List of Devices Companies in New Jersey - 22

Avalon GloboCare Corp. is an intelligent biotech developer and healthcare service provider. The Company engages in the management of stem cell banks and specialty clinical laboratories. It is developing of exosome technology to improve the diagnosis and management of diseases. The Company operates through two platforms, Avalon Cell and Avalon Rehab. Its technology and service ecosystem covers the areas of regenerative medicine, cell-based immunotherapy, exosome technology, as well as rehabilitation medicine. The Company also focused on diagnostic advancements in the fields of oncology, infectious diseases and fibrotic diseases, and the discovery of disease-specific exosomes to provide the disease origin insight necessary to enable.

Avertix is committed to advancing life-sustaining patient care and the long-term management of Advanced Cardiovascular Disease through innovation, clinical science, and collaboration. With FDA-approved labeling indicating the Guardian System is safe and effective, we’re dedicated to providing physicians, health systems, and allied health professionals with the Avertix Guardian to help advance the standard of patient care. Avertix’s Guardian™ is the first implantable, patient alerting system designed to warn patients to seek medical attention for Acute Coronary Syndrome (ACS), including silent heart attacks. Delays in treatment contribute to the high level of mortality and morbidity from heart attacks. Symptoms (such as chest pain) are a poor predictor of ACS events with less than 20% of patients presenting to the emergency room actually having a true positive ACS event and more than one-third of heart attacks having atypical or no symptoms.

An innovation driven start up company catering to the unmet needs of the biomaterial community and medical device industry. With our state of the art research and development facilities in theUS and India, combined with our platform technologies derived from a family of novel and proprietary biodegradable polymeric biomaterials, we work with and for our customers to translate their demands into high quality products for a wide range of medical device and therapeutic applications in a cost effective manner. Our expertise lies in the area of absorbable polyurethanes, absorbable polymers derived from functionalized natural products, drug molecules and amino acids, adhesion prevention barriers, absorbable drug eluting stent coatings, tissue adhesive and sealant, medical device coatings, drug delivery, drug device combination, absorbable implantable devices and tissue engineering.

At Castor, we believe in the power of clinical research and the power of technology. And we know that together, these forces can help extend human healthspan. To achieve this reality, we must make patient-centered clinical trials a possibility for everyone, anywhere in the world. That's why we are using technology to capture the world's research data and optimize each activity of a clinical trial. From recruitment to monitoring, our modular clinical trial platform makes it easier to design and deploy trials, enroll and engage patients, collect data and analyze results. Each module can be used individually or in unison with others, providing the ability to customize each solution to fit your needs, and grow at your own pace. That's delightful for patients, effortless for study teams, risk-free for sponsors.

Chemo Mouthpiece, LLC is an oncology supportive care company. We are proud to introduce our new device, the Chemo Mouthpiece™. The Chemo Mouthpiece™, is a new 510(k) cleared device for marketing in the US. This device is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis, a painful and debilitating side effect. Historically, oral cryotherapy was used for short half-life drugs only, the Chemo Mouthpiece™ shifts that paradigm by studying its efficacy in multiple long half-life drugs, giving you and your patients a better choice!! The Chemo Mouthpiece™ device was developed based on the personal experience of inventor, founder and CEO David Yoskowitz, who when diagnosed with Hodgkin’s Lymphoma experienced oral mucositis firsthand. His treatment options included ice chips to mitigate and minimize the pain. Yet this caused nausea, was difficult to maintain in his mouth, and did not effectively cool the entire oral cavity which led him to search for a better option. An engineer by trade, he made it his mission to find a better way for cancer patients to cope with oral mucositis during treatment. He created a simple, effective, easy-to-use device to be used during chemotherapy treatments at home or in a hospital. The Chemo Mouthpiece™ efficiently cools the entire oral cavity. Patients can freeze the device at home and take it with them to be used during treatment, creating a simple solution for an unmet patient need.

Collagen Matrix is a biotechnology company that specializes in developing medical devices and products for regenerative medicine using collagen as a key component.

