The pharmaceutical company’s Discovery Fast Track program is designed to identify and collaborate with academic researchers developing novel therapeutics and help advance their work.

Applicants submit a therapeutic hypothesis and target information and the status of the biological screen. Judging criteria for the submissions, according to the contest website, includes:

• Strength of the therapeutic hypothesis
• The degree of originality of the work presented
• Level of completeness of the target/screening assay
• Potential impact or benefit of the target to medicine (unmet medical need)
• Investigator’s and institution’s capabilities to support entry into the Discovery Fast Track Competition and for joint execution of a DPAc project

In August 2013, an expert panel of judges will select up to 20 finalists, who will then submit an expanded application including confidential supporting data and present their proposal to GSK. Winners will be selected in October 2013.

Those academic researchers who are chosen will get access to some of the vast resources of the big pharma business, such as high throughput screening. That means that they can test millions of pure compounds (1.8 million to be exact) using a diverse set of technologies in biochemical and cellular assays of different complexity. It also has proprietary software for validation.

The deadline for submissions is July 19. Applicants can apply here.

Winning researchers will partner with investigators on GSK’s Discovery Partnerships with Academia team to develop viable, research-stage drug candidates into innovative medicines, according to a company statement. The three year old Discovery Partnerships program got its start in the UK and to date has led GSK to initiate nine collaborations, including two in the U.S. — one with Vanderbilt University to deveop a group of drugs to treat severe obesity and the other with the Fred Hutchinson Cancer Research Center to develop muscular dystrophy therapeutics.

Other drug developers have used innovation challenges to crowdsource ways to improve chronic conditions and help solve painpoints in healthcare like Sanofi with its Data Design Diabetes challenge and Janssen’s Connected Care challenge.

NEW YORK (Reuters Health) - Adding a plant-derived compound called a sterol to the cholesterol-lowering agent red yeast rice doesn't make it work any better, according to a new study.

"I expected to see a synergistic effect with red yeast rice, and I was shocked to see no effects whatsoever," the study's lead author Dr. David Becker told Reuters Health.

Statin drugs like Lipitor are the first-line option for lowering low-density lipoprotein (LDL) levels, or "bad cholesterol," for patients at risk for heart disease, said Becker, a cardiologist with Temple Health Systems in Philadelphia.

But while 15 million Americans take statin drugs, according to IMS Health, "10 to 20 percent of people can't tolerate statins and stop them," said Becker, because of bothersome side effects, like muscle pain.

Some of those people turn to red yeast rice, which is made by culturing yeast on the grain, and contains a statin-like compound that slows the body from making its own cholesterol.

Red yeast rice supplements usually cost about $20 for a bottle of between 100 and 200 600-milligram tablets.

Previous studies found that phytosterols, plant-derived steroids found in vegetable oil, lower LDL levels when used alone. Outside of dietary sources like margarine, phytosterol supplements are available in drug stores for about $20 for 200 900-milligram tablets.

The study included 220 people with high LDL, averaging around 150 milligrams per deciliter, who had discontinued or declined statins prescribed by their doctor. (For people without heart disease risk factors, national U.S. guidelines recommend levels below 130.) They all took 1,800 milligrams of red yeast rice twice per day.

Half of the group also took two 450-milligram tablets of phytosterols twice daily, while others took a placebo, for one year.

Half of the participants attended meetings with doctors, dietitians and exercise physiologists for three months and was told to exercise and eat a Mediterranean diet for the rest of the year. The other half did not have special diet or exercise instructions.

There was no difference in LDL cholesterol between the phytosterol or placebo groups at three months, six months or one year, according to the study published in the American Heart Journal.

"There was absolutely no effect of phytosterols in any manner across the board," Becker said.

Though the diet and exercise group members seemed to have a head start at lowering their LDL, at the end of the study both groups had arrived at the same average of about 110 milligrams per deciliter.

SEVERAL LIMITATIONS

The trial had several limitations, according to Dr. Jeffrey Shanes, a cardiologist at Loyola-Gottlieb Memorial and Elmhurst Memorial Hospitals in Melrose Park, Illinois.

About 30 percent of study participants dropped out of the trial after being screened and put in a treatment group, Shanes, who was not involved in the study, told Reuters Health. The statin-like compound in red yeast rice can cause the same muscle pain as synthetic statins for some patients, he said.

Red yeast rice contains some sterols of its own, so it's possible that adding more sterols didn't appear to lower LDL any further because they were already in play, Shanes said.

Becker would recommend diet and exercise before red yeast rice, he said. Batches subject to poor quality control may contain a potentially fatal liver-damaging byproduct of yeast fermentation, for example. And it may also increase the risk of muscle injury when combined with other cholesterol drugs.

"Under no circumstances should people be going to Walgreens and getting red yeast rice because of the potential drug interactions, because every batch is different," Shanes said.

SOURCE: http://bit.ly/16hllda American Heart Journal, online May 2, 2013.

In addition to severe sepsis, they have also mapped infection hotspots for more than 25 different types of infection such as measles, whooping cough, pneumonia and salmonella.

Sepsis is the 10th leading cause of death in the US — there are 750,000 cases of the infection each year resulting in 300,000 deaths.

Researchers used ICD-10 codes to identify primary cause of death codes for infection and severe sepsis for 2010. They identified four major hotspots in the US, two of them in the Mid-Atlantic. Two regions in the Midwest and Mid-Atlantic states had three times the national mean of infection-related deaths and two regions of the South and Mid-Atlantic states had four times the national death rate from severe sepsis. On the other hand, the research has also revealed parts of the country that had disproportionately low incidences of the infection, particularly in the Mountain states.

One of the things that caught the eye of researchers in mapping the hotspots were facilities that had lower incidence rates within geographic hotspots. The thinking is that best practices from those institutions could be used to improve education and cut down on infections at other facilities in the regions.

Dr. David Gaieski, an associate professor of Emergency Medicine and Brendan Carr, an assistant professor of emergency medicine, authored the study and presented the findings this week at the Society for Emergency Medicine in Atlanta. “…While our understanding of the causes of infection-related death rates has improved, we are still struggling to prevent these diseases and identify individuals who are most susceptible,” said Gaieski. “We need to be able to pinpoint the geographic distribution of infection-related death rates in order to further study how and why these infections are happening in these areas and the best methods to prevent these deaths.”

Hospital acquired infections kill more than 1 million people each year and cost upwards of $17 billion, according to the research. In an effort to reduce infections, entrepreneurs and diagnostic developers have devised wide arranging approaches  from advanced handwashing adherence technology to air filtration systems to diagnostics that identify infections like sepsis early enough to take action.

Penn’s department of physics and astronomy are also collaborating on the project, funded by an $80,000 grant from the Kaleidoscope of Hope Foundation for ovarian cancer.

