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Incubator Facility. Clients

Our Clients:

Advanced NanoTherapies Inc.

Learn more about Advanced NanoTherapies Inc.

Advanced NanoTherapies Inc. (AdvNanoT) aims to take Drug Coated Balloons (DCBs) to the next level with a safe therapeutic option for PAD patients using a drug called Sirolimus.
AdvNanoT is developing a novel Sirolimus-based medical device to treat atherosclerosis and blockage for Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD). We have designed, first, a DCB platform for PAD management delivering a therapeutic payload with an angioplasty balloon. AdvNanoT’s novel DCB applies to any stenosed artery with the need to remain open for an extended period. Due to the technically challenging requirements, our functionalized nanoparticle (f-NP) is the most comprehensive technology platform to achieve this goal.
AdvNanoT uses biodegradable functionalized nanoparticles (f-NP), a technology licensed from the Cleveland Clinic.

https://advnanot.com/

Aeroscena

Learn more about Aeroscena

Aeroscena is the world’s leading resource for essential oil-based clinical inhalation therapy.  We focus our expertise on developing evidence-based formulas and cutting-edge diffusion systems that create opportunities for better health safely, affordably and effectively.  Our 100% natural, allergen-free therapies provide consumers, healthcare professionals and business organizations solutions that support both physical and emotional well-being.

http://www.aeroscena.com

Centerline Biomedical, Inc.

Learn more about Centerline Biomedical, Inc.

Centerline Biomedical Inc. develops and commercializes a radiation-minimizing system for endovascular procedures based on the research from Cleveland Clinic’s Heart & Vascular Institute and Lerner Research Institute. Centerline’s advanced surgical navigation system significantly reduces radiation exposure to patients and caregivers, and provides the surgeon with a “GPS-like” tool, making these procedures more efficient and accurate. The platform technology aims to revolutionize endovascular repair in addition to a variety of vascular applications.

http://www.centerlinebiomedical.com

Cleveland Cord Blood Center

Learn more about Cleveland Cord Blood Center

The Abraham J. & Phyllis Katz Cord Blood Foundation, dba Cleveland Cord Blood Center (CCBC), is a non-profit organization that collects, stores, and distributes stem cell-rich umbilical cord blood units for the treatment of hematologic disorders and regenerative medicine, and for medical research. Cord blood is collected in-utero from umbilical cords after delivery of full-term, healthy infants. Our research team, housed at GCIC, conducts bench research translational studies focused on cord blood hematopoietic stem cell transplantation and regenerative medicine including cardiovascular disease. Established in 2007, CCBC is accredited by the Foundation for Accreditation of Cellular Therapy (FACT), and is designated as a Health Resources and Services Administration (HRSA) funded center, and is a member bank of the National Marrow Donor Program (NMDP). CCBC has collected over 33,000 units and banked over 5,900 units meeting strict clinical criteria. To date, more than 270 cord blood units have been distributed under NMDP IND to transplant centers in the United States and 15 other countries as treatment for patients with leukemia and other disorders. Over 5,300 cord blood units not meeting clinical criteria have been sent to investigators at the Cleveland Clinic, Case Western Reserve University, Memorial Sloan Kettering, Ohio State University, Northwestern University, University of Louisville, and others for research studies in blood and metabolic disorders.

http://www.clevelandcordblood.org/

Diasome

Learn more about Diasome

Diasome is developing hepatocyte directed vesicle (HDV) nanotechnology to lessen the instances of high and low blood sugar levels in people with diabetes to improve disease management and quality of life. HDV nanotechnology can be added to any available insulin to improve its safety and efficacy by restoring the liver’s natural role in blood glucose control.

https://www.diasome.com/

Enhale Medical

Learn more about Enhale Medical

Created by Frank Papay, MD, Chairman of Dermatology and Plastic Surgery, Cleveland Clinic, the technology is a next generation implant device for the treatment of obstructive sleep apnea (OSA). The neurostimulator electrode is implanted locally and activated externally. The device electrodes stimulate a portion of the hypoglossal nerve that contracts the anterior lingual musculature whose actions relieves the apnea event, which results in a more open oropharyngeal airway, which increases airflow and prevents obstruction during sleep. This next generation technology works proactively, unlike existing technology which reacts after the apnea event. The primary goal of this device is to increase oropharyngeal airflow, thereby preventing obstructive sleep apnea.

https://www.enhalemedical.com/

Flow MedTech

Learn more about Flow MedTech

Flow MedTech is developing an implantable device that minimizes the risk of stroke for individuals suffering from an irregular heart rhythm, called atrial fibrillation. The technology aims to lower the need for blood thinners, which can reduce the bleeding risk in patients. Flow MedTech is currently in the testing phase of the device and in the process of pursuing FDA approval. Our competitive advantages include custom fit, being recapturable, and ease of implantation. The mission of Flow MedTech is to reduce the risk of stroke for those with atrial fibrillation by using a safe, implantable device, and improve patient quality of life.

