image description

Incubator Facility. Clients

Our Clients:

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

Balance Innovation & Design

Learn more about Balance Innovation & Design

Balance Innovation & Design is a strategic human-centered design consultancy creating Physical, Digital, and Service Products that delight end-users and drive business growth.
We use a proven and highly collaborative process to systematically identify unmet end-user and customer needs resulting in multiple focused innovation platforms that can be quickly transformed into revenue-generating products and services.

Balance has been Empowering Innovation with our clients and partners for more than 14 years. Experience our full suite of capabilities, and find out how Balance can build your custom plan for success.

http://www.balanceinc.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/

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/

Family Care Path Inc.

Learn more about Family Care Path Inc.

Family Care Path develops, adapts and markets web-based clinical software applications designed to improve patient outcomes, increase physician and clinical process efficiency, and interface with a variety of electronic health records. Our current products and services include MyLegacy, a family health history tool; CarePathConnect, telegenetic counseling; and CancerNav, a patient navigation tool.

Many exciting concepts for healthcare applications remain isolated within the development environment. Our company’s mission is to identify these opportunities and develop software solutions utilizing industry standard protocols, so widespread adoption is possible.

We utilize the latest technology to develop secure and scalable applications to improve the quality of healthcare, and reduce cost. Leveraging industry standard technologies such as Microsoft Cloud and both the SMART® and HL7® FHIR® open standards, Family Care Path creates applications which can seamlessly communicate with all electronic health record systems.

http://www.familycarepath.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

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

NAMSA

Learn more about NAMSA
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.
http://www.namsa.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/

OptoQuest

Learn more about OptoQuest

OptoQuest is the leader in patient-specific modeling for refractive surgery. We provide researchers and physicians with a simulation-based refractive surgery guidance platform to create structurally validated, personalized predictions of corneal and refractive surgery outcomes. Our complementary core technologies include a novel OCT-based elastography device, Vectralis, and a patient-specific finite element modeling product, SpecifEye, for combining imaging data and biomechanical measurements in robust, personalized predictions of surgical outcomes and disease risk.

http://optoquest.net

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

RelateCare

Learn more about RelateCare

RelateCare connects patients, providers and caregivers to ensure that patients receive the right care, at the right time, in the right place. We offer a range of Consultancy Solutions to help health systems improve patient access, enhance patient experience and maximize efficiency.

http://relatecare.com/

Renovo Neural, Inc.

Learn more about Renovo Neural, Inc.

Renovo Neural is a drug discovery company involved in development of proprietary small molecule pharmaceutical candidates that can provide complementary therapeutics for neuro-immunomodulation market. In addition, Renovo is creating a niche of specialty services that can revolutionize development of therapies for neural diseases, specifically multiple sclerosis.

http://www.renovoneural.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/

Securus Medical Group

Learn more about Securus Medical Group

Securus Medical Group is developing clinical tools to monitor core body temperature within body cavities. Thermal injury to the tissue due to energy from various sources can create damage to surrounding tissue. Securus will provide clinicians a simple to use, real-time, noncontact, thermal map of body cavity tissue temperature. This information will guide the physician to achieve the desired clinical outcome without risk of injury to surrounding tissue. For more information, please contact Steve Girouard at sgirouard@securusmg.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

Viscus Biologics

Learn more about Viscus Biologics

Viscus Biologics is a life science company providing biologic extracellular matrix components and devices to partners under an original design manufacturing business model. Novel wound care, orthopedic, cardiovascular, and general surgery products are in the pipeline based upon allograft or xenograft tissue. The company has a development office in Cleveland, Ohio and a manufacturing facility in Dayton, Ohio. Our business model combines internal development of innovative allograft and xenograft devices and custom development of products for partners based upon our design services model. Additionally, our close relationship with our sister company Proxy Biomedical offers partners an integrated approach to the development of products that combine biologics with synthetic materials.

http://www.viscusbiologics.com/

Yokowo Co., Ltd.

Learn more about Yokowo Co., Ltd.

Yokowo Co., Ltd. , is a global company engaged in the development and manufacture of medical components and assemblies, whose products are used in a broad range of medical specialties. Precious metal components are utilized to manufacture custom components such as radiopaque marker bands, guidewire coils, guidewire shafts, and electrodes. In addition, prototyping to mass production of finished medical devices, such as guidewires and speciality catheters are assembled in cleanrooms. Capabilities include assembly of finished products, metal tube drawing, cutting, wire coiling, straightening, centerless grinding, micromachining, and laser welding. Yokowo Co., Ltd. is an ISO 13485 certified and FDA registered company. For more information, please contact Eve Nakaoka (e_nakaoka@yokowo.com).

http://www.yokowo.com/

Global Cardiovascular Innovation Center