Research has shown that trained detection dogs and electronic devices can detect minute quantities of odorants that signal the presence of ovarian cancer, even before the cancer can be detected by current methods, according to a statement from Penn.

Tissue and blood samples collected by Penn Medicine will be used by the working dog center for training and analysis. The initial study will assess the ability of dogs and other sensors to detect the total odorant signatures that distinguish disease from healthy samples.

Cynthia Otto, director of the Working Dog Center and associate professor of Critical Care at Penn Veterinary school said: “By utilizing the acute sense of smell in detection dogs in conjunction with chemical and nanotechnology methods, we hope to develop a new system of screening for ovarian cancer using analysis of odorants to facilitate early detection and help decrease future cancer deaths.”

Ovarian cancer is the fifth leading cause of death among women. If caught early the survival rate is 90 percent but it usually is not diagnosed until it has progressed to later stages when it becomes more difficult to treat.

Although dogs are currently only detecting samples, the idea is that future studies will determine the most suitable tissue for evaluation and will measure odor differences among various tumor grades, according to the statement.

In addition to the ovarian cancer research at Penn, dogs are being trained to detect breast cancer and prostate cancer.

PHILADELPHIA - Multinational drug companies, like other businesses, see Africa as an emerging market with tremendous opportunities and challenges, and that was a backdrop to Thursday's announcements of two programs designed to deliver more medicine and better health care to the continent.

Merck & Co. and GlaxoSmithKline Plc joined the GAVI alliance in announcing from Cape Town, South Africa, an agreement to supply human papillomavirus (HPV) vaccine at lower prices to developing countries to help girls and women in those nations avoid cervical cancer.

A few hours later, Glaxo chief executive officer Andrew Witty joined Save the Children CEO Justin Forsyth in Nairobi, Kenya, to announce a $23 million program to increase vaccinations, train health-care workers, and deliver better care for basic but deadly problems such as diarrhea, pneumonia and malnutrition.

One example in the works is reformatting an antiseptic mouthwash that Glaxo makes into a gel that can be applied to the umbilical stump of newborns to ward off infection.

The Bill and Melinda Gates Foundation created the GAVI alliance, which is based in Geneva, Switzerland, and stands for Global Alliance for Vaccines and Immunization. Bill Gates has championed using market forces and measurements to help achieve greater success in philanthropic efforts to improve health in the developing world.

GAVI said that of the 275,000 women in the world who die of cervical cancer every year, more than 85 percent are in low-income countries. UNICEF will administer the program, for which countries must apply. The price they pay will be determined by the nation's relative wealth, with richer countries paying more.

GAVI CEO Seth Berkley said that with Merck and Glaxo on board to provide HPV vaccine for a lower price, he hopes other drug companies will seek to join the market, making more medicine available at still lower prices.

Merck is based in Whitehouse Station, N.J. Gardasil, Merck's HPV vaccine, is made at the company's facility in West Point, Montgomery County, and had $1.6 billion in sales in 2012.

"It is essential that every young girl around the world have access to HPV vaccines," Julie Gerberding, president of Merck Vaccines, said in a statement.

HPV vaccine requires three doses and can cost $100 in developed countries. Merck and Glaxo will provide their HPV vaccine for $4.50 and $4.60 per dose, respectively, to GAVI. The lowest previous public-sector price was $13.

Philadelphia native Kate Elder, the vaccines policy adviser for Doctors Without Borders, said the prices were still "unjustifiably high" and unaffordable for most governments where cervical cancer is a problem.

Glaxo, based in London, has employees in Philadelphia and its suburbs. North America pharmaceuticals president Deirdre Connelly said the company would match employee contributions to Save the Children dollar for dollar.

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Contact David Sell at 215-854-4506, dsell@phillynews.com, or follow on Twitter @phillypharma. Read his blog at www.philly.com/phillypharma. ___

His proposal to set up his software-as-a-service marketing platform for the big pharma company to launch drugs into multiple markets won the $50,000 prize along with $1,000 worth of Amazon web service credit.

On the bright side, the days ahead as he works with Teva and launches his new company with the $50,000 he won to help develop the platform are not likely to get any more stressful.

“After that, I slept for two days,” he told MedCity News in a phone interview.

Quillen is a veteran of GlaxoSmithKline where he worked for 12 years in bioinformatics on the research and development side until he was laid off. He later started a life sciences consulting company, Euclidean Group.

“When I was at GSK I developed customized software internally, but as the market matured, we started using more and more off-the-shelf solutions, comparing business requirements with systems on the market,” said Quillen. “I was excited by the hackathon because ideally [Teva] wants this as a software as-a-service — they want something custom built for their needs that fills a gap in the market, but they want to make it available to others in the market to reduce its cost.”

The platform needs to do two things: provide transparency so management can observe how the countries are moving along on their plans to execute but also have a standard process to operate efficiently in each country.

PHILADELPHIA - In guidelines issued Friday, the American Urological Association recommends against routine PSA testing for men before age 40 or after age 70, men of any age with a life expectancy of less than a decade, or average-risk men ages 40 to 54.

Men 55 to 69, and younger men who are at high risk because of their race or family history, should go through "shared decision making" with their doctors to weigh the pros and cons of screening, and their individual values, the guidelines say.

The advice puts the urologists' group -- traditionally fervent defenders of the PSA test -- more in step with the U.S. Preventive Services Task Force.

A year ago, that influential federal panel said men should abandon routine PSA testing because early detection saves few if any lives, most prostate tumors would never become life-threatening if left alone, and treatment often causes sexual and urinary problems.

It remains to be seen whether rank-and-file urologists will embrace the guidelines, developed by a committee that spent two years reviewing the scientific evidence. Even if clinicians get on board, shared decision making -- a strategy for helping patients choose from several prudent options -- can be time-consuming. And some patients would rather just be told what to do.

"I think urologists do what's in the best interests of their patients," said H. Ballentine Carter, the urological oncologist who led the guidelines committee. "Yes, there will be differences of opinion, but the members of the AUA will recognize that a one-size-fits-all approach is not the way to go right now."

The directive doesn't address the practice of offering free PSA testing at public events, but Carter said it is frowned upon.

"It is very, very clear that the panel discourages the use of the PSA test outside the context of shared decision making," he said. "Health fairs and community organizations should not do it."

The nonprofit Prostate Conditions Education Council in Colorado disagrees. As "one of the most successful health screening projects in the world," it brings free or low-cost screenings to 125,000 men a year.

"I call it early detection, not mass screening," said urological oncologist E. David Crawford, chair of the council. "You can call it mass screening; I think it's case-finding."

"It's a money machine," said Richard J. Ablin, 72, an Arizona immunobiologist and a harsh critic of screening. "Without this test, there would be a significant financial impact on the urological industry."

