PharmaJet: Needle-Free Vaccinations for Everyone

While needle-free injections aren’t an entirely new technology, PharmaJet is pushing innovation in the field of vaccine immunizations with its Stratis and Topis injection technologies. The company, based out of Golden, Colorado, primarily touts its ability to solve the problems of needle sticks and patient compliance. That said, there is a bigger story to be told and that’s why they’re the focus of our spotlight today.

If you’ve ever given an injection or seen one drawn into a syringe, you’re likely familiar with the waste that the process creates. There’s always that last little bit of fluid that sits in the bottom of the vial, and the process of removing air from the syringe often produces waste as well. PharmaJet’s solution not only provides for safer, easier vaccine delivery via a specially designed “needle-free” syringe delivered via a spring powered injector system, but it also dramatically reduces waste because of how the system operates.

In two separate field studies, PharmaJet’s platform allowed for 2-3x faster administration of vaccines, while capturing 20 percent more fluid from the vials, and generating less than 50% of the weight and waste footprint. Also, because the system does not require the use of sharps, there is an extended saving by eliminating amortized liability costs associated with needles. In some cases, these savings can be up to 50 percent versus traditional injection methods.

The monetary savings are a big story, but it’s also worth reiterating the fact that users of the PharmaJet system can have access to 20 percent more vaccine than providers who use traditional methods of injection. The World Health Organization has already recognized the importance of these savings, awarding PQS status for UNICEF procurement of PharmaJet’s products.

PharmaJet notes some other important points as well:

  • There are over 800,000 needle-stick injuries in the US alone each year
  • These sticks account for a $2 billion financial burden to an already-strained system
  • In developing countries, up to 70 percent of needles are reused
  • Patient fear of needles is the leading cause of voluntary noncompliance

The PharmaJet system couples with standard vials via a filling adapter that is used to pierce the top of the vial with a tiny spike. The needle-free syringe is then screwed onto the filling adapter, a verifiably precise amount is pulled into the syringe, and then the syringe is loaded into the spring-powered injector. Since there are no needles, there is no risk of needle-stick injury, and each syringe auto-disables after use. Some patients report that receiving an injection via the PharmaJet system feels similar to the snap of a rubber band, while many patients report no discomfort at all.

There are currently two products — Stratis and Tropis. Stratis is intended for use in intramuscular or subcutaneous injections, while Tropis allows the PharmaJet system to be used for intradermal injections. Both systems have been awarded clearance by the FDA, among numerous other device and vaccine specific approvals globally.

We’re glad to have PharmaJet on the AngelMD platform. Make sure to drop by the company’s profile and click the follow button. You’ll stay up to date with news from the company, as well as any upcoming funding rounds.

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AngelMD Friday Roundup – December 1st, 2017

The Friday Roundup is a collection of five stories that you need to know about each week. From policy to innovations, look to us to keep you up to date on what’s happening in the healthcare industry.

Apple has Heart

In September, Apple announced that they were working with Stanford on a study to determine the Apple Watch’s ability to detect abnormalities in heart rhythm. Today, the FDA approved a sensor embedded in the Apple Watch that uses AI to detect irregularities, and then prompts the user to take an EKG.

They’ve also released the app associated with their heart study, which anyone over the age of 22 can participate in by downloading the app. If a participant’s watch flags an issue, they receive a free consultation with a remote doctor.

Gene Therapy Needs Viruses to Go Viral

Since the FDA expedited approval of gene therapies, genetics has gained a lot of traction but now they’re hitting an unusual obstacle. For a genetic therapy to work, a disabled virus is needed that scientists can modify to carry the desired genes into the targeted cell.

Turns out, those viruses aren’t so easy to come by. The viruses have to be custom made in a costly process which often has to be outsourced as most companies aren’t qualified to produce the viruses themselves. Many firms are at capacity and struggling to meet demand, throwing a wrench in gene therapy’s workflow.

FDA Keeps its Foot on the Gas

In a hearing, FDA commissioner Scott Gottlieb states that the FDA would approve drugs based off early clinical trial results if they show an impact on survival. This fits into the FDA’s tone-shift to “accelerated approval” processes, including expedition of digital health products.

This means that the FDA would wait until later to determine if the effect was coincidental or not. The drug approval process can otherwise be lengthy, and an earlier approval of promising drugs could benefit patients currently affected.

X Rays Get a Radiation Reduction

A new study has determined an algorithm that could reduce radiation exposure significantly. Reading scans has always been a challenge due to the fact that all soft tissue has the same density, and therefore shows up similarly on the scan with little differentiation.

The new technique will accomplish both – reduce radiation by 100 fold and produce clearer scans with more definition. X rays and CT scans account for 26 percent of imaging but account for 89 percent of annual radiation exposure, meaning the new algorithm could have widespread impact.

The Thrill of a Digital Pill

Adherence to prescriptions has historically been weak. Only 50 percent of people actually take their medication as directed by their physician, even in countries with more developed health infrastructure.

The digital pill is a solution to that. Using an electric sensor, the pill sends a signal to a patch on the body which pings the patient’s accompanying app that the dose has been taken. Patients can then share these results with their care provider.

Digital pills have already been FDA approved, and there’s a lot of future potential, including monitoring acidity or temperature.

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  • Aluna, Core Simulations, and Havn are just three of the many startups to join the AngelMD community. Check out their profiles to see how they’re changing the face of healthcare.

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Alleviant Medical: A Novel Approach to Treating Heart Failure

According to the Centers for Disease Control (CDC), nearly six million people in the United States are suffering from heart failure, and about half of those people will die within five years of their initial diagnosis. It’s a $35 billion annual problem that, until recently, has had very little innovation in how it is addressed. Alleviant Medical, however, is taking a novel approach to treating heart failure.

