PRESS RELEASES
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