Dr. Howie Levinson shows off his hernia mesh design to President Price. Deep Blue is addressing the unacceptably high rate of hernia occurrence and recurrence. Photo by Jared Lazarus/Duke Photography

Deep Blue Awarded $295K

Medical device startup Deep Blue Medical Advances has raised $295,000 in a debt round, adding to their $517,000 secured in January.

Deep Blue is a start-up company founded in 2014 by a Duke plastic surgeon, Howard Levinson, MD.

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Dr. Howie Levinson shows off his hernia mesh design to President Price. Deep Blue is addressing the unacceptably high rate of hernia occurrence and recurrence. Photo by Jared Lazarus/Duke Photography
Dr. Howie Levinson shows off his hernia mesh design to President Price. Deep Blue is addressing the unacceptably high rate of hernia occurrence and recurrence. Photo by Jared Lazarus/Duke Photography

The company has been advancing a hernia mesh with enhanced anchoring strength to resist wounds from gapping and bursting open, as well as a suture anchoring device to overcome large suture knots associated with wide sutures. In separate efforts, Dr. Levinson is working on additional translational projects including an anti-biofouling Foley catheter, a non-invasive light imaging technology to diagnose skin disorders, and tissue-engineered skin that resists contraction.

“I have worked closely with Duke OLV to protect intellectual property, navigate entrepreneurial activities, and to raise non-dilutive grant funds to advance ideas. Duke OLV’s support has been critical to our success and is a clear distinguishing factor between Duke University and its existing peer institutes.” –Howard Levinson, MD, Associate Professor of Surgery, School of Medicine

Young assistant analyzing substances in tubes

$34 Million in Series D Financing Awarded to PhaseBio

Proceeds will advance clinical development of PB2452, a potentially first-in-class reversal agent for patients on ticagrelor, and PB1046, a novel treatment for PAH

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PhaseBio Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan diseases, with an initial focus on cardiopulmonary disorders, today announced the completion of a $34 million Series D financing, including the conversion of existing convertible promissory notes.

New investors in the financing include Cormorant Asset Management, Rock Springs Capital and Mountain Group Partners. Existing investors New Enterprise Associates, Hatteras Venture Partners, AstraZeneca (NYSE: AZN), Johnson & Johnson Innovation – JJDC, Inc., Syno Capital and Fletcher Spaght Ventures also participated in the financing.

“PhaseBio has the potential to bring life-saving therapies to patients with orphan cardiopulmonary diseases. PB2452 addresses a growing unmet medical need for patients on ticagrelor who are experiencing a major bleeding event or who need urgent surgery,” said Clay B. Thorp, Executive Chairman of PhaseBio and General Partner of Hatteras Venture Partners. “In addition, with PB1046 and future product candidates based on our elastin-like polypeptide (“ELP”) technology, PhaseBio has the potential to build a significant pipeline in the orphan disease space.”

PhaseBio plans to use the proceeds from the Series D financing to advance the clinical development of its lead product candidate PB2452. PB2452 is a potentially first-in-class reversal agent for the antiplatelet drug ticagrelor that is being developed for the treatment of patients on ticagrelor who are experiencing a major bleeding event or who require urgent surgery, and is currently in a Phase 1 proof of concept study. Additionally, the company plans to initiate a Phase 2 clinical study of its ELP-based therapy PB1046 in pulmonary arterial hypertension (“PAH”) in the third quarter of 2018 and to explore additional indications for its half-life extending ELP technology platform.

“We are encouraged by the enthusiasm of our new and existing investors for the potential of our clinical programs and our proprietary ELP technology platform,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio. “We look forward to the readout of data from the Phase 1 study of PB2452, exploring partnership opportunities for our drug products outside of the U.S. and dosing patients in the Phase 2 study of our second product candidate, PB1046, in patients with PAH shortly. In addition, we plan to continue to leverage our ELP technology to expand our development pipeline.”

Just this past February, PhaseBio was awarded a $2.8 million Fast Track Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of PB1046, a first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue, in patients with pulmonary arterial hypertension (PAH).

About PhaseBio

PhaseBio Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company developing therapies for the treatment of orphan diseases. PhaseBio is leveraging its proprietary elastin-like polypeptide (ELP) biopolymer technology platform to develop therapies with the potential for less-frequent dosing and better patient compliance. PhaseBio’s lead development candidate, PB1046, is a first-in-class weekly vasoactive intestinal peptide (VIP) receptor agonist for the treatment of pulmonary arterial hypertension. The company is also developing PB2452, a reversal agent for the antiplatelet therapy ticagrelor. PhaseBio is privately owned, with headquarters and research laboratories in Malvern, PA.

