image description

Incubator Facility. Clients

Our Clients:

Abeona Therapeutics

Learn more about Abeona Therapeutics

Abeona is developing novel gene therapies for children with rare genetic diseases. Our initial programs utilize technology exclusively licensed from Nationwide Children’s Hospital for the treatment of the deadly childhood genetic diseases Mucopolysaccharidosis (MPS) IIIA and IIIB. Also known as Sanfilippo Syndromes type A and type B, MPS III is a progressive neuromuscular disease with profound CNS involvement.1-3 MPS III is a devastating lysosomal storage disease (LSD), caused by a single gene defect consisting of autosomal recessive defects in a lysosomal enzyme essential for the stepwise breakdown of a class of biologically important glycosaminoglycan (GAG), heparan sulfates.4-6 This results in in dramatic loss of intellectual ability due to improper cell function within the central nervous system (CNS), which results in cognitive decline, motor dysfunction, and eventual death.

Our two lead products, ABX-A and ABX-B, are viral vector based gene transfer drugs that can deliver the functioning version of the Sanfilippo genes to the CNS with the aim of reversing the effects of the genetic errors that cause the disease. After a single dose in Sanfilippo animals, ABX-A and ABX-B induced cells in the CNS and peripheral organs to produce the missing enzymes and help repair damage caused to the cells.

Safety studies conducted in large animal models have demonstrated that delivery of ABX-A and ABX-B are well tolerated with minimal side effects. Importantly, efficacy studies in animals with Sanfilippo syndrome have demonstrated functional benefits that remain for months after treatment. A single dose of ABX-A or ABX-B significantly restored normal cell and organ function, corrected cognitive defects that remained months after drug administration, increased neuromuscular control and increased the lifespan of animals with SF over 100% one year after treatment compared to untreated control animals. These results are consistent with studies from several laboratories suggesting ABX-A and ABX-B treatment could potentially benefit patients with for Sanfilippo Syndrome Type A and B, respectively. Development of a cost-effective treatment that can be administered as a single injection with the potential to significantly improve the quality of life of patients with Sanfilippo may have a major impact on an incipient $400M market. Activities leading to IND applications for both therapies are fully funded by disease foundations and NIH grants.

The Company closed on initial funding of $750,000 in November 2013 and currently seeks up to $5M to develop both ABX-A and ABX-B through Phase I/II clinical trials for treatment of Sanfilippo Syndromes A and B. Both ABX-A and ABX-B have received Orphan Drug Designation from the USA FDA.

http://abeonatherapeutics.com

ADEO

Learn more about ADEO

ADEO is the online exchange dedicated to innovating healthcare by bringing world-class solutions to market. ADEO offers a convenient way to shop for the solutions you need in order to tackle a variety of clinical and business challenges. Products on ADEO are proven and have the benefit of being developed by the renowned organizations that make up Cleveland Clinic’s Global Healthcare Innovations Alliance. Behind each solution is a comprehensive team of specialists and industry leaders devoted to pioneering medical innovations that improve patient care.

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

Alive Technologies Group LLC

Learn more about Alive Technologies Group LLC

Alive Technologies Group LLC is a privately owned limited liability company residing in Cleveland, Ohio that operates as a holding company for developing technologies in the field of stem cells and regenerative medicine.

ASAHI INTECC

Learn more about ASAHI INTECC

ASAHI INTECC was established in 1976 as a company specializing in manufacturing and sales of ultrafine stainless wire rope used in industrial components. ASAHI INTECC expanded into medical device business in 1990’s. Currently, its net sales of medical devices accounts for over 90 percent of the total sales revenue, and ASAHI INTECC’s medical products are being distributed to over 100 countries and territories.

With sophisticated technology of stainless steel treatment, ASAHI INTECC builds an integrated in-house production system from raw material to finished products. In the medical device field, ASAHI INTECC’s core business develops, manufactures and sells original brand products of guidewires and catheters used in less invasive procedure of cardiovascular, peripheral vascular, abdominal vascular and neurovascular, etc., as well as OEM products and medical components. The original brand PTCA guidewires have top market share in Japan.

In industrial device field, ASAHI INTECC supplies ultrafine stainless wire rope in wide range of applications such as office automation equipment and automobiles, etc. ASAHI INTECC identifies its mission as continuing to provide the world market with its “Only One” technology and “Number One” product to spread less invasive procedure and to improve a patient’s quality of life.

http://www.asahi-intecc.com/

Autonomic Technologies, Inc. (ATI)

Learn more about Autonomic Technologies, Inc. (ATI)

Autonomic Technologies, Inc. (ATI) is a medical device company focused on the development and commercialization of innovative therapies for the treatment of severe headache. The company’s initial product, the ATI Neurostimulation System, is approved in Europe for the treatment of cluster headache.