In 1970, Ablin discovered the prostate-specific antigen, a blood protein that can surge with benign as well as malignant prostate gland changes. In 1986, the government approved the PSA test to monitor cancer patients for recurrence after treatment, a use Ablin endorses. But medical and patient groups promoted the test for screening.

The test "is not cancer-specific, there is no reliable PSA level for diagnosis, and it can't distinguish between indolent and aggressive cancers," Ablin said. "But once you take a psychologically healthy man and . . . tell him he has cancer, his inclination is to cut it out."

Early detection has dramatically reduced the proportion of men who have metastatic disease at the time of diagnosis, from 70 percent in the early 1990s to 3 percent now.

But does that translate to lives saved? The best studies offer different answers. A major U.S. screening study found prostate cancer death rates were the same among screened and unscreened men after 13 years. A major European trial found 1 fewer prostate cancer death per 1,000 men screened over 11 years.

However, that European study also found that 210 out of every 1,000 screened men were sent for a biopsy, fewer than half of whom were found to have cancer. Of 99 who wound up having surgery or other treatment, 40 became incontinent or impotent.

Numerous companies have developed tests intended to improve -- but not replace -- the PSA test. These assays clarify biopsy results, indicate whether to repeat the biopsy, or assess whether the cancer can be monitored rather than treated.

But the best combinations of tests -- not to mention the added costs -- are far from clear.

"We've come a long way since 1989," Crawford said. "Basically, the whole controversy comes down to this: We diagnose 240,000 men a year; 30,000 die. How do we focus on that group at risk of dying?"

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Contact Marie McCullough at 215-854-2720 or mmccullough@phillynews.com. ___

NEW YORK (Reuters Health) - Many more breast cancer patients had breast reconstruction following a 1998 federal law mandating insurance coverage for the procedure, according to a new study.

"I think it's the first large-scale study that shows that, slowly, legislation like the Women's Health and Cancer Rights Act is having an effect," said Dr. Evan Garfein, a plastic surgeon who has helped to draft a New York law aimed at improving access to breast reconstruction but who was not involved in the new research.

The study's authors note that the greatest increases in reconstructions were among women on Medicaid and Medicare, suggesting that before the law, the uninsured cost of the procedure was an obstacle for many poor breast cancer patients.

But researchers cautioned against interpreting the study results to give all the credit to the legislation.

"The utilization of reconstruction overall has increased over the study time period because surgical techniques have changed and we've also expanded the people that are eligible for reconstruction compared to what was possible even 10 years ago," said Dr. Rachel Kelz, an assistant professor of surgery at the University of Pennsylvania in Philadelphia and one of the authors of the study.

Breast reconstruction is considered by many to be part of the recovery from breast cancer.

Mastectomy (surgical removal of the breast) "can be a fairly deforming operation," said Garfein, of New York's Montefiore Medical Center. "Reconstruction is helpful in restoring a sense of self, it's helpful in restoring a sense of sexuality, it's helpful in helping women move on from treatment of the disease."

In an effort to make sure all women have access to the procedure, Congress passed the Women's Health and Cancer Rights Act of 1998.

The law requires health insurance plans that cover mastectomy to also cover plastic surgery to reconstruct the breast.

Past research has shown that not all women are equally likely to get reconstruction; women with private insurance are more likely to have the surgery than women with Medicare and Medicaid, Garfein said.

To see whether those tendencies have been changing, Kelz and her colleagues gathered information from a large database of hospital patients' records.

Between the years 2000 and 2009, more than 168,000 women in the database underwent breast removal and 35,000 of them had breast reconstruction immediately following the cancer treatment.

As a percentage of all the women treated for breast cancer in a given year, the number who got reconstructions rose from roughly 13 percent in 2000 to 36 percent in 2009, the team reports in the medical journal Cancer.

The greatest increase in reconstruction rates over this decade was among women covered by Medicaid, the government-funded health insurance for the poor.

In 2000, just about five percent of the women on Medicaid had the surgery, whereas 20 percent had it in 2009, a four-fold rise.

Similarly, reconstruction rates among women on Medicare, the government-funded insurance for seniors or the disabled, nearly tripled, from 4.3 percent to 12.3 percent.

Women with private insurance more than doubled their rate of reconstructions, from 22.1 percent to 57.1 percent.

Kelz said the increases are likely due in part to the Women's Health and Cancer Rights Act.

"Some of this has nothing to do with policy changes, but you would expect the same rates of expansion to affect different groups equally if it was just related to technical expertise," she told Reuters Health.

Garfein said the overall increases in reconstruction were "quite a jump," but that there is still a long way to go in leveling the disparities in who gets the procedure.

Rachel Yang, the study's lead author and a medical student at the University of Pennsylvania, said one of the reasons women without private insurance don't get breast reconstruction as often could be because their doctors aren't referring them for the procedure.

And that could be because doctors at facilities that treat patients with Medicaid don't have the time to discuss reconstruction options.

Yang said it's important that all physicians discuss the options with their patients.

Garfein said it's also possible that doctors might not be referring patients for reconstruction because there isn't a readily available plastic surgeon to do the procedure.

"It is really incumbent upon all hospitals, anyone that treats breast cancer, to make sure that reconstruction availability is not only a theoretical option but an actual option," he said.

Patient education is also an important component of making sure women can choose the best option for breast cancer treatment, said Yang.

Not all women are going to want reconstruction, she said, "but we believe that all women should have access to it and all women that want it should have the conversation with their provider about this option."

SOURCE: http://bit.ly/157GOFF Cancer, online April 12, 2013.

DermaFlow: The diagnostic company founded by Irene Jaffe believes that changes in peripheral circulation in the capillaries can be an early indicator of acute and chronic medical situations such as multi-organ dysfunction, sepsis, shock, peripheral arterial disease and cardiovascular distress. Its noninvasive diagnostic technology creates an early monitoring system for some of these conditions and uses stand-alone wired, embedded/integrated and wireless monitoring products, and sensors placed on the skin.

Hsiri Therapeutics: The antibiotics company uses technology licensed from the University of Notre Dame to develop antibiotics in areas where bacterial resistance is an issue. Its initial plan is to develop antibiotics to a point where it would be attractive for large and midsized pharmaceutical companies to license its products. Earlier this year it acquired the assets and staff of  PracticaChem. Among the bacterial targets the company is developing antibiotics for are Pseudomonas, Acinetobacter, Gonococcus and Burkholderia, according to its website. It is also targeting new antifungal compounds against Candida and Aspergillus. Its labs are partly funded by a multiyear grant from the Department of Defense.

LifeAire Systems: The air purification company that developed an air duct system for the niche area of improving air quality for in vitro fertilization labs sees scope for its system in operating rooms, burn units, neonatal intensive care units and other rooms in hospitals across the country where airborne biologicals present a risk. Led by Kathryn Worrilow, LifeAire Systems wants to help solve the $30 billion hospital-acquired infection problem, an issue that impacts hospitals nationwide.

