Stanford University

2015 BMEidea Third Prize Winner

E-Team stage 1 grant winner, $5,000

The team members:

Dr. Thomas M. Krummel, Professor and Chair of the Department of Surgery

Viral Gandhi, MSE, Biodesign Innovation Fellow

Andrew Lee Mesher, MD, Biodesign Innovation Fellow

Christian Moyer, PhD, Biodesign Innovation Fellow

Elizabeth Wynne, MD, Biodesign Innovation Fellow

Summary of problem & solution:

End-stage renal disease (ESRD) affects more than 2 million men, women, and children worldwide. For these patients, renal-replacement therapy is a life-sustaining treatment and reliable access to the bloodstream for hemodialysis is their lifeline. Arteriovenous fistulas and grafts with surgically created connections between arteries and veins in the extremities constitute the most prevalent and best options for hemodialysis access. However, due to scarring and narrowing of the blood vessels, these connections frequently fail within months and only 50-60% of connections last a full year. This translates to further invasive procedures, hospitalizations, and riskier modes of dialysis access for patients and a substantial economic burden to the healthcare system. Our team aims to address this problem by targeting the most upstream biological event in the development of blood vessel narrowing or stenosis. By targeting the root cause of stenosis, we aim to significantly improve the short and long-term patency of arteriovenous fistulas and grafts for patients with ESRD. Our solution is a one-time intervention at the time of creation that integrates easily into existing surgical procedures and leverages new scientific insights into vascular biology. With this novel approach we aim to bring innovation to this truly unmet clinical need.

One in eight women in the US will be diagnosed with breast cancer in her lifetime, yet 20-50% of breast tumor removal procedures are unsuccessful, requiring patients to undergo a second surgical procedure or ionizing radiation therapy. Innoblative is developing Sira™, a saline-assisted Intraoperative Radiofrequency Ablation device, that uses bipolar current to intraoperatively create a controlled zone of ablation. Sira’s unique design and saline microinfusion system allows it to have maximum contact with target tissue and to be powered with existing electrosurgical generators. Innoblative Designs, Inc. has completed a National Science Foundation STTR Phase I grant and is working towards obtaining FDA 510(k) clearance. The team from Northwestern University first participated in VentureWell’s E-Team Program in 2013, and was also the first-place winner at the 2014 BMEidea competition. VentureWell invested in Innoblative Designs, Inc. in 2014.

innoblativedesigns.com

Purdue University

2015 BMEidea First Prize Winner

stage 2 E-Team grant winner, $25,000

The team members:

Dr. Ji-Xin Cheng, Professor
Rui Li, PhD candidate, Biomedical Engineering
Lu Lan, PhD candidate, Biomedical Engineering

Collaborators:

Dr. Pu Wang, Vibronix, Inc.
Frank P. Lloyd Jr., MD, Putman County Hospital, Indiana
Dr. Shaoxiong Chen, Indiana University School of Medicine
Dr. Craig J. Goergen, Purdue University
Linda K. Han, MD, Indiana University Health

Summary of problem & solution:

Breast-conserving surgery, or lumpectomy, is well accepted for breast cancer treatment. To prevent local cancer recurrence after lumpectomy, histology (tissue study) is performed to check whether the excised tumor specimen is surrounded by a sufficient amount of normal tissue. If a positive margin, i.e., less than 2 mm between the surfaces of the excised specimen to the tumor, is identified, then a second operation will be performed. Currently, the reoperation rate is 20~70%. This results in several problems: additional cost for the second or even third surgical operation, and emotional distress and physical pain for the patients, which highlights a critical need for rapid and highly sensitive intraoperative margin assessment. Our MarginPAT system is an intraoperative imaging tool based on multispectral photoacoustic tomography, which uniquely provides contrast of tumor and non-tumor tissue based on the difference between their optical absorption properties. Our technology can provide close to 100% detection sensitivity, three-dimensional visualization of the excised tissue, and only take less than 2 minutes procedure time, the fastest intraoperative margin assessment tool so far to our knowledge. Therefore, MarginPAT enables 1) surgeon to clear the cancer residue during the first operation, thus reducing the re-operation rate to 0%; 2) decrease the average cost of lumpectomy by close to 30%.