The ATI Neurostimulation System was voted #2 among the Cleveland Clinic’s top 10 medical innovations for 2013, and Autonomic Technologies was named one of FierceMedicalDevices’ Fierce 15 most promising privately held medical device and diagnostics companies in the world.

ATI is located in the San Francisco Bay Area and is backed by blue chip investors Kleiner Perkins Caufield and Byers, InterWest Partners, Versant Ventures, Novartis Ventures, Aberdare Ventures, and the Cleveland Clinic.

http://www.ati-spg.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/

Creganna Medical

Learn more about Creganna Medical

Creganna Medical designs and manufactures finished medical products, sub-assemblies and components specialising in Minimally Invasive (MI) delivery and access devices. Serving the world’s leading MI device companies, we are market specialists in the contract design, development and manufacturing of catheter based delivery systems for Cardiovascular, Peripheral Vascular, Neurovascular, Structural Heart and Electrophysiology therapies. The company operates from 6 facilities in 4 continents including sites in California, Oregon, Minnesota, Costa Rica, Ireland & Singapore.

Our products and services span the full spectrum of capabilities to design, develop and deliver finished medical devices to market. We offer a comprehensive range of outsourced solutions to medical device companies – from clinical and regulatory support to innovative design and reliable manufacturing services. Components and sub-assemblies are manufactured across our extensive global network to include metal, wire, coil, braid and extruded device shafts, complex overmolding, medical balloon manufacturing and associated assembly services.

As a trusted partner with an unsurpassed industry reputation we serve a range of innovative medical device companies from the world’s largest OEMs to emerging technology ventures.

http://www.creganna.com

Farm Design, Inc.

Learn more about Farm Design, Inc.

Farm is a full-service, ISO 13485-certified and FDA-compliant product development company celebrating 40 years of experience providing complete development and regulatory services for medical, life sciences, and consumer health companies. Our services include User Research, Human Factors Engineering, User Interface Design, Industrial Design, Systems Engineering (Mechanical, Electrical, Software), Usability Testing, Pilot Production Support, and Regulatory Compliance.

http://www.farmpd.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

Inspherion

Learn more about Inspherion

We help clients better understand the whitespace associated with technology, opportunity, and competition by bringing a business context to the analysis versus the traditional patent or technology based context. Clients can then:

  •  Make better business and strategic decisions
  • Design better products
  • Improve product protection 
http://www.inspherion.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

R&Q is keenly focused on Customer Satisfaction and Team Member Satisfaction; these two things together have driven our skyrocketing success; rated one of the Fastest Growing Companies in Western PA for the last three years as well as making the Inc. 5000 in 2014.

R&Q is an integrated team of regulatory and quality experts that provide your company with the best practices it needs to succeed. From strategic advice and guidance, to full spectrum, hands-on regulatory and quality engineering support, R&Q has the right resources to ensure the success of your medical device business. Our experts are people-oriented, experienced, knowledgeable, and scalable to whatever challenges your medical device business faces during its entire life cycle.

R&Q has been built from the ground up to provide the solutions you need, when you need them, by incredible fun and giving people, and only where they provide optimum value.

R&Q team members act as part of your medical device corporate family because they care as much about your business as you do. Special care goes into R&Q recruiting practices to ensure we have givers and not takers who will do whatever it takes to ensure your success.

R&Q is keenly focused on the happiness of our team members. R&Q has consistently been rated a Best Place to Work in Western PA as well as nationally and is continually upgrading programs to ensure we stay this way. Happy team members ensures stability on your project.

We continually monitor customer satisfaction via the R&Q Net Promoter Score program. Our customers indicate that we continually exceed their expectations and that they would highly recommend us to their colleagues.

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.

Shield Biotech, Inc.

Learn more about Shield Biotech, Inc.

Shield Biotech is a company dedicated to developing immune prevention of adult onset cancers. Its preventive breast cancer vaccine is based on research from Cleveland Clinic’s Lerner Research Institute. Shield Biotech is conducting preclinical development to seek permission from the FDA to test the vaccine as an investigational new drug in proof-of-concept first-in-human trials.

Thermalin Diabetes, Inc.

Learn more about Thermalin Diabetes, Inc.

Thermalin’s portfolio of next-generation insulin analogs fills multiple gaps in a rapidly growing $17B 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 at Case Western Reserve Medical School (CWRU). Our new molecules, novel formulations, and devices address unmet clinical needs, enable new delivery technologies and reach rapidly developing markets. For more information, please contact Richard Berenson (rick@thermalin.com).

http://www.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