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, currently in a Phase 3 clinical trial enrolling patients undergoing chronic hemodialysis. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for five additional years of QIDP market exclusivity in the event of U.S. approval. It is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes and topical hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.

Validation Consulting

CytoSorbents Corporation (NASDAQ: CTSO) is a New Jersey-based company involved in the R&D and commercialization of medical devices using its proprietary polymer adsorption technology. CytoSorbents is a leader in the treatment of life-threatening conditions in the ICU and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is distributed in more than 70 countries and has CE Mark approval in the EU for cytokine, bilirubin and myoglobin removal in numerous critical care applications and the removal of ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorbents has multiple active, clinical trials ongoing, including two pivotal randomized, controlled trials in the United States designed to support eventual FDA marketing approval for antithrombotic removal during cardiothoracic surgery using the DrugSorb™-ATR Antithrombotic Removal System.

Dandelion Science is a US-Swiss Generative Neuromodulation™ company, committed to advancing precision therapies for vision and brain disorders. Led by a world-class team, Dandelion's mission is to enhance the lives of people affected by these conditions through the integration of advanced generative technologies and deep scientific expertise. The company boasts extensive intellectual property and has received prestigious funding from the US National Institutes of Health and the Swiss Innovation Agency.

In 2005, we were founded on a unified belief that neuromodulation could be used in novel ways to help patients break free from treatments they aren’t happy with. Because different modalities of neuromodulation had previously proven to be effective and safe, we recognized an opportunity to be the leader in this new frontier of medicine and took it head on. Our mission is simple—help patients across the globe who suffer from pain and chronic conditions. We are doing this by harnessing the power of nVNS, innovation, and technology to develop safe and clinically backed treatments. Bringing new treatments to market will help improve patients'​ treatment options and lives.

At embecta (formerly part of BD), we are singularly focused on improving the lives of people living with diabetes. With a 100-year legacy of developing and providing solutions to the diabetes community, today, we are a global medical technology company and leader in insulin delivery devices. More than 30 million people in over 100 countries rely on our pen needle and syringe products every day.  BD is the manufacturer of the advertised products.   Privacy Policy: https://www.embecta.com/en-us/about/policies/privacy-policy-statement 

Endomedix is a development stage, Medical Device venture, a C corp. The Company has developed a tunable polysaccharide platform that can produce a family of new biomaterials. The first spinoff of this platform is PlexiClot™ Absorbable Hemostat to control bleeding in brain & spinal surgeries, a $1.9B market. PlexiClot introduces the first fundamental innovation in bleeding control in these procedures since the current standard of care was introduced in 1945. The innovation is based on new mechanisms of action that will likely obsolete the current methods of relying on the biochemical action of thrombin and manual pressure to produce coagulation. PlexiClot will eliminate one cause of reoperations caused by current devices as documented in dozens of clinical publications. In addition to reducing the incidence of complications, PlexiClot is poised to save hospitals hundreds of millions of dollars in unreimbursed costs due to reoperation, lengthy hospital stays and early readmission to hospitals. PlexiClot's performance has been confirmed in 3 large animal trials, and Endomedix is currently planning to scale up production. PlexiClot's composition of matter, method of manufacture and mechanisms of action are protected by 8 issued patents, the most important of which expire in 2038. The Endomedix team is led by Richard Russo, a medical device vet with experience in prior start-ups with exits, and he is the lead cash investor. He has a history of success with new products, clinical & regulatory, and international. R&D is led by Piyush Modak, who leverages a small internal team through a constellation of renown subject matter experts. 18 neurosurgeons & physicians are investors. PlexiClot will be the 1st device approved by FDA specifically for brain surgery. This sector is marked by a high level of M&A activity, much of which occurs prior to final FDA approval. The program has drawn interest & support from surgeons and physicians, 18 of whom are investors.

