., Ultrasound-guided IV Placement Superior to Traditional Approaches at Establishing Peripheral Intravenous Access in Difficult-access Patients. Acad Emerg Med, 2004. 11(5): p. 582-b-583.
14. Moureau, N., Vascular safety: it's all about PICCs. Nurs Manage, 2006. 37(5): p. 22-7; quiz 50.
15. Jefferson, P., et al., A survey of the use of portable ultrasound for central vein cannulation on critical care units in the UK. Anaesthesia, 2002. 57(4): p. 365-8.