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WHALEN BIOMEDICAL, INC

Address

11 MILLER ST
SOMERVILLE, MA, 02143-
USA

UEI: N/A

Number of Employees: N/A

HUBZone Owned: No

Woman Owned: No

Socially and Economically Disadvantaged: No

SBIR/STTR Involvement

Year of first award: 1986

Phase I Awards

Phase II Awards

44%

Conversion Rate

$1,736,259

Phase I Dollars

$5,870,192

Phase II Dollars

$7,606,451

Total Awarded

Awards

Up to 10 of the most recent awards are being displayed. To view all of this company's awards, visit the Award Data search page.

A point-of-care device for generating nitric oxide for inhalation

Amount: $152,430 Topic: NIAID

DESCRIPTION (provided by applicant): Nitric oxide (NO) gas was considered to be a highly toxic pollutant as recently as the 1980s. It is now recognized to be an important messenger molecule in mammalian physiology. Inhaled NO is currently used to treat approximately 25,000 patients per year in this country with pulmonary hypertension. It is safe, effective, but costly. Published studies in which the per patient acquisition cost for bottled NO gas was over 5,000 suggest that even at that cost level, inhaledNO remains cost-effective compared with alternative, more invasive therapies such as extracorporeal membrane oxygenation. We are proposing to develop and test a compact point-of-care device that will generate unlimited quantities of NO gas at clinically useful concentrations from room air using a low-power electrical energy source. The device has the potential to eliminate cost as a factor in the utilization of NO inhalation therapy. In the proposed program, mass spectroscopy will be employed to characterize and optimize the output of the device. Its performance, mechanical endurance, and electrical safety also will be examined. We will then test its efficacy experimentally for a new and emerging application of NO for inhalation that we believe represents arapid path to commercialization. As an adjunct in the treatment of malaria, NO inhalation appears to significantly prolong survival in experimental studies of severe malaria. While effective drug therapy for malaria exists, the disease is often in an advanced stage before therapy is begun, and many patients die before the drugs can take effect. Extending their survival with NO inhalation has the potential to be a means for salvaging a significant number of those patients. We will demonstrate that electrically-generated NO from the device is able to similarly prolong survival using a well-established murine model of severe malaria. Almost a million children under the age of 5 die each year from malaria in sub-Saharan Africa alone. In those regions where malaria is endemic, the limited available resources make it unlikely that NO inhalation using bottled gas is feasible. The proposed device may offer clinicians in under-developed countries a new tool for dealing with this major world health problem. Ultimately, we believe the device will also be employed for NO inhalation therapy for pulmonary hypertension in developed countries by virtue of the cost reduction it offers compared with using bottled gas. PUBLIC HEALTH RELEVANCE: The objective of this program is the development and evaluation of a point-of-care device to produce nitric oxide (NO) for inhalation from atmospheric nitrogen and oxygen. Presently used primarily as a life-saving therapy for treating newborns with hypoxia, NO inhalation also has the potential to be an important adjunct in the treatment of severe malaria, a disease that results in the death of an estimated 700,000 to 900,000 children under the age of five annually in sub-Saharan Africa alone.

SBIR

Phase I

2011

HHS

NIH

A system to monitor the inlet pressure of rotary blood pumps

Amount: $85,747

DESCRIPTION (provided by applicant): Axial flow rotary blood pumps have been successfully introduced clinically to provide prolonged mechanical circulatory support, but these devices do not provide load-responsive mechanisms for adjusting pump performance to match venous return and changes in physiologic demand. Most of these devices operate at an adjustable fixed speed, and they have the potential to generate excessive suction pressures that can have serious consequences for the patient. A new device is pr oposed to monitor the inlet pressure in rotary blood pumps to improve their safety and efficacy. Conventional strain gauge transducers are subject to drift and have stability issues that make them unsuitable for long-term implantation. The proposed device employs a comparatively large displacement diaphragm in an elliptical cross-section conduit whose excursion is sensed by a planar transformer system operating at radio frequencies. There is no direct physical contact with the moving diaphragm. Unlike contr ol algorithms that infer hemodynamic conditions at the pump inflow from parameters such as the motor current, the proposed device will enable the development of control systems that dynamically adjust pump speed to avoid excessive suction pressures and opt imize pump blood flow. In essence this will make these devices operate similar to Starling's law devices in which the available blood at the inflow determines the pump output. In Phase I we will design the new inlet pressure sensor and evaluate its static and dynamic performance to evaluate its applicability for controlling a rotary blood pump. A demonstration of feasibility will consist of showing that the device accurately measures inlet conduit pressure and that it has a response time that will permit au tomatic speed control on a beat-by-beat or short-term averaged basis. PUBLIC HEALTH RELEVANCE The proposed device is an electromechanical component designed to measure pressure in the inlet conduit of a blood rotary pump in order to prevent excessive sucti on pressures. The device output will be referenced to intrathoracic pressure. It works by monitoring the deflection of an elliptical cross section elastomeric conduit in response to changes in its internal pressure. This deflection is measured using a plan ar transformer system operating at radio frequencies transparent to body tissues. No direct electrical or physical connection to the moving wall of the conduit is required. The output of the device will be usable as a control signal that may be employed to adjust the pump speed to prevent the development of excessive negative pressures in the pump inflow conduit, left ventricle, and upstream vasculature.