At Glucotrack, we are pioneers in diabetes technology, dedicated to transforming the way diabetes is managed. Our mission is to develop innovative, long-term solutions that prioritize accuracy and ease of use. With a commitment to reducing the daily burden of diabetes management, we create cutting-edge technologies designed to enhance the lives of those we serve. Join us in our journey towards a future where managing diabetes is simpler, more effective, and empowering.

Jeiven Pharmaceutical Consulting, Inc. (JPC) brings over twenty years of experience to our goal of providing pharmaceutical, biotechnology, medical device and dietary supplement companies with an unparalleled level of service and dedication to ensure the success of their projects. Our clients, which range from the small start-up to the large pharmaceutcial firms, come back to us because they know we will provide them with the highest level of service in combination with the expertise of our skilled consultants. The hallmark of our success has been our outstanding customer satisfaction and client retention. We take pride in providing, above all else, Reliable Guidance to clients of all sizes. Our areas of expertise include: 1) Clinical Trial Materials Project Management 2) Quality Assurance and Compliance 3) Auditing (contractors, suppliers, due diligence audits, mock-PAI audits, general GMP, GLP, GCP audits) 4) Training (GMP, GLP, GCP, DEA) 5) Regulatory Submissions (IND, IDE, CMC, 510(k), PMA, NDA, ANDA, eCTD) 6) Authoring SOPs and Quality Manuals 7)Formulation Development 8) Scale-up, Optimization and Method Transfer 9) Equipment Qualification 10) Analytical Method Development 11) Combination Drug / Device Products 12) Due Diligence Services for Venture Capital Firms 13) Process / Facilities Validation 14) Staffing 15) Comparator Drug Sourcing 16) Organizing the Clinical Supplies Support Group (CSSG) 17) Medical Device and In-vitro Diagnostics

Koios DS™ is a Smart Ultrasound™ solution for radiologists diagnosing cancer. Using AI algorithms trained on tens of thousands of images combined with data from pathology results, Koios DS™ is clinical decision support for a new era of diagnostic excellence. Smart Ultrasound™ redefines what radiology professionals can discern in the radiology suite. Our proprietary technology and patented methods provide an invaluable “second opinion” that is already being adopted by leading healthcare institutions to improve diagnostic accuracy, speed clinical decision making, and elevate the quality of care. Our software is FDA cleared for use in the USA. Koios DS. We put the AI in ultrasound.

MakroCare is expert Regulatory Consulting and Clinical Services partner for pharmaceutical, biotechnology and medical device industries. Our global/regional teams and fit-for-purpose costing models to your development strategy, regulatory management, clinical research, medical/scientific support and quality assurance areas. MakroCare has operations and presence in US, UK, EU, and Asia.

Electrodiagnostics

NeuroDx is a medical technology company that specializes in using non-invasive thermal dilution to detect fluid flow in CSF shunts.

Orthobond is an antimicrobial technology company that has developed proprietary antimicrobial nanosurfaces, with broad applications in the medical device industry and more such as commercial, industrial, automotive, and beyond. We’re the first company to utilize nanoscale surface modifications that can be permanently bound to any surface, killing bacteria, viruses, and fungi by mechanically rupturing pathogens without using antibiotics.

We are an independent, full-service, family-owned CRO specializing in dermatology since 1944. We manage global phase 2/3 trials in conjunction with our standalone phase I unit. Our structure and experience allow us to approach each and every study with agility and innovation, providing our sponsors with a truly bespoke turnkey solution. We are not your traditional CRO.

WCG is a true partner to research sponsors, CROs, sites and participants in navigating the clinical research journey. The pioneer of independent ethical review, now the industry gold standard, WCG's 55-year legacy of independent review solutions serves as the foundation on which we continually build to accelerate and improve the clinical research journey. We lead the way by reimagining processes, optimizing quality and safety, strengthening productivity, and pioneering new solutions that leverage data and technology to accelerate research and impact global health. WCG liberates study stakeholders from the constraints that risk trial efficacy while improving quality outcomes and efficiency through the process. Ninety percent of all clinical trials leverage our knowledge, highly specialized solutions, and data-driven insights to mitigate risk today for a more promising tomorrow.