1315 Capital closes on $200 million inaugural fund for niche markets

Kids who play with letter and number puzzles for fun grow up to start venture capital firms with alphanumeric names. At least, that was the case for Adele Oliva, partner of 1315 Capital LLC, which just closed a $200 million inaugural fund. The Philadelphia-based firm invests in commercial-stage companies in the medical technology, specialty pharmaceutical and health care services sectors.

Oliva, who led the fund along with co-founder Michael Koby, Oliva told Medical Device Daily that she was indeed a kid who enjoyed matching numbers to their corresponding letter (based on alphabetical position), a method that inspired the naming of 1315 Capital.

Choosing an alphanumeric name is a good strategy for a VC firm, she explained, because VC directories are often in alphabetical order, with numerical names at the top. And that's important because entrepreneurs tend to use those directories when they begin their search for capital.

As for how Oliva and Koby landed on the number 1315, she said it is derived from the numbers that correspond with each of their initials, beginning with 13 representing Koby's first initial, "M", followed by Oliva's last initial, represented by 15. "It was just something unique, hopefully something very endearing, that will go beyond us, the founders," Oliva said. While 1315 may be the new kid on the VC block, the partners have built an operating team of industry veterans with many of their resumes boasting of experience both on the investment and the company management side of med-tech and pharma.

Names of other investors that participated in the fund were not disclosed but 1315 Capital said it included endowments, foundations, state and corporate pension funds and family offices.

Oliva said consolidation in the health care industry has provided opportunities for innovation, particularly in niche markets. Those happen to be the markets that tend to fly under the radar of most larger strategic VC firms, which is why Oliva said 1315 wants to focus its resources on those smaller companies.

An example of that, she said, is the firm's med-tech company, Onkos Surgical, founded last year to act as 1315's commercial engine in the very niche space of ortho-oncology.

"We partnered with a larger 3-D printing company to innovate in that market, which is a very different market [from the traditional knees and hips ortho sector]," Oliva said, adding that a lot of the patients in need of oncology orthopedic devices are pediatric patients.

Onkos Surgical's products are designed to leverage 3-D printing technology, provided through its partnership with Microport, to make devices that mimic the weight and anatomy of the patient's bone.

More than a name

By so strategically (and numerically) representing Oliva and Koby's partnership, the name 1315 also hints at the firm's unique operating partner model. Teams of two executives, who have worked together at multiple companies, are engaged with the investment team and portfolio companies. The founders said they implemented that model with the intention of adding valuable human capital to the investment equation.

"Our unique operating partner model leverages not only the CEO, but also the Chairman, COO and CFO relationships, allowing us to provide a more complete set of skills to help navigate diligence, drive decisions and achieve premium exits," Koby said.

As an example, one of the firm's first three portfolio companies, JDS Therapeutics LLC, is led by a father-son team. Phillip Satow, the company's chairman, and his son Michael Satow, previously founded JDS Pharmaceuticals, which they sold to Noven Pharmaceuticals in 2007.

"We look for highly experienced commercial teams and products in markets where a realitively targeted sales force, usually 40 to 60 reps, can cover the vast majority of the country in a very capital efficient way," Oliva said.

JDS is a specialty pharmaceutical and nutrition company that develops drugs, supplements and food based on bioactive compounds.

Source: http://www.medicaldevicedaily.com

Narrow band imaging can reduce recurrence of bladder tumors

Research into bladder tumor surgery has found that using narrow band imaging can significantly reduce the risk of disease recurrence. The results of the clinical trial, published in European Urology, compared two groups of bladder cancer patients who were due to undergo bladder tumor resection surgery.

Only 5.6% of low-risk patients in the narrow band imaging (NBI) facilitated surgery group experienced a recurrence of bladder tumors in the 12 months following surgery, compared to 27.3% in those who underwent conventional TURBT (trans urethral resection of bladder tumors) surgery.

According to the World Cancer Research Fund, bladder cancer is the ninth most common cancer in the world, with 430,000 new cases diagnosed in 2012.

For patients with early bladder cancer, a specialist will remove the tumors from the bladder lining using a thin telescope called a cystoscope.

The trial, co-ordinated by the Clinical Research Office of the Endourological Society (CROES, Amsterdam), recruited 965 patients from 16 countries to be randomised to either conventional "white light" TURBT or NBI-facilitated bladder tumor surgery.

Mr Richard Bryan, from the University of Birmingham, explained, "Narrow band imaging makes it easier to identify bladder tumors. It can detect small bladder tumors that might otherwise by overlooked by more conventional 'white light' cystoscopy."