PHmHealth: The three co-founders of the home-health market services group wants to add transparency to home care both for families and for insurers. Using its smartphone system, providers can access patient information and gather data to view visit activity. The company says its system can reduce payers’ risk of improper billing or fraud and help keep families informed about their loved ones’ care. It sees its primary market as payers looking to reduce inaccurate billing. It cites 2012 data from the Office of the Inspector General that says  home healthcare agencies submitted 22 percent of claims in error and tallied up to $432 million in improper Medicare payments.

picWell: The mobile health company’s decision-making app helps seniors pick the best Medicare part D plan. Users take pictures of their current medicine bottles, pick plans from the top two suggestions and click to connect with the desired insurance provider.

Skelegen: The biotechnology company that’s part of University of Pennsylvania’s UpStart incubator program in the Center for Technology Transfer is developing tissue-engineering strategies for bone regeneration. Developed by Dr. Kurt Anderson, a professor with the university’s school of veterinary medicine. The group’s technology involves converting stem cells into osteoblasts–bone-producing cells. Its technology wants to target the 10 percent to 13 percent of bone fractures that have trouble healing and could require surgical intervention.

(Reuters) PHILADELPHIA - Auxilium Pharmaceuticals Inc reported a big fall in quarterly sales in the United States for both its drugs, and said it acquired Actient Holdings LLC to bolster its urology business.

Shares of Auxilium fell as much as 13.5 percent to $13.87 — their lowest in a year-and-a-half — on the Nasdaq on Monday.

Revenue fell 10 percent in the first quarter to $66.2 million, below analysts' average estimate of $81.23 million, according to Thomson Reuters I/B/E/S.

Testosterone gel Testim's sales, almost all of which come from the United States, fell 23 percent to $45.5 million.

Chief Executive Adrian Adams blames the slide on slowing growth of the testosterone replacement therapy market, competition and reduced managed care cover.

Testim covered 71 percent of patients under managed care plans, down from 83 percent in the fourth quarter.

Endo Pharmaceuticals Inc's Fortesta, which bagged some big managed care contracts, could have affected Testim sales by competitive pricing, Stifel Nicolaus analyst Annabel Samimy said.

"It seems like the competitive environment is overwhelming them. They were going to depend on market growth to maintain their sales level."

U.S. sales of Xiaflex, a drug that treats a thickening of the fibrous tissue layer underneath the skin of the palm and fingers, fell 5 percent to $12 million in the quarter ended March 31. The drug's total sales, however, grew 39 percent.

Auxilium cut its forecast range for 2013 global Testim sales to $210 million to $240 million from $250 million to $265 million.

The company also reduced its U.S. sales forecast for Xiaflex — also being developed as a treatment for Peyronie's disease, a curvature of the penis caused by scar tissue — by $10 million to between $65 million and $80 million.

Auxilium also announced the acquisition of Actient from private equity firm GTCR for $585 million plus contingent payments.

"You've got a deal that was done on the same day as they reported unfortunate performance for their base products, so it calls into question the urgency of the deal," Samimy said.

"It feels a bit like a defensive move for Auxilium."

Actient's testosterone replacement therapies Testopel and Striant and erectile dysfunction products such as Edex complement Auxilium's drugs.

The combined company will sell 11 products for urology, orthopedic and respiratory ailments.

"With a broader portfolio we will have a more diverse revenue stream, reducing our reliance on any single product," CEO Adams said.

Auxilium expects the deal to contribute $85 million to $95 million to 2013 revenue and immediately add to adjusted net income. It now expects 2013 revenue of $360 million to $415 million, up from $325 million to $355 million forecast earlier.

The company said it would fund the deal by cash on hand and a $225 million loan from Morgan Stanley Senior Funding Inc.

Auxilium recorded a net loss of $8.2 million, or 17 cents per share, in the quarter ended March 31, compared with a loss of $1.7 million, or 4 cents per share, a year earlier.

Shares of the company, one of the biggest losers on the Nasdaq on Monday, were trading down 11.6 percent at $14.16 a little after noon.

Photo courtesy freedigitalphotos.net

Why? For one thing, epilepsy can be tough to diagnose because there are other conditions that share similar symptoms. Pollard, a clinician in the Epilepsy Center at Perelman School of Medicine, pointed out that one group of conditions it is often confused with are psychogenic disorders that can produce fainting spells. In the context of an ER visit, that could appear to be epilepsy. To get a more accurate diagnosis, where available, patients are admitted as inpatients for a multi-day test that combines closed circuit TV, EEG monitoring and MRI scans that comes with a $10,000 price tag. Underdiagnosis is a problem too, but not as much as overdiagnosis.

Another goal of the diagnostic would be to improve the quality of clinical trials and thereby, theoretically, the outcomes for drug development for epilepsy.

The blood-based diagnostic is designed to find an anti-inflammatory protein that originates in the brain which people with epilepsy have in relatively low concentrations. Cognizance, founded in 2011 with fellow neurologist Dr. Peter Crino, now at Temple University School of Medicine, is seeking an SBIR grant from the National Institutes of Health to carry out a proof of principle trial for its diagnostic. It plans to apply for 510(k) clearance and it would be given by neurologists.

About 2.2 million people in the US are diagnosed with epilepsy along with 50 million to 65 million outside the US, according to the Centers for Disease Control.

 [Feature picture from flickr user Wheeler Cowperthwaite]

The alliance with Becton Bioscience will help CytoVas assess cardiovascular disease progression, as well as evaluate the side effects of existing and experimental medicines for cardiovascular disease.

Last year CytoVas became the first company to get funding as part of the American Heart Association’s accelerator program, an initiative designed to speed up the investigation and development of products for cardiovascular disease patients. As of February it had begun to enroll patients in a proof of concept trial for its diagnostic to evaluate an individual’s vascular health profile. The test would be administered to patients being treated for cardiovascular disease, diabetes and cancer who may be symptom-free for cardiovascular disease and stroke but face an elevated risk for developing those condition.

CytoVas was co-founded by Dr. Emile Mohler, a cardiologist and professor of medicine at the Perelman School of Medicine at the University of Pennsylvania and a co-inventor of the technology, as well as Jonni Moore and Wade Rogers, of the Department of Pathology and Laboratory Medicine, and faculty with Perelman School of Medicine

Moore said in the statement: “The partnership with BD is a promising step in bridging the gap from research to patients for this potentially life-saving diagnostic.”

Ross Tonkens, a cardiologist and head of the American Heart Association’s Science and Technology Accelerator Fund said: “This test not only offers the promise of identifying symptom-free individuals at high risk, but could also assess the effectiveness of new therapies to prevent heart attack and stroke.”