According to Jacob Kriegel, MD, CEO of Alleviant Medical, today’s treatment options are focused either on making the heart pump more efficiently or treating the fluid accumulation that results from the failing heart pump. Pulmonary fluid buildup, the primary driver of heart failure symptoms, leads to shortness of breath, swelling, general weakness, and a host of other problems. Diuretics are usually prescribed to treat these symptoms, but Dr. Kriegel and his team are addressing the underlying cause of pressure buildup within the left atrium.

Heart failure is a progressive condition in which the heart muscle is unable to pump or fill adequately with blood during and between heartbeats. As a result, pressure builds within the left atrium and backs up to the lungs, leading to fluid accumulation and severe symptoms. Only recently have practitioners begun to focus on elevated left atrial pressure as a potential intervention point, being that it is one of the earliest signs of heart failure exacerbations.

Alleviant Medical is focused on relieving pressure within the left atrium. In layman’s terms, they are developing a minimally invasive device that bores a hole (termed an interatrial shunt) between the left and right atrium, allowing for left atrial pressure offloading to the low-pressure right atrium.  While Alleviant Medical is not the first company to propose interatrial shunting as a novel form of treatment, their approach does not necessitate the implantation of a foreign body to do so. This affords a lower risk profile, as well as a shorter regulatory pathway; as a result, their device is eligible for  FDA 510(k) clearance as a Class II medical device.

Interestingly, one of the insights for their approach came from studying the small percentage of the population born with a larger hole between the left and right atrium. While some patients have to undergo surgery to have the issue resolved, those who don’t have their defect closed seem to be naturally protected from some of the symptoms of heart failure. According to Dr. Kriegel, “We know from those patients what shunt size is appropriate as well as other concerns that we need to monitor in potential recipients of our treatment.”

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Alpha Speaker Spotlight – Dr. J. Basil Peters

If you ask Dr. J. Basil Peters what he likes most about being an Angel Investor, he’ll quickly tell you that it’s the exit. In fact, he likes the exit so much that he’s started a company called StrategicEXITS that helps companies do just that — design and execute exit transactions. We’re honored to have Basil coming to the stage at Alpha, the first AngelMD conference, running from January 5th through the 7th, 2018.

Basil’s taste for the exit came early in his career when he sold the company that he founded while still in graduate school. Nexus Engineering manufactured headends — the facility that originates and communicates cable television and modem services — for cable television providers. The company was sold to Scientific Atlanta, which then became part of Cisco Systems.

It’s likely that you’ve already read Basil’s work, or seen him speak before. He’s a prolific writer on the StrategicEXITS blog, and he authored Early Exits: Exit Strategies for Entrepreneurs and Angel Investors (But Maybe Not Venture Capitalists), which was chosen by Inc. Magazine as one of the ten best business books.

Basil will be joining a distinguished group of doctors, healthcare innovators, and other investors as we cultivate an environment of learning focused on better understanding and capitalization of healthcare innovations. Join us at AngelMD’s Alpha Conference, and be help shape the future of healthcare.

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Friday Roundup

The Friday Roundup is a collection of five stories that you need to know about each week. From policy, to innovations, look to us to keep you up to date on what’s happening in the healthcare industry.

Bill Gates’ Newest Gift: Alzheimer’s Research

The world’s richest man has committed $50 million to finding a treatment for the neurodegenerative disease. On his blog, Gates identifies the financial burden of Alzheimer’s as how he became interested in the disease, noting patients spend five times more on healthcare due to the disease.

But is the U.S. ready for such a drug? Over 5 million Americans have Alzheimer’s, and that number is expected to triple by 2050. The current healthcare system simply isn’t equipped to handle that volume — there aren’t enough doctors or equipment to diagnose early stage patients who could benefit from a drug.

Why Tech Gets Abandoned in Healthcare

On the Healthcare Leadership blog, professor Trisha Greenhalgh argues for more studies of non-adoption, or abandonment of tech. Though more challenging because of the future sight required to study it, valuable information could be gathered.

“If researchers studied real-world implementation at all, they focused on small-scale demonstration projects – but didn’t look at why such projects failed to extend locally (scale-up), more distantly (spread) or continue long-term (sustainability),” Greenhalgh wrote.

Greenhalgh outlines the NASS framework in the post, a new way to study “the non-adoption and abandonment of technologies by individuals (staff and patients) and problems with scale-up, spread and sustainability.”

First In-Body Gene Editing Attempted

Brian Madeux suffers from Hunter’s syndrome, a metabolic disorder that can affect organ function, mental development, and physical abilities. On Monday, billions of corrected genes entered Madeux’s system via an IV.

Madeux is the first to receive such a treatment, and the scientists who administered it will know whether or not it worked in three months. The therapy will permanently alter Madeux’s DNA, and if successful, would boost the already growing field of gene therapy.

AMA Pushes for More Organ Donors with New Policy

The American Medical Association adopted a policy that encourages employers to provide paid leave for organ donors. Studies show costs to living organ donors can exceed 76 percent of one month’s pay. In addition, living donors often cannot take enough time off to recover.

At any given time, there are 116,000 people waiting for an organ transplant nationwide and in 2016, 6,000 transplants were made possible by living donors.

Amish Gene could Lead to Diabetes Treatment

The SERPINE1 gene, which seems to be exclusive to the Old Order Amish community in Indiana, has been linked with significant health benefits, including significantly less diabetes and lower fasting insulin levels. Individuals with the gene also live 13 percent longer on average.

The gene also leads to low levels of plasminogen activator inhibitor 1 (PAI-1), a protein involved in blood clotting, which a research team from Northwestern is hoping to test as a treatment for insulin sensitivity in individuals with type 2 diabetes and obesity.

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