Category Archives: Industry Innovators

Industry Innovator: InVivo Therapeutics is Reversing a Life Sentence

invivo therapeutics

InVivo Therapeutics may not have any FDA approvals yet, but the company is already changing lives with their Neuro-Spinal Scaffold (NSS) treatment.

Reversing a Life Sentence

Just hours after Jordan Fallis was in a life-altering dirt bike accident, he was the first patient to be implanted with an experimental Neuro-Spinal Scaffold, a bioresorbable scaffold designed to provide structural support for the damaged spinal tissue and help facilitate repair. In the simplest of terms, think of the Neuro-Spinal Scaffold as a “cellular bandage”, similar to a butterfly suture but for healing internal wounds.

Little did Jordan know that just 9 months after his devastating accident, he would be walking with the support of braces.

Spinal cord injury frequently strikes very young and healthy adults. It’s a life sentence. We’re changing that. We’re turning the world upside down in this space.” – Mark Perrin, InVivo Therapeutics CEO

An Unmet Need

InVivo Therapeutics’ role as a disruptive innovator has the potential to address a huge unmet clinical need. There are 12,000 new cases of spinal cord injuries (SCI) a year and 273,000 currently living with a spinal cord injury. InVivo hopes to accomplish three unique goals for patients who receive the NSS treatment:

  • Recover motor skills including muscle control, movement, and strength.
  • Decrease neuropathic pain and help avoid bed sores.
  • Recover autonomic functions including bowel/bladder control and sexual function.

All About the Patient

Sure, I’d like to walk someday, too. But just give me sexual function and bowel and bladder control — I’m a happy camper.”
– Patient with paraplegia1

This quote came directly from InVivo’s website. The company is dedicated to listening to the patient voice and places a high value on the needs of the patient. In a survey completed by paraplegic patients, bladder control and sexual function were seen as higher priorities than regaining the ability to walk. InVivo recognizes this little known plight that patients face and they take it very seriously.

Chief Medical Officer Lorianne Masuoka says they have taken a patient-centered approach throughout the clinical trials and emphasize improving patients’ quality of life:

We care more about what the patient is experiencing – even if we don’t get [FDA] credit for it.”

“The sun rises in the east and social media exists.” – Mark Perrin

Photo Credit: www.today.com

Photo Credit: http://www.today.com

Social media has certainly played an interesting role in the InVivo story. Jordan Fallis (Patient One in the NSS trial) and Jesi Stracham (Patient Two in the NSS trial) connected via social media, fell in love, and took the media by storm.

Mark Perrin and the InVivo team have embraced the social media movement. It has brought the promising numbers of the clinical trial to life and has allowed their team an additional outlet to understand the patient perspective. Mark shared that through reading the social media posts of patients, he discovered that wrinkled bed sheets were a major issue for paraplegic individuals as they contributed to the formation of bed sores. Unless you’re living it, this isn’t something anyone would think twice about. Social media is illuminating the daily struggles that patients endure and InVivo is listening.

Promising Progress

Not only has the NSS treatment worked wonders for Jordan, but for the other patients in the trial as well.

As of July, Jesi Stracham (Patient Two) has seen significant improvement in sensory function. She has regained partial sensation from the lower ribs to the hip on the right and continues to make progress.

One-month post-surgery, Patient Three converted from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury – an improvement that less than 4% of patients ever achieve with such a severe case.

On the Horizon

InVivo is excited about the road ahead. The company recently achieved a major milestone when the fifth and final patient was enrolled in the pilot trial. They have already requested an expansion of the trial and hope to see a quick turnaround so that they can continue working to reverse the life sentence of SCI patients.

InVivo is not stopping there. The company has a treatment for chronic SCI in the pipeline that combines biomaterial with neural stem cells designed to help promote the generation of new neural circuitry.

InVivo also has plans to ramp up their involvement with patient advocacy organizations and are enthusiastic about exploring the additional ways they can make an impact on patient lives.

Learn more about InVivo by visiting their website at www.invivotherapeutics.com.

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Industry Innovator: Curadel is Finding Cancer, Empowering Research

Curadel

After almost two decades of research at academic medical centers, Dr. John Frangioni realized that while academia was a rich environment for innovation, it was not an ideal setting for invention to be converted into commercial products that could tangibly help patients and doctors. He then founded Curadel in an effort to move his potentially life-changing technologies into the clinical setting.

The road has not been easy, as it rarely is for new startups. But Curadel is well on its way to success with its revolutionary FLARE® technology lighting the way.

Using FLARE® to Light the Way

FLARE®, which stands for Fluorescence Assisted Resection and Exploration, has the potential to empower surgeons with real-time critical information that could result in greatly improved outcomes for patients undergoing cancer surgery with curative intent.

Mark W. Bordo, Chief Chemist (left) and Dr. John V. Frangioni, Founder and Chief Executive Officer.

Mark W. Bordo, Chief Chemist (left) and Dr. John V. Frangioni, Founder and Chief Executive Officer.

“The system uses near-infrared light, which is invisible to the human eye but penetrates millimeters through blood and tissue,” explains Chief Chemist Mark Bordo. Bordo notes that Curadel is developing “special contrast agents that could be injected into the bloodstream to highlight various structures, such as tumors, blood vessels, nerves, lymph nodes, glands, etc. When realized, FLARE® imaging will allow one to simultaneously identify different structures, enabling surgeons to resect tumors while avoiding normal tissues, all in real time.”