More than 82 million people in the US have at least one type of heart or blood vessel disease, according to data from the Stroke Association.  The idea is that if people who are likely to suffer strokes and heart disease earlier, there’s more time for healthier lifestyles to be adopted and reduce healthcare costs associated with hospitalization. The direct costs of medical care and therapy to treat strokes every year are estimated at $28 billion per year, with indirect costs from lost productivity and other factors estimated at $15 million per year, according to the Stroke Center at Newark, New Jersey-based University Hospital.

PHILADELPHIA - Three private equity firms have contacted Children's Hospital of Philadelphia during the last six months about partnering to open urgent-care centers, Steven Altschuler, the hospital's chief executive, said Thursday.

Urgent-care centers are increasingly common, staffed by doctors and touted as a way to keep people out of emergency rooms for relatively minor ailments.

"I'm not that smart," Altschuler said at the Philadelphia Health Care Expansion Summit in Center City, "but I figured there must be money to be made, because [private equity firms] don't do anything unless there's money to be made and an exit strategy."

Children's turned down the invitations and is trying to get more out of its existing primary-care network while pursuing other experiments, Altschuler said.

First is using its specialty-care center in Mays Landing, N.J., which has X-ray systems and a laboratory, as an urgent-care center evenings and weekends, he said.

Other CEOs on the panel -- Larry Kaiser of the Temple University Health System; John Lynch III of Main Line Health; and Richard Miller of Virtua Health -- also shared their strategies for this rapidly expanding segment of health care.

For-profit firms see a moneymaking opportunity in the anticipated surge of the insured under the Affordable Care Act. At the same time, urgent-care centers are part of the efforts of nonprofit health systems to spread their tentacles further into the community in a bid to capture patients as hospital admissions decline.

Lower prices and shorter waiting times are selling points for urgent care over emergency departments, experts say.

Emergency rooms that contract with Independence Blue Cross, for example, generally charge from $550 to $750 to treat strep throat compared with an average of $110 to $130 at urgent care centers and retail health clinics, according to the insurer.

Urgent-care centers are not new to the Philadelphia region, but there has been a burst of activity since last fall. Several for-profit sites have opened, including Patient First in Montgomeryville, Doctors Express in South Philadelphia, and MedExpress in Cinnaminson.

Nonprofit hospital owners have been active as well. Cooper University Health Care and Virtua have opened urgent-care centers in South Jersey, and Lourdes Health System plans to add urgent care to its new facility in Cherry Hill this year.

In Southeastern Pennsylvania, Temple has recently opened two urgent-care centers, in Northeast Philadelphia and Jenkintown, and plans a third this summer in Fort Washington.

"It's certainly our strategy to place more of these in strategic areas," said Kaiser, Temple health's CEO.

Lynch, Main Line Health's CEO, was the only one to express skepticism: "Unless reimbursement rates for minor emergencies or for urgent care are enough to support what you need in [delivering] urgent care, I'm not sure you're going to see the kind of proliferation that some people predict."

Main Line Health, Lynch said, plans to consolidate its 66 primary-care locations "into fewer locations that offer more services, more convenience, easier walk-in appointments."

Lynch described Main Line Health's strategy as taking a position between drugstore clinics, which deal with minor issues, and urgent-care centers.

"We're going to see if that works," Lynch said.

The event was sponsored by Bisnow, an events organizer and publisher of online real estate information.

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Contact Harold Brubaker at 215-854-4651 or hbrubaker@phillynews.com. ___

Philips Respironics is trying to remedy the issue with a self-management smartphone app and Web-based tool to troubleshoot any problems patients have using its System One positive airway pressure device. The SleepMapper also provides educational material, such as videos to demonstrate how to put on the mask, as well as motivate users and help them better understand their condition.

It helps users set goals for themselves, and track problems they might encounter using the device like adjusting the fit of their mask. It can also provide reminders such as when to change filters for the device. Users are also encouraged to set goals for themselves and track their progress. They can also monitor how many hours of sleep therapy they have had.

Obstructive sleep apnea involves a narrowing or closing of the upper airway, that causes people with the condition to stop breathing while they are sleeping. The condition affects 4 percent of men and 2 percent of women in the US, according to data from the World Congress on Sleep Medicine.

The settlement gives Actavis the license to make and sell its version of Intuniv in the United States from December 1, 2014.

Actavis will get a 180-day period to exclusively market Intuniv, during which it will have to pay Shire a royalty of 25 percent of gross profits from the sale of the drug.

Watson will be allowed to make and sell its version of the drug in the United States 181 days after Actavis launches its version.

(Reporting by Abhishek Takle in Bangalore; Editing by Roshni Menon)

Pennsylvania could expect budget savings and more tax revenue if it takes billions of dollars in federal funding to expand a health insurance program for the poor.

The state budget could realize an average positive impact of $425 million a year from 2014 through 2021 by expanding Medicaid to cover more people, as called for by the federal health care reform law, according to an analysis by the Independent Fiscal Office.

"The report provides information and analysis that policymakers can use to inform the decision on whether or not to expand Pennsylvania's Medicaid program," said Matthew Knittel, director of the state agency.

The positive impact would come from two places: the federal government would pick up more of the cost of insuring people the state currently covers, and from higher tax revenue from insurers who will add more customers.

Gov. Tom Corbett has rejected the idea of expanding Medicaid, saying that costs could be too high. A chorus of Democratic lawmakers and health care advocates have called on Corbett, a Republican, to reconsider.

A similar study was released last week by the Pennsylvania Economy League showing the state could save $4.4 billion over 10 years if the program is expanded. Another study, commissioned by the state Hospital and Healthcare Association, found at least $3.2 billion in annual economic growth under expansion.

"I'm not surprised by a new independent study showing the federally funded Medicaid expansion would be good for Pennsylvania," said state Rep. Dan Frankel, D-Squirrel Hill. "At this point, we're approaching 'beyond a reasonable doubt.'"

But the state Department of Public Welfare warned that the reports fail to account for the possibility that increases in tax revenue may not happen.

"I'm very concerned that not everyone has the facts, and this includes the fact that over a billion dollars for our Medicaid program is in doubt," acting Public Welfare Secretary Beverly Mackereth said.

The U.S. Department of Health and Human Services is considering eliminating or reducing the amount of gross-receipts taxes charged to health insurers that the state can spend on Medicaid, she said.

HHS spokeswoman Emma Sandoe declined to comment on the tax issue but said the Medicaid expansion "is completely paid for by the federal government in the first three years, and the federal government will cover at least 90 percent of these costs in the years thereafter."

Corbett spokeswoman Christine Cronkright said the governor will review the Independent Fiscal Office's report, "but receiving clarity on the GRT (gross-receipts tax) moving forward will significantly impact any analysis of costs and savings around Medicaid expansion."

Under the IFO's analysis, new tax revenue from the gross-receipts tax would increase from $78 million in 2015 to $120 million in 2021.