http://flowmedtech.com/

genae Americas

Learn more about genae Americas

genae is an innovative services provider for the medical industries. The development and marketing of medical devices and therapies in today’s global marketplace is a highly regulated process with strict requirements from many competent authorities. genae is a catalyst between the health care authorities, investigators in clinical practice and the medical industry to set up and support development processes. We communicate with civil servants in ministries of health, regional and local healthcare authorities, healthcare associations, healthcare technology assessment bodies, health insurance funds and other relevant parties. genae’s ultimate objective is to support the medical industry in obtaining product approval and in achieving a marketable product and market acceptance, in a timely and cost-effective way, while meeting or exceeding all relevant quality standards.

http://www.genae.com/

Global Clinical Connections

Learn more about Global Clinical Connections

Global Clinical Connections is involved in total Supply Chain Management. Services range from API (active pharmaceutical ingredient) production through drug manufacturing, packaging, labeling of supplies, and worldwide distribution of Phase I-IV trial supplies to clinical sites. Global Clinical Connections coordinates all or part of the process, monitors progress, and provides updates toward milestones for contracted activities at the vendors. 

http://www.globalclinicalconnections.com

Matrix Medical Devices

Learn more about Matrix Medical Devices

Matrix Medical Devices provides Medical Device Product Development expertise to accelerate its Client’s product development cycle while streamlining post-market surveillance activities. Matrix Medical Devices offers both strategic and tactical support and currently serves as the in-house regulatory staff for numerous medical products companies. Since its formation in July 2013, Matrix Medical Devices has grown steadily to support both start-ups and large institutions, from across the globe, including such places as Ohio, California, Florida, Canada, and Israel. In 2014, Matrix Medical Devices acquired REU Associates, increasing its breadth and depth in FDA and International Regulatory Submissions, including PMA approvals, as well as FDA remediation.

http://www.matrixmedicaldevices.com/

MED Institute

Learn more about MED Institute

MED Institute supports consultants, manufacturers, and developers of medical products through the key phases between the start of an idea and making a product available to clinicians and patients. With more than 30 years of experience in nonclinical testing, data analysis, and global regulatory submission preparation, our team knows what it takes to guide a product through all the complex steps required for market approval. Please visit our website to learn how you can benefit from partnering with us.

http://www.medinstitute.com

MediView XR, Inc.

Learn more about MediView XR, Inc.

MediView XR, Inc., is an Ohio-based medical device startup that has exclusively licensed patented intellectual property and know-how from the Cleveland Clinic Foundation. MediView is refining and further developing that IP to create a revolutionary Extended Reality Surgical Navigation System with initial intended use in the biopsy and ablation of cancerous tumors. MediView has contracted with Lerner Research Biomedical Engineering at the Cleveland Clinic as a continuing development partner. Through distinct disruptive technology this team is poised to redefine percutaneous oncology procedures with Extended Reality Navigation.

https://mediviewxr.com

muRata

Learn more about muRata

Murata is a global leader in the design, manufacture and supply of advanced electronic materials, leading edge electronic components, and multi-functional, high-density modules. Murata innovations can be found in a wide range of applications from mobile phones to home appliances, and automotive applications to energy management systems and healthcare devices.

http://www.murata.com

NeuroTherapia

Learn more about NeuroTherapia

NeuroTherapia, Inc., a Cleveland Clinic spin-off company, was founded in 2015 by Drs. Mohamed Naguib and Joseph Foss, and the Cleveland Clinic. NeuroTherapia is developing new therapies for diseases with an underlying component of neuroinflammation. Initial research has led to the development of the lead compound, NTRX-07. NTRX-07 (previously known as MDA7) has been shown to decrease activation of microglial cells in the brain. Decreasing activation of these cells leads to decreased inflammation and decreased injury to surrounding nerve cells. Decreasing this inflammation can treat and even prevent the development of neuropathic pain in settings of nerve injury or chemotherapy. Recent work has shown that blocking this inflammation is also important in reversing the effects seen in Alzheimer’s disease. NeuroTherapia is currently performing preclinical safety studies and plans on studying NTRX-07 in humans in late 2016, early 2017.

http://neurotherapia.com/

NexStep Medical

Learn more about NexStep Medical

NexStep Medical is a company based in France that develops and manufactures in the United States. NexStep Medical has a robust Product Development Pipeline, namely a line extension on current All’InCath®. The All’InCath® 035M is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulas. The All’InCath® 035M is also intended to provide angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media.

http://www.nexstepmedical.com/

Photoswitch Biosciences

Learn more about Photoswitch Biosciences

Photoswitch Biosciences is creating next generation instrumentation for use in the early stages of drug discovery and basic cell biology research. The need for a fluorescent plate reader capable of high speed acquisition and light-activation was born from internal research on the therapeutic applications of designed-for-purpose, light-activated ion channels (‘photoswitches’). The therapeutic mission of the company has been separated out so that Photoswitch Biosciences is solely focused on bringing advanced instrumentation to the market for the research community.