Backside of white woman back pain and ache concept

TRPblue

MANAGEMENT: Barney Koszalka
DUKE INVENTOR: Wolfgang Liedtke

A therapeutics company developing a unique, dual acting inhibitor that targets transient receptor potential (TRP) cation channels TRPV4 and TRPA1.

TRPblue has developed small molecule antagonists that preferentially attenuate signaling of these calcium-permeable channels with proven efficacy in several acute pain and chemical denervation nerve-pain models. These inhibitors have also demonstrated anti-pruritic, anti-fibrotic and anti-inflammatory activity in relevant preclinical models. The team will develop a topically applied, highly tolerated go-to dermatology therapeutic.

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THE PROBLEM:

Severe dermatitis is often treatment-resistant and taxing. When induced by chemo-therapy, it can curtail cancer treatment.

THE SOLUTION:

Powerful, systemically-acting immune-modulating drugs are used, e.g., methotrexate and cyclosporine, but are prescribed reactively and are difficult to administer and dose. Thus, they are a late line of therapy.
Skillful sonographer using ultrasound machine at work

MicroElastic Ultrasound Systems

MANAGEMENT: Peter Hollender
DUKE INVENTOR: Peter Hollender
microelastic.com

MicroElastic Ultrasound Systems is developing a handheld device that quantifies the elasticity of skin at the touch of a button. This proprietary technology uses ultrasound to locally vibrate tissue and measure the response in order to directly and noninvasively characterize tissue elastic properties.

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Skin elasticity is both important for planning, guiding, and evaluating procedures and treatments in aesthetic dermatology and crucial for tracking and managing life-threatening chronic conditions like Graft-Versus-Host-Disease, yet existing methods are subjective, qualitative, or unreliable, causing the NIH to declare that “there is an urgent need for the development of more quantifiable and reproducible measurements”.

MicroElastic aims for early assessment, active feedback speeds, tailored treatments while reducing discomfort and other complications, reducing costs, and improving outcomes.

MicroElastic is taking its functional prototype into clinical testing and developing its first commercial product via funding from an NIH STTR grant and is negotiating a strategic partnership in the aesthetic space for application to anti-aging procedures. MicroElastic will be seeking funding in 2018 to complete development and regulatory approval as a class II device under the 510(k) pathway.

blood vessels

Humacyte lands $150M from Fresenius Medical Care

This past June, Humacyte, an emerging biotechnology company focusing on technology to grow stable, “off-the-shelf” human tissue replacements exclusively licensed their human acellular vessel, Humacyl, to Fresenius Medical Care.  The investment gives Fresenius 19% fully diluted ownership stake in Humacyte.

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This investment is added to the $75,000 in Series C preferred stock financing secured in March.  Prior to Fresenius, the company had received more than $405 million in total funding to date, with more than $365 million in private investments and awards of up to $40 million through federal and state grants and contracts.

Humacyte was founded by former Duke professor Laura Niklason and includes Duke alums Shannon Dahl and Juliana Blum. A target goal of the company has been to create lifesaving and long-lasting vascular access or replacement for patients with End Stage Renal Disease.

HUMACYL is an investigational product that has not yet been approved by the FDA. However, clinical trials to date suggest that HUMACYL has the potential to become a part of the body’s living tissue. These trials also suggest that HUMACYL may have the potential to last longer with fewer complications than existing synthetic alternatives used for hemodialysis access, possibly lowering healthcare costs by decreasing the number of surgical interventions.

About Humacyte

Humacyte, Inc., a privately held company founded by Dr. Laura E. Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient.

Experimental lab test-tubes with test substance

Grid Therapeutics Signs Exclusive License Agreement

In August 2017, Grid Therapeutics, LLC, an oncology-focused biotechnology company announced the execution of an exclusive license agreement with Duke University to develop the first human-derived antibody as a targeted immunotherapy for cancer. Under the agreement, Grid has acquired the exclusive rights to all intellectual property, including relevant patents, related to Complement Factor H (CFH) antibodies as a cancer therapy, and diagnostics around CFH.

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Edward Patz

Grid is based on the innovative science developed by Edward F. Patz, Jr., MD and his team at Duke University. Grid is currently developing its lead candidate for the treatment of solid tumors and plans to begin clinical trials in cancer patients in early 2019.