Budget savings would jump to $465 million in 2015, as more people are covered under Medicaid and as the federal government covers 100 percent of the cost of those new recipients, the IFO report shows. But savings slowly decline as the federal contribution decreases, dropping to $73 million in 2021.

Knittel said that even by removing the positive effect of higher gross-receipts tax collections, the state would still realize significant yearly savings under an expanded Medicaid program.

For instance, in 2021, the state is estimated to see $299 million in positive budget impact. Taking out $120 million in additional gross-receipts tax would leave "significant savings," Knittel said.

Up to 771,000 additional state residents could be covered by Medicaid by 2021, the IFO said.

"After adding up to one million new Medicaid recipients in Pennsylvania, the federal government will pull back after three years, leaving our taxpayers on the hook to the tune of billions of dollars," said Jennifer Stefano, Pennsylvania director of Americans for Prosperity, a limited-government advocacy group. "We must not head down this path."

Alex Nixon is a staff writer for Trib Total Media. He can be reached at 412-320-7928 or anixon@tribweb.com. ___

Among the initiatives Corbett was credited with was his move in 2011 to assemble a Life Sciences Leadership Advisory Council that included members of the Pennsylvania legislature, the administration, academia, industry and the investment community, to develop a 10-year strategic plan to strengthen the industry.

BIO CEO Jim Greenwood credited Corbett with “positioning Pennsylvania as a valued leader within the industry.” He said Corbett has enhanced the business environment in the state to support research and development, as well as growing innovation companies facing significant start-up costs.

Corbett was also recognized for his support of the state’s three Life Science Greenhouses that have aided in the creation of 32 new bioscience firms in the past two years.

“By supporting initiatives that stimulate growth within the industry — from helping entrepreneurs quickly transform ideas into commercial products to supporting the establishment and expansion of biotech companies — we are ensuring the biotech economy will continue to grow and flourish in Pennsylvania,” Corbett said in a statement.

PHILADELPHIA - It was 8 a.m., and 86-year-old Allan Ford had delayed his breakfast to help researchers at the Hospital of the University of Pennsylvania figure out whether a hormone called ghrelin can combat frailty -- a combination of muscle loss and fatigue -- in the elderly by making them eat more.

Clinical trials have been something of an avocation for Ford, a former marketing and advertising man from Wynnewood, since the mid 1990s. With no chronic illnesses, he was always in the healthy control groups. But this time, even though he looks young for his age and is mentally sharp, he was weak and physically slow enough to qualify for the treatment.

While many U.S. researchers want to block ghrelin in the obese, Anne Cappola, an endocrinologist who is leading the Penn study, hopes the appetite stimulant will counteract the weight loss and weakness that often accompany aging. Many older people complain that they're just not hungry.

That recent morning, Ford got a shot of the hormone under the skin of his belly, then waited half an hour before eating a hearty breakfast of eggs, bacon, cereal, and toast from two trays. An earlier arm of the study had proven he ate more after the shot. This part was to find out whether he could learn to give the daily shot himself. (He could.)

Next, Cappola's team will test what happens when the drug is combined with exercise.

Many people still believe that the words old and frail naturally go together, but aging experts increasingly view frailty as a separate syndrome that often can be prevented and treated.

"While death is inevitable, this kind of long, slow decline into frailty and . . . disability is not really inevitable," said William Evans, an expert on aging, exercise, and nutrition who heads GlaxoSmithKline's muscle metabolism discovery performance unit in North Carolina. His group is studying drugs that may help build muscle or improve its quality. There may be human trials next year.

If doctors can figure out how to keep people stronger, that could lead to longer, more independent lives for the elderly and lower health costs for everybody.

The issue is gaining importance as baby boomers enter their final decades. Many will be prime candidates for frailty because of unhealthy lifestyle habits.

"It's going to be an enormous problem in the next 10 to 20 years," said Evans, who taught at Penn State in the 1990s. "The societal cost of nursing homes and institutionalization is enormous."

In a paper to be published in June, a consensus group representing six international geriatrics groups will recommend that both primary care doctors and specialists screen all patients older than 70 for frailty. Early identification, the group says, will help the elderly achieve one of their highest priorities -- aging at home -- and reduce costs.

Because cancer and its treatments seem to accelerate frailty, the National Cancer Institute has made research on frailty one of its funding priorities this year, said Catherine Alfano, deputy director of the office of cancer survivorship.

What exactly is frailty? For years, doctors agreed they knew it when they saw it, but had no definition. We all can picture the shrunken, old lady who needs help with her grocery bags and walks at a snail's pace. Linda Fried, then an aging expert at Johns Hopkins University, came up with the first definition for the syndrome about 10 years ago.

People with three of these five symptoms are considered frail: slow walking speed, weakness as measured by hand grip, physical inactivity, exhaustion, and unintentional weight loss of more than 10 pounds in a year.

Others have somewhat different definitions, and doctors now realize that obese patients also are often frail. The bottom line is that frail people are weak and at high risk of death and disability. They don't bounce back well from injury or surgery.

While frailty can occur in people like Ford with no chronic health problems, it is also common in people with cancer, heart failure, and chronic obstructive pulmonary disease.

Cappola said 7 percent of people 65 and older and 15 percent of those in their 80s are frail. A much higher percentage are "pre-frail," a group experts want to target for help.

Researchers are focusing on the physiological underpinnings of the syndrome, which Fried says involve poorer coordination between bodily systems. Inflammation is one possible culprit; genetics is another. Vitamin D has potential to help.

Evans also has developed a urine test -- not yet FDA approved -- that will for the first time help doctors measure how much muscle patients have.

As all that is sorted out, the advice is the same as for so many health problems: exercise more and eat better. People naturally lose muscle mass and quality as they age, but many are declining too fast due to the way they live.

"We're an aging population, and we're aging faster than we need to," said Kathryn Schmitz, an exercise physiologist at Penn who has studied exercise in breast cancer survivors and will soon work with Cappola's study subjects.

Many elderly people complain they've lost their appetite -- hence the ghrelin trial. They may need to focus on eating more, especially more protein, which is needed for muscle building. Eating less saturated fat may improve muscle quality, Evans said.

Moving more is key. "It's the single most important thing you can do for healthy aging," Alfano said. "Everyone's looking for the magic pill. We have it. It's exercise."

Aging experts strongly recommend exercising all through life, but studies have shown that aerobic activity and weight lifting can help even very old, very weak people.

Getting older people to exercise can be challenging. "The real problem often is attitude," Evans said. "Older people think that frailty and weakness are inevitable."

It often helps when a family member exercises too. Many a daughter has told him, , "This has been the most important thing I've ever done with my mother."

Fried, who is now dean of Columbia University's Mailman School of Public Health, said society needs to make keeping citizens strong a priority.

"This is one of the things we need to invest in . . . as we become a society of longer lives," she said.

