PRESS RELEASES & NEWS ARTICLES
Deep Blue Medical Receives Luis Villalobos Award from Angel Capital Association as Innovative Life Science Company of 2024
Durham, NC. May 21, 2024. Deep Blue Medical Advances announced today it has received the Luis Villalobos Award – Life Sciences from the Angel Capital Association (ACA), a professional association of more than 15,000 accredited angel investors and 250 angel groups, accredited platforms and family offices across North America.
This award recognizes the most ingenious and innovative ideas recently financed by members of the Angel Capital Association. Only two Luis Villalobos Awards are given each year – one in the Technology category and one in the Life Sciences category. The award honors Luis Villalobos, who founded the Tech Coast Angels, one of the largest and most respected angel organizations in the world. Award winners are startups recognized at the annual Summit Meeting each year for their strong track record of world-changing, best-in-class innovation and growth.
Award winner Deep Blue Medical is transforming soft tissue surgery by developing next generation surgical devices to prevent soft tissue surgery failure. In the USA each year, 11% of 5M abdominal surgical site closings go on to become hernias requiring repair. Further, ~600K+ abdominal hernia repairs suffer from a 32% long-term failure rate with a $10B annual cost. This failure in soft tissue surgery due to suture pull-through of tissue or mesh (“cheesewiring”) is unacceptably common, and is directly related to a lack of fast, reliable reinforcement that reduces tissue stress. It’s very painful for the patient and leads to recurrence and re-operation. Deep Blue Medical’s soft tissue surgery platform utilizes mesh extension sutures that distribute and reduce tension at the surgical site to reduce cheesewiring, reduce pain, and provide a quick, convenient surgical approach.
The Luis Villalobos Award was received by the Deep Blue Medical CEO, Bill Perry, at the 2024 ACA Summit in Columbus, OH, on May 13. Says Perry, “We are honored to have received this prestigious award, and grateful to our supporters. If we are reaching new heights, it is because we are lifted up by our clinicians and investor partners, the lifeblood of the company.”
Also in attendance at the Summit was surgeon-inventor Howie Levinson: “As a surgeon, I can help one patient at a time, but as an inventor I am deeply gratified to witness how an innovative platform can be developed and leveraged to help many more patients find relief and healing.”
Deep Blue expands innovative hernia technology to new surgical applications
Article shared from North Carolina Biotechnology Center
Nancy Lamontagne, NCBiotech Writer
3/13/2024
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.
Deep Blue Medical Advances Announces FDA Clearance for Sublay Application in Hernia Surgery, Enabling Broader Use of T-Line Hernia Mesh
Durham, NC. December 7, 2022. Deep Blue Medical Advances announced today it has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its T-Line® Hernia Mesh for the sublay technique in open hernia surgery. This significantly expands the patient population that can be treated with T-Line and experience the unique benefits of its novel design and application.
The sublay procedure is the most widely performed open surgery ventral hernia repair method for large incisional hernias. With this clearance, the T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sublay approach in adults.
Deep Blue’s T-Line mesh design includes novel mesh extensions that provide superior anchor strength designed to prevent mesh fixation failure. T-Line’s design offers the surgeon the ability to provide optimal mesh tension adjustment and many other potential surgical and clinical advantages compared to conventional mesh application.
“Many hernia surgeons prefer the sublay technique for hernia repair and have been eager to use T-Line for this, so we are thrilled to receive this clearance to enable broader clinical use,” said Dr. Howard Levinson, Deep Blue's founder and Chief Medical Officer.
“There are 4–5 million abdominal incisions (laparotomies) performed annually in the United States with hernias resulting after approximately 25% of these procedures1. Further, long-term ventral hernia repair failure rates are up to 32% using conventional mesh and 63% with suture repair only, creating a multibillion-dollar clinical cost to the US healthcare system2. Consequently, there are over 400,000 incisional hernia repairs performed each year in the United States making it one of the five most common procedures performed by general surgeons1,” said CEO Bill Perry. “This expanded clinical indication allows our growing number of clinical sites to address this important problem in significantly more patients with T-Line Hernia Mesh.”
1. Harris HW Innovations for Incisional Hernia Prevention, J. of Abdom. Wall Surg. (2022) 1:10945
2. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. (2004) Oct;240(4):578-83
About Deep Blue Medical Advances: Established in 2015, Deep Blue Medical Advances is dedicated to addressing the unacceptably high rate of hernia recurrence and providing surgeons a superior surgical experience. Deep Blue Medical is commercializing T-Line® Hernia Mesh and has a portfolio of additional hernia and surgical products in development.
Deep Blue Medical Advances Closes Successful Series A1 Funding Round
SAN FRANCISCO, June 28, 2022 /PRNewswire/ -- Deep Blue Medical Advances, developer of the T-Line® Hernia Mesh, today announced the close of its Series A1 funding round. This capital will enable Deep Blue Medical to scale up its commercialization and product development efforts to meet rapidly increasing market demand for its T-Line Hernia Mesh.