Narrow band imaging technology (NBI) was developed by Olympus Medical Systems (Japan) and was first used for bladder cancer patients at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust in 2005.

Mr Bryan continued, "My colleague, Mike Wallace, and I immediately saw the potential of this technology. Now this potential has been confirmed by a large international randomised controlled trial, and the results can only be good news for bladder cancer patients worldwide."

Olympus stated, "We are pleased to see the widespread use of NBI globally, and have been delighted to support this trial in the bladder cancer setting. We will continue to work very closely with urologists to further understand their needs and challenges, and will strive to develop technologies such as NBI that could contribute to improving patient care across the globe."

On behalf of CROES, Professor Jean de la Rosette said, "Conducting a trial of this size across 16 countries has been a great achievement for CROES and the Trial Management Group. We appreciate the time and effort that urologists across the globe have committed to this study, and these results are just the start of the study outputs. We are extremely grateful to Olympus for their support from the outset -- so often such technologies are not robustly assessed in this way, and this represents a breakthrough for urology and CROES."

Source: https://www.sciencedaily.com

Personalized virtual heart predicts the risk of sudden cardiac death

When electrical waves in the heart run amok in a condition called arrhythmia, sudden death can occur. To save the life of a patient at risk, doctors currently implant a small defibrillator to sense the onset of arrhythmia and jolt the heart back to a normal rhythm. But a thorny question remains: How should doctors decide which patients truly need an invasive, costly electrical implant that is not without health risks of its own?

To address this, an interdisciplinary Johns Hopkins University team has developed a non-invasive 3-D virtual heart assessment tool to help doctors determine whether a particular patient faces the highest risk of a life-threatening arrhythmia and would benefit most from a defibrillator implant. In a proof-of-concept study published May 10 in the online journal Nature Communications, the team reported that its new digital approach yielded more accurate predictions than the imprecise blood pumping measurement now used by most physicians.

"Our virtual heart test significantly outperformed several existing clinical metrics in predicting future arrhythmic events," said Natalia Trayanova, the university's inaugural Murray B. Sachs Professor of Biomedical Engineering. "This non-invasive and personalized virtual heart-risk assessment could help prevent sudden cardiac deaths and allow patients who are not at risk to avoid unnecessary defibrillator implantations."

Trayanova, a pioneer in developing personalized imaging-based computer models of the heart, supervised the research and was senior author of the journal article. She holds faculty appointments within Johns Hopkins' Whiting School of Engineering and its School of Medicine, and she is a core faculty member of the university's Institute for Computational Medicine. For this study, she joined forces with cardiologist and co-author Katherine C. Wu, associate professor in the Johns Hopkins School of Medicine, whose research has focused on magnetic resonance imaging approaches to improving cardiovascular risk prediction.

For this landmark study, Trayanova's team formed its predictions by using the distinctive magnetic resonance imaging (MRI) records of patients who had survived a heart attack but were left with damaged cardiac tissue that predisposes the heart to deadly arrhythmias. The research was a blinded study, meaning that the team members did not know until afterward how closely their forecasts matched what happened to the patients in real life. This study involved data from 41 patients who had survived a heart attack and had an ejection fraction--a measure of how much blood is being pumped out of the heart--of less than 35 percent. To protect against future arrhythmias, physicians typically recommend implantable defibrillators for all patients in this range, and all 41 patients in the study received the implants because of their ejection fraction scores. But research has concluded that this score is a flawed measure for predicting which patients face a high risk of sudden cardiac death.

The Johns Hopkins team invented an alternative to these scores by using pre-implant MRI scans of the recipients' hearts to build patient-specific digital replicas of the organs. Using computer-modeling techniques developed in Trayanova's lab, the geometrical replica of each patient's heart was brought to life by incorporating representations of the electrical processes in the cardiac cells and the communication among cells. In some cases, the virtual heart developed an arrhythmia, and in others it did not. The result, a non-invasive way to gauge the risk of sudden cardiac death due to arrhythmia, was dubbed VARP, short for virtual-heart arrhythmia risk predictor. The method allowed the researchers to factor in the geometry of the patient's heart, the way electrical waves move through it and the impact of scar tissue left by the earlier heart attack.

Eventually, the VARP results were compared to the defibrillator recipients' post-implantation records to determine how well the technology predicted which patients would experience the life-threatening arrhythmias that were detected and halted by their implanted devices. Patients who tested positive for arrhythmia risk by VARP were four times more likely to develop arrhythmia than those who tested negative. Furthermore, VARP predicted arrhythmia occurrence in patients four-to-five times better than the ejection fraction and other existing clinical risk predictors, both non-invasive and invasive.