Once 6 feet, Ford said he is now 5-foot-9 and 150 pounds. He looks good, but his arms and legs are thin. He likes to hold onto things as he walks and admits that he gets "more mental exercise than physical exercise."

A reporter wasn't allowed to watch Ford eat for fear it would affect the study results, but he reported a robust meal. "I ate the whole first tray and. . . practically the whole second tray. I was hungry."

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Contact Stacey Burling at 215-854-4944 or sburling@phillynews.com. ___

PHILADELPHIA - Imagine coming back to a home powered by technology. You open the door lock. It can talk to your light switch and turn out the light. Next, it talks to your thermostat and brings up the temperature you’re most comfortable with.

Zonoff, which provides home automation software solutions, raised $3.8 million in venture capital funding from Valhalla Partners and Grotech Ventures.

“This investment validates our approach in building a software platform for our channel partners, who are typically large, consumer-facing companies that have deep and trusted ties with consumers,” said cofounder and chief executive Mike Harris, who sold his earlier company, AnySource Media, to DivX in 2009.

AnySource Media was a software and services platform for Internet-connected consumer electronics devices.

Founded in 2011, Zonoff can enable smart devices, like HDTVs, Blu-ray players, wireless routers, and thermostats, present in your home to work seamlessly together and communicate with one other. Its core technology brings together a wide range of such devices available on the market in a single system.

“The important thing is connectivity and synchronization between those different devices,” Bob Cooper, chief marketing officer at Zonoff, told VentureBeat. “Our software is very widely embedded. It can reside in the control box, set top box, Wi-Fi router.”

With Zonoff, you can control everything with one app instead of using multiple apps to run different systems in the home, Cooper said.

The Zonoff platform consists of home, cloud, and app software that works with the its partners’ products to deliver home automation, remote control, energy management, and safety monitoring, ranging in solutions from entry level to comprehensive.

Zonoff built and powers Somfy’s TaHomA experience. The company is working with two other customers: one, a large supplier in the new home industry, and the other, a large retailer, Cooper said, without disclosing names.

“With the new investment, we’ll be growing our technical staff as well as our support team and infrastructure,” said Cooper.

The Pennsylvania-based Zonoff has 18 employees.

This article originally appeared on VentureBeat

The start of Q2 means the nearing of a big milestone for Pittsburgh drug startup Complexa Inc. — if it can raise the necessary capital.

Complexa is looking for a $7 million Series B so that it can file its Investigational New Drug Application early this summer and begin its first in-human trials in August.

The company is developing a synthetic form of nitro fatty acids, which occur naturally in the body to shut down harmful inflammatory pathways and activate the body’s protective mechanisms against inflammation.

Its drug will first be applied to treat acute kidney injury that occurs from inflammatory reaction to dye injections used with certain types of medical imaging, such as coronary angiography. Called contrast-induced nephropathy, this complication is more likely to occur in certain patients, like the elderly and those with diabetes, and is a common cause of hospital-acquired acute renal failures.

A $3.4 million Series A last summer funded IND-enabling studies of CXA-10, which are nearly complete, said President and CEO Josh Tarnoff. The next round would support Phase 1A and 1B proof-of-concept studies of the company’s oral drug candidate. Because it leverages naturally occurring compounds, Complexa says there’s a low risk of toxicity.

A few other pharmaceutical companies are also targeting acute kidney injury — AlloCure and Novartis are a bit ahead with their Phase 2 drugs. Although it’s initially going after treatment of acute kidney injury, for which the regulatory pathway is relatively clear and quick, the company also sees future applications in a host of inflammatory conditions including chronic kidney disease, which would be the next target, Tarnoff said.

Complexa was founded in 2008 and is based in Pittsburgh.

PHILADELPHIA - Thomas Jefferson University Hospital has notified 51 patients who underwent gastrointestinal procedures that a lapse in infection-control practices may have exposed them to dangerous blood-borne viruses, according to a hospital statement.

Patients were warned by letter of potential exposure to viruses that cause Hepatitis B, Hepatitis C, and HIV. Subsequent review of patients' records found no known cases of HIV infection, said hospital spokeswoman Jacqueline Kozloski.

The patients were offered free blood tests to screen for infection.

"As of last week, 48 patients had received their free baseline testing and there was no evidence of infection," the statement said. "Additional follow-up testing has been recommended for all patients."

During gastrointestinal endoscopic procedures, a flexible fiber-optic scope is threaded into the digestive tract to visualize the stomach, intestines, or esophagus. Surgical instruments may also be inserted to remove biopsy tissue samples.

The possible contamination occurred during four weeks in February and March. In the letter to patients, the hospital explained that during a biopsy, "sterile, single-use" forceps are rinsed in a cup of water that is supposed to be discarded after the procedure. Instead, "some rinse water was reused for a small number of patients."

The hospital said it was waiving the cost of the patients' GI procedures and "in the highly unlikely event that an infection has been transmitted," it will provide free follow-up treatment.

As a corrective measure, Jefferson has reviewed infection-control practices and required retraining of all employees in the GI unit.

Jefferson's website says it has one of the busiest GI units on the East Coast, performing more than 13,000 endoscopic procedures a year.

Expert medical groups have developed stringent guidelines for disinfecting GI endoscopy equipment. As a result, transmission of infection is very rare, with an estimated frequency of one in 1.8 million procedures.

Both Hepatitis B and C infect the liver and may cause chronic infection that leads to liver cirrhosis, failure, or cancer. The C form is generally mild in its early stage, but causes chronic liver disease about 85 percent of the time, compared with 10 percent for the B form.

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Contact Marie McCullough at 215-854-2720 or mmccullough@phillynews.com. ___

PHILADELPHIA, PA - In advanced emphysema, the lungs become progressively enlarged and overinflated. Sufferers are literally stuck holding more and more of their breath.

Researchers have long tried to find ways to reduce lung volume and improve airflow without resorting to risky surgery.

Now, three promising lung-shrinking techniques -- coils, one-way valves, and an injectable sealant -- are in or near clinical testing at Temple University and other U.S. medical centers. All three methods are already approved in Europe.

"They all have pluses and minuses," said Temple University pulmonologist Gerard J. Criner, a leading emphysema researcher. "I foresee a day where a patient would have several of these techniques, based on their anatomy."

Criner estimated that day is still about five years away in the United States, and there are no guarantees. Two years ago, for example, the commercial development of airway stents -- tubular supports that opened new lung passages to release trapped air -- was abandoned after researchers, including Penn lung-transplant pioneer Joel Cooper, reported disappointing results from a major study. The main problem was that airway stents became blocked, much like stents designed to keep heart vessels open.

Still, biotech companies are doggedly pursuing new technology, recognizing the vast need. Emphysema, which is usually caused by smoking, afflicts about 60 million people worldwide, including four million Americans.