Stanford University

2014 BMEIdea Third Prize Winner, winning $2,500

The team members:

Tiffany Chao, 31, Chappaqua, NY;
Nick Damiano, 31, San Francisco, CA;
Shreya Mehta, 30, Phoenix, AZ;
John Woock, 31, Louisville, KY

The device:

The MITS team is creating a non-surgical solution for the treatment of benign prostatic hyperplasia or BPH. The device consists of a set of indwelling urethral expanders that allow the circumferential “propping open” of the prostatic urethra to allow for urination and relief of BPH symptoms.

The problem:

Benign prostatic hyperplasia (BPH), also known as prostate enlargement, is the most common cause of obstructive urinary symptoms and progresses with age. Forty percent of men over 50 and 90% of men over 80 experience symptoms of BPH. Symptoms include urinary hesitancy, urgency, straining, weak flow, dripping, incomplete emptying, dysuria, nocturia, frequent urination, and incontinence, all of which are extremely distressing for patients and significantly impact their quality of life. Gold standard treatments for BPH are surgical in nature and involve removing all or part of the prostate gland. Less invasive methods, such as prostatic stents (e.g., UroLume) or energy therapy (e.g., TUNA) have been developed; however, stents often become encrusted or calcified when exposed to the urine stream, while energy therapies can cause irritating symptoms. Both methods cause discomfort and inflammation, and results have not been shown to be durable.

The solution:

Our invention is a set of indwelling urethral expanders which allow the circumferential propping open of the prostatic urethra in order to enable a patient to urinate, thereby providing relief of urinary symptoms arising from conditions such as BPH. These indwelling expanders span the prostatic urethra and are anchored at their locations to prevent migration. Their circumference may be larger than that of the urethra, and combined with their anchoring systems, the rings are designed to invaginate into the urethral wall. The thinness of the rings would facilitate the enfolding of the urethral wall around the rings so that they stay out of the urine stream, thereby protecting them from calcification or encrustation. Previous studies have demonstrated that the prostate is highly compressible and able to be stented, and our initial prototypes have demonstrated these rings to be successful in in-vitro models.

Challenges encountered:

Team leader Tiffany Chao says, “BPH is a huge market, but many technologies have been developed for this space already. It was a challenge for us to develop our story in a way that would make people excited about a project for BPH. After a lot of work, we were able to leverage the current state of the market and existing technology in order to create an effective story that would demonstrate the potential for our innovative device.”

Accomplishments and progress to date:

The MITS team has a number of prototypes and is finalizing its designs now. The team has already worked in in-vitro and tissue models, and will be getting prototypes into cadaver models this month.

Their tip for other student innovators:

Taking advantage of student status and the connections that are available to students are immeasurably helpful. Once you reach out and make an effort, you might be surprised at how many people working in industry, intellectual property, and venture capital are willing to donate some time to help students!

Massachusetts Institute of Technology

2014 BMEIdea Second Prize Winner, winning $5,000

Stage 1 & 2 E-Team grantee, $25,000

A new drug delivery technology that will simplify drug reconstitution between a lyophilized (freeze-dried) drug and water at the point of care. It is designed for patients who regularly inject lyophilized drugs such as hCG, insulin or HGH.

http://www.recontherapeutics.com

The team members:

Christopher Lee, 24, Ann Arbor, MI;
John Lewandowski, 24, Shaker Heights, OH;
Ben Maimon, 24, Westfield,. NJ;
Babak Movassaghi, 39, Dusseldorf, Germany;
Ho-Jun Suk, 28, Incheon, South Korea

The device:

LyoKit is a drug delivery technology designed for patients who regularly inject lyophilized drugs such as hCG, insulin or HGH. This technology simplifies drug reconstitution between a lyophilized (freeze-dried) drug and sterile solvent. The LyoKit device couples a standard off-the-shelf syringe with an external pressurized water chamber, resulting in a simple one-step reconstitution process. The device is customizable to a full range of biologics and can be rapidly adopted to market with minimal regulatory concerns.