"We demonstrated that VARP is better than any other arrhythmia prediction method that is out there," Trayanova said. "By accurately predicting which patients are at risk of sudden cardiac death, the VARP approach will provide the doctors with a tool to identify those patients who truly need the costly implantable device, and those for whom the device would not provide any life-saving benefits."

Wu agreed that these encouraging early results indicate that the more nuanced VARP technique could be a useful alternative to the one-size-fits-all ejection fraction score.

"This is a ground-breaking proof-of-concept study for several reasons," Wu said, "As cardiologists, we obtain copious amounts of data about patients, particularly high-tech imaging data, but ultimately we use little of that information for individualized care. With the technique used in this study, we were able to create a personalized, highly detailed virtual 3-D heart, based on the patient's specific anatomy. Then, we were able to test the heart virtually to see how irritable it is under certain situations. We could do all this without requiring the patient to undergo an invasive procedure. This represents a safer, more comprehensive and individualized approach to sudden cardiac death risk assessment."

Wu pointed out that an implantable defibrillator also has a few risks of its own and that avoiding implantation of this device when it is not truly needed eliminates these risks. Implantable defibrillators, she said, require invasive access to the heart, frequent device checks and intermittent battery changes. Complications, she added, can include infection, device malfunction and, in rare instances, heart or blood vessel damage.

In addition to eliminating unnecessary device implantations, Trayanova noted that this new risk prediction methodology could also be applied to patients who had prior heart damage, but whose ejection fraction score did not target them for therapy under current clinical recommendations. Thus, Trayanova said, VARP has the potential to save the lives of a much larger number of at-risk patients. With the proof-of-concept study completed, the researchers next hope to conduct further tests involving larger groups of heart patients. The VARP technique is covered by patent protection obtained through the Johns Hopkins Technology Ventures office.

Source: https://www.sciencedaily.com

DC Healthcare Provider Limps On After Malware Attack

Despite its computer systems being infected with malware since Monday, MedStar Health, which operates 10 hospitals and more than 250 outpatient facilities in and around Washington, D.C., has continued to provide patient care at near normal levels, according to several updates released this week.

Since the malware attack occurred, MedStar Health has treated an average of 3,380 patients a day at its 10 facilities, it announced Thursday. It has treated nearly 4,000 patients in its ERs and performed more than 1,000 surgeries.

Neither MedStar nor the FBI, which is investigating the incident, will say if ransomware was used in the attack.

However, perpetrators of the attack have asked for 45 bitcoins -- about US$18,500 -- to unlock all of the healthcare provider's infected systems, The Baltimore Sun reported.

The ransom note appeared on the screens of all computers on the MedStar network when users tried to access any files on the system, according to the paper.

MedStar did not respond to our request to comment for this story.

A cyberattack on Hollywood Presbyterian Hospital earlier this year set the game plan for hackers targeting healthcare providers.

"They know the playbook they have to run to take advantage of these situations," said Chris Ensey, COO of Dunbar Security Solutions.

"They received $17,000 for the Hollywood hack," he told TechNewsWorld. "That set the market rate."

Healthcare systems in particular are susceptible to cyberattacks because of the way they share information.

"They have to share information quickly and with a lot of different constituents that are part of the caregiving process," Ensey said. "That requires lots of different openings to be poked open in your firewalls so the attack surface is broader."

What's more, there are many medical devices with network connections and software that hasn't been updated or maintained, he continued.

"There are lots of soft points that a hacker can take advantage of in that infrastructure," Ensey said.

Lack of Commitment

Despite years of FBI cyberthreat warnings, healthcare providers have been tightfisted when it comes to security spending.

"Healthcare has not made a significant investment in information security technology," said David Holtzman, vice president of compliance at CynergisTek.

"Over the past several years, we have seen healthcare organizations devoting only 3 percent of their IT budgets to information security, and only a little over half of them have a dedicated resource focused on information security," he told TechNewsWorld.

"These are strong indicators of the lack of commitment across the healthcare sector for putting appropriate weight and resources to safeguarding health information across the enterprise," Holtzman said.

Every year security is underfunded is a year healthcare systems become more susceptible to attack.

"I think we are seeing the effect of that now in cases like MedStar," Bugcrowd VP of Operations Jonathan Cran told TechNewsWorld.

The healthcare industry is not equipped to handle these attacks, observed Linn F. Freedman, a partner with the law firm of Robinson+Cole.

"These attacks are malicious," she told TechNewsWorld. "They are debilitating, and healthcare entities do not have the resources to be able to combat these highly sophisticated cyberintrusions."

Damage Control

Even when MedStar gets its systems back online, it will be difficult to ascertain exactly what happened to them and if they remain at risk.