"It is a difficult disease," said pulmonologist Frank Sciurba, director of emphysema research at the University of Pittsburgh. "We've used drugs for symptom relief. Now, we're trying to do things that structurally improve the mechanics" of the diseased lungs.

A decade ago, researchers thought they had a breakthrough with "lung volume reduction surgery." A federally funded study showed that cutting out diseased tissue improved patients' exercise capacity and quality of life -- the only treatment short of a lung transplant to do so. Surgery even improved survival for a subgroup of patients.

Nonetheless, the surgery is rarely performed anymore, mostly because it is perceived -- unfairly, proponents say -- as too risky. (After two years, a quarter of patients had died, whether they had surgery or medical therapy.)

"The surgery is almost nonexistent, even though we proved it works," Sciurba said.

Since then, the goal has been to find simpler, safer, minimally invasive ways to reduce lung volume.

All three approaches now being tested are deployed through a bronchoscope -- a long, flexible tube that is threaded through the nose or mouth to airways in the lungs.

The lung coils, developed by PneumRx of Mountain View, Calif., are the newest innovation. The four-inch-long device, made of a super-elastic alloy, is straight when released into the airway, then recoils into a double loop that catches and compresses diseased tissue -- sort of like gathering a curtain on a rod -- making it far easier to breathe. Each lung gets 10 coils.

Linda Sachs, 65, of Hampton Township, near Pittsburgh, two months ago became the second American to get the coils during a one-hour procedure at the University of Pittsburgh Medical Center.

"After the anesthesia wore off, I told Dr. Sciurba I noticed a difference immediately," she said.

Now, for the first time in years, she can carry a load of laundry up stairs -- one of many minor tasks that had become a herculean feat due to her emphysema.

She will have to undergo rigorous evaluation to separate any placebo effects from real ones. And the history of lung-shrinking technology suggests that breathing improvements tend to be modest.

In late 2008, for example, the U.S. Food and Drug Administration refused to approve one-way valves designed to reduce the volume of diseased lung tissue, thus improving the function of healthier parts of the lungs.

"It worked in some patients, but overall, it was not a dramatic effect," said Sciurba, one of the study's leaders.

But the valve technology was acquired by a new company, Switzerland-based Pulmonx, which has developed a pulmonary assessment system to identify the most suitable patients and the best placement of valves. Last year, it announced plans for a new U.S. trial, co-led by Temple's Criner, to begin this year.

Temple is also a test site for the latest version of a sealant, made by Aeris Therapeutics, that permanently collapses and seals selected areas of the lung.

Criner is not concerned that smoking-related emphysema is preventable. "We're all human beings," he said. "A lot of things we do when we're younger aren't very smart."

What matters, he said, is that science is finally making progress in understanding the biology, mechanics, and genetics of a common, suffocating illness.

"It's a pretty exciting time to be working on a disease that is third leading cause of death in the world," he said.

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Contact Marie McCullough at 215-854-2720 or mmccullough@phillynews.com. ___

Tiger Woods and Hines Ward are just two of the athletes who have received platelet-rich plasma therapy – a procedure where doctors take a small sample of patient’s blood, separate the platelet-rich plasma, and inject it at the site of an injury after surgery to accelerate tissue healing.

The therapy is gaining traction in sports medicine but has some limitations, according to Alan West, the CEO of Pittsburgh startup Carmell Therapeutics. For one, some people have higher concentrations of growth factors in their blood than others, and that’s what stimulates cellular growth. PRP injections are also liquid, so they don’t stick well to a tendon or muscle.

Carmell is trying to solve those problems by taking pre-evaluated blood plasma from a blood bank and plasticizing it, so that it retains natural growth factors and can be injected at the site of injury to accelerate bone and soft tissue healing.

In its first application, it’s being turned into an off-the-shelf bone putty to accelereate the healing of sports-related bone injuries, like the tibia fracture Kevin Ware suffered.

Carmell was founded in 2007 based on technology developed jointly at Carnegie Mellon University and Allegheny General Hospital. It sounds like the company’s strategy has changed a bit since it raised its Series A in 2011, when its planned first product was a surgical scaffold for tendon injuries.

Now it’s testing the bone putty technology in a study of 30 patients in South Africa and raising a Series B to fund work toward a launch of the product Europe toward the end of next year, West said. He said he was “cautiously confident” the product could begin a U.S. trial next year.

In an interview with MedCity News Christopher Bettinger, an assistant professor with Carnegie Mellon University’s biomedical engineering and materials science and engineering departments, said he and research partner Jay Whitacre, a materials science and engineering professor, have been working on the technology over the past four years. They are developing sensors that would pick up data before they are flushed out of the body with the next meal and ones that could be programmed and deployed in the small intestine where the battery would be activated for longer time frames.

The biosensors could measure biomarkers or monitor gastric problems. Bettinger said one of the sensor’s optimal uses is to detect core body temperature as oral thermometers can be inaccurate. It could also be used to measure heartbeats, as well as pH levels in the small intestine to detect or predict ulcers.

Additionally, they could be used for targeted drug delivery for certain types of cancer, according to a press statement.

Bettinger said that its design includes polymer electrodes and a sodium ion electrochemical cell, which can be folded into an edible pill.

The sensors are designed to be produced economically, said Bettinger. The data they collect could be passed by email to healthcare providers to improve patient outcomes.

[Photo from Flickr user ex-magician]

The grant will help the company advance its drug delivery platform for synthetic vaccines. It uses an electrical charge to make cell membranes more porous in order to introduce a molecule or DNA code to change the cell’s function, a method called electroporation. It transmits the charge through a scratch on the skin surface.

Inovio Pharmaceuticals, based in Blue Bell, Pennsylvania, is working on the project in collaboration with Dr. Connie Schmaljohn, chief scientist at the U.S. Army Medical Research Institute of Infectious Diseases. It will use the funds to construct an electroporation device to painlessly deliver multiple vaccinations at once.  That device will help advance Inovio’s other vaccines it’s developing, such as one that could combat all flu strains, referred to as “universal flu,” as well as an HIV vaccine.

So far, a team of researchers from Inovio has collaborated with scientists from the U.S. Army Medical Research Institute of Infectious Diseases to advance a DNA vaccine for the Lassa virus, designated as a “Category A” pathogen by the Department of Defense, according to the statement.  It’s an acute viral illness endemic to portions of West Africa transmitted through rodent droppings. It has a relatively high mortality rate and can cause deafness, according to the Centers for Disease Control.

Among the synthetic vaccines in its pipeline, Inovio has two in Phase 2 development including one for cervical cancer caused by HPV. Last month it raised $15 million to advance the vaccine through Phase 2 trials and expects to have data available in the beginning of 2014. It also has a leukemia vaccine. Additionally, it is collaborating with Chron Tech Pharma, providing its drug delivery platform for the company’s Hepatitis C vaccine.