Neose Technologies, Inc. (Nasdaq: NTEC) announced that it has closed its previously announced registered direct offering. The Company sold approximately $4.7 million shares of its common stock at $6.77 per share, the closing bid price on May 17, for aggregate gross proceeds of approximately $32 million. Investors included existing shareholders, new shareholders and several executive officers of the company. J.P. Morgan Securities Inc. and UBS Securities LLC acted as lead placement agent and co-placement agent, respectively, for the transaction.

Source: Neose Technologies

According to recently released numbers from the National Institutes of Health (http://grants1.nih.gov/grants/award/awardtr.htm), Pennsylvania ranked fourth among U.S. states for funding awarded in fiscal year 2003. In total, Pennsylvania research institutions garnered $1.3 billion in research grants, training grants, R&D contracts, and other awards.

Pennsylvania again had two institutions in the top 10—University of Pennsylvania (#3) and University of Pittsburgh (#8). University of Pennsylvania was awarded nearly $435 million and University of Pittsburgh garnered nearly $349 million. Other Pennsylvania university and research institution awards for 2003 included:

Pennsylvania State University: $83,562,790
Thomas Jefferson University: $82,285,296
Children’s Hospital of Philadelphia: $74,992,380
Temple University: $41,359,922
Fox Chase Cancer Center: $32,363,198
Wistar Institute: $25,296,135
Drexel University: $22,678,422
Carnegie Mellon University: $16,385,422

To date in 2004, Pennsylvania institutions have received 1579 awards totaling $550 million.

The University of Pittsburgh's McGowan Institute for Regenerative Medicine has been awarded a five-year $4.5 million contract from the National Heart, Lung, and Blood Institute to develop a heart assist device for infants. Working with Children's Hospital of Pittsburgh, Carnegie Mellon University and industry partners, the Pitt researchers envision the pediatric ventricular assist device (PVAD) to be about the size of a quarter, with features designed to meet the special needs of patients with congenital and acquired heart defects who are as young or small as a newborn baby.

Principal investigator for the contract is Harvey S. Borovetz, Ph.D., professor and chairman, department of bioengineering, University of Pittsburgh School of Engineering, and Robert L. Hardesty Professor of Surgery at the School of Medicine.

The only means of mechanical support currently available in the United States for infants and children up to age 2 is ECMO, or extracorporeal membrane oxygenation, which can only be applied for up to several weeks and completely immobilizes patients with its elaborate network of tubes and medical equipment. Despite it being standard practice for nearly 30 years for pediatric patients of all ages who are in heart failure, its use is associated with a high death rate. Less than half of children and infants survive the therapy. Larger children sometimes have the option of  being supported by ventricular assist devices (VADs) that have been designed with the adult patient in mind, but no devices currently approved by the U.S. Food and Drug Administration are small enough to be implanted in infants.

"Historically, infants and toddlers have been overlooked by technology development. Yet the smallest of our patients have the greatest need because the only means of support available to them is ECMO, which has unacceptably high mortality and complication rates. We hope to be able to develop a device that will allow more babies with congenital heart defects or end-stage heart disease to survive to transplantation, or perhaps even recover cardiac function and avoid the need for transplantation," said Dr. Borovetz.

The goal of the contract is to develop a miniature centrifugal flow pump utilizing suspended magnetic levitation technology for use in babies between 5 and 35 pounds. It's conceived that the device could be used for up to six months as a bridge to heart transplantation. In some babies, the device may allow the heart to recover. As such, the team plans to develop a smart control system that will indicate patterns consistent with a recovering heart. Since the device will be fully implantable with a small lead to an external power supply, children supported by the device will be able to be mobile and active.

The technology being applied to the development of the PVAD builds on the innovative work of James F. Antaki, Ph.D., associate professor of biomedical engineering and computer science at Carnegie Mellon University and associate professor of bioengineering and surgery at the University of Pittsburgh. Dr. Antaki is a co-investigator and the project director for the contract.

"Our primary objective is to develop a highly reliable circulatory assist device for infants who would otherwise perish from heart failure," said Dr. Antaki. "This contract will enable our collaborative research team to apply over two decades of experience with cardiovascular support to design a novel device for this high-risk population. We aim to perform our first clinical trials within five years."

Under the direction of Robert L. Kormos, M.D., director of the University of Pittsburgh Medical Center (UPMC) Artificial Heart Program and one of the project's co-investigators, there have been more than 275 implants of VADs at UPMC since 1985, including implants in 13 children between the ages of 7 and 17. Of these children, eight survived until a donor heart became available and two recovered while on the device. One patient is currently on a device awaiting a transplant.

