Deep Blue expands innovative hernia technology to new surgical applications

It’s an exciting time at Durham-based Deep Blue Medical Advances as the start-up builds on the success of its T-Line Hernia Mesh, a surgical product that helps prevent the recurrence of hernias after abdominal hernia repair surgery. 

Over the next two years, the company plans to launch several new products that will offer more options for soft tissue surgeries and extend the T-Line technology to other clinical areas such as breast reconstruction. 

Eliminating failure 

A hernia occurs when layers of abdominal muscle become weak or tear, allowing an organ or fatty tissue to squeeze through. If the hernia is painful or problematic, surgery can be used to repair the weakened area and return the protruding organ or tissue to its proper place. However, these surgeries are not always successful. About 30 percent of the 600,000 abdominal hernia repairs performed in the U.S each year end up failing. 

After seeing so many hernia repairs fail, Deep Blue founder Howard Levinson, M.D., a plastic surgeon and researcher at Duke University, developed a solution. The resulting product, called the T-Line Mesh, eliminates a key point of failure for conventional mesh products: the mesh-suture-tissue interface. It also increases anchoring strength while safeguarding against mesh failure by distributing force across a wider surface area. This not only means fewer failures but also translates into reduced pain for patients undergoing the procedure.

Although the T-Line Mesh made its clinical debut just three years ago, it is already being used by about 45 clinical sites in the United States and over 8,000 of the novel extensions and lockstitches of the mesh have been implanted to date with no adverse events. The company has also amassed a great deal of clinical data, which are reported in 15 published manuscripts and 27 conference presentations. 

Providing a better surgical experience is another important advantage for the T-Line Mesh. “It is great to have better outcomes and less pain, but you still must have a surgeon who wants to put it in,” said Bill Perry, CEO of Deep Blue. “When surgeons put in our mesh, it lies flat, has great tension and offloads stress at the surgical or fixation site. This makes for a faster, easier and less stressful surgical experience.”

New products ahead

In April 2024, the company plans to launch a new smaller version of the T-Line Mesh, called the T-Line Mini, which is ideal for umbilical hernias and small defects. Biosynthetic and coated composite versions of the T-Line Hernia Mesh are also being developed. 

“Soft tissue surgery needs a Swiss Army Knife, and there's not any one product that's perfect for all categories of patients,” said Perry. “For hernia surgeries there is a growing trend to use biosynthetic meshes, which are made of polymers that will get absorbed into the body over time. We are also working on a coated composite T-Line Hernia Mesh that is designed to stop adhesions, which can be a problem if the mesh is placed inside the abdomen.”

After the launch of the T-Line Hernia Mesh, the Deep Blue team spent a great deal of time visiting surgeons at clinical sites and getting input from key opinion leaders so that they could fully optimize the product. This input proved to be critical for taking the company in new directions. 

“During these conversations it became clear that the same types of failures that can occur in hernia repair also occur in soft tissue just about everywhere in the body,” said Perry. “One example of where this is particularly true for breast reconstruction performed after cancer or for cosmetic reasons, and we are developing the T-Line Scaffold for Breast Surgery to meet this need. So now, the T-Line has moved from being one product that proves the principles of solving this soft tissue failure mode to being a soft tissue surgery platform with several applications.”

Investment and validation

The North Carolina Biotechnology Center has been supporting Deep Blue and its technology since 2016, when Levinson received a $75,000 Technology Enhancement Grant that helped him develop the hernia mesh technology. This was followed in 2017 with a $250,000 loan and a $200,000 loan in 2019 that helped the company gain FDA marketing clearance for T-Line.

“The support from NCBiotech came in at a critical time, providing crucial capital for our early efforts,” said Perry. “Securing these loans and grants through a competitive process not only bolstered our financial foundation but also served as a powerful validation of our technology. Additionally, NCBiotech helped us network and connect with potential investors and partners, further amplifying growth opportunities.”

Greta Brunet, NCBiotech's senior director, investments for Emerging Company Development, said that when it comes to developing a solution to a challenging healthcare problem, having an in-depth understanding of the problem, how the patient is impacted, and the clinical environment is incredibly important if the solution, in the end, will truly improve patient care and outcomes. Levinson’s clinical experience was truly the cornerstone to the development of Deep Blue’s mesh solution, she said. 

“I’ve had the pleasure of working with Bill and Howie since 2017 when the initial T-Line Mesh product was at the prototype stage,” Brunet said. “To see them reach the milestone of FDA 510k clearance and their continued success in developing the company’s product portfolio has been a delight. The role that end-user feedback from other clinicians has had in this has been impactful.” 

The company has also received about $4.6 million in non-dilutive grants, mostly from the NIH. It is also supported by several angel investor groups in North Carolina and California.

Perry says that for the next few years Deep Blue is focused on generating more clinical data, launching and growing the sales of new products and forming new strategic partnerships. It also intends to broaden its market beyond the U.S. by introducing the product in Europe.