Organovo (ONVO) Commences ExVive Human Kidney Commercial Contracting Service

September 7, 2016 8:07 AM EDT

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Organovo Holdings, Inc. (Nasdaq: ONVO) announced that it has begun commercial contracting for its second tissue service, the ExVive Human Kidney. This kidney proximal tubule model is a natural expansion of the Company’s preclinical product and service portfolio, allowing customers to study the effects of drug exposure on a key portion of the human kidney relevant to drug discovery and development. Organovo has already signed multiple commercial orders and is collaborating on toxicology panels and transporter studies, including with two global, top 25 pharmaceutical companies, as part of an early access program.

The ExVive Human Kidney has demonstrated important functional aspects that offer significant value in preclinical testing, including:

  • Demonstrated proximal tubule function for more than four weeks, as measured by gamma-glutamyl transferase (GGT) production;
  • Tissue-like complexity that supports the detection of injury, compensation, and recovery
  • Physiological expression of key transporters as measured by gene and protein expression, which allows for the assessment of kidney toxicity and drug:drug interactions by modeling normal tissue function;
  • Modulatable activity of key renal transporters P-gp, SGLT2, and OCT2, demonstrating a high correlation to difficult to replicate human biology;
  • Demonstrated toxicity of model kidney toxicant cisplatin, and inhibition of toxicity when blocking OCT2 function, demonstrating specific inhibition of cisplatin transport through a known transporter; and
  • Barrier function (permeability) comparable to in-vivo values, as measured by trans-epithelial electrical resistance (TEER).

“The powerful data Organovo is releasing on the ExVive Kidney Tissue demonstrates significant potential value for our pharmaceutical customers,” said Keith Murphy, chairman and CEO of Organovo. “The compelling symphony of transporter function and the demonstration of a response to a known toxicant boost our excitement as we bring to market an advanced way to investigate preclinical kidney toxicity of new drug candidates.”

The Company and its customers released several posters and presentations during the scientific conferences at EUROTOX 2016 in Seville, Spain this week, and expects to continue to release information at the 12th Annual Applied Pharmaceutical Analysis Meeting during the week of September 12, 2016.

The Company believes that, as it penetrates the toxicology market, the ExVive Human Kidney tissue service has the potential to grow into the tens of millions in annual revenue and has $100M+ revenue potential in the future as it pursues diligent sales and marketing efforts (inside of a total addressable market of over $2B). This kidney revenue opportunity is expected to be accretive to previous market projections for liver tissue, which are of similar magnitude. The ExVive Human Kidney and Liver products are unique in the industry in the ability to replicate complex cell-cell interactions and key elements of native tissue architecture to enable the detection of multiple clinically-relevant modes of tissue injury and to provide the unique resolving power of a controlled human tissue microenvironment to investigate mechanism and develop solutions.

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