List of Medical Device Companies in North Carolina - 16

410 Medical is a medical device company dedicated to developing innovative products that enable clinicians to improve care for critically ill patients. LifeFlow® PLUS, 410's recently approved product, is designed to enhance the speed and efficiency of volume resuscitation, improving care for patients with life-threatening conditions such as sepsis, hemorrhage and cardiac arrest.

Baebies Inc. is a growth-stage medical device company developing innovative products to enable early disease detection and multifunctional diagnostics for syndromic testing for children and adults. Guided by the vision that everyone deserves to be healthy, we aim to deliver ‘Any test. Anywhere. To Everyone.’ We deliver millions of tests globally every year to save lives and make lives better. Baebies is a pioneer in digital microfluidics technology, which maximizes diagnostic yield from low-volume samples. Baebies is headquartered in Durham, North Carolina, and our products are used in central laboratories and point-of-care settings around the world. Over 20 million tests delivered, and counting. Every test is a chance to save a life. Our current pipeline of test panels on the multifunctional FINDER platform include molecular (Respiratory panel - Flu A, Flu B, RSV, and SARS-CoV-2, STI panel - CT/NG/TV), coagulation (anti-factor Xa, aPTT), and chemistry (G6PD).

Bryn Pharma is a privately held pharmaceutical company based in North Carolina. Primary focus is on the development and commercialization of innovative allergy products for the management of anaphylaxis. The mission of Bryn Pharma is to empower patients with a life-saving device that is small enough to comfortably fit in your pocket and easy to use in the event of an anaphylactic attack. Our intranasal delivery system will be an exciting alternative to epinephrine auto-injectors providing patients a needle-free option that is easy to use, portable, and affordable.

Lifechanging breakthroughs like cell and gene therapy are driving a medical revolution. But a lack of purpose-built development and manufacturing tools keeps these treatments from reaching more patients. At Charter Medical, we're on a mission to evolve single-use cell processing step-by-step with the needs of the biopharmaceutical innovators who count on us. With proven customization capabilities and an innovation roadmap that includes pioneering design and biomaterials. With industry-leading expertise and continuous improvement to simplify and standardize biomanufacturing systems so they can scale reliably. And with a deep commitment to responsiveness, collaboration and urgency. Because we know single-use advances are essential to helping our clients make revolutionary therapies more accessible to patients who need them – now.

CivaTech Oncology® designs innovative products that bring meaningful improvements to low dose rate brachytherapy. The CivaString® and CivaSheet™ can substantially reduce procedure time, provide homogeneous dose distribution and minimize trauma. Customizable CivaTech products ensure that radiation oncologists can deliver individualized, targeted therapy to treat cancer. http://www.civatechoncology.com/

Duke University spin-out, Deep Blue Medical Advances has developed a novel hernia mesh to address the unacceptably high rate of hernia occurrence and recurrence. Millions of hernia surgeries are done globally with billions of dollars in clinical cost. Our 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. In addition, several additional products are in development, including an anchor clip for even faster, easier implantation; a biosynthetic version of the T-Line Hernia Mesh; and a coated composite version of the T-Line Mesh. Deep Blue products enhance hernia surgery with a potentially significant impact on the $1.1B 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.

Dignify Therapeutics is a drug development company focused on delivering novel drug therapies for bladder and bowel disorders in spinal cord injured individuals.

Entegrion identifies, invents and systematically develops device and biological technologies to meet clearly defined medical needs. Our pipeline is distinguished by its uniqueness--- we pursue areas with limited competition and profound needs. We design efficient and focused development plans to assure that the products we deliver perform as intended and are ready for market. Twitter @entegrioninfo

Gilero offers end-to-end device design, development and contract manufacturing in the medical and pharmaceutical industries. Specializing in the areas of consumable and reusable medical devices, drug delivery, combination products and complex electromechanical systems, Gilero offers a wide range of services to meet your medical or drug delivery device needs.

Surgical software

InSoma Bio is a company that borrows nature's own designs to develop unique products for reconstructive plastic surgery. Their product enables surgeons to use a person's own tissues to enhance the stability of autologous fat grafts and solve problems in tissue engineering and regenerative medicine.

Levee Medical, Inc. designs, develops, and manufactures innovative urological devices with the focus of improving recovery outcomes post-prostatectomy so that patients can quickly and confidently return to normal activity. The company's inaugural product is designed to support and stabilize the post-operative bladder neck and urethra following prostatectomy to accelerate the return of continence and reduce the overall risk of chronic incontinence.

Novex Innovations is a true CDMO (Contract Development/Manufacturing Organization) supporting our clients efforts in the commercialization of their products. Our areas of operation include: Biological Formulations Clinical Formulation Tissue Processing Bioengineered Tissue Active Pharmaceuticals Diagnostic Materials Medical Devices Development to Pre-Clinical to Commercial Regulatory Support Storage & Distribution & Order processing services. Scale-up optimization Product characterization Manufacturing through all phases of clinical trials Commercial modeling, manufacturing, and distribution Proof of concept Our clients range from single person operations to multinational companies. We provide process development, manufacturing, storage, and product distribution, all under cGMP procedures and policies. We operate cleanroom space at Class 1,000 and smaller scale spaces at Class 100, all for clinical and commercial manufacturing. Our Quality System is regularly monitored to the current ISO 13485 standards by BSI. Novex is also registered with the FDA. Our customers are both national and international and have a good understanding of other regulatory agencies as well. Customers have the option of storing their products at and having Novex ship on their behalf.

We're a small but rapidly growing neurotechnology company based in Durham, North Carolina. Our vision is to enable and support outstanding basic and translational neuroscience research through innovative and affordable products. We launched XCSITE 100, our tDCS/tACS research solution, in 2016. Today, XCSITE 100 is used in leading brain stimulation labs across the United States. We are actively developing new technology and working with our stakeholders to provide new research solutions to enable cutting edge neuroscience.

restor3d enables surgeons to improve the reconstruction and repair of the human body through 3D printed implants with enhanced anatomical fit and superior integrative properties. Leveraging expertise and experience in 3D printing of key biomedical materials spanning a wide range of properties, restor3d seeks to improve medical device solutions.

Sequence Inc. provides turn-key consulting solutions and services for the biopharmaceutical manufacturing industry with a focus on Commissioning, Qualification and Validation (CQV) and Digital Solutions for facilities, utilities, equipment, computerized systems and labs. Through a fully functional, mock pharmaceutical manufacturing training facility, consultants are trained in a hands-on environment that is unique in the industry that includes both equipment and software. Founded in 2002, Sequence provides consulting solutions to clients across the U.S. and parts of Europe. The company is headquartered in the heart of RTP in Morrisville, NC with a second hub in Framingham, MA.