"What you have to do is shut down your network and painstakingly gather all the evidence," explained Karthik Krishnan, vice president of product management at Niara.

"That's an extremely hard thing to do for most companies," he told TechNewsWorld. "The down time could be weeks. That's unacceptable."

Since MedStar's service levels don't seem to be severely impacted by the malware on its systems, it may be able to ignore its attackers' ransom demands.

"Every situation is different with respect to whether an entity should pay a ransom," Robinson+Cole's Freedman said. "Hollywood Presbyterian made that decision because they needed to get their [electronic medical records] up and running. In the MedStar case, the EMR wasn't affected."

Taking a hard line against extortionists has its merits, but the decision is rarely uncomplicated.

"In the financial sector, our stance was never pay the ransom because we didn't want to encourage the attackers," said Sean Tierney, director of cyber intelligence for Infoblox.

However, "if you aren't equipped to defend against the problem," he told TechNewsWorld, "then you have to consider paying the ransom -- but it should always be your very last resort."

Source: http://www.technewsworld.com

For kids with autism, this tech matters

For these kids, games and cute robots are more than just fun. On World Autism Awareness Day, we look at some of the ways technology is improving the lives of those with the condition.

Both Katie and her teacher look like they'd be right at home in a Pixar film, and at first their conversation seems like it would fit in one too.

The ponytailed and pink-clad Katie really wants to sharpen her pencil, but her teacher won't let her until the other kids in the class finish taking a test. Katie asks again, but the teacher offers the same frustrating answer.

"Katie seems upset that her teacher said 'no.' How should Katie respond? Let's help Katie make the best choice," a narrator says. "Remember, sometimes parents and teachers say 'no' when you ask them for something. It's important that we stay calm and respond appropriately."

The conversation, highlighted in software called The Social Express, aims to help kids diagnosed with autism spectrum disorder, or ASD, resolve conflicts and understand that no means no.

It's an important lesson packaged in kid-friendly animation. And it's just one of several programs and robots that help kids with autism communicate, interact socially and control repetitive behaviors. All these can be a struggle for those affected by the broad and complicated range of brain development issues that fall under the ASD umbrella.

The Social Express was created by Marc and Tina Zimmerman, who have identical twin boys, both diagnosed with autism. The twins reacted positively to the use of a laptop during home therapy sessions, and that inspired the Zimmermans to create software that teaches social cues through animated, interactive lessons. It works on computers, iPads and with interactive white boards in school settings, and it lets parents, educators and kids work through lessons on topics like making eye contact, taking turns, listening to others, showing respect and controlling emotions.

ASD today affects 74 million people, or 1 percent of the world's population, according to the US Centers for Disease Control and Prevention. Many on the spectrum struggle to talk to other people and understand others' thoughts and emotions, as well as their own. This makes it hard for many kids to form lasting relationships with those around them.

ASK Nao, a cute humanoid robot with a welcoming face, is another tech tool that can help. The bot, from Aldebaran Robotics, has a very specific purpose: to move, dance and interact with children with autism. The bot comes with special programs, like Guess Emotions, which involves NAO acting out an emotions and asking the child to identify it.

"Most children on the autism spectrum have a natural attraction towards technology, and Nao's humanoid shape creates a perfect link between technology and humanity," said Olivier Joubert, autism business unit manager at Aldebaran.

ASK Nao isn't the only robot built to teach social skills to kids with autism. Back in 2010, a low-cost, child-size bot named Kaspar worked with kids who needed help learning proper social reactions.

Robots and apps are patient. They don't judge. Even personal voice assistants like Siri can play a role, as the unlikely friendship between Apple's artificial intelligence system and one child with autism shows.

Games can play a role too.

For kids with autism in a classroom in Australia, Minecraft is an effective teaching tool for communicating English, science, geography and art lessons. The multiplayer mode in this game, where you can build whole 3D worlds, encourages social interaction between students, improving conflict resolution and communications skills for kids with autism. Those skills can then translate to life outside the classroom. It can be challenging for people with autism to read body language and facial expressions.

April 2 is World Autism Awareness Day, with the entire month designated in the US as National Autism Awareness Month for promoting awareness of not only the condition itself, but also of the many creative tools for dealing with it. The campaign has designated blue as its signature color, and the hashtag #LIUB, for Light It Blue, is picking up traction on social media.

Autism organizations often use a puzzle piece as a symbol. It can represent the complexity of the disorder, but it can also be seen as a visual representation of how people with autism are key parts of a bigger picture, important pieces in the lives of their families and friends. Technology is finding its place in that jigsaw.

Source: http://www.cnet.com