Why is this so important? Cancer cells don’t stick out like a sore thumb. Instead, tumors often blend into their environment often making it difficult to discern malignant tissues from normal, healthy ones. FLARE® will help to eliminate the guesswork. In sharing Curadel’s near-term goals, Chief Operating Officer Saira Y. Valley points out that when developed for human use, “FLARE® technology will be able to affect every stakeholder in the healthcare spectrum. For insurance companies and hospitals, it could reduce the cost of care. For the patient and their family, it would provide emotional relief because they would know in real time the outcome of their surgery. For the surgeon, it could provide the expediency of seeing the tumor and removing it quickly, without having to dissect for long periods. Everyone would benefit from this kind of technology.”

Although FLARE® technology products have not yet been approved by the FDA, both the medical device and the imaging agent constituents have been successfully tested in both small and large animals.

Finding Cancer, Empowering Research

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Industry Innovator: Asymmetrex Crowdsources for a Solution

asymmetrex

What do you do if you are the head of a new start-up company, with limited product development funds, but a new and exciting technology that would benefit greatly from independent evaluation in a wide array of applications? James Sherley, director of Asymmetrex, found himself facing just such a challenge.

Professor James Sherley of Biological Engineering

James Sherley, Founder and Director of Asymmetrex, LLC.

Sherley founded Asymmetrex, LLC, a MassBio member company, in October 2013. The company was launched with a unique portfolio of patented technologies for stem cell medicine. Asymmetrex now faces a unique challenge in the commercial development of one of its most promising stem cell medicine technologies.

A Revolutionary Technology

Earlier this year, Asymmetrex published a scientific report on its latest specific biomarker for adult tissue stem cells. Called “H2A.Z asymmetry,” the new biomarker has sufficient specificity to provide, for the first time, a means to count adult tissue stem cells. These data have the potential to significantly improve the success rate of stem cell transplant and regenerative medicine therapies and also have many other important applications in drug development and tissue stem cell research.

The H2A.Z asymmetry biomarker is designed to be universal, capable of detecting ideally functioning stem cells in many different tissues of a variety of different mammalian species, including humans.

A New Approach

Asymmetrex’s commercialization plans would be accelerated by a more rapid evaluation of the new biomarker’s wide-ranging application.

Examples of H2A.Z asymmetry detection of tissue stem cells.

Examples of H2A.Z asymmetry detection of tissue stem cells.

As a strategy to achieve immediate evaluation in many different tissues, Asymmetrex launched a crowdsourcing campaign to invite stem cell biologists, bioengineers, stem cell transplant physicians, and regenerative medicine companies around the world to test H2A.Z asymmetry for identifying and counting their own tissue stem cells of interest.

Director Sherley states that, “Our crowdsourcing effort is a grand ideal experiment. Crowd evaluators may discover a valuable research and clinical tool that they can employ right away; and Asymmetrex may realize sooner an otherwise very difficult to achieve milestone towards beginning a new era of tissue stem cell counting.”

Get Involved

Over the next year, through varied social media outlets and conference presentations, Asymmetrex will encourage tissue stem cell investigators to use H2A.Z asymmetry and report their findings at research conferences and in peer-reviewed publications.

The company has set up a website (http://crowdsourcing.asymmetrex.com/) to provide a means for crowd evaluators to report unpublished findings. As such information accrues, Asymmetrex will report it in an anonymous aggregated format on the company website (http://asymmetrex.com).

Industry Innovator postings on the MassBioHQ blog in no way represent the opinions or endorsement of MassBio or its officers, directors, employees, agents, and consultants. MassBio does not represent or guarantee the truthfulness, accuracy, or reliability of statements or facts posted under the Industry Innovator postings on the MassBioHQ blog. MassBio accepts no liability for errors, omissions or representations. The copyright of Industry Innovator content belongs to the interviewee and any liability with regard to infringement or intellectual property remains with the interviewee.

MIT Biotech Group Inspires the Next Generation

The MassBioHQ is thrilled to announce the launch of our new Industry Innovators Blog Series where we will share the stories of incredible individuals and companies making an impact in the life sciences industry! If you are interested in being interviewed or contributing a guest post to our blog please email lilly.stairs@massbio.org.

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The Beginning

james and nate

MIT Biotech Group Co-Founders James W. Weis and Nate Stebbins.

At one of MIT’s recent major career fairs, only 3% of the employers in attendance represented the life sciences. Surprising? Yes, considering that MIT is in the heart of Kendall Square, recently named the number one hub for life sciences in the world. It certainly shocked James W. Weis and Nathan Stebbins, PhD students at the prestigious institution and co-founders of the MIT Biotech Group.

There’s a lot of anxiousness towards careers [you hear statements like] ‘there’s no faculty jobs’ and ‘what’s everyone going to do’. James and I originally started digging around to understand what resources exist at MIT for students that want to get connected to the biotechnology industry and what avenues exist for students who want to be entrepreneurs in the lifesciences. We actually found that MIT students, surprisingly, have a small connection with the outside biotechnology world.” – Stebbins.

About 25% of PhD students at MIT are doing research directly involved in the life sciences and many more are doing tangential work. Weis and Stebbins recognized a need to close the gap between academia and industry at MIT, and decided to take the necessary steps to make it happen. After countless hours of brainstorming and meetings with high level executives from academia and industry, the empowered entrepreneurs launched the MIT Biotech Group in April of this year – with the full support and encouragement of MIT’s administration. Their hard work has paid off. Within a few days of the inaugural email invitation, over 200 students signed up to get a taste of the life sciences industry. The group currently has over 500 members comprised of undergrads, graduates, and PhD students. Read the rest of this entry