"The PVAD must be more than just a smaller version of the adult devices. It also must be designed to meet the special medical and circulatory needs of infants with complex congenital heart disease," noted Bradley B. Keller, M.D., professor of pediatrics at the University of Pittsburgh School of Medicine and chief of cardiology at Children's, and principal investigator for the Children's Hospital subcontract. Also playing a key role for Children's is Steven Webber, MBChB, associate professor of pediatrics at the University of Pittsburgh School of Medicine and medical director of Heart and Heart/Lung Transplantation at Children's; and Sanjiv Gandhi, M.D., assistant professor of surgery, division of pediatric cardiac surgery, at the University of Pittsburgh School of Medicine.

"As surgeons, physicians, bioengineers and bench scientists, we have different perspectives to the challenge at hand. But then, this interdisciplinary PVAD effort exemplifies the kind of collaboration that has existed for nearly 30 years at the University of Pittsburgh. We happen to believe it's the best way to solve problems in the clinical setting," added Dr. Kormos, who also is medical director of the McGowan Institute, where much of the research and development of the PVAD will occur.

Source: University of Pittsburgh

Penn State researchers recently were awarded a $5 million contract from the National Heart, Lung, and Blood Institute of the National Institutes of Health to develop a pediatric heart assist device. 

“This contract will allow us to develop two blood pumps small enough to provide heart support for infants, children and teens,” said William J. Weiss, Ph.D., principle investigator for the project and associate professor of surgery and bioengineering, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center. “Our multidisciplinary team combines expertise from faculty in several Penn State colleges to develop an effective, safe, pediatric heart assist system. Our goal is to make the product available for clinical use in about five years.”

Few heart assist pumps have been developed or adapted specifically for use in children. Most currently-available heart assist devices were designed for adults and are too large for pediatric patients. Currently, short-term heart or heart/lung support is available for children via extracorporeal membrane oxygenation, or ECMO, and the Bio-Pump, but both provide support for only a few days to, at most, a few weeks. Other devices either are not available in the United States, or are adaptations of adult technology, which are not useful for very small children and infants.

Development of a child-size heart assist device started in 1986 at Penn State College of Medicine under the direction of William S. Pierce, M.D., a pioneer in the development of mechanical heart assist devices. Although the research team has continued to work on certain aspects of the pump, a lack of industry and federal funding slowed development of the device.

“Since the late 1980s, there have been numerous successes with adult heart assist devices such as the Arrow LionHeart™,” Weiss said. “That has sparked renewed interest in funding research and development of a pediatric version of a heart assist device.”

Children in need of heart support typically are suffering with congenital heart diseases like hypoplastic left heart syndrome, in which the left part of the heart is underdeveloped, or left ventricle dysfunction due to infection or inflammation of the heart. This heart assist device will provide support for at least six months until the heart recovers or until a donor heart can be found.
Challenges with this type of device include developing very smooth materials and making seamless connections between parts to ensure red blood cells and platelets will not collect in crevices and seams where clots can form, break loose, travel through the blood stream and cause a stroke. Heart assist pumps also can create stress in the blood. When blood undergoes fluid stress it may become activated and begin to clot, or red blood cells may rupture.
 Pediatric heart assist devices pose even more complex problems. Due to the smaller size of the blood pump, blood flow in the smaller version is completely different than in the larger adult heart devices.

“Making these pumps smaller is not just a matter of shrinking everything. We really have to be careful about how we design the pump. When you make blood pumps, or even grafts or tubes, the fluid dynamics change as the size changes,” Weiss said. “In the smaller pumps, dead zones, or low-rate flow zones, can form inside the blood pumps. This slow-flowing blood can create clots. Our challenge is to be sure the blood is neither too active or too slow.”

Penn State researchers have acquired significant expertise in the design, development, clinical use and technology transfer of circulatory support systems. Among their accomplishments are the adult-sized Pierce-Donachy pneumatic ventricular assist device manufactured by Thoratec Corporation, Pleasanton, Ca., the Arrow Lionheart™, a fully-implantable ventricular assist device developed at the College of Medicine in cooperation with Arrow International, Reading, Pa., and currently in clinical trials, and the Penn State Total Artificial Heart currently under further development by Abiomed, Inc., Danvers, Mass.

Source: Penn State College of Medicine