“We are pleased to sign this exclusive license agreement with Duke to advance this truly innovative science into clinical trials and begin evaluating the therapeutic treatment options for multiple forms of cancer,” said Dr. Paolo Paoletti, on Business Wire.  Dr. Paoletti is a Grid Board member and CEO of GammaDelta Therapeutics. “This agreement allows Grid to rapidly develop a new generation of cancer immunotherapies based on a human-derived antibody that inhibits CFH, a protein that serves to protect cancer cells.” As part of the license agreement, Duke University has become a shareholder in Grid.

This past April, Grid closed on Series B Financing.  They used this money to accelerate and expand the development of their lead therapeutic candidate, GT103, for the treatment of solid tumors, and to prepare for clinical trials starting early next year.

About Grid Therapeutics

Grid Therapeutics is a biotech company based on the innovative platform for discovering and isolating human derived antibodies. Dr Edward F. Patz, Jr, is the co-founder and CEO of Grid, located in Durham, North Carolina. The lead antibody was discovered in exceptional outcome early stage lung cancer patients who did not progress to develop metastasis. The antibody was isolated from patient’s B-cells using state of the art molecular genomic techniques. GT103, the company’s lead asset, will begin a Phase 1 clinical trial in cancer patients with advanced-stage solid tumors.

Suyesh Kunar and other members of the kelaHealth team explain how a group of surgeons, statistician, and engineers have set out to improve surgery outcomes through predictive data analysis.

kēlaHealth Among 6 to Win NC IDEA Grant

In November, a private foundation supporting entrepreneurial innovation North Carolina announced the recipients of the Fall 2017 NC IDEA Seed Grant Awards. These awards total up to $300,000 and Duke start-up kēlaHealth is among the six selected winners to receive a piece of that pie.

Since its inception in 2006, the NC IDEA SEED grant program has awarded over $5 million to 126 companies across the state, with these most recent awards being the 24th cycle of the program.

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About kēlaHealth

kēlaHealth is a software-as-service health informatics company founded by a team of surgeons, statisticians, and engineers that uses machine learning for predicting complications during surgery. Through rigorous data analysis, kēlaHealth delivers precision medicine by leveraging data from millions of patients, standardizing surgeon variability, and addressing administrative and regulatory needs for quality compliance in surgical care.

Scanslated

MANAGEMENT: Ryan Short
DUKE INVENTOR: Nicholas Befera
scanslated.com

Creating radiology reports that people can actually understand: A patient-education software solution for explaining medical results.

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Scanslated software analyzes the text of a standard radiology report, translates that text into simple language, and displays the report results on a diagrammatic, interactive webpage.

THE PROBLEM

92% of Americans have access to their medical records online. More than 50% of patients who use the online portal are accessing their radiology reports. However, these reports are technical documents written in medical terminology, and most patients don’t understand them.

THE SOLUTION

We’re creating a radiology report that people can actually understand. Our software analyzes the text of a standard radiology report, translates that text into simple language, and displays the report results on a diagrammatic, interactive webpage.

line snuggler

Nursing & Patient Care Innovations

MANAGEMENT: Robert Thelen
DUKE INVENTOR: Marybeth Tetlow

Line Snugglers are nursing products developed by Marybeth Tetlow, a clinical nurse on the Duke Pediatric Blood and Marrow Transplant Unit.

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Marybeth Tetlow Invented at Duke 2017

These waterproof sleeves or adjustable vests with waterproof sleeves provide a means to protect central line lumens and their connected IV tubing from contamination or entanglement in infants, small children, and now older patients as well.

Line Snugglers unique design keeps lines bundled and organized for easy movement and shields the central lines and all IV connection points from body fluids and other debris, such as glitter, playdoh, glue, or paint. Additionally, this innovation decreases the anxiety of patients, families, and nurses, as children actively go through intense treatment for life-threatening illnesses.

“The Duke OLV team has helped me in protecting my ideas’ design and in the early stages of a start-up, something we will continue to work on so that soon patients, families, and nurses everywhere can benefit from my invention!” –Marybeth Tetlow, inventor of Line Snugglers

Nivi

MANAGEMENT: Sid Goyal
DUKE INVENTOR: Eric Green
nivi.io

Nivi uses data to revolutionize family planning for everyone, everywhere.

Nivi logo

Nivi from asknivi on Vimeo.

Everyone should have access to accurate family planning information and the ability to choose the method that is right for them.

Nivi works towards this goal by providing a free mobile phone service that empowers people through better information, services customized to their needs, and gives them a voice in the health care system.

Trusted Source

Our vision to become the most trusted source of information about women’s health and well-being.

Nivi was launched with funding from Merck for Mothers. Their mission every day is to build great products and offer the highest quality service to help people achieve their goals of living a healthy, happy, and productive life.