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BIO Investor Forum Company Snapshot: InvivoSciences

September 16, 2014
What is your company’s lead product or technology?

InvivoSciences, Inc. (IVS) is a leading developer of proprietary human 3D cell/tissue culture models for highly-predictive, multi-parameter phenotypic assays both in pharmacology safety & discovery screening and in personalized and regenerative medicine.  IVS’s Functional 3D tissue models recapitulate the physiological properties of human cardiac, smooth and skeletal muscle and connective tissue.  Application of induced pluripotent technology allows to fabricate tissues in diseased states, e.g., hereditary cardiac diseases, cardiac fibrosis, cancer and orphan diseases.  Our unique combination of tissue engineering technology with assay automation and sample miniaturization offers a rapid and cost effective platform for unprecedented therapeutic discovery.

IVS is addressing a significant, well-recognized but underserved problem with a technology that can effectively fill the gap in the existing large market.

Cardiovascular diseases (CVDs) are the number one cause of death globally. The high failure rate of cardiovascular clinical trials (e.g., 11% of Phase II failure between 2008-11) indicates that there is an unmet need for more focused approaches, including personalized drug discovery for specific patient groups or even for rare genetic diseases, i.e., orphan drug market.

Cardiovascular safety liabilities remain the major cause of costly drug withdrawals (e.g. 52.3 % drug withdrawals were cardiac safety related between 1980-2011). Our engineered heart tissue based phenotypic analyzer enables scientists to address cardiac safety issues and identify their mechanisms for rapid optimization.

Tailored to represent diverse human populations and specific diseased states, our cardiac tissue model can offer an exceptional ability to predict potential cardiac safety issues and drug efficacy in clinical studies.

What sets your company apart from competitors?

IVS holds a patent portfolio of issued and pending patents in major markets of US, EU, Canada, China, and Japan with exclusive rights to its core platform technologies, materials and methods specifically covering the technologies to screen drug candidates based on physiological responses (e.g., cardiac contractility) measured with 3D engineered tissues fabricated from patient specific cells (primary culture or induced pluripotent derived cells). IVS also presents a low risk yet high value investment opportunity.

What has been your company’s most exciting recent milestone?

IVS seeks series A funds to enable and support our global commercial growth plans as well as to scale up and fully-automate manufacturing of human engineered heart tissues and their personalized derivatives.  Recently also funded additional NIH-supported project aims to complete proof-of-concept studies for developing disease models of inherited heart failure.

How has the NIH SBIR program helped you in working to achieveyour long-term goals?

National Institute of Health (NIH) SBIR program has supported IVS to achieve proof-of-concept studies of drug discovery applications of our innovative technologies in collaboration with major pharmaceutical companies. NIH’s leadership has recognized our invention and its future value at its early phase.  This enabled IVS’s scientific team to continue critical proof of concept studies to build a strong foundation for commercialization. Strong data led to the establishment of collaborative strategic partnerships.  The funds also created new jobs to support the future growth of the industry segment.  The National Federation of Independent Businesses estimates that about two-thirds of the new jobs in recent years have been created by small businesses, and that start-ups including technology base account for a large share of these new jobs.

Without NIH support and the entrepreneurial mechanism of its funding structure, IVS would be only “a dream concept “ in the minds of its three founders. It would not have been able to sustain the business structure essential for its growth and hire a technical team to support the creation of solid data that led to a rich globally competitive IP portfolio. Moreover, without this support IVS would not have been able to attract multiple dynamic collaborations with key industry and academic partners that helped IVS create a rich and diverse product/assay and service portfolio that is designed towards unmet needs of drug discovery, development and patient populations with debilitating diseases.  We appreciate NIH’s visionfor innovation-based growth economies and its ability to prepare entrepreneurs with commercial guidance under the CAP program. Thanks to the leading efforts of Dr. Lenka Fedorkova, PhD, program manager for NIH SBIR/STTR programs, IVS and hundreds of other biomedical companies can dare to take the path to commercialization of innovative technologies.

What do you hope to accomplish through your company presentation and participation at the BIO Investor Forum?

IVS seeks series A funds and connect with potential private funding partners to share the business opportunity. IVS also wants to promote its innovative technologies, product and service portfolio to potential customers and to establish strategic partnerships with pharmaceutical and biotech companies.

Tell us something about your company that investors might not know.

US food and drug administration (FDA) will most likely amend the current preclinical cardiac safety protocol.  InvivoSciences, Inc. is an active member of the cardiac safety technical committee organized by HESI to review new technologies such as applications of human induced pluripotent stem cells (iPSC) derived cardiomyocytes for improving preclinical cardiac safety assays. Other members of the committee include FDA and most of the global pharmaceutical companies.

Please see our presentation on October 7 at 10:15 AM in Marina Room.  www.invivosciences.com