The problem:

The gold standard for at-home, self-injection of large biologics involves providing a patient with a vial of drug and a vial of injection solvent. The process of preparing a dose involves 5-10 steps, and necessitates the use of 2-4 syringes and needles, transfer vials, and patient calculations leading to frequent mistakes and decreased compliance. In addition, unused doses require immediate refrigeration, which is extremely inconvenient.

The solution:

Recon Therapeutics has developed a new drug delivery technology that simplifies drug reconstitution between a lyophilized drug and sterile solvent at the point of care. The Lyokit Drug Reconstitution System differentiates itself by being highly intuitive to use, reconstituting biologics with simple one finger actuation. In addition, the reconstitution process occurs using an external pressurized chamber, enabling reconstitution of biologics with a wide spectrum of solubility profiles. Lastly, the Lyokit is an all-inclusive kit that encompasses injection site sterility, needle safety, and disposal all in one embodiment. Coupled with our business model of integrating the system with off-the-shelf syringes, Recon can provide a cost advantage of up to 60% to both the customer and pharmacy, enabling Recon Therapeutics to access an annual market for drug reconstitution technologies exceeding $1.8 billion.

Challenges encountered:

According to team member Christopher Lee, “As a team we have faced many challenges in distilling our regulatory pathway and getting in touch with the correct experts in this domain. In addition, we also initially struggled to determine what type of products that require reconstitution should be targeted with our device first.”

Accomplishments and progress to date:

Recon Therapeutics has incorporated as a LLC and filed a full utility patent application. They have completed a first pass design freeze and developed a beta prototype, which has been designed for manufacturing. Critically, Recon has secured additional funding as an MIT Global IDEAS winner and Harvard Innovation Labs Dean’s Health Life Science Challenge Finalist. They have also established additional working relationships with sterilization facilities, compounding pharmacies, and injection molders. Through Men’s Health Boston, the team spoke with patients and nurses, and was able to perform several rounds of usability and human factors studies.

Their tip for other student innovators:

Always try to do something more with a student project, don’t let it just sit on a shelf.

Johns Hopkins University

2015 BMEidea Second Prize Winner, TREAT Prize Winner

stage 1 E-Team grant winner, $5,000

The team members:

Dr. Soumyadipta Acharya, Graduate Program Director and Assistant Research Professor

Erin Reisfeld, M.S.E. Bioengineering Innovation & Design, 2015

Ian Graham, M.S.E. Bioengineering Innovation & Design, 2015

Melody Tan, M.S.E. Bioengineering Innovation & Design, 2015

Shruthi Rajan, M.S.E. Bioengineering Innovation & Design, 2015

David Blumenstyk, M.S.E. Bioengineering Innovation & Design, 2015

Summary of problem & solution:

Tremtex is working in conjunction with clinical and research partners at the Johns Hopkins School of Medicine to develop an intervention to help Parkinson’s disease patients manage their debilitating motor symptoms. Parkinson’s disease is an incurable, neurodegenerative disorder that affects over 1 million people in the United States and 7 million people worldwide. The standard of care for Parkinson’s disease is medication; however, the effectiveness of medication wanes as the disease progresses. Another option for patients in advanced stages of the disease is deep brain stimulation, an expensive and invasive surgical procedure with strict eligibility criteria. This leaves a significant number of patients without an effective intervention. Tremtex is addressing this gap by providing a low-risk solution for patients whose symptoms are under-managed with existing interventions. The team has designed, STIMband, a non-invasive electrical stimulation device, which delivers low and safe doses of transcranial direct current stimulation (tDCS), to the motor cortices of the brain. The result is the reduction of motor symptoms, including tremors, and improved mobility. STIMband has been designed to ensure patient safety and usability, allowing patients to receive treatment within the comfort of their homes.