Our mission is to provide best-in-class instrumentation to the industrial and academic research communities. Founded by scientists familiar with need for reliable instrumentation and advanced software, the user experience is at the core of our design.

https://www.photoswitchbio.com/

Quest Medical Imaging

Learn more about Quest Medical Imaging

Quest Medical Imaging and SPECTRUM 3.0 are the next generation of Fluorescence Guided Surgery. With advanced optical imaging, smart sensors and machine learning software the SPECTRUM 3.0 device provides real time information to assist surgeons in decision making.

https://www.quest-mi.com/

R&Q

Learn more about R&Q

Regulatory and Quality Solutions (R&Q) provides industry-leading regulatory and quality consulting and engineering services throughout the entire product lifecycle. R&Q exists to improve people’s lives; the patients, our clients and our team members. R&Q helps bring more safe and effective medical devices to market for both medical device companies and combination product companies. Leveraging our deep industry experience, our company provides solutions that help improve the world. Drawing on expertise across the entire medical device product lifecycle, R&Q is uniquely positioned to present a range of strategic and tactical options and execute on the solution that best suits our clients’ individual regulatory and quality needs. R&Q’s headquarters are in Pittsburgh, PA with additional offices in Cleveland, OH, Boston, MA, Minneapolis, MN and Philadelphia, PA. From these offices, we service both nationally and internationally. R&Q is 100% women owned and is a certified Women’s Business Enterprise by WBENC.

Services include areas of:

o Regulatory
o Quality Systems
o Design Assurance
o Product Quality
o Post-Market Surveillance
o Remediation

http://www.rqteam.com

SDG, Inc.

Learn more about SDG, Inc.

SDG, Inc. is a leading developer of cell targeting and oral formulation nanotechnology systems for active ingredients ranging from proteins and peptides to small molecules and consumer product actives. SDG’s most advanced clinical-stage technology is called Hepatocyte Directed Vesicle Insulin (HDV), a novel liver hepatocyte targeting system that is approved for Phase 3 testing by the US FDA and that is being developed by Diasome Pharmaceuticals, Inc. As a nanotechnology that can be added directly to commercial insulin therapies, HDV represents an entirely new class of pharmaceutical technology. This system also led to the development of the first oral insulin technology approved for Phase 3 testing by the FDA, and SDG’s oral protein delivery platform can be used with a wide variety of large molecules that are currently available only by injection. SDG’s platform for enhancing consumer product actives has been utilized by many leading US and international consumer product companies, including DEP Corporation, Redmond Products, and Matrix Essentials. For more information, please email Bob Geho at bob@sdgpharma.com.

http://sdgpharma.com/

Thermalin, Inc.

Learn more about Thermalin, Inc.

Thermalin’s portfolio of next-generation insulin analogs fills multiple gaps in a rapidly growing $25B market. Thermalin’s world-class team is leveraging breakthroughs with significant IP built on 25 years of research on insulin by Dr. Michael Weiss, Chairman of Biochemistry and Molecular Biology at Indiana University Medical School. Our new molecules, novel formulations, and devices address unmet clinical needs, enable new delivery technologies and reach rapidly developing markets. In July, 2017, Thermalin entered into a license and collaboration agreement with Sanofi for 2 of our 7 insulin programs. For more information, please contact Richard Berenson (rick@thermalin.com).

http://thermalin.com/

Trailhead Biosystems

Learn more about Trailhead Biosystems

Trailhead Biosystems has developed a platform of technologies and services that will make it a leader in the cell therapy field. We are a contract research organization that develops cell culture recipes, products and services for the cell therapy industry.

There are significant barriers in cell therapy including, but not limited to:
How can cells be expanded and differentiated using animal-origin-free and non-serum components?
How do these components effect the biology of the cells?
What are the manufacturing tolerances for these components to achieve the same product?
Are these recipes scalable?
Will these methods be sufficient for FDA approval for potency and clinical release?

All of these questions can create impediments to rapid growth, and increase complexity, time and expenses.

One of our goals is to develop cost-effective industry-standard assays that will be used to qualify cell therapies for clinical studies, and, downstream, to qualify every batch for commercial therapeutic use. We work for cell therapy companies and academic labs who are entering clinical studies to develop cell culture media and recipes using our proprietary software systems and expert knowledge. For those academic researchers who don’t have a commercial outlet, we will serve as a ‘development house’ to partner with and create subsidiary companies under our umbrella.

http://www.trailbio.com

XaTek Inc.

Learn more about XaTek Inc.

Launched in 2016, XaTek is an innovative diagnostic solutions company. The company’s platform technology is an in vitro diagnostic global assay for the assessment of any patient’s bleeding profile. This novel technology has the ability to serve the unmet clinical needs for numerous clinical scenarios. The company is initially focused on the factor Xa inhibitor anticoagulants and hemophilia markets. XaTek is currently in the clinical stage of development of its handheld point-of-care device.

https://www.clotchip.com/

Global Cardiovascular Innovation Center