SBIR

Phase I

2008

HHS

NIH

A new negative pressure ventilator

Amount: $103,588

DESCRIPTION (provided by applicant): Long-term respiratory support using endotracheal intubation and positive pressure ventilation is associated with very high rates of infection, and ventilator-associated pneumonia (VAP) is among the leading and more seri ous forms of nosocomial infection in hospitals today. The objective of this program is the development of a new negative pressure ventilator that eliminates indwelling components and allows the patient to breathe room air to reduce the incidence of VAP. Th e prototype negative pressure ventilator is the iron lung originally developed by Drinker in 1929. It essentially consisted of a metal tank containing the patient's entire body up to the neck. The pressure inside the tank was cycled below ambient pressur e to induce inhalation, and then returned to ambient to allow exhalation. That device was used successfully to support many patients for extended periods during the polio epidemics in the late 1950s, but it was large, greatly limited access to the patient for routine nursing care, and provided a very limited quality of life. We are proposing to build and test prototypes of a new negative pressure ventilator that is small and light in weight. The principle of operation is the similar to the iron lung, but in stead of a tank, it employs a two-segment artificial rib cage assembly with an elastomeric jacket closely surrounding the chest wall. The artificial rib cage is mechanically actuated to mimic the movement of the chest wall during respiration, creating a ne gative pressure around the chest and upper abdomen during inhalation. Using a manikin, we have demonstrated that this design is able to generate negative pressures greater than -20 cm of water, enough to induce inhalation in an adult human subject. Because it is mechanically actuated, it may also be used to induce or augment a cough to clear the airways, a unique capability. In the proposed program, we will design and build prototypes of the device and develop an electronic control system that will permit e ither patient triggered fixed rate operation. We will then characterize its performance with a series of 6 acute in vivo studies using a porcine model. The new device overcomes many of the limitations of existing negative or positive pressure ventilation s ystems and has the potential to significantly reduce the incidence of VAP. PUBLIC HEALTH RELEVANCE: The objective of this proposal is the development of a novel negative pressure ventilator that will provide respiratory support without endotracheal intubat ion or the use of a conventional positive pressure ventilator. The latter devices are associated with high rates of infection (gt60%) when used for periods exceeding 30 days, and ventilator-associated pneumonia is one of the major classes of nosocomial inf ection and causes significant morbidity. By introducing no indwelling components into the airway and allowing the patient to breathe room air, the infection rate associated with prolonged respiratory support can be significantly reduced.

SBIR

Phase I

2008

HHS

NIH

An all titanium transcutaneous access device (TAD) for peritoneal dialysis

Amount: $102,256

DESCRIPTION (provided by applicant): Chronic transcutaneous access is needed for peritoneal dialysis (PD) and new emerging medical therapies. Since a transcutaneous device breeches the skin, the normal barrier to bacterial entry, infection is a significant problem over long periods. The objective of this program is the design and testing of an all-titanium transcutaneous access device (TAD) that will be significantly more resistant to exit site infection than existing PD catheters. The device employs microporous titanium metal (MTM) to obtain a stable epithelial junction at the exit site, inhibit bacterial entry, and facilitate improved exit site hygiene. MTM is a new material for soft tissue applications. The porous metal surface provides a complicated three-dimensional matrix whose internal geometry is fully adjustable. Connective tissue proliferation into the porous metal creates a physical barrier to prevent bacterial entry, and it also limits epithelial down-growth that can lead to sinus tract formation. In preliminary studies, it has been shown that this material provokes a minimal foreign body response with virtually no inflammation in comparison to polymer fiber surfaces used on conventional PD catheters. Foreign body giant cells are not found adjacent to the material, which is encapsulated in a thin, collagenous tissue capsule whose attachment to the material exceeds the tensile strength of the tissue. These are characteristics that make the material uniquely suitable for this application. In Phase I, we will design, build, and test the all-titanium TAD and evaluate it using an adult sheep animal model in studies of 8 week duration using Tenckhoff PD catheters as a control. We will characterize healing at the exit site, and a bacterial challenge test will be employed to compare the ability of the new device to prevent bacterial entry versus a conventional PD catheter. Chronic transcutaneous access is needed for peritoneal dialysis and new emerging medical therapies. As a transcutaneous device breeches the skin, the normal barrier to bacterial entry, exit site infection is a significant problem over long periods. The objective of this program is the design and testing of an all- titanium transcutaneous access device (TAD) designed to be resistant to infection and provide a stable skin interface.