More than 1.5 million abdominal hernia repairs are performed each year globally, and hernia surgeries generate billions of dollars in clinical cost. Nevertheless, there remains an unacceptably high rate of hernia repair failure. The surgeon-invented T-Line Hernia Mesh with integral suture-like extensions is designed to eliminate a key point of failure for conventional mesh fixation - the mesh, suture, tissue interface - and to provide superior anchor strength.
"The T-Line Hernia Mesh is increasingly preferred by surgeons due to its unique design, 275% greater fixation strength compared to conventional mesh-suture attachment, and superior surgical experience, such as providing optimal mesh tension", said Bill Perry, CEO of Deep Blue Medical Advances, Inc. "This investment will allow Deep Blue Medical to expand our commercial sales team to bring this novel ventral hernia mesh to more surgeons. In addition, we will continue accelerated development of several additional products, including a biosynthetic version of the T-Line Hernia mesh; a coated anti-adhesion version of the T-Line Mesh for minimally invasive surgery; and an absorbable Anchor Clip for even faster, easier implantation."
Dr. Gary Gershony, Founding General Partner of BayMed Venture Partners, which led the Series A1 financing, will join the Deep Blue Board of Directors. "We look forward to working closely with the Deep Blue leadership team to help bring their innovative and clinically needed pipeline of surgical products to market as we draw on our past experience of effectively launching important new medical devices with high growth companies" said Dr. Gershony. "We believe Deep Blue has tremendous growth opportunities and is a great example of a compelling investment where BayMed will add significant value to support achievement of key milestones," added Neil Meyer, Co-Founding General Partner of BayMed.
About Deep Blue Medical Advances
Deep Blue Medical Advances is developing a portfolio of novel hernia surgery products to address the unacceptably high rate of hernia occurrence and recurrence. Our products enhance hernia surgery with a potentially significant impact on the multi-billion-dollar global hernia device market. Due to its simple yet revolutionary design, the T-Line Hernia Mesh has the potential to reduce hernia occurrence and recurrence by preventing or reducing mesh fixation failure.
About BayMed Venture Partners
BayMed Venture Partners is a San Francisco, California based venture capital firm focused on early-stage companies in the medical device and digital health sectors. Founded by Dr. Gary Gershony, a successful serial medical device entrepreneur and internationally recognized interventional cardiologist, and Neil Meyer, a highly experienced healthcare investment professional and former medical device industry finance executive, BayMed seeks to leverage its wealth of industry experience to support growth and success of portfolio companies through collaborative partnership.
Deep Blue Medical Advances Announces FDA Clearance and U.S. Clinical Launch of the T-Line Hernia Mesh
DURHAM, N.C., Aug. 11, 2020 /PRNewswire/ -- Deep Blue Medical Advances today announced it has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for its T-Line® Hernia Mesh with integrated suture-like extensions. T-Line Hernia Mesh provides superior anchoring strength and eliminates a key point of failure for conventional mesh fixation - the mesh, suture, tissue interface that often leads to mesh migration, contraction and eventual failure.
Hernia occurrence and recurrence is often a problem following abdominal surgery, when abdominal pressure (e.g. from lifting or coughing) can cause sutures to cut or pull through the tissue or mesh. Invented by surgeons, Deep Blue's large-pore, mid-weight T-Line Hernia Mesh is designed to increase anchoring strength and prevent mesh fixation failure. The mesh extensions have 15x more surface area than traditional sutures and act similar to how snowshoes prevent sinking into snow, reducing fixation stress by spreading force over a greater area. T-Line mesh extensions are designed to withstand significant abdominal pressures (in literature, up to 50 N/cm of stress), which is beneficial for all patients, including Grade II patients with comorbidities.
"Sewing a bit of each extension into the abdominal wall, in lieu of traditional sutures, significantly increases mesh anchoring strength and thus the durability of the repair," said Dr. Howard Levinson, Deep Blue's founder. "We believe this approach will greatly improve patient outcomes without necessitating significant changes to current surgical practice."
"In literature, long term hernia repair failure rates are 32% using conventional mesh and 63%¹ using suture alone, creating a multibillion-dollar clinical cost to the US healthcare system. Deep Blue's products enhance hernia surgery with a potentially significant impact," said CEO Bill Perry. "Furthermore, extensive lab and benchtop testing indicate that the T-Line Mesh has ~275% greater anchoring strength than standard of care in the perioperative period. This is always important, but particularly so in the period before significant tissue in-growth into the mesh has occurred."
The company expects to clinically launch the product in selected sites in Q3, 2020.
About Deep Blue Medical Advances: Established in 2015, Deep Blue Medical Advances is dedicated to addressing the unacceptably high rate of hernia occurrence and recurrence. It manufactures the T-Line® Hernia Mesh.
¹Burger, Luijendijk, Hop, Halm, Verdaasdonk, Jeekel. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004; 240(4): 578-583