SBIR

Phase I

2007

HHS

NIH

Vehicular power adapter for implanted blood pumps

Amount: $100,525

DESCRIPTION (provided by applicant): With the approval by the Food and Drug Administration in 2003 of electrically powered ventricular assist systems as destination therapy (i.e., as an alternative to cardiac transplantation), the number of patients wi

SBIR

Phase I

2004

HHS

NIH

A drug releasing urinary catheter

Amount: $750,000

DESCRIPTION (provided by applicant): Catheter-associated urinary tract infection (UTIc) is the most common nosocomial infection acquired in hospitals and nursing homes. The goal of this Phase II program is to continue the development and evaluation of a new, drug releasing urinary catheter fabricated from silicone rubber containing the antiseptic agent chlorhexidine gluconate (CHG). The CHG is confined in a polyethylene glycol matrix uniformly dispersed in the elastomer, and it is released in sustained fashion over periods up to 4 weeks. This catheter material has been shown to be effective in vitro against organisms commonly associated with UTI. The choice of CHG as the antiseptic agent is based on its broad spectrum of activity, comparatively low toxicity, and low incidence of the development of bacterial resistance. In Phase II, methods for fabricating the catheters will be refined, and the effectiveness of the catheter material to inhibit or kill bacteria as a function of usage time evaluated. Toxicity studies required to fulfill the requirements of ISO 10993-18, a standard for medical device materials, will be conducted; and the shelf life of the catheters will be determined. Finally, a double blind, randomized trial of drug releasing versus nondrug releasing catheters in a large animal model will be conducted to measure efficacy in lessening or preventing the development of UTIc or pylonephritis over a 28 day period.

SBIR

Phase II

2003

HHS

NIH

A drug releasing urinary catheter

Amount: $0

SBIR

Phase I

2003

HHS

NIH

A conductance telemetry system for implant blood pumps

Amount: $0

DESCRIPTION (provided by applicant): An ideal permanent ventricular assist system (VAS) or total artificial heart (TAH) will not include tubes or wires passing through the skin. This proposal describes development of a telemetry system capable of providing the bi-directional communications between implanted and external components required for safe operation. The ECG signal is a naturally occurring form of telemetry. The voltages sensed by the ECG machine are the result of minute electrical currents generated by the heart flowing through the resistances of the tissues in the thorax. In similar fashion, the Conductance Telemetry System (CTS) transmitter admits minute high frequency currents into tissues via one pair of electrodes producing voltages that can be detected by a remote receiver connected to a second pair of external electrodes. A telemetry system based on this principle will be highly resistant to interruptions of service if issues pertaining to its reliance on chronic skin electrodes can be adequately addressed. The goals of this program are to: 1) develop custom electronic components that make it easy to integrate the CTS into a host system; 2) develop skin electrode systems suitable for use in VAS and TAH patients, and, 3) obtain third party certification of compliance with safety standards. PROPOSED COMMERCIAL APPLICATION: Both the NHLBI and private industry are supporting the devleopment pumps to address the needs of an estimated 30-40,000 patients annually from permanent mechanical circulatory support. The proposed device virtually all of these systems. of implantable blood who might benefit is applicable to

SBIR

Phase I

2001

HHS

NIH

A conductance telemetry system for implant blood pumps

Amount: $376,664

DESCRIPTION (provided by applicant): An ideal permanent ventricular assist system (VAS) or total artificial heart (TAH) will not include tubes or wires passing through the skin. This proposal describes development of a telemetry system capable of providing the bi-directional communications between implanted and external components required for safe operation. The ECG signal is a naturally occurring form of telemetry. The voltages sensed by the ECG machine are the result of minute electrical currents generated by the heart flowing through the resistances of the tissues in the thorax. In similar fashion, the Conductance Telemetry System (CTS) transmitter admits minute high frequency currents into tissues via one pair of electrodes producing voltages that can be detected by a remote receiver connected to a second pair of external electrodes. A telemetry system based on this principle will be highly resistant to interruptions of service if issues pertaining to its reliance on chronic skin electrodes can be adequately addressed. The goals of this program are to: 1) develop custom electronic components that make it easy to integrate the CTS into a host system; 2) develop skin electrode systems suitable for use in VAS and TAH patients, and, 3) obtain third party certification of compliance with safety standards. PROPOSED COMMERCIAL APPLICATION: Both the NHLBI and private industry are supporting the devleopment of implantable blood pumps to address the needs of an estimated 30-40,000 patients annually who might benefit from permanent mechanical circulatory support. The proposed device is applicable to virtually all of these systems.

SBIR

Phase II

2001

HHS

NIH

Not Available

Amount: $100,045

N/A

SBIR

Phase I

